louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02156830: Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery
Official title: Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery: Qualitative Interviews
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The different health care professionals of the obesity team

Brief summary: The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

Detailed description: The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. We will do a benchmarking and also qualitative analyses of the interviews using Nvivo 10.

This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* All the members of the obesity team should be prepared to participate in the study

Primary outcomes:
measure: Difference between multidisciplinary approach in bariatric surgery population in Flanders and the guidelines
timeFrame: The interviews will be performed once
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Ina Gesquiere
Study officials:
affiliation: KU Leuven
name: Veerle Foulon, PhD PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570230: Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study
Official title: Low Dose Intraoperative Intravenous Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Postoperative Period
Keywords: Thoracotomy
Postoperative pain
Ketamine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracotomy is one of the most painful operation. Continuous thoracic epidural or paravertebral analgesia are gold standard for postoperative pain. But both techniques require skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose ketamine during intraoperative may be helpful in postoperative pain relief.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-3
* elective thoracotomy
* can operate patient-controlled analgesia (PCA) machine

Exclusion Criteria:

patient with history of

* allergy to morphine or ketamine
* contraindicate to ketamine
* remain intubated in the postoperative period

Primary outcomes:
measure: Time to first trigger of morphine
timeFrame: 24 hours
Secondary outcomes:
measure: 24-hr morphine consumption
timeFrame: 24 hours
measure: NRS score at 6, 24 hours
timeFrame: 24 hours
measure: Incidence of nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652730: Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
Official title: Comparative, Randomized, 3-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar)15 mg Buspirone HCl Tablets Following Administration of a 30 mg Dose in Healthy Adult Males Under Fed and Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine Bioequivalence Under Fed Conditions
Keywords: bioequivalence
buspirone HCl
fed
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Phoenix International Life Sciences, Inc.
First posted: 2008-04-04
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

Detailed description: To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, 18-45 years of age
* Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", metropolitan Life Insurance Company, 1983)
* Physical examination and laboratory tests of hematologic, hepatic and renal functions.
* Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
* In addition, the presence of alcoholism or drug abuse within the past year: hypersensitivity or idiosyncratic reaction to buspirone HCl.
* Subjects who have been receiving monoamine oxidase inhibitors.
* Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
* Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL blood in 14 days (unless approved by the Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year.
* Subjects who have participated in another clinical trial with 28 days of study start.

Primary outcomes:
measure: Rate and extent of absorption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: St-Laurent
country: Canada
facility: Phoenix International Life Sciences inc
state: Quebec
Study officials:
affiliation: Phoenix International Life Sciences, Inc.
name: Samuel Surfaty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03177330: Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion
Official title: Safety and Efficacy of Heparin Dosing Score Protocol for Anticoagulation During Polymyxin-B Hemoperfusion: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Polymyxin B Hemoperfusion
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion

Brief summary: Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. We developed a heparin dosing score protocol for heparin dosage adjustment. The purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.


Eligibility criteria: Inclusion Criteria:

* intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion in National Taiwan University Hospital during October 2013-December 2016

Exclusion Criteria:

* pregnant woman
* patients with do-not-resuscitate declaration
* uncontrolled bleeding within 24hr

Primary outcomes:
measure: premature cartridge clotting rate
timeFrame: 2 hours
Secondary outcomes:
measure: bleeding event rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, NTUH, Taipei, Taiwan
Study officials:
References:
Clinical trial NCT01470430: VEGF In Systemic Circulation Of ROP-infants
Official title: Study to Measure Systemic VEGF Levels in ROP Infants Following Intravitreal Anti-VEGF Therapy or Retinal Laser Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Retinopathy of Prematurity (ROP)
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prematurely born infants with retinopathy of prematurity requiring treatment

Brief summary: The purpose of this study is to measure systemic levels of vascular endothelial growth factor (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with retinopathy of prematurity (ROP) following ocular treatment with either intravitreal injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to determine if serum VEGF levels change after treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of retinopathy of prematurity requiring treatment

Exclusion Criteria:

* Anemia

Primary outcomes:
measure: Systemic VEGF levels following treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Systemic levels of other growth factors (e.g. IGF-1)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Eye Hospital
state: Baden-Wuerttemberg
Study officials:
affiliation: University Eye Hospital Freiburg, Germany
name: Andreas Stahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873530: Circadian Modulation of Grape Consumption and Oxidative Stress Response
Official title: Circadian Modulation of Grape Consumption and Oxidative Stress Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Idaho State University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.

Detailed description: Grape consumption acts on the immune system to produce antioxidant and anti-inflammatory effects. Since immune activity demonstrates circadian rhythmicity, with peak activity occurring during waking hours, the timing of grape intake may influence the magnitude of its antioxidant effect. This study followed a 2 x 2 factorial randomized, controlled design wherein healthy men and women (n = 32) consumed either a grape or placebo drink with a high-fat meal in the morning or evening. Urine was collected for measurements of biomarkers of oxidative stress and grape metabolites at baseline and post-meal at hour 1 and hours 1-6

Eligibility criteria: Inclusion Criteria:

* Healthy
* Age 18-50 y

Exclusion Criteria:

* Employed in shift or night work
* Extreme early or late chronotype
* Presence of acute infection or chronic inflammatory disease
* Smoking
* Heavy aerobic exerciser
* Greater than moderate alcohol intake
* Pregnancy or lactation
* Use of non-steroidal anti-inflammatory medications or antioxidant dietary supplements.

Primary outcomes:
measure: Urine F2-isoprostane
timeFrame: baseline
measure: Urine F2-isoprostane
timeFrame: hour 1
measure: Urine F2-isoprostane
timeFrame: hours 1-6
Secondary outcomes:
Other outcomes:
Locations:
city: Pocatello
country: United States
facility: Idaho State University
state: Idaho
Study officials:
References:
Clinical trial NCT01644630: To Compare Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
Official title: A Randomized Controlled Clinical Trial Comparing Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant-supported Single Crowns
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to test whether or not the use of screw-retained implant crowns on customized zirconia abutments results in biological, technical and esthetic outcomes similar to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both made with a computer-aided design and manufacturing procedure (CAD/CAM).

The null-hypotheses is that marginal bone level change is equal at screw-retained and cemented crowns


Eligibility criteria: Inclusion Criteria:

* Single-tooth Straumann Bone Level in the anterior maxilla or mandible
* At least one adjacent natural tooth present
* Implant position enabling both screw-retained and cemented crown
* Informed consent signed

Exclusion Criteria:

* Smoking more than 15 cigarettes a day
* Poor oral hygiene (Plaque index over 30%)
* Pregnancy at the date of inclusion

Primary outcomes:
measure: Marginal bone level
timeFrame: 5 years
Secondary outcomes:
measure: Biological, technical and esthetic outcome
timeFrame: up to 5 years
measure: Biological, technical and esthetic outcome
timeFrame: up to 5 years
measure: Biological, technical and esthetic outcome
timeFrame: up to 5 years
measure: Biological, technical and esthetic outcome
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic of Reconstructive Dentistry
Study officials:
affiliation: Clinic of Reconstructive Dentistry
name: Daniel Thoma, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681130: Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success
Official title: Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Pregnancy
Keywords: depression
anxiety
stress
pregnancy
IVF
Lead sponsor: Eurofertil IVF Health Center
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ages 20-40, without history of RIF or known genetic aneuploidy. Men without severe sperm problem without known genetic aneuploidiy. Only blastocyst transferred copules will be eligible for final analysis.

Brief summary: Psychological status of couples attending to IVF programmes is important due to possible effect on final result. Observers aim to investigate the depression, anxiety and stress scores of couples before and after the procedure.

Detailed description: Studying effect of psychology on IVF is not a new idea. "Before and after" scores of women attending to IVF programmes had been studied numerous times. However, there is not sufficient data about the contbibution of male compartment upon the process. Investigators aimed to study both male and female participants. Final scores will not be evaluated unless at least good quality blastocsyt is transferred.

Eligibility criteria: Inclusion Criteria:

* 20 to 40 year old women attending to IVF programme

Exclusion Criteria:

* Azospermia and severe male factor for whom sperm freezing will be required
* History of RIF
* Known genetik abnormality of couples

Primary outcomes:
measure: positive pregnancy test
timeFrame: 12 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Eurofertil
Study officials:
affiliation: Eurofertil IVF Health Center
name: gerçek aydın
role: STUDY_DIRECTOR
References:
Clinical trial NCT05694130: Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
Official title: Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sjogren Syndrome With Other Organ Involvement
Keywords: Sjogren's syndrome
Thrombocytopenia
Tacrolimus
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.

Detailed description: This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
* Baseline platelet counts less than 30×109/L.

Exclusion Criteria:

* Concomitant other systemic autoimmune diseases.
* Other severe complications of Sjogren's syndrome.
* Abnormal laboratory tests such as: white blood cell count \<2.5x10\^9/L, hemoglobin \<80 g/L, AST/ALT \>1.5 ULN, serum creatine \> 1.5 mg/dL.
* Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
* Active acute or chronic infections.
* History of malignancy.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Complete response rate
timeFrame: week 12
Secondary outcomes:
measure: Complete response rate
timeFrame: week 4 and week 8
measure: Partial response rate
timeFrame: week 4, week 8 and week 12
measure: ESSDAI improvement
timeFrame: week 12
measure: ESSPRI improvement
timeFrame: week 12
Other outcomes:
measure: Immunoglobulins
timeFrame: week 12
measure: Rheumatoid Factor
timeFrame: week 12
Locations:
Study officials:
References:
Clinical trial NCT02969330: Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli
Official title: Effect of Short Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli Evaluated by BOLD and Functional Diffusion MRI: a Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Activity
Glucose Control
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2016-11-21
Enrollment: 20
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: The aims of this study are twofold: (1) to develop an innovative approach for studying brain glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans; (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on brain and brain-stem targets, associated with control of food intake and energy expenditure, in response to glucose stimuli, in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18-65 years old.
* Body mass index 18 to 25 kg/m2
* Capable of giving informed consent

Exclusion Criteria:

* Pregnancy, or nursing
* Permanent pacemakers
* Metal prosthesis
* Skin disease
* Claustrophobia
* History of neurological disorders

Primary outcomes:
measure: Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion.
timeFrame: changes from baseline to 30 minutes after glucose ingestion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03510130: Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries
Official title: Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Delivery Affecting Fetus or Newborn
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean delivery rates have risen in the US in a dramatic fashion from less than 5% in the 1960 to 32.7% by 2013 with stable rate around 32-33% in the last five years , cesarean delivery is associated with increased maternal morbidity and mortality, Labor arrest is the most common indication for cesarean delivery, Maternal position during the second stage of labor has been suggested to affect the risk of instrumental vaginal delivery. A Cochrane review of position in the second stage of labor in women without epidural showed a reduction in instrumental vaginal delivery in the upright group, although the quality of the included trials was reported to be generally poor, A Cochrane review of position in the second stage of labour for women with epidural analgesia was published in 2017, This review included trials that compared upright with recumbent positions and suggested no effect.

No prior studies examined whether maternal legs movement during the second stage of labor has any effect on the rate of operative deliveries.

Detailed description: A randomized controlled trial to determine whether routine maternal leg movement during the second stage of labor decreases the rate of operative deliveries (instrumental delivery of cesarean section )

Eligibility criteria: Inclusion Criteria:

•Women who had a low risk pregnancy followed by an uncomplicated vaginal delivery, instrumental delivery or cesarean section.

Exclusion Criteria:

•Women who had a high risk pregnancy ((IUGR, hypertension disorders of pregnancy, maternal cardiovascular or respiratory illness).

Primary outcomes:
measure: Routine legs movement during the second stage of labor and the rates of cesarean deliveries (In percentage of the total deliveries) and instrumental deliveries (In percentage of total deliveries)
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: