louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02664974: Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer
Official title: Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malnutrition
Gastrointestinal Cancer
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.

The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).


Eligibility criteria: Inclusion Criteria:

* Both gender with age higher than 18 years.
* Documented cancer of the gastrointestinal tract: oesophagus, stomach, pancreas, biliary tract
* Candidate for major elective surgery.
* Preoperative nutritional risk score ≥ 3
* Written informed consent.

Exclusion Criteria:

* Age \< 18 years
* Karnofsky index \< 60
* Renal insufficiency (Ongoing haemodialysis or plasma creatinine \> 3 mg/dL)
* Respiratory insufficiency
* Child-Pugh class C
* Short Bowel Syndrome
* Pregnancy
* Emergency operation
* Foreign residence or residence in Italian region with no regulation designed for home artificial nutrition

Primary outcomes:
measure: Maintenance of body weight
timeFrame: 2 months
Secondary outcomes:
measure: Improvement of quality of life
timeFrame: 2 months
measure: Improvement of tolerance to chemotherapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Cecilia Gavazzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06735274: Transcranial Doppler (TCD) Ultrasound and Cognition in Cerebral Vascular Disease. (SUNRISE)
Official title: Transcranial Doppler (TCD) Ultrasound for Predicting and Understanding Cognitive Decline in Cerebral Vascular Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Vascular Accident (CVA)/Stroke
Keywords: Ischemic Stroke
Haemorrhagic Stroke
Cerebral Vascular Disease
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Hospital de Sao Joao, Porto
name: RISE Study Group
First posted: 2024-12-16
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes participants who suffered a stroke admitted in the stroke unit (Centro Hospitalar Universitário de São João, Porto, Portugal), being included in order of admission. Provide signed and dated informed consent; more than 18 years; Patients with intracerebral haemorrhages; Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source.

Brief summary: This study aims to contribute to the identification of factors that may be predictive of cognitive function and to provide data on cerebral hemodynamic in ischemic and haemorrhagic stroke. This study will prospectively study cerebral autoregulation, neurovascular coupling and microembolic signs in cerebrovascular patients with ischemic and haemorrhagic stroke and its relationship with cognitive function and functional recovery


Eligibility criteria: Inclusion Criteria:

* Minimum age limit: 18 years
* Patients with intracerebral haemorrhages; Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source;
* Previous mRS equal or more than 4;
* National Institutes of Health Stroke Scale (NIHSS)≤20 at admission;
* IQCODE final score\&amp;amp;lt;3.0

Exclusion Criteria:

* History of dementia or other central nervous system disease associated with cognitive impairment;
* Absence of adequate temporal bone window for Transcranial Doppler monitoring;
* Patients with a large cerebral infarct (greater than on third of the middle cerebral artery territory) or a strategic infarct (paramedian thalamus, medial frontal cortex, or hippocampus) evaluated in the 24 hours-CT;
* Average life expectancy less than 1 year for a different cause of cardiovascular disease;
* Patients with intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour and haemorrhagic transformation within an infarct;
* Serious kidney and systemic diseases;
* Active cancer patients;

Primary outcomes:
measure: Functional status
timeFrame: 3±1 months after onset; 12±1 months after onset
measure: Cognitive status
timeFrame: 12±1 months after onset
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar e Universitário de São João, EPE
Study officials:
affiliation: Universidade do Porto
name: Pedro Castro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770965: Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Official title: Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

  1. Coverage of the body surface area (BSA) of 10% or more with plaques
  2. A score of 3 or more on the IGA (Investigator Global Assessment) scale
  3. A PASI score of at least 12 at baseline;

     Exclusion Criteria:
* Have forms of psoriasis other than the required "plaque psoriasis"
* Women of childbearing potential
* Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
* Previous treatment with this investigational drug
* Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities

Other protocol-defined inclusion/exclusion criteria may have applied.

Primary outcomes:
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
timeFrame: baseline, week 4
Secondary outcomes:
measure: Change From Baseline in PASI
timeFrame: baseline, weeks 12, 14, 16, 20, 24, 28 and 32
measure: Investigator Global Assessment (IGA) Scores
timeFrame: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639665: Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus
Official title: Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Cocoa, diabetes, polyphenols
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: MasterFoods
First posted: 2008-03-20
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic (Type I and II)

Brief summary: Observing how cocoa effects the cardiovascular and renal system.

Detailed description: Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols. Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of the effects will be studied in healthy normal (including elderly), and also in subjects with Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance. Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by plethysmography. Urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.

Eligibility criteria: Inclusion Criteria: Diabetes (Type I and II), with or without Hypertension, blood pressure \<165/105

Exclusion Criteria: Under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication

Primary outcomes:
measure: Hemodynamic Measurements
timeFrame: Hourly measurements (5-6 hours total)
Secondary outcomes:
measure: Blood Pressure
timeFrame: Hourly (5-6 hours)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Norman K Hollenberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Ebrahim Barkouadh, M.D., M.P.H.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01607320: Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome
Official title: Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Keywords: PCOS
Infertility
Anovulation
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).

Detailed description: Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC

Eligibility criteria: Inclusion Criteria:

1. Women aged 18 to 36
2. BMI \> 19 \& \< 40
3. PCOS diagnosis as evidenced by:

Oligo- and/or anovulation (\< 6 cycles per year) and one of the following:

* Clinical and/or biochemical signs of hyperandrogenism
* Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)

Exclusion Criteria:

1. Use of ovulation induction agents within the past 6 months
2. Positive pregnancy test before taking study medications
3. History or current thromboembolic disorder
4. Coronary artery disease such as heart attack or stroke
5. Tobacco use or history within the past 6 months
6. History of pelvic inflammatory disease and tubal factor infertility
7. Congenital adrenal hyperplasia
8. Diabetes Mellitus

   * Any subject on Metformin must "wash out" for 30 days prior to screening
9. History of endometriosis
10. Known male factor infertility

Primary outcomes:
measure: Pregnancy
timeFrame: 4 months
Secondary outcomes:
measure: Ovulation
timeFrame: Cycle day 22-24
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
affiliation: Greenville Hospital System
name: Bruce A. Lessey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04701320: Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients
Official title: Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer Versus Conventional Glass Ionomer in Treatment of Root Caries in Geriatric Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dental Restoration Failure
Keywords: Glass Carbomer GCP glass fill root caries Clinical perfomance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?

Detailed description: Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies

Eligibility criteria: Inclusion Criteria:

* • ≥ 50 years old

  * Males or females.
  * Community-dwelling
  * Have five or more of their own teeth
  * With ≥ 1 root caries lesion

Exclusion Criteria:

* • Patients younger than 50 years old

  * Disabilities.
  * Systemic diseases or severe medically compromised.

Primary outcomes:
measure: Clinical restorative performance Service (USHPS)
timeFrame: Change from the baseline at 3, 6 and12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
Study officials:
References:
Clinical trial NCT06540820: NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
Official title: NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity; Endocrine
Pituitary Dysfunction
Bone Health
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Federico II University
name: University of Catanzaro
name: Istituto Auxologico Italiano
First posted: 2024-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with or without pituitary/gonadal disorders will be enrolled. Patients enrollment will take place in Ospedale San Raffaele, Azienda Ospedaliera Universitaria Federico II di Napoli and UOC Endocrinologia-AOU Renato Dulbecco, Università degli Studi di Catanzaro Magna Graecia.

A total of n=150 obese individuals will be recruited as it follows:

1. n=30 obese patients with acromegaly
2. n=30 obese patients with hyperprolactinemia
3. n=30 obese patients with hypopituitarism, including secondary male hypogonadism
4. n=30 obese patients with Cushing syndrome
5. n=30 obese patients without neuroendocrine diseases as control group

Brief summary: To study the effect of neuroendocrine dysfunctions on bone health in obesity

Detailed description: It is a multicentric, observational, cross-sectional non-profit study with additional procedures. The study will include obese patients (BMI\>30) with and without hyper functioning pituitary adenomas (acromegaly, Cushing and prolactinoma) and hypopituitarism (GH deficiency, secondary hypogonadism) aimed at studying the effect of metabolic phenotypes of obesity and neuroendocrine dysfunctions on bone health.

Patients enrollment will take place in Ospedale San Raffaele, Azienda Ospedaliera Universitaria Federico II di Napoli and UOC Endocrinologia-AOU Renato Dulbecco, Università degli Studi di Catanzaro Magna Graecia.

Eligibility criteria: Inclusion criteria for subjects with pituitary disease:

* Male and female subject \> 18-year-old (also fertile patients can be included)
* Patients with prolactinoma or Cushing disease, Acromegaly or hypogonadism/hypopituitarism
* BMI ≥30 Kg/m2
* Able to sign an informed consent

Inclusion criteria for subjects without pituitary disease

* Male and female subject \> 18-year-old
* BMI ≥ 30 Kg/m2
* Able to sign an informed consent

Exclusion Criteria:

* Male and female subject \<18-year-old
* pregnant or breastfeeding women
* Subject unable to sign informed consent
* BMI \< 30 Kg/m2

Primary outcomes:
measure: To study the neuroendocrine control of bone-fat crosstalk in obesity. Obese patients with and without neuroendocrine dysfunctions will be enrolled in the study to evaluate bone health, as well as the content of circulating adipokines/osteokines.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05269420: Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
Official title: Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Detailed description: in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Eligibility criteria: Inclusion Criteria:

obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity

* patients fit for laparoscopic surgery
* give approval to share in the study
* previous restrictive bariatric procedure

Exclusion Criteria:

* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases

Primary outcomes:
measure: weight loss
timeFrame: 12 months
Secondary outcomes:
measure: the rate of improved co morbidity
timeFrame: 12 months
measure: the incidence of nutritional deficiency
timeFrame: 12-24 months
measure: the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
References:
Clinical trial NCT06902220: Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery
Official title: Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery: a Study Protocol for a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pulmonary Atelectasis
Keywords: postcardiac surgery
oscillation
postoperative pulmonary complications
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study aims to evaluate the effectiveness of continuous high-frequency oscillation therapy in reducing PPCs in patients following elective cardiac surgery. Through a prospective, multicenter, randomized controlled trial, we seek to establish evidence that could lead to improved postoperative pulmonary care and outcomes for cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years or older) undergoing elective cardiac surgery will be included. Participants must provide informed consent upon ICU admission and have at least one risk factor for PPCs, including age ≥ 75 years, American Society of Anesthesiologists (ASA) score ≥ 2, history of chronic obstructive pulmonary disease (COPD) stage ≥ 2 or asthma (moderate to severe), current heavy smoking or heavy smoking history within the past 6 months, obstructive sleep apnea, frailty index \> 0.21 or body max index (BMI) ≥ 30 kg/m².

Exclusion Criteria:

* Patients will be excluded if they have contraindications for oscillation treatment (e.g., untreated tension pneumothorax); have pneumothorax or air leak syndrome at entry; require more than 2 μg/kg/min of norepinephrine; have been diagnosed with pneumonia within 2 weeks prior to surgery; have refractory arrhythmia at entry; have a left ventricular ejection fraction \< 35%; have mean pulmonary artery pressure (mPAP) \> 35 mmHg; are postoperative from spinal surgery within the past 2 weeks; require a ventricular assist device; have renal failure requiring continuous renal replacement therapy (CRRT) at entry; are planned for re-operation within 48 hours or have undergone organ transplantation.

Primary outcomes:
measure: The primary outcome is the pulmonary complication severity score within 7 postoperative days, or hospital discharge, whichever came sooner.
timeFrame: within 7 postoperative days
Secondary outcomes:
measure: incidence of > 48 hours invasive mechanical ventilation
timeFrame: within 7 postoperative days
measure: duration of mechanical ventilation
timeFrame: within 7 postoperative days
Other outcomes:
Locations:
Study officials:
References: