louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01418105: Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
Official title: Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prevention
Rehabilitation
Keywords: spine injuries
brain lesions
dysphagia
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The research is about a prospective study conducted in patients suffering from dysphagia and cervical spine disorders and how they are interrelated. Three questionnaires have been given to patients with neurologic deficits, the first of these investigates the occurence of dysphagia in the three stages of swallowing, the second looks into the quality of life following a stroke or other neurologic damage and the third analyses how cervical spine disorders can affect every day life. After the bedside examination, VFSS or FEES, the patients are submitted to swallowing and cervical resistance exercises in fixed time periods after their hospitalisation. The results will be collected and evaluated using the statistical programme SPSS.


Eligibility criteria: Inclusion Criteria:

* brain lesions and cervical spine disorders

Exclusion Criteria:

* age
* peripheral damages

Primary outcomes:
measure: change in swallowing ability and quality of life by swal-quol questionnaire
timeFrame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
measure: change of swallowing ability by Okuma's questionnaire
timeFrame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
measure: change of cervical scoliosis measured by Cobb method in x-rays
timeFrame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
Secondary outcomes:
measure: change of cervical oswestry disability index
timeFrame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
Study officials:
References:
Clinical trial NCT00367497: Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
Official title: Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Keywords: aggressive non-Hodgkin's lymphoma
salvage chemotherapy
rituximab
Lead sponsor: Keio University
Sponsor class: OTHER
First posted: 2006-08-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of aggressive non-Hodgkin's lymphoma
* Refractory to the first line chemotherapy or relapsed
* Expression of CD20 on lymphoma cells
* Measurable lesions on imaging studies

Exclusion Criteria:

* Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
* Circulating lymphoma cells equal to or more than 25,000/microliter
* Hepatic dysfunction
* Renal insufficiency
* Cardiac dysfunction or arrhythmia
* Sever infection (bacterial, viral)
* CNS involvement
* Other malignancies
* Pregnancy or breast feeding

Primary outcomes:
measure: Overall response
Secondary outcomes:
measure: Complete response
measure: Safety
measure: Overall survival
measure: Progression free survival
measure: Effectiveness of peripheral blood stem cell collection
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Keio University School of Medicine
Study officials:
affiliation: Keio University
name: Norihiro Awaya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754697: IASTM Versus PRT in Patients With Chronic PF
Official title: Instrument Assisted Soft Tissue Mobilization Versus Positional Release Technique in Patients With Chronic Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: Positional release technique
Instrument assisted soft tissue mobilization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial\] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis

The main question\[s\] it aims to answer are:

1. Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis?
2. Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?

Detailed description: Design of the study:

Pretest - posttest randomized controlled trial.

Subjects selection:

Sixty patients their age range from 30-50 years of both genders with chronic plantar fasciitis will participate in this study according to sample size calculation.

Eligibility criteria: Inclusion Criteria:

1. Clinically diagnosed cases of plantar fasciitis not less than 3 months.
2. Heel pain felt maximally over plantar aspect of heel.
3. Pain in the heel on the first step in the morning.
4. Their age ranging from 30-50 years.
5. Body mass index range from (18.5 to 24.9 kg/m2).

Exclusion Criteria:

1. Subjects can't tolerate close physical contact.
2. Athletes.
3. Subjects with skin infections.
4. Subjects with recent fracture with incomplete bony union.
5. Subjects with acute inflammatory or infectious process.
6. Subjects with hematoma.
7. Subjects with osteoporosis.
8. Subjects with foot deformity.
9. Subjects that take medications that may increase blood clotting.
10. Surgery to the ankle or foot.

Primary outcomes:
measure: Pressure Algometer (Change in pain pressure threshold)
timeFrame: Pre-intervention and immediately after intervention
Secondary outcomes:
measure: The Arabic Version of Foot and Ankle Ability Measure
timeFrame: Pre-intervention and immediately after intervention
Other outcomes:
Locations:
city: Port Said
country: Egypt
facility: Private Clinic
Study officials:
affiliation: Cairo University
name: Doaa Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00633997: Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
Official title: An Open-label, Multiple Dose Study to Assess the Steady-state Skin Concentrations and Pharmacokinetics of Vildagliptin 50 mg BID for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus
type 2 diabetes
vildagliptin
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look at the skin accumulation of vildagliptin and its two major metabolites, LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10 days in both healthy volunteers and patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers and patients with type 2 diabetes
* Non-smoking, Caucasian and African American, male and female (postmenopausal, surgically sterile or using double-barrier method of contraception) subjects between 30 and 65 years of age (inclusive)
* Type 2 diabetics on metformin and/or sufonylurea

Exclusion Criteria:

* History of type 1 diabetes or insulin use
* History of coagulation abnormalities
* History of abnormal heart conditions
* Pregnancy or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10
timeFrame: Baseline (Day -1) to End of Study (Day 17 +/- 2 days)
Secondary outcomes:
measure: 10 day's treatment with vildagliptin 50 mg orally twice daily on hematology, blood chemistry and physical exams in healthy volunteers and patients with type 2 diabetes
timeFrame: Baseline (Day -1) to End of study (Day 17 +/- 2 days)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Novartis Investigator Site
state: Maryland
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05251597: Comparison of the Effects of Green Exercise Programs on Metabolic Syndrome Parameters in Elderly Individuals
Official title: Comparison of the Effects of Green Exercise Programs Including Resistance Exercises and Aerobic Exercises on Metabolic Syndrome Parameters in Elderly Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
exercise
geriatrics
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept.

Detailed description: One hundred twenty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into three groups as aerobic, aerobic and resistance and control group. While a group will receive only aerobic exercise, the other group group will receive both aerobic and resistance exercises and one of the group will receive no exercise. Exercises will be held in an open and green area. At the beginning of the treatment and at the end of the twelfth week Hemoglobin A1c (HbA1c), Triglyceride, Hdl cholesterol, Ldl cholesterol, total cholesterol and blood glucose will be evaluated.

Eligibility criteria: Inclusion Criteria:

* people aged over 65 years
* Be fit to participate in exercise program after the first cardiac examination by the physician
* Individuals whose blood lipids, Hg a1c and glucose values were checked within 3 months
* According to the International Physical Activity Assessment Questionnaire, those who are physically inactive
* Having a score above 24 in the Minimental Test

Exclusion Criteria:

* Having neuromuscular disease
* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
* Having an orthopedic disease that interferes with walking
* Having a score below 24 in the Minimental Test

Primary outcomes:
measure: physical activity level
timeFrame: Change from baseline physical activity level at week 12.
measure: blood pressure
timeFrame: Change from baseline blood pressure at week 12.
measure: hemoglobin A1c
timeFrame: Change from baseline hemoglobin A1c at week 12.
measure: lipid profile
timeFrame: Change from baseline lipid profile at week 12.
measure: fasting blood glucose
timeFrame: Change from baseline fasting blood glucose at week 12.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
city: Istanbul
country: Turkey
facility: Emel Mete
Study officials:
References:
Clinical trial NCT02710097: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
Official title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cannabis
Alcohol Effect
Driving Under the Influence of Alcohol and Other Drugs
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Detailed description: To study the effects of oral ethanol (target BAC of \~0.04g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized cannabis (\~450 mg cannabis plant material at a THC concentration of \~1.7%; roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Eligibility criteria: Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Occasional current cannabis users.
* Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naïve.
* Alcohol naïve.
* Positive pregnancy screen
* Hearing deficits.

Primary outcomes:
measure: Road Tracking Error
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol administration
Secondary outcomes:
measure: Biphasic Alcohol Effects Scale (BAES)
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Visual Analog Scale (VAS)
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Cognitive Test Battery
timeFrame: +40 mins after start of alcohol administration
measure: Willingness to Drive Scale
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Number of Joints Scale
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Number of Drinks Scale
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit, VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT02221297: Lipid-lowering Effect of a Plant Stanol Ester Supplement Product
Official title: Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Institute HUCH Ltd
First posted: 2014-08-20
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.


Eligibility criteria: Inclusion Criteria:

* male and female over 18 years old
* serum LDL cholesterol \> 3.0 mmol/L
* BMI \< 35
* subjects must voluntarily sign the informed consent

Exclusion Criteria:

* subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
* subjects with any hepatic or renal disorder according to medical history
* subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
* subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
* subjects who have history of temporal ischemic attack or stroke within six months prior to screening
* subjects who have a history of cancer or other malignant disease within the past five years
* subjects who are consuming more than 15 portions of alcohol / week
* subjects who are pregnant or lactating
* subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
* subjects with intolerance to any ingredient of the test product

Primary outcomes:
measure: Proportional change in serum LDL cholesterol
timeFrame: 3 to 4 weeks
Secondary outcomes:
measure: Proportional change in total cholesterol
timeFrame: 3 to 4 weeks
measure: Proportional change in non-HDL-cholesterol
timeFrame: 3 to 4 weeks
measure: Proportional change in serum triglycerides
timeFrame: 3 to 4 weeks
measure: Proportional change in lipids in all study participants
timeFrame: 3 to 4 weeks
measure: Proportional change in lipids in subjects without metabolic derangements
timeFrame: 3 to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05380297: Validation of acceXible's Automated Speech Analysis Method for the Early Detection and Monitoring of Patients With Mild Impairment or Dementia in Primary Care
Official title: Validación Del método de análisis Automatizado Del Habla "AcceXible" Para la detección Temprana y Seguimiento de Pacientes Con Deterioro Cognitivo Leve o Demencia en atención Primaria.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Lead sponsor: Accexible
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 248
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

Thus, the purpose of this study is to validate speech analysis AI models.


Eligibility criteria: Inclusion Criteria:

* Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.
* Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
* (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.

Exclusion Criteria

* To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
* To have significant vision problems that would affect the ability to perceive visual stimuli.
* To have significant hearing problems that would affect the ability to understand verbal cues.

Primary outcomes:
measure: Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.
timeFrame: Change from the baseline cognitive function at 9 months.
Secondary outcomes:
measure: Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: Change of economic implications of accexible's use in a primary care center.
timeFrame: Through study completion, an average of 1 year.
Locations:
city: País Vasco
country: Spain
facility: País Vasco
Study officials:
References:
Clinical trial NCT03977597: Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation
Official title: Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplant, Diaphragmatic Function
Keywords: lung transplant
diaphragm evaluation
ultrasound
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in immediate postoperative bi-pulmonary transplantation

Brief summary: A current complication after lung transplantation is diaphragmatic dysfunction. These dysfunction result to several factors: duration of mechanical ventilation, chest tube, atelectasis, denutrition, phrenic nerve injury during surgical dissection... Only monocentric and retrospective studies collected diaphragmatic paralysis after lung transplant are published. The incidence of diaphragmatic paralysis in post-operative lung transplantation varies from 3.2% to 16.8%.

The main hypothesis of the study is to defined the incidence of diaphragmatic dysfunction in post-operative lung transplantation.


Eligibility criteria: Inclusion Criteria:

* Adults (≥ 18 years old)
* Admitted for intensive care that can be spontaneously ventilated after bi- pulmonary transplantation

Exclusion Criteria:

* Minor patient
* Ventilated patients less than 24 hours
* patients in controlled ventilation

Primary outcomes:
measure: incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
Study officials:
References: