louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05237427: Inspiratory Muscle Endurance of Adults
Official title: Determination of Respiratory Muscle Endurance in Healthy Adult Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers between the ages of 18-35

Brief summary: The aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance.

Detailed description: Since respiratory muscles are used in daily life at the submaximal level, evaluation of their endurance is more meaningful functionally. In addition, evaluation of endurance with respiratory muscle strength is effective in determining respiratory muscle dysfunction. Failure to routinely evaluate respiratory muscle endurance, which is one of the main components of respiratory muscle function, may lead to failure to identify respiratory muscle dysfunction in early stage respiratory patients who have not yet developed muscle strength loss. However, normal value ranges have not been determined for the respiratory muscle endurance test.

Determining the normal value ranges for this test will help determine muscle fatigue and investigate the physiological course in respiratory diseases.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-35
* Not having any disease
* Not exercising regularly
* Not smoking

Exclusion Criteria:

* Having a respiratory disease
* Have heart disease
* Have a neuromuscular disease
* Have Scoliosis
* Having had thoracic surgery
* Having experienced the respiratory muscle endurance protocol before

Primary outcomes:
measure: Incremental threshold loading test.
timeFrame: 15 minute
measure: Maximal inspiratory pressure
timeFrame: 20 minute
Secondary outcomes:
measure: Pulmonary function test - Forced expiratory volume in 1 second (FEV1)
timeFrame: 5 minute
measure: Pulmonary function test - Forced vital capacity (FVC)
timeFrame: 5 minute
measure: Maximal voluntary ventilation (MVV)
timeFrame: 5 minute
measure: International Physical Activity Questionnaire - Short Form
timeFrame: 5 minute
Other outcomes:
measure: Anthropometric assessment
timeFrame: 5 minute
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Selda Gokcen
role: PRINCIPAL_INVESTIGATOR
affiliation: Kutahya Health Sciences University
name: Ozgen Aras
role: STUDY_DIRECTOR
References:
Clinical trial NCT06388473: Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting
Official title: Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Men's Health Screening
Implementation
Web-based Application
Keywords: mass screening
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months.


Eligibility criteria: Inclusion Criteria:

1. Healthcare providers that were involved in the clinic health screening program.
2. Patients who were aged 18 years and above were eligible to participate.

Exclusion Criteria:

1. Temporary healthcare providers (working in the clinic less than six months during the study period) and those who were away on leave.
2. Patients who did not understand Bahasa Malaysia, English or Mandarin, cognitively impaired, had an active psychiatric illness or were too ill.

Primary outcomes:
measure: Reach
timeFrame: Beginning of intervention
measure: Reach
timeFrame: Through study completion, 5 months.
measure: Adoption of ScreenMen using qualitative methods
timeFrame: 5 months into study
measure: Implementation of ScreenMen using qualitative methods
timeFrame: 5 months into study
measure: Maintenance of ScreenMen using qualitative methods
timeFrame: 5 months into study
Secondary outcomes:
measure: Impact of COVID-19 on the clinic using qualitative methods
timeFrame: 5 months into study
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kesihatan Cheras Baru
Study officials:
affiliation: University of Malaya
name: Chirk Jenn Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02821273: Surfactant Administration in Preterm Infants
Official title: Modified INSURE vs INSURE in Preterm Infants With Respiratory Distress Syndrome: A Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Modified INSURE Technique
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 200
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In preterm infants with respiratory distress syndrome, mechanical ventilation is related to increased risk of death and complications. Surfactant is an important methods to reduce mortality and intubation rates. INSURE technique is a standard method to administrate surfactant. However, several preterm infants need two or more surfactant, and therefore one more intubation is needed. How to reduce the times of intubation is an challenges for neonatologists.

Detailed description: INSURE technique meas surfactant administration through intubation-surfactant-extubation. And noninvasive ventilation is immediately used after surfactant.

The differences of modified INSURE compared with INSURE is intubation-surfactant-X-ray relieved-extubation. Extubation and noninvasive ventilation is used after the X-ray relieving.

Eligibility criteria: Inclusion Criteria:

* All preterm infants with respiratory distress syndrome

Exclusion Criteria:

* congenital abnormalities or refuse the trials

Primary outcomes:
measure: intubation rate
timeFrame: 100-days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics,Daping Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT05187273: Hemodynamic Optimization Based on a Dynamic Elastance Protocol
Official title: Intraoperative Fluid Optimization Based on a Dynamic Elastance Protocol During Major Abdominal Surgery: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Management
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In this study investigators explore the effects of a dynamic elastance guided protocol compared to a stroke volume variation fluid therapy on lactate levels during major abdominal surgery. Hence investigators created two groups: in the intervention group fluids are given in fluid-responders (SVV \> 13%) based on high value of dynamic elastance (ie. Eadyn \> 0.9). In the standard group fluids are administered when SVV \> 13%.


Eligibility criteria: Inclusion Criteria: patients enrolled for major abdominal surgery

-

Exclusion Criteria:

1. end-stage renal disease
2. severe heart dysfunction
3. heart rhythm alterations

Primary outcomes:
measure: lactate levels
timeFrame: at the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Andrea Russo
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: andrea russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05505773: Systemic Metabolic Rate of Diabetic Patients Before and After Bariatric Gastric Bypass Using the Breezing® Device.
Official title: Prospective Clinical Study to Evaluate the Metabolism Using the Breezing Device in the Preoperative and Postoperative Periods of Gastric Bypass in Patients With Type II Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes Mellitus, Type 2
Lead sponsor: Kaiser Clinic and Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obesity

Brief summary: To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Detailed description: Objective of the research:

Primary To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Secondary

* To measure the indirect metabolic rate by quantifying O2 gas consumption (g) and CO2 gas release (g);
* To analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated;
* To correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor;
* To validate the accuracy of the Breezing® device.

Evaluation of the risks and benefits Risks As the patient only needs to blow on the Breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. Thus, the risks are indirect and are more associated to the malfunctioning of the device.

Benefits The advantage is that the procedure is simple and can provide results with important information about the metabolic rate even just using the iPhone or iPad of patients as a strategy to monitor metabolic control.

Eligibility criteria: Inclusion Criteria: over 18 years -

Exclusion Criteria: obesity

-

Primary outcomes:
measure: To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Clinica and Day Hospital
name: Luiz Gustavo de Quadros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02314273: Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
Official title: Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancytopenia Due to Chemotherapy
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Xiamen Amoytop Biotech Co., Ltd.
First posted: 2014-12-11
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.

Detailed description: Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group

Eligibility criteria: Inclusion Criteria:

* new diagnosis of ALL
* TBIL≤34umol/L，Cr≤120umol/L，a normal EF
* age \<18 years

Exclusion Criteria:

* patients with uncontrolled infection
* patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias

Primary outcomes:
measure: platelet infusion
timeFrame: 14 days
Secondary outcomes:
measure: hemorrhagic tendency
timeFrame: 14 days
measure: infection
timeFrame: 14 days
measure: remission rate
timeFrame: 14 days
measure: platelet Count
timeFrame: 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
city: Soochow
country: China
facility: Soochow University Affiliated Children's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Tang Jingyan, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03926273: Serum and Urine Ghrelin in Adult Epileptic Patients
Official title: Serum and Urine Ghrelin in Adult Epileptic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
serum ghrelin
urine ghrelin
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The present study was a case control type. All patients were selected from out- patient clinic of Neurology department, Zagazig university hospitals, Sharkia Governorate, Egypt in the period from July 2018 to January 2019.

Brief summary: Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response.

Detailed description: Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response. Objective: to evaluate ghrelin effect in adult epileptic patients and in response to AED. Methods: This case control study included 40 adult epileptic patients and 40 healthy controls. Participants were subjected to history taking of seizure semiology, full general and neurological examination, electroencephalography and cranial CT or MRI. Fasting serum acylated ghrelin (AG) and unacylated ghrelin (UAG) and urine AG levels were estimated to all participants by enzyme - linked immunosorbent assay (ELIZA).

Eligibility criteria: Inclusion Criteria:

* All participants were included if their age more than or equal to 18 years. Body mass index \< 30 kg/m2, total cholesterol \< 200mg/dl, serum triglycerides \< 200 mg/dl and random blood glucose level \< 126 mg/dl.

Exclusion Criteria:

* Participants had acute or chronic metabolic disorders (liver, kidney, thyroid, endocrine or gastrointestinal disorders).
* Females with irregular menstrual cycle or on estrogen therapy (7).
* Participants with organic cerebral lesion that was detected on cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI).

Primary outcomes:
measure: Serum ghrelin in Adult Epileptic Patients
timeFrame: 6 months
measure: Urine ghrelin in Adult Epileptic Patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Nageeb
state: El Sharkia
Study officials:
affiliation: zagazig U
name: nageeb rania, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354973: ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy
Official title: ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Reported Outcome Measures
CAR T-Cell Therapy
Keywords: CAR T-Cell Therapy
ePRO
PRO
Patient Reported Outcome Measure
Immunotherapy
Lead sponsor: Stiftung Swiss Tumor Institute
Sponsor class: OTHER
Collaborators: name: Klinik Hirslanden, Zurich
name: Palleos Healthcare GmbH
First posted: 2022-05-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or older receiving CAR T Cell therapy and congnitive ability to utilitze a smartphone.

Brief summary: This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting. ePRO assessments will be explored for their feasibility to engage in monitoring and management of CAR T-related toxicities as well as using these digital ePRO tools may improve both, its safety and accessibility.


Eligibility criteria: Inclusion Criteria:

1. Signed ICF
2. Patients \> 18 years
3. Patients receiving CAR T cell treatment
4. Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions.

Exclusion Criteria:

1. Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted.
2. Patients with insufficient knowledge about the use of a smartphone.

Primary outcomes:
measure: Response time
timeFrame: 84 day +/- 6 days
Secondary outcomes:
measure: Occurrence of CRS-related adverse events (ePRO)
timeFrame: 84 day +/- 6 days
measure: Number and severity of adverse events (AE) according to the CTCAE
timeFrame: 84 day +/- 6 days
measure: Occurrence and type of therapy-associated unplanned consultations
timeFrame: 84 day +/- 6 days
measure: Adherence
timeFrame: 84 day +/- 6 days
measure: Well-being
timeFrame: 84 day +/- 6 days
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Hämatologie und Onkologie
Study officials:
affiliation: Klinik für Hämatologie und Onkologie
name: Panagiotis Samaras, PD.Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018473: Gene-Environment Interactions in Alzheimer's Disease
Official title: Gene-Environment Interactions in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Risk Factors
Genes
Epidemiology
Apolipoproteins E
Alzheimer's Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study will create Alzheimer 's disease risk profiles for defined combinations of genotypes and environmental exposures. This study will carry out a molecular epidemiologic study to identify genetic and environmental risks factors using state of the art techniques. The following will be done during the course of this study 1) Recruit both Alzheimer's patients and cognitively normal aged veterans. 2) Evaluate gene interaction in Alzheimer's disease. 3) Evaluate gene-environment interactions on the risk of Alzheimer's disease. These procedures should initially address the question as to whether certain genes either independently or synergistically modify the risk of Alzheimer's disease. This study will also determine whether certain environmental factors (smoking, alcohol consumption etc.) can modify the risk of AD and whether this effect is dependent on certain genetic backgrounds. This study will provide information that will be useful in designing therapies, develop risk factor profiles to be further tested in future studies, designating patients for specific therapies based on genetic factors and providing data and genetic material for future studies. This study will also provide a cohort of older and well characterized cognitively normal veterans for prospective genetic epidemiological studies on aging.


Eligibility criteria: The GRECC located at this hospital represents the leading edge of clinical care focusing on the needs of the aging veteran. We will recruit all 100 patients currently hospitalized at the Dementia Unit. We will also recruit from the outpatient memory clinic. We will enroll 400 AD patients total. Since, cases and controls will be ascertained from the same population, we also expect the socioeconomic status of individuals in these two groups to be the same. In the past year 9600 patients were treated on an outpatient basis. They were almost entirely white and male (\>90%). The age demographics are 23% between 60-69, 23% between 70-79 and 5 % 80 or greater. The outpatients are seen for a wide variety of conditions. We plan to enroll 100 patients a year for 4 years (400 total). They will be seen once and have the same neuropsychological exams as the AD patients. Control subjects will be enrolled if their Mini-Mental score is greater than 24.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VAMC- Bedford (Station 518)
state: Massachusetts
Study officials:
References: