louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02235103: The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.
Official title: The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unexplained Infertility
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unexplained fertility treated with intra-uterine insemination (first cycle) and ovulation induction with clomiphene citrate.

Brief summary: Recent research has revealed that subtle abnormalities can be found in sperm samples that seem to be normal with conventional analysis techniques. The DNA in the sperm heads is sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained infertility do not achieve pregnancy.

We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples with previously unexplained infertility. In a first treatment cycle with intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the results of the patients who are pregnant will be compared with those of the not pregnant ones. We expect to find differences between both groups.

100 patients will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes; normal sperm analysis (WHO criteria).
* Patient agrees to have a first treatment cycle with intra-uterine insemination and ovulation-induction with clomiphene citrate.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2 1/2 weeks after insemination
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 20 weeks after insemination
measure: Live birth rate
timeFrame: 42 weeks after insemination
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Fertility Centre of the University Hospital
state: East Flanders
Study officials:
affiliation: Fertility Centre, University Hospital Ghent
name: Frank Vandekerckhove, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03246503: BiliCam Clinical Validation Study
Official title: BiliCam Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Newborn Jaundice
Lead sponsor: BiliCam, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-08-11
Enrollment: 203
Sex: ALL
Minimum age (years): 0
Maximum age (years): 191
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.

Detailed description: Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level.

For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.

Eligibility criteria: Inclusion Criteria:

* Newborn born at ≥ 35 weeks gestation
* Parent speaks and reads English
* Parent provides written informed consent

Exclusion Criteria:

* previous or ongoing treatment with phototherapy for hyperbilirubinemia
* Medical or other complications that preclude completion of the study

Primary outcomes:
measure: BCB - TSB Correlation
timeFrame: Newborns up to 192 hours old
Secondary outcomes:
measure: Intercept of Regression Line
timeFrame: Newborns up to 192 hours old
measure: Slope of Regression Line
timeFrame: Newborns up to 192 hours old
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hopsital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02488603: Decision Aids for Tamoxifen Treatment in Breast Cancer Patients
Official title: Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Neoplasms
Tamoxifen
Decision Aids
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-07-02
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. Patients will randomly assign to DA group or conventional group. Both groups will have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later follow-up questionnaire surveys.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea
* - Age at least 18 years and more

Exclusion Criteria:

* Age under 18 years
* Inability to read or speak Korean
* Disagree to provide a written informed consent

Primary outcomes:
measure: Change in Knowledge of Tamoxifen Scale
timeFrame: baseline, 4weeks later
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: baseline, 4weeks later
measure: Satisfaction with Decision Questionnaire
timeFrame: baseline, 4weeks later
measure: EORTC QLQ-C30 Questionnaire
timeFrame: baseline, 4weeks later
measure: EQ-5D Questionnaire
timeFrame: baseline, 4weeks later
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00013403: The Impact of Rehabilitation on Quality of Life in Visually Impaired
Official title: The Impact of Rehabilitation on Quality of Life in Visually Impaired
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blindness
Keywords: Vision, quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 300
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: The project has four primary objectives: 1) Determine if blind rehabilitation improves the quality of life of legally blind veterans; 2) Determine the relationship between quality of life and visual function; 3) Determine if factors, such as cognitive status, level of depression, age and the presence of additional medical conditions besides vision loss, intervention of blind rehabilitation extends beyond the visually impaired individual and improve the quality of life of their primary caregiver (e.g. spouse, partner, family member or friend.)


Eligibility criteria: Visually impaired

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: VAMC, Birmingham
state: Alabama
Study officials:
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D., Asst. Director
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Nancy Rocheleau, Program Analyst
References:
Clinical trial NCT01993303: Direct Comparison of 2D Cardiac PET With 3D Cardiac PET
Official title: Direct Comparison of 2D Cardiac PET With 3D Cardiac PET Using a 3D Monte-Carlo Scatter COrrection Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Myocardial Perfusion Imaging
PET
Rb-82
Lead sponsor: Cardiovascular Imaging Technologies
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male.

Brief summary: Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82 PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (\~20 mCi) processed using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage (\~50 mCi) 2D Rb-82 PET MPI.

Detailed description: This study re-examines 2D an 3D myocardial perfusion PET data from 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Rest and stress scans were acquired on a Siemens Accel™ PET scanner in 2D (septa extended) and 3D (septa retracted) modes. Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi. Imaging times were 2D emission scan for 3 mins (90 sec delay post Rb-82 infusion), followed by a 3 minute, 3D gated emission scan (180 sec delay). Decay and shorter acquisition times led to a 62% reduction in the effective dosage 2D vs 3D datasets. 3D images were first pre-processed using a Monte-Carlo scatter and prompt gamma correction algorithm (Imagen3D™) then reconstructed using ImagenProTM (CVIT, Kansas City, MO). Reconstructed images were evaluated using relative, 17 segment raw scores (Cedars QPET). Studies were read by consensus of 2-blinded readers for: image quality (1-4, poor-excellent), interpretive certainty (1-3, low-high) and rest perfusion using a 17 segment model (0=normal; 1-3 = mild, moderate, or severe perfusion defects). Stress segmental scores were not evaluated due to differences in imaging start time post dipyridamole infusion.

Eligibility criteria: Inclusion Criteria:

* \>18 Years of Age
* Have ability to provide informed consent
* Have a technically adequate rest/stress Rb-82 perfsion PET study within the past 60 days

Exclusion Criteria:

* Pregnant or nursing feamle
* Weight \> 275 lbs
* Have contraindications to adenosine stress testing
* Unstable cardiac rhythm (atrial fibrillation, frequent PVCs
* PTCA or CABG within the last 60 days

Primary outcomes:
measure: Quantitative Accuracy
timeFrame: 1 day
measure: Visual Assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Lukes Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT06742203: WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects
Official title: WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects- a Phase 1, Single-center, Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBD
Lead sponsor: Exosomm Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.
Primary purpose: TREATMENT

Brief summary: This phase 1, single-center, open-label study aims to evaluate the tolerability and usability of WPMDE1, a whey protein milk-derived exosome (EV) nutritional supplement, in healthy adults. The study will assess dose tolerability and determine the appropriate dosage for future studies targeting patients with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD).

Detailed description: WPMDE1 is a nutritional supplement derived from cow's milk using a novel production process designed to preserve extracellular vesicles (EVs) and their biological functions. This single-arm, unblinded trial will explore the effects of ascending doses of WPMDE1 on tolerability and usability in up to 30 healthy adults aged 18-60. Participants will be divided into five groups to test incremental doses over 7-30 days.

The study includes blood sampling, vital sign measurements, and daily symptom tracking via validated gastrointestinal symptom questionnaires. The outcomes will inform the design of future clinical trials targeting IBS and IBD patients. The trial will be conducted at Hadassah University Hospital.

Eligibility criteria: Inclusion Criteria:

* Healthy participants who have not undergone any major surgeries or hospitalization 6 months prior to entering the study
* All genders
* Participants aged 18-60
* Participants with no underlying known health or mental conditions
* Participants who are not participating in another clinical study simultaneously or taking any other nutritional supplements or chronic drugs.
* Participants must pre-sign the informed consent form.

Exclusion Criteria:

* Participants who violate one or more of the inclusion criteria
* participants with chronic diseases, particularly those that are related to the GI tract
* Participants with cow milk allergy/ intolerance or history of such.
* Participants suffering from constipation or diarrhea
* Participants who use drugs or drink alcohol on a regular basis (more than one glass per week)
* Pregnant or breastfeeding women
* Participants with a BMI over 30

Primary outcomes:
measure: Tolerability of adverse symptoms over the study period.
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT02850003: Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel
Official title: A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Detailed description: An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Eligibility criteria: Key Inclusion Criteria:

* Male or female between the ages of 9 and \<17 (16 years 11 months)
* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
* Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
* Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
* Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, or participation in a research study concurrent with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
* Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.
* Subjects with a facial beard or mustache that could interfere with the study assessments
* Subjects with more than 2 facial nodules.

Primary outcomes:
measure: Evaluators Global Severity Score At Day 15
timeFrame: 15 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Valeant Site 01
state: Texas
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric
role: STUDY_DIRECTOR
References:
Clinical trial NCT05039203: Bacteriuria and Indwelling Urinary Catheter.
Official title: The Risk of Symptomatic Bacteriuria and Persistence of Asymptomatic Bacteriuria After Removal of an Indwelling Urinary Catheter- a Prospective Observational Study Among Elderly Inpatients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bacteriuria Asymptomatic
Urinary Tract Infections
Keywords: Urinary Catheter
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2021-09-09
Enrollment: 196
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden.

Brief summary: Investigation of 1. The incidence of symptomatic bacteriuria during four weeks after removal of an IUC in inpatients at a rehabilitation clinic for patients ≥ 65 years compared with the incidence of symptomatic bacteriuria among inpatients not treated with an IUC and 2. For how long does ABU persist in inpatients at a rehabilitation clinic for patients

≥ 65 years during a follow-up time of four weeks after IUC-removal?


Eligibility criteria: Inclusion Criteria:

* Admission to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden
* Ability to understand oral and written instructions in Swedish
* Ability to produce a voided urine-sample

Exclusion Criteria:

* Severe cognitive failure and/or disability to understand oral and written instructions in Swedish according to the healthcare-personnel's judgment at the ward
* End-of-life care
* Physical disability to produce voided urine-samples
* Ongoing antimicrobial treatment for symptomatic bacteriuria

Primary outcomes:
measure: Symptomatic bacteriuria (urinary tract infection)
timeFrame: Four weeks
Secondary outcomes:
measure: Asymptomatic bacteriuria (ABU)
timeFrame: One day
measure: Persistence of ABU
timeFrame: Four weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Geriatric Department, Danderyd Hospital
city: Södertälje
country: Sweden
facility: Geriatric Department, Södertälje Hospital
Study officials:
References:
Clinical trial NCT02292303: Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Official title: Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Keywords: Zinc/pharmacokinetics
Lead sponsor: Lesaffre International
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.


Eligibility criteria: Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Sex: female (premenopausal), male
* Age: 20 - 50 years
* BMI ≥19 or ≤30 kg/m²
* Non-smoker
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology

Exclusion Criteria:

* Relevant history or presence of any medical disorder, potentially interfering with this trial
* For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
* Migraine or regular headache, intense premenstrual symptoms
* Coffee consumption \>3 cups / day
* Blood donation within 2 months prior to trial start or during trial
* Regular intake of mineral supplements within 4 weeks prior to trial start or during trial
* Chronic intake of substances affecting the intestinal absorption of zinc
* Vegetarians / vegans
* Drug-, alcohol- and medication abuses
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance
* Known pregnancy, breast feeding or intention to become pregnant during the study
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
* Not anticipating any planned changes in lifestyle for the duration of the study

Primary outcomes:
measure: Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.
timeFrame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
Secondary outcomes:
measure: Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate.
timeFrame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
Other outcomes:
Locations:
Study officials:
References: