louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03870022: Pivot Breath Sensor Performance Study
Official title: Pivot Breath Sensor Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: UserWise, LLC
First posted: 2019-03-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A clinical study enrolling 70 subjects to:

* evaluate the user performance of the Pivot Breath Sensor
* compare measurements from the Pivot Breath Sensor to a similar device
* assess user documentation comprehension
* obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.

Detailed description: The objectives of this performance study are to:

* Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
* We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device.
* assess user documentation comprehension
* obtain feedback on the Pivot Breath Sensor via rating scales.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Owns and uses a smartphone
* Willing to sign the Informed Consent Form
* Resident of the United States
* Able to read and comprehend English

Exclusion Criteria:

* Prior experience with a study sponsored by Carrot Inc.
* Pregnancy

Primary outcomes:
measure: User Performance of Pivot Breath Sensor
timeFrame: Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
measure: Compare Performance of Pivot Breath Sensor With a Similar Device.
timeFrame: Each study session lasted up to 60 minutes per participant.
Secondary outcomes:
measure: User Documentation Assessment With Observer Ratings
timeFrame: Each study session lasted up to 60 minutes per participant. The user documentation assessment with observer ratings was done between approximately 10 and 35 minutes into the study session.
measure: Participant Feedback Using Rating Scale
timeFrame: Each study session lasted up to 60 minutes per participant. Use performance was assessed with rating scales at approximately 35 minutes into the study session.
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Carrot Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: Jen Marler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03937622: Northern Survey on Therapeutic Oxygen Prescription
Official title: Northern Survey on Therapeutic Oxygen Prescription
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxygen Toxicity
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients fulfilling the Inclusion criteria and not the exclusion criteria at 3 Centers in nothern Germany

Brief summary: This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic lung disease, age \> 18 years
* Established domiciliary LTOT \> 4 weeks
* Scheduled for control of oxygen therapy with arterial/capillary

Exclusion Criteria:

* No informed consent
* Pulmonary exacerbation within the last 2 weeks
* Signs of heart failure (edema, congestion)

Primary outcomes:
measure: Validation of indication of Long-term Oxygen therapy (LTOT)
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Dep. Respiratory Medicine, Hannover Medical School
city: Hannover
country: Germany
facility: Department of Respiratory Medicine, Medizinische Hochschule Hannover
Study officials:
affiliation: Hannover Medical School
name: Jens Gottlieb, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00571922: A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
Official title: A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Methamphetamine Dependence, Treatment Seeking
Keywords: methamphetamine, crystal, treatment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2007-12-12
Enrollment: 72
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: TREATMENT

Brief summary: This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.


Eligibility criteria: Inclusion Criteria:

* Methamphetamine dependence
* Treatment seeking
* Urine sample (+) for methamphetamine

Exclusion Criteria:

* Pregnancy
* Dependence on other drugs (except nicotine)
* DSM-IV axis I disorder unrelated to drug abuse
* Serious medical condition in clinicians opinion.
* AIDs
* Untreated syphilis
* Allergy to acamprosate
* Methadone, or other ORP, maintenance

Primary outcomes:
measure: Methamphetamine Abstinence
timeFrame: 7 day
Secondary outcomes:
measure: Craving
timeFrame: 7 day
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System, MHAD clinic
state: New York
Study officials:
affiliation: NYU Langone Health
name: Malcolm Reid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00603122: Acclimatization Mechanisms During Ascent to 7500m
Official title: Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Mountain Sickness
Keywords: altitude illness
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2008-01-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.


Eligibility criteria: Inclusion Criteria:

* Healthy, physically fit subject
* Mountaineering experience

Exclusion Criteria:

* Any type of cardiac or respiratory disease
* Regular intake of any medication
* History of high altitude pulmonary oedema
* Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.

Primary outcomes:
measure: acute mountain sickness
timeFrame: during ascent
Secondary outcomes:
measure: mountaineering success, oxygen saturation, breathing pattern
timeFrame: during ascent
Other outcomes:
Locations:
Study officials:
affiliation: Pulmonary Division, University Hospital of Zurich, Zurich, Switzerland
name: Konrad E Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.
citation: Garde A, Giraldo BF, Jane R, Latshang TD, Turk AJ, Hess T, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Hefti U, Merz TM, Schoch OD, Bloch KE. Periodic breathing during ascent to extreme altitude quantified by spectral analysis of the respiratory volume signal. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:707-10. doi: 10.1109/EMBC.2012.6346029.
citation: Latshang TD, Turk AJ, Hess T, Schoch OD, Bosch MM, Barthelmes D, Merz TM, Hefti U, Hefti JP, Maggiorini M, Bloch KE. Acclimatization improves submaximal exercise economy at 5533 m. Scand J Med Sci Sports. 2013 Aug;23(4):458-67. doi: 10.1111/j.1600-0838.2011.01403.x. Epub 2011 Nov 3.
citation: Bloch KE, Turk AJ, Maggiorini M, Hess T, Merz T, Bosch MM, Barthelmes D, Hefti U, Pichler J, Senn O, Schoch OD. Effect of ascent protocol on acute mountain sickness and success at Muztagh Ata, 7546 m. High Alt Med Biol. 2009 Spring;10(1):25-32. doi: 10.1089/ham.2008.1043.
Clinical trial NCT01110122: Effect of Whey Protein on Soccer Performance
Official title: The Effect of Post-exercise Supplementation With Whey Protein Versus Carbohydrate on Soccer Performance.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Damage
Keywords: Muscle recovery
Intermittent exercise
Whey protein
Soccer
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 50
Sex: MALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Rationale: During exercise protein breakdown in muscles is larger than protein synthesis. This negative muscle protein balance leads to increased muscle damage and thereby to a reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce muscle damage, many athletes use proteins. In professional soccer players, considerable stress is placed on the musculoskeletal system. Recovery time is often too short for these players to restore homeostasis, which results in catabolic processes. This increases playing errors and will lead to lapses in concentration. Therefore, it is of great importance for a professional soccer team to be in optimal condition and a fast recovery after exercise is desirable to accomplish maximum performance. Supplementation with whey proteins is thought to support this.

Objective: To assess whether post-exercise supplementation with whey protein will lead to a better muscle recovery than supplementation with carbohydrates in Dutch soccer players between the age of 15 and 18 years old.

Study design: A double blind randomised controlled cross-over trial.

Study population: Healthy soccer players of the A and B selection of AJAX between the age of 15 and 18 years old.

Intervention: Supplement, containing either whey proteins or an isocaloric carbohydrate placebo. Each supplement will be administered for 2 weeks separated by a 7 day washout period. Treatment order will be randomly assigned.

Main study parameters: The main study parameter will be the Yo-Yo intermittent recovery test level 2 score and the vertical jump test. The scores will evaluate the soccer players' ability to repeatedly perform intense exercise and his potential to recover from this exercise.


Eligibility criteria: Inclusion Criteria:

* performing soccer \>1 year
* part of A \& B selection of AJAX

Exclusion Criteria:

* presence of lactose intolerance
* presence of illness
* presence of injury

Primary outcomes:
measure: Muscle recovery
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Ajax
Study officials:
affiliation: VU University of Amsterdam
name: Ingeborg A Brouwer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958122: Cefixime Clinical Trial
Official title: Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Syphilis
Human Immunodeficiency Virus
Keywords: Cefixime
Treponema pallidum
Penicillin
Early Syphilis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: AIDS Healthcare Foundation
name: Universidad Peruana Cayetano Heredia
First posted: 2021-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.

Detailed description: This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
* 18 years of age or older
* Able to provide informed consent
* Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load \<200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment

Exclusion Criteria:

* Pregnancy or a positive pregnancy test on the day of enrollment
* Patients showing signs and symptoms of neurosyphilis
* Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater
* Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin)
* Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test
* Self-reported allergy to cephalosporins or penicillin
* Unwilling or unable to attend follow-up visits

Primary outcomes:
measure: Response to treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Jeffrey D Klausner, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00716222: Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients
Official title: Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Sleep Disorders
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the output clinics in the endocrinology and pediatric endocrinology departments at the university hospital.

Brief summary: There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. The goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.

Detailed description: The main purpose of the study is investigate whether the concentrations of 2 hormones that regulate appetite (leptin, ghrelin), cytokines (TNF-a, IL-6) and CRP are modified in obese adolescents and young adults who had sleep disorders in comparison to obese adolescents and young adults who sleep longer.

Eligibility criteria: Inclusion Criteria:

* 13-25 years old
* BMI \> 30 kg/m2 (If adolescents aged under 18 years: BMI equivalent to a BMI for age and sex to a BMI of 30, according to the Cole et al. obesity criteria).

Exclusion Criteria:

* Infection
* Liver disease
* Chronic inflammatory disease
* Endocrine disease
* Use of drugs that alter the sensitivity of insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Veronique Beauloye, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01475422: Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home
Official title: Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home in Metabolic Control of People With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The self-monitoring of capillary blood glucose is part of the package of interventions in diabetes mellitus and an effective therapeutic strategy for the adequate control of the disease; and the continuing education of people with DM is recognized as one of the goals to delay the complications arising from chronic disease and alleviate the symptoms of hypoglycemia and hyperglycemia.

Detailed description: This study aims to evaluate the effects of educational intervention on self-monitoring of capillary blood glucose in metabolic control, knowledge and attitude in two groups of patients with diabetes mellitus: a group of diabetic patients who participate in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive educational interventions (Intervention Group - G1) and a group of diabetic patients who participle in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive conventional treatment (Control Group - G2). As an educational tool in diabetes will be used Conversation Maps which is considered an interactive program of diabetes education.

Eligibility criteria: Inclusion Criteria:

* Ages 18 Years and older;
* Diagnosis of type 1 and 2 diabetes mellitus;
* In follow-up in the Self-Monitoring of Capillary Blood Glucose at Home Program;
* Have cognitive conditions that enable participation (minimum ability of users to understand issues of data collection instruments, observation of the researcher and/or of the caregivers).

Exclusion Criteria:

* Patients with gestational DM;
* Patients with DM who are not located;
* Those who die in the proposed period for the research;
* Those who dropout the Self-Monitoring of Capillary Blood Glucose at Home Program;
* Those who report difficulties to participate of the study due to work and those with amaurosis;
* Used Conversation Maps as an educational tool.

Primary outcomes:
measure: HbA1c
timeFrame: baseline, 3 and 6 months post intervention
Secondary outcomes:
measure: Diabetes Knowledge Questionnaire - DKN-A
timeFrame: baseline, 3 and 6 months post intervention
measure: Diabetes Attitude Questionnaire - ATT-19
timeFrame: baseline, 3 and 6 months post intervention
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo
state: São Paulo
Study officials:
References:
Clinical trial NCT06393322: Evaluate the Usefulness of Mental Health e-Learning
Official title: Randomized Trial to Evaluate the Usefulness of Mental Health e-Learning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: Depression
Mental Health
Mental Health Literacy
e-Learning
Knowledge
Stigma
Randomized Controlled Trial
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 125
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this proposal, the investigators plan to study the impact of In this proposal, we plan to study the impact of e-learning on mental health literacy and stigma related to anxiety and depression. Participants will be randomized to one of four groups - Depression e-Learning A, Depression e-Learning B, Anxiety e-Learning A, and Anxiety e-Learning B. All participants will be given access to all e-learning at the conclusion of the study.


Eligibility criteria: Inclusion Criteria:

* Live in Canada
* 45 years of age and over
* Good command of the English language
* Access to email and high speed internet
* Comfortable using email and internet

Exclusion Criteria:

* Lives outside of Canada
* Not 45 years of age or over
* Does not speak English,
* Does not have access to email or high speed internet
* Is not comfortable using email of internet

Primary outcomes:
measure: Change from baseline in the Depression Literacy Questionnaire
timeFrame: 0, 2, 4 weeks
measure: Change from baseline in the Anxiety Literacy Questionnaire
timeFrame: 0, 2, 4 weeks
Secondary outcomes:
measure: Change from baseline in the Depression Stigma Scale
timeFrame: 0, 2, 4 weeks
measure: Change from baseline in the Generalized Anxiety Stigma Scale
timeFrame: 0, 2, 4 weeks
measure: Participant satisfaction
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: