louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05316090: Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy
Official title: Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group and control group
Primary purpose: TREATMENT

Brief summary: Purpose of the study:

To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.

Detailed description: Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria:

1. The age of the selected children ranged from 3 To 6 years old.
2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale
3. Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program.
4. Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.

Eligibility criteria: Inclusion Criteria:

1. The age of the selected children ranged from 3 To 6 years old.
2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987).
3. Children with hemiparetic cerebral palsy

Exclusion Criteria:

1. Fructures and fixed deformities

Primary outcomes:
measure: Pediatric reach test
timeFrame: assessment after 6 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
affiliation: Cairo University
name: Mai Abbass, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01019590: Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
Official title: Single-Dose Fed Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute Ltd.
name: Alan K Copa, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03086590: EVALUATION OF RESPIRATORY MECHANICS AND FUNCTIONALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Official title: BODY COMPOSITION, PERIPHERAL MUSCULAR FORCE, KINEMATIC THORACIC-ABDOMINAL, VENTILATORY METABOLIC RESPONSE, DIAPHRAGM MOBILITY AND THICKNESS PREDICTION OF OBSTRUCTION LEVEL OF COPD?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Body composition
Ultrasound
Chronic Pulmonary Obstructive Disease
Respiratory muscles
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Chronic Obstructive Pulmonary Disease, selected at the Hospital das Clínicas of the Federal University of Pernambuco, Hospital Otávio de Freitas and Pharmacy of the State of Pernambuco.

Brief summary: To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD

Detailed description: Individuals with COPD present restriction in their daily lives due to changes and bodily disorders promoted by the disease, such as changes in types of muscle fibers and chronic inflammatory process, causing a low level of physical activity and quality of life, besides being closely Related to the need for hospitalizations and increased mortality. A cross-sectional study with a convenience sample was performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco during the period from December 2016 to February 2018. As measurements of body composition were performed with a bio-balance scale, Evaluation of the peripheral muscle strength will be used the dynamometer, a load cell and electromyography, a kinematic thoracic-abdominal will be measured by optoelectronic plethysmography, a respiratory metabolic response will be verified during the 6-minute walk test using the gas analyzer, and for evaluation of mobility and diaphragmatic thickness are used on ultrasound associated with pneumotachograph.

Eligibility criteria: Inclusion Criteria:

* Young adults, adults and elderly subjects

Exclusion Criteria:

* Others respiratory diseases;
* Heart diseases;
* Those who are in some previous training program or rehabilitation;

Primary outcomes:
measure: Fat-free mass
timeFrame: Baseline
measure: Quadriceps Force
timeFrame: Baseline
measure: Handgrip strength
timeFrame: Baseline
measure: Total chest wall volume
timeFrame: Baseline
measure: Oxygen uptake
timeFrame: Baseline
measure: Diaphragm mobility
timeFrame: Baseline
measure: Diaphragm thickness
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT00979290: Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs
Official title: Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Fix-dose combination anti-TB drug
adverse effect
efficiency
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed TB patients in E-DA hospital

Brief summary: The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
2. No previous anti-TB drugs treatment
3. Age≥18years old

Exclusion Criteria:

1. Expected life \< 6months
2. Baseline AST/ALT \> 3x upper limit of normal (ULN)
3. Age \<18years old

Primary outcomes:
measure: To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
timeFrame: two year
Secondary outcomes:
measure: To compare the efficacy of anti-TB treatment between using FDC and single drugs
timeFrame: two year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
Study officials:
References:
citation: Wu JT, Chiu CT, Wei YF, Lai YF. Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment. Clinics (Sao Paulo). 2015 Jun;70(6):429-34. doi: 10.6061/clinics/2015(06)08. Epub 2015 Jun 1.
Clinical trial NCT05690490: Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms
Official title: Treament for Colorectal Neoplasms by Metod Endoscopic Mucosal Resection With Circumferential Mucosal Incision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Mucosal Resection With Circumferential Incision
Keywords: C-EMR
Endoscopic treatment
colorectal neoplasm
circumferential incision
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2023-01-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-center, randomized, non inferiority
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.

Detailed description: Generally, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are the methods of choice for the removal of benign and early malignant neoplasms of the colon. However, there are certain difficulties in terms of the EMR technique - this is an increase in the frequency of fragmentation with a lesion size of more than 20 mm, which in turn increases the risk of recurrence; with regard to ESD technique, this is a long procedure time; high incidence of complications; significant time required for teaching the technique; technical difficulties. In this regard, it is worth paying attention to the method of "endoscopic mucosal resection with circumferential mucosal incision" (C-EMR). This method deserves interest due to the fact that it allows more often to perform en-block resections in comparison with the classical method of endoscopic mucosal resection (EMR - endoscopic mucosal resection); technically easier to do; takes a short procedure time.

Eligibility criteria: Inclusion Criteria:

* patients with benign colon neoplasms without signs of deep invasion (I, II, IIIL and IV type according to Kudo, I and II type according to Sano)
* the size of the neoplasm is from 20 mm to 30 mm
* patient for treatment

Exclusion Criteria:

* unsatisfactory tumor lifting
* refusal of the patient from research at any stage of treatment

Primary outcomes:
measure: R0 resection rate
timeFrame: 14 day
Secondary outcomes:
measure: En-block resesction rate
timeFrame: 14 day
measure: conversion rate
timeFrame: 1 day
measure: intervention time
timeFrame: 1 day
measure: intra- and postoperative complications rate
timeFrame: 30 day
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Elmira
Study officials:
References:
Clinical trial NCT05248490: Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home
Official title: Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone and Joint Infection
Keywords: osteo articular infection
adverse event
antibiotic treatment
pharmaceutical interview
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.


Eligibility criteria: Inclusion Criteria:

* Patient \> or =18 years;
* Informed consent signed;
* French-speaking and reading;
* Affiliated to a social insurance;
* Benefiting from medical and surgical care for an osteoarticular infection;
* Treated with an oral antibiotic therapy on discharge from hospital.
* Indication of the antibiotic therapy osteoarticular infection;
* Return home immediately after discharge.

Exclusion Criteria:

* Refusal to participate
* Protected adult patient, under guardianship or curatorship.
* Minor patient
* Patient benefiting from an AME.
* Pregnant or breastfeeding woman.
* Non-French speaking patient.
* Patient unable to understand the course of the study.
* Patient with a documented history of cognitive or psychiatric disorders.
* Patient treated with oral antibiotic therapy for an indication other than osteoarticular infection.
* Patient treated with parenteral antibiotic therapy.
* Discharge: Institution (EHPAD), rehabilitation or other health establishment.
* Patient systematically using one of the symptomatic treatments proposed in the discharge prescription before hospitalization.

Primary outcomes:
measure: Adverse effects self-management measurement
timeFrame: at day 7
measure: Adverse effects self-management measurement
timeFrame: at day 14
Secondary outcomes:
measure: Patient knowledge assessment
timeFrame: at day 7
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Pharmacy of Ambroise-Paré hospital, APHP
Study officials:
affiliation: Pharmacy of Ambroise-Paré hospital, APHP
name: Thomas Tritz, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic surgery department, Ambroise Paré hospital, APHP
name: Christophe Menigaux, MD
role: STUDY_CHAIR
affiliation: Infectiology mobile team, Ambroise Paré hospital, APHP
name: Nathalie Dournon, MD
role: STUDY_CHAIR
affiliation: Pitié-Salepetrière hospital, APHP
name: Jessica Berdougo Berdougo, PharmD
role: STUDY_CHAIR
References:
Clinical trial NCT00542490: Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Official title: Phase II Trial of Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy in Patients With Stage I-IIb Papillary Serous, Clear Cell and Endometrioid Endometrial Cancer With High-Intermediate Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Papillary Serous
Clear Cell Endometrial Cancer
Keywords: Endometrial cancer
Gynecologic Cancer
Vaginal Cuff Brachytherapy
Vaginal radiation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2007-10-11
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.

Detailed description: All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.

Eligibility criteria: Inclusion Criteria:

* All patients must have undergone specified complete surgical staging.
* Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
* Patients must have adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

* Patients with recurrent disease.
* Patients with GOG performance status of 3 or 4.

Primary outcomes:
measure: Number of Patients With Progression-free Survival at 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Scott McMeekin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05904990: High-intensity Laser Therapy Improves Pain, Health Status and Quality of Life in Women With Fibromyalgia
Official title: High-intensity Laser Therapy Improves Pain, Health Status and Quality of Life in Women With Fibromyalgia: A Single Blinded-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 52
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: High intensity laser
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate High-intensity laser therapy improves pain, health status and quality of life in women with fibromyalgia


Eligibility criteria: Inclusion Criteria:

1. WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between \> 3-6/19 and SSS \> 9/12
2. symptoms have been present at a similar level for at least 3 months
3. the patient does not have another disorder that would otherwise sufficiently explain the pain
4. generalized pain, defined as pain in at least four of five regions, is present

Exclusion Criteria:

* uncontrolled diabetes
* known history of cancer

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: up to 6 weeks
measure: Visual Analog Scale (VAS)
timeFrame: up to 6 weeks
measure: pressure algometer
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kerolous Ishak Shehata Kelini
Study officials:
References:
Clinical trial NCT01709890: Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures

Brief summary: Patients under sedation not uncommonly develop upper airway obstruction or other respiratory complications and no airway device is available to provide reliable maintenance of the airway at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway in most sedated patients and improve O2 delivery to the airway. In addition it may also greatly facilitate the monitoring of expired CO2, which is widely recognised as the most important monitor of adequacy of breathing, yet frequently impossible to perform satisfactorily in sedated patients at the moment.


Eligibility criteria: Inclusion Criteria:

1. Adult patient, age \>18 and \<80
2. Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures

Exclusion Criteria:

1. Expected procedure require access to or involve the nostrils.
2. Obesity (BMI \>=30)
3. Chronic lung diseases (e.g. COPD) associated with chronic hypoxia
4. Pregnant or lactating women.
5. Known chronic liver or renal disease.
6. Mentally incapable of providing informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Anaesthesiology, The University of Hong Kong
state: Hong Kong
Study officials:
References:
Clinical trial NCT01292590: Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes
Official title: Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2011-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.

Detailed description: This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes using insulin pump and CGM

Exclusion Criteria:

* renal or hepatic failure
* cancer or lymphoma
* malabsorption or malnourishment
* hypercortisolism
* alcoholism or drug abuse
* anemia (hematocrit \< 36 in females and \<40 in males)
* eating disorder
* dietary restrictions
* Acetaminophen allergy
* Chronic acetaminophen use
* Glucocorticoid therapy

Primary outcomes:
measure: Change in insulin requirements
timeFrame: postprandially until 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center/Beth Israel Deaconess Medical Center
name: Howard Wolpert, MD
role: PRINCIPAL_INVESTIGATOR
References: