linjc16/ctgov huggingface dataset:
Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

Study Overview
=================
Brief Summary
-----------------
In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.

Official Title
-----------------
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Conditions
-----------------
Thrombophilia With Recurrent Pregnancy Loss

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form. Exclusion Criteria: having experiencedsevere allergies, trauma history and/or operation history within 3 months with a history of mental illness and/or family history of mental illness limb disabled taking medicine within one month suffering major events or having mood swings with a history of recurrent pregnancy loss having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine) Chromosome aberrations in anyone of the couple. patients who have drug contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin group<br>low dose aspirin, 75-100mg, bid, after pregnancy | Drug: Aspirin<br> <br> |
| Experimental: low molecular weight heparin group<br>low molecular weight heparin, 4100u, qd, after pregnancy | Drug: Heparin<br> <br> |
| Experimental: combination group<br>low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy | Drug: Aspirin<br> <br> Drug: Heparin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-Dimer |  | through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI in kg/m^2 |  | through study completion, an average of 3 year |
In Stent ELUTES Study

Study Overview
=================
Brief Summary
-----------------
This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.

Official Title
-----------------
ELUTES II - In Stent ELUTES Study

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: drug eluting coronary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has given informed consent Patient has target lesion in native coronary artery or coronary bypass graft Patient has in-stent restenosis >60% Patient has reference artery diameter 2.7-3.5 Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months. Exclusion Criteria: Patient is less than 18 years of age Patient is pregnant or breast feeding Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study. Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: drug eluting coronary stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic target vessel failure (TVF) at follow up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events |  |  | 
| Target lesion revascularization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery, stent, drug eluting, patency, restenosis
Correlation Study Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers

Study Overview
=================
Brief Summary
-----------------
Traditionally, the more severity of dementia patients, the heavier the burden of the comparators, and in the clinical observation,the dementia patients with rich mental behavior symptoms are more burdened. Therefore, exploring the impact of psychological burden and different subtypes of different dimensions with Behavioral and psychological symptoms (BPSD) will more comprehensive understanding of the factors affecting the burden of caregivers. The starting point of this project is to analyze the relationship between the types of mental behavior symptoms of dementia patients and the emotional disorders of caregivers. The topic will analyze the correlation of psychological burden of caregivers and different symptom dimensions from the perspective of refinement, helping more effective identifying high-burden mental behavior symptoms in clinically , judging the risk of emotional problems in caregivers, and adopting better humanities or medical care, so that dementia patients can better adapt to care and improve the mental health of caregivers.

Official Title
-----------------
Correlation Analysis Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: Cross section resaerch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age is greater than 18 years old, gender is not limited Comply with ICD-10 diagnostic criteria, diagnosed with dementia, including Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy body, dementia caused by Parkinson's disease Exclusion Criteria: senile schizophrenia; senile depression; cognitive impairment caused by endocrine system diseases (such as decreased thyroid and adrenal function); Cognitive impairment or dementia caused by serious diseases such as cardiovascular, lung, liver, kidney, and hematopoietic system; Cognitive impairment or dementia caused by alcohol, drug use, psychotropic drugs; 6）Other physical or chemical factors that cause cognitive impairment or dementia-

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dimensions with Behavioral and psychological symptoms<br> | Other: Cross section resaerch<br>* Assessment of cognitive (MoCA), mental behavioral symptoms (NPI） the Self-rating Depression Scale (SDS) and the Self-rating Anxiety Scale (SAS).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric inventory questionnaire | Behavioral and psychological symptoms | baseline |
Life Satisfaction and Psychopathology in Institutionalized Elderly People

Study Overview
=================
Brief Summary
-----------------
The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several selfreport questionnaires and were assessed with Mini Mental State Examination. Participants attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48 sessions (16 weeks) and Participants were evaluated before and after the intervention.

Official Title
-----------------
Life Satisfaction and Psychopathology in Institutionalized Elderly People: The Results of an Adapted Mindfulness-Based Stress Reduction Program

Conditions
-----------------
Anxiety Depression (Mild or Not Persistent)

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Stress Reduction (MBSR) program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: literacy age above 65 years Exclusion Criteria: presence of cognitive or sensorial impairment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 institutionalized elderly people<br>Mindfulness-Based Stress Reduction program. | Behavioral: Mindfulness-Based Stress Reduction (MBSR) program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression levels assessed with the GDS | GDS; Geriatric Depression Scale; Greenberg et al., 2005 | Pre-test and Post-test (4 months later) | 
| Change in anxiety levels assessed with the DASS-21 | DASS-21; Depression Anxiety Stress Scale; Lovibond e Lovibond, 1995 | Pre-test and Post-test (4 months later) | 
| Change in experiential avoidance levels assessed with the AAQ-II | AAQ-II; Acceptance and Action Questionnaire; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz e Zettle, 2011 | Pre-test and Post-test (4 months later) | 
| Change in subjective pain levels assessed with the Faces Scale | Faces Scale; Wong et al., 2001 | Pre-test and Post-test (4 months later) | 
| Change in life satisfaction levels assessed with the SWLS | SWLS; Satisfaction with Life Scale; Diener et al., 1985 | Pre-test and Post-test (4 months later) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Mindfulness, Psychopathology
Post-op Ketamine Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.

Official Title
-----------------
Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Drug: Isotonic saline
* Drug: Ketamine Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 85 years of age ASA I - IV Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia Exclusion Criteria: BMI over 40* Contraindication or allergy to opioid pain medication or ketamine* Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg* Ejection fraction (EF) less than 30% Creatinine clearance less than 30 mL/min* History of chronic liver failure Desire for nerve block or general anesthesia Any neurologic or psychiatric disorder (including bipolar disorder, post traumatic stress disorder, schizophrenia) Prior surgery on ipsilateral knee within the last 6 months Alcohol abuse

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Isotonic saline<br>* Placebo<br>|
| Active Comparator: Ketamine<br> | Drug: Ketamine Injectable Solution<br>* Active comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as reported on Visual Analog Scale | VAS pain reported 0-100mm | Up to 6 weeks post-operatively |
A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

Study Overview
=================
Brief Summary
-----------------
This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type

Detailed Description
-----------------
IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.

Official Title
-----------------
An Open-label, Single-arm, Global Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

Conditions
-----------------
Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK/T-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: IMC-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ENKTL diagnosis; Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type At least 1 previous line of systemic therapy Documented disease progression of last therapy Adult age(as defined by respective country) The nature of the study and voluntarily sign an ICF ECOG 0 or1 Adequate hematologic function, hepatic function, and renal function Exclusion Criteria: Previously treated with an anti-PD-L1 or anti-PD-1 antibody Known presence of symptomatic CNS metastases Prior allogeneic HSCT or solid organ transplantation Any active autoimmune disease or a documented history of autoimmune disease Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus Pregnant or lactating

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMC-001<br>Single Dose level (IMC-001 20mg/kg, every 2 weeks) | Drug: IMC-001<br>* Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)<br>* Other names: Not confirm yet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Objective Response Rate(ORR) | Lugano criteria with LYRIC modification | 1 year (Not confirmed yet) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IMC-001, IMC-001-201, DISTINKT
Intravitreous CytokinE Level in pAtient With retiNal Detachment

Study Overview
=================
Brief Summary
-----------------
Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis. Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines. RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.

Official Title
-----------------
Intravitreous CytokinE Level in pAtient With retiNal Detachment

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary retinal detachment requiring vitrectomy Patients with idiopathic macular hole requiring vitrectomy Exclusion Criteria: History of retinal detachment or intraocular inflammatory diseases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Patients undergoing vitrectomy for primary retinal detachment | Procedure: Vitrectomy<br>* Pars plana vitrectomy<br>|
| Control<br>Patients undergoing vitrectomy for idiopathic macular hole | Procedure: Vitrectomy<br>* Pars plana vitrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravitreous cytokine levels |  | up to one month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal detachment, Photoreceptor apoptosis, Cytokine
the Related Factors of Bariatric Surgery on Bone Mineral Density

Study Overview
=================
Brief Summary
-----------------
Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise. In this study, prospective randomized controlled trials were conducted to explore the possible causes of bone mineral after bariatric surgery and to explore ways to prevent bone mineral after bariatric surgery.

Official Title
-----------------
The Impact of Bariatric Surgery on Estimated Bone Mineral Density in Chinese Obesity Patients: a Retrospective Cohort Study

Conditions
-----------------
Bone Mineral, Bariatric Surgery

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy
* Procedure: gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI <45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In our country, the BMI less than 45 is majorities. Exclusion Criteria: -BMI<27.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bone density<br>bone density | Procedure: sleeve gastrectomy<br>* sleeve gastrectomy<br>Procedure: gastric bypass<br>* gastric bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative of bone density | bone density in g/cm3 | Preoperative | 
| Postoperative of bone density at 3 months | bone density in g/cm3 | 3 months | 
| Postoperative of bone density at 6 months | bone density in g/cm3 | 6 months | 
| Postoperative of bone density at 1 year | bone density in g/cm3 | 1 year |