louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03472222: Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
Official title: Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Arsha Vidya Study Centre
name: United Research International
First posted: 2018-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi experimental design
Primary purpose: PREVENTION

Brief summary: Substance abuse remain critical problems in both developed and developing countries. Under privileged communities where health and economic system is weakest, use of drugs and illicit substances starts during adolescence and young adulthood. This not just affect physical development, mental health and social integration, but also family formation and stability, deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood pursuits. Therefore, emphasises the need for preventive education at this impressionable age.


Eligibility criteria: Inclusion Criteria:

* Parental consent to participate

Exclusion Criteria:

* Family not involved in de-addiction program
* Planning to move the area
* Mental incapacity to consent or participate

Primary outcomes:
measure: Percent days abstinent of tobacco, alcohol and drugs
timeFrame: change from baseline to 12-weeks
Secondary outcomes:
measure: Well being
timeFrame: change from baseline to 12-weeks
Other outcomes:
measure: Craving
timeFrame: change from baseline to 12-weeks
Locations:
city: Ahmedabad
country: India
facility: NMP Medical Reserach Institute
state: Gujarat
Study officials:
affiliation: Arsha Vidya Study Centre, India
name: Buddhatmananda Saraswati
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute
name: Rajubhai P Odedra
role: PRINCIPAL_INVESTIGATOR
affiliation: United Research International
name: Divya Gaur
role: STUDY_DIRECTOR
References:
Clinical trial NCT06042322: Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Official title: Retrospective Analysis of Pain in Patients Who Receive a Nerve Block for Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Regional Anesthesia Morbidity
Acute Pain
Knee Osteoarthritis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Using the Mass General Brigham Enterprise Data Warehouse, electronic health record data will be retrieved: adult patients, 18 years of age or older, who received a primary total knee arthroplasty, an adductor canal nerve block, pericapsular injection, and admitted to stay overnight (\>16 hours post nerve block).

Brief summary: This is a retrospective study looking at patients who received a nerve block for surgery and assessing pain after the nerve block resolves, with or without an educational intervention, over two periods of time.

Detailed description: Regional anesthesia (RA) is a vital tool that can serve as the primary anesthetic or as part of a multimodal perioperative pain regimen. RA is strongly associated with decreased acute and persistent pain and opioid consumption postoperatively. However, some patients experience an acute worsening of pain into the severe range around the time of RA resolution, also known as "rebound pain" (RP). The incidence of RP has been reported as high as 40-50% after a single shot nerve block for patients undergoing ambulatory surgery.

This retrospective study aims to look at patients who received a nerve block for surgery and assessing pain after the nerve block resolves in the presence and absence of certain interventions, such as a multidisciplinary educational intervention.

The investigators will assess patients who received a primary total knee arthroplasty who received a single shot adductor canal nerve block, received pericapsular injection by the surgeon, and had a length of stay \> 16 hours.

Eligibility criteria: Inclusion Criteria:

* primary total knee arthroplasty
* received an adductor canal nerve block
* received pericapsular injection by surgeon intraoperatively
* admitted for overnight stay and \> 16 hours post-nerve block

Exclusion Criteria:

* age \< 18
* prior total knee arthroplasty on ipsilateral knee

Primary outcomes:
measure: Difference in maximum pain score, 0-10; (0 = no pain, 10 = worst pain)
timeFrame: 6-24 hours
Secondary outcomes:
measure: Average pain score 0-10; (0 = no pain, 10 = worst pain)
timeFrame: 6-24 hours
measure: Difference in incidence of rebound pain
timeFrame: 6-24 hours
measure: Comparison of evening opioids given
timeFrame: 6-24 hours
measure: Difference in total opioids given
timeFrame: 6-24 hours
measure: Difference in length of stay
timeFrame: 0-2 years
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Yun-Yun K Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06203522: Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin
Official title: Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Procedural Sedation
EEG
MRI
Keywords: Dexmedetomidin
procedural sedation
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 81
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under 18 years of age sedated with DEX IN prior to MRI.

Brief summary: This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children.

Detailed description: Performing brain MRI on children under 5, or in cases of autism or disability, is often complex. In fact, this examination requires total immobilization of the child for at least 20 minutes. The noise and the fact that the child is lying in a sort of tunnel add to the child's stress.

General anesthesia with propofol is widely used in France, but requires invasive orotracheal intubation or mask ventilation. There are no national or international recommendations for pediatric MRI sedation procedures.

Intranasal dexmedetomidine (DEX) is used for brain MRI, cardiac ultrasound, ophthalmology, dental treatment and brain computed tomography (CT) in patients aged 3 months to 12 years. Its superior efficacy has been demonstrated in a number of studies compared with the most commonly used medicated procedural sedation techniques, but only one study in France has prospectively analyzed the efficacy of DEX IN for performing cerebral MRIs, but without assessing efficacy and tolerance in subgroups of children: with or without neurodevelopmental disorders, epilepsy, autism, age.

Eligibility criteria: Inclusion Criteria:

* patients under 18 years of age sedated with DEX IN prior to MRI.

Exclusion Criteria:

* incomplete or missing medical records

Primary outcomes:
measure: Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.
timeFrame: Immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital Mercy
name: Anne Charlotte CULLIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01988922: CYP2B6 Polymorphisms in Ketamine
Official title: Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: ketamine polymorphisms
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.


Eligibility criteria: Inclusion Criteria:

1. 18-50 yr old
2. CYP2B6\*1/\*1, CYP2B6\*1/\*6 or CYP2B6\*6/\*6 genotype (see table) (Note: subjects of other rare genotype but with one or more 516G\>T, 785A\>G, 983T\>C or 1459C\>T polymorphism may be enrolled at PI's discretion)
3. Good general health with no remarkable medical conditions
4. BMI \<33
5. Provided informed consent

Exclusion Criteria:

1. Known history of liver or kidney disease
2. Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
3. Females who are pregnant or nursing
4. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)

Primary outcomes:
measure: The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lesley Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321722: The Effect of Colonoscopy on Intralocular Pressure
Official title: The Effect of Colonoscopy on Intralocular Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Keywords: Colonoscopy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are healthy examinees, undergoing routine colonsocopy examination. All have no ocular disese and family history of glucoma.

Brief summary: Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed and treated properly. The major risk factor for the development and progression of glaucoma is increased intraocular pressure. Colonoscopy is one of the most preformed world wide screening exam. It is used to detect colon cancer at its early stages. As part of this examination, the examiner inflates the inspected colon with air in order to increase the colon lumen for better visualization of the colon. As a consequence of the insufflation the intrabdominal pressure increases as well. the increase in intrabdominal pressure could increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure increase while preforming colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Age \>18.
* Patients referred by a gastroenterologist for a colonoscopy examination.
* Patients the are interested in participating in this study and who are able to sign an informed consent.

Exclusion Criteria:

* Family history of Glaucoma - first degree relatives.
* Patients with known ocular disease, excluding refraction.
* Patients receiving eye pharmacologic treatment.
* Patients with known allergies to Oxybuprocaine Hydrochloride drops.

Primary outcomes:
measure: Increase of Intraocular pressure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT03190122: Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
Official title: Neurocognitive Outcome Assessment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.


Eligibility criteria: Inclusion Criteria:

* preoptic meningioma, not recurrent, size is operative.

Exclusion Criteria:

* other meningiomas than preoptic , recurrent cases, size is not operative, other medical conditions affect the mental condition of the patient.

Primary outcomes:
measure: Neurocognitive Outcome Assessment using MOCA scale
timeFrame: 1 year
Secondary outcomes:
measure: Neurocognitive Outcome using neuropsychological assessment questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05162222: A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants
Official title: An Open-label, Randomized, 2-Period Crossover Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose Pharmacokinetics of Danicamtiv in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Danicamtiv
Itraconazole
Diltiazem
BMS-986434
CYP3A4
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of co-administration of itraconazole or diltiazem on the single-dose pharmacokinetics of danicamtiv in healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
* Normal ECG at the Screening Visit
* Normal renal function at Screening

Exclusion Criteria:

* History of ventricular arrhythmias
* History of heart disease or conduction disorders
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 17 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
timeFrame: Up to 17 days
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
timeFrame: Up to 17 days
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 17 days
measure: Concentration at 24 hours (C24)
timeFrame: Up to 17 days
measure: Apparent terminal plasma half-life (T-HALF)
timeFrame: Up to 17 days
measure: Incidence of adverse events (AEs)
timeFrame: Up to 28 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 28 days
measure: Incidence of participants with vital sign abnormalities
timeFrame: Up to 17 days
measure: Incidence of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 17 days
measure: Incidence of participants with physical exam abnormalities
timeFrame: Up to 17 days
measure: Incidence of participants with clinical laboratory abnormalities
timeFrame: Up to 17 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit - Dallas
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01635439: Prostin and Propess in Induction of Labor
Official title: Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Labor Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: North West Armed Forces Hospital
First posted: 2012-07-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).

Detailed description: A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.

Eligibility criteria: Inclusion Criteria:

* Gestational age 37 weeks or more
* Singleton pregnancy
* Cephalic presentation.

Exclusion Criteria:

* Previous cesarean section
* Any contraindication for vaginal delivery
* Suspected Cephalo-Pelvic Disproportion
* Unexplained antepartum Hemorrhage

Primary outcomes:
measure: Induction to Delivery Interval
timeFrame: 24 hours
Secondary outcomes:
measure: Induction to Onset of Labor Interval
timeFrame: 24 hours
measure: Uterine Hyper-stimulation Rate
timeFrame: 24 hours
measure: Need for Syntocinon Augmentation
timeFrame: 24 hours
measure: Normal Vaginal Delivery Rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tabuk
country: Saudi Arabia
facility: NWAFH, North west Armed Forces Hospital
Study officials:
affiliation: North West Armed Forces Hospital
name: Ahmed Abdelaziz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. doi: 10.1016/j.tjog.2018.06.016.
Clinical trial NCT04388722: Monitoring Noninvasively for Infusion and Transfusion Optimization
Official title: Monitoring Noninvasively for Infusion and Transfusion Optimization in a Randomized (MONITOR) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Operative Hemorrhage
Transfusion Related Complication
Blood Transfusion Associated Adverse Reactions
Hypovolemia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.


Eligibility criteria: Inclusion Criteria:

* 18 years or older at the time of consent.
* Ability to provide written informed consent.
* Scheduled for non-urgent major surgery with general anesthesia
* At least one finger available and accessible for performing non-invasive pleth variability index (PVi) and hemoglobin (SpHb) monitoring.
* The Attending surgeon, attending anesthesiologist and the clinical care team agree with enrollment in the study, including the restrictions on monitoring procedures defined in the control group.

Exclusion Criteria:

* Untreated or uncontrolled hypertension defined as mean arterial pressure (MAP) greater than 120 mmHg, despite medications.
* Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease.
* Surgeries where no bleeding is expected to occur (i.e., total knee surgery where blood loss is prevented by use of tourniquet).
* Surgeries performed in the prone position.
* Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome.
* Aortic pathology that could lead to misinterpretation of hemodynamic variables (e.g. intra- aortic balloon pump, thoracic aorta aneurysm).
* Renal vascular surgery.
* Preoperative sepsis.
* Circulatory shock.
* Preoperative vasoactive substance infusion before study entry.
* Concurrent participation in any interventional study.
* Pregnant or lactating women.
* Patients who refuse to receive blood transfusion(s).
* Patients with Do Not Resuscitate (DNR) orders.
* Open chest surgeries.
* Prisoners
* Patients for whom monitoring of CO, SV, PPV, and/or SVV to guide GDT or similar intra-operative fluid management, including continuous SpHb monitoring, would be standard of care.
* Patients have skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors.
* Cardio-pulmonary bypass (CPB) surgery.

Primary outcomes:
measure: Post-operative complication
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04299139: Chiropractic Treatment of Arthrogenic Torticollis in Infants; a Retrospective Study on Outcome in 1000 Infants
Official title: Chiropractic Treatment of Arthrogenic Torticollis in Infants; a Retrospective Study on Outcome in 1000 Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthrogenic Torticollis
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children between the age of 3-12 months

Brief summary: Patient data is collected from previously treated patients and entered into the Research Electronic Data Capture (REDCap).

Detailed description: Already collected patient data (1995-2013) from a privat practice, is screened and entered into a individually design REDCap form.

Eligibility criteria: Inclusion Criteria:

* arthrogenic torticollis
* male or female age 3-12 month
* treatment was conducted between 01/1995-12/2013

Exclusion Criteria:

* uncompleted record
* decline of further use of patient data

Primary outcomes:
measure: Treatment outcome
timeFrame: 3-12 month of age
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
state: Zurich
Study officials:
affiliation: Balgrist University Hospital
name: Anke Langenfeld, PhD
role: STUDY_CHAIR
References: