louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05958329: Short Sessions of HRV Biofeedback
Official title: Remote Short Sessions of Heart Rate Variability Biofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Remote 5 minute sessions of heart rate variability (HRV) biofeedback will be employed by participants for 5 weeks. Subjects will be followed for a total of 17 weeks. Surveys assessing psychological well being will be completed during the study period. Wearable devices will be worn to monitor HRV response during the study period.


Eligibility criteria: Inclusion Criteria:

* Participants were recruited from The Mount Sinai Hospital, Morningside Hospital, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai Queens, New York Eye and Ear Infirmary, and Mount Sinai Brooklyn.
* Eligible participants were 18 years of age or greater.
* Had an iPhone series 5 or greater.
* Had or were willing to wear an Apple Watch 4 or greater.
* Potential participants were excluded if they had an underlying chronic disease or used a medication that is known to impact autonomic nervous system function.

Exclusion Criteria:

* Underlying chronic diseases including but not limited to:

  * rheumatoid arthritis
  * systemic lupus erythematosus
  * inflammatory bowel disease
* Use of medications that impact heart rate variability including but not limited to:

  * beta-blockers (ie. atenolol, carvedilol, metoprolol, Coreg, Tenormin, Normodyne, Trandate)
  * digoxin
  * calcium channel blockers (ie. Norvasc, amlodipine, Cardene, nicardipine, Procardia, nifedipine, Cardizem, diltiazem)
  * regularly used benzodiazepines

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Up to Week 7
Secondary outcomes:
measure: Connor-Davidson Resilience Scale (CD-RISC
timeFrame: Up to Week 17
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert Hirten
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084629: The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus
Official title: The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) for the Detection of Dysplasia in Barrett's Esophagus and in Post Ablation Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Surveillance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Barrett's esophagus

Brief summary: The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa post ablation and to assess the ability of the Fujinon FICE system to detect this, as compared to white light endoscopy. A subgroup will also be compared with laser confocal microscopy


Eligibility criteria: Inclusion Criteria:

* Visible Barrett's esophagus
* Scheduled for Surveillance Endoscopy
* Able to undergo endoscopy

Exclusion Criteria:

* Unable to undergo endoscopy
* Unable to stop blood thinning medications

Primary outcomes:
measure: detection of dysplasic areas
timeFrame: during surveillance endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Kenneth K Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03034629: Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses
Official title: Assessing the Reliability and Influence of Timing of Exercise on Transcranial Magnetic Stimulation (TMS) Neuroplasticity Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overall goal of this proposed study is to assess the reliability of plasticity measured by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst stimulation plasticity measures and to assess the influence of an acute bout of aerobic exercise on TMS plasticity measures.


Eligibility criteria: Inclusion Criteria:

* Adult males and females aged 18-70 years old.
* Primary language is English
* Exercise clearance

Exclusion Criteria:

* Presence of cognitive, neurologic or orthopedic conditions that could affect performance of the testing and training procedures
* History of migraines
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistance epilepsy
* Any current history of psychiatric illness
* Any unstable medical condition
* No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:
* The subject's past medical history, drug does, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs.
* The published TMS guidelines review medications to considered with TMS (Rossi, Hallet, Rossini, Pascual-Leone, \& Safety of TMS Consensus Group, 2009)
* Any metal in the brain, skull or elsewhere unless approved by the responsible MD
* Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
* Intracranial lesion
* Substance abuse or dependence within the past six months

Primary outcomes:
measure: Change in cortical synaptic plasticity
timeFrame: Baseline, 1 week
Secondary outcomes:
measure: Assess TMS plasticity measures on healthy individuals after an acute bout of exercise
timeFrame: Baseline, 3 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Joyce R Gomes-Osman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061229: Homeopathic Drug Proving Trial
Official title: Homeopathic Drug Proving Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2010-02-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main aim of the study is to determine whether a homeopathic drug in the potency C12 provokes more characteristic homeopathic proving symptoms after three weeks compared to a placebo in healthy volunteers.

Secondary aims are to develop and to test a qualitative analysis methodology on which to base a definition for drug-specific (characteristic) symptoms and to compile a profile of characteristic homeopathic proving symptoms of the drug being trialled for therapeutic purposes.

This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.


Eligibility criteria: Inclusion Criteria:

* Medical doctors or medical students
* Not being treated for any acute or chronic diseases on the day of inclusion
* Written informed consent.

Exclusion Criteria:

* Pregnant women or nursing mothers
* Homeopathic treatment over the previous six weeks
* Participation in another clinical trial during the last six months
* Anyone with a personal or professional dependence on the study physician or sponsor
* Anyone who has been placed in hospital or other institution by authorities or decree

Primary outcomes:
measure: The primary outcome parameter is the number of characteristic proving symptoms per subject, derived from the qualitative data analysis of the homeopathic proving drug compared to placebo.
timeFrame: 3 weeks
Secondary outcomes:
measure: Total number of proving symptoms
timeFrame: 3 weeks
measure: Number of serious adverse events
timeFrame: 3 weeks
measure: Qualitative differences in the profiles of characteristic proving symptoms
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University
Study officials:
affiliation: Charité University Berlin
name: Claudia M Witt, Prof, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teut M, Hirschberg U, Luedtke R, Schnegg C, Dahler J, Albrecht H, Witt CM. Protocol for a phase 1 homeopathic drug proving trial. Trials. 2010 Jul 22;11:80. doi: 10.1186/1745-6215-11-80.
citation: Teut M, Dahler J, Hirschberg U, Luedtke R, Albrecht H, Witt CM. Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial. Trials. 2013 Apr 5;14:96. doi: 10.1186/1745-6215-14-96.
Clinical trial NCT05173129: Posture Analysis for Patients With Haemophilia
Official title: Comparison of Posture and Muscle Stiffness of Adolescent Boys With Haemophilia and Those of Age-matched Healthy Peers: a Controlled Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Postural; Defect
Muscle Disorder
Keywords: haemophilia
posture
anti-gravity muscles
joint health
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 44
Sex: MALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cross-sectional study for two groups
Primary purpose: DIAGNOSTIC

Brief summary: Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may cause irreversible joint damage. Some degree of damage may already occur after the first haemarthrosis or even in children who never experienced clinically evident joint bleeds. Joints are mechanical systems with a structure strictly related to functioning. Therefore, any alteration in structure may have an impact on function (starting from the primary level of posture and anti-gravity muscles), which might in turn stress the joints and increase the risk of bleeding.The primary aim of this study is to investigate the changes in posture and the mechanical properties of anti-gravity muscles of adolescent PwH. The secondary aim is to determine the effect of joint dysfunction on posture in adolescent PwH.


Eligibility criteria: Inclusion Criteria:

* Adolescent boys with haemophilia A or haemophilia B (for experimental group) and healthy adolescent boys (for control group).

Exclusion Criteria:

* To be with another congenital coagulopathy such as von Willebrand syndrome.
* To be unable to stand without support due to hemophilic arthropathy.
* To be having another musculoskeletal problem.
* To be having factor VIII or IX level in the plasma above 6%

Primary outcomes:
measure: Photogrammetry
timeFrame: Baseline
measure: Myotonometric assessment
timeFrame: Baseline
Secondary outcomes:
measure: Haemophilia Joint Health Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Gazi University
name: Nevin A Guzel, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000229: Buprenorphine Detox With Two Types of Treatment. BBD II - 11
Official title: Buprenorphine Detox With Two Types of Treatment. BBD II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare overall treatment outcome between behavioral versus enhanced behavioral treatment types.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Weeks abstinent
measure: Weeks continuous abstinence
measure: Overall treatment outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110029: Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
Official title: Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Onychomycosis of Toenail
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 13
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.

Detailed description: Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.

Eligibility criteria: Inclusion Criteria:

* Female age 19-70, as 19 is the legal age in Alabama
* DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte
* Suitable for application of topical antifungal therapy, in the opinion of the investigator
* Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis
* Women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment

Exclusion Criteria:

* History of immunosuppression or concurrent use of immunosuppressant drugs
* History of uncontrolled diabetes mellitus
* History of psoriasis or any other condition that might interfere with the toenail evaluation
* Three or more dermatophytomas (streaks) on the target nail
* Severe DLSO of the target nail
* Patients who cannot refrain from wearing gel or plastic based polishes that are used in salons and that require curing

Primary outcomes:
measure: Percentage of Nail Polish Disruption Using the Likert Scale
timeFrame: 52 weeks
Secondary outcomes:
measure: Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
timeFrame: 52 week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Boni E Elewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643629: A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
Official title: A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Kasiak Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.


Eligibility criteria: Inclusion Criteria:

* Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
* Subjects willing to refrain from other AGA treatments during the entire study duration
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects aged \<18 or \> 50 years
* Subjects with dermatological disorder of scalp that might interfere with study evaluation
* Subjects on Anti-coagulant therapy
* Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
* Subjects with dermatological disorder of scalp that might interfere with study evaluation
* Subjects unwilling to or unable to comply with the study protocol.

Primary outcomes:
measure: Change in Calibre & Density of Hair as assessed by Folliscope
timeFrame: Day 0, Month 4, End of study - Month 6
Secondary outcomes:
measure: Photographic Assessment
timeFrame: Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Other outcomes:
measure: Physician's Assessment Score
timeFrame: End of study - Month 6
measure: Patient's Assessment Score
timeFrame: End of study - Month 6
Locations:
city: Thane
country: India
facility: Kasiak Research Pvt Ltd
state: Maharashtra
Study officials:
affiliation: Dr. Rajesh Rajput Hair Restore
name: Rajendarsingh Rajput, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hairrevive
name: Sandeep Sattur, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06155929: Traveler's Constipation
Official title: Traveler's Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Travel-Related Illness
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators are investigating wether a flight abroad is causing a decrease in stools.
Primary purpose: PREVENTION

Brief summary: The occurence of traveler's constipation is sparsely covered in the medical litterature. This study aims to determine the gastrointestinal-related discomforts related to traveling on a trip to Turkey.

Detailed description: Traveler's constipation, which is characterized by the more hard and less frequent stools, is sparsely covered in the medical litterature. Only a few studies have examined this problem and the actual occurrence and extent of this problem is not known. Hypotheses about why travel constipation occurs are, among other things, about changed circadian rhythm due to jet lag, changed schedules and tight sanitary conditions. Other factors such as dehydration, change in cabin pressure and the content of the in-flight food in connection with flights have not been investigated.

The research project aims to clarify changes in the test subjects' bowel habits as well as other gastrointestinal-related discomforts in connection with a flight abroad with only an hour's time difference and without the consumption of flight food.

Eligibility criteria: Inclusion Criteria:

* Can understand danish and is able to answer the questionnaires
* Given written consent

Exclusion Criteria:

* History of intestinal resection
* Medically treated intestinal disease
* IBS at baseline

Primary outcomes:
measure: Stool frequency
timeFrame: 14 days
Secondary outcomes:
measure: Bristol Stool Chart.
timeFrame: 14 days
measure: VAS-IBS: Visual Analog Scale for Irritable Bowel Syndrome
timeFrame: 14 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Danmark
Study officials:
References: