louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04826068: Emotional Processing Intervention for Children With TBI
Official title: The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Emotional Processing
Pediatric Traumatic Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).

Detailed description: The first stage of this project will evaluate the appropriateness of an emotional processing intervention modified for a pediatric population. The researchers will modify the intervention prior to the evaluation by the 15 typically developing children.

The second stage of the project will evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI. Emotional processing includes both facial affect recognition and social perception measures.

Eligibility criteria: Inclusion Criteria:

Ages of 9 and 17. Speak and read English fluently.

Healthy Volunteer or

Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.

Exclusion Criteria:

Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.

History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).

Uncontrolled seizures or other unstable medical complications.

Primary outcomes:
measure: Facial Identification Task
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT00953368: Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
Official title: Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ischemic Heart Disease
Keywords: remote ischemic preconditioning
cognitive function
off-pump coronary artery bypass graft
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 270
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective off-pump coronary artery bypass graft surgery

Exclusion Criteria:

* Emergency operation
* Preoperative use of inotropic drugs or mechanical assistant device
* Ejection fraction less than 30%
* Combined operation using CPB such as valve surgery
* Previous psychiatric and neurologic disorder
* Inability to perform the cognitive function test

Primary outcomes:
measure: cognitive function
timeFrame: preoperative, 1 week and 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center, Department of Anesthesiology and Pain Medicine
name: In-Cheol Choi, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.
Clinical trial NCT02779868: Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy
Official title: Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: body composition
functional capacity
quality of life
Lead sponsor: Brazilian National Cancer Institute
Sponsor class: OTHER_GOV
First posted: 2016-05-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment.

The investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

* Cervix cancer at FIGO stage II and III
* Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
* Nutritional diagnosis of pre-cachexia ou cachexia

Exclusion Criteria:

* metastasis (FIGO stage IV)
* Nutritional diagnosis of refractary cachexia

Primary outcomes:
measure: Change in Body composition
timeFrame: 45 days
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 45 days
measure: Change in Quality of life
timeFrame: 45 days
measure: Change in IL-6 serum levels
timeFrame: 45 days
measure: Change in IL-1 serum levels
timeFrame: 45 days
measure: Change in TNF-alfa serum levels
timeFrame: 45 days
measure: Change in INF-gama serum levels
timeFrame: 45 days
measure: Change in membrane incorporation of non-esterified fatty acids
timeFrame: 45 days
measure: Change in handgrip strength
timeFrame: 45 days
measure: Change in functional capacity (30 second stand chair test)
timeFrame: 45 days
measure: chemoradiotherapy toxicity
timeFrame: 15 and 45 days
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Brazilian National Cancer Institute
state: RJ
Study officials:
affiliation: Brazilian National Cancer Institute
name: Mariah A Aredes, Ms
role: STUDY_CHAIR
References:
Clinical trial NCT03671668: Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration
Official title: Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Bases in Implant Supported Complete Overdentures: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Completely edentulous patients
Primary purpose: TREATMENT

Brief summary: On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, we want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients
* Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
* Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
* Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
* Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )

Exclusion Criteria:

* Patients having a medical condition that absolutely contraindicates implant placement.
* Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
* Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
* Patients who are having complete lower denture
* Patients who have history of bruxism

Primary outcomes:
measure: Crestal bone loss
timeFrame: 6 to 12 months
Secondary outcomes:
measure: Patients satisfaction
timeFrame: 6 to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00627068: The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
Official title: The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: cardiovascular
vasodilation
endothelium
Subjects with high cardiovascular risk
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population in both low and high risk groups should represent the general population.

Brief summary: Our main hypothesis is that EPC function is impaired in some populations with high cardiovascular risk as a result of reduced eNOS-dependent NO production.

Detailed description: To determine if a correlation exists between EPC function and eNOS-dependent NO production in EPCs from populations with high versus low cardiovascular risk:

1. High and low cardiovascular risk subjects will be identified based on age or history of cardiovascular disease. Endothelial function will be measured by ultrasound.
2. EPCs will be isolated from peripheral blood of these subjects. EPC function will be assessed by measuring adhesion to endothelium, migration, proliferation, and differentiation, and compared to their expression and activity of eNOS.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give written informed consent and comply with study requirements
* Adult of 18 years or older
* Subjects willing to provide blood and tissue samples

Exclusion Criteria:

* Failure to give informed consent.
* Those unable to consent for themselves.
* Those who cannot read English.
* Patients on Viagra, Levitra, or Cialis
* Patients with malignant disease
* Patients with hematological abnormalities
* Patients with fevers of unknown origin
* Severe comorbidity or alcohol/drug dependence
* Women who are post-menopausal and on hormone replacement therapy, or premenopausal and on birth control pills (premenopausal women will be screened verbally and then by assay of LH and FSH levels in blood samples to identify women in the follicular phase of their menstrual cycle, to reduce variability)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF, Department of Cardiology
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yerem Yeghiazarians, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604068: Pulsed Short Wave Therapy In Cesarean Section
Official title: Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: Caesarean section
Lead sponsor: BioElectronics Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.

Detailed description: Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

Eligibility criteria: Inclusion Criteria:

* Voluntarily
* Performed using spinal anesthesia
* ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)
* PARA 0000, 1, 2, 3 \[i.e. First, Second, or Third C-Section)
* At term pregnancy (\>38 weeks)
* BMI \<35
* Age between 18 - 50 years

Exclusion Criteria:

* Longitudinal surgical incision
* Placental abnormalities noted
* Time of extraction of the fetus \>10 min from cutaneous incision
* Blood loss during surgery of \>800 ml
* Any of the conditions not considered in inclusion criteria

Primary outcomes:
measure: Medication Use
timeFrame: Data collected daily for 7 Days
Secondary outcomes:
measure: Change in Visual Analogue Pain
timeFrame: Data collected for 7 Days
measure: Time to patient Patient Mobility
timeFrame: 2 Days
measure: Would Closure at Day 7, Wound Complications
timeFrame: 7 Days
Other outcomes:
Locations:
city: Tripoli
country: Lebanon
facility: Haykal hospital
city: Tripoli
country: Lebanon
facility: New Mazloum Hospital
Study officials:
affiliation: Haykal hospital
name: Moustafa Chaaban, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Clinical trial NCT06898268: Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux
Official title: Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux, a Comparative Study of Short Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disorder
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 290
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to fill the gaps by comparing the efficacy and safety of ondansetron versus metoclopramide for the control of gastroesophageal reflux disorder in children 1-12 months of age, presenting at the outdoor department of Allama Iqbal Teaching Hospital, Dera Ghazi Khan.

Detailed description: Since the FDA issued a warning against domperidone as a potential proarrhythmic drug in children, its use has been widely discouraged and no longer recommended in safe practices. This warning at one end persuaded the pediatricians to search for the new options; on the other end, the use of metoclopramide, H2 receptor antagonists, and alginate-based medications became superfluous, opening a wide area of research in search of the next potential best option. The findings of this study would add to the existing statistics and help clinicians to have better outcomes among infants with gastroesophageal reflux disorder.

Eligibility criteria: Inclusion Criteria:

* Infants of any gender
* Aged 1-12 months
* Presenting with symptoms of gastroesophageal reflux disease not responding to dietary modifications and positioning
* Afebrile at the time of presentation
* Vitally stable

Exclusion Criteria:

* No evidence of hypertrophic pyloric stenosis on ultrasonography
* Children with congenital heart disease
* Any history of prior illness associated with symptoms
* With abdominal distension
* Neurological impairment, like developmentally delayed, grossly microcephalic

Primary outcomes:
measure: Response to treatment
timeFrame: 1 week
measure: Treatment-emerged adverse events
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: Allama Iqbal Teaching Hospital
state: Punjab
Study officials:
affiliation: Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan
name: Irum Jabeen, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan
name: Asma Akbar, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02955368: Clinical Trial to Evaluate the Efficacy and Safety of DP-R212
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension
Hypercholesterolemia
Keywords: DP-R212
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 19
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 determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Both man and woman who is over 19 years old
* Hypertension patient with hypercholesterolemia

Exclusion Criteria:

* sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
* A history of cardiovascular disease
* rhabdomyolysis, myopathy
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes
* Evidence of hepatic or renal disease

Primary outcomes:
measure: Percent change of LDL-Cholesterol
timeFrame: 0, 8 weeks
measure: Change of mean seated Systolic Blood Pressure
timeFrame: 0, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04085068: Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery
Official title: Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 women will participate in this study, thirty women diagnosed as having back ar neck pain after surgery.They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre.

All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study

Brief summary: Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath of dura mater. As they exit the cranial vault they are described by Gray's Anatomy as having a "dural cuff".


Eligibility criteria: Inclusion Criteria:

* The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs.

Exclusion Criteria:

* Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality.

Primary outcomes:
measure: body mass index
timeFrame: 3 months
measure: Satisfaction assessed by the VAS
timeFrame: 3 months
measure: a pressure-pain threshold
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00643968: Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
Official title: Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV virological control
Lipid profile and morphological fat distribution
Treatment Experienced
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (\< 50 copies/mL) (c/mL) at 48 weeks (W48)

Main Secondary objectives:

Comparison of the two arms for genotypic resistance profile in case of virological failure

CD4 changes from baseline

Evolution of the lipid profile and morphological changes in fat distribution, and safety

Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters


Eligibility criteria: Inclusion Criteria:

* Stable HAART ≥ 3 months
* HIV-1 RNA \< 50 c/mL ≥ 6 months
* No HAART failure history

Exclusion Criteria:

* Weight \> 45 kg
* No CD4+ cell count criteria
* No significant laboratory or clinical abnormalities
* Creatinine Clearance \> 60 mL/min

Primary outcomes:
measure: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
timeFrame: 48 wks
Secondary outcomes:
measure: Comparison of the two arms for genotypic resistance profile in case of virological failure
timeFrame: 48 wks
measure: CD4 changes from baseline
timeFrame: 48 wks
measure: Evolution of the lipid profile and morphological changes in fat distribution, and safety
timeFrame: 48 wks
Other outcomes:
Locations:
city: Paris
country: France
facility: France and French West Indies
Study officials:
affiliation: Gilead Sciences
name: Aldo Trylesinski, MD
role: PRINCIPAL_INVESTIGATOR
References: