louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03257176: Stepping Stones and Creating Futures Intervention Pilot
Official title: Stepping Stones and Creating Futures Intervention Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Physical Violence
Sexual Violence
Livelihoods
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: Project Empower
First posted: 2017-08-22
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce gender inequality.


Eligibility criteria: Inclusion Criteria:

* Over 18
* Mentally competent
* Able to communicate in English, Zulu, or Xhosa
* Normally resident in the informal settlement

Exclusion Criteria:

* Over 30
* Unable to do informed consent

Primary outcomes:
measure: Past three month physical IPV perpetration (men) and experience (women)
timeFrame: 12 months post baseline
measure: Past three month sexual IPV perpetration (men) and experience (women)
timeFrame: 12 months post baseline
measure: Earnings in past month
timeFrame: 12 months post baseline
Secondary outcomes:
measure: Work stress
timeFrame: 12 months post baseline
measure: Feelings about work shame
timeFrame: 12 months post baseline
measure: Gender attitudes
timeFrame: 12 months post baseline
measure: Controlling behaviours
timeFrame: 12 months post baseline
measure: Condom use at last sex
timeFrame: 12 months post baseline
measure: Hunger in the past month
timeFrame: 12 months post baseline
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Gender and Health Research Unit, South African Medical Research Council
state: KwaZulu-Natal
Study officials:
References:
citation: Gibbs A, Willan S, Jama-Shai N, Washington L, Jewkes R. 'Eh! I felt I was sabotaged!': facilitators' understandings of success in a participatory HIV and IPV prevention intervention in urban South Africa. Health Educ Res. 2015 Dec;30(6):985-95. doi: 10.1093/her/cyv059.
citation: Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325.
Clinical trial NCT06492876: Gene Therapy for DME
Official title: A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
FT-003
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.


Eligibility criteria: Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients 18-74 years old at the time of signing the ICF;
* Clinically diagnosed with CI-DME;
* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion Criteria:

* Presence of any other intraocular diseases other than DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Primary outcomes:
measure: Safety and tolerability after FT-003 injection
timeFrame: At Week 12
Secondary outcomes:
measure: To evaluate the efficacy after FT-003 injection
timeFrame: At Week 24
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin,China
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: Xiaorong Li, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02669576: Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy
Official title: Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
meopausal syptoms
mind body medecine
yoga
acupuncture
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.

Detailed description: Breast cancer patients undergoing endocrine therapy are often suffering from side effects. This randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosed breast cancer (Stage I-III), no metastases
* Current endocrine therapy (minimum 3 months)
* Score of 9 or greater on the Menopausal Rating Scale (MRS)
* Signed informed consent

Exclusion Criteria:

* Severe other somatic or psychiatric comorbidity
* Pregnancy
* Planned or existing chemotherapy, radiation or other cure treatment
* Participation in other clinical studies with behaviour-oriented, psychological or compementary medicine intervention.

Primary outcomes:
measure: Menopausal symptoms
timeFrame: week 11
Secondary outcomes:
measure: General health-related quality of life
timeFrame: week 11
measure: Spiritual health-related quality of life
timeFrame: week 11
measure: Fatigue
timeFrame: week 11
measure: Mental wellbeing
timeFrame: week 11
measure: Stress
timeFrame: week 11
measure: Compliance
timeFrame: week 11
measure: Adverse events
timeFrame: week 11
measure: Menopausal smptoms
timeFrame: week 23
measure: Genaeral health-related quality of life
timeFrame: week 23
measure: Spiritual health-related quality of life
timeFrame: week 23
measure: Fatigue
timeFrame: week 23
measure: Mental wellbeing
timeFrame: week 23
measure: Stress
timeFrame: week 23
measure: Compliance
timeFrame: week 23
measure: Adverse Events
timeFrame: week 23
Other outcomes:
measure: Mindfulness
timeFrame: week 11
measure: Social Support
timeFrame: week 11
measure: Expectation
timeFrame: week 0
measure: Statisfaction
timeFrame: week 11
Locations:
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte
state: NRW
Study officials:
affiliation: Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02910076: The Influence of Plaquenil/Hydroxychloroquine (HCQ) on Insulin Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Type Two
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antimalarials such as hydroxychloroquine (HCQ), are among the oldest prescribed drugs still used in clinical practice. Relatively inexpensive and well tolerated, these drugs have been recognized to be effective in autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Interestingly, there is growing evidence of their beneficial impact on cardiovascular risk, particularly diabetes. HCQ therapy can improve balance in patients with unbalanced diabetes. This drug therapy may be a new therapeutic approach for diabetes. There is need for a better understanding of the mechanisms responsible for the improvement of the metabolic response to drug treatment. The investigators hypothesize that treatment with a drug improves the function of the beta cell and its ability to secrete insulin in response to glucose. The investigators will examine the impact of short-term therapy for HCQ in beta cell function in healthy volunteers and in patients with type 2 diabetes.


Eligibility criteria: Two groups will participate in this study: Healthy volunteers and Diabetes patients

A. Healthy volunteers

* Inclusion Criteria:

  * Age: 18-40
  * Without acute disease at the day of the experiment.
  * Signed informed consent
* Exclusion Criteria:

  * Malignancy
  * Steroids or NSAID on a daily basis

B. Diabetes patients

* Inclusion Criteria:

  * Age: 20-60
  * Diabetes type two
  * Untreated or on metformin treatment
* Exclusion Criteria:

  * Hypoglycemic medications

Primary outcomes:
measure: glucose level
timeFrame: the change in glucose level between baseline and after three hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03730376: Decision Making in Hypothetical Carpal Tunnel Syndrome
Official title: Patient and Consumer Decision Making in a Hypothetical Case of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention.

We will use a random block generator to assign participants to their study arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.

Detailed description: Participants will be randomized into 1 of 2 groups and receive a hypothetical scenario of carpal tunnel, with or without cost information, and asked to decide if that hypothetical patient should undergo a carpal tunnel release.

Eligibility criteria: Inclusion Criteria:

* patients presenting to hand clinic OR mturk workers
* age 18 or older

Exclusion Criteria:

* traumatic mechanism of injury

Primary outcomes:
measure: Decision to have Treatment
timeFrame: immediately after completing survey
Secondary outcomes:
measure: Opinion on healthcare costs
timeFrame: immediately after completing survey
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT06248476: Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation in Spinal Cord Injury Patients
Official title: Effect of Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation and Lower Extremity Motor Function in Chronic Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injury
rTMS
iTBS
Ambulation
Lower extremity motor function
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 30
Sex: ALL
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: Comparison of different types of transcranial magnetic stimulation techniques which are intermittent theta burst stimulation (iTBS) and high frequency repetitive transcranial magnetic stimulation (rTMS) in patients with spinal cord injury

Detailed description: iTBS lasts shorter than rTMS so that this technique comfortable than rTMS for both patients and also physicians. Aim of this study is to compare effectiveness of this techniques. If results are same, iTBS can be used instead of rTMS.

Eligibility criteria: Inclusion Criteria:

* Incomplete spinal cord injury (ASIA C and D)
* 12 months after spinal cord injury
* At least 10 meters walking independent or with canadian, walker or walking stick
* Put signature to approved form

Exclusion Criteria:

* Epileptic seizure
* Pacemaker
* Pregnancy
* Neurological disease different from spinal cord injury
* Metalic implant in brain or scalp
* Brain surgery
* Orthopedic problem in lower extremity
* Malignity

Primary outcomes:
measure: Lower extremity motor score
timeFrame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Secondary outcomes:
measure: Walking index for spinal cord injury II
timeFrame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
measure: Spinal cord injury independence measurement III (SCIM III)
timeFrame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
measure: 10 meter walking test
timeFrame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
measure: Time up and go test
timeFrame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
measure: Motor evoked potential
timeFrame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
state: Çankaya
Study officials:
References:
Clinical trial NCT01152476: Emergency Agitation in T&A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy pediatric patients undergoing tonsillectomy and adenoidectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status I or II
* 2-6 year-old children
* patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria:

* upper respiratory disease
* mental retardation

Primary outcomes:
measure: emergency agitation
timeFrame: during 1 hour after recovering of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00940576: Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases
Official title: Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Crohns Disease
Keywords: mare's milk, Crohn's disease, ulcerative colitis, clinical
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-07-16
Enrollment: 17
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.

Detailed description: Background: Dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk.

Objective: Dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated.

Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study, eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL mare's milk or placebo drink.

Eligibility criteria: Inclusion Criteria:

clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.

Exclusion Criteria:

lactose intolerance and pregnancy

Primary outcomes:
measure: Score of Crohn´s Disease and/or Ulcerative Colitis
timeFrame: 8 weeks
Secondary outcomes:
measure: Extra-intestinal Pain
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University Jena, Department of Nutritional Physiology
state: Thuringia
city: Jena
country: Germany
facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: Professor in Ordinary
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948376: Natural History of Asphyxiating Thoracic Dystrophy (DTJ)
Official title: Clinical and Molecular Study, Natural History of Asphyxiating Thoracic Dystrophy (DTJ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asphyxiating Thoracic Dystrophy
Keywords: Natural history
IFT80
short ribs
multivisceral involvement
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 50
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 with:

* Short ribs with narrow thorax
* Trident acetabular roof
* Short hands

Brief summary: The aim of the project is to prospectively analyze at a clinical and molecular level a series of 50 asphyxiating thoracic dysplasia (ATD) patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

Detailed description: Asphyxiating thoracic dysplasia (ATD, MIM 208500) belongs to the short rib polydactyly group and is characterized by short ribs often responsible for an early death due to respiratory distress, trident acetabular roof and short long bones.

In the course of the disease, renal, liver and eye complications may occur. However, their frequencies are unknown.

ATD is transmitted with an autosomal mode of inheritance and up till now only one gene has been identified, namely IFT80, which accounts only for a small part of ATD.

The aim of our project is to prospectively analyze at a clinical and molecular level a series of 50 ATD patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

Eligibility criteria: Inclusion Criteria:

* Short ribs with narrow thorax
* Trident acetabular roof
* Short hands
* All ages
* Informed consent signed

Exclusion Criteria:

* Other disease
* Ellis van creveld syndrome
* No social security

Primary outcomes:
measure: Natural history of asphyxiating thoracic dystrophy (ATD)
timeFrame: 3 years
Secondary outcomes:
measure: Correlation Phenotype-Genotype
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Valérie Cormier-Daire, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06829576: Examining Health-related Physical Fitness in Individuals With Diabetic Dyslipidemia.
Official title: Comparative Examination of Health-related Physical Fitness in Individuals With Diabetic Dyslipidemia With Diabetic Individuals Without Dyslipidemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Dyslipidemia
Lead sponsor: Istanbul Galata University
Sponsor class: OTHER
Collaborators: name: Biruni University
First posted: 2025-02-17
Enrollment: 128
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Followed up in the Diabetes Polyclinic, Department of Internal Medicine, Endocrinology and Metabolic Diseases, Istanbul University, Istanbul Faculty of Medicine

Brief summary: To compare health-related physical fitness parameters in Type 2DM patients with and without dyslipidemia.Cardiometabolic biomarkers glucose and lipid profile will be noted from medical records. Body composition, functional capacity will be assessed with a six-minute walk test, peripheral muscle strength with a dynamometer, and physical activity level with a pedometer.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Type 2 DM for at least 1 year,

  * Having an HbA1c value between 6.5-11%,
  * Being between the ages of 35-65,
  * Knowing how to read and write Turkish,
  * Having signed the informed consent form

Exclusion Criteria:

* Lack of cooperation

  * Patients with peripheral or central serious neurological disorders
  * Patients with uncontrolled hypertension and uncontrolled arrhythmia
  * Pregnant or lactating patients
  * Patients with diabetic ulcers or neuropathy
  * Chronic renal failure (eGFR\<30 ml/min)
  * Chronic liver disease (ALT/AST\<3X Upper limit of normal)
  * Patients with serious respiratory system disease
  * Patients with cardiac pacemakers
  * History of previous stroke or myocardial infarction
  * Presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests

Primary outcomes:
measure: Muscle strength
timeFrame: 1 day
measure: Funcitonal capacity
timeFrame: 1 day
measure: Waist circumference
timeFrame: 1 day
measure: Hip circumference
timeFrame: 1 day
measure: Body fat-muscle ratios
timeFrame: 1 day
Secondary outcomes:
measure: Physical activity level (step count)
timeFrame: 1 week (seven days)
measure: Glucose profile
timeFrame: 1 day
measure: Glucose profile
timeFrame: 1 day
measure: Lipid profile
timeFrame: 1 day
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Galata University
Study officials:
affiliation: Biruni University
name: Buket Akinci, Assoc.Prof
role: STUDY_DIRECTOR
affiliation: Istanbul Galata University
name: Safak Yigit, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: