louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03778242: Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.
Official title: The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: cesarean section
tranexamic acid
postpartum hemorrhage
oxytocin
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label Randomized Clinical Tria
Primary purpose: PREVENTION

Brief summary: Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section

Detailed description: Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.

Eligibility criteria: Inclusion Criteria:

* patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml

Exclusion Criteria:

* placenta praevia and placental abruption
* Women with a medical disorder,
* placenta accrete,
* allergy to TA, and
* intraoperative bleeding thanks to causes aside from uterine atony
* Patients over 40 or who have

  * pre-existing coagulation disorders,
* with a severe medical disorder
* allergy to tranexamic acid
* refuse to consent

Primary outcomes:
measure: number of patients need of additional pharmacological uterotonic
timeFrame: 24 hours post operative
Secondary outcomes:
measure: estimation of intraoperative blood loss (ml)
timeFrame: during the operation
measure: amount of postoperative blood loss
timeFrame: 4 hours postoperative
measure: number of patient with postpartum hemorrhage
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02878642: Adherence to Dolutegravir and Outcome
Official title: Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected with HIV-1 treated with dolutegravir at week 16 and week 24

Brief summary: The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).

While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.


Eligibility criteria: Inclusion Criteria:

* HIV-1
* Age over 18 years
* Information letter signed
* ART (antiretroviral therapy) with at least 3 active molecules
* Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure)

Exclusion Criteria:

* pregnant woman
* HIV-2
* Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization)
* Patient receiving aid incompatible with compliance with the use of electronic pillbox

Primary outcomes:
measure: Adherence to dolutegravir measured by the electronic pill boxes
timeFrame: From baseline up to week 24
measure: Virologic Efficacy
timeFrame: week 24
Secondary outcomes:
measure: Patient Genotype resistance if failure
timeFrame: Week 16 and 24
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT01451242: The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER
Official title: The Reliability of Heart Rate Variability Measurements Among Patients With Acquired Brain Injury as Measured During Physical Activity by POLAR RC810XE Compared to HOLTER EKG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acquired Brain Injury
Keywords: Heart Rate Variability
Acquired Brain Injury
Physical Activity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients following brain injury hospitalized in sheba medical center in the Brain injury rehabilitation unit.

Brief summary: Following a brain injury (BI) in addition to all other systems, there can be a failure in the control of the autonomic system activity. Heart rate (HR) has its own normal variability. Heart rate is controlled by the Sympathetic and Parasympathetic systems. Therefore, monitoring HR variability (HRV) can help us evaluate the balance of the two systems and their efficiency.Decrease in HRV was found to be in correlation with death among patients in the acute stage following ABI. Decrease in HRV is a pre-stage of HR irregularity and ventricular fibrillation.This disturbance can have a great impact on the patients health condition. In addition there was found an inverse correlation between this situation and the rehabilitation outcomes. Based on this data there is a great importance in monitoring HRV during rehabilitation among patients following BI while the patients are required to perform physical activity.The aim of this work is to check whether we can replace the traditional way of measuring HR by EKG Holter (gold standard) with a more simple,accessible tool-the POLAR watch.

The aim of this work is to check if the data collected from a POLAR watch is reliable compared to the data collected from an EKG holter.


Eligibility criteria: Inclusion Criteria:

* Brain Injury

Exclusion Criteria:

* a medical condition which doesn't allow the patient to participate physical activity.
* patients that can not be there own legal guardian.
* uncontrolled psychomotoric restlessness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Brain Injury Rehabilitation Department
Study officials:
affiliation: Sheba Medical Center
name: Ofer Keren, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00857142: Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
Official title: A Study to Evaluate the Relative Bioavaility of Oxymorphone Hydrochloride 40 mg Extended-Release Tablets(Sandoz, Inc. Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Edo Pharmaceuticals Inc.) in Healthy Volunteers Under Non-fasted COnditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol abuse
* Allergy to opiates

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Daryl G. Ficklin, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914042: Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica
Official title: Prediction of Inter-individual Differences in the Response to Morphine by Psychophysical Assessment of Pain Enhancing and Inhibiting Mechanisms in Patients With Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Opioid induced hyperalgesia
Neuropathic pain
Opioids
Sciatica
Serotonin-norepinephrine reuptake inhibitor (SNRI)
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.


Eligibility criteria: Inclusion Criteria:

1. Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
2. Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
3. Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (\< 30 mg of oral morphine-equivalents per day).
4. Ability to understand the purpose and instructions of the study and to sign an informed consent.

   -

   Exclusion Criteria:

1.Diabetic Neuropathy 2.Pain in upper limbs 3.Receiving anti- depressants and/or anticonvulsants 4.Pregnant women 5.Inability to comply with study protocol. 6.Allergy to Opioids 7.A diagnosis of Raynaud's Syndrome 8.History of substance abuse

-

Primary outcomes:
measure: Neuropathic pain intensity (NPS)
timeFrame: 1 month
Secondary outcomes:
measure: Heat pain intensity in a remote area (Opioid induced hyperalgesia)
timeFrame: 1 month
measure: The McGill Pain Questionnaire
timeFrame: At baseline and at the end of 4-week treatment period
measure: Assessment of Adverse events
timeFrame: Ongoing throughout the entire study period, an expected average of 4 weeks.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT04192942: Protocol of Management of Major Pediatric Burn in Intensive Care Unit
Official title: Protocol of Management of Major Pediatric Burn in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Decrease mortality and morbidity in major pediatric burns

Detailed description: The goals of initial patient management include preservation of overall homeostasis while appreciating the physiologic challenges that the burn injury poses to the body. Major burn injury not only results in local damage from the inciting injury, but in many cases results in multisystem injury. Initial efforts are focused on resuscitation, maintaining hemodynamic stability, and airway management. Intermediate efforts are focused on managing the multi-organ failure that results from systemic inflammatory mediators that result in diffuse capillary leak and surgical therapy. Finally, efforts shift to issues with chronic wound healing, pain management, restoration of functional capabilities, and rehabilitation.. Burn injury in children continues to be a major epidemiologic problem around the globe. Nearly a fourth of all burn injuries occur in children under the age of 16, of whom the majority are under the age of five This provides a team of pediatricians, surgeons, anesthesiologists, intensivists, nurses, respiratory therapists, and other healthcare providers with a unique opportunity to make a multidisciplinary collaborative effort.

Eligibility criteria: Inclusion Criteria:

* age below 18 year
* children with burn between 20% to 50% of total body surface area
* recent burn within 48 hour

Exclusion Criteria:

* old burn over 48 hour after injury -burnt surface area less than 20% of total body surface area - -
* burnt surface area more than 50% of total body surface area
* old age over 18 year

Primary outcomes:
measure: Changing mortality rate
timeFrame: baseline
Secondary outcomes:
measure: Changing hospital stay time
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Azza Eltayeb, Professor
role: STUDY_DIRECTOR
References:
citation: Krishnamoorthy V, Ramaiah R, Bhananker SM. Pediatric burn injuries. Int J Crit Illn Inj Sci. 2012 Sep;2(3):128-34. doi: 10.4103/2229-5151.100889.
citation: Williams FN, Herndon DN, Hawkins HK, Lee JO, Cox RA, Kulp GA, Finnerty CC, Chinkes DL, Jeschke MG. The leading causes of death after burn injury in a single pediatric burn center. Crit Care. 2009;13(6):R183. doi: 10.1186/cc8170. Epub 2009 Nov 17.
Clinical trial NCT01591642: Physical Activity, Functional Fitness and Quality of Life After Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Graft
Keywords: physical activity
functional fitness
quality of life
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 315
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: . All patients who underwent CABG at the Department of Cardiovascular Center at Far-Eastern Memorial Hospital since January 2000 were selected for recruitment to this study.

Brief summary: The main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (QOL) among different physical activity levels in post-coronary artery bypass graft (CABG) patients; (2) to analyze the relationships between physical activity and physical fitness and QOL in this population. The investigators predict physical activity and physical fitness remain limited in patients after CABG, and patients with higher physical activity levels will have higher QOL and physical fitness.

Detailed description: Heart diseases continue as the top 3 causes of death in Taiwan in recent ten years. Coronary artery disease (CAD) is the most prevalent fatal heart disease. Coronary artery bypass graft surgery (CABG) is now one of the most common procedures to treat CAD. It was reported that CABG intervention could prolong the life. However, outcomes of CABG have historically been measured in terms of mortality and recurrence of symptoms or complications.There is ample evidence to demonstrate the effect and benefit of cardiac rehabilitation in QOL and function activity in patients post CABG. However, the participation rate of postoperative cardiac rehabilitation is low, especially in women.Little research has been done to examine the physical activity, physical performance, and QOL in this population outside the cardiac rehabilitation setting.

Eligibility criteria: Inclusion Criteria:

* patients undergoing CABG without valve surgery

Exclusion Criteria:

1. systemic disease, such as liver, renal disease,
2. amputation,
3. cerebrovascular disease or any others disease with limbs dysfunction,
4. lung deficit,
5. cancer,
6. cognitive disorders.

Primary outcomes:
measure: physical activity
timeFrame: The participants were followed at one time points after operation in past 10 years
Secondary outcomes:
measure: physical fitness
timeFrame: The participants were followed at one time points after operation in past 10 years
measure: quality of life
timeFrame: The participants were followed at one time points after operation in past 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03032042: Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Helminth Infection
Keywords: intestinal microbiome
soil-transmitted helminths
mass drug administration
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 0
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted PCR testing to next generation sequencing techniques. In addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. Rectal swabs are more efficient and may result in higher participation. In this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. The investigators will compare the PCR test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. In addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.


Eligibility criteria: Inclusion Criteria:

* all children 0 to 5 (up to 6th birthday)

Exclusion Criteria:

* individuals with a macrolide allergy
* refusal of parent/guardian

Primary outcomes:
measure: Microbial diversity in the intestinal microbiomes of children aged 1-60 months
timeFrame: Day 7
Secondary outcomes:
measure: Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5
timeFrame: Day 7
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: The Carter Center Ethiopia
Study officials:
affiliation: F.I. Proctor Foundation, University of California San Francisco
name: Jeremy Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509742: Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes
Official title: Effect of NNC 90-1170 on Hypoglycaemic Counterregulation During Stepwise Hypoglycaemic Clamp in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, 2-period Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-13
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC 90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.


Eligibility criteria: age: minimum 30, maximum 75 years

Primary outcomes:
measure: Area under the Curve (AUC) glucagon
Secondary outcomes:
measure: Insulin secretion
measure: Glucose
measure: Cortisol
measure: Growth hormone
measure: Adrenaline
measure: Noradrenaline
measure: Adverse events
Other outcomes:
Locations:
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nauck MA, El-Ouaghlidi A, Hompesch M, Jacobsen J, Elbroend B. No Impairment of Hypoglycaemia Counterregulation via Glucagon with the long-acting GLP-1 Derivative, NN2211, in Subjects with Type 2-Diabetes. Diabetologia 2003; 46 (Suppl 2): A285
citation: Nauck MA, El-Ouaghlidi A, Hompesch M, Jacobsen J, Elbroend B. No Impairment of Hypoglycemia Counterregulation via Glucagon with NN2211, a GLP-1 Derivative, in Subjects with Type 2-Diabetes. Diabetes 2003; 52 (Suppl 1): A128
Clinical trial NCT04285242: Metabolic and Immunological Phenotyping in Patients With Cancer
Official title: Metabolic and Immunological Phenotyping in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Non-Hematologic Malignancy
Keywords: Cancer
Non-haematological
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and Female participants who have cancer or are healthy

Brief summary: An observational study to investigate cachexia in participants with non-haematological cancer.

Detailed description: A single-centre, non-randomised, observational study. This study will investigate the systemic metabolic and immunological changes that occur in cachexia. The aim is to better understand the mechanism(s) underlying weight loss in people with non-haematological cancer. This will help to facilitate future research to generate treatments to reverse weight loss and improve outcomes.

Eligibility criteria: Inclusion Criteria:

* Have given written informed consent to participate
* Be aged 18 years or over at the time of signing the informed consent form
* Have a histological or cytological diagnosis of a non-haematological cancer
* Are willing and able to comply with study procedures and visits

Exclusion Criteria:

* Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics
* Current treatment with chemotherapy, oral steroids or other immunosuppressive drugs (within 7 days of baseline investigations or during the study phase)
* Significant acute, chronic or psychiatric condition or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the study.
* Intolerance to dairy products
* Women, who are pregnant, plan to become pregnant or are lactating

Primary outcomes:
measure: Serum cortisol level
timeFrame: Change from baseline serum cortisol level at Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust,
state: Cambridgeshire
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: England
Study officials:
affiliation: University of Cambridge
name: Claire Connell
role: PRINCIPAL_INVESTIGATOR
References: