louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00067964: Diet and Physical Activity Interactions in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-09-05
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The projects funded by this grant, primarily focus on environmental factors that promote weight-gain in the general human population, and how to modify these factors, to prevent further weight-gain in the future. In the coming years, the researchers at the University of Colorado-HSC hope to gain an understanding as to how small changes in diet and physical activity can be achieved and sustained to prevent weight-gain.


Eligibility criteria: * BMI: 21-26
* \< 5lb. weight change in 6 mo.
* usual fat intake 25-35%
* regularly eats 3 meals/day
* no chronic health problems known to affect appetite
* either active or inactive (specific criteria do exist)
* no smoking
* women must be on bcps
* no evidence of depression, eating disorder, or restrained eater (determined from validated questionnaires).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado-HSC Center for Human Nutrition
state: Colorado
Study officials:
References:
Clinical trial NCT00654264: Water Immersion in Right-Sided Heart Failure: A Pilot Study
Official title: Water Immersion in Right-Sided Heart Failure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Right Sided Cardiac Failure
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2008-04-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.

Detailed description: Patients will be immersed in a tub for 3 hours (on one day) and neurohormones will be obtained before and after immersion. Urine will be collected for quantification and evaluation of sodium concentration.

Eligibility criteria: Inclusion Criteria:

* Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation
* Age greater than 18 years of age
* Right heart catheterization within the last year to rule out left-sided failure.
* Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites

Exclusion Criteria:

* Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures.
* Serum creatinine \> 2.0
* Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.

Primary outcomes:
measure: Diuresis
timeFrame: 4 hours
Secondary outcomes:
measure: Neurohormonal activation
timeFrame: 4 hours
measure: Natriuresis
timeFrame: 4 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Stephen Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01439464: Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion
Official title: Clinical Efficacy and Safety of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion and, Titanium Cage Controlled, 1-year, Single-Blind, Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disk Disease
Lead sponsor: BioAlpha Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 86
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare Bonglass-SS with titanum cage.


Eligibility criteria: Inclusion Criteria:

* 30\~80 aged patients needed single-level posterior Interbody fusion at L1\~S1
* A subject who provided written informed consent to participate in this study

Exclusion Criteria:

* Patitents with BMD T-score \< -3.0
* Women who are pregnant or plan to be pregnant within 3 years
* Patient with malignant tumor

Primary outcomes:
measure: Radiographic assessments of fusion and instability at 12 months after surgery
timeFrame: 12 months
Secondary outcomes:
measure: CT assessments of fusion at 12 months after surgery
timeFrame: 12 months
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Medical Center
state: Gyeonggi-do
city: Sungnam-Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Seoul Metropolitan Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: JaeHyup Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06578364: Effect of Educational Program About Preconception Care on Knowledge and Attitude of Adolescents University Students
Official title: Effect of Educational Program About Preconception Care on Knowledge and Attitude of Adolescents University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preconception Care
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This quasi-experimental study used a pre-test-post-test design to assess the effectiveness of the teaching program. A sample of 400 students from El Mansoura University was selected using a simple random sample. The participants were given a pre-test questionnaire to evaluate their knowledge and attitude towards PCC. The educational program consisted of a single session, which included a lecture, pictures, videos, and discussions. The post-test was administered immediately after the program


Eligibility criteria: Inclusion Criteria:

* The study included males and females from the targeted colleges.
* Students from grade 1 to grade 4.
* Students who accepted to participate in the study.

Exclusion Criteria:

* Students from the medical sector.
* Students who refused to participate were excluded from the study.

Primary outcomes:
measure: knowledge and attitude towards Preconception care (PCC)
timeFrame: The educational program consisted of a single session, which included a lecture, pictures, videos, and discussions. The post-test was administered immediately after the program.
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT00433264: The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis
Official title: The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: peritoneal dialysis
endothelium
endothelial dysfunction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2007-02-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary referral center university hospital

Brief summary: Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. This relation is present from early stages of chronic kidney disease on.

Several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. In peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking.

The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients


Eligibility criteria: Inclusion Criteria:

* age \> 18
* Maintenance peritoneal dialysis

Exclusion Criteria:

* No informed consent
* Peritonitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Bjorn Meijers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Kathleen Claes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Pieter Evenepoel, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02937064: Multimodal Assessment of Knee Conditions
Official title: Multimodal Assessment of Knee Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Injury of Anterior Cruciate Ligament
Knee Injuries and Disorders
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2016-10-18
Enrollment: 109
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls will be recruited using the newspaper advertisement. Subject with anterior cruciate ligament injuries will be recruited from the orthopaedic department and osteoarthritic subjects using patient Records of Oulu University Hospital.

Brief summary: The purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.


Eligibility criteria: Inclusion Criteria:

* Age 45 - 65

Exclusion Criteria:

* Rheumatoid arthritis
* Weight over 110 kg
* Previous total knee replacement surgery
* Contraindications to MRI

Primary outcomes:
measure: Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Univerisity of Oulu
Study officials:
affiliation: University of Oulu
name: Simo Saarakkala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Osmo Tervonen, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01665664: Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients
Official title: Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enteral Feeding
Keywords: Indirect calorimetry
hypocaloric feeding
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-08-15
Enrollment: 200
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: Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.

Detailed description: Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.

Eligibility criteria: Inclusion Criteria:

* Anticipated Mechanical ventilation for at least 72 hrs.
* Need for enteral feeding
* men and woman aged 18 or older.

Exclusion Criteria:

* Abdominal surgery with inability to feed enterally.
* FiO2 greater than 80%
* Bronchopleural fistula
* Hemodynamic instability in spite the use of vassopressors.

Primary outcomes:
measure: All cause mortality, ICU mortality, Hospital mortality.
timeFrame: 1 year
Secondary outcomes:
measure: ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
timeFrame: 1 year
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson MC
Study officials:
affiliation: Wolfson MC
name: Arie Soroksky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02736864: Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae
Official title: Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Tuberculosis
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cured pulmonary tuberculosis

Brief summary: The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

Detailed description: This study evaluates structural and functional repercussions of pulmonary tuberculosis sequelae by chest imaging (computed tomography and radiograph), functional respiratory tests (spirometry and six minute walking test) in patients with cured pulmonary tuberculosis.

Eligibility criteria: Inclusion Criteria:

* Pulmonary tuberculosis with completed treatment (patients that received at least six months of treatment and with confirmed cure by negative culture and/or sputum smear, or clinical and radiological improvement after well succeed treatment);
* Treatment finalized at least one year before.

Exclusion Criteria:

* Physically impaired to perform the functional tests;
* Coexisting lung pathology (history of previous respiratory disease or clinical or radiological evidence of lung disease other than tuberculosis);
* Pregnants.

Primary outcomes:
measure: Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry
timeFrame: At least one year after completion of the tuberculosis treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama)
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Thulio Cunha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507364: Treatment of Anal Fissure by Activated Human Macrophages
Official title: Treatment of Anal Fissure by Activated Human Macrophages
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Biological Therapy for Chronic Anal Fissure
Treatment by Biological Factors - Activated Macrophages
Interventional Study
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-07-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure permanently weakens the internal sphincter and may be associated with permanent complications such as incontinence. Current topical treatment or " chemical sphincterotomy" is effective in the short term for about 70% of the patient more than 50% of them will suffer from recurrence. Number of studies support the hypothesis that local ischemia is the reason for failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is an innovative method since 1995, macrophage suspensions have been used successfully in more than 1400 patients in several hospitals in Israel without any side effect.Macrophages have key function in almost every stage of wound healing. They help in the digestion of bacteria, in a later stage, they secret IL-6, which influences endothelial cell proliferation and the initiation of angiogenesis.

The study hypothesis is that local injection of activated human macrophages into chronic anal fissure may induce fissure healing.


Eligibility criteria: Inclusion Criteria:

* Consecutive symptomatic adults with chronic idiopathic anal fissure

Exclusion Criteria:

* Pregnant women
* Acute fissures
* Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease)
* Immunosuppressed patients

Primary outcomes:
measure: COMPLETE FISSURE HEALING
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Gastroenterology Unit
Study officials:
affiliation: Hadassah University Hospital
name: Yosef (Joseph) Lysy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danon D, Madjar J, Edinov E, Knyszynski A, Brill S, Diamantshtein L, Shinar E. Treatment of human ulcers by application of macrophages prepared from a blood unit. Exp Gerontol. 1997 Nov-Dec;32(6):633-41. doi: 10.1016/s0531-5565(97)00094-6.
Clinical trial NCT04324164: Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC
Official title: Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Brief summary: This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Detailed description: inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history

Eligibility criteria: Inclusion Criteria:

* 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology

  * Uncommon EGFR Mutant Advanced NSCLC

Exclusion Criteria:

* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: 5 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
measure: ORR
timeFrame: 5 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02947464: Rapid Maxillary Expansion for Residual Pediatric
Official title: Rapid Maxillary Expansion for Residual Pediatric Obstructive Sleep Apnea After Adenotonsillectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-10-28
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.

Detailed description: Cure rate of pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment adenotonsillectomy is 50-80%. Treatment alternatives are scarce, poorly effective and based upon low scientific evidence. This means one out of five patients will remain exposed to the well-known neurocognitive, behavioral and quality of life adverse effects of disease.

Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion, has recently shown promising results in the treatment of pediatric OSAS based upon its effect on craniofacial and upper airway growth, usually limited in these patients.

The investigators propose a randomized, prospective, controlled trial in patients with Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the treatment success rate avoiding morbimortality associated to disease persistence during childhood and development during adult life.

Eligibility criteria: Inclusion Criteria:

* Children (boys and girls) between 4 and 9 years of age.
* Residual OSAS after adenotonsillectomy (described as an Apnea Hypopnea Index over 3 objectively measured by means of polysomnography).
* Rapid maxillary expansion indication.
* Parents or tutors sign Informed Consent.

Exclusion Criteria:

* Craniofacial syndromes or neurologic disease diagnosis.
* Adenoid residual hypertrophy occluding \>50% nasal airway as measured by means of nasal flexible fiberoptic endoscopy and or tonsillar residual hypertrophy \>2 as measured by direct intraoral physical exam.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: During sleep, an average of 10 hours
Secondary outcomes:
measure: Sleep-related quality of life
timeFrame: 2 years
measure: Craniofacial growth
timeFrame: 2 years
measure: Dental arch growth
timeFrame: 2 years
measure: Adenotonsillar hypertrophy
timeFrame: 2 years
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Marcos Fernandez-Barriales
state: Alava
Study officials:
affiliation: Basque Health Service
name: Marcos Fernández-Barriales
role: PRINCIPAL_INVESTIGATOR
References: