louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01487278: Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali
Official title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
prevention
misoprostol
Uniject
oxytocin
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: The Aga Khan Foundation
name: Guttmacher Institute
First posted: 2011-12-07
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

Detailed description: This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Eligibility criteria: Inclusion Criteria:

* women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria:

* women with known contraindications to prostaglandins

Primary outcomes:
measure: Mean change in hemoglobin
timeFrame: during 3rd trimester and 1-3 days postpartum
Secondary outcomes:
measure: occurrence and management of side effects
timeFrame: 1 hour postpartum
measure: correct timing of drug administration
timeFrame: collected immediately following birth, verified 1-3 days postpartum
measure: change in hemoglobin ≥ 2 g/dL
timeFrame: during third trimester and 1-3 days postpartum
measure: additional interventions
timeFrame: during birth and 1-3 days postpartum
measure: referrals
timeFrame: 1-3 days postpartum
measure: acceptability
timeFrame: 1-3 days postpartum
Other outcomes:
Locations:
city: Mopti
country: Mali
facility: Villages in Mopti
Study officials:
affiliation: Gynuity Health Projects
name: Ayisha R Diop, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Laura J Frye, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan Foundation
name: Yacouba Kone, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02133378: Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery
Official title: Prospective, Randomized Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Keywords: Bleeding
Hemostatic
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. The investigators compared such hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis routine.

Following sample size calculation, in a prospective randomized study design, 100 patients will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group).

To make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding transversal aortotomy.

Study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.


Eligibility criteria: Inclusion Criteria:

* Surgery on Ascending Aorta with Dacron Graft or transverse Aortotomy
* Moderate bleeding

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Successful Hemostasis in under 3 minutes
timeFrame: 3 minutes
Secondary outcomes:
measure: Post Operative Blood Loss
timeFrame: 6 hours
Other outcomes:
measure: Allogeneic Blood Transfusion
timeFrame: 4 days
Locations:
city: Rome
country: Italy
facility: European Hospital
Study officials:
References:
citation: Nasso G, Piancone F, Bonifazi R, Romano V, Visicchio G, De Filippo CM, Impiombato B, Fiore F, Bartolomucci F, Alessandrini F, Speziale G. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009 Nov;88(5):1520-6. doi: 10.1016/j.athoracsur.2009.07.014.
Clinical trial NCT01262378: Harmonic vs HF Knife in Patients Requiring Abdominal Surgery
Official title: Clinical Outcome of the Seroma Amount Using the Harmonic vs the HF Knife for Surgery According to Lockwood and Abdominoplastic Surgery: A Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ABDOMINAL SUBCUTANEOUS FAT
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
Collaborators: name: Ethicon Endo-Surgery
First posted: 2010-12-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or body lift (Lockwood)

Detailed description: Aim of the study is to measure amount of seroma in each interventional arm.

Eligibility criteria: Inclusion Criteria:

* 18 years
* willing to give consent
* indication for abdominoplastic surgery
* no contraindication for general anaesthesia

Exclusion Criteria:

* Smoking more than 10 p/day
* Diabetes mellitus I or II
* known neoplasms
* not willing or able to conform with study requirements

Primary outcomes:
measure: amount of seroma
timeFrame: first post operative day until hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik Wandsbek
Study officials:
References:
Clinical trial NCT00731978: NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial
Official title: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial A Prospective Randomized Study of Near-infrared Spectroscopy Directed Fluid Therapy vs Standard Fluid Therapy in Patients Undergoing Open Elective Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Keywords: Near-Infrared Spectroscopy
Intraoperative Care
Lead sponsor: Hutchinson Technology Inc
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the amount of fluid needed during colorectal surgery.

The study hypothesis is that intraoperative fluid limitation can be safely accomplished when guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction in postoperative morbidity when compared to standard monitoring and fluid therapy.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective open colorectal surgery
* Age greater than or equal to 18 years
* Low to moderate risk colorectal surgery patients

Exclusion Criteria:

* Unacceptable Baseline vital sign measurements
* High risk colorectal surgery patients
* Jehovah's Witness

Primary outcomes:
measure: Major postoperative complications
timeFrame: within the first 30 days of the postoperative period
Secondary outcomes:
measure: StO2 changes during intraoperative fluid management, hospital-free days, surgical site infections, time to first bowel movement, total fluid and total intraoperative fluid volumes, daily fluid volumes through 3 days postoperative, daily weights
timeFrame: within the first 30 days of the postoperative period
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: San Antonio
country: United States
facility: University of Texas Health Science Center (UTHSCSA)
state: Texas
Study officials:
affiliation: University of Texas
name: Stephen M Cohn, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441578: A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
Official title: Special Drug Use Surveillance of ADZYNMA Intravenous 1500 (All-Case Investigation)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombotic Thrombocytopenic Purpura (TTP)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP.

During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months.


Eligibility criteria: Inclusion Criteria:

- All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
timeFrame: Up to 18 Months
Secondary outcomes:
measure: Percent Change in Observed Platelet Count from Baseline at the End of Treatment
timeFrame: Up to 18 Months
measure: Percent Change in Observed ADAMTS13 Activity from Baseline at the End of Treatment
timeFrame: Up to 18 Months
measure: Percent Change in Observed ADAMTS13 Inhibitor from Baseline at the End of Treatment
timeFrame: Up to 18 Months
measure: Number of Participants with Thrombotic Thrombocytopenic Purpura (TTP) Events on Periodic Replacement Therapy
timeFrame: Up to 18 Months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00530478: Effect of Donepezil on the Reorganization of Cognitive Neural Network in Patients With Post-Stroke Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Donepezil
Stroke
Cognitive function
Cognitive neural network
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-09-17
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to demonstrate the efficacy and safety of donepezil on the recovery of cognitive function in patients with stroke and to delineate the neurophysiologic mechanisms of the therapeutic effect of donepezil on the recovery of cognitive network using functional neuroimaging technique.


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke in the territory of right or left middle cerebral artery
* Post-onset duration of the recent-onset stroke is over 3 months
* Cognitive deficit ranged from 10 to 26 by minimal mental status examination (MMSE) score
* Disturbance in activities of daily living (ADL) ranged 0.5 \~ 2.0 by clinical dementia rating (CDR) scale

Exclusion Criteria:

* Severe internal carotid artery stenosis on the lesion side
* Cardiac pacemaker or intracranial metal insertion
* Post-stroke seizure disorder or any evidence of epileptic spikes on electroencephalography (EEG)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Suk Hoon Ohn, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Yun Hee Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02922478: Role of Comorbidities in Chronic Heart Failure Study
Official title: Role of Comorbidities in Chronic Heart Failure (RoC-HF) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Comorbidity
Osteoporosis
Pulse Wave Analysis
Blood Pressure Monitoring, Ambulatory
Osteoporotic Fractures
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 205
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: Stable patients with chronic heart failure

Brief summary: This study aims to create a database of patients with stable and chronic heart failure with comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine samples will be stored to facilitate future biomarker analyses.


Eligibility criteria: Inclusion Criteria:

1. Age \>= 18
2. NYHA (New York Heart Association) class II-IV symptoms
3. Left ventricular ejection fraction \< 50% at Visit 1.
4. Treatment according to current Heart Failure Guidelines of the European Society of Cardiology
5. Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures
6. Previous diagnosis of heart failure with reduced ejection fraction defined as symptomatic left ventricular ejection \< 40% requiring optimization of heart failure therapy

Exclusion Criteria:

1. Unplanned hospitalization within 1 month prior to the Baseline Visit.
2. Discontinuation or initiation of a pharmacologic or device treatment for HFrEF within 1 month prior to the baseline visit.
3. Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
4. Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
5. Any acute illness
6. Disease reducing life expectancy to \< 1 year, except HFrEF
7. Recipient of any organ transplant
8. Primary significant valve disease (at least moderate to severe valve disease)

Primary outcomes:
measure: Prevalence of osteoporosis in chronic heart failure
timeFrame: 1 day
measure: Prevalence of vertebral fractures in chronic heart failure
timeFrame: 1 day
Secondary outcomes:
measure: Peripheral and central pulse wave velocity
timeFrame: 24 hours
measure: 24-hours systolic and diastolic blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Nicolas Verheyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Klemens Ablasser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04069078: Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
Official title: Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bradycardia
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Cesarean Section Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.


Eligibility criteria: Inclusion Criteria:

* ASA physical status class I-II.
* Age: 18 Years to 40 Years.
* Women scheduled for elective Cesarean section under spinal anesthesia.
* indications for CS other than fetal or maternal pathology.

Exclusion Criteria:

* Height \< 150 or \> 180 cm
* Body mass index (BMI) \>35 kg/m2
* Contraindication for central neuraxial block
* Refusal to undergo regional anesthesia
* Known allergy to any of the study drugs,
* Infection at the site of injection,
* Coagulopathy,
* Indication to general anesthesia
* Baseline bradycardia (heart rate \< 60/min), or any cardiovascular disease
* Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs.
* Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block,
* Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy,
* Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)

Primary outcomes:
measure: Bradycardia
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
citation: Abbas MS, Hassan SA, Abbas AM, Thabet AM, Thabet AM, Mahdy MM. Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 21;22(1):112. doi: 10.1186/s12871-022-01659-9.
Clinical trial NCT04391478: Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
Official title: Milrinone Versus Sildenafil in Treatment of PPHN in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Persistent Pulmonary Hypertension
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

Detailed description: 40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Eligibility criteria: Inclusion Criteria:

* gestational age \>34 weeks
* postnatal age \<10 days

Exclusion Criteria:

* neonates with congenital heart disease
* neonates with congenital diaphragmatic hernia

Primary outcomes:
measure: efficacy of milrinone versus sildenafil in treatment of PPHN
timeFrame: 6 - 12 months
Secondary outcomes:
measure: final outcome
timeFrame: 6 - 12 months
measure: Bleeding
timeFrame: 6-12 months
measure: Ventilation
timeFrame: 6-12 months
measure: Ventilatory settings
timeFrame: 6-12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Imam SS, El-Farrash RA, Taha AS, Saleh GA. Milrinone Versus Sildenafil in Treatment of Neonatal Persistent Pulmonary Hypertension: A Randomized Control Trial. J Cardiovasc Pharmacol. 2022 Nov 1;80(5):746-752. doi: 10.1097/FJC.0000000000001332.
Clinical trial NCT01467778: Safety Study of Three Formulations of the Dermal Implant ELAPR
Official title: A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Conditions
Keywords: skin
Lead sponsor: Elastagen Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

Detailed description: A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Good general health status

Exclusion Criteria:

* Clinically significant abnormalities of haematology or biochemistry testing
* Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
* Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
* History of keloid formation
* Systemic corticosteroids within last 12 weeks
* Diabetes or metabolic disorders
* Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
* Pregnancy/lactation
* A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine

Primary outcomes:
measure: Safety and tolerability measured by the amount of adverse events and serious adverse events
timeFrame: 6 weeks
Secondary outcomes:
measure: Persistence
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Glebe
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Woolcock Institute of Medical Research
name: Carlos China, MBBS
role: PRINCIPAL_INVESTIGATOR
References: