louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01892358: Preventing Bacterial and Viral Infections Among Injection Drug Users
Official title: Preventing Bacterial and Viral Infections Among Injection Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infection
HIV
Keywords: injection drug use
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission
* have injected heroin, cocaine, or meth for at least three months
* positive urine screen for heroin, cocaine, or meth

Exclusion Criteria:

* currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal
* cannot provide informed consent
* not able to complete interviews in English (expected to exclude \<5% of IDUs)
* in police custody, expecting incarceration
* unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes
* plan to move out of the Boston area in the next 12 months.

Primary outcomes:
measure: bacterial infections
timeFrame: one year
measure: high-risk behavior
timeFrame: one year
measure: health service use
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
citation: Freibott CE, Phillips KT, Anderson BJ, Stewart C, Liebschutz JM, Stein MD. Under the Skin: The Relationship Between Subcutaneous Injection and Skin Infections Among People Who Inject Drugs. J Addict Med. 2022 Mar-Apr 01;16(2):164-168. doi: 10.1097/ADM.0000000000000844.
citation: Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.
Clinical trial NCT06390358: Effects of Remote Cardiac Ischemic Preconditioning
Official title: Acute and Chronic Effects of Tefillin Use on Remote Cardiac Ischemic Preconditioning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Function and Preconditioning
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A heart attack occurs when blood flow is disrupted to the heart and is related to both the blockage and flow restoration (reperfusion injury). An occlusion during a heart attack can be cleared (mostly via stents), but there are no methods to decrease reperfusion injury even though animal studies have found that "preconditioning" has powerful protective effects. Through the observation of Jewish men wearing tefillin the investigators have discovered a method of bringing preconditioning to patients at risk for heart attacks. This study will focus on women as the majority of people who wear tefillin (and have been studied) are men.

Detailed description: Remote ischemic preconditioning (RIPC) is a process via which short bursts of ischemia result in dramatic subsequent protection in remote organs from a prolonged ischemic injury such as myocardial infarction from reperfusion injury. The translation of RIPC stimuli to clinically relevant therapies has not been successful as almost all prior research on RIPC (animal and human) involved the full blockage of blood flow to an organ or extremity (in humans commonly with full inflation cycles of a blood pressure cuff). Our laboratory's key translational insight involved the Jewish tradition of donning tefillin (phylacteries) that is traditionally worn on an almost daily basis by Jewish orthodox men on the non-dominant arm in a non-obstructive manner (NOB).

My laboratory has made substantial progress by demonstrating that tefillin induced NOB induces an RIPC phenotype in healthy (mostly) men. The overarching hypothesis of this proposal is that full arm NOB via tefillin results in a preconditioning stimulus in women that is sufficient to induce an RIPC phenotype. The sole aim will test the hypothesis that full arm NOB (in healthy females) results in an inducible RIPC phenotype that increases over time as measured via clinically relevant variables derived from heart rate variability monitoring and inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* Females over 18 years of age

Exclusion Criteria:

* Current medication use for medical condition or active medical condition

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: 6 days
Secondary outcomes:
measure: Inflammatory changes
timeFrame: 6 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References:
Clinical trial NCT06143358: Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
Official title: Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Qingkepingchuan Granules
Primary purpose: TREATMENT

Brief summary: Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of AECOPD.
2. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence
3. 40 years old ≤ age ≤ 90 years old
4. Patients who signed the informed consent form and volunteered to participate in the study

Exclusion Criteria:

1. Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.
2. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.
3. Pregnant or lactating patients.
4. Allergic to the clinical trial drugs.

Primary outcomes:
measure: Chinese Medicine Symptoms Scale
timeFrame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
measure: COPD assessment test
timeFrame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
measure: breathlessness measurement using the modified British Medical Research Council
timeFrame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Secondary outcomes:
measure: 6-minute walking test
timeFrame: Before the start of treatment, 2 weeks of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing University of Chinese Medicine
Study officials:
References:
Clinical trial NCT04617158: Comparing Adjustable Sutures Surgery
Official title: Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus, Comitant
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment

Detailed description: Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance

Eligibility criteria: Inclusion Criteria:

* More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients

Exclusion Criteria:

* Patients with previous strabismus surgery Patients with oblique deviations

Primary outcomes:
measure: Alignment of the strabismus
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine- Minia University
Study officials:
affiliation: Faculty of Medicine, Minia University
name: Sahar TA Abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04169958: Suicide Risk Assessment by Digital Means
Official title: Suicide Risk Assessment by Digital Means
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicide
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will recruit a total sample of N=50 in three stages:

* Males and Females
* 30 patients aged 12 - 18 years old (20% of the study sample) Participants will be recruited from the psychiatric ER (\~50%), outpatient clinics (\~20%), and inpatient wards (\~30%) at the Sheba Medical Center, the largest hospital in Israel, serving a very large, demographically heterogenic and socioeconomically diverse population.
* Psychiatric diagnosis: None, Affective Disorder, PTSD, ADHD, Personality Disorder, Anxiety Disorder, OCD.

Brief summary: This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients.

The system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately).

The data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior.

After the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously.

Note that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.


Eligibility criteria: Inclusion Criteria:

* Every patient who is examined in the psychiatric ward at the Sheba Medical Center
* Proper ability to give informed consent

Exclusion Criteria:

* A patient who is not independent and without an active therapist / guardian involved in the treatment

Primary outcomes:
measure: Correlations between collected digital data and suicidality rating score
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02840058: Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
Official title: Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.

Thus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.


Eligibility criteria: Inclusion Criteria:

* Patient with metastatic or locally advanced cancer candidate to anti-PD1/PDL1 immunotherapy
* Performance status 0, 1 or 2 on the ECOG scale
* Written informed consent

Exclusion Criteria:

* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
* Active autoimmune diseases, HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.

Primary outcomes:
measure: anti-telomerase specific Th1 responses
timeFrame: up to 12 months after the initiation of anti-PD1/PDL1 therapy
measure: objective response rate
timeFrame: up to 12 months after the initiation of anti-PD1/PDL1 therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital of Besançon
Study officials:
References:
Clinical trial NCT02028858: Cannabis and Parkinson's Disease Tremor: A Natural History Study
Official title: Cannabis and Parkinson's Disease Tremor: A Natural History Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinics; Washington State Parkinson's Disease Registry

Brief summary: This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.

Detailed description: Ten individuals with Parkinson's disease (PD) and tremor who use Cannabis were observed for two weeks. Individuals were asked to keep a journal of Cannabis use (form, delivery method, amount) and wear an accelerometer on the wrist with the dominant tremor. Analyses will be performed to describe whether Cannabis use affects PD tremor following use.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease
* Presence of PD-related tremor
* Currently using Cannabis for management of tremor
* Obtaining Cannabis in accordance with Washington State law
* Willing to log activities and experiences
* Willing to wear a motion sensor
* Able to attend 2 on-site visits

Exclusion Criteria:

* Presence of active infection within 5 days prior to enrollment
* Presence of unusual stressor within 5 days prior to enrollment
* Pregnancy

Primary outcomes:
measure: Percent reduction in tremor as measured by Opal movement sensor
timeFrame: Upon enrollment, ongoing for 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: Bastyr University
name: Laurie K Mischley, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03477058: In-Use Test With a Cosmetic Product to Treat Pruritus
Official title: In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pruritus
Keywords: chronic pruritus
acute pruritus
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: SIT Skin Investigation and Technology Hamburg GmbH
First posted: 2018-03-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of a questionnaire in an interview situation after two weeks of product treatment, giving special consideration to the cosmetic performance, efficacy and skin compatibility and with special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a dermatologist.


Eligibility criteria: Inclusion Criteria:

* age: ≥ 18 years
* sex: approx. 25% to 50% male and 50% to 75% female
* with acute pruritus (lasts less than 6 weeks) or chronic pruritus (lasts longer than 6 weeks): max. 50% with acute pruritus and at least 50% with chronic pruritus

Exclusion Criteria:

* any deviation from the above-mentioned criteria
* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
* topical medication in the test area within 1 month prior to study start
* systemic medication with antibiotics within 2 weeks prior to starting of the study
* change in the medication with anti-inflammatory agents within 2 weeks prior to starting the study
* systemic medication with immunomodulators (immunsuppressive drugs in the course of a transplantation) and/or chemotherapeutic agents within 4 weeks prior to starting the study
* neurodermatitis (atopic dermatitis)
* pregnancy and period of breastfeeding

Primary outcomes:
measure: Cosmetic Features of the Test Product
timeFrame: baseline, two weeks
measure: Reduction of Pruritus
timeFrame: baseline, two weeks
Secondary outcomes:
measure: Tolerance of the Test Product on the skin
timeFrame: baseline, two weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: SIT Skin Investigation and Technology Hamburg GmbH
Study officials:
affiliation: Dermatologist
name: Alexandra Gust, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01902758: Drug Combination on Exercise Performance at High Altitude
Official title: Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Mountain Sickness
Keywords: exercise performance
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.


Eligibility criteria: Inclusion Criteria:

* healthy males

Exclusion Criteria:

* VO2max below 45ml/kg/min
* currently taking any medication

Primary outcomes:
measure: Time (Minutes) to Complete 2 Miles on a Treadmill
timeFrame: after arriving at high altitude (within 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Missoula
country: United States
facility: Montana Center for Work Physiology and Exercise Metabolism
state: Montana
Study officials:
References:
Clinical trial NCT04407858: Cardiovascular Complications of Carfilzomib
Official title: Insuffisance Cardiaque Sous Carfilzomib: étude Prospective
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myeloma
Heart Failure
Hypertension
Keywords: Adverse drug event
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 60
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: Prospective cohort of patients starting carfilzomib treatment.

Brief summary: Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.


Eligibility criteria: Inclusion Criteria:

* Intention to treat by Carfilzomib

Exclusion Criteria:

* History of carfilzomib treatment

Primary outcomes:
measure: Incidence of cardio-vasculo-toxicity of carfilzomib
timeFrame: 6 months
Secondary outcomes:
measure: Systemic hypertension
timeFrame: 6 months
measure: Heart Failure Reduced Ejection Fraction
timeFrame: 6 months
measure: Heart Failure Preserved Ejection Fraction
timeFrame: 6 months
measure: Predictors of Cardiotoxicity
timeFrame: 6 months
measure: Impact on outcomes
timeFrame: 1 year
measure: Safety
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris - Centre Université de Paris
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris - Université de Paris
name: Mariana Mirabel
role: PRINCIPAL_INVESTIGATOR
References: