linjc16/ctgov huggingface dataset:
Effectiveness of MBSR Among Student Teachers

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate the effectiveness of Mindfulness-based Stress Reduction among Danish student teachers on their mental well-being. The study is a randomised, controlled trial including 100 teachers.

Official Title
-----------------
Effectiveness of Mindfulness-based Stress Reduction Among Student Teachers

Conditions
-----------------
Stress Reduction, Mental Well-being

Intervention / Treatment
-----------------
* Behavioral: MBSR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Danish student teacher Exclusion Criteria: acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia abuse of alcohol, drugs, medicine
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR<br>MBSR according to international standards (2.5 hours group session once a week in 8 weeks; a silence retreat day; and 45-60 minutes homework six days a week). Content in accordance with MBSR curriculum. | Behavioral: MBSR<br>* Described previously<br>|
| No Intervention: Wait-list control<br>Usual practice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | Change in perceived stress among the student teachers | 2 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale | Change in resilience among the student teachers | post MBSR (8 weeks from baseline) | 
| Symptom Check List - 5 | Change in symptoms of anxiety and depression among the student teachers | post MBSR (8 weeks from baseline) | 
| WHO-5 | Change in well-being among the student teachers | post MBSR (8 weeks from baseline) | 
| Five Facet Mindfulness Questionnaire-15 | Change in mindfulness among the student teachers | post MBSR (8 weeks from baseline) | 
| Amsterdam Resting State Questionnaire | Change in resting state among the student teachers | post MBSR (8 weeks from baseline), 6 and 12 months from baseline |
Changes of Parameters of Transcranial Magnetic Stimulation in Patients With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
CNS reorganization is evidenced in patients with CNS lesion, no exception to the patients with spinal cord injury. The paraplegics have to increase their loading of upper extremities to compesate the lost function of lower extremities. We hypothesize that CNS reorganization can happen in the chronic paraplegics. We try to compare the changes of parameters of transcranial magnetic stimulation in these patients with the normal population cross-sectionally.

Official Title
-----------------
Reorganization of Cortical Motor Activation in Patients With Spinal Cord Injury: a Study of Motor Evoked Potential

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with complete thoracic spinal cord injury onset > 6 months ASIA scale: A normal bilateral upper extremities Exclusion Criteria: Evidence of brain injury Evidence of peripheral neuropathy Active major medical diseases (eg: fever, maligancies, DM, liver or kidney diseases)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Study Overview
=================
Brief Summary
-----------------
Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures. Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.

Official Title
-----------------
Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Conditions
-----------------
Sleep Disorder, Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, Mahidol University Exclusion Criteria: Unstable medical conditions Known psychiatric disease Patients who could not withhold sedative drugs Pregnant patients Obese patients with body mass index (BMI) ≥ 35 kg/m2 Refuse to sign a consent/ had cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality | PSQI (Pittsburg sleep questionaire index) scores at first day then every month. PSQI contains ten questions, scoring provides sleep duration, latency, disturbance, efficiency, and quality. Total PSQI score of > 5 indicates poor sleep quality. | 12 months | 
| Objective sleep quality | Sleep efficiency (percentage of total sleep time compared to time-in-bed) provided by ambulatory wrist actigraphy on first seven consecutive days and at 12-month period. Score less than 85% is considered poor sleep quality. | 12 months |
Multi-disease Carrier Screening Test Validation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect blood samples to enable validation of genetic testing for diseases within a multi-disease carrier screening panel. Samples will be collected from adult women or men who have previously tested positive as carriers for various recessive conditions. These are healthy adults who carry a mutation that might place them at increased risk of having a child with a specific genetic disorder. Study participation will be open to adults that were previously tested as part of their routine medical care and where test results demonstrated positive carrier status for a specific genetic disease. Samples will be tested for the disease mutation for which the subjects provides documentation of prior testing.

Official Title
-----------------
Collection of Blood Samples for Development of Multi-disease Carrier Testing

Conditions
-----------------
Spinal Muscular Atrophy (SMA), Carrier Screening, Genetic Testing

Intervention / Treatment
-----------------
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Individuals who are carriers of an SMN1 deletion consistent with Spinal Muscular Atrophy carrier status and are able to provide documentation of carrier status determined from prior testing Able to provide a blood sample Pregnant women may be include in the study Exclusion Criteria: Minors under the age of 18 years Individuals who are not carriers of a Spinal Muscular Atrophy mutation Individuals who are unable to provide documentation of Spinal Muscular Atrophy carrier status.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood draw|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular Atrophy (SMA), Carrier Screening, Genetic Testing
Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

Study Overview
=================
Brief Summary
-----------------
The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.

Official Title
-----------------
Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: pegylated Somatropin
* Drug: pegylated Somatropin
* Drug: Jintropin AQ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA); be in preadolescence (Tanner stage 1) and have a CA >3 years; have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV; receive no prior GH treatment. sign informed consent Exclusion Criteria: patients with severe cardiopulmonary patients with hematological diseases a current or past history of malignant tumors immunodeficiency diseases mental diseases patients positive for hepatitis B e-antibody (HBeAb) hepatitis B surface antigen (HBsAg) hepatitis B e antigen (HBeAg) patients with other growth disorders, such as Turner syndrome constitutional delay of growth and puberty, and Laron syndrome
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegylated Somatropin|0.1 mg/kg/wk once a week for 25 weeks|
|Drug: pegylated Somatropin|0.2 mg/kg/wk once a week for 25 weeks|
|Drug: Jintropin AQ|0.25 mg/kg/wk, once a day for 25 weeks|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth velocity |  | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height standard deviation score for chronological age (Ht SDSCA) |  | 25 weeks | 
| IGF-1 |  | 25 weeks | 
| IGFBP3 |  | 25 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pegylated Somatropin, PEG-GH, Growth hormone, PEG-rhGH, Growth hormone deficiency (GHD), Phase 2 study
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.

Official Title
-----------------
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Conditions
-----------------
Peripheral Arterial Disease, Critical Limb Ischemia

Intervention / Treatment
-----------------
* Device: Retrograde tibiopedal arterial access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a totally occluded infrainguinal artery, due to peripheral arterial atherosclerotic disease, for which a previous attempt to cross the occlusion using an antegrade approach was unsuccessful. For institutions where tibiopedal access is performed as a primary standard-of-care procedure, a prior unsuccessful antegrade approach attempt is not required. Exclusion Criteria: Patient will not sign the Informed Consent
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrograde access<br> | Device: Retrograde tibiopedal arterial access<br>* Retrograde, percutaneous arterial access of vessels at or below the tibioperoneal trunk, using a 21 gage needle or micropuncture introducer set, to facilitate crossing and treatment (e.g., angioplasty, stenting, atherectomy) of occlusive arterial lesions in the lower limb.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success deeming tibial pedal arterial access |  | 1 - 4 hours post-procedure. |
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.

Official Title
-----------------
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_RT Trial)

Conditions
-----------------
Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Hypofractionated Dose

Intervention / Treatment
-----------------
* Radiation: POHIM-RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed cervical cancer radical hysterectomy and pelvic lymph node dissection was done histologically indicated adjuvant radiotherapy ( more than one as below) tumor size ≥4 cm positive lymphovascular invasion more than half stromal invasion depth ECOG performance status 0 or 1 Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl Exclusion Criteria: positive pelvic lymph node metastasis positive distant metastasis (including retroperitoneal lymph node metastasis) positive tumor involvement on resection margin positive parametrial invasion previous history of pelvic radiotherapy more than 3 months after radical surgery for cervical cancer neoadjuvant chemotherapy was done previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: One group for hypofractionaed IMRT for adjvuant cervical cancer patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POHIM-RT<br>adjuvant hypofractionated IMRT for cervical cancer patients | Radiation: POHIM-RT<br>* postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute toxicities according to CTCAE v4.0 | evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late toxicities according to CTCAE v4.0 | evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0 | 5-years | 
| Progression free survival rate | progression free survival rate after the time of surgery | 5-years |
Tolerance and Pharmacokinetics Study of MNTX Tablets

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Official Title
-----------------
A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

Conditions
-----------------
Normal Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Oral methylnaltrexone
* Drug: Oral placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight between 55 and 85 kg In good health with no evidence of a clinically significant chronic medical condition Non-Smokers. Exclusion Criteria: History of asthma, allergic skin rash, significant allergy or other immunologic disorder Known or suspected hypersensitivity to opioids or opioid antagonists History or suspicion of alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Oral methylnaltrexone | Drug: Oral methylnaltrexone<br> <br> |
| Experimental: Arm 2<br>Oral methylnaltrexone | Drug: Oral methylnaltrexone<br> <br> |
| Experimental: Arm 3<br>Oral methylnaltrexone | Drug: Oral methylnaltrexone<br> <br> |
| Placebo Comparator: Arm 4<br>Oral placebo | Drug: Oral placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days | 
| Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days | 
| Half-life of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days |
Prospective Cohort Study of Outcome After Minimally Invasive Posterior Cervical Spine Surgery

Study Overview
=================
Brief Summary
-----------------
In case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF) and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF. Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no comparative study. The primary object of the study is to compare radiological outcome (segment angle) after MTPF or P-PECD.

Detailed Description
-----------------
P-PECDs are performed in Seoul National University Hospital MTPFs are performed in Kyoung-Pook National University Hospital and ACDF are performed in Seoul National University Bundang Hospital.

Official Title
-----------------
Prospective Cohort Study of Outcome After Minimally Invasive Posterior Surgery (Posterior Percutaneous Endoscopic Foraminotomy or Tubular Retractor Assisted Micro-foraminotomy) for Single Level Cervical Foraminal Stenosis

Conditions
-----------------
Spinal Curvature

Intervention / Treatment
-----------------
* Procedure: surgical procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical radicular pain no cervical myelopathy Exclusion Criteria: motor weakness less than MMT Gr III cervical myelopathy OPLL and myelopathy previous cervical spine surgery combined fracture or spinal tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PECD<br>percutaneous endoscopic cervical foraminotomy | Procedure: surgical procedure<br> <br> |
| MTPF<br>microscopic tubular retractor assisted foraminotomy | Procedure: surgical procedure<br> <br> |
| ACDF<br>anterior cervical discectomy and fusion | Procedure: surgical procedure<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of segmental angle |  | postoperative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time |  | postoperative 1 year | 
| neck/arm pain |  | postop 1 year | 
| neck disability, index |  | postop 1 year | 
| cervical curvature |  | postop 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscope, cervical vertebra, surgery, tubular retractor