linjc16/ctgov huggingface dataset:
Acupuncture in Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee

Detailed Description
-----------------
Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling. Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design. Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design. Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more. Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.

Official Title
-----------------
Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above age 35 knee osteoarthritis grade II or III according to the Kellgren classification. Exclusion Criteria: orthopedic deformations of the knee, malignant disease auto-immune disorders surgery including arthroscopy during the past 12 months pain medication with steroids physical therapy or acupuncture within the last for weeks no or a pain medication in continuous dosage

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, double-blind, sham control, osteoarthritis, pain
Study of Aripiprazole in Patients With a History of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if aripiprazole is effective in the treatment of patients with a history of bipolar disorder.

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

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with a history of Bipolar I Disorder

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole|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
-----------------
Bipolar I disorder
An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

Study Overview
=================
Brief Summary
-----------------
The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.

Official Title
-----------------
An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders

Conditions
-----------------
Neuromyelitis Optica Spectrum Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients; AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay; Female or male, age 14-80; Patients or authorized family members volunteered to participate in this study and signed informed consent. Exclusion Criteria: Patients with coagulation disorders; Infection-related encephalitis; Immune-related encephalitis; A patient with severe mental illness who cannot cooperate clinically; A patient with severe jaundice.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| results of AQP4 -immunoglobulin G detection kit | The Serum test results of participants using AQP4 -immunoglobulin G detection kit | through study completion, an average of 6 months |
Prevention of Capecitabine Induced Hand and Foot Syndrome

Study Overview
=================
Brief Summary
-----------------
Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. The investigators aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

Detailed Description
-----------------
Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. Our aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms. The patients will use socks containing copper-oxide impregnated fibers which are sold in the Pharma stores without physician's prescription.(EPA numbers 8454-2, 8454-3 from April 30 2009). Drug Toxicity and skin reaction will be documented.

Official Title
-----------------
A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: socks containing copper-oxide fibers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of stage IV cancer - treated with Capecitabine Exclusion Criteria: Any patient who can not sign an informed consent Pregnant women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: socks containing copper-oxide fibers<br> | Device: socks containing copper-oxide fibers<br>* The patients will use a sock which contains copper fibers. The socks are sold in the free market (different Pharma stores) for various purposes such as prevention of diabetic foot. It is a product of Cupron company EPA :84542-2, 84542-3 from April 30 2009.<br>* Other names: Cupron company EPA :84542-2, 84542-3 from April 30 2009.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin feet toxicity | within the first year from starting Capecitabine use | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Socks, Capecitabine, Hand and foot syndrome, Copper, Toxicity
Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the survival and relapses of patients with diagnosis of acute lymphoblastic leukemia at two tertiary level hospitals in the metropolitan area of the valley of Mexico

Detailed Description
-----------------
Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from July, 2016, to October, 2020. The patients were cared for in the hematology department of the Hospital General de Mexico and in the hematology department of the Hospital Regional de Alta Especialidad Ixtapaluca. Relapse was considered in those cases with more than 5% of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid.

Official Title
-----------------
Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia. Experience of Two Centers in Mexico City

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization. Exclusion Criteria: Age less than 15 years Age over 60 years

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Overall survival |  | 4-years | 
| Progression free survival |  | 4-years | 
| Number of relapses | Cases with more than 5 percent of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid | 4-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival, Leukemia, Relapse, Retrospective study
Non-invasive Substrate Evaluation in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the right and left atrial electrophysiological substrate in atrial fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus) as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging. The results will also be compared when the patient is in sinus rhythm and atrial fibrillation.

Official Title
-----------------
Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging

Conditions
-----------------
C14.280.067.198

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation Exclusion Criteria: Cardiomiopathy (FEVI<40%) or significant valvulopathy. MRI not possible or contraindicated. Previous atrial fibrillation ablation.

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 |
| --- | --- | --- |
| Correlation between conduction velocity and MRI fibrosis. | The conduction velocity in sinusal rhythm and with extra estimuli will be correlated with the MRI late gadolinium enhancement sequence (MRI-LGE). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between voltage and MRI fibrosis. | The voltage in sinus rhythm and in atrial fibrillation will be correlated with the MRI-LGE. | Baseline | 
| Correlation between electrocardiographic image (ECGi) and MRI-LGE. | The xxx of the ECGi will be correlated with the MRI-LGE. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Metvix Daylight PDT in Actinic Keratosis

Study Overview
=================
Brief Summary
-----------------
Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction.

Official Title
-----------------
Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Other: Metvix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;

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 |
| --- |
|Other: Metvix|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of physician satisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question Overall are you satisfied with Metvix DL-PDT? |  | 3 months | 
| Percentage of patient satisfisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question Overall, how satisfied are you with this treatment?. |  | 3 months |
Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight

Study Overview
=================
Brief Summary
-----------------
This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female. The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females

Conditions
-----------------
Appetite Suppression, Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: PolyGlycopleX (PGX)
* Dietary Supplement: Rice flour


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25 - 35 Kg/m2 Exclusion Criteria: Medications and supplements that affect appetite Known diabetes Contraindications to LCD Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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: PolyGlycopleX (PGX)<br> | Dietary Supplement: PolyGlycopleX (PGX)<br>* The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.<br>|
| Placebo Comparator: Rice Flour<br> | Dietary Supplement: Rice flour<br>* The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in appetite score assessed from appetite Visual Analog Scale |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight (kilograms) |  | 18 weeks | 
| Change in percentage of body fat |  | 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
viscous, fibre, polysaccharide, appetite, hunger, satiety, weight management
A Pilot Study - Comparison of Two Hologic 3D Mammography Systems

Study Overview
=================
Brief Summary
-----------------
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

Detailed Description
-----------------
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.

Official Title
-----------------
A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Genesis and Gemini
* Device: Investigational 3D Mammography system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, any ethnic origin No contraindication for diagnostic mammography Exclusion Criteria: Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants. Under 30 years of age at the time of consent Unable to understand and execute written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| 3D investigational imaging<br>Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition | Device: Investigational 3D Mammography system<br>* 3 dimensional breast mammography system<br>|
| 3D Imaging with commercial Mammography Device<br> | Device: Genesis and Gemini<br>* 3 dimensional breast mammography system<br>* Other names: Selenia Dimensions;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design | images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, tomosynthesis
Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

Study Overview
=================
Brief Summary
-----------------
To assess the effect of long-term treatment by Genotonorm on linear growth

Official Title
-----------------
Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Conditions
-----------------
Growth Hormone Deficiency, Growth Retardation

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014 All patients who have stopped during one year will be included if a signed written informed consent Exclusion Criteria: Endocrine disease, except well substituted hypothyroidism Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main efficacy variable is the height SDS (SEMPE) before and after treatment. |  |  | 
| The standing height of the patients is measured during the inclusion visit and at each follow-up visit. |  |  | 
| The height measurements are always performed at the same time of the day by |  |  | 
| use of a wallmounted device (e.g. Harpenden Stadiometer). |  |  | 
| Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height. |  |  | 
| The body weight is measured by use of a balance scale. |  |  | 
| Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured. |  |  |