louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00292123: Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Dependence
Cocaine Abuse
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-02-15
Enrollment: 200
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: The primary goal of this study is to determine how contingency management can best be combined with standard or high doses of methadone to increase simultaneous abstinence from heroin and cocaine.

Detailed description: A study of people pmaintained on Methadone using contingency management

Eligibility criteria: Inclusion Criteria:

* Opioid dependence; cocaine use

Exclusion Criteria:

* Medical or psychiatric conditions that would contraindicate participation in a methadone maintenance study; inability to give informed consent; inability to attend clinic seven days a week

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NIFA Intramural Research Program
name: Kenzie Preston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghitza UE, Epstein DH, Preston KL. Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients. Addict Behav. 2008 Apr;33(4):593-604. doi: 10.1016/j.addbeh.2007.11.009. Epub 2007 Nov 17.
citation: Willner-Reid J, Belendiuk KA, Epstein DH, Schmittner J, Preston KL. Hepatitis C and human immunodeficiency virus risk behaviors in polydrug users on methadone maintenance. J Subst Abuse Treat. 2008 Jul;35(1):78-86. doi: 10.1016/j.jsat.2007.08.011. Epub 2007 Oct 10.
citation: Ghitza UE, Epstein DH, Schmittner J, Vahabzadeh M, Lin JL, Preston KL. Randomized trial of prize-based reinforcement density for simultaneous abstinence from cocaine and heroin. J Consult Clin Psychol. 2007 Oct;75(5):765-74. doi: 10.1037/0022-006X.75.5.765.
citation: Ghitza UE, Epstein DH, Preston KL. Psychosocial functioning and cocaine use during treatment: strength of relationship depends on type of urine-testing method. Drug Alcohol Depend. 2007 Dec 1;91(2-3):169-77. doi: 10.1016/j.drugalcdep.2007.05.018. Epub 2007 Jul 10.
citation: Heinz A, Epstein DH, Preston KL. Spiritual/Religious experiences and in-treatment outcome in an inner-city program for heroin and cocaine dependence. J Psychoactive Drugs. 2007 Mar;39(1):41-9. doi: 10.1080/02791072.2007.10399863.
citation: Heinz AJ, Epstein DH, Schroeder JR, Singleton EG, Heishman SJ, Preston KL. Heroin and cocaine craving and use during treatment: measurement validation and potential relationships. J Subst Abuse Treat. 2006 Dec;31(4):355-64. doi: 10.1016/j.jsat.2006.05.009. Epub 2006 Aug 1.
citation: Ghitza UE, Epstein DH, Preston KL. Nonreporting of cannabis use: Predictors and relationship to treatment outcome in methadone maintained patients. Addict Behav. 2007 May;32(5):938-49. doi: 10.1016/j.addbeh.2006.06.034. Epub 2006 Aug 1.
Clinical trial NCT01612923: Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians
Official title: Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Medical Abortion
Keywords: abortion
medical abortion
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 1180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The physical examination before an abortion is usually performed by a physician. However, in many countries access to physicians is limited. To increase access to safe abortion this study wishes to examine if midlevel providers such as specially trained midwives can provide safe abortion services. Midwives in study were specially trained to perform early pregnancy ultrasound and if needed to consult a physician. The midwife then provided the abortion service as well as the contraceptive advice. Women were randomized to receive the service from a midwife or a physician.


Eligibility criteria: Inclusion Criteria:

* healthy women aged 18-45 with no contraindication to medical abortion

Exclusion Criteria:

* any medical condition which contraindicates medical abortion

Primary outcomes:
measure: feasibility
timeFrame: 3 weeks
Secondary outcomes:
measure: efficacy
timeFrame: 3 weeks
measure: acceptability
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Helena Kopp Kallner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kopp Kallner H, Gomperts R, Salomonsson E, Johansson M, Marions L, Gemzell-Danielsson K. The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by doctors or by nurse-midwives: a randomised controlled equivalence trial. BJOG. 2015 Mar;122(4):510-7. doi: 10.1111/1471-0528.12982. Epub 2014 Jul 18.
Clinical trial NCT00348023: Bimatoprost Monotherapy vs. Dual Therapy With Travoprost and Timolol in Patients With Glaucoma and Ocular Hypertension
Official title: Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age

  * Diagnosis of primary open-angle glaucoma or ocular hypertension
  * Untreated IOP \> 18 mm Hg in each eye at the baseline evaluation
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication

  * Uncontrolled systemic disease
  * Active ocular disease other than POAG or ocular hypertension
  * Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted)
  * History of intraocular surgery within the last 3 months
  * Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dr. Noecker
state: Pennsylvania
Study officials:
affiliation: UPMC Eye Center
name: Robert Noecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364723: Place of Glycation in Diabetic Retinopathy
Official title: Place of Glycation in Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Descriptor
Keywords: glycation
diabetic retinopathy
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic population in the eastern region of Morocco

Brief summary: 1. Definition: Diabetic retinopathy is a microangiopathic complication of diabetes diabetes mellitus. Its pathophysiology includes glycation and intracellular hypoxia. Diabetic retinopathy (DR) is a microvascular complication of diabetes. It is the leading cause of It is the leading cause of blindness and visual impairment in people under the age of 60 in industrialized countries.

   Chronic hyperglycemia during diabetes plays a major role in the occurrence of diabetic diabetic retinopathy by promoting protein glycation and the accumulation of glycation end products (GTPs). GTPs are a heterogeneous group of compounds resulting from non-enzymatic and irreversible reactions between reducing sugars and amine groups of biological molecules such as proteins, lipids or nucleic acids.
2. Interest: The aim of our work is to describe the mechanisms by which glycation participates in the pathophysiology of diabetic retinopathy and to discuss the use of AGEs as biomarkers in this biomarkers in this pathological context and the therapeutic means that limit the toxicity of of AGEs.

The study is designed through a retrospective and prospective observational study to establish the of glycation in the occurrence of diabetic retinopathy. It will describe the demographic demographic profiles, glycemic control, clinical and paraclinical status of patients with diabetic diabetic retinopathy and will evaluate the relationship between glycation and diabetic retinopathy as well as the factors that influence this glycation in these patients, and induce the occurrence and / or of diabetic retinopathy. The data collected will allow to improve the knowledge, the diagnosis and the treatment of diabetic diabetic retinopathy, as well as a good management of the patients who should benefit from a more individualized and individualized and adequate treatment.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients type 1 and type 2, of both sexes, and of all ages. Regular follow-up

Exclusion Criteria:

* Other types of diabetes. Irregular follow-up.

Primary outcomes:
measure: distribution of diabetic retinopathy in eastern morocco
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04081623: Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
Official title: Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fetal Distress
Lead sponsor: Raydiant Oximetry, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor

Brief summary: This project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters,

Detailed description: The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women with singleton pregnancies, vertex presentation
2. Age ≥ 18 years
3. Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
4. Healthy women ≥ 37 weeks in labor
5. Vertex presentation

Exclusion Criteria:

1. Age \<18 years
2. Multiple gestation ( twins, triplets)
3. Presentation other than vertex
4. \< 28 weeks of gestation

Primary outcomes:
measure: Fetal signal integrity
timeFrame: During NST, BPP, or active labor
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01005823: A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
Official title: A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Age 18-55 years
* Atopic dermatitis of 850-1700cm2
* In good health

Criteria for exclusion:

* Co-morbid conditions
* Hepatic dysfunction
* Clinical infection
* Immunocompromised status
* Clinically significant illness
* Use of immunomodulating treatment
* Medications related to respiratory system or to heart rhythm

Primary outcomes:
measure: Adverse events, laboratory testing, ECG, vital signs
timeFrame: Day 9
Secondary outcomes:
measure: To assess the efficacy of LEO 29102 cream in the treatment of AD
timeFrame: Day 9
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA International, University Medical Centre
Study officials:
affiliation: PRA Health Sciences
name: Kahlid Aboufarha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00930423: Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease
Official title: Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atypical Hemolytic Uraemic Syndrome
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with endstage renal failure treated in het University Hospital of Ghent

Brief summary: Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the alternative pathway of the complement system. Triggering can cause an uncontrolled complement activation with endothelial damage and thrombotic micro-angiopathy, especially in the kidneys. This can result in endstage renal failure. Complement activation during hemodialysis has been described as a result of contact between blood and the dialysis membrane. Our hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger complement activation during hemodialysis than patients with another underlying kidney disease. This could be a reason to treat patients with endstage renal failure due to atypical hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.


Eligibility criteria: Inclusion Criteria:

* cases: endstage renal failure due to atypical hemolytic uraemic syndrome treated with hemodialysis.
* controls: endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis.

Primary outcomes:
measure: C3a-des-Arg measuring (as a marker of activation).
timeFrame: at time 0, at 15 minutes, at 60 minutes and at 180 minutes
measure: white blood cell count
timeFrame: before and after 15 minutes of hemodialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05406323: Web-Based Fall Prevention Program for Elderly
Official title: The Effect of Web - Based Fall Prevention Program on Fall, Fall Risk and Fall Fear Among Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Fall Risk
Fear of Falling
Keywords: fall prevention
web-based intervention
elderly
Falling
Fear of Falling
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fall is one of the most common problems experienced by the elderly, is an important public health problem in many societies. Falls are one of the leading causes of fatal and non-fatal injuries in the elderly. An average of one-third of individuals aged 65 and over have a fall at least once each year. The research will be carried out on the web page that on fall prevention prepared within the scope of this project. The aim of this project is to assess the effect of Web-Based Fall Prevention Program on falling, fall risk and fear of fall.

Detailed description: The research was planned as a experimental design with a pretest- posttest control group design. It will be with individuals over the age of 65. The sample size of the research is consists of 72 people who agreed to participate in the research. Participant will be randomly assigned to the experimental and control groups via computer programı (random.org).

The research will be conduct on a web-based basis.The six-week web-based program includes health education, exercise and safe home environment initiatives.

Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study,
* 65 years or older,
* Completing the Timed Up and Go (TUG) test for 12 seconds or more,
* Having internet access and the ability to use communication tools such as computers, tablets or smartphones,
* Not dependent on bed,
* Without moderate and severe cognitive impairment (Mini Mental State Test-MMD ≥24),

Exclusion Criteria:

* Illiterate,
* Visually impaired,
* Physical condition or disease that may prevent exercise (Multiple Sclerosis, Parkinson, with a fracture, artificial knee- hip-joint in the last six months etc..)

Primary outcomes:
measure: Change in number of falls
timeFrame: Pre, post (6 weeks), 3 months, 6 months
measure: Change in Fall Risk
timeFrame: Pre, post (6 weeks), 3 months, 6 months
measure: Change in Falls Efficacy Scale (FES)
timeFrame: Pre, post (6 weeks), 3 months, 6 months
Secondary outcomes:
measure: Change in The Falls Behavioral (FaB) Scale
timeFrame: Pre, post (6 weeks), 3 months, 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Nur Sema KAYNAR, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT01505023: Partial Meal Replacement and Inulin in Obese Women
Official title: Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Cindetec
Sponsor class: OTHER
Collaborators: name: Nucitec SA de CV
First posted: 2012-01-06
Enrollment: 179
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to test the efficacy of a partial meal replacement added with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women


Eligibility criteria: Inclusion Criteria:

* BMI \> 25 kg/m 2

Exclusion Criteria:

* Pregnant
* Lactating
* Diagnosed with diabetes
* Diagnosed with hypertension
* Fasting glucose ≥126 mg/dL
* Blood triglycerides ≥400mg/dL

Primary outcomes:
measure: Weight
measure: Blood lipids
Secondary outcomes:
measure: Micronutrients intake
Other outcomes:
Locations:
city: Querétaro
country: Mexico
facility: Universidad Autónoma de Querétaro
Study officials:
References:
citation: Tovar AR, Caamano Mdel C, Garcia-Padilla S, Garcia OP, Duarte MA, Rosado JL. The inclusion of a partial meal replacement with or without inulin to a calorie restricted diet contributes to reach recommended intakes of micronutrients and decrease plasma triglycerides: a randomized clinical trial in obese Mexican women. Nutr J. 2012 Jun 18;11:44. doi: 10.1186/1475-2891-11-44.
Clinical trial NCT06871423: The Effect of Virtual Reality on Pain and Memory.
Official title: Magic Bowl VR Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adult
Keywords: virtual reality
pain
distraction
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Using a repeated measures within-subject crossover design with treatment order randomized, with healthy volunteers,
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of Virtual Reality on pain and memory.

Detailed description: The primary outcome measure was the participants' accuracy of remembering the pattern of a total of five pain stimuli per set. Using the Quantitative Sensory Testing "method of limits", each participant selected a temperature they found "painful but tolerable" that they were willing to receive several more times, later in the study. They then received a sequence of five brief stimuli to their wrist, with a brief inter-stimulus interval between each stimulus.

Eligibility criteria: Inclusion Criteria:

* must be English speaking (but English does not necessarily need to be native/first language).
* must be willing to follow our UW approved instructions,

Exclusion Criteria:

* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Non-English-speaking
* Extreme susceptibility to motion sickness
* Seizure history
* Unusual sensitivity or lack of sensitivity to pain
* Sensitive skin
* sensitive feet
* migraines
* cold symptoms
* Diabetes
* Or if you are under 18 years old

Primary outcomes:
measure: Pain Memory Recall Test
timeFrame: After each brief pain stimulus set, participants performed a brief distractor task before completing the Pain Memory Recall Test. The Pain Memory Recall Test was completed within 5 minutes after each brief thermal stimulus set.
measure: Participants subjective rating of the accuracy of their memory for painful stimuli
timeFrame: measured within 10 minutes after each pain stimulus set
Secondary outcomes:
measure: Presence ratings using Graphic Rating Scales
timeFrame: measured within 10 minutes after participant was in virtual reality
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Hunter G Hoffman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: