louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03712683: Thyroxin in Subclinical Hypothyroidism
Official title: Prevalence of Subclinical Hypothyroidism in Women With Unexplained Infertility and the Effect of Thyroxin on Pregnancy Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sub Clinical Hypothyroidism
Pregnancy Loss
Keywords: Unexplained Infertility, pregnancy rate,hypothyroidism
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. It has been suggested that SCH is more prevalent in infertile women (especially in women with ovulatory disorders.Various rates of SCH was reported in infertile women in different populations

Detailed description: Despite well-established recommendations on screening and treatment of overt hypothyroid in infertile women, there is a controversy regard the treatment of SCH in infertile women .

There are few published data on the prevalence of SCH and the outcome of treatment of SCH in infertile women, many were conducted during IVF cycles . Moreover there are inconsistent results in these studies being authors advised to treat SCH before IVF and some other articles find out no any benefit regarding treatment with Thyroxine in SCH

Eligibility criteria: Inclusion Criteria:

1. Unexplained infertility
2. TSH more than 2.5 and normal T3,T4 levels
3. Negative for Anti-thyroid antibodies

Exclusion Criteria:

1. current history of overt hypo or hyperthyroidism
2. recurrent pregnancy loss
3. women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor
4. Ovarian dysfunction or decreased ovarian reserve
5. abnormal seminal fluid analysis or male factor

Primary outcomes:
measure: Pregnancy
timeFrame: 2 years
Secondary outcomes:
measure: Miscarriage rate
timeFrame: 13 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hawler Medical University
name: Ariana Kh. Jawad, CABOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03310983: Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
Official title: Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy; Nutritional Diseases
Keywords: Fat mass
Gestational weight gain
Fetal adipose tissue
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are invited from those already participating in the parent study, ADORE.

Brief summary: The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.


Eligibility criteria: Participants for this study are invited from the parent study, ADORE. Eligibility listed reflects criteria for the ADORE study.

Inclusion Criteria:

* Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
* Available by telephone

Exclusion Criteria:

* Expecting multiple infants
* Gestational age at baseline \<12 weeks or \>20 weeks
* Unable or unwilling to agree to consume capsules until delivery
* Unwilling to discontinue use of another prenatal supplement with DHA that contains ≥ 200 mg DHA
* Women with allergy to any component of DHA product (including algae), soybean oil or corn oil

Primary outcomes:
measure: Infant Fat Mass (FM)
timeFrame: 24 months
Secondary outcomes:
measure: Central Fat Mass
timeFrame: 24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Holly Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00918697: Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
Official title: Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractive Error
Myopia
Keywords: photorefractive keratectomy
PRK
alcohol-assisted debridement
mechanical debridement
confocal scan
confocal microscopy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.


Eligibility criteria: Inclusion Criteria:

* spherical equivalent ≤ -4.0 D
* cylinder ≤ 1.50 D

Exclusion Criteria:

* history of ocular trauma or surgery
* any corneal and ocular pathologies
* central corneal thickness \< 500 µm
* scotopic pupil diameter \> 6.0 mm
* any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
* the presence of systemic disorders such as collagen vascular diseases

Primary outcomes:
measure: Corneal cellular elements.
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT04740697: Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer
Official title: Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Tamoxifen
Alternative and complementary therapies
Treatment adherence
Turmeric
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.

200 patients will be included in the study.

Each patient will be followed for one day.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at entry into the study.
2. Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
3. Patients treated with tamoxifen for a maximum of 1 to 3 years.
4. Patient affiliated with a Social Security system in France.
5. Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Primary outcomes:
measure: Rate of patients who adhere to tamoxifen treatment.
timeFrame: 18 months after the start of the research
Secondary outcomes:
measure: Rate of patients taking ACT.
timeFrame: 18 months after the start of the research
measure: Rate of patients consuming turmeric-based dietary supplements.
timeFrame: 18 months after the start of the research
measure: Plasma concentration of tamoxifen in patients.
timeFrame: 18 months after the start of the research
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References:
Clinical trial NCT00558597: Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation
Official title: Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rejection
Lung Transplantation
Keywords: Proteomics
Lung Transplantation
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2007-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients after lung transplantation

Brief summary: In patients with acute rejection after lung transplantation the peptide profile in broncho-alveolar lavage (BAL) and urine should be compared in order to identify a paradigm that allows an non-invasive rejection therapy.

Detailed description: Goal of the study is the establishment of biomarkers for early diagnosis of acute rejection, followed by a late validation of the paradigm with prospectively collected samples, which will be examined blinded.

Eligibility criteria: Inclusion Criteria:

* Patients with stable graft function
* Patients with acute rejection

Exclusion Criteria:

* Acute infection
* BOS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Jens Gottlieb, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02378597: Resiliency Program for Medical Interpreters
Official title: Developing a Resiliency Program for Medical Interpreters in Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psychological Stress
Keywords: Resiliency burnout stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
First posted: 2015-03-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To develop and test a 4-session program to teach resiliency skills to Medical Interpreters.

Detailed description: This study aims to improve quality of cancer care for LEP patients through improving medical interpreters' ability to cope with difficult encounters. We propose to (1) identify the needs of medical interpreters working with cancer patients, and (2) develop and test a psychoeducational resiliency program at 3 DF/HCC cancer centers: MGH, DFCI, and BWH) intended to enhance interpreters' skills to effectively manage stressful encounters and to cope with the personal effects of encounters.

Eligibility criteria: Inclusion Criteria:

1. Interpreter employed at one of the 3 study hospitals
2. \>=20 hours/week

Exclusion Criteria:

1) Interpreter working \<20 hours per week

Primary outcomes:
measure: Feasibility and Acceptability of Intervention (participant feedback questionnaire)
timeFrame: Post-Intervention (4 weeks)
Secondary outcomes:
measure: Psychological Variables including Perceived Stress and Resiliency ( PSS-1021 is a 10-item scale)
timeFrame: Baseline, Post-Intervention (4 weeks), and 12 week follow up
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Michele Russell-Einhorn, JD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05953597: Nutrition Education Program in Spinal Cord Injury (SCI)
Official title: Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals with Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Metabolic dysfunction
Nutrition education
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2023-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to assess the effectiveness of a nutrition education program in increasing nutrition knowledge and improving health-related biomarkers in individuals with spinal cord injury (SCI).


Eligibility criteria: Inclusion Criteria:

- Adults with SCI with complete and incomplete (American Spinal Injury Association Impairment Scale Score A-D) paraplegia or ventilator-independent tetraplegia.

Exclusion Criteria:

* Participants who do not meet inclusion criteria.
* Adults unable to consent.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women (self-report)
* Prisoners

Primary outcomes:
measure: Change in Nutrition Knowledge
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in Cardiometabolic Biomarkers - Fasting Sodium
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Potassium
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Chloride
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Glucose
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers -Triglycerides
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Total Cholesterol
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Hemoglobin a1c
timeFrame: Baseline, 12 months
measure: Change in Cardiometabolic Biomarkers - Insulin
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Christine E. Lynn Rehabilitation Center
state: Florida
Study officials:
affiliation: University of Miami
name: Elizabeth R Felix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sneij A, Farkas GJ, Carino Mason MR, Gater DR. Nutrition Education to Reduce Metabolic Dysfunction for Spinal Cord Injury: A Module-Based Nutrition Education Guide for Healthcare Providers and Consumers. J Pers Med. 2022 Dec 7;12(12):2029. doi: 10.3390/jpm12122029.
Clinical trial NCT01815697: Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms
Official title: A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Urinary Retention
Vascular Endothelium
Counterpulsation, External
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.

Detailed description: Patients with benign prostatic hyperplasia and will be randomized into two groups: EECP intervention or not. Lower urinary tract symptoms, hemodynamic parameters, vascular endothelial function will be measured and compared

Eligibility criteria: Inclusion Criteria:

1. men over 18 years old;
2. provide signed informed consent;
3. existence of lower urinary tract symptoms
4. agree not to use any lower urinary tract symptoms treatment at least one month;
5. suitable for receiving EECP treatment

Exclusion Criteria:

1. history of long drug abuse;
2. pelvic, spine, brain trauma or surgery;
3. endocrine, liver, lung, kidney disease, malignancies, hematological disorders;
4. Severe infection without effective control；
5. lower limbs deep vein thrombosis；
6. Large area of ulcerative rash；
7. unsuitable for receiving EECP treatment

Primary outcomes:
measure: Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
timeFrame: 7 weeks
Secondary outcomes:
measure: Urinary flow rate
timeFrame: 7 weeks
measure: Endothelial function
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat- sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yan Zhang, M. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02257983: Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Official title: A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Noise-induced Hearing Loss
Keywords: hearing
noise
oxidative stress
Lead sponsor: Edison Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.


Eligibility criteria: Inclusion Criteria:

* Healthy adults ages 18-30
* Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation
* Non-smokers
* Abstention from alcohol from day 0 and throughout the duration of study
* Normal audiology exam
* Subject must be able to swallow size 0 capsules

Exclusion Criteria:

* Allergy to EPI-743 or sesame oil or nuts
* Any medical disordere that would prevent subject participation
* Any prescription meds other than for contraception or seasonal allergies
* Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney)
* Fat malabsorption syndromes
* Anticoagulation thereapy within 30 days of enrollment

Primary outcomes:
measure: Pure tone audiometry
timeFrame: 9 days
Secondary outcomes:
measure: Time to recovery following acute noise exposure
timeFrame: 9 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Colleen Le Prell, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05939583: Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache.
Official title: Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Shock wave therapy
Trapezius trigger points
Cervicogenic headache
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.

Detailed description: Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Fifty patients from both genders.
* Age ranging from 20 to 40 years.
* Referred by an orthopedist with a diagnosis of Mechanical neck dysfunction (MND) to physical therapy at the outpatient clinic of the Faculty of Physical Therapy, MTI University.

Exclusion Criteria:

* All other disorders.

Primary outcomes:
measure: Visual analogue scale
timeFrame: 4 weeks
measure: Neck disability index
timeFrame: 4 weeks
measure: Kinesiological EMG
timeFrame: 4 weeks
measure: Kinesiological EMG
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: El-Sheikh Zayed City
country: Egypt
facility: October 6 University
state: Giza
Study officials:
References: