louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00551226: Follow up of Autoantibodies in Active Tuberculosis
Official title: Follow up of Autoantibodies in Active Tuberculosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Keywords: TB
Patients with tuberculosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with active tuberculosis who are currently receiving anti tuberculosis drugs

Brief summary: We have previoulsy shown that patients with active Tuberculosis develop a wide array of autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm antibodies. The purpose of this study is to evaluate whether the level of autoantibodies decrease after treatment aganist tuberculosis.


Eligibility criteria: Inclusion Criteria:

* Active Tuberculosis treated

Exclusion Criteria:

* None

Primary outcomes:
measure: Follow up after levels of autoantibodies
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Ori Elkayam, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056026: A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
Official title: A Single Dose FMT Infusion From a Healthy Family Donor Via Colonoscopy as an Adjunct to Keytruda for the Benefit of Improving Efficacy of Immunotherapy for Metastatic Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mesothelioma
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda

Detailed description: Studies have shown that a favorable microbiome can be the difference between response and non-response of certain cancer treatments such as PD-1 blockade inhibitors. As such the investigators propose to ensure a favorable microbiome in this patient by fecal microbiota transplant to enhance the efficacy of such a drug, Keytruda.

Eligibility criteria: Inclusion Criteria:

* Patient with metastatic mesothelioma deemed a candidate for PD-1 blockade inhibitor therapy

Exclusion Criteria:

* Patient unable/unwilling to comply with protocol
* Patient deemed not a candidate for PD-1 Blockade inhibitor therapy

Primary outcomes:
measure: Progression free survival
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
References:
Clinical trial NCT06528626: Tools to Identify People At Risk or Already Infected with HIV and HCV
Official title: Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to Identify People At Risk or Already Infected with HIV and HCV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
STD
HCV
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: European Union
First posted: 2024-07-30
Enrollment: 240000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV

Detailed description: Objectives: To reduce hidden and incident HIV and HCV infection, through the implementation of a risk and indicator conditions self-questionnaire SQ-R\&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests (RT), in the Health Centers (HC). Methodology: stepped-wedge cluster randomized trial in 8 CS of the community of Madrid, to to know if the implementation of the 2 tools described above, improve risk identification and subsequent screening for HIV and HCV infection. In the standard of care branch (SOC), the health personnel will ask people a series of questions to identify the HIV risk exposition, and also they will be provided pop-up computer alerts of HIV indicator conditions in the electronic medical record, moreover HIV and HCV serological tests will be carried out in the reference laboratory, while in the intervention branch in addition to the SOC, a SQ-R\&IC of HIV and HCV will be made available to the HC population, through a quick response (QR) code, as well as HIV and HCV RT. The variables that will be compared are the percentage of HIV and HCV tests performed, of people referred to receive PrEP, and of new HIV and HCV diagnoses or not linked to care that are made during the periods assigned to the EDC branch vs. those in the intervention branch.

Eligibility criteria: Inclusion Criteria:

- 14-65 years in the health area or who are captured for inclusion by health personnel. They give their consent to participate.

Exclusion Criteria:

* Having already been included in the study, not signing the consent.

Primary outcomes:
measure: Implementation of a risk and indicator conditions self-questionnaire SQ-R&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Maria J. Vivancos-Gallego
Study officials:
References:
Clinical trial NCT02566226: Impact of Intrathecal Morphine on Sleep Apnea Syndrome
Official title: Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.


Eligibility criteria: Inclusion Criteria:

* physical status I - III
* patients scheduled to undergo hip arthroplasty

Exclusion Criteria:

* planned surgical duration more than 3 hours
* contraindication to spinal anaesthesia
* severe respiratory disease
* patient known and treated for sleep apnea syndrome

Primary outcomes:
measure: apnea hypopnea index while lying supine
timeFrame: postoperative night 0
Secondary outcomes:
measure: apnea hypopnea index while lying in another position than supine
timeFrame: postoperative night 0
measure: mean pulse oxymetry
timeFrame: postoperative night 0
measure: STOP-BANG questionnaire
timeFrame: 24 h before surgery
measure: Berlin questionnaire
timeFrame: 24 h before surgery
measure: Epworth questionnaire
timeFrame: 24 h before surgery
measure: pain scores (numeric rating scale, 0-10)
timeFrame: postoperative day 0, 1, 2 and 3
measure: oxycodone consumption (mg)
timeFrame: postoperative day 0, 1, 2 and 3
measure: postoperative nausea and vomiting (yes/no)
timeFrame: postoperative day 0, 1, 2 and 3
measure: Pruritus (yes/no)
timeFrame: postoperative day 0, 1, 2 and 3
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
Study officials:
affiliation: University of Lausanne Hospitals
name: Eric Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albrecht E, Bayon V, Hirotsu C, Al Ja'bari A, Heinzer R. Intrathecal morphine and sleep apnoea severity in patients undergoing hip arthroplasty: a randomised, controlled, triple-blinded trial. Br J Anaesth. 2020 Nov;125(5):811-817. doi: 10.1016/j.bja.2020.07.052. Epub 2020 Sep 6.
Clinical trial NCT02483026: Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy
Official title: Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy: Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Bone Density and Structure, Unspecified
Vitamin D Deficiency
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2015-06-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will examine the effect of providing a structured program of daily nutritional supplements for a 8 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on bone mass density status and formation of critical nutritional deficiencies years after the surgery.

Detailed description: The present study hypothesis holds that providing an adequate nutritional supplements program prior to the surgery, combined with postoperative monitoring, will significantly lower the incidence of nutritional deficiencies in patients undergoing Sleeve Gastrectomy surgery, and will reduce complications arising from these pre-operative deficiencies.

The investigators plan to examine the effect of Vitamins supplementation prior to surgery on the status of postoperative deficiencies one year after the surgery. Evaluation of outcomes will be made based on the results of blood tests specified, and related tests of bone density.

Eligibility criteria: Inclusion Criteria:

* Candidates for bariatric surgery
* BMI over 35 kg / m 2 accompanying morbidity or BMI over 40 kg / m 2,
* pre-operative evaluation standards with matching to carry sleeve gastrectomy surgery
* Vitamin D deficiency prior to surgery

Exclusion Criteria:

* patients who underwent bariatric surgery in the past
* psychiatric or mentally contraindication for the procedure
* lack of consent to follow-up
* endocrine problem that affects the weight that is unbalanced.
* Chronic kidney disease (CKD), nephrolithiasis
* Hypercalcaemia
* Hypercalciuria and renal stones nephrolithiasis
* Pregnancy, breastfeeding
* Using medications or disease condition known as affecting the status of calcium or bone metabolism 3 month prior to intervention
* Taking any nutritional supplements 2 weeks before the study.

Primary outcomes:
measure: bone mass density
timeFrame: 1 year
Secondary outcomes:
measure: Weight loss after the surgery
timeFrame: 1 year
measure: Vitamin D status after the surgery
timeFrame: 1 year
measure: Vitamin B12 status after the surgery
timeFrame: 1 year
measure: Iron status after the surgery
timeFrame: 1 year
measure: Parathyroid hormone (PTH) status after the surgery
timeFrame: 1 year
measure: Folate status after the surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah hebrew university medical center
Study officials:
References:
Clinical trial NCT03139526: Social Participation After Childhood Craniopharyngioma
Official title: Social Participation After Childhood Craniopharyngioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children With a Craniopharyngioma
Keywords: Craniopharyngioma
Children
Social participation
Life-H questionnaire
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the pediatric neurosurgery department of Hospices Civils de Lyon between 2007 and 2013

Brief summary: Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of multiple complications, from endocrinology to vision, neurology and neurocognitive functions. This morbidity can lead to reduced participation in life activities, as described in the International Classification of Functioning, Disability, and Health (ICF). The primary objective of this study is to measure participation in life activities in a population of children affected by childhood craniopharyngioma, using the assessement of life habits questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in various pediatric disabilities.


Eligibility criteria: Inclusion Criteria:

* Children with a craniopharyngioma

Exclusion Criteria:

* None

Primary outcomes:
measure: LIFE-H questionnaire (Assessment of Life Habits)
timeFrame: At maximum 6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03095326: Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
Official title: Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thalassemia
Pneumococcal Infection
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial. The subjects were then randomly assigned into one of 2 groups (the zinc group and the placebo group). Zinc was provided in the form of syrup at a dose of 1.5 mg/kg/day, with a maximum of 50 mg/day. The placebo was also provided in the form of syrup, with similar shape and flavor.
Primary purpose: PREVENTION

Brief summary: Splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2 groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day (maximum of 50 mg/day). Pneumococcal IgG examinations were conducted at the start of the trial and after 12 weeks.

Detailed description: This study is a single blinded randomised-control trial. Splenectomized thalassemia major patient samples were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2 groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day (maximum of 50 mg/day). Placebo containing sucrose syrup of the same form, taste, consistency and color was given to the other group. Everyone except the primary researcher are blinded to which of the treatment is placebo and which is actual zinc syrup. Pneumococcal IgG examinations were conducted at the start of the trial and after 12 weeks.

Sample size was measured using:

n1=n2=n= {((Zα+Zβ) Sd)/d}\^2 where N = number of subject Za = degree of significance (5%), a = 5% Zb = strength of study (80%). b = 20% Sd = standard deviation d = meaningful difference between the two groups The measured sample size is 816, but due to limited patient total population sampling was used instead.

Eligibility criteria: Inclusion Criteria:

* Splenectomised thalassemia patient

Exclusion Criteria:

* non-splenectomised thalassemia patient

Primary outcomes:
measure: Pneumococcal IgG
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Faculty of Medicine University of Indonesia
name: Teny T Sari, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00153426: West Virginia WISEWOMAN Project
Official title: West Virginia WISEWOMAN Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction Behavior
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 733
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.


Eligibility criteria: Inclusion Criteria:

* NBCCEDP

Exclusion Criteria:

-

Primary outcomes:
measure: change in physical activity and nutrition lifestyle behaviors
timeFrame: baseline and one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Julie Will
role: STUDY_CHAIR
References:
Clinical trial NCT03369626: Effectiveness of a Digital Therapeutic on Type 2 Diabetes
Official title: Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: FareWell
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: evaluation of pre/post measures of a single group
Primary purpose: TREATMENT

Brief summary: A clinical study evaluating a three month digitally delivered lifestyle change program in adults with Type 2 Diabetes. The FareWell Program (the "Program") aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. The current study is designed to evaluate to what degree adults with Type 2 Diabetes engaged with the Program can improve glycemic control and/or decrease medication needs.

Detailed description: The Program aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. It includes meal planning tools, smart shopping lists, recipes curated by a physician, dietitian and chef educator, daily self-monitoring features with personalized weekly goals, bi-weekly live one-on-one health coaching and support from an online member community, and an educational curriculum. Subjects in the Program may receive support from other members of a Care Team (lifestyle medicine physician, chef educator, registered dietitian and/or psychologist/psychiatrist) as needed. The Care Team does not provide medical advice, nor replace traditional medical care. Instead, the Care Team encourages behavior change by providing support and sharing its expertise.

Study participants will have access to the Program for a twelve week period and will be asked to complete short health surveys at baseline and at the end of the study.

Eligibility criteria: Inclusion Criteria:

* diagnosis of type 2 diabetes

Exclusion Criteria:

* Inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend English.
* Does not have a smartphone (either an iPhone or Android phone)

Primary outcomes:
measure: Level of engagement with the assigned mobile app
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in self-reported Hemoglobin A1c
timeFrame: 12 weeks
measure: Change in self-reported diabetes medication type or dose
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: FareWell LLC
state: California
Study officials:
affiliation: FareWell
name: Mark Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03253926: Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
Official title: Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cannabis Use
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-08-18
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Detailed description: In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have developed a laboratory model to investigate the effects of potential treatment medications on cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non treatment-seeking cannabis smokers. In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Eligibility criteria: Inclusion Criteria:

* Current cannabis use
* Able to give informed consent and perform study procedures
* Women practicing an effective form of birth control
* English speaking

Exclusion Criteria:

* Presence of any clinically significant medical diagnoses
* History of heart disease and cardiac risk factors, severe chronic obstructive pulmonary disease, uncontrolled hypertension, or diabetes
* Current parole or probation
* Certain psychiatric diagnoses
* Current pregnancy or lactation

Primary outcomes:
measure: Cannabis Self-administration
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References: