louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01809652: Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
Official title: Remote Implant Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Sudden Cardiac Arrest
Keywords: Pacemaker
Defibrillator
Remote Consultation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics.

The intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. As such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. This may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.


Eligibility criteria: Inclusion Criteria:

* Planned IPG implant or planned ICD (without CRT) implant
* Signed informed consent

Exclusion Criteria:

* Pacing dependency
* Defibrillation threshold testing planned
* Basal ventricular rate \>110 beats per minute
* Younger than 18 years
* Pregnant
* Currently involved in another IPG or ICD related clinical trial

Primary outcomes:
measure: System Integrity
timeFrame: At implant
measure: Successful Support
timeFrame: At implant
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Centennial Heart
state: Tennessee
Study officials:
References:
Clinical trial NCT04111952: The Effect of Additional Laser Treatments.
Official title: The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lax Vaginal Introitus
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Detailed description: The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.

Eligibility criteria: Inclusion Criteria:

* Previously treated with 3 laser treatments.
* Clear PAP test from the last 3 years.

Exclusion Criteria:

* Vaginal bleeding of unknown source.
* Vaginal surgery in the past 9 months.

Primary outcomes:
measure: Length of effect
timeFrame: From the treatment session up to 6 months post-treatment
Secondary outcomes:
measure: Female sexual function index
timeFrame: From the treatment session up to 6 months post-treatment
measure: Sexual intercourse
timeFrame: From the treatment session up to 6 months post-treatment
measure: Urinary distress index
timeFrame: From the treatment session up to 6 months post-treatment
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339452: Impella Supported OPCABG
Official title: Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: a Single Center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischemic Cardiomyopathy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2020-04-09
Enrollment: 30
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 fitting inclusion criteria will undergo Impella supported OPCABG using coronary shunts. Inclusion criteria will target patients with ischemic cardiomyopathy, similarly defined to the STICH trial which evaluated coronary revascularization in the setting of heart failure (defined by an EF≤35%). Patients would be considered for enrollment in the setting of symptomatic severe multi-vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon).

Brief summary: The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Ejection fraction ≤ 35%
* Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or Left main disease
* Adequate Distal target caliber (as determined by the PI or operating surgeon)

Exclusion Criteria:

* Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:

  * Patients with structural heart disease requiring cardiopulmonary bypass
  * Patients with cardiogenic shock who require a period of short-term mechanical circulatory support
  * Patients with mechanical aortic valve
  * Patients with previous median sternotomy
  * Patients with evidence of non-viability on preoperative cardiac MRI or CT scan
  * Insufficient conduit
  * BMI over 50
  * Suspected or known pregnancy

Primary outcomes:
measure: Intraoperative hemodynamic stability
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Lucian A Durham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03151252: Improvement of Foodallergy Diagnostic in Gastrointestinal Tract
Official title: Improvement of Foodallergy Diagnostic in Gastrointestinal Tract With a New Kind of Sampling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s controversial.

Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.


Eligibility criteria: Inclusion Criteria:

* all patients with suspicion of food intolerance and confirmed food allergy

Exclusion Criteria:

* pregnant and patients under allergy medication (antihistaminic, cortison)

Primary outcomes:
measure: detection of specific IgE Antibodies in colon
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
References:
citation: Dieterich W, Tietz E, Kohl M, Konturek PC, Rath T, Neurath MF, Zopf Y. Food Intolerance of Unknown Origin: Caused by Mucosal Inflammation? A Pilot Study. Clin Transl Gastroenterol. 2021 Feb 17;12(2):e00312. doi: 10.14309/ctg.0000000000000312.
Clinical trial NCT03053752: Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
Official title: Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and 3 of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for Parkinson's Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints, with the current Burst. We used the paired sample t-test, considering p ≤ 0.05.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn \& Yahr (HY) scale

Exclusion Criteria:

* Patients with Mini Mental State Examination (MMSE) lower than 18 points, with other associated neurological diseases and on medication for depression, anxiety, psychosis and sleep inducers.

Primary outcomes:
measure: Scale for Parkinson's disease (PDSS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07000552: Emotional Freedom Technique During Pregnancy
Official title: The Effect of Emotional Freedom Technique Applied to Primigravidas on Fear of Childbirth, Memory of Childbirth and Postpartum Security Sense: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fear of Birth
Birth Memory
Keywords: emotional freedom technique
sense of security
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emotional Freedom Technique (EFT), also known as "Tapping Therapy" and "Needleless Acupuncture", is a new and emerging complementary and energy-based therapy. It is a psychophysiological intervention combining cognitive behavioural therapy, exposure therapy and physical stimulation using acupressure points. This research will be conducted to evaluate the effect of emotional liberation technique applied to primigravidas on fear of childbirth, birth memory and postpartum feelings of safety. The research will be conducted between June 2025 and December 2025 in Konya Necmettin Erbakan University Faculty of Medicine Hospital, Department of Obstetrics and Gynaecology, Pregnant Outpatient Clinic with primiparous women planning vaginal delivery. This research is planned to be conducted with two groups, EFT intervention and control group. The population of the study consisted of pregnant women who applied to the pregnancy outpatient clinic of a university hospital located in the city centre of Konya province and were evaluated for eligibility.


Eligibility criteria: Inclusion Criteria:

* Primary education level or higher
* Able to speak, understand and write Turkish,
* 18 years of age or older,
* Residing in Konya province,
* No disability for vaginal delivery,
* Primigravida,
* Anxiety level of 1 or higher when measured with the subjective discomfort unit scale,
* Pregnant women who are at 32 weeks of gestation or above according to the last menstrual date or according to calculations made with USG data for pregnant women who do not know the last menstrual date.

Exclusion Criteria:

* Pregnant individuals with high-risk pregnancies,
* Those who have undergone infertility treatment,
* Those with any fetal health problems,
* Those with physical or mental illnesses,
* Those with a cesarean section indication or who plan to deliver via cesarean section,
* Those with chronic and/or psychiatric health issues and those who have participated in any childbirth preparation education were excluded from the study.

Primary outcomes:
measure: EFT Intervention
timeFrame: 4 weeks
measure: Control grup
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
References:
Clinical trial NCT00882752: Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy Sample
Official title: Retrospective Study Protocol: Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molecular Analysis
Keywords: Ulcerative Colitis (UC)
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with ulcerative colitis.

Brief summary: The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. Therefore, this methodology may prove useful to other researchers or physicians.

Detailed description: The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. The molecular method worked well, so it is appropriate to share the method with the medical and scientific communities.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ulcerative colitis
* Age \>= 18 years old
* Female

Exclusion Criteria:

Anyone not meeting inclusion criteria.

Primary outcomes:
measure: The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southwest Regional Wound Care
name: Randall Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Regional Wound Care Center
name: Randall Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05401552: Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans
Official title: The Impact of Phosphate Bioavailability on the Hormonal Response to a Breakfast Meal in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phosphate Overload
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: cross-over design
Primary purpose: OTHER

Brief summary: Convenience food is enhanced with phosphate additives in order to modify taste and texture and for preservation. The purpose of this study is to measure the response of phosphate-related hormones to two different types of breakfast meals that contain the same amount of phosphate but in different forms. This study is a cross-over design.

Detailed description: In the first meal, the participant will consume a standard convenience breakfast meal comprised of a cheese tea biscuit and two Eggo waffles. The amount of phosphorus contained in this meal is 700 mg and the majority of this phosphate would be in the form of phosphate additives. Urine and blood will be collected before and after consumption of the meal to measure how the body responds to the meal. Specifically, levels of phosphate, calcium, creatinine (measure of kidney function) and three hormones involved in phosphate regulation (parathyroid hormone, fibroblast growth factor-23 and vitamin D) will be measured in each blood sample. Creatinine, calcium and phosphate will be measured in each urine sample. The second meal will also contain 700 mg of phosphorus and similar caloric content but in a healthy breakfast meal that does not contain any phosphate additives, consisting of one cup of All-Bran breakfast cereal with milk and a piece of fruit. The same blood and urine tests will be assessed after the second meal.

Eligibility criteria: Inclusion Criteria

* healthy

Exclusion Criteria:

* kidney disease

Primary outcomes:
measure: Urine phosphate excretion
timeFrame: 4 hours
Secondary outcomes:
measure: urine calcium excretion
timeFrame: 4 hours
measure: Blood phosphate and calcium
timeFrame: 3 hours
measure: Parathyroid hormone
timeFrame: 4 hours
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Kingston
country: Canada
facility: Rachel Holden
state: Ontario
Study officials:
affiliation: Queen's University
name: Rachel M Holden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06120452: A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation
Official title: A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Lead sponsor: Rael
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the efficacy of the Rael Miracle Clear Complete Acne Serum product in improving facial acne and post-acne pigmentation. This study will last for 56 days. The study will be conducted as a single-arm trial where all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 1, Day 3, Day 7, Day 14, Day 28, and Day 56. Photos will be taken at Baseline, Day 28, and Day 56. The photos from Baseline and Day 56 will undergo expert skin grading


Eligibility criteria: Inclusion Criteria:

* Female. Age 18+. Currently experiencing mild to moderate acne issues. Generally healthy -and not living with any uncontrolled chronic disease.

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Anyone currently using an oral and/or topical prescription acne treatment. Anyone unwilling to stop using their current acne supplements. Anyone with known severe allergic reactions. Anyone unwilling to avoid excessive sun exposure. Anyone who is breastfeeding, pregnant, or attempting to become pregnant. Anyone unwilling to follow the study protocol. Anyone who identifies as having sensitive skin.

Primary outcomes:
measure: Changes in the appearance of facial acne. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in the appearance of post-acne pigmentation. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
Secondary outcomes:
measure: Changes in facial skin hydration. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in facial skin softness. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in facial skin texture. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT05848752: Studies of Human Inference Using On-line Testing
Official title: On-line Crowdsourcing of Multi-Timescale Inference Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Houston
First posted: 2023-05-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will record behavioral responses from human participants on crowdsourcing platform Prolific to identify the decision strategies humans apply short-term, long-term, and multi timescale (across both timescales) inference tasks. Participants will perform a Jar Switching Task (described in Research Strategy Aim 1- "Jar Switching Task") in which balls are drawn with replacement from one of two known jars. The current jar in use switches based on an underlying change rate across trials. Subjects must perform three task blocks: 1) report the current jar in use (short-term inference), 2) predict the subsequent jar (long-term inference), and 3) both report and predict the jars (multi-timescale inference). The investigators will record these responses, the number (and sequence) of balls drawn, and the response time (time from the end of trial until the response) for each trial. Subjects will perform all blocks (parameters and number of blocks to be determined by inference model development and testing prior to task development) so that we can compare responses at each timescale. Since participants participate voluntarily for small sums of money (around $10/ hour based on duration of task) and the investigators' previous studies have collected over 200 subjects in a matter of days, they will aim to record behavioral data from 1000 subjects. This number allows them to address the broad range of subject variability expected using Bayesian statistical methods such as Bayes factors.


Eligibility criteria: Inclusion Criteria:

* Adult Prolific participants who have a 95% approval rating and achieve a minimum score of 80% on our pre-test,
* Speak fluent English
* Are in the US.

Exclusion Criteria:

* None

Primary outcomes:
measure: Binary Behavioral Decision Responses
timeFrame: Through task completion on each task trial, approximately 1-5x/ minute for approximate 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Tahra Eissa
role: PRINCIPAL_INVESTIGATOR
References: