linjc16/ctgov huggingface dataset:
CTC Detection Rate in SCCHN With a in Vivo Device

Study Overview
=================
Brief Summary
-----------------
Detection rate and isolation yield of CTC is low in squamous cell carcinoma of head and neck (SCCHN) with in vitro approaches rely on limited sample volumes. In this study, we applied a new method, the CellCollector, which could capture CTC in vivo from peripheral blood.

Official Title
-----------------
Enumeration and Molecular Characterization of Circulating Tumor Cells (CTCs) Using a in Vivo Device in Squamous Cell Carcinoma of Head and Neck (SCCHN)

Conditions
-----------------
Circulating Tumor Cell, Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
-----------------
* Diagnostic Test: circulating tumor cell analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SCCHN confirmed with clinical examination Have agreed to undergo CTC analysis in vivo; ECOG：0-2 Exclusion Criteria: the other cancer types

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCCHN<br>squamous cell carcinoma of the head and neck | Diagnostic Test: circulating tumor cell analysis<br>* Detect circulating tumor cells with CellCollector in SCCHN and control group.<br>|
| Experimental: Control<br>health volunteers | Diagnostic Test: circulating tumor cell analysis<br>* Detect circulating tumor cells with CellCollector in SCCHN and control group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTC isolation | Isolate circulating tumor cells in vivo with CellCollector | 9 month |
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Official Title
-----------------
CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Dimebon
* Drug: Dimebon
* Drug: Placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild-to-moderate Alzheimer's disease (AD) Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR)) Mini-Mental State Examination (MMSE) score between 12 and 24, inclusive Stable on donepezil for at least 6 months Exclusion Criteria: Other causes of dementia Major structural brain disease Unstable medical condition or significant hepatic or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dimebon, 5 mg orally three times daily | Drug: Dimebon<br>* 5 mg orally three times daily<br>|
| Experimental: 2<br>Dimebon, 20 mg orally three times daily | Drug: Dimebon<br>* 20 mg orally three times daily<br>|
| Placebo Comparator: 3<br>Placebo orally three times daily | Drug: Placebo comparator<br>* Placebo orally three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) |  | Week 52 | 
| Alzheimer's Disease Assessment Scale - Cognitive Subscale |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) |  | Week 52 | 
| Neuropsychiatric Inventory (NPI) |  | Week 52 | 
| Resource Utilization in Dementia Lite (RUD lite) |  | Week 52 | 
| Euro Quality of Life 5 (EQ-5D) |  | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, clinical trial, mitochondria, memory loss, neurodegenerative disease, dementia, investigational drug
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis

Study Overview
=================
Brief Summary
-----------------
Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis

Detailed Description
-----------------
Abstract Introduction:- dialysis is one of the technological innovation in medicine in which patients are being reported to face psychosocial and physiological problems such as anxiety, stress and hypertension etc. To relieve these problems, music therapy has been widely used as a non-pharmacological intervention with the aim to assess the effectiveness of music therapy on blood pressure and anxiety among haemodialysis patients. Methods:- current study using true experimental pre-test post-test design was conducted among 60 haemodialysis patients which were randomly allocated to experimental (30) and control (30) group using simple random sampling. The data was collected through sample characteristics performa, blood pressure monitoring data sheet and beck anxiety inventory. Patients in experimental group were provided with 30 minutes of music therapy using slow and calm relaxing instrumental piano music whereas in control group only usual care was given.

Official Title
-----------------
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Behavioral: music therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to participate in study alert, oriented and able to comprehend, speak and listen Hindi or English language. Exclusion Criteria: altered sensorium hypotension unresponsiveness hearing disabilities

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>music therapy was used in the study for 30 minutes | Behavioral: music therapy<br> <br> |
| No Intervention: control<br>usual care was given to participant in control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beck anxiety inventory | minimum score was 1 and maximum score was 63 | 10 minutes |
The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

Study Overview
=================
Brief Summary
-----------------
High dose aspirin have been shown to increase the level of Methotrexat in patients with Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the purpose of this study is to assess the effect of low dose aspirin on the levels of methotrexate.

Detailed Description
-----------------
Thirty Rheumatoid Arthritis patients currently treated with low dose methotrexate (MTX) will participate in this study. On the day of intake of methotrexate, the patients will receive 10 mg of MTX. Serum levels of MTX will be measured at time 0,30 ,90, 120 minutes, and after 12 and 24 hours. Two weeks later, the patients will be recommended to take 100 mg aspirin/d during a week. The levels of MTX will be measured after a week of treatment in a way similar to a week before.

Official Title
-----------------
The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RApatients treated with Methotrexate Exclusion Criteria: Contraindication to aspirin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate aspirin pharmacokinetics
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Study Overview
=================
Brief Summary
-----------------
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Detailed Description
-----------------
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN. Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.

Official Title
-----------------
A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: teduglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have completed 24 weeks of dosing of the CL0600-020 study Exclusion Criteria: none

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: teduglutide<br>0.05 mg/kg/day | Drug: teduglutide<br>* 0.05 mg/kg/day subcutaneously taken once per day for 24 months<br>* Other names: Gattex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in PN/IV Volume by Visit | The mean change from baseline in weekly PN.IV volume in percent change is shown by visit. | 24 months | 
| Absolute Change in PN/IV Volume by Visit | The mean change from baseline in weekly PN.IV volume in Liters is shown by visit. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving PN/IV Reduction | The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week. | 24 Months or Last Dosing Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
short bowel syndrome, parenteral nutrition, PN, HPN, TPN, SBS
Beta-CIT-SPECT and Neurophysiology in Depression

Study Overview
=================
Brief Summary
-----------------
Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.

Official Title
-----------------
Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: β-CIT-SPECT, Neurophysiology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychiatric in or outpatients with acute depressive episode Indication for pharmacological treatment Exclusion Criteria: Acute suicidality Neurological or severe somatic disorders Occupational exposition to radiation >15 mSv per year Women during pregnancy or lactation

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: β-CIT-SPECT, Neurophysiology|β-CIT-SPECT scans and EEG recordings, two assessments each|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in β-CIT/neurophysiological measurements from baseline to week 4 |  | two assessments, at baseline and week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SERT, depression, β-CIT-SPECT, DAT, neurophysiology, LDAEP, escitalopram, SSRI
An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.

Official Title
-----------------
An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.

Conditions
-----------------
Lymphocytic Leukemia, Chronic

Intervention / Treatment
-----------------
* Drug: rituximab [Mabthera/Rituxan]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >/= 18 years of age chronic lymphocytic leukemia treated with rituximab (MabThera) rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles informed consent to data collection Exclusion Criteria: participation in an interventional clinical study

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 |
| --- | --- |
| Cohort<br> | Drug: rituximab [Mabthera/Rituxan]<br>* As prescribed by physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infusion-related adverse events |  | data collection every 4-6 weeks for up to 6 months for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usage and applicability of 90-minute iv infusion in patients with CLL |  | data collection every 4-6 weeks for up to 6 months for each patient |
Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)

Study Overview
=================
Brief Summary
-----------------
This is an observational epidemiologic multicentric study of follow-up a cohort for described the situation of patients with primary ovarian insufficiency in public population with respect to the age of apparition the primary ovarian insufficiency . iPOI (Investigators in premature ovarian insufficiency): M. Guinot, B. Roca, J. Tomás, P. Escamilla, J. Hernández, P. Llaneza, N. Mendoza Ladrón de Guevara, B. Otero García, I. Ñiguez, A. Castro, L. Baquedano, P. Romero, S. Sánchez.

Official Title
-----------------
Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)

Conditions
-----------------
Primary Ovarian Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women between 18 years and 39 years. Primary ovarian insufficiency demonstrated with amenorrhea and levels of follicle stimulating hormone (FSH) over to 40 IU in two determinations measured with a difference of one moth. Not present linguistic barriers ,shaw attitude towards collaboration ,be able to attend the study center for all follow-up visits. Signed informed consent before inclusion in the study and after having been informed of the procedures performed in this study. Exclusion criteria : Women with secondary hormonal alteration that do no meet the diagnostic criteria of the disease. Refusal to participate. Withdrawal of informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with Primary Ovarian Insufficiency<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age when diagnosed primary ovarian insufficiency | Day 0 |
Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment

Study Overview
=================
Brief Summary
-----------------
To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.

Official Title
-----------------
Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment

Conditions
-----------------
Lateral Ligament Repair, Talar Cartilage Lesion, Microfracture

Intervention / Treatment
-----------------
* Procedure: without lateral ligament repairment
* Procedure: lateral ligament repairment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full - thickness cartilage injury Exclusion Criteria: Age: > 40 years old or < 18 years old; BMI > 30; lesion > 4 cm2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lateral ligament repairment<br> | Procedure: lateral ligament repairment<br>* microfracture combined with repairment of the lateral ligament<br>|
| Experimental: without lateral ligament repairment<br> | Procedure: without lateral ligament repairment<br>* microfracture without repairment of the lateral ligament<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function score | AOFAS ankle function score | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging result | Anatomical data from imaging results when bearing | One year after surgery |