louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01874912: Human Irisin Concentration in Sarcopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 406
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in Korean Sarcopenic Obesity Study (KSOS), an prospective observational cohort study designed to examine the prevalence of sarcopenia and sarcopenic obesity in Korean adults and to evaluate their effects on metabolic disorders and health outcomes.

Brief summary: Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white adipose tissue. In this cross-sectional study, the researches investigated whether serum irisin levels are decreased in patients with sarcopenia compared with control subjects with normal muscle mass, and assessed the association between serum irisin levels and various metabolic parameters.


Eligibility criteria: Inclusion Criteria:

* 20\<age\<80
* apparently healthy subjects

Exclusion Criteria:

* a history of cardiovascular disease
* diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease

Primary outcomes:
measure: Serum concentration of irisin in the subjects with sarcopenia
timeFrame: 12 week
Secondary outcomes:
measure: The relationship of serum irisin levels with lipid profiles
timeFrame: 12 week
measure: The relationship of serum irisin levels with skeletal muscle mass index
timeFrame: 12 wks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
citation: Choi HY, Kim S, Park JW, Lee NS, Hwang SY, Huh JY, Hong HC, Yoo HJ, Baik SH, Youn BS, Mantzoros CS, Choi KM. Implication of circulating irisin levels with brown adipose tissue and sarcopenia in humans. J Clin Endocrinol Metab. 2014 Aug;99(8):2778-85. doi: 10.1210/jc.2014-1195. Epub 2014 Apr 29.
Clinical trial NCT03817112: Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation
Official title: The Effect of Continuous Propofol Versus Dexmedetomidine Infusion on Regional Cerebral Tissue Oxygen Saturation During Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Cerebral Tissue Oxygen Saturation
Keywords: cerebral oxygen saturation
cardiopulmonary bypass
dexmedetomidine
propofol
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 50 patients divided into 2 groups

.Group I Dexmedetomidine infusion. Group II with Propofol infusion

Detailed description: : 50 patients anticipated for open heart surgeries were encompassed in the study. Patients were divided into 2 groups, group P (receiving propofol) and group D (receiving dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2 as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score (MMSE) test.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing valve surgeries
* Patients undergoing on pump coronary artery bypass grafting surgeries

Exclusion Criteria:

* emergency cases, patients with cervical spine pathology (cervical stenosis, cervical disc herniation, carotid stenosis), patients with cerebral pathology (cerebral strokes, ischemic attacks), patients with Mini Mental State Examination Score (MMSE) of 23 or less, complicated cases with prolongation of the cardiopulmonary bypass period, patients needing moderate hypothermia

Primary outcomes:
measure: cognitive function assessment
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Cardiothoracic hospital
Study officials:
References:
Clinical trial NCT04096612: The Therapeutic Effect of Dysthyroid Optic Neuropathy
Official title: The Therapeutic Effect of Dysthyroid Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Eye Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.


Eligibility criteria: Inclusion Criteria:

- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months

Exclusion Criteria:

- With any serious systemic diseases With any surgery on eyes in six months

Primary outcomes:
measure: BCVA
timeFrame: 6 months
measure: IOP
timeFrame: 6 months
measure: proptosis
timeFrame: 6 months
measure: upper eyelid retraction
timeFrame: 6 months
measure: CAS
timeFrame: 6 months
Secondary outcomes:
measure: MD
timeFrame: 6 months
measure: PSD
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06105112: Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
Official title: Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a 24-month Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 60
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: To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.


Eligibility criteria: Inclusion criteria:

* Diagnosis of stage III-IV periodontitis.
* Completed steps I-II periodontal therapy.
* FMPS \<15% at 3-month re-evaluation.
* FMBS \<15% at 3-month re-evaluation.
* At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.
* Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral).
* Signed informed consent.

Exclusion criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
* Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers.
* Pregnant or nursing women.
* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.

Primary outcomes:
measure: Clinical attachment level change
timeFrame: 24 months
Secondary outcomes:
measure: Probing pocket depth change
timeFrame: 24 months
measure: Radiographic bone level change
timeFrame: 24 months
measure: Patient reported outcome measures
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References:
Clinical trial NCT00056212: Evaluating Yoga for Chronic Low Back Pain
Official title: Evaluating Yoga for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.

Detailed description: Back problems are among the most prevalent conditions affecting adults and are a leading reason for using complementary or alternative medical (CAM) therapies. Despite the common use of CAM therapies for back pain, little is known about how they compare with conventional treatments. This study will lay the groundwork for a full-scale trial that compares yoga with conventional exercise and usual care for chronic low back pain.

This study will randomize 30 people with chronic low back pain to each of the following groups: yoga, a conventional therapeutic exercise program, and usual care. There will be 12 weeks of weekly treatment and follow-up assessments via phone at 6, 12, and 26 weeks to measure each treatment's impact on symptoms, function, quality of life, and utilization and costs of back pain related care.

Eligibility criteria: Inclusion criteria:

* Group Health Cooperative enrollee
* Uncomplicated low back pain
* At least moderate pain levels

Exclusion criteria:

* Sciatica persisting 3 or more months after physician visit
* History of cancer (other than nonmelanoma skin cancer)
* Severe disk problems
* Unstable medical conditions
* Back surgery within past 3 years
* Physically unable to do the yoga or exercise classes and homework
* Unable to attend classes
* Currently doing yoga
* Taken exercise class for back pain within past year
* Currently in litigation for back pain
* Seeking other treatment for back pain

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
affiliation: Center for Health Studies, Group Health Cooperative
name: Karen J. Sherman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sherman KJ, Cherkin DC, Erro J, Miglioretti DL, Deyo RA. Comparing yoga, exercise, and a self-care book for chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2005 Dec 20;143(12):849-56. doi: 10.7326/0003-4819-143-12-200512200-00003.
Clinical trial NCT02051712: Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure
Official title: Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
exercise training
preferred training
prevention
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2014-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.


Eligibility criteria: Inclusion Criteria:

* women and men
* age 30-75 years
* chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
* disease duration ≥ 6 month
* medical therapy accruing to guidelines (drug, devices, including CRT)
* written informed consent

Exclusion Criteria:

* acute myocarditis
* instable angina
* heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
* severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) \< 6 weeks before study start
* preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
* uncorrected valve regurgitation or stenosis (\> second degree)
* safety concerns regarding or other reasons against exercise training
* severe depression
* regular exercise training within the last 6 weeks
* life expectancy \< 1 year

Primary outcomes:
measure: VO2@AT
timeFrame: Month 9
Secondary outcomes:
measure: Training adherence
timeFrame: 9, 12, 18 and 24 month
Other outcomes:
measure: AE
timeFrame: 9, 12, 18 and 24 month
Locations:
city: Greifswald
country: Germany
facility: Marcus Dörr
Study officials:
affiliation: University Greifswald
name: Marcus Dörr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05007912: Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy
Official title: Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasm
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 100
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: Gastric cancer patients involving the upper stomach

Brief summary: Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy.

Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as gastric adenocarcinoma
* Involving the esophagogastric junction or gastric cardia
* Age 18 - 80 years
* Anticipated to undergo laparoscopic total or proximal gastrectomy
* cT1-T4a

Exclusion Criteria:

* Previous history of gastrectomy
* Neoadjuvant chemotherapy or radiotherapy for gastric cancer
* Invasion to other organs
* Open conversion

Primary outcomes:
measure: Anastomosis complication
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06023212: Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients
Official title: Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients: a Triple Blinded, Randomized Controlled Trial to Assess the Efficacy of Tranexamic Acid for Hemostasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastasis Spinal Tumor
Keywords: Tranexamic Acid
blood loss
seperation surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Massive blood loss occurs in metastatic spinal tumor resection and may cause severe complications. The objective of this study is to investigate whether the use of tranexamic acid will reduce perioperative and postoperative bleeding when compared to those without use of tranexamic acid.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as metastatic carcinoma of the thoracolumbar spine
* solitary neoplasm involve only one segment of spine
* patients underwent separation surgery

Exclusion Criteria:

* coagulation function was abnormal preoperatively
* patients are allergic to tranexamic acid
* neoplasm involve more than one segment of spine
* patients with rich blood supply who need embolization

Primary outcomes:
measure: total blood loss
timeFrame: measured 3 days postoperatively
measure: Intraoperative blood loss
timeFrame: 1 day (measured once after surgery)
Secondary outcomes:
measure: allogeneic transfusion blood volume
timeFrame: 1 day (measured once during surgery)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT02666612: Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
Official title: Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Cancer
Keywords: Patients
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 2240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic solid tumor
* Age\> 18 years
* Signed consent

Exclusion Criteria:

* Patients with diseases associated with vascular lesions known.
* Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health.
* Mental pathology that can interfere with the proper conduct of the study.
* Refusal of consent.

Primary outcomes:
measure: Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val de Marne
Study officials:
affiliation: Gustave Roussy Cancer Campus
name: Jean Charles Soria, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03592212: Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma
Official title: Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Salbutamol response
Phosphodiesterase 4 variant
lung function
airflow limitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 6-18 years old asthmatic patients consulting in the Department of Pediatric Pulmonology and Allergy of Necker University Hospital.

Brief summary: This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.

Detailed description: Patients from 6 to 18 years old with asthma and receiving a treatment by salbutamol according to the usual care will be recruited. Saliva from patients will be collected using Oragen®.DNA OG-575 kit.

Eligibility criteria: Inclusion Criteria:

* Children 6-18 years
* Asthma: confirmed asthma symptoms (wheeze, cough, dyspnea, chest tightness) and evidence for variable airflow limitation (≥ 12% increase in post bronchodilator FEV1, or ≥ 20% decrease in FEV1 post methacholine)
* Spirometry prescribed for follow-up
* Airflow limitation: FEV1\<80% and/or FEV1/FVC \<80 pre-bronchodilator

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: pre- and post-bronchodilator VEMS value
timeFrame: Day 0
Secondary outcomes:
measure: Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)
timeFrame: Day 0
measure: Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker -Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guillaume LEZMI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: