louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02848274: ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
Official title: Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients With Advanced Mycosis Fungoides and Sézary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mycosis Fungoides
Non-Hodgkin's Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with advanced stage mycosis fungoides and/or sezary syndrome

Brief summary: The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.


Eligibility criteria: Inclusion Criteria

* Diagnosis of advanced stage MF or SS (Stages IIB - IVB) within 6 months of presentation to the participating center
* Patients that are expected to have care administered at the participating center or jointly with referring physician(s) where follow-up data would be available

Exclusion Criteria

* Patients diagnosed with early stage MF/SS (Stages IA-IIA) before progressing to advanced stage
* Patients diagnosed with advanced MF/SS more than 6 months prior to initial presentation to the participating center
* Exclude one-time consultation type of new patients.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: date of diagnosis to death from any cause, up to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Pittsburgh
country: United States
facility: University of Pittsburg
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center,
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo Medical School
city: Beijing
country: China
facility: Peking University First Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
Study officials:
affiliation: Stanford University
name: Youn H Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01389674: Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods
Official title: Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Angina Pectoris
Left Ventricular Wall Motion Abnormalities
Keywords: coronary stenosis
Angina pectoris
left ventricular wall motion abnormalities
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).

Detailed description: After myocard vitality diagnostics with MRI patients will underwent additionally an stress echocardiography within the exploration. By this ultrasound we will measure the LV mass and the ejection fraction per apical 2-, 3- and 4-chamber view.

In addition a 2D-strain-analysis will be done to measure the systolic and diastolic strain and also the circumferential and radial strain rate parameter (by depicting three parasternal short axis views in the basal, mid-ventricular and apical plane).

These measurements will be compared with the studies-conditioned MRI-finding (as reference) to find the optimal strain-parameter and the optimal cut-off-data for an intraprocedural vitality diagnostics of the single layers (endocardial, myocardial, and epicardial) for this patient group.

The data upraised through this are compared off-line to the MRI findings.

Eligibility criteria: Inclusion Criteria:

* left ventricular wall motion abnormalities
* existent myocardial vitality MRI exploration
* reduced LV-function
* steady angina pectoris
* patients which are legally competent and which are mentally able to understand the study staff
* patients give their written consent

Exclusion Criteria:

* pregnancy or lactation
* acute or instable angina pectoris
* acute myocardial infraction in the last 3 month

Primary outcomes:
measure: Cut-Off-Value of vital myocardial tissue
timeFrame: time during hospitalization
Secondary outcomes:
measure: feasibility and safety of echocardiography during catheter investigations
timeFrame: time during hospitalization and 1 months afterwards
measure: Determination of Strain-Parameter for identification of vital myocardial tissue
timeFrame: time during hospitalization
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: RWTH Aachen University
name: Michael Becker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05998174: Faecal Microbiota Transplantation for Microscopic Colitis
Official title: Faecal Microbiota Transplantation for Microscopic Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Microscopic Colitis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot trial
Primary purpose: TREATMENT

Brief summary: A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of microscopic colitis
* Date of diagnosis/histological confirmation \< 12 months
* Active disease according to Hjortswang's criteria

Exclusion Criteria:

* Diagnosed with ulcerative colitis or Crohn's disease
* Diagnosed with celiac disease
* Active gastrointestinal infection
* Previous bowel resection of bowel (except appendectomy)
* Previous cholecystectomy
* Treatment with systemic steroid within 4 weeks, including budesonide
* Antibiotics 3 months prior
* Severe immunodeficiency,
* Pregnancy, planned pregnancy and breastfeeding
* Treatment with constipants such as psyllium, loperamide, bile binders, opium drops or codeine up to 2 weeks before inclusion and during participation

Primary outcomes:
measure: Treatment effect
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02060565: Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease
Official title: Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease. a Retrospective and Prospective 20-year Follow-up.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Disease
Keywords: diagnosis
survival
non-invasive method
cirrhosis
FibroScan
Lead sponsor: Association HGE CHU Bordeaux Sud
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients with an age over eighteen and chronic liver disease

Brief summary: The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.

Detailed description: All consecutive patients with chronic liver disease will be followed during 20 years.

Eligibility criteria: Inclusion Criteria:

* chronic hepatitis C
* chronic hepatitis B
* alcohol liver disease
* non alcoholic liver disease

Exclusion Criteria:

* ascitis

Primary outcomes:
measure: Overall survival
timeFrame: 20 years
Secondary outcomes:
measure: Survival without liver complications
timeFrame: 20 years
Other outcomes:
measure: Survival without liver transplantation
timeFrame: 20 years
Locations:
city: Pessac
country: France
facility: Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque
Study officials:
affiliation: Association HGE CHU Bordeaux Sud
name: Juliette Foucher, MD
role: STUDY_CHAIR
affiliation: Association HGE CHU Bordeaux Sud
name: Faiza Chermak, MD
role: STUDY_CHAIR
affiliation: Association HGE CHU Bordeaux Sud
name: Victor de Lédinghen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Association HGE CHU Bordeaux Sud
name: Jean-Baptiste Hiriart, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00005765: Behavioral Economics of Human Drug Self-Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Dependence
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-02
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: CROSS_SECTIONAL

Brief summary: The objective of this protocol is to examine the utility of behavioral economics for understanding reinforcer interactions as they pertain to drug self-administration. In a series of 6 experiments, the researchers will attempt to quantify the effects of qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their interactions. This work represents a continuation of research by this investigator in the area of addiction and pharmacology.


Eligibility criteria: Inclusion Criteria:

* Use of 20 or more cigarettes per day
* CO levels \>15 ppm
* More than 12 alcohol drinks per week and beer as preferred alcoholic beverage

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT01964365: Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers
Official title: An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 45 years
2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
2. A subject who shows the following result in clinical laboratory test

   * AST, ALT \> 1.25 times of the upper limit of normal range
   * PR ≥ 210 msec
   * QRS ≥ 120 msec
   * QT ≥ 500 msec
   * QTcF ≥ 500 msec
3. Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication

Primary outcomes:
measure: Cmax
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: AUCtau
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary outcomes:
measure: Cmin
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Tmax
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: CL/F
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: T1/2
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Metabolic Ratio
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University College of Medicine Busan Paik Hospital
Study officials:
affiliation: BUSAN PAIK HOSPITAL
name: Jae-Gook Shin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04518865: Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods
Official title: Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods: A Cone Beam Computed Tomographic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion, Division 1
Keywords: Class II malocclusion.
prepubertal patients.
postpubertal patients.
Herbst appliance.
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.

Detailed description: Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance.

Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.

Eligibility criteria: Inclusion Criteria:

1. Skeletal Class II malocclusion with retrognathic mandible (ANB \>5°, SNB\<76°)
2. Normal growth pattern (SN/MP angle was in 25°- 35° range)
3. Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
4. Minimal or no crowding in the mandibular arch (0-5mm).
5. Average inclination or slight retroclination of the lower incisor.
6. An overjet greater than 5 mm.

Exclusion Criteria:

1. Skletal Class I
2. Craniofacial syndrome.

Primary outcomes:
measure: Skeletal and dental changes
timeFrame: 8 months
Secondary outcomes:
measure: Condylar head position
timeFrame: 8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university
Study officials:
affiliation: Al-Azhar University
name: khaled Farouk, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443365: Should we Repair Ischemic Mitral Regurgitation?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Mitral Valve Insufficiency
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Poland
First posted: 2007-03-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.


Eligibility criteria: Inclusion Criteria:

* Stable coronary artery disease
* Patient accepted for coronary artery bypass surgery
* Ischemic mitral regurgitation

Exclusion Criteria:

* Acute coronary syndrome within 30 days
* Organic valvular heart disease
* Need for other than CABG and mitral valve repair cardiac surgical procedure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: 2nd Dept of Cardiac Surgery, Medical University of Silesia
Study officials:
affiliation: Medical University of Silesia
name: Marek A Deja, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913965: To Demonstrate the Relative Bioavailability of Atenolol Tablets
Official title: Bioavailability of Atenolol Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Atenolol tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Rudolph C. Cane, Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858865: A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Primary Hypercholesterolaemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.

Detailed description: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-228A compared with coadministration AD-2281 and AD-2282 in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied

Primary outcomes:
measure: Maximum concentration of drug in plasma (Cmax)
timeFrame: pre-dose to 72 hours
measure: Area under the plasma concentration-time curve during dosing interval (AUCt)
timeFrame: pre-dose to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H+ Yangji Hospital
Study officials:
References:
Clinical trial NCT04930965: Impact of LA-CEAL HALT COVID-19 Ambassador Program on Likelihood to Vaccinate
Official title: Louisiana Community-Engagement Alliance Against COVID-19 Disparities (LA-CEAL): Impact of HALT COVID Ambassador Program on Likelihood to Vaccinate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Vaccine Refusal
Keywords: Community Health Worker
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-06-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to assess the effectiveness of the HALT COVID Ambassador educational outreach program on increasing likelihood to vaccinate against COVID-19

Detailed description: Investigators will use a randomized controlled trial to test the effectiveness of HALT COVID educational outreach by HALT COVID Ambassadors. HALT COVID Ambassadors will receive training to answer common vaccine questions \& address misconceptions; conduct motivational interviewing; and implement basic behavioral economics and related strategies to remove barriers to vaccination. A random sample of FQHC patients will be identified in EHR data downloads of adult patients seen in the last year and contacted by telephone to gain consent and assess eligibility. A total of 100 individuals will be enrolled into the trial and randomized to intervention (engagement with the HALT COVID Ambassador over a 1 month period via in-person or virtual sessions exploring their own questions and concerns about vaccines) or usual care (no extra engagement). Baseline, 1-month, and 2-month follow-up surveys will assess for vaccine likelihood.

Eligibility criteria: Inclusion Criteria:

* Unlikely to vaccinate in next month
* Age \>=18 years
* Self-identification as Black or African American
* Ability to understand and speak English
* Willingness to engage with HALT COVID Ambassador via in-person or virtual sessions exploring questions and concerns about vaccines

Exclusion Criteria:

* Unable or unwilling to give informed consent

Primary outcomes:
measure: Difference in Proportion of Participants "Likely to Vaccinate" Between Study Arms at Month 1
timeFrame: Month 1 follow-up
Secondary outcomes:
measure: Difference in Proportion of Participants "Likely to Vaccinate" Between Study Arms at Month 2
timeFrame: Month 2 follow-up
measure: Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 1
timeFrame: Month 1 follow-up
measure: Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 2
timeFrame: Month 2 follow-up
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Marie Krousel-Wood, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: