louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02999594: Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial
Official title: Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tramadol for Labor Analgesia
Lead sponsor: Maulana Azad Medical College
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tramadol for labor analgesia: a low risk placebo controlled randomised control trial

Detailed description: Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. Visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end

Eligibility criteria: Inclusion Criteria:

* delivering for first time(nulliparous)
* well established labor ( 3 or more contractions in a span of ten minutes
* cervical dilation of 4 cm or more
* \>= 80% effacement of cervix

Exclusion Criteria:

* any medical disorder- diabetes,hypertension
* obstetric high risk factors

Primary outcomes:
measure: visual analogue scale
timeFrame: at 2nd hour of administration
Secondary outcomes:
measure: patient satisfaction
timeFrame: at the end of labor( within 12 hours)
measure: fetal distress
timeFrame: during labor
measure: duration of 1st and 2nd stage of labor
timeFrame: 1st and 2nd stage
measure: women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness
timeFrame: till the end of labor
measure: neonatal safety in terms of apgar score and nicu admission
timeFrame: apgar score at 0 and 5 min
measure: need for caesarean section or instrumental delivery
timeFrame: during labor
Other outcomes:
Locations:
Study officials:
affiliation: Maulana Azad Medical College
name: dr aastha raheja
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03020394: Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation
Official title: Comparison of High Flow Nasal Cannula, Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Keywords: COPD Exacerbation
Noninvasive Positive Ventilation
Invasive Positive Ventilation
severe
High flow nasal cannula
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with acute exacerbation of chronic obstructive pulmonary disease in medical ICU.

Brief summary: Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. But there's no high-quality clinical studies which can confirm this. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in order to reduce IMV-related complications and improve patients' outcomes.

Detailed description: In part of the patients who were AECOPD with pH \<7.25 , preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of VAP. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. At present, there's no high-quality clinical studies which can confirm this, and clinical guidelines do not have a recommendation on the use of NPPV in these patients. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, as well as the progress of medical technology in NPPV in recent years, in order to reduce IMV-related complications and improve patients' outcomes.

Eligibility criteria: Inclusion Criteria:

* AECOPD;

Exclusion Criteria:

* refuse to engage in the study;
* have been included in other study.

Primary outcomes:
measure: The incidence of ventilator-associated pneumonia (VAP)
timeFrame: 90days
measure: The all cause mortality of ICU and hospitalization
timeFrame: 90 days
Secondary outcomes:
measure: The length of stay of ICU and hospitalization
timeFrame: 90 days
measure: The length of stay of mechanical ventilation
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Qingyuan Zhan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891394: Human Epididymis Protein 4 in Women With Severe Preeclampsia / HELLP Syndrome
Official title: Prognostic Value of Human Epididymis Protein 4 (HE4) for Persistent Proteinuria in Women With Severe Preeclampsia / HELLP Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The diagnosis is made after 20 weeks of gestation in previously normotensive women who develop:

* Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg and proteinuria (with or without signs and symptoms of significant end-organ dysfunction).
* Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg (with or without proteinuria) and one or more of the following signs and symptoms of significant end-organ dysfunction

Brief summary: Pre-eclampsia seems to be associated with a four to five times increase risk of later microalbuminuria and CKD which might suggest a possible direct renal damage from pre-eclampsia


Eligibility criteria: Inclusion Criteria:

1. Pregnant women 18-35 years old.
2. Fulfilling the criteria for diagnosis of sever preeclampsia.
3. Fulfilling the criteria for diagnosis of HELLP syndrome

Exclusion Criteria:

1. Diabetes mellitus
2. Preexisting renal disease.
3. Chronic hypertension
4. Rheumatologic diseases
5. Adnexal mass.

Primary outcomes:
measure: protein in urine
timeFrame: 12 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01215994: Estimation of Glomerular Filtration Rate (GFR) in Patients With Type 2 Diabetes Mellitus.
Official title: Comparative Study of New Formulae of GFR Estimation Based on Creatinine, Cystatin C and Cr51-EDTA.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Diabetic Nephropathy
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic patients treated in the primary care clinic

Brief summary: The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin C and creatinine based equations for GFR estimation compared with 51Cr-EDTA (chromium-51 labeled ethylenediamine tetraacetic acid) measured GFR in patients with diabetes.

Detailed description: The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin C and creatinine based equations for GFR estimation compared with 51Cr-EDTA measured GFR in patients with diabetes.

Additional, we will check which equation detects better the reduction of renal function over the time, in patients with diabetes.

Finally, we will investigate if cystatin C levels can be influenced by factors other than GFR

Eligibility criteria: Inclusion Criteria:

* Type 2 and type 1 diabetes mellitus

Exclusion Criteria:

* Patients with other type diabetes: gestational, exocrine pancreatic defects, endocrinopathies, drugs
* Patients with end-stage renal disease, cardiac failure, hepatic failure, malignancies, immunosuppression, pregnant, diabetic ketoacidosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital of Thessaloniki
Study officials:
affiliation: Aristotle University of Thessaloniki, Greece
name: Dimitrios Grekas, PhD, MD
role: STUDY_CHAIR
References:
citation: Iliadis F, Didangelos T, Ntemka A, Makedou A, Moralidis E, Gotzamani-Psarakou A, Kouloukourgiotou T, Grekas D. Glomerular filtration rate estimation in patients with type 2 diabetes: creatinine- or cystatin C-based equations? Diabetologia. 2011 Dec;54(12):2987-94. doi: 10.1007/s00125-011-2307-1. Epub 2011 Sep 23.
Clinical trial NCT00974194: Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
Official title: Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Keywords: Cholecystolithiasis
Cholecystectomy
Laparoscopic surgery
Single port
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 268
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: Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

Detailed description: Design:

* Prospective Randomized Controlled trial
* Population analysis based on Intention To Treat
* Patient and data analyzer blinded (double-blind trial)

Outcomes observed:

* Primary: pain
* Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption

Nbr of patients included: 260

Port used: Triport, Olympus

Eligibility criteria: Inclusion Criteria:

* Cholecystolithiasis
* Age 18 to 75 y.o.
* BMI \< 35

Exclusion Criteria:

* Immunodeficiency
* Choledocholithiasis
* Previous upperGI open surgery

Primary outcomes:
measure: Pain (value on a Visual Analog Scale)
timeFrame: 1 day
measure: Pain (value on a Visual Analog Scale)
timeFrame: 2 days
measure: Pain (value on a Visual Analog Scale)
timeFrame: 1 month
measure: Pain (value on a Visual Analog Scale)
timeFrame: 3 month
measure: Pain (value on a Visual Analog Scale)
timeFrame: 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1 month
measure: Operative time
timeFrame: Operative day
measure: Cost analysis
timeFrame: 1 year
measure: Cosmetic results
timeFrame: 1 month
measure: Cosmetic results
timeFrame: 3 month
measure: Cosmetic results
timeFrame: 1 year
measure: Complications
timeFrame: 3 month
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: CHV/CHUV
name: Pierre Allemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04048694: Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed
Official title: Comparative Study of Calculating the Dose to the Skin by the Dosemap® Software and Its Measurement in Vivo by Gafchromic Movie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measure of the X-ray Dose
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 100
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 undergoing a Interventional Cardiology procedure

Brief summary: The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

Detailed description: The procedures of Interventional Cardiology are realized under exposure in the X-rays which can be sometimes important for the patient according to the nature of the procedure.

The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct.

Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter.

It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.

Eligibility criteria: Inclusion Criteria:

* Procedure of Interventional Cardiology potentially more irradiant (angioplasty of the circumflex artery , or of several vessels)
* Body mass index \> 25
* Collection of the Non-opposition of the patient

Exclusion Criteria:

* Diagnostic coronarography,
* Emergency procedures,
* Minor patients

Primary outcomes:
measure: Difference between the calculation by the software and the measurement by the dosimetry film
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: David Bourhis
role: STUDY_DIRECTOR
References:
Clinical trial NCT04371094: Sore Throat After Intubation Using Glidescope With Stylet and Bougie
Official title: Comparison Between Using Glidescope With Stylet Technique and With Bougie Technique on the Incidence and Severity of Postoperative Sore Throat Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Sore Throat
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a prospective double-blinded clinical trial aiming to compare the incidence and severity of sore throat after laparoscopic cholecystectomy when using two different techniques of intubation using glidescope

Detailed description: The first technique is loading the endotracheal tube on a stylet the second technique is sliding the endotracheal tube over a bogie that is dragged into the trachea at both techniques, the investigators are using glidescope

Eligibility criteria: Inclusion Criteria:

* ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA

Exclusion Criteria:

* ANTICIPATED DIFFICULT INTUBATION

Primary outcomes:
measure: postoperative sore throat (POST)
timeFrame: IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER
Secondary outcomes:
measure: postoperative sore throat (POST)
timeFrame: immediately postoperative at recovery room
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT03979794: A Distress Screening and Intervention in Cancer Surgery
Official title: A Distress Screening and Intervention in Cancer Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Stress
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (intervention vs. standard care)
Primary purpose: TREATMENT

Brief summary: The goal of this project is to examine initial effectiveness of a brief (2 preoperative, 2 postoperative session) cognitive behaviorally-based telephone intervention compared to standard care on postoperative outcomes for patients who are scheduled to undergo a cancer-related surgery in 12 or more days and screen positive for distress (4 or higher on 0-10 Distress Thermometer). The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care. Participants will be randomly assigned to receive the intervention or to receive standard care. Outcomes assessed 4 and 6 weeks post-operatively will include: Depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), health-related QOL (SF-36 MCS and PCS), number and type of complications, length of stay, and 30-day readmission.


Eligibility criteria: Inclusion Criteria:

* ADULT (18 years of age or older)
* SCHEDULED FOR SURGERY FOR CANCER (excluding non-melanoma skin cancer) 12 OR MORE DAYS IN ADVANCE OF CONSENT
* SIGNIFICANTLY DISTRESSED (\>4 on the 0-10 Distress Thermometer)
* ABLE TO SPEAK ENGLISH

Exclusion Criteria:

* COGNITIVE IMPAIRMENT : \<4 on baseline Mini Cog measure
* SERIOUS MENTAL ILLNESS: a diagnosis of a bipolar or psychotic disorder (noted in medical record)
* NON-ENGLISH SPEAKING: This study only involves participants who can speak English.

Primary outcomes:
measure: Patient Health Questionnaire-8
timeFrame: 4-weeks post-operation (+/-1 week)
measure: Generalized Anxiety Disorder-7
timeFrame: 4-weeks post-operation (+/-1 week)
Secondary outcomes:
measure: Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)
timeFrame: 4-weeks post-operation (+/-1 week)
measure: Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)
timeFrame: 4-weeks post-operation (+/-1 week)
measure: Number of Complications
timeFrame: 30 days post-operation
measure: Length of post-operative hospital stay
timeFrame: 30 days post-operation
measure: Hospital Readmission
timeFrame: 30 days post-operation
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine/Sam Houston State University
name: Chelsea G Ratcliff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356194: Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Official title: A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Drug-Drug Interaction Potential Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.

Primary outcomes:
measure: PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).
timeFrame: Day 2, Days 4-7, Days 14-17, Days 21-24
measure: To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine)
timeFrame: Days 7-10, Day 12, Days 14-17, Days 21-24.
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
state: Montreal
Study officials:
References: