louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05911854: Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema
Official title: Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted:

* To investigate the effect of MLS Laser in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
* To investigate the effect of CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
* To compare the effect of MLS Laser versus CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.


Eligibility criteria: Inclusion Criteria:

* Female patients with unilateral BCRL.
* Age of patients above 18 years old
* Patient history of modified radical mastectomy, chemotherapy and/or radiotherapy.
* Patients undertaken have history or current hormonal treatment.
* Patients with moderate lymphoedema (20-40% increase in extremity volume)

Exclusion Criteria:

* Patients who have severe co-morbid diseases.
* Presence of other cancers, cancer recurrence, lymphatic malformation, or vascular disease
* Patients who are having current chemotherapy and/or radiotherapy.
* Patients who have bilateral lymphedema, current metastases, elephantiasis, infection, lymphangiosis carcinomatosa, cellulitis, venous thrombosis, or congestive heart failure
* Patients with musculoskeletal disorders affecting upper extremity.

Primary outcomes:
measure: Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
timeFrame: Baseline
measure: The change of Volumetric measurement of the arm pre and post treatment
timeFrame: Baseline
Secondary outcomes:
measure: The change of Lymphedema Life Impact Scale scores pre and post treatment
timeFrame: Baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed H El-Gendy, professor
role: STUDY_CHAIR
References:
Clinical trial NCT02037854: PEP-1324: Glycemic Response Testing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glycemic Response
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2014-01-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.


Eligibility criteria: Inclusion Criteria:

* Subject is 18-75 years of age
* Subject is male or non-pregnant females, 18-75 years of age, inclusive
* Subject has a body mass index (BMI) ≥ 20.0 and \< 35 kg/m² at screening (visit 1).
* Subject has to be non-smoker.
* Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Subject is willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
* Subject has normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
* Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

-

Primary outcomes:
measure: Incremental area under the blood glucose response cruve
timeFrame: 0-2 hours
Secondary outcomes:
measure: peak blood glucose
timeFrame: 0-2 hours
measure: peak insulin
timeFrame: 0-2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: GI Labs
state: Ontario
Study officials:
References:
Clinical trial NCT04503954: Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
Official title: Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: chronic disease self-management program
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.

Detailed description: Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia by DSM-5
* age \> 20 years
* Stable mental symptoms
* Willing to sign the subject's consent

Exclusion Criteria:

* History of severe brain injury
* Substance abuse
* Diagnosis of intellectual developmental disorder
* Unable to follow instructions

Primary outcomes:
measure: Stanford Self-Management Questionnaire
timeFrame: 6 week
measure: Beck Depression Inventory-II,
timeFrame: 6 week
measure: Activities of Daily Living Rating Scale III,
timeFrame: 6 week
measure: Instrumental Activities of Daily Living
timeFrame: 6 week
measure: Participation Measure-3 Domains Domains, 4 Dimensions
timeFrame: 6 week
measure: Work Behavior Inventory
timeFrame: 6 week
measure: Schizophrenia-Quality of Life questionnaire
timeFrame: 6 week
measure: Mini Mental State Examination-2nd edition
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
state: Wanhua Dist
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: En-Chi Chiu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04085354: Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation
Official title: Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Ejaculation
Keywords: Premature Ejaculation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 120
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will be randomized equally divided into four groups (30 patients each).
Primary purpose: TREATMENT

Brief summary: This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.

Detailed description: In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.

All patients will be randomized equally divided into four groups (30 patients each).

Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.

Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.

Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12

Eligibility criteria: Inclusion Criteria:

Premature ejaculation

Exclusion Criteria:

* Erectile dysfunction
* Diabetes mellitus
* chronic prostatitis
* Advanced renal or hepatic diseases
* Neurological diseases

Primary outcomes:
measure: Arabic Index of Premature Ejaculation
timeFrame: 0-6 weeks after treatment
measure: Intravaginal ejaculatory latency times
timeFrame: 0-6 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University, Egypt
Study officials:
affiliation: Assistant Professor
name: Mohammed Abu El-Hamd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944254: The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients
Official title: Comparison of the Precision of Cardiac Output-measures at Random to Respiration, Synchronised With Expiration and Instructed Slow Exhalation, Obtained by Pulmonal Artery Catheter Thermodilution Technique With Cold Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Cardiac surgical procedures
Pulmonary Artery Catheterizations
Cardiac output
Swan Ganz Catheterization
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-09-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.


Eligibility criteria: Inclusion Criteria:

* Every patient that receives a pulmonary artery catheter (PAC) related to elective cardiac surgeries,
* informed and written consent to participation in the study in accordance with the Helsinki declaration
* hemodynamic stability

Exclusion Criteria:

* Hemodynamical instability
* atrial fibrillation
* tricuspid insufficiency ≥ grade 2
* hemodialysis or other conditions where extra volume load can be negative,
* lack of ability to give a written consent to participate in the study

Primary outcomes:
measure: The observed variance amongst the cardiac output measures
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Idar Kirkeby-Garstad, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjetsa E, Skjaervold NK, Skogvoll E, Kirkeby-Garstad I. Synchronizing thermodilution cardiac output measurements with spontaneous breathing does not improve precision. Acta Anaesthesiol Scand. 2016 Mar;60(3):354-9. doi: 10.1111/aas.12650. Epub 2015 Oct 26.
Clinical trial NCT06791954: The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients
Official title: The Efficacy of a Telerehabilitation Pilates Program on Lumbopelvic Muscle Morphology in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia
Pain
Telehealth
Telemedicine
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of FMS at least one year before the study
* Stable general health condition for the past 6 months

Exclusion Criteria:

* Inability to cooperate with measurements
* Regular engagement in exercise

Primary outcomes:
measure: Ultrasonographic assessment
timeFrame: First day (at beginning) and last day (8. weeks)
measure: McGill core endurance tests
timeFrame: First day (at beginning) and last day (8. weeks)
measure: Fibromyalgia Impact Questionnaire
timeFrame: First day (at beginning) and last day (8. weeks)
measure: Fatigue Severity Scale
timeFrame: First day (at beginning) and last day (8. weeks)
measure: Central Sensitization Inventory Short-Form
timeFrame: First day (at beginning) and last day (8. weeks)
measure: Hospital Anxiety and Depression Scale
timeFrame: First day (at beginning) and last day (8. weeks)
measure: Numeric Rating Scale
timeFrame: First day (at beginning) and last day (8. weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References:
Clinical trial NCT01157754: Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients
Official title: Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility patients requiring IVF
good prognosis
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.


Eligibility criteria: Inclusion Criteria:

* 1st or 2nd IVF cycle
* BMI \<30 kg/m2
* regular menstrual cycles
* basal FSH \<10 IU and E2 \<60 pg/ml

Exclusion Criteria:

* Polycystic ovaries
* endometriosis
* previous ovarian surgery
* previous low ovarian response

Primary outcomes:
measure: implantation rate
timeFrame: 2 weeks after the embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
References:
Clinical trial NCT03401554: Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement
Official title: Titanium Mesh Versus Collagen Membrane for Closure of Lateral Window Approach in Maxillary Sinus Floor Elevation With Simultaneous Implant Placement. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.

Detailed description: this study is aimed to review the bone height, quality and closure of lateral osteotomy used for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.

Eligibility criteria: Inclusion Criteria:

* no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site

Exclusion Criteria:

* Sinus pathology. Heavy smokers more than 20 cigarettes per day Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Primary outcomes:
measure: bone height
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: الجيزة
Study officials:
affiliation: Study principal investigator
name: Mostafa Mahmoud, Bds
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00618254: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions
Official title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Prevention of nausea and vomiting associated with radiation or chemotherapy
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-19
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to granisetron or any other comparable or similar drug.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, four period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
Study officials:
affiliation: MDS Pharma Services
name: James Kissling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739854: Prevalence of Atelectasis in Critical Trauma Patients
Official title: The Prevalence and Risk Factors for Lung Atelectasis in Patients With Critical Trauma Who Are Intubated and Mechanically Ventilated
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Atelectasis
Keywords: trauma
atelectasis
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The critically traumatic patients who were admitted to the traumatic surgical intensive care unit at Khon Kaen Hospital (February 2016 to February 2017).

Brief summary: The purpose of this study is to identify the prevalence rate and risk factors for pulmonary complications in patients with critical trauma who intubated and mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* An inclusion criterion is the traumatic patients (e.g. head injury, blunt chest, blunt abdomen, and fracture of spine; with or without operative, pure or multitrauma) with intubation and mechanical ventilation who admit at this time period will recruit to the study.

Exclusion Criteria:

* a patients who admit less than 1 day will be excluded such as sudden death or moving to other ward because of improving conditions, etc.

Primary outcomes:
measure: number of participants with pulmonary atelectasis
timeFrame: from the date of randomization until the date of first documented of atelectasis, assessed up to 1 years
Secondary outcomes:
measure: number of participants with pneumonia
timeFrame: from the date of randomization until the date of first documented of pneumonia, assessed up to 1 years
measure: number of participants with pleural effusion
timeFrame: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
measure: number of participants with abnormal laboratory values
timeFrame: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
measure: number of participants with adverse events that are related to treatment
timeFrame: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
References: