louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02270229: Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.
Official title: Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Peritoneal Dialysis
Lead sponsor: La Isla Foundation
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be performed in a public hospital in northwest Nicaragua.

There will be four groups of participants:

1. Healthcare professionals, including physicians, nurses, technicians, and administrators
2. PD patients
3. Primary caregivers of the PD patients
4. Laboratory personnel

Brief summary: The purpose of this study is to develop recommendations to assist in improving the current peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will consist of a needs assessment, a review of aggregate quantitative patient data from hospital records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers, laboratory technicians, patients and primary caregivers. The final report will be used to obtain funding for the implementation of the recommendations.


Eligibility criteria: Inclusion Criteria:

1. Participants must be affiliated with the PD program that is under evaluation

Exclusion Criteria:

1. Being physically unable to participate in an interview of approximately one hour
2. Being younger than 18 years of age
3. Refusal to participate

Primary outcomes:
measure: Identification of needs of the PD program
timeFrame: Hospital visits for the duration of 1 week
measure: Adherence to established protocols on administering PD treatment in the hospital
timeFrame: 3 days of observation sessions for the duration of 8 hours
measure: Levels of knowledge, attitudes and practices towards PD of healthcare providers, laboratory staff patients and primary caregivers
timeFrame: Interviews of each group for the duration of 1 week
measure: Prevalence of peritonitis and causative agents
timeFrame: Sample collections according to PD patients' appointment times during one week and culturing of samples for 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CISTA UNAN-Leon
name: Marvin Gonzalez, MD. MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120429: Effects of Moderate Consumption of Lean Fish on Weight Loss
Official title: Effects of Moderate Consumption Lean Fish on Weight Loss of Overweight and Obese Women During a Weight Loss Program, a 24 Week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: lean fish
weight loss
Diet
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2017-04-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of present study is to compare the specific effects moderate consumption of lean fish on weight loss of healthy obese and overweight female adults, while participants follow energy-restricted diets also to investigate the effects of this intervention on carbohydrate and lipid profiles, as cardiometabolic risk factors.


Eligibility criteria: Inclusion Criteria:

* female
* 18-45 years of age.
* Body mass index (BMI) between 27.5-35 kg/m²
* Must be able to have moderate exercise.
* Must be interested to lose weight

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Use of supplements containing n-3 fatty acids, calcium or vitamin-D during the last 3 months.
* Consumption of fish and sea foods regularly
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Primary outcomes:
measure: weight loss
timeFrame: 24 Weeks
Secondary outcomes:
measure: waist circumference
timeFrame: 24 Weeks
measure: fasting plasma glucose
timeFrame: 24 Weeks
measure: serum insulin level
timeFrame: 24 Weeks
measure: insulin resistance (HOMA-IR)
timeFrame: 24 Weeks
measure: glycosylated hemoglobin (HbA1c)
timeFrame: 24 Weeks
measure: lipid profiles
timeFrame: 24 Weeks
measure: liver enzymes (SGOT, SGPT)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
References:
Clinical trial NCT01062529: Peripheral Metabolic Effects of Somatostatin
Official title: Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly
Growth Hormone Deficiency
Diabetes
Keywords: GH signalling
insulin resistance
somatostatin
acromegaly
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2010-02-04
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.


Eligibility criteria: Inclusion Criteria:

* BMI \< 27 kg/m2
* Written informed consent
* Healthy

Exclusion Criteria:

* Any disease
* Any use of medications
* Present or previous malignancy
* Alcohol dependency
* Allergy to trial medication

Primary outcomes:
measure: Plasma levels of glucose
timeFrame: 3 months
Secondary outcomes:
measure: GH signalling
timeFrame: one year
measure: Serum levels of free fatty acids (FFA)
timeFrame: one year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical department M
Study officials:
name: Jens Otto L Jørgensen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03147729: Radiofrequency in Anal Incontinence: Randomized Clinical Trials
Official title: Radiofrequency in Anal Incontinence: Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiation Exposure
Keywords: Radiofrequency
Anal incontinence
Fecal incontinence
Women sexual function
Sexuality
Lead sponsor: Escola Bahiana de Medicina e Saude Publica
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. Based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to correlate the anal incontinence severity and to evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a blind randomized clinical trial. For the collection of data it was used a fecal quality of life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI), the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises. It was accomplished in eight sections. As a result, it is expected the efficiency of the treatment of radiofrequency in the quality of life, in sexual function and in it's severity.


Eligibility criteria: Inclusion Criteria:

- Individuals between 18 and 66 years of age with a clinical complaint of Anal Incontinence and who agree to participate voluntarily in the research.

Exclusion Criteria:

* Individuals with cognitive impairment, use of pacemakers, women who use the Intra-Uterine Device (IUD) of copper, pregnant women, individuals who are taking vasodilators or anticoagulants and hemophiliacs, patients with cognitive deficits or psychiatric illness, patients with chronic neurological degenerative diseases and individuals with hemorrhoid metallic clamp.

Primary outcomes:
measure: The effectiveness of radiofrequency in anal incontinence
timeFrame: 8 radiofrequency sessions will be performed, with a 7 day interval between them. The session will be 20 minutes.Participants will be followed up for a minimum of 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador/
country: Brazil
facility: Escola bahiana de Medicina e Saúde Pública
state: BA
Study officials:
References:
Clinical trial NCT00247429: Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients
Official title: Vandral Retard (Venlafaxine Extended Release) in Depressive Syndrome With Anxiety and Painful Symptoms in Elderly Patients. Observational Study in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Syndrome
Anxiety
Keywords: depression
anxiety
elderly
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-01
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care centers

Brief summary: In this study we will assess as a primary objective the effect of venlafaxine retard treatment on primary care attended elderly patients with depressive syndrome. We will also study secondarily its effects on anxiety, somatic and painful symptoms of depression.


Eligibility criteria: Inclusion Criteria:

* Patients older than 60 years
* Depressive syndrome with associated anxiety symptoms, according to a symptoms intensity HAM-D17³14

Exclusion Criteria:

* Participation in other studies in the last 3 months before the start of the study
* Known hypersensibility to venlafaxine
* Clinically significant abnormalities according to the venlafaxine labeling

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04814329: Glioblastoma Response Prediction to Apatinib
Official title: Study on Predicting Response of Recurrent Glioblastoma to Apatinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Keywords: Vascular Endothelial Growth Factor Receptor 2
Biomarkers
glioblastoma
Lead sponsor: Beijing Sanbo Brain Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University

Brief summary: Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. However, a subset of patients progressed in 2 months. There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old
2. recurrent glioblastoma
3. received apatinib plus temozolomide treatment，response and survival data were available
4. tumor tissues were acquired

Exclusion Criteria:

-

Primary outcomes:
measure: genetic outcome
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Sanbo Brain Hospital
Study officials:
References:
Clinical trial NCT05615129: Sequence and Time-of-day Infusion of immunoCHemotherapy Affect Response in Oesophageal Cancer in the NeOadjuvant Setting
Official title: Effect of Immunochemotherapy Sequence and Time-of-day Infusion on Efficacy and Prognosis of Patients With Advanced Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Shantou University Medical College
name: Peking University Shenzhen Hospital
First posted: 2022-11-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study

Brief summary: It is reported that compared to chemotherapy alone, immunochemotherapy has significantly improved the overall survival of patients with advanced metastatic ESCC. However, there are still more than 30% of patients who cannot benefit from this treatment modality. In addition to these factors, the time-of-day infusion and administration sequence of immunochemotherapy have been reported to be associated with tumor responses and overall survival. In this study, The investigators aimed to explore the roles of infusion time and administration sequence of immunochemotherapy in predicting tumor responses and overall survival in patients with advanced ESCC.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed as esophageal squamous cell carcinoma
* KPS≥80
* Adequate organ function
* No distant metastasis
* The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist

Exclusion Criteria:

* incomplete medical record which affects statistical analysis
* have participated in previous interventional clinical trials
* other situations evaluated by investigators not meet the enrollment

Primary outcomes:
measure: Overall survival
timeFrame: from the date of diagnosis to the date of death, assessed up to 100 months
Secondary outcomes:
measure: Pathologic complete response rate (pCR)
timeFrame: Three to five working days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01543529: A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers
Official title: A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, 18 to 45 years, inclusive
* Body Mass Index (BMI) 18 to 30 kg/m2, inclusive
* Non-smoker or smoker of fewer than 10 cigarettes per day
* Females, who are not menopausal must agree to use two adequate methods of contraception

Exclusion Criteria:

* Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk
* History of alcoholism
* History of drug abuse and/or addiction within one year of study start
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer

Primary outcomes:
measure: Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
timeFrame: Day 1 of each treatment period
Secondary outcomes:
measure: Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838
timeFrame: Days 1, 2, 3, 4, 6, and 8 of each treatment period
measure: Safety: Incidence of adverse events
timeFrame: Approximately 4 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: BIOTRIAL
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01741129: Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Noninvasive Ventilation for Respiratory Distress Syndrome
Keywords: Nasal CPAP
Nasal IMV
Surfactant
Preterm infants
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.


Eligibility criteria: Inclusion Criteria:

- Gestational age 26-32 weeks

The criteria for failure were met by at least 1 of the following:

* pH: 7.10 and PaCO2: 70 mm Hg
* Recurrent apnea with \>3 episodes (Prophylactic caffeine were used in all infants)
* Single episode of apnea that required bag-and-mask ventilation
* PaO2: 50 mmHg with a fraction of inspired oxygen of \>0.5.

Exclusion Criteria:

* Major congenital anomalies
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused

Primary outcomes:
measure: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
timeFrame: 3 months
Secondary outcomes:
measure: Complications of respiratory support
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
References:
citation: Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.
Clinical trial NCT06375629: ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer
Official title: A Multi-institutional Prospective Data Collection of Patients Treated With Partial Gland High-Intensity Focused Ultrasound (HIFU) Ablation for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 14
Sex: MALE
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: Patients newly diagnosed with localized prostate cancer and eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.

Brief summary: The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.


Eligibility criteria: Inclusion Criteria:

* Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
* Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds).
* Gleason ≤ 4+3.
* Patient scheduled for HIFU treatment as determined by the physician.
* Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent

Exclusion Criteria:

* Patient with bilateral prostate cancer requiring whole gland treatment.
* Patients clinically detected metastasis.
* Patient with an extension of cancer or seminal vesicle invasion.
* Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.

Primary outcomes:
measure: Evaluation of adverse events
timeFrame: 1 year
measure: Evaluation of quality of life
timeFrame: 3, 6, 9 and 12 months
measure: Evaluation of urinary incontinence
timeFrame: 3, 6, 9 and 12 months
measure: Erectile function assessment
timeFrame: 3, 6, 9 and 12 months
measure: Urinary Symptoms
timeFrame: 3, 6, 9 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo
city: Oviedo
country: Spain
facility: Hospital Universitario Central De Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués De Valdecilla
city: Valencia
country: Spain
facility: Hospital Consorcio General Universitario de Valencia
Study officials:
References: