louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01382732: Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia
Official title: Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Severe Preeclampsia
Postpartum Hemorrhage
Keywords: Pre-eclampsia
Postpartum hemorrhage
Carbetocin
Oxytocin
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 636
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage but the hemodynamic changes associated with this pathology make the management of any kind of bleeding particularly troublesome. There are many pharmacological options, being oxytocin the first line of treatment. However there is no evidence about the safety and efficacy of carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 28 weeks and term
* Severe pre-eclampsia

Exclusion Criteria:

* Twin pregnancy
* Coagulation disorders
* HELLP Syndrome
* Eclampsia

Primary outcomes:
measure: Need for additional uterotonics
timeFrame: Six months
Secondary outcomes:
measure: Development of oliguria
timeFrame: six months
measure: Changes in hemodynamic status
timeFrame: six months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo A Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07026032: Effects of Biofeedback Exercises on Severity of Dysphagia in Parkinson's Clients
Official title: Effects of Biofeedback Exercises on Severity of Dysphagia in Parkinson's Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Dysphagia
Keywords: Parkinson
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be made. Group A and Group B. One group will have traditional exercises and the other will have exercises using the Biofeedback.
Primary purpose: TREATMENT

Brief summary: A randomized control trial will be conducted to test if there will be a significant effect or not, of biofeedback exercises vs traditional exercises for clients with oropharyngeal dysphagia in Parkinson's disease. For this purpose, 32 participants will be taken for the study. Half will be given traditional exercises where as the other half will be given exercises using the biofeedback; tongueomter.

Detailed description: An RCT will be conducted on 32 Parkinson's patients having oropharyngeal dysphagia. FOIS and biofeedback will be used as a baseline instrument to determine the tongue strength and severity of dysphagia at the initial level of the study. The experimental group will perform tongue isometric pressure exercises using biofeedback for twelve sessions, four sessions per week. The control group will perform only traditional tongue-strengthening exercises for twelve sessions, four sessions per week. Both groups will receive therapy for 30 minutes. Both groups will undergo twelve sessions of exercises, starting after a baseline evaluation. Each patient will receive therapy for 30 minutes and have four sessions of therapy weekly. Two exercise protocols will be used. Protocol A will involve biofeedback strengthening exercises using the tongueometer. Protocol B will involve traditional tongue exercises to improve coordination and strength in tongue movement. The experimental group will be instructed to perform Protocol A while the control group will be instructed to perform Protocol B. Each group after randomization will undergo twelve sessions of exercises and baseline assessment will be taken at initial, middle, and final levels.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of Parkinson disease
* Diagnosed patients of oropharyngeal dysphagia with both genders

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: FOIS
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maryam Nadir
role: STUDY_DIRECTOR
References:
Clinical trial NCT03985332: Evolution of the Rate and Causes of Death in Geriatric SSR
Official title: Epidemiological Study on the Evolution of the Rate and Causes of Mortality in Geriatric SRH in the HUS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Death
Keywords: evolution of the rate
causes of death in geriatric SSR
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who died during their stay in geriatric SSR between 01/01/2013 and 31/12/2017

Brief summary: In view of the ageing population and the increasing fragility of geriatric patients, it seems interesting to carry out a retrospective epidemiological observational study, on the evolution of the mortality rate and the causes of death in services of suite care and geriatric rehabilitation, in order to apprehend at best the supports, in particular palliative


Eligibility criteria: Inclusion Criteria:

* Major patients (≥ 18 years)
* All patients who died during their stay in geriatric SSR between 01/01/2013 and 31/12/2017
* Patients who have not expressed their living refusal to reuse their medical data for research purposes

Exclusion Criteria:

- Refusal on the part of patients of their living to reuse their medical data for research purposes

Primary outcomes:
measure: Study of the different causes of death in geriatric SSR unit
timeFrame: The period from January 1st, 2013 to December 31st, 2017 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Gériatrie
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Thomas VOGEL, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05729932: Cannabis and Opioid Use Disorder
Official title: Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Opioid Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-02-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.


Eligibility criteria: Inclusion Criteria:

* Current opioid use disorder

Exclusion Criteria:

* Current medical conditions that require medical management

Primary outcomes:
measure: Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)
timeFrame: Change from baseline
Secondary outcomes:
measure: Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)
timeFrame: Change from baseline
measure: Change from Baseline - Respiration
timeFrame: Change from baseline
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Center on Drug and Alcohol Research
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shanna Babalonis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342432: Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
Official title: Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
balance reeducation
pain
function
Lead sponsor: Centro Universitari Fieo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2011-04-27
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.

Detailed description: Both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. The evolution of the two groups concerning pain level, function and postural control will be compared.

Eligibility criteria: Inclusion Criteria:

* must have low back pain longer than three months and age between 40 and 69 years old

Exclusion Criteria:

* balance or neuromuscular disorders, spine surgery, diabetes.

Primary outcomes:
measure: Perceived pain
timeFrame: 5 weeks
Secondary outcomes:
measure: Function
timeFrame: 5 weeks
measure: Postural Control
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Centro Universitário Fieo
state: São Paulo
Study officials:
affiliation: Centro Universitario Fieo
name: Thais Bojadsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00363532: Functional MRI (fMRI) in CGRP Induced Migraine
Official title: Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Keywords: migraine with out aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then be stimulated with noxious heat via a thermode placed at the forehead. At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of interest (ROI) will be thalamic region and medulla oblongata.

Then the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the BOLD response at the RIO's previously defined. A 3-Tesla MRI scanner will be used in this trail.

This study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach.


Eligibility criteria: Inclusion Criteria:

* Patients know with migraine without aura.
* No less then 1 migraine attach pr month and no more then 6 attaches per month.
* Weight 50-100 kg.
* Women must be using secure birthcontrol.

Exclusion Criteria:

* Tension type headache more then 1 day/month.
* All other prim. og sec. headache types then migraine without aura.
* Daily use of medication other then birthcontrol pills.
* Pregnant and lactation women.
* Headache on the trail day or 5 days previous to the trail day.
* Contraindications to MRI-scans.
* Hypertension or hypotension.
* Known heart or lung condition.
* Mental illness or substance abuse.
* Other considerable conditions judged by the including doctor.

Primary outcomes:
measure: Changes in BOLD response before and after CGRP infusion.
measure: Changes in BOLD response before and after injection of sumatriptan.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, Neurological Dep. Glostrup hospital
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD,PH.d
role: STUDY_CHAIR
References:
Clinical trial NCT02456532: Safety and Efficacy of Chronic Hypnotic Use 2
Official title: Risks for Transition From Therapeutic Hypnotic Use to Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Insomnia
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.

Detailed description: Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.

Eligibility criteria: Inclusion Criteria:

* DSM-5 diagnosis of insomnia

Exclusion Criteria:

* acute or unstable medical disease,
* current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders

Primary outcomes:
measure: Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
timeFrame: total number of capsules chosen in week 1 and week 2 of the discontinuation period
Secondary outcomes:
measure: Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period
timeFrame: mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period
Other outcomes:
Locations:
city: Detroit
country: United States
facility: HFHS Sleep Disorders Ctr
state: Michigan
Study officials:
affiliation: Henry Ford Health System Sleep Disorders Ctr
name: Timothy A Roehrs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375232: Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
Official title: Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise-Induced Bronchospasm
Keywords: Exercise-Induced Bronchospasm
Asthma
Cardiopulmonary Stress Test
Eucapnic Voluntary Hyperventilation
Induced sputum
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.

Detailed description: Exercise-Induced Bronchospasm (EIB) affects between 7-30% of highly trained athletes. The first phase of this study is to screen varsity level college athletes for EIB using Eucapnic hyperventilation (EVH). Those athletes who screen positive, will be enrolled in phase two, a randomized double-blinded placebo controlled double crossover study. At enrollment, athletes will undergo a cardiopulmonary stress test (CPST) and induced sputum sampling and will then be prescribed daily montelukast/placebo for a three week period. Athletes will return after three weeks and repeat the EVH, CPST, and induced sputum. They will then have a one week washout period followed by crossover once again to daily montelukast/placebo for another three weeks. After the second three weeks they will once again return for a final EVH, CPST, and induced sputum. The goal of this study is to demonstrate that effectively blunting the EIB response with montelukast, indices of ventilation,exercise tolerance, and perhaps overall physical fitness improve, allowing athletes to train more effectively, in a nonergogenic manner.

Eligibility criteria: Inclusion Criteria:

* College level varsity athlete
* age 18yr or older
* healthy.
* Able to swallow pills
* No prior history of asthma

Exclusion Criteria:

* Younger than 18yr
* smoker
* Prior history of asthma
* Unable to swallow pills

Primary outcomes:
measure: Effective blunting of the EIB response by Spirometric measurement
measure: Improvement in indices of ventilation and cardiopulmonary response measured on CPST
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: National Institue Of Fitness and Sport
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
name: Mark O Farber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936932: Laser Treatment of Basal Cell Carcinoma
Official title: Laser Treatment of Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: Superficial Basal Cell Carcinoma
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laser treatment of Basal cell carcinoma

Detailed description: The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.

Eligibility criteria: Inclusion Criteria:

1. Healthy subjects 18 years of age or older
2. Lesion is biopsy-proven superficial BCC \<= 2.0 cm in largest diameter
3. BCC is on trunk or extremities
4. Seeks and is scheduled for treatment of BCC
5. Willing to have photographs taken of the treatment area
6. Ability to understand and the willingness to sign a written informed consent document
7. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

1. Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (\>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
2. Pregnancy
3. Subjects unable to follow-up for the full 12-months
4. Subjects not willing to have biopsy taken from the treatment area
5. Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

Primary outcomes:
measure: Complete clearance of BCC
timeFrame: 1 year
Secondary outcomes:
measure: Cosmetic outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Spring Hill
country: United States
facility: Skin & Allergy Center
state: Tennessee
Study officials:
affiliation: Skin & Allergy Center
name: Chris Robb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04403932: Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency
Official title: Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019 (COVID-19)
Keywords: Coronavirus Disease 2019 (COVID-19)
Vitamin D Deficiency
Severe Acute Respiratory Syndrome
Angiotensin Converting Enzyme 2
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive adult subjects attending the emergency department with symptoms suggestive of COVID-19 and a positive reverse-transcriptase polymerase chain reaction for SARS-CoV-2

Brief summary: In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

Detailed description: Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and follow-up obtained. The primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The primary association between VDD - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. The estimated sample size is n=500 and the expected inclusion time lapse 3 months.

Eligibility criteria: Inclusion Criteria:

* \>18 years old
* symptoms suggestive of COVID-19
* positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2

Exclusion Criteria:

* Bacterial community acquired pneumonia

Primary outcomes:
measure: severe COVID-19
timeFrame: 17/04/2020 to 01/06/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
References: