louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06379204: A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test
Official title: A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Lead sponsor: Taiyuan Central Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients.


Eligibility criteria: Inclusion Criteria:

1. Patients were included who met the Chinese Diabetic Society diagnostic criteria for MS-i.e., three or more of the following five items: (i) abdominal obesity (i.e., central obesity) with waist circumference ≥ 90 cm in males and ≥ 85 cm in females; (ii) hyperglycemia defined as fasting blood glucose ≥ 6.1 mmol/L or blood glucose ≥ 7.8 mmol/L two hours after glucose loading, or diagnosis of diabetes mellitus; (iii) hypertension defined as blood pressure ≥ 130/85 mmHg or diagnosed with hypertension; (iv) fasting triglycerides (TG) ≥ 1.70 mmol/L; and (v) fasting high-density lipoprotein cholesterol (HDL-C) \&amp;lt; 1.04 mmol/L.
2. Patients were aged 25 to 65 years, with no restrictions on number of males or females.
3. Patients exhibited a long-term sedentary lifestyle and did not carry out moderate-intensity physical activity for at least three d/week of 30 min/d duration within three months of the study.
4. Patients were willing to participate and sign the informed consent form.

Exclusion Criteria:

1. Patients in an acute phase of various diseases or with organ failure, tumor, myocardial infarction, cardiac insufficiency, myocarditis, or chronic lung disease;
2. Patients with long-term alcohol consumption and those unable to ensure regular lifestyle habits during the intervention period;
3. Patients who were unable to ensure that they would carry out the stipulated exercise protocol during the intervention; and
4. Patients with drug modifications during the intervention that could affect the outcome markers.

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: From enrollment to the end of 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Taiyuan Cardiac Rehabilitation Center
state: Shanxi
Study officials:
References:
Clinical trial NCT04970004: Study in Adult and Pediatric Patients With HSCT-TMA
Official title: A Retrospective Observational Study of Adult and Pediatric Patients With Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplant (HSCT)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stem Cell Transplant Complications
Thrombotic Microangiopathies
Keywords: Hematopoietic Stem Cell Transplant
Transplant-associated TMA
Thrombotic Microangiopathy (TMA)
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients who were diagnosed with TMA within 6 months after a HSCT procedure

Brief summary: This is an observational, retrospective study designed to assess outcomes in patients diagnosed with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who were not treated with complement component (C5) inhibitor therapy. Data required to evaluate study outcomes will be abstracted from the medical records of all patients who meet study eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Body weight ≥ 5 kg at the time of HSCT-TMA diagnosis
* Documented TMA diagnosis within 6 months from the HSCT
* Evidence of renal dysfunction
* Presence of hypertension

Exclusion Criteria:

* History or presence of familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity \< 5%)
* Shiga toxin-related hemolytic uremic syndrome (ST-HUS)
* Positive direct Coombs test
* Diagnosis of disseminated intravascular coagulation
* History or presence of bone marrow/graft failure
* Diagnosis of veno-occlusive disease
* Received a complement inhibitor (eg, eculizumab) post-HSCT through 12 months post TMA diagnosis

Primary outcomes:
measure: Proportion of patients achieving TMA Response
timeFrame: During the 26-week period after HSCT-TMA diagnosis
Secondary outcomes:
measure: Proportion of patients achieving TMA response
timeFrame: During the 52-week period after HSCT-TMA diagnosis
measure: Changes in individual components of TMA response
timeFrame: From baseline to 26 weeks and to 52 weeks after HSCT-TMA diagnosis
measure: Overall survival
timeFrame: At 26 weeks and 52 weeks after HSCT-TMA diagnosis
measure: Nonrelapse mortality
timeFrame: At 26 weeks and 52 weeks after HSCT-TMA diagnosis
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Clinical Trial Site
state: Utah
Study officials:
References:
Clinical trial NCT00803504: Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
Official title: Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open Angle Glaucoma
Keywords: optic disc morphology
ocular blood flow
retina
ocular physiology
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. It is, however, assumed that vascular factors do not contribute to same degree in all glaucoma patients. Generally, it is believed that a vascular component is more important in normal tension glaucoma patients and patients with underlying cardiovascular disease. Little is, however, known about a potential association between optic nerve head morphology and ocular perfusion in POAG patients. The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years
* Unilateral or bilateral primary open angle glaucoma
* At least 3 reliable visual field tests showing CPSD \>= 2.0 in the eye that will be studied

Exclusion Criteria:

* History of acute angle closure
* Closed or barely open anterior chamber angle
* Standard deviation of visual field testing \> 10
* Intraocular surgery or argon laser trabeculoplasty within the last six months
* Ocular inflammation or infection within the last three months
* Topical or systemically/oral therapy with steroids

Primary outcomes:
measure: Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry)
measure: Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer)
measure: Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry)
measure: Optic nerve head morphology parameters
measure: Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265,
measure: Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62,
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Deparmtent of Clinical Pharmacology
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhöfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503204: Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
Official title: A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Glioblastoma
Brain Tumor
Keywords: cancer
tumor
advance solid tumour
glioblastoma
malignant brain tumour
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.


Eligibility criteria: Inclusion Criteria:

* Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis \& stage
* Patients received no more than 2 previous systemic chemotherapy regimes
* Life Expectancy \> 12 weeks
* Patients must be at least 3 months from the completion of cranial radiation therapy

Exclusion Criteria:

* History of poorly controlled high blood pressure
* Recent major surgery prior to entry into the study

Primary outcomes:
measure: Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
timeFrame: Assessed at each visit
Secondary outcomes:
measure: Compare the pharmacokinetics of cediranib alone versus when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min) steady-state plasma concentration
timeFrame: assessed 2 & 4 hours post dosing
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Tracy Batchelor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02006004: Epidemiologic Registry PETHEMA LMA 2013
Official title: Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2013)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AML
Keywords: AML
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute myeloid leukemia

Brief summary: Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary AML in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach

Detailed description: To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases with the appropriate security.

Eligibility criteria: Inclusion Criteria:

Patients diagnosed with acute myeloid leukemia

Exclusion Criteria:

no exclusion criteria

Primary outcomes:
measure: Characteristics of the patients diagnosed with AML
timeFrame: 3 years
Secondary outcomes:
measure: Prognosis factors
timeFrame: 3 years
measure: Risk factors
timeFrame: 3 years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital La Fe
name: Sanz Miguel Angel, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02033304: Factors Predicting Postoperative Cesarean Section Pain
Official title: Analysis of Factors Predicting Postoperative Pain and Wound Hyperalgesia After Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Cesarean section
Pain
Wound hyperalgesia
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 229
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women after cesarean section

Brief summary: In spite of identical analgesic protocols, parturients suffer different levels of pain postoperative lay. In this study we hope to identify factors which influence the perception of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.


Eligibility criteria: Inclusion Criteria:

* Women undergoing spinal anesthesia

Exclusion Criteria:

* women unable to cooperate
* Women undergoing general anesthesia

Primary outcomes:
measure: Postoperative pain
timeFrame: Postoperative day1
Secondary outcomes:
Other outcomes:
Locations:
city: Petach tikvah
country: Israel
facility: Beilinson hospital
city: Petach tikvah
country: Israel
facility: Rabin medical center
Study officials:
References:
Clinical trial NCT01470404: Pharmacogenomic Study (Adjuvant Chemotherapy)
Official title: Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients enrolled on to the adjuvant trial will be considered as candidates for the study. Once the patient signed written informed consent, 10cc blood will be drawn in EDTA tube for DNA extraction.

Brief summary: To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile.

To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* gastric cancer patients treated with adjuvant chemotherapy

Exclusion Criteria:

Primary outcomes:
measure: germline polymorphisms in xenobiotic metabolism genes in toxicity profile
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: won ki kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995904: Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Official title: A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthmatic children
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
First posted: 2009-10-15
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.


Eligibility criteria: Key Inclusion Criteria:

1. Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH \[EPR\] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
2. Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
3. Body weight \>=45 lbs, body mass index (BMI) \<=30 kg/m2
4. ICS users had to have been taking an ICS for \>=3 months and on a stable dose for \>= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration,
5. Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

Key Exclusion Criteria:

1. Females of child-bearing potential/menarche.
2. Diagnosis of any other significant chronic illness or abnormality.
3. Use of corticosteroids

Primary outcomes:
measure: Cmax of Budesonide After Administration of MAP0020
timeFrame: 12 hours
measure: AUC(0-inf) of Budesonide After Administration of MAP0020
timeFrame: 12 hours
measure: Half-life (t1/2) of Budesonide After Administration of MAP0020
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials LLC
state: California
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
Study officials:
affiliation: Sylvana Research Associates
name: Paul Ratner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Coast Clinical Trials LLC
name: Ammar Hatab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03195504: High-flow Nasal Oxygenation in Obese Patients During Apnea
Official title: Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apneic Oxygenation
High-flow Nasal Cannulae
Bariatric Surgery
Anesthesia Induction
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consented patients will be randomly assigned either to the interventional group (High Flow Nasal Cannula- HFNC) or to the control group (CON). The Group HFNC will be preoxygenated using HFNC and the Group CON will receive standard preoxygenation.
Primary purpose: TREATMENT

Brief summary: Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.


Eligibility criteria: Inclusion Criteria:

* Age more than18 years old
* ASA status I-III
* Elective surgery performed under general anesthesia requiring endotracheal intubation
* BMI more than 40 kg/m2

Exclusion Criteria:

* Chronic respiratory disease
* SpO2 \<98% after supplementing oxygen
* Previous or anticipated difficult intubation
* Uncontrolled hypertension
* Ischemic heart disease
* Congestive heart failure
* Increased intracranial pressure
* Uncontrolled GERD
* Known allergy or contraindication to anesthesia drugs
* Nasal blockade contraindicating the use of HFNC

Primary outcomes:
measure: Measurement of safe apnea time
timeFrame: Maximum up to 6 minutes
Secondary outcomes:
measure: Highest EtCO2
timeFrame: Every minute up to 5 minutes on commencing ventilation
measure: Lowest SpO2
timeFrame: Every minute up to 5 minutes after intubation
measure: Time to regain baseline SpO2
timeFrame: Up to 5 minutes after intubation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
citation: Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.