louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03045744: Long-term PAS in Rehabilitation After SCI
Official title: Long-term Paired Associative Stimulation in Rehabilitation of Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Validia Rehabilitation
name: University of Helsinki
First posted: 2017-02-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators have recently shown in two pilot incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1). In this study, the investigators will administer long-term paired associative stimulation to incomplete SCI patients in a long-term manner, keeping each patient in the study for as long as continuous improvement is observed.


Eligibility criteria: Inclusion Criteria:

* incomplete SCI

Exclusion Criteria:

* epilepsy
* metal inclusion in the head area
* pacemaker
* hearing device
* high intracranial pressure

Primary outcomes:
measure: Daniels and Worthingham's Muscle Testing
timeFrame: 2 days after the last stimulation session
measure: Daniels and Worthingham's Muscle Testing
timeFrame: 1 month after the last stimulation session
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: BioMag laboratory, Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Anastasia Shulga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Restoration of hand function with long-term paired associative stimulation after chronic incomplete tetraplegia: a case study. Spinal Cord Ser Cases. 2019 Oct 1;5:81. doi: 10.1038/s41394-019-0225-5. eCollection 2019.
citation: Holopainen K, Tolmacheva A, Bersch I, Haakana P, Pohjonen M, Kirveskari E, Arokoski J, Shulga A. Stable improvement in hand muscle strength in incomplete spinal cord injury patients by long-term paired associative stimulation-a case series study. Front Neurol. 2025 Feb 4;16:1486591. doi: 10.3389/fneur.2025.1486591. eCollection 2025.
Clinical trial NCT03105492: Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing
Official title: Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant
Keywords: Prenatal Testing
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-04-10
Enrollment: 553
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women.

Brief summary: Background:

Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic data about their baby. This raises ethical concerns. Researchers want to find out if women want access to the kind of data PWGS provides. They want to know why and under what circumstances women would or would not want the data.

Objective:

To explore the views of pregnant women about possible use of PWGS. To find out whether they would want different categories of genetic data, and how they would use such findings.

Eligibility:

Women ages 18 and older who pregnant and speak English or Spanish

Design:

Participants will be recruited by their doctors.

Participants will take a survey about their views of PWGQ. They may take it online or on paper.

Detailed description: The impending implementation of prenatal whole genome sequencing (PWGS) raises a host of ethical concerns given the massive amounts of genetic information that expecting parents will be able to learn about their baby. This project involves a cross-sectional quantitative survey of pregnant women to explore whether they want access to the kinds of information provided by PWGS, why and under what circumstances. The survey will address questions such as: What sorts of information do pregnant women want to know about their baby, and why? What, if anything, would they do with the information? What kind of guidance would pregnant women like from their medical team regarding fetal genetic testing? Given the range of practical and ethical challenges posed by PWGS, our data will inform practitioners approaches towards PWGS as the technology develops and becomes more widely available. It is imperative that government regulators and professional societies take into account the views of people directly affected by any policies that are created - including patients themselves - before crafting rules for whether, when and how to utilize PWGS.

Eligibility criteria: * INCLUSION CRITERIA:
* Participants must be 18 years of age
* Participants must be pregnant
* Participants must speak English or Spanish

Primary outcomes:
measure: Views of pregnant women
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
Study officials:
affiliation: National Human Genome Research Institute (NHGRI)
name: Benjamin E Berkman, J.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917592: Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
Official title: Prospective Randomized Clinical Trial Assessing the Efficacy of a Short Course of Intravenous Amoxicillin Plus Clavulanic Acid Followed by Oral Antibiotic in Patients With Uncomplicated Acute Diverticulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diverticulitis
Keywords: Diverticulitis
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2009-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.

Detailed description: A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours

Exclusion Criteria (prerandomization):

* immunocompromised patients
* pregnant women
* clinical suspicion or CT confirmation of complicated acute diverticulitis
* Karnofsky performance score less than 50%
* allergy to penicillin

Exclusion Criteria (postrandomization):

* withdrawal of the trial
* CT confirmation of complicated acute diverticulitis
* CT not conforming to acute diverticulitis
* CT performed 72 hours after the admission
* adverse reaction to the antibiotic
* bacteriemia

Primary outcomes:
measure: failure of treatment
timeFrame: the 4th day (group 1) or the 8th day (group 2)
Secondary outcomes:
measure: emergency admission or hospital readmission for reasons related to the previous diverticulitis
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Yolanda Ribas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04330144: Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Official title: A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Contact Person From COVID-19 Confirmed Patient
Keywords: Postexposure prophylaxis
hydroxychloroquine
SARS-CoV-2
COVID-19
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2.

* Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group.
* Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment).
* Safety comparison: Safety verification by identifying major side effects in the HCQ group."


Eligibility criteria: Inclusion Criteria:

* A contact person from confirmed case of SARS-CoV-2 infection
* Medical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals
* Persons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc.

  * Subjects of study include both symptomatic and asymptomatic contacts.

Exclusion Criteria:

* Hypersensitivity to Chloroquine or Hydroxychloroquine
* Those who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc.
* Human immunodeficiency virus (HIV) infected person
* Patients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease)
* Patients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis)
* Arrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2
* A person who is positive in the COVID-19 screening PCR test before starting PEP

Primary outcomes:
measure: The rate of COVID-19
timeFrame: PCR test of COVID-19 at 14 days after the contact from confirmed case
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Yong Goo Song, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457544: Spontaneous Coronary Artery Dissection National Swiss Registry
Official title: Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Coronary Artery Dissection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational study will recruit consecutive male and female patients presenting with newly diagnosed SCAD or having been diagnosed with SCAD within the last 5 years.

For the purposes of study inclusion, the definition of SCAD will be based on a central review of the coronary angiographic images confirmed by 2 independent assessors

Brief summary: Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death.

Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood.

In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years of age.
* Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5 years.
* Subject must be willing to sign a Patient Informed Consent (PIC).

Exclusion Criteria:

* Patient unwilling or unable to provide informed consent.
* Patients with atherosclerotic or iatrogenic coronary dissection.

Primary outcomes:
measure: Incidence of safety events at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of safety events at 1 year
timeFrame: 1 year
measure: Incidence of safety events at 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: Hopitaux universitaires de Geneve
name: Sophie Degrauwe, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356792: Obstetrics , Prenatal Outcomes in Recurrent Miscarriage
Official title: The Associations Between History of Recurrent Miscarriage and Obstetric and Perinatal Outcomes in the Subsequent Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Miscarriage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 102
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who had ≥2 abortions during early pregnancy, patients had no abnormal reproductive tract anatomy , single fetus

Brief summary: The effect of recurrent miscarriage on the outcome of the current pregnancy and if there's a relation between it and adverse out come


Eligibility criteria: Inclusion Criteria:

1- patients who had ≥2 abortions during early pregnancy 2.patients had no abnormal reproductive tract anatomy 3. Pregnant in single fetus

Exclusion criteria:

chronic hypertension, chronic kidney diseases autoimmune diseases multiple pregnancy

Primary outcomes:
measure: If there's relation between recurrent abortion and having a medical disorder during current pregnancy
timeFrame: 2023 to 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT01180192: Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
Official title: Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Keywords: blood loss
oxygen inhalation
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 450
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the aetiology of postpartum uterine atony, hypoxia is considered an important factor although some suggest that peripheral oxygen saturation is not influenced by oxygen inhalation in women during the first and second stages of labor. Enhancing oxygen delivery to myometrium through additional inhaled oxygen may improve uterine contractions. Therefore, it is reasonable to consider that oxygen inhalation may promote myometrial contraction and prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to relax in women encountering respiratory problems immediately after cesarean section under general anaesthesia further strengthened this theory.

The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen helps to maintain uterine retraction during immediate postpartum period and hence reduces vaginal blood loss.


Eligibility criteria: Inclusion Criteria:

* gestational age between 37 and 42 weeks;
* singleton pregnancy;
* live fetus;
* cephalic presentation;
* neonatal birth weight of 2500-4500 g;
* parity between one and five;
* maternal age \< 35 years old;
* vaginal birth

Exclusion Criteria:

* blood pressure ≥ 140/90mmHg;
* placenta previa;
* placental abruption;
* a history of any bleeding during pregnancy;
* a history of curettage;
* cesarean section or any uterine scar;
* a history of postpartum hemorrhage;
* polyhydramnios;
* signs or symptoms of maternal infection;
* known uterine anomalies;
* history of any drug use during labor;
* abnormal placentation;
* coagulation defects;
* instrumental deliveries;
* hemoglobin concentration \< 8 g/dL;
* history of anticoagulant drugs;
* beta-mimetic medications during pregnancy;
* prolongation of the first stage of labor \> 15 hours

Primary outcomes:
measure: The primary outcome was the amount of blood loss in the third and fourth stages of labor.
timeFrame: two hours
Secondary outcomes:
measure: incidences of Postpartum Haemorrhage (PPH) (≥500 ml)
timeFrame: two hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Women's and Children's Teaching Hospital
Study officials:
References:
Clinical trial NCT01107392: Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 315
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.


Eligibility criteria: Inclusion Criteria:

* Clinical enlargement of the prostate gland
* Body weight ≥ 50 kg or 110 lbs

Exclusion Criteria:

* History of chronic prostatitis
* History of two or more urinary tract infections in the past year or one in the last 6 months
* History of bladder stones
* History of previous prostate surgery
* History of bladder cancer or prostate cancer
* Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
* Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry

Primary outcomes:
measure: Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Total International Prostate Symptom Score (IPSS)
timeFrame: Baseline, Week 6, Week 24
measure: Change From Baseline in Peak Urine Flow Rate
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Duration of Effect
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Surrey
country: Canada
state: British Columbia
city: Praha
country: Czechia
city: Paris
country: France
city: Munich
country: Germany
city: Seoul
country: Korea, Republic of
city: Manila
country: Philippines
city: Poznan
country: Poland
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: McVary KT, Roehrborn CG, Chartier-Kastler E, Efros M, Bugarin D, Chen R, Patel A, Haag-Molkenteller C. A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol. 2014 Jul;192(1):150-6. doi: 10.1016/j.juro.2014.02.004. Epub 2014 Feb 7.
Clinical trial NCT01770392: Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
Official title: Relative Bioavailability of a Single Oral Dose of Nintedanib Given Alone and in Combination With Multiple Oral Doses of Rifampicin in Healthy Male Volunteers (an Open-label, Two-period, Fixed Sequence Phase I Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-01-17
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib
measure: Maximum Measured Concentration (Cmax)
timeFrame: 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib
Secondary outcomes:
measure: Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)
timeFrame: 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1199.162.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9.