louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02804828: Mitochondrial Cocktail for Gulf War Illness
Official title: Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gulf War Syndrome
Persian Gulf Syndrome
Mitochondrial Disorders
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 15
Sex: ALL
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Design study is followed by Crossover to open label treatment.
Primary purpose: OTHER

Brief summary: The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).

Detailed description: See below.

Eligibility criteria: Inclusion Criteria:

* Meet symptom criteria for Gulf War illness with BOTH the Centers for Disease Control and Prevention (CDC) Criteria (persistent symptoms in at least 2 of 3 designated symptom domains of fatigue/sleep, mood/cognition, and musculoskeletal) and Kansas Criteria (score a moderate or severe rating in at least 3 of the 6 symptom domains of fatigue, pain, neurological/cognitive/mood, skin, GI and respiratory).

Exclusion Criteria:

* Have conditions like multiple sclerosis or lupus that can produce similar symptoms and be confused for Gulf War illness.
* Participating in a concurrent treatment trial.
* Unwilling or unable to comply with the treatment protocol
* Failed run-in; do not take at least 80% of run-in medications

Primary outcomes:
measure: Mean change in single item General Self-Rated Health Visual Analog Scale from baseline
timeFrame: 0, 3, 6 months (double-blind phase)
measure: Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises
timeFrame: 6 months (double-blind phase)
measure: Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo
timeFrame: 0, 3, 6 months (double-blind phase)
measure: Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo
timeFrame: 6 months (double-blind phase)
Secondary outcomes:
measure: Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)
timeFrame: 6, 9, 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
Clinical trial NCT03148028: Immunological Characteristics of Patients With PID and IBD
Official title: Immunological Characteristics of Patients With Primary Immunodeficiencies and Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Primary Immune Deficiency Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-05-10
Enrollment: 45
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a known or unknown immunodeficiency who develop inflammatory bowel disease or are suspected to have such a condition.

Brief summary: The investigators wish to characterize alterations in the architecture and function of immune cells in patients with a primary immunodeficiency that also develop inflammatory bowel disease. In addition, The investigators' goal is to characterize the microbiome of these patients, in order to determine whether specific microbial alterations are related to inflammation.

Detailed description: The pathogenesis of inflammatory bowel diseases (IBD), like Crohn's disease and ulcerative colitis is complex and is thought to be related to genetic, environmental and microbial alterations that lead to a hyperactive/dysregulated immune system that mediates tissue damage. In rare cases, IBD can develop in patients with primary immunodeficiencies (PID) who develop severe, atypical or recurrent infections. The bowel disease in these patients can present after they develop infectious complications but also prior to that. The goal of the current study is to characterize immune function in patients with PID and IBD in order to identify alterations in pro-inflammatory and regulatory pathways.

The investigators will obtain blood samples from PID patients with IBD in order to perform deep immune profiling using various techniques such as flow cytometry, ELISA and others. Moreover, the investigators wish to characterize the microbiome of these patients. This multi-disciplinary approach will advance our understanding why specific patients with an immunodeficiency develop an IBD-like phenotype.

Eligibility criteria: Inclusion Criteria:

* age \<18 years
* diagnosis of an immunodeficiency
* suspected or confirmed IBD

Exclusion Criteria:

* none

Primary outcomes:
measure: Characterization of immune cells
timeFrame: 3 years
Secondary outcomes:
measure: Characterization of stool microbiome
timeFrame: 3 years
Other outcomes:
Locations:
city: Be'er Sheba
country: Israel
facility: Soroka University Medical Center
city: Tel Hashomer
country: Israel
facility: Edmond and Lily Safra Children's Hospital
Study officials:
affiliation: Edmond and Lily Safra Children's Hospital
name: Dror S Shouval, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03916328: BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study
Official title: A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate Based Anti-Retroviral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bone Loss
Lead sponsor: MU-JHU CARE
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 330
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).


Eligibility criteria: Inclusion Criteria:

* Age 20 through 40 years (inclusive) at screening, verified per site SOPs
* Able and willing to provide written informed consent to be screened for and to take part in the study.
* Able and willing to provide adequate locator information, as defined in site SOPs
* Previously participated in the BONE: CARE study. Additional women will be recruited from the health centers where the BONE: CARE participants were receiving HIV care, and these will be matched to those from the BONE: CARE cohort based on age, duration on ART and contraception use.
* Per participant report, plans to stay in the study catchment area in the next 24 months
* Per participant report, willing to continue using similar contraceptive method as in the BONE: CARE study.

Exclusion Criteria:

* Currently pregnant/ breastfeeding or was pregnant/ breastfeeding in the last 6 months prior to screening
* Intentions to get pregnant in the next two years
* History of active tuberculosis
* Pathologic bone fracture not related to trauma (ever)
* Has pre-existing condition known to affect bone metabolism (e.g. thyrotoxicosis, tuberculosis, diabetes mellitus, liver or renal disease)
* Is taking the following medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs, etc.).

Primary outcomes:
measure: Changes in bone mineral density
timeFrame: 2 years
measure: Changes in trabeculae bone score (TBS)
timeFrame: 2 years
Secondary outcomes:
measure: Changes in bone biomarkers
timeFrame: 2 years
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MU-JHU Care Limited
Study officials:
affiliation: MU-JHU CARE
name: Flavia Kiweewa Matovu, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03261128: Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)
Official title: Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment. Feasibility and Acceptability Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 75 Years Old and More
Cancer
Chemotherapy
Keywords: cancer
chemotherapy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 75 years and over Cancer and treated with chemotherapy

Brief summary: Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a self-administered questionnaire carried out by the patient before each chemotherapy cure. The objective is to secure the quality of patient care and to detect the appearance and / or aggravation of geriatric fragilities.

Detailed description: Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment:

* Number of D-FOGs filled in: comparison with the number of patients included in the study and the number of visits of each patient.
* Regularity of the D-FOG self-questionnaire by the patient: comparison with the number of visits of the patient for a chemotherapy cure (HDJ or HDS).
* Number of criteria entered by D-FOG: comparison with the total number of criteria to be filled in
* Criterion analysis of D-FOG

Eligibility criteria: Inclusion Criteria:

* Patients aged 75 years and over
* Carriers of diagnosed cancer (excluding hematology)
* Whatever the location, uniqueness or multiple, duration of development and treatment status (adjuvant, neoadjuvant, locally advanced or metastatic)
* Seen in nursing consultant
* Beginning an oncological treatment
* Supported for oncology day hospital (HDJ) or weekly (HDS) chemotherapy
* Patient not opposed to participate in the study

Exclusion Criteria:

* Patients under 75 years of age
* Having not had an IDE ad consultation
* During oncological treatment
* Receiving Oral Therapy or hormone therapy alone
* Treated by radiotherapy alone or surgery alone
* Not attending a day or week oncology hospital
* Refusal to participate in research

Primary outcomes:
measure: Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU
Study officials:
affiliation: CHU Poitiers
name: VALERO SV SIMON, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02482428: Efficacy and Tolerability of Topical LFX453 for External Genital Warts
Official title: A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of Topical LFX453 Formulations in Patients With External Genital Warts (EGWs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: External Genital Warts
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-06-26
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%.

During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Circumcised male 18-60 years
* Clinical diagnosis of external genital warts
* Agree to remain abstinent or to use condoms during intercourse for the duration of the study
* Agree to digital photographs of treated area

Exclusion Criteria:

* Any treatment of genital warts within one month of treatment start
* HPV vaccination
* presence of warts larger than 200 mm2
* Genital herpes within one month of treatment start
* History of Bowenoid papulosis
* significant illness within 2 weeks of treatment start
* use of other investigational drugs
* known hypersensitivity to study drugs or constituents
* history of ECG abnormalities
* History of significant heart conditions
* Impaired renal function
* Abnormal liver function
* History of immunodeficiency disease
* Drug or alcohol abuse
* Immunosuppressive therapies
* Malignancies in the past 5 years
* hypertrophic scarring

Primary outcomes:
measure: Complete Clearance of Disease at Week 14
timeFrame: Week 14
measure: Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks
timeFrame: 30 weeks
Secondary outcomes:
measure: Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16
timeFrame: End of Treatment (EOT) Week 12 or Week 16
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Novartis Investigative Site
state: Illinois
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02521428: End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding
Official title: End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 226
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Surgical Intensive Care Department patients will be enrolled in the study

Brief summary: The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Detailed description: Decisions to limit life-support therapy are common on the intensive care unit (ICU). End-of-life decisions (EOLD) underlie a dynamic process and limitation of ICU-therapies is done sequentially. Questionnaire-based and observational studies on medical ICUs and in palliative care reveal blood transfusions as the first therapy physicians withhold in EOLDs. Whether this practice also applies to surgical ICU-patients is unknown.

The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Eligibility criteria: Inclusion Criteria:

* All surgical patients admitted to the ICU All surgical patients discharged death from the ICU

Exclusion Criteria:

* All patients discharged alive from the ICU

Primary outcomes:
measure: sequence of withdrawing life-sustaining treatment
timeFrame: 3 years
Secondary outcomes:
measure: factors associated with the withholding of specific ICU-therapies
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00233428: Study to Determine Racial and Gender Differences in Platelet Aggregation
Official title: Phase 1 Study to Determine Racial and Gender Differences in Platelet Aggregation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation
Keywords: Healthy volunteers
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2005-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to see if there is a racial and/or gender difference in platelet aggregation.

Detailed description: Genetic variability of various components of the coagulation system has been reported. Data on racial and gender differences in platelet aggregation are lacking.

We hypothesize that there are significant racial and gender differences on aggregatory response of platelets to commonly used agonists to evaluate platelet function such as adenosine diphosphate (ADP), epinephrine, collagen and arachidonic acid.

Eligibility criteria: Inclusion Criteria:

* Race of Caucasian, African American, or Hispanic

Exclusion Criteria:

* Chronic medical conditions
* Tobacco use
* Regular non-steroidal anti-inflammatory use, aspirin use, or use of one of the other anti-platelet drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTUHSC
state: Texas
Study officials:
affiliation: TTUHSC
name: Chanwit Roongsritong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Otahbachi M, Simoni J, Simoni G, Moeller JF, Cevik C, Meyerrose GE, Roongsritong C. Gender differences in platelet aggregation in healthy individuals. J Thromb Thrombolysis. 2010 Aug;30(2):184-91. doi: 10.1007/s11239-009-0436-x.
Clinical trial NCT05248828: Testing of New Method in Sanitizing Breast Pump Equipment in the NICU
Official title: Testing of New Method in Sanitizing Breast Pump Equipment in the NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Pumping
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 30
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: In the Neonatal Intensive Care Unit, mothers who wish to pump human milk for their hospitalized infant do so with an electric breast pump. All 10 breast pump parts are used to pump human milk 8-10 times a day. After each pumping session, breast pump parts that contact human milk are washed and air-dried thoroughly until next use. Once a day, clean pump parts are placed in a sanitation bag and steam sanitized in the microwave.

Brief summary: This study will evaluate a newly developed device, Q. Basin. The Q. Basin is a multifunctional, single patient use device that can sanitize breast pump parts, bottles, and reusable feeding devices for patients admitted under one year of age. Improving the current sanitation method would provide a quick and efficient sanitation process for breast pump parts. This study will compare the Q. Basin to the current method of steam bag sanitation.

Detailed description: Firstly, 10 participant's breast pump parts are collected, divided, washed, and dried before comparing the two methods of steam sanitation. We will test to compare the safety of the Q. Basin compared to the current method of steam bag sanitation. We will collect participant's breast pump parts and complete surface swab testing for bacteria and mold immediately after sanitation and additionally 24 hours later.

Secondly, 20 participant questionnaires will measure satisfaction ratings of participants pumping human milk for hospitalized infants using two different wash, dry and steam sanitation methods. This study design will determine if participant satisfaction improves with breast pump part sanitation using the Q. Basin, compared to the current steam sanitization bag method.

Eligibility criteria: Inclusion Criteria:

* Mothers who are pumping human milk for hospitalized infants in the Neonatal Intensive Care Unit.

Exclusion Criteria:

* Mothers under the age of 18 years.

Primary outcomes:
measure: Safety Rate
timeFrame: Immediately after steam bag sanitation
measure: Safety Rate
timeFrame: 24 hours later
Secondary outcomes:
measure: Satisfaction Rate Questionnaire
timeFrame: At the end of 2 cycles (each cycle is 3 hours) of steam bag sanitation
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Childrens Hospital Delaware
state: Delaware
Study officials:
affiliation: Nemours Childrens Health- Delaware
name: Marron
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01393028: Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
Official title: Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Angina Pectoris
Chest Pain
Keywords: coronary artery disease
angina pectoris
Stable chest pain complaints
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.


Eligibility criteria: Inclusion Criteria:

* Men and women aged \>18 years.
* Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.

Exclusion Criteria:

* A history of surgical or percutaneous coronary revascularization
* Non-revascularized angiographic obstructive coronary artery disease (\>50% diameter reduction).
* Normal invasive coronary angiography or stress imaging less than 1 years ago.
* Inability or unwillingness to provide informed consent.

Primary outcomes:
measure: Chest pain
timeFrame: 1 year
measure: Class IA Revascularizations
timeFrame: 1 year
Secondary outcomes:
measure: Overall medical expenses
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1 year
measure: Radiation dose
timeFrame: 1 year
measure: Major adverse cardiovascular events
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Leidschendam
country: Netherlands
facility: MC Haaglanden
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Havenziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
Study officials:
References:
citation: Lubbers M, Coenen A, Bruning T, Galema T, Akkerhuis J, Krenning B, Musters P, Ouhlous M, Liem A, Niezen A, Dedic A, van Domburg R, Hunink M, Nieman K. Sex Differences in the Performance of Cardiac Computed Tomography Compared With Functional Testing in Evaluating Stable Chest Pain: Subanalysis of the Multicenter, Randomized CRESCENT Trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Artery Disease). Circ Cardiovasc Imaging. 2017 Feb;10(2):e005295. doi: 10.1161/CIRCIMAGING.116.005295.