louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02570633: Ginger Capsules for the Prophylactic Treatment of Migraine
Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Ginger
Prophylactic treatment
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

Detailed description: Patients with the diagnosis of migraine according to the IHS criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 60 years old;
* Migraine diagnosis;
* Agree to sign the informed consent.

Exclusion Criteria:

* Patients with headaches not characterized as migraine;
* Pregnant or lactating women;
* Fertile and sexually active women who do not use contraception;
* Abuse of painkillers, alcohol or other drugs;
* People with hypersensitivity to ginger compounds;
* People with severe neurological diseases (e.g. epilepsy)
* People in use of anticoagulant drugs.

Primary outcomes:
measure: Change in the frequency of migraine attacks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in migraine impact in the last month.
timeFrame: 4 weeks
measure: Change in migraine impact in the last three months.
timeFrame: 12 weeks
measure: Changes in the serum levels of biomarkers.
timeFrame: 12 weeks
measure: Changes in Resting Energy Expenditure
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Ambulatório Bias Fortes
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Adaliene VM Ferreira, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Laís B Martins, Ma
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Antônio L Teixeira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martins LB, Rodrigues AMDS, Monteze NM, Tibaes JRB, Amaral MHA, Gomez RS, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger (Zingiber officinale Rosc.) in the prophylactic treatment of migraine. Cephalalgia. 2020 Jan;40(1):88-95. doi: 10.1177/0333102419869319. Epub 2019 Aug 9.
Clinical trial NCT05313633: Plyometric Exercises Versus Wii Training in Children with Unilateral Cerebral Palsy
Official title: Efficacy of Plyometric Exercises Versus Wii Training on Upper Extremity Function in Children with Unilateral Cerebral Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Cerebral palsy
Unilateral Cerebral Palsy
hand grip strength
upper extremity function
range of motion
Wii training
plyometric exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.

Commercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* aged 8-12 years;
* able to understand and follow simple commands.

Exclusion Criteria:

- severe uncontrolled seizures;

Primary outcomes:
measure: Upper extremity function
timeFrame: after 3 months of treatment
measure: Hand grip strength
timeFrame: after 3 months of treatment
Secondary outcomes:
measure: Range of motion
timeFrame: after 3 months of treatment
measure: Selective motor control
timeFrame: after 3 months of treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo university, faculty of physical therapy
name: walaa A El-nabie, Phd
role: STUDY_CHAIR
affiliation: Cairo university, faculty of physical therapy
name: Hazem A Ali, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04575233: A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy
Official title: Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Colectomy
Pain, Postoperative
Keywords: Transversus Abdominis Plane (TAP) Block
Local Anesthetic Infiltrations
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the postoperative pain, the time needed and other clinical outcomes in patients who, during laparoscopic colectomy, will be injected with a local anesthetic (Ropivacaine) through an ultrasound guided technique performed by the anaesthesiologist or throught a laparoscopic assisted technique performed by the surgeon


Eligibility criteria: Inclusion Criteria:

* Patients candidates to laparoscopic colorectal surgery
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years old
* Pregnancy
* Allergy to local anaesthetics
* Spinal or epidural analgesia
* Acute inflammatory abdominal pathologies
* Chronic pain syndrome
* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)

Primary outcomes:
measure: Opioids consumption
timeFrame: 24 hours from surgery
Secondary outcomes:
measure: Opioid consumption within the first 48 hours after the operation
timeFrame: 48 hours from surgery
measure: postoperative pain
timeFrame: at 3, 6, 12, 24 hours from surgery
measure: length of hospital stay
timeFrame: during hospitalization,approximately 6 days
measure: Time required to perform the (Transversus Abdominis Plane) TAP block
timeFrame: during procedure
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale
Study officials:
affiliation: Ente Ospedaliero Cantonale (EOC)
name: Davide La Regina, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05272033: Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly
Official title: The Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension Related to Spinal Anesthesia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite prophylactic measures, hypotension remains a common side-effect of spinal anesthesia. Electroacupuncture influences hemodynamics. We hypothesized that transcutaneous electrical acupuncture point stimulation (TEAS) at traditionally used acupuncture points would reduce the severity of hypotension after spinal anesthesia in geriatric patients undergoing hernia surgery.

Detailed description: After obtaining written informed patient consent, 60 geriatric patients undergoing hernia surgery under spinal anesthesia were randomized into two groups. In the placebo TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. The acupoint group will receive TEAS at the PC-5, PC-6, and ST-36 points bilaterally before the spinal anesthesia. The spinal anesthesia will be performed using 12.5 mg 0.5% bupivacaine was from the L3-4 or L4-5 interval with a 25G Quincke spinal needle. Hemodynamic data will be followed every five minutes.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair

Exclusion Criteria:

* Patients with neurological or psychological diseases
* Patients who have been treated with TEAS or acupuncture before,
* Patients with heart failure and pace-maker
* Those who have a local infection in the TEAS area.

Primary outcomes:
measure: patients blood pressure will be measured
timeFrame: 30 minutes following spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References:
Clinical trial NCT06169033: Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS)
Official title: Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Type 2 Diabetes Mellitus
Bariatric Surgery
Keywords: Obesity
Type 2 Diabetes Mellitus
Radiomics
Abdominal adipose
Subcutaneous adipose
Prediction model
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 800
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients with type 2 diabetes who will undergo bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) and receive abdominal CT scan will be included in the study.

Brief summary: Using radiomics of intra-abdominal and subcutaneous adipose tissue and clinical features to predict the weight loss efficacy and remission of type 2 diabetes mellitus after bariatric surgery.

Detailed description: In this study, the investigator intend to collect abdominal CT from patients who are proposed to undergo bariatric surgery, to extract the radiomics of intra-abdominal fat and subcutaneous fat, and to establish a prediction model for predicting the efficacy of weight loss and remission of type 2 diabetes mellitus at 1 year, 3 years, and 5 years postoperatively, in conjunction with the clinical data.

Eligibility criteria: Inclusion Criteria:

* BMI\>27.5kg/m2; Type 2 diabetes mellitus; Patients who will undergo bariatric surgery

Exclusion Criteria:

* Patients without abdominal CT scan; Patients did not undergo sleeve gastrectomy or Roux-en-Y gastric bypass.

Primary outcomes:
measure: Area under curve (AUC) of the weight loss prediction model after 1 year
timeFrame: 1 year
measure: Area under curve (AUC) of the T2DM remission prediction model after 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Area under curve (AUC) of the weight loss prediction model after 3 years
timeFrame: 3 years
measure: Area under curve (AUC) of the T2DM remission prediction model after 3 years
timeFrame: 3 years
measure: Area under curve (AUC) of the weight loss prediction model after 5 years
timeFrame: 5 years
measure: Area under curve (AUC) of the T2DM remission prediction model after 5 years
timeFrame: 5 years
measure: Area under curve (AUC) of the weight regain model
timeFrame: 5 years
measure: Area under curve (AUC) of the T2DM relapse model
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yuntao Nie
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yuntao Nie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259233: The Role of Peptide YY (PYY)in Inhibiting Food Intake.
Official title: The Effects of Peripheral Administration of Saline, PYY1-36 and PYY3-36 on ad Libitum Energy Intake and Appetite.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Aditech Pharma AB
First posted: 2005-11-29
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses PYY3-36 on 5 different test days within one week. The patients will be tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.


Eligibility criteria: Inclusion Criteria:

* Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2)
* Body weight fluctuations \< 5 kg over the past 2 months.
* Blood pressure normal to mildly hypertensive(\<159/99 mm Hg)
* Non-elite athletes and not planning to change physical activity during the study.

Exclusion Criteria:

* Any physiological or psychological illnesses that could influence the study results.
* Regular use of medicine.
* Smoking defined as \<1 cigarette per day.
* Substance abuse or dependence.
* Blood donation within the past 3 months before entering the study.
* Drinking \>21 alcoholic units/week.
* Food allergies.
* Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.

Primary outcomes:
measure: appetite
measure: energy intake
Secondary outcomes:
measure: Plasma PYY profile
measure: Blood pressure
Other outcomes:
Locations:
Study officials:
affiliation: Department of Human Nutrition, RVAU
name: Arne Astrup, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814333: Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Official title: A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epistaxis
Keywords: epistaxis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
First posted: 2008-12-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.


Eligibility criteria: Inclusion Criteria:

* English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital

Exclusion Criteria:

* Non-english speaking patients
* Patients with bleeding disorders
* Known pregnant women or women that think they may be pregnant
* Patients with a know presence of antibodies to bovine thrombin preparations
* Patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis
* Patients found to have posterior epistaxis
* Patients requiring a surrogate for medical decisions

Primary outcomes:
measure: Cessation of Epistaxis
timeFrame: baseline, day 4-6
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Keith Sale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00703833: A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)
Official title: A Double-Blind, Multicenter, Placebo-Controlled Study of MK0777 Gel Extrusion Module (GEM) 1.5 mg b.i.d. in the Treatment of Outpatients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 51
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: The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Current diagnosis of Generalized Anxiety Disorder
* Age 18 - 70

Exclusion Criteria:

* Women who are pregnant, or breast-feeding
* Use of illicit drugs
* History of drug or alcohol dependence

Primary outcomes:
measure: Measure the reduction of anxiety
timeFrame: after 4 weeks and at end of study
Secondary outcomes:
measure: Safety and efficacy
timeFrame: throughout study and at end of study
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02847533: Inflammatory Markers and Resistant Depression
Official title: Inflammatory Markers and Resistant Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: resistant depression
inflammation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.


Eligibility criteria: Inclusion Criteria:

* group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA,
* group 2: patients with MDD remission after response to an antidepressant treatment.

Exclusion Criteria:

* comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection

Primary outcomes:
measure: plasmatic concentration of Interleukin 6
timeFrame: at patient inclusion
Secondary outcomes:
measure: concentration of proinflammatory cytokine
timeFrame: at patient inclusion
measure: concentration of antiinflammatory cytokine
timeFrame: at patient inclusion
measure: functional polymorphisms of expression genes of inflammatory proteins
timeFrame: at patient inclusion
measure: plasmatic concentration of Retinoid X receptor signaling pathway
timeFrame: at patient inclusion
measure: Expression rate of monocytes costimulation molecules
timeFrame: at patient inclusion
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Emmanuel Haffen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05896033: Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
Official title: The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Prevention and Control
Keywords: Smoking
Menthol
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Minnesota
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-09
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.


Eligibility criteria: Inclusion Criteria:

1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
2. usual brand (the brand used most often) is mentholated
3. have a smartphone that can receive text messages and access the internet (necessary for diary completion).

Exclusion Criteria:

1. other tobacco and pharmacotherapy criteria
2. health and safety criteria
3. planning to move out of the area within the next 3 months

Primary outcomes:
measure: Changes in cigarettes per day
timeFrame: Week 1- Week 6
Secondary outcomes:
measure: Fagerstrom Test for Nicotine Dependence
timeFrame: Week 1- Week 7
measure: Ability to abstain from smoking
timeFrame: Week 7
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: