louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050543: Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
Official title: A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuromuscular Blockade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 128
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: This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Class 1 or 2 or 3
* \>=18 years of age and of either sex
* scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade
* Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address

Exclusion Criteria:

* expected difficult intubation due to anatomic malformations
* expected transfer to intensive care unit after surgery
* neuromuscular disorders affecting neuromuscular blockade
* significant hepatic or renal dysfunction
* require use of pneumatic tourniquet during surgery
* (family) history of malignant hyperthermia
* allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate

Primary outcomes:
measure: Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9
timeFrame: From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.
Clinical trial NCT06879743: Effect of Suboccipital Release in Patients With Fibromyalgia Syndrome
Official title: Effect of Suboccipital Release on Neck Pain and Quality of Life in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to examine the efficacy of suboccipital release in Patients With FMS and to provide preliminary evidence regarding its effects on pain and QOL by objectively measuring Cortisol level in FMS patien

Detailed description: Forty female patients with FM ( age : 20- 45 Years ) participated in the study after suing the consent form . Participants were randomly allocated assigned into 2 equal groups ( control group \[ G1 \] and study \[G2 \] ) . Group

1 received selected physical therapy programme. Group 2 recieved suboccipital release. All participants were assessed for cortisol and pain level by using visual analogues scale and neck disability scale. Also participants were assessed by pressure algometer for pain intensity. Participants were assessed for QOL by FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQR) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were Done

Eligibility criteria: Inclusion Criteria:

* women between 20-45 years old, (ii) diagnoses according to the 2016

American College of Rheumatology criteria for fibromyalgia \[1\]

* Symptoms have been present at a similar level for at least three months (iii) Absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratory investigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinated peptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor(RF)).
* Exclusion Criteria:

  * any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than FM. Presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus

Primary outcomes:
measure: Cortisol level
timeFrame: Six weeks after begining of intervention
Secondary outcomes:
measure: Fibromyalgia impact questionair
timeFrame: Six weeks after begining of intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy laps at cairo university
Study officials:
References:
Clinical trial NCT03944343: Prebiotic Effects on Glucose Tolerance
Official title: Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Prevention of Metabolic Diseases
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover study design. Healthy young adult volunteers.
Primary purpose: PREVENTION

Brief summary: The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.


Eligibility criteria: Inclusion Criteria:

* BMI 18.5 - 25 kg/m2
* age 20-40 years
* normal diet
* healthy

Exclusion Criteria:

* fasting blood glucose \>6.1
* diagnosed or known disease
* known gastrointestinal disorder
* food allergies or intolerance
* special diet regiments
* smokers

Primary outcomes:
measure: Glucose tolerance
timeFrame: 3 hours
Secondary outcomes:
measure: Subjective appetite variables
timeFrame: 3 hours
measure: Mood parameters
timeFrame: 3 hours
measure: Breath hydrogen
timeFrame: 3 hours
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University, Food Technology, Engineering and Nutrition
Study officials:
affiliation: Lund University
name: Anne Nilsson, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02583243: Project BEST: Buprenorphine Entry Into Substance Abuse Treatment
Official title: Project BEST: Buprenorphine Entry Into Substance Abuse Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-related Disorders
HIV Infections
Hepatitis C, Chronic
Depression
Keywords: Opioid dependence
HIV/AIDS
Hepatitis C
Severe mental illness
Injection Drug Use
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective cohort of opioid dependent patients at risk for HIV or with HIV seeking treatment with buprenorphine. Subjects may have severe mental illness and other co-morbid medical conditions.

Brief summary: Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.

Detailed description: The investigators propose to create a prospective cohort that will track outcomes for an opiate dependent population on buprenorphine maintenance. Individuals who have already decided to undergo buprenorphine treatment in Project BEST will be invited to participate in the following data collection process. The investigators propose the following series of data collection to assess clients during their time in the cohort:

GPRA, supplemental instrument, ASI, SCID, COWS, Urine toxicology.

Patients who are enrolled will enter a standardized, manual based weekly counseling regimen. Urine toxicology will be performed a minimum of twice monthly, but will not occur at the same times monthly to decrease the probability of sampling error.

This is a prospective cohort to follow a group of individuals on buprenorphine treatment. The goal of this prospective cohort is to generate thoughtful observations. Specific items of interest which will be compared with age, race matched historical controls on methadone will be:

1. Changes in addiction severity over treatment time
2. Changes in sexual risk behaviors and injection practices
3. Improvements in urine toxicology
4. Co-occurring mental illness

Eligibility criteria: Inclusion Criteria:

* Opiate dependent by DSM IV criteria - to be determined by clinician - on buprenorphine through the Project BEST Program.

Exclusion Criteria:

* Inability to adhere to study instruments.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University AIDS Program
name: Frederick L Altice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06095843: "Bony Changes Around Dental Implant in Free Fibular Graft Versus Non-Vascularized Iliac Crest Graft"
Official title: "Bony Changes Around Dental Implant Placed in Free Vascularized Fibular Graft Versus Non-Vascularized Iliac Crest Graft in Mandibular Reconstruction"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crestal Bone Loss
Survival Rate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.

The main question it aims to answer are:

• evaluate the bony changes around dental implants and it's survival rate in both groups

Detailed description: The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022.

The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.

Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.

Eligibility criteria: Inclusion Criteria:

* patients following traumatic injuries
* gunshot injuries
* tumor ablative surgeries
* osteomylitis and osteonecrosis affecting the mandible

Exclusion Criteria:

* cardiovascular or pulmonary disease
* vascular or bone disorder
* previous fractures or surgeries related to the donor site

Primary outcomes:
measure: bony changes around dental implants
timeFrame: 1 year
measure: survival rate of dental implants
timeFrame: 1 year
measure: stability of dental implants
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02022943: Alzheimer's Prevention Registry: A Program to Accelerate Enrollment Into Studies
Official title: Alzheimer's Prevention Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Dementia
Keywords: Alzheimer's
prevention
Lead sponsor: Banner Health
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone who meets entry criteria is eligible to join the Registry.

Brief summary: The Alzheimer's Prevention Registry (www.endALZnow.org) will collect contact and demographic information on individuals. The objective is to provide information the latest news and advances in Alzheimer's prevention research, and to inform enrollees about research studies in their community. Enrolled individuals will receive regular email communications. As research studies become available, individuals will be notified via email with information as to how proceed should they be interested. Registry enrollees are under no obligation to participate in a research study. Study opportunities may include surveys, healthy lifestyle interventions (e.g., diet, exercise), memory \& thinking tests, brain scans, and investigational drug trials. To join the Registry, please visit www.endALZnow.org


Eligibility criteria: Inclusion Criteria:

* Must be able to accept the Alzheimer's Prevention Registry website terms and conditions

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of individuals enrolled into Alzheimer's prevention studies
timeFrame: 16 years
Secondary outcomes:
measure: Number of individuals referred to Alzheimer's prevention research studies / sites
timeFrame: 16 years
Other outcomes:
measure: Total number enrolled into the Alzheimer's Prevention Registry
timeFrame: 16 years
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
Study officials:
affiliation: Banner Alzheimer's Institute
name: Jessica Langbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langbaum JB, High N, Nichols J, Kettenhoven C, Reiman EM, Tariot PN. The Alzheimer's Prevention Registry: A Large Internet-Based Participant Recruitment Registry to Accelerate Referrals to Alzheimer's-Focused Studies. J Prev Alzheimers Dis. 2020;7(4):242-250. doi: 10.14283/jpad.2020.31.
Clinical trial NCT04673643: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease
Official title: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dry Eye Disease
Keywords: taVNS
Dry eye
RCT
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Transcutaneous Auricular Vagus Nerve Stimulation
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction.

Methods: We enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.OSDI score, TBUT, Schirmer I, tCFS, MGD score, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 and Age \<=75.
2. Clinical diagnosis of dry eye disease.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of phthalmology surgery.
3. Pregnant or lactating women.

Primary outcomes:
measure: OSDI
timeFrame: Baseline, month 1, 3, and 6
Secondary outcomes:
measure: TBUT
timeFrame: Baseline, month 1, 3, and 6
measure: Schirmerl
timeFrame: Baseline, month 1, 3, and 6
measure: Corneal fluorescein staining (tCFS)
timeFrame: Baseline, month 1, 3, and 6
measure: Meibomian Gland Dysfunction Score
timeFrame: Baseline, month 1, 3, and 6
measure: Psychological status
timeFrame: Baseline, month 3, 6 and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Beijing
country: China
facility: Wu Dong
Study officials:
affiliation: BeijingTongren Hospital, Capital Medical University
name: Haihong Lian, Doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04780243: Expanded Program for Immunization, a Missed Opportunity for Postpartum Family Planning Utilization
Official title: Enhancing Postpartum Family Planning Utilization Through Integration With Expanded Program for Immunization in Sidama, South Ethiopia: A Quasi Experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraceptive Usage
Lead sponsor: Hawassa University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 1474
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This study is aimed to enhance postpartum family planning by integrating family planning information with infant immunization services, which is the most widely utilized health services globally.

Detailed description: In this study, a before-and-after type of quasi-experimental study will be conducted in purposely selected health centers Sidama region, Ethiopia. base line assessment of postpartum contraceptive utilization rate will be done which will be followed by an intervention. The intervention consists of screening, counseling for family planning and referring mothers coming for infant immunization services to family planning units. All mothers coming for infant immunization service will be screened for and counseled for family planning and those who will be voluntary to take any method will be referred to family planning unit. All mothers who will not be voluntary will be re-counseled by the next visit.

Finally, the effect of this intervention on postpartum contraceptive utilization rate will be reassessed. The expected outcome will be to see an improved contraceptive uptake during the first year after delivery.

Eligibility criteria: Inclusion Criteria:

* all women visiting health facilities for infant immunization for at least two times will be included.

Exclusion Criteria:

* Women who are in difficulty of communicating during the study period will be excluded.

Primary outcomes:
measure: After the initiation of the intervention, improved Contraceptive prevalence rate will be expected as an outcome
timeFrame: the outcome is measured two months after the initiation of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hawassa
country: Ethiopia
facility: Sidama regional health bureau
state: Sidama
Study officials:
affiliation: Hawassa University
name: Abebaw Muluneh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200590: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
Official title: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: prostaglandin
analgesia
congenital
heart
defect
induced
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.


Eligibility criteria: Inclusion Criteria:

* Full-term newborn
* Under one month of age
* With ductus dependent congenital heart disease requiring prostaglandin infusion and elevated pain score

Exclusion Criteria:

* Contraindication to either morphine, acetaminophen, or nalbuphine
* Other painful condition
* Poor neurological condition
* Cardiac instability requiring urgent surgery

Primary outcomes:
measure: Pain score
timeFrame: before inclusion and at 8 hours (H8), H24, H48, H72
Secondary outcomes:
measure: Incidence of apnea
measure: Need for mechanical ventilation
measure: Incidence of fever
measure: Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Véronique Gournay, MD
role: PRINCIPAL_INVESTIGATOR
References: