louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02311517: The Effects of Serratus Anterior Plane Block on Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Postoperative pain still remains a challenging problem in patients undergoing video-assisted thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the possibility to provide analgesia following thoracic surgery. Pain following surgery is a critical side effect of surgery, which increases the risk of complications and delays a recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided SPB on the quality of recovery and pain in patients undergoing VATS.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (20-65 years of age) scheduled for elective video-assisted thoracoscopic surgery
2. ASA class I and II

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of ropivacaine
2. Pregnancy
3. Neurologic and psychologic disease
4. Severe cardiovascular disease
5. Liver failure
6. Renal failure
7. Chronic treatment with analgesics

Primary outcomes:
measure: Quality of Recovery 40 score
timeFrame: 24 hours after operation day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03074617: Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation
Official title: Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of electromagnetic fields of the latest standard in mobile communication (long term evolution, LTE) on sleep is studied in healthy, young individuals.


Eligibility criteria: Inclusion Criteria:

* Age 18-30 years
* German knowledge (reading and writing)
* Right-handedness
* Body mass index (BMI) 18.5-25.0 kg/m2
* Mobile communication (phone calls) less than 2 hours per week
* Moderate alcohol consumption (less than 5 alcoholic beverages per week)
* Moderate caffeine consumption (less than 5 caffeinated foods per day, e.g. coke, coffee, energy drinks, green or black tea, chocolate)
* Informed consent

Exclusion Criteria:

* Travels across more than 2 time zones in the last 30 days or during the study
* Nocturnal shift work
* Extreme chronotype or extreme sleep duration (less than 5 hours or more than 10 hours on average)
* Sleep disorders or problems
* Severe acute or chronic neurological, mental or general health disorders, which might impair the participant's safety or affect the study's outcome
* Use of medication (regular or during the study), which might affect the study's outcome
* Recreational drug use
* Smoking (or other tobacco products)
* Severe skin allergies
* Relevant findings in physical examination or during the screening night (e.g. sleep disorders)
* Participation in an other clinical trial in the last 30 days or during the study

Primary outcomes:
measure: electroencephalographic power during sleep after LTE exposure
timeFrame: up to 9 hours (approximately 11 p.m. to 8 a.m.)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Institute of Pharmacology and Toxicology
Study officials:
affiliation: University of Zurich, Institute of Pharmacology and Toxicology
name: Hans-Peter Landolt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01136317: Comparison of Antisecretory Effect of a Single Dose of Rabeprazole 20 mg and Omeprazole 20 mg in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-06-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: This study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days. The main outcome criteria of analysis is the percentage of time with gastric pH above 3 during 24hours.


Eligibility criteria: Inclusion Criteria:

* Helicobacter negative obese subject (BMI 30 to 40),
* 18 to 55 years old,
* normal hepatic biology and morphology (echography)
* Contraceptive methods in women.

Exclusion Criteria:

* Subjects with previous abdominal surgery, with diabetic or immunosuppressive treatment.

Primary outcomes:
measure: In order to measure antisecretory effect, the main outcome criteria of analysis will be the percentage of time with gastric pH above 3 and measured during 24hours following rabeprazole administration in comparison with omeprazole administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Stanislas Bruley des Varannes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belhocine K, Vavasseur F, Volteau C, Flet L, Touchefeu Y, Bruley des Varannes S. Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole. BMC Gastroenterol. 2014 Jul 15;14:128. doi: 10.1186/1471-230X-14-128.
Clinical trial NCT01044017: A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
Official title: A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is \<50.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-75 years of age
* Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
* Treatment with diet and exercise
* BMI between 27 and 40 kg/m2

Exclusion Criteria:

* Type 1 diabetes
* History of ketoacidosis, hyperosmolar coma, or lactic acidosis
* Renal disease or renal dysfunction
* Evidence of significant diabetic complication
* Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
* History of anti-diabetic triple therapy

Primary outcomes:
measure: Effect on postprandial plasma glucose concentration
timeFrame: Following meal 13 hours after dosing
Secondary outcomes:
measure: Mean postprandial daily plasma glucose concentration (3 consecutive meals)
timeFrame: 25 hours
measure: Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
timeFrame: Assessments up to 25 hours after dosing
measure: Urinary glucose excretion
timeFrame: Assessments up to 25 hours after dosing
measure: Safety and tolerability: AEs, laboratory parameters
timeFrame: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02514317: Percutaneous Treatment of Carpal Tunnel Syndrome With Scan
Official title: Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 40
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.

Detailed description: Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.

The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.

The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years who signed the informed consent.
* Patient with an Carpal Tunnel Syndrome

Exclusion Criteria:

* patient has already undergone surgery of Carpal Tunnel Syndrome
* Patient with contra-indications to anesthesia (heart failure, kidney, liver).
* Pregnant women
* alcoholics in weaning period
* Patient whose consent is altered or unable to get a safety procedure
* Patient with contra-indication to lidocaine
* Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)

Primary outcomes:
measure: Pain (visual analogic scale)
timeFrame: change between baseline and day 90 after surgery
measure: paresthesia
timeFrame: change between baseline and day 90 after surgery
measure: muscle strength (dynamometer JAMARD)
timeFrame: change between baseline and day 90 after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT03194217: BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Official title: Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Excessive Daytime Sleepiness
Parkinson Disease
Lead sponsor: BenevolentAI Bio
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 244
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.

Detailed description: Phase 2b study will be conducted with the aim of investigating the efficacy and safety of three fixed doses of Bavisant (0.5, 1 and 3 mg/d) compared to placebo for the treatment of excessive daytime sleepiness (EDS) in subjects with Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

* Subjects of either sex aged 50 to 80 years \*Subjects with previous diagnosis of Parkinson's disease (following the UK Parkinson's disease society brain bank clinical diagnostic criteria)\*
* Subjects capable of understanding and complying with protocol requirements
* Subjects with medical history of excessive daytime sleepiness

Exclusion Criteria:

* Subjects with excessive daytime sleepiness due to conditions other than Parkinson's disease (including narcolepsy)
* Subjects with clinical evidence of depression with significant psychiatric comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or equal to 17; with or without treatment)
* Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater than or equal to 36
* Subjects with known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
* Subjects with known allergies or hypersensitivity to Bavisant or any of its excipients.
* Subjects who are pregnant or lactating.

Primary outcomes:
measure: Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: MaxBlue Institute
state: Florida
Study officials:
affiliation: Methodist Neurological Institute
name: William G Ondo, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04238117: Laser Acupuncture Therapy in Postpartum Low Back Pain
Official title: Laser Acupuncture Therapy in Postpartum Low Back Pain: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Postpartum Period
Keywords: Laser acupuncture therapy
Low back pain
Postpartum
low-level laser therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over half of women after giving birth have low back pain (LBP), however, LBP is often accepted as a normal part of postpartum. Unsolved low back pain undoubtedly affects women's physical health and may be negatively affect their psychological health. This study was aimed to investigate the efficacy of laser acupuncture therapy (LAT) in postpartum LBP. Postpartum women with LBP admitted at a postpartum care center were recruited and randomly assigned to the intervention group or the control group. The participants in the intervention group underwent 10 sessions/2 weeks of LAT and received standard obstetric care. The participants in the control group only received standard obstetric care. Primary outcome measurements were Visual Analogue Scale (VAS) for pain and salivary cortisol values. Secondary outcome measurements were Chinese versions of the Roland and Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI) version 2.1and the Perceived Stress Scale (PSS).


Eligibility criteria: Inclusion Criteria:

1. Age not less than 20 years
2. Women postpartum within one month
3. Low back pain with visual analogue scale (VAS) score ≧1
4. Low back pain was not relieved by rest for 30 minutes.

Exclusion Criteria:

1. with systemic diseases
2. with cancers
3. with psychiatric diseases
4. under treatment for severe pain by a physician.

Primary outcomes:
measure: Change in visual analogue scale (VAS) for pain
timeFrame: 2 weeks
measure: Change in salivary cortisol values
timeFrame: 2 weeks
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 2 weeks
measure: Chinese version of Oswestry Disability Index (ODI)
timeFrame: 2 weeks
measure: Perceived stress (PSS)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
name: Chun-Ting Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02910817: Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women
Official title: Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria restricted the patients to 39 years old with basal FSH \< 10 IU/ml and normal TSH and prolacin.

Exclusion Criteria:

* Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)

Primary outcomes:
measure: Total number of retrieved oocytes
timeFrame: Two weeks Metformin treatment
Secondary outcomes:
measure: Live birth rate
timeFrame: End of the pregnancy
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Women health center
name: Osama Abdalmageed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdalmageed OS, Farghaly TA, Abdelaleem AA, Abdelmagied AE, Ali MK, Abbas AM. Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial. Reprod Sci. 2019 Oct;26(10):1336-1342. doi: 10.1177/1933719118765985. Epub 2018 Mar 25.
Clinical trial NCT04734717: Coordination and Locomotor Problems in Patients With Covid-19 Virus
Official title: Coordination and Locomotor Problems in Patients With Covid-19 Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Motility Disorder
Balance
Keywords: 6MWT
Berg balance
Beam Walking
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coordination and Locomotor Problems in Patients With Covid-19 Virus


Eligibility criteria: Inclusion Criteria:

* COVID 19 diagnosis

Exclusion Criteria:

* Severe heart problems
* severe demeanor
* alcoholism
* drug problems

Primary outcomes:
measure: EQ5D-5L
timeFrame: 5 weeks-long
measure: Berg test
timeFrame: 5 weeks-long
measure: SPPB test (gait, balance, leg stregth)
timeFrame: 5 weeks-long
measure: 6MWT
timeFrame: 5 weeks-long
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Dr. József Tollár
state: Somogy
Study officials:
References:
Clinical trial NCT03616717: Modafinil Effects on EEG Biomarkers of Reward and Motivation
Official title: Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Adults
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Experimental medicine model; not an intervention. Within-subject double-blind placebo-controlled dose-response study.
Primary purpose: OTHER

Brief summary: The effects of modafinil on measures of brain electrical activity will be tested.


Eligibility criteria: Exclusion criteria

* history of substance abuse
* mental illness in a first degree relative
* significant medical illness (e.g. cancer, diabetes, heart disease, HIV)
* history of seizure
* open head injury or closed head injury with loss of consciousness \> 1 min
* pregnancy
* current psychotropic drug use
* R-hand injury
* hearing or visual impairment
* urine toxicology positive for recreational drug use

Primary outcomes:
measure: Reward Positivity
timeFrame: 1 year
measure: Motivation Signal
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego; Clinical Teaching Facilities, Hillcrest
state: California
Study officials:
affiliation: UCSD
name: Jared W Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: