louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00858832: Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Official title: Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometritis
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection.

This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.


Eligibility criteria: Inclusion Criteria:

1. Female singleton gravidas
2. Patients receiving non-elective cesarean deliveries after trial of labor
3. No evidence of chorioamnionitis

Exclusion Criteria:

1. Diagnosis of chorioamnionitis
2. Elective cesarean section
3. Unable to provide informed consent
4. Immunocompromised patients and those on antiretroviral drugs
5. Patients with known infection
6. Hypertension (blood pressure greater than 140/90 x 2, six hours apart), including those with a past history, gestational or Preeclampsia.
7. Allergic to ergot alkaloids. This would include people allergic to migraine medicine.

Primary outcomes:
measure: Endometritis Incidence
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Univeristy of South Florida OB/GYN
name: Patrick Teefey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772837: Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms
Official title: Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Helicobacter Pylori Infection
Keywords: Functional Dyspepsia
Helicobacter Pylori eradication
Quality of Life
Dyspeptic Symptoms
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries.

The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.


Eligibility criteria: Inclusion Criteria:

* Ambulatory adult males and non-pregnant females.
* Dyspeptic symptoms for at least 3 months.
* Normal endoscopic findings.
* H. Pylori positive on testing.

Exclusion Criteria:

* Patients with erosive and non erosive esophagitis.
* Barrette's esophagus.
* Duodenal Ulcer, Gastric Ulcer or gastric erosions.
* Patients with known sensitivity to antibiotics.
* Patients with severe concomitant systemic disease.
* Patients with upper GI surgery except cholecystectomy.
* Females with pregnancy or breast-feeding.
* Malignancy
* Alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.

Primary outcomes:
measure: Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia
timeFrame: 1 year
Secondary outcomes:
measure: To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36.
timeFrame: 1 year
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: DR.SHAHAB ABID, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05382637: Growth Hormone in a Patient With a Dominant-Negative GHR Mutation
Official title: Growth Hormone in a Patient With a Dominant-Negative GHR Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Growth Disorders
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 1
Sex: MALE
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective interventional study designed for a single patient with a dominant-negative mutation in the growth hormone receptor gene (GHR) which results in increased levels of growth hormone binding protein (GHBP). The patient will receive escalating doses of growth hormone titrated to achieve an insulin like growth factor-1 level above the mean and then growth response to therapy will be monitored.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Be the specific subject with the a specific mutation in GHR leading to high GHBP.

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Growth hormone dose
timeFrame: 1 year
Secondary outcomes:
measure: Growth Velocity
timeFrame: 1 year
measure: Height standard deviation
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Andrew Dauber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204737: Short Course Glucocorticoid Treatment for PTSD
Official title: A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-traumatic Stress Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
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 investigate if a 2-wk course of 20mg/day of oral prednisone in addition to standard care will result in reduced PTSD symptoms or symptom severity compared to placebo


Eligibility criteria: Inclusion Criteria:

* Must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for PTSD w/ symptom exacerbation (CAPS score ≥ 50)
* Stable on other psychotropic meds x1 month

Exclusion Criteria:

* Current or past history of bipolar, schizophrenic, or other psychotic disorder
* Organic mental disorder
* Alcohol or substance abuse in last 3 months
* Clinically significant hepatic or renal disease or other acute or unstable medical condition
* Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes, rheumatologic diseases

Primary outcomes:
measure: Change in Clinician-Administered PTSD Scale (CAPS)
timeFrame: baseline, 2 weeks, 6 weeks, 12 weeks
measure: Number of Participants Achieving CAPS Response
timeFrame: baseline, 2 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in Hamilton Depression Rating Scale (HAM-D)
timeFrame: baseline, 2 weeks, 6 weeks, 12 weeks
measure: Change in PCL-PTSD Score
timeFrame: baseline, 2 weeks, 6 weeks, 12 weeks
measure: Change in Clinical Global Impression Severity (CGI-S) Score
timeFrame: baseline, 2 weeks, 6 weeks, 12 weeks
measure: Change in Dehydroepiandrosterone Sulfate (DHEA-S)
timeFrame: Baseline, 2 weeks, 6 weeks, and 12 weeks
measure: Change in Salivary Cortisol (First 6 Participants)
timeFrame: Baseline, 2 weeks, 6 weeks, and 12 weeks
measure: Change in Salivary Cortisol (Last 6 Participants)
timeFrame: Baseline, 2 weeks, 6 weeks, and 12 weeks
measure: Change in Serum Glucose
timeFrame: Baseline, 2 weeks, 6 weeks, and 12 weeks
measure: Number of Other Adverse Events
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Catherine Johnson
state: Wisconsin
city: Madison
country: United States
facility: Wm. S. Middleton VA Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Catherine D. Johnson, PharmD, MS, BCPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422537: Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers
Official title: The Effect of One Single Dose of Different Bran-based Dietary Platforms on the Colon Metabolism - A Study With (Stable) Isotopes in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: During this project the effect of 3 different bran-based dietary platforms on the fermentation on a readily fermentable substrate will be investigated using stable isotope techniques.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Aged between 18 and 65 years
* BMI between 18 and 27 kg/m²
* Stable eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria:

* Use of antibiotics in the month preceding the study
* Abdominal surgery (except from appendectomy)
* Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
* Use of pre- or probiotic supplements in the month preceding the study
* Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease...
* Pregnancy or lactation
* Blood donation in the last 3 months
* Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
* Participation in clinical studies involving radiation exposure in the past year

Primary outcomes:
measure: Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform
timeFrame: 2 years
Secondary outcomes:
measure: Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/ UZ Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT02529137: Pivotal Study for Validation of Philips Dx (PDx)
Official title: Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pathologic Processes
Lead sponsor: Philips Digital & Computational Pathology
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both: surgical pathology slides of both female and male participants are being studied.

Brief summary: The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.


Eligibility criteria: Inclusion Criteria

* All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available.
* Original sign-out diagnosis is available.
* The selected slide or slides fulfill the quality checks according to general clinical practice.
* Target enrollment of organs and subtypes according pre-specified list.

Exclusion Criteria

* Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site.
* The selected slide or slides do not match any subtype of the organ for which the case was selected.
* Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained.
* Selected slides contain indelible markings.
* Selected slides with damaged tissue.
* More than one case was selected for a patient (only one case may be enrolled per patient).
* Case consists of frozen section(s) only.
* Case consists of gross specimens only.

Primary outcomes:
measure: Major Discordance Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Shady Grove Adventist
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Irving
country: United States
facility: Miraca Life Sciences
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Philips DPS
name: Mischa Nelis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03859037: Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
Official title: Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Distress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups,one will have umbilical cord milking and other will have immediate cord clamping ,two groups will put on warmer after birth and blood pressure,heart rate ,oxygen saturation will be assessed by monitor every 30 seconds up to 10 minutes
Primary purpose: OTHER

Brief summary: Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not

Detailed description: Investigators will make milking for 100 preterm babies and placed them on warmer and assess heart rate,blood pressure,oxygen saturation,fio2,maximum pip,PEEP and 100 babies other without milking to see the difference between two groups.

Eligibility criteria: Inclusion Criteria:

* babies who need resuscitation
* Preterm babies with 28-34 weeks gestatinal age

Exclusion Criteria:

* preterm babies above 34 weeks gestational age, -- -
* refusal by mother or obestatracain, -- -babies with congenital anomalies

Primary outcomes:
measure: measure mean blood pressure
timeFrame: Changes of all data will be assessed every 30seconds for ten minutes
Secondary outcomes:
measure: Measure heart rate
timeFrame: Heart rate will be assessed every 30 seconds for 10 minuets
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03123237: Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.
Official title: Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Hypertension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: the investigators explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* • Patients with diabetes (type2), weather controlled or not.

  * Patients with essential hypertension.
  * Patients with diabetes \& hypertension.
  * Within normal renal function (urea \& creatinine).
  * Control cases may be normal individuals (apparently healthy) like donors for renal transplant.

Exclusion Criteria:

* • Patients with abnormal renal function.

  * Patients with diseases known to affect kidney function rather diabetes \& hypertension e.g. SLE, heart failure or liver cell failure.

Primary outcomes:
measure: Renal Counts
timeFrame: 2-4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT03722537: Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
Official title: Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Basal Joint Arthritis
Keywords: Allograft
Osteochondral Allograft
Arthritis
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.

Detailed description: Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described, but few multicenter prospective evidence based trials exist comparing standard treatments. This continuing search for consensus and improvement of best clinical practice has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Operative treatments range from osteotomy, partial or complete trapeziectomy with or without reconstruction of the ligaments, tendon interposition to arthrodesis, however the functional outcome varies. Allograft has been previously described in joint replacement / prosthetic implantation surgery in other areas of the body, however not in the thumb. The purpose of this study is to investigate using osteochondral allograft in the surgical intervention phase of treatment for patients with basal joint arthritis.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Indicated for operative management of basal joint arthritis

Exclusion Criteria:

* Pregnant women/fetuses/neonates, prisoners
* Previously operated on for treatment of basal joint arthritis

Primary outcomes:
measure: Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: Up to 1 year post-operatively
Secondary outcomes:
measure: Score on the Thumb Disability Exam (TDX)
timeFrame: Up to 1 year post-operatively
measure: Visual Analog Scale for pain (VAS)
timeFrame: Up to 1 year post-operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melvin P Rosenwasser, MD
role: PRINCIPAL_INVESTIGATOR
References: