louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02440776: Pathway CH S&E Registry
Official title: Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cluster Headache
Lead sponsor: Autonomic Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 30
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: Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System

Brief summary: Monitor the safety and performance of the Pulsante Microstimulator System.


Eligibility criteria: Inclusion Criteria:

1. Patient meets CE marked labeling for cluster headache.
2. Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
3. Patient is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

1. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

Primary outcomes:
measure: Characterization of all device/procedure related Adverse Events
timeFrame: Through five years post implant
Secondary outcomes:
measure: Acute response to therapy
timeFrame: Through five years post implant
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet Neurocenter
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-University
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Kassel
country: Germany
facility: Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29
city: Munich
country: Germany
facility: Neurologie + Kopfschmerzzentrum Münchner Freiheit
city: Stockholm
country: Sweden
facility: Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26
city: Liverpool
country: United Kingdom
facility: The Walton Center
Study officials:
References:
Clinical trial NCT03240276: A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method
Official title: A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. an Ultra Morphology Section Method - Intracytoplasmic Morphology Selected Sperm Injection (IMSI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.


Eligibility criteria: Inclusion Criteria:

* Males aged 18-60
* Females aged 18-35
* Males defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
* Patients with 0.5- 7% normal sperm according to MSOME analysis
* Females with normal FSH and AMH values
* Females who have retrieved at least 6 oocytes in previous cycles
* Couples who have had at least 2 failed IVF-ICSI cycles

Exclusion Criteria:

* Couples who have been exposed to heavy smoking, drugs and chronic diseases
* Males who have undergone testicular surgery (TESE) or defined as severe OTA
* Females with egg factor infertility

Primary outcomes:
measure: Comparison of fertilization rate
timeFrame: Three years
measure: Comparison of embryo quality
timeFrame: Three years
Secondary outcomes:
measure: Implantation rate
timeFrame: Three years
measure: Pregnancy rate
timeFrame: Three years
measure: Miscarriage rate
timeFrame: Three years
measure: Live birth rate
timeFrame: Three years
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Einat Shalom Paz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillel Yaffe Medical Center
name: Medeia Michaeli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01659060: Chocolate Consumption in Healthy Pregnant Women Trial
Official title: Assessment of Blood Pressure and Endothelial Function Pregnancy After Acute and Daily Consumption Flavanol-rich Chocolate Among Healthy Pregnant Women: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension Pregnancy-induced
Keywords: Cacao
Chocolate
Theobromine
Flavonoids
Pregnant women
Hypertension pregnancy-induced
Pre-eclampsia
Epicatechin
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to to test the feasibility of design methods and procedures for later use on a larger scale and to examine the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.


Eligibility criteria: Inclusion Criteria:

* non-smoking normotensive women aged from 18 to 35 years, between the 7 and 12 weeks of gestation (documented by ultrasound) and having a live fetus confirmed by fetal heart auscultation

Exclusion Criteria:

* Patients with family history of premature cardiovascular disease
* Chronic hypertension
* Currently or previously use of medications interfering with glucose or lipids metabolism.
* Use of supplements or natural health products that interfere with blood pressure.
* Consumption of 1 or more alcohol drink per day.
* Allergy or intolerance to nuts or chocolate.

Primary outcomes:
measure: Changes in endothelial function and blood pressure
timeFrame: within the first 12 weeks of chocolate intake (week 12 and baseline)
Secondary outcomes:
measure: Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks
timeFrame: within the first 12 weeks of chocolate intake (week 12 and baseline)
measure: Weight change from baseline at 12 weeks
timeFrame: within the first 12 weeks of chocolate intake (week 12 and baseline)
measure: Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache)
timeFrame: within the first 12 weeks of chocolate intake (week 12 and baseline)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels
state: Quebec
Study officials:
affiliation: Laval University
name: Sylvie Dodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mogollon JA, Bujold E, Lemieux S, Bourdages M, Blanchet C, Bazinet L, Couillard C, Noel M, Dodin S. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial. Nutr J. 2013 Apr 8;12:41. doi: 10.1186/1475-2891-12-41.
Clinical trial NCT00001460: Evaluation and Treatment of Heart Disease in Patients Not Participating in Research
Official title: Evaluation and Therapy of Heart Disease in Patients Not Participating in Research (Teaching Protocol)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Congenital Heart Defect
Heart Disease
Keywords: Training Protocol
Cardiac Diagnosis
Congenital Heart Disease
Acquired Heart Disease
Arrhythmias
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: There is an important need to maintain clinical skills, provide quality training and expertise, and provide an environment that stimulates ideas for clinical research.

This study permits inpatient evaluation and management of patients with heart disease who do not qualify to participate in studies currently being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute.

Detailed description: There is an important need to maintain clinical skills, to ensure adequate training and expertise, and provide an environment that stimulates ideas for clinical research. This protocol permits inpatient evaluation and management of patients with heart disease who do not fulfill criteria for participation in existing Cardiology Branch research protocols.

Eligibility criteria: Patients with signs or symptoms of heart disease.

Patients selected because of either medical or research interest to the Principal Investigator.

Patients must not have unstable angina pectoris, unstable course following recent (within one month) myocardial infarction.

Must not be in New York Heart Association functional class IV heart failure.

A positive pregnancy test will obviate any cardiovascular testing requiring ionizing radiation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
Clinical trial NCT05786560: BABE(Body Appreciation and Better Eating), Add Some Self-compassion
Official title: BABE(Body Appreciation and Better Eating), Add Some Self-compassion: a Randomized Controlled Pilot Study for Black/African American High School Teenage Girls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Image
Eating Behavior
Binge Eating
Nutrition, Healthy
Disordered Eating
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 13
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Body dissatisfaction is most common among girls in their teenage years and young adulthood, this is also around the time where the risk of developing binge eating disorder is the highest. Black/African American girls are more likely to engage in binge eating behaviors compared to their White American counterparts; however, they receive less help for eating issues. Further, increase rates of obesity in the Black/African American population may indicate that binge eating may be a bigger problem for this population than discussed. Therefore, the primary purpose of this randomized controlled pilot is to assess the feasibility of this pilot study to be used in a large scale fully-powered study. The secondary purpose of this study is to assess if two different nutrition and body image programs elicit positive outcomes among Black/African American teenage girls who indicate a desire to improve body image.


Eligibility criteria: Inclusion Criteria:

* Female
* Black (Afro-Latina)/African American teenage girls
* Age 13 to 18 years old
* Attend high school in the United States
* Interest in nutrition

Exclusion Criteria:

* Eating disorder diagnosis
* Pregnancy

Primary outcomes:
measure: Feasibility of the BABE program (sample size)
timeFrame: 12 weeks
measure: Feasibility of the BABE program (retention)
timeFrame: 12 weeks
measure: Feasibility of the BABE program (randomization)
timeFrame: 12 weeks
measure: Participants' acceptability of the program
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-compassion for youth scale
timeFrame: 12 weeks
measure: Body Appreciation Scale-2
timeFrame: 12 weeks
measure: Mindful eating questionnaire
timeFrame: 12 weeks
measure: Childrens Brief Binge Eating Questionnaire
timeFrame: 12 weeks
measure: Motivations for Electronic Interaction Scale (MEIS)
timeFrame: 12 weeks
measure: The Social Connectedness Scale
timeFrame: 12 weeks
measure: Body-Related Shame and Guilt Scale (WEB-SG)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Nkechi Okpara, MS, RDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820560: Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB007839 Following Multiple Oral Doses in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors and Hematologic Malignancy
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.


Eligibility criteria: Inclusion Criteria:

* Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
* Evidence of venous thrombosis by flow Doppler examination at Screening
* A history of thrombosis or a coagulation disorder
* Patients with a contraindication to use of low dose warfarin and/or aspirin.
* Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
* Brain metastases or spinal cord compression
* Impaired renal function
* Inadequate bone marrow reserve

Primary outcomes:
measure: Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
timeFrame: Baseline through study completion
Secondary outcomes:
measure: Evaluation of response rates as measured by RECIST criteria
timeFrame: At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
measure: Evaluation of PSA laboratory values for response
timeFrame: Baseline and every visit through study termination
measure: Evaluation of PD markers for HER2 and ErbB ligand levels
timeFrame: Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Baltimore
country: United States
state: Maryland
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Incyte Corporation
name: William V Williams, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01174160: A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Official title: A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
First posted: 2010-08-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.

Detailed description: Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Eligibility criteria: Inclusion Criteria:

* Abstinent or willing to use 2 acceptable methods of birth control
* Patient has an atrial arrhythmia with dysrhythmic symptoms
* Patient is receiving adequate anticoagulant therapy
* Patient has stable blood pressure
* Patient weighs between 45 and 136 kg (99 and 300 lbs)
* Patient is adequately hydrated

Exclusion Criteria:

* Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
* Patient routinely consumes more than 2 alcoholic drinks per day
* Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
* Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
* Patient has severe aortic stenosis
* Patient has atrial flutter
* Patient has Class IV congestive heart failure (CHF)
* Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS)
* Patient has had cardiac surgery within 30 days
* Patient has known atrial thrombus
* Patient has reversible causes of Atrial Fibrillation
* Patient has failed electrical cardioversion during current episode of Atrial Fibrillation
* Patient has uncorrected electrolyte imbalance
* Patient has clinical evidence of digoxin toxicity
* Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days
* Patient is known to be HIV positive
* Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers

Primary outcomes:
measure: Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
timeFrame: Within 90 minutes after first exposure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06670560: Onco-Respirology Epidemiology Based on Real-world Big Data in Respiratory Medicine
Official title: Onco-Respirology Epidemiology Based on Real-world Big Data in Respiratory Medicine
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiratory
Epidemiology
Neoplasms
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A respiratory oncology epidemiology study based on real-world big data from respiratory medicine, with retrospective data collected from respiratory medicine inpatients at a multicenter for nearly 10 years.

Brief summary: The purpose of this observational study is to understand the changes in the types of respiratory patients hospitalized in China in recent years through a multicenter retrospective clinical study, and at the same time to understand the reasons for hospitalization and the distribution of different tumor types in oncology patients, so as to provide data support and theoretical basis for the future development of China's respiratory department.

The main questions it aims to answer are

1. the trend of change of respiratory diseases in China in the past 10 years.
2. the trend of change in the causes of hospitalization of respiratory tumor patients in China in the past 10 years.
3. the trend of the proportion of each tumor in the respiratory department in China over the past 10 years.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Respiratory diseases Must be an inpatient

Exclusion Criteria:

Non-respiratory inpatients

Primary outcomes:
measure: proportion
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Chengzhi Zhou
state: Guangzhou
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Xiaohong Xie
role: STUDY_CHAIR
References:
Clinical trial NCT05997160: Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
Official title: Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vaginal Infection
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Bioperfectus Technologies Co., Ltd
First posted: 2023-08-18
Enrollment: 5590
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VENUS study plans to enrol 5590 participants, aged 15-49 years, from visiting our research settings across the country who evaluate vaginal discharge based on Gram-stained smear.

Brief summary: The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.

Detailed description: This study consists of two sub-studies:

1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy.
2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear.
* No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours.
* Not during menstruation (menstrual period ended ≥3 days ago).

exclusion Criteria:

* Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.

Primary outcomes:
measure: The score for smear
timeFrame: December 2023
measure: Diagnosis of vaginitis type
timeFrame: March 2024
measure: Relative Abundance
timeFrame: May 2024
measure: Intensity
timeFrame: May 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Fengxia Xue, PhD
role: PRINCIPAL_INVESTIGATOR
References: