linjc16/ctgov huggingface dataset:
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.

Official Title
-----------------
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Drug: Psilocybin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression Exclusion Criteria: Comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Psilocybin<br>25mg of Psilocybin | Drug: Psilocybin<br>* Open-label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score | From Baseline (Day -1) to three weeks post-dose. |
Evaluation of Low Dose Laser in Treatment of Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.

Official Title
-----------------
Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus

Conditions
-----------------
Subjective Tinnitus

Intervention / Treatment
-----------------
* Radiation: Low dose laser
* Radiation: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults older than 18 years old Idiopathic, subjective, unilateral tinnitus with at least 2 month duration Exclusion Criteria: Patients with chronic otitis media Patients with tympan perforation with any underlying cause Patients with external otitis Patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser group<br> | Radiation: Low dose laser<br>* 5mv laser with a wavelength of 650nm<br>|
| Placebo Comparator: Placebo group<br>Randomly,half of the patients receive placebo. | Radiation: Placebo<br>* The act of radiating laser to the ear is done while the set is off.<br>|

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
-----------------
Tinnitus, Low power laser
Elecsys HE4 Chinese Reference Value Study

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.

Official Title
-----------------
A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (all cohorts): appropriate clinical data normal appearance of sample minimum 0.5 ml volume available Exclusion Criteria (all cohorts): < 18 years of age insufficient volume insufficient clinical information > 3 freeze/thaw cycles of samples Stored or shipped at > 0°C Icteric, lipemic, hemolytic, substantial particulates

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apparently healthy subjects<br> | |
| Non-malignant conditions subjects<br> | |
| Malignant conditions subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish reference in Chinese population |  | October 2012 - March 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian cancer, HE4, normal range
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

Detailed Description
-----------------
Retrospective analysis of all patients receiving TAVI in the UK. Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts. Factors to be examined include (but not limited to): need for Pre-procedure Balloon aortic Valvuloplasty (BAV) Need for two valves need for post-dilatation need for rapid ventricular burst pacing

Official Title
-----------------
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke Rates in the United Kingdom

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Procedure: Balloon Aortic Valvuloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had TAVI procedure in UK Exclusion Criteria: Nil

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-TAVI Balloon Aortic Valvuloplasty<br>This is the cohort of patients in the study who did receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation | Procedure: Balloon Aortic Valvuloplasty<br>* Some patients receive BAV prior to TAVI implantation to facilitate better deployment of the TAVI valve<br>|
| No Pre-TAVI Balloon Aortic Valvuloplasty<br>This is the cohort of patients in the study who did not receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | Stroke, defined as new neurological deficit with corresponding change on CT scan of brain, is a self reported event following TAVI. All centres performing TAVI in the United Kingdom are required to report this to the National Institute for Cardiovascular Outcomes Research (NICOR) registry which is being analysed in this study | 30 days |
Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma

Study Overview
=================
Brief Summary
-----------------
The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression

Detailed Description
-----------------
Glioblastoma is the most common malignant primary brain tumor in adults, and despite aggressive treatment, it is incurable Patient prognosis differs considerably within the different World Health Organization (WHO) grades, poorest prognosis for patients with the grade IV tumour- the glioblastoma multiform (GBM). Fibrinogen-like protein 2 (FGL2),regulates both innate and adaptive immunity. FGL2 is a 439 amino acid secreted protein that is similar to the β- and γ-chains of fibrinogen. Secreted FGL2 (sFGL2) is the key regulator in immunosuppression may play important role in malignant transformation of low to high by inhibiting the proliferation of T cell Study the role of fibrinogen-like protein2 on Immunosuppression and progression ，free survival and overall survival in high grade glioma

Official Title
-----------------
Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma

Conditions
-----------------
Brain Tumor Adult

Intervention / Treatment
-----------------
* Genetic: FGL2 immunohisyochemistry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pateints>18 years old Pathologically proven high grade glioma Total or subtotal resection of the tumor Patients received concurrent radiation therapy with temozolomide followed by adjuvant temozolamide for 6 months Exclusion Criteria: Pregnancy Breast feeding Other comorbidity Previous malignancy or radiation therapy or chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: FGL2 immunohisyochemistry|Correlation between FLG2 expression and progression free survival and overall surviv|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rple of FGL2in high grade glioma as aprognostic factor | Correlation between FLG2 expression and progression free survival and overall survival | baseline |
A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

Detailed Description
-----------------
The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.

Official Title
-----------------
A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Galantamine
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS < 16; MADRS < 16 Exclusion Criteria: Current substance dependence; serious unstable medical conditions; active suicidal ideation; current DSM-IV for a major mood episodes; history of COPD, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet DSM-IV criteria for dementia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-Blind Galantamine vs Placebo<br>Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction | Drug: Galantamine<br> <br> |
| Placebo Comparator: Placebo Control Group<br>Placebo-Controlled Group | Drug: Placebos<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function |  | 6 Months |
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Detailed Description
-----------------
Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Official Title
-----------------
Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin

Conditions
-----------------
Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: Cefmetazole (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on) Elective colorectal resection Exclusion Criteria: Emergent operation Ileus No resection Preoperative infectious diseases Penicillin or cephalosporin allergy Antibiotics administration before surgery Inflammatory bowel diseases Angina or myocardial infarction Renal dysfunction Diabetes mellitus Steroid administration before surgery

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cefmetazole (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of incisional surgical site infection (SSI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotics, Prophylaxis, Surgical wound infection
Natural History Study and Establishment of a Biorepository-TANGO2-related Disorder

Study Overview
=================
Brief Summary
-----------------
The study aims to establish a biorepository of individuals with TANGO2 deficiency to support scientific research and establish a comprehensive clinical database of affected individuals to understand the disease course.

Detailed Description
-----------------
TANGO2-related disorder is a rare autosomal recessive genetic disorder that can cause recurrent rhabdomyolysis and life-threatening cardiac arrhythmias. Metabolic crises can be triggered by prolonged fasting and dehydration. Intellectual disability, seizures, hypothyroidism, and gait abnormalities are observed frequently. The function of TANGO2 is unknown and the pathogenesis of this disease is poorly understood. Understanding disease mechanism requires studying disease cells/samples and thus establishing a biobank of tissues (blood and fibroblasts) of individuals affected with TANGO2 deficiency is paramount. Natural History Study of TANGO2-related disorder will allow investigators to understand the course of the disease and develop new therapies in the future to decrease morbidity associated with this genetic condition.

Official Title
-----------------
Natural History Study and Establishment of a Biorepository-TANGO2-related Disorder

Conditions
-----------------
TANGO2-related Disorder

Intervention / Treatment
-----------------
* Genetic: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with pathogenic TANGO2 variants will be included. Exclusion Criteria: Patients who do not have TANGO2-related disease will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 0 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with TANGO2 deficiency<br>Individuals with TANGO2 deficiency known to have disease causing variants in TANGO2 | Genetic: Observation<br>* Retrospective and prospective Natural History Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with metabolic and cardiac crisis assessed by the number of hospitalizations | Detailed interview with participants and review of medical records will be used to assess the frequency and triggers of metabolic and cardiac crises | 10 years |
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor

Study Overview
=================
Brief Summary
-----------------
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st & 2nd complete remission w/no HLA matched related donor

Official Title
-----------------
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor

Conditions
-----------------
Leukemia, Monocytic, Acute

Intervention / Treatment
-----------------
* Drug: Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with AML in 1st & 2nd complete remission w/no HLA matched related donor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Drug: Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation|Autologous PBSCT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 2009-2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML in 1st & 2nd complete remission w/no HLA matched related donor
Anti-Inflammatory and Anti-Platelet Effect of Clopidogrel and Aspirin vs Aspirin Alone in Symptomatic Polyvascular Disease and in Patients With Multiple Recurrent Cardiovascular Events

Study Overview
=================
Brief Summary
-----------------
This is a monocentric, randomized, opened study to assess the anti-inflammatory and anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular events.

Conditions
-----------------
Polyvascular Disease, Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: aspirin
* Drug: clopidogrel
* Drug: clopidogrel plus aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic polyvascular disease or recurrent cardiovascular events. In particular patients with established stable coronary artery disease associated with peripheral disease or cerebrovascular disease and patients with more than two acute cardiovascular events. Exclusion Criteria: chronic treatment with anticoagulant drugs and the use of other antiplatelet therapy; intolerance/allergy to Aspirin or to Clopidogrel platelet counts outside the range of 125-450 10^9/l inflammatory or infectious disease malignancies or immunologic or hematological disorders.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin<br> | Drug: aspirin<br>* Aspirin (75-100 mg)die for three months<br>|
| Active Comparator: clopidogrel<br> | Drug: clopidogrel<br>* Clopidogrel (75mg) die for three months<br>|
| Active Comparator: clopidogrel plus aspirin<br> | Drug: clopidogrel plus aspirin<br>* clopidogrel 75 mg die plus aspirin 75-100 mg for three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of the present study is to demonstrate the superior antinflammatory effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of levels of selected circulating inflammatory markers |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of the present study is to demonstrate the superior antiplatelet effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of TXA2 serum levels |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptomatic Polyvascular disease, Multiple recurrent cardiovascular events