louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03088696: Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.
Official title: Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis
Vomiting
Nausea
Keywords: laparoscopic
acupuncture
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized comparative double blind prospective study
Primary purpose: PREVENTION

Brief summary: Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Detailed description: Utilizing acustimulation, the effect of PC 6 "Neiguan" (acupuncture point Pericardium 6) has been studied in PONV . Conventional acupuncture has not been tested yet in laparoscopic cholecystectomy.

The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with PONV management.

Eligibility criteria: Inclusion Criteria:

* Female and male patients
* \> 18 y
* General anesthesia
* Undergoing laparoscopic surgery
* Patient with American Society of Anesthesiologists physical status I-II
* Written informed consent

Exclusion Criteria:

* Pregnant women and breastfeeding
* Patient with cardiac disease
* Surgery more than 2 h
* No bowel surgery
* Signs of skin infection at or near the purposed site of the acupuncture point
* Patient with American Society of Anesthesiologists physical status IIII-IV

Primary outcomes:
measure: Vomiting and Nausea
timeFrame: 24 hours
Secondary outcomes:
measure: Use of antiemetic
timeFrame: 24 hours
measure: Use of analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams-Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, PhD MD
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Güngör Badaş, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Vincent Van Tittelboom, MD
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Brussel
name: Philippe Bral, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01056796: Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
Official title: Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: compression anastomosis
Colorectal cancer
Low anterior resection
Radiated to the pelvic area
Radiotherapy
Lead sponsor: Niti Medical Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Gasthuisberg
First posted: 2010-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.


Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years old.
* Patient is scheduled for a non-emergency TME and low anterior resection (\< 10cm from the anal verge).
* Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
* Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

* Patient has known allergy to nickel.
* Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
* Patients are participating in another clinical trial which may affect this study's outcomes.
* Patient has been taking regular steroid medication.
* Patient has contraindications to general anesthesia.
* Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Primary outcomes:
measure: To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
timeFrame: Approx. 1 year
Secondary outcomes:
measure: Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients
timeFrame: Approx. 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital, Gasthuisberg
Study officials:
affiliation: Gasthuisberg University Hospital
name: Andre D'Hoore, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00396396: Role of Acetylcysteine in Creatinine Clearance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Creatinine Clearance
Keywords: Creatinine clearance
Acetylcysteine
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2006-11-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate the exact role of Acetylcysteine (Mucomyst) in altering creatinine clearance. Prior studies have shown the protective effects of Acetylcysteine on contrast-induced renal dysfunction. In these studies, Acetylcysteine lowered the incidence of serum creatinine elevation after administration of radiographic contrast agents. Not only was the increase in serum creatinine prevented, the studies also demonstrated a significant increase in creatinine clearance after administration of the agent. These prior studies did not evaluate if the increase in creatinine clearance was indeed from a protective benefit of Acetylcysteine in preserving the GFR versus simply increasing the proximal tubular creatinine secretion without actually affecting the GFR. We propose an experiment to help support our hypothesis that Acetylcysteine increases creatinine clearance via an increase in proximal tubular secretion of creatinine.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 79 years
2. In good general health
3. Able to provide informed consent

Exclusion Criteria:

1. Allergy to acetylcysteine or cimetidine,
2. Age less than 18 years or greater than 79 years of age,
3. Women of childbearing age and not able to use adequate contraception, or 4. Anyone currently on any medication that interferes with tubular secretion of creatinine such as trimethoprim-sulfamethoxazole (Bactrim).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School/Nephrology Associates
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Thomas R McCune, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00445796: Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance
Official title: Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.

Secondary Objective:

To compare the clinical safety of the two treatment regimens.


Eligibility criteria: Inclusion Criteria:

* weighing ≥ 10 kg
* residing in the area covered by the investigating centre throughout the entire follow-up period
* axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours
* Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre

Exclusion Criteria:

* presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure \< 70 mmHg in adults or \< 50 in children, spontaneous bleeding, inability to sit or stand
* serious concomitant disease
* allergy to one of the investigational medicinal products
* pregnant women or breast-feeding women.
* documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.

Primary outcomes:
measure: clinical and parasitological cure on Day 14
measure: Secondary: incidence and severity of adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Sanofi-Aventis
city: Dakar
country: Senegal
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Valérie Lameyre
role: STUDY_DIRECTOR
References:
Clinical trial NCT05582096: A Study of LY3457263 in Obese Participants
Official title: A Dose-Escalation Treatment, Phase 1, Investigator- and Participant-Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3457263 in Combination With Tirzepatide in Overweight or Obese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3457263 when administered in combination with tirzepatitide in overweight or obese participants. The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. The study will last up to approximately 11 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²)
* Male or female participants not of childbearing potential

Exclusion Criteria:

* Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements
* Have an abnormal 12-lead electrocardiogram (ECG) at screening
* Have type 1 or type 2 diabetes mellitus

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to 11 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263
timeFrame: Predose on Day 1 up to 43 days postdose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: LabCorp CRU, Inc.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00554216: Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity, morbid obesity
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2007-11-06
Enrollment: 1267
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 purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥ 35 kg/m2
* Informed consent
* 70 years of age or less
* Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
* Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
* Fasting blood glucose level of ≤ 110 mg/dL

Exclusion Criteria:

* Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* History of glaucoma or intraocular pressure
* Pregnancy or breastfeeding
* Alcohol abuse
* Smoking cessation within previous 3 months or plans to quit smoking during study
* Eating disorders
* Cholelithiasis within past 6 months
* Excluded medications
* Type 2 diabetes
* Previous bariatric surgery
* History of bipolar disorder or psychosis

Primary outcomes:
measure: Percent Weight Loss From Baseline to Week 56
timeFrame: baseline to 56 weeks
measure: Percentage of Subjects With at Least 5% Weight Loss at Week 56
timeFrame: baseline to 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: Ridgefield
country: United States
facility: Research
state: Connecticut
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Austin
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: VIVUS LLC
name: Craig Peterson
role: STUDY_DIRECTOR
affiliation: Duke University
name: Kishore Gadde, MD
role: STUDY_CHAIR
References:
citation: Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.
Clinical trial NCT04459416: Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma
Official title: Opioid-Sparing Pain Treatment In Myeloma And Lymphoma Patients Undergoing High-Dose Chemotherapy (OPTIMAL-HiChemo): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Hodgkin Disease
Non-Hodgkin Lymphoma
Keywords: Pain management
Acupuncture
20-264
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Hackensack Meridian Health
First posted: 2020-07-07
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, two-arm randomized controlled trial. Randomization will be stratified by study site, primary cancer diagnosis (MM versus HD versus NHL) and transplantation setting (inpatient versus outpatient) to ensure these characteristics are comparably distributed between the two study arms.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* pathological diagnosis of MM, HD or NHL
* scheduled for high dose chemotherapy for auto-HSCT in the following month (30 days)
* not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed)

Exclusion Criteria:

* absolute neutrophil count (ANC) of \<500/μl, platelet count of \<20,000/ μl or INR \>2.0
* acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture)
* unable to provide informed consent

Primary outcomes:
measure: the Number of Patients Using Opioids at a Given Time
timeFrame: at day 7
measure: the Number of Patients Using Opioids at a Given Time
timeFrame: at day 90
measure: Symptom Burden
timeFrame: At baseline
measure: Symptom Burden
timeFrame: At Day 7
measure: Symptom Burden
timeFrame: At Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancel Care Alliance (Data Collection Only)
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04390516: Respiratory Decompensation and Model for the Triage of COVID-19 Patients
Official title: Prediction Of Respiratory Decompensation In Covid-19 Patients Using Machine Learning: The READY Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Coronavirus
Mortality
Mechanical Ventilation
Lead sponsor: Dascena
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to prospectively evaluate a machine learning algorithm for the prediction of outcomes in COVID-19 patients.

Detailed description: In a multi-center prospective clinical trial, a machine learning algorithm was deployed at five partner hospitals to analyze live patient data, including blood pressure and Creatinine levels, to determine the algorithm's ability to predict COVID-19 patient prognosis. The primary endpoint was mechanical ventilation of study subjects within 24 hours after hospital admission separate from a decompensation alert related to oxygen levels.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Confirmed COVID-19 infection through RT-PCR test

Exclusion Criteria:

* Patients aged less than 18 years

Primary outcomes:
measure: Mechanically ventilated patient outcome
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: Mortality or mechanically ventilated patient outcome
timeFrame: Through study completion, an average of 2 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Dascena
state: California
Study officials:
References:
Clinical trial NCT06756516: Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain
Official title: Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Feldenkrais method
mechanical low back pain
balance
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Feldenkrais method affects balance in patients with mechanical low back pain. The main questions it aims to answer is:

does Feldenkrais method affects balance in patients with mechanical low back pain.

Participants will:

Be assessed for inclusion using slump and straight leg raise tests. Visit the clinic twice every week for sessions. Assessed pre and post treatment using Biodex Balance.

Detailed description: Sample size calculation showed that our sample is 40. Forty patients with mechanical low back pain not referring beyond the knee will be recruited from Souad Kafafi Hospital and multiple outpatient clinics in Giza, Egypt. Inclusion criteria is male or female patients, 18-45 years, mechanical pain for the last 6 months, with no previous surgeries or diseases in the spine. Treatment strategy include 10 treatment sessions for each allocated subject. Core strengthening exercises and Feldenkrais method (balance exercises) are the treatment approached used in this study. Two experienced physical therapists will apply the treatment in the Faculty of Physical therapy clinic. Overall, mediolateral, and anteroposterior stability will be assessed for each patient. The measurement will be done twice pretreatment and immediately after the last session.

Eligibility criteria: Inclusion Criteria:

* Mechanical back pain.
* Symptoms lasted for the last 6 months.
* Not referring beyond the knee.
* Mild to moderate pain in Numerical Pain Rating Scale and mild to moderate disability on Oswestry Disability Index

Exclusion Criteria:

* Spine Surgeries
* Chronic diseases
* Accidents and Fractures

Primary outcomes:
measure: Balance
timeFrame: Baseline and 5 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology
Study officials:
affiliation: Cairo University Faculty of Physical Therapy
name: Neveen A Abdelraouf, Professor
role: STUDY_CHAIR
affiliation: Cairo University Faculty of Physical Therapy
name: Aya A Khalil, Lecturer
role: STUDY_DIRECTOR
affiliation: Misr University for Science and Technology
name: Shereen M Said, Lecturer
role: STUDY_DIRECTOR
affiliation: Misr University for Science and Technology
name: Mohamed E Fahmy, Instructor
role: PRINCIPAL_INVESTIGATOR
References: