linjc16/ctgov huggingface dataset:
A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and tolerability of arimoclomol in ALS patients following 90 days of dosing. In addition, the amount of arimoclomol in blood and cerebrospinal fluid will be measured.

Detailed Description
-----------------
Arimoclomol is a small molecule that upregulates molecular chaperones in cells under stress. Arimoclomol extends survival by five weeks when given both pre-symptomatically and at disease onset in a mutant superoxide dismutase (SOD1) transgenic mouse model of ALS. Furthermore, it has been demonstrated to have neuroprotective and neuroregenerative effects in other rat models of nerve damage. Molecular chaperone proteins are critical in the cellular response to stress and protein misfolding. Recent data suggest that the SOD1 mutation responsible for ALS in some patients with familial disease reduces the availability of a variety of molecular chaperones, and thus weakens their ability to respond to cellular stress. Protein misfolding and consequent aggregation may play a role in the pathogenesis of both the familial and sporadic forms of ALS. Therapeutic agents such as arimoclomol that improve cellular chaperone response to protein misfolding may be helpful in ALS.

Official Title
-----------------
A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
-----------------
* Drug: arimoclomol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Familial or sporadic ALS Vital capacity equal to or more than 60% predicted value for gender, height and age at the screening visit First ALS symptoms occurred no more than five years prior to screening Must be able to take oral medication Exclusion Criteria: Dependence on mechanical ventilation

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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  | 
| ALSFRS-R |  |  | 
| Vital Capacity |  |  |
Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

Detailed Description
-----------------
This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

Official Title
-----------------
Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation

Conditions
-----------------
Dry AMD With Macular Drusen

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen. Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization. Able and willing to make the required study visits. Able and willing to give consent and follow study instructions. Exclusion Criteria: History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction. Thick media opacity or inability to fixate that precludes obtaining acceptable scans. Concomitant use of hydrochloroquine or chloroquine. Unable to make the required study visits. Unable to give consent or follow study instructions.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| AMD with macular drusen<br>Patients diagnosed with dry AMD with macular drusen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle. |  | Single visit observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle. |  | Single visit observation |
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System

Study Overview
=================
Brief Summary
-----------------
Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.

Official Title
-----------------
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.

Conditions
-----------------
Benign Uterine Tumor

Intervention / Treatment
-----------------
* Device: Haifu Focused Ultrasound tumor therapeutic System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Benign uterine fibroids. Women over the age of 20. Abdominal circumference <100 cm. The largest fibroids are ≥ 4 cm. Exclusion Criteria: Pregnant women or those with positive pregnancy test results. Those with other pelvic diseases. Those with immune diseases. There are unsuitable interfaces in the ultrasonic treatment path. Those with tumor calcification. People with severe heart, blood vessel and kidney disease. Those with abnormal coagulation function and low platelets. Type III fibroids according to Funaki classification

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

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

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: Haifu Focused Ultrasound tumor therapeutic System<br> | Device: Haifu Focused Ultrasound tumor therapeutic System<br>* The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In Uterine benign tumor female, the investigators will observe the possibility of complication and tumor response of treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tumour response | Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging | 3 month after treatment |
Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis

Study Overview
=================
Brief Summary
-----------------
Traditional school scoliosis screening approaches remains debatable due to unnecessary referal and excessive cost. Deep learning algorithms have proven to be powerful tools for the detection of multiple diseases; however, the application of such methods in scoliosis screening requires further assessment and validation. Here, the investigators develop an artificial system for the automated screening of scoliosis using disrobed back images, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.

Official Title
-----------------
Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis Using Back Images

Conditions
-----------------
Orthopedic Disorder of Spine, Artificial Intelligence, Scoliosis

Intervention / Treatment
-----------------
* Device: An artificial system for the screening of scoliosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients included both pretreatment back photos and whole spine (C7-S1) standing X-ray or ultrasound images (for healthy population); 2. All the documents are clear to be recognized by naked eyes; 3. Back photos and are taken at the same time (not >1month); 4.Patients were consider as idiopathic scoliosis according to clinical photos. Exclusion Criteria: 1. Patients were considered as non-idiopathic scoliosis for obvious abnormal features of trunck,such as Cafe-au-Lait spots for neurofibromatosis, Spider finger, Abnormal hair spot of back, pelvic tilt, lower limb discrepancy and so on; 2.The taken time between back photo and X-ray or ultrasound was more than 1month; 3.The clinical photos and images were not clear; 4. The X-ray film or ultrasound images not including whole spine (C7-S1).

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 22 Years


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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eligible patients for AI test.<br>Device: An artificial system for the screening of scoliosis | Device: An artificial system for the screening of scoliosis<br>* An artificial intelligence to make evaluation of scoliosis using back images<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system. |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedic Disorder of Spine
BRCA 1/2 Mutation in Korean Patients With Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2 mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian cancer (EOC). PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between 2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA 1/2 mutation, regardless of the family history. Mutation screening was performed using the Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform according to the manufacturer's instructions. Clinical characteristics including survival outcome was assessed in gBRCAm carriers.

Official Title
-----------------
Prevalence Study of Germline and/or Somatic BRCA1/2 Mutation in Korean Patients With High-Grade Serous and/or Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Conditions
-----------------
To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer

Intervention / Treatment
-----------------
* Genetic: Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 18 years of age and older with previously untreated, HG serous and/or endometrioid EOC, fallopian tube or primary peritoneal carcinoma who consented to genetic testing between 2010 and 2015 Exclusion Criteria: women with mucinous , clear cell, low-grade serous or endometrioid, mixed epithelial adenocarcinoma, undiffereniated carcinoma or malignant brenner's tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| KGOG 3019<br>Korean women with HG serous and/or endometrioid epithelial ovarian cancer | Genetic: Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform<br>* BRCA1,2 Germline /Somatic mutation test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of positive mutation among ovarian cancer patients |  | 5 year |
How Total Knee Prosthesis Dessigns Influence in Quality of Live

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients

Detailed Description
-----------------
Objectiu Criteris d'inclusió Mesura dels resultats

Conditions
-----------------
Osteoarthritis Knee, Total Knee Replacement

Intervention / Treatment
-----------------
* Procedure: Total Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65-80 years. Primary Ostheortritis Mechanical Axis 0+/- 7 degrees Exclusion Criteria: Patients with any new important disease after the surgical procedure. Important complications related with the surgical procedure, as fractures, infections and vascular lesions. Patients not following a rehabilitation program

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee Osteoarthritis patients with prostesis treatment<br>Patients operated previously of Knee Osteoarthritis with different prostesis designs according the Hospital guide | Procedure: Total Knee Arthroplasty<br> <br> * Other names: Total Knee Prostesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Results |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis Knee, Total Knee Arthroplasty, Quality of Life
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy. we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is widely used in this group of patients.

Official Title
-----------------
A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer

Conditions
-----------------
Superficial Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: mitomycin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified superficial transitional cell carcinoma of the bladder. patients with primary or recurrent intermediate risk superficial bladder cancer after TUR. Patients with primary tumor with stage TaG1 with multiple lesions (>3) or lesions bigger than 3 cm or patients with TaG2-3 or T1G1-2. Patients must not be pre-treated with any intravesical immunotherapy (BCG) or chemotherapy. Male or female, age greater than 18. Exclusion Criteria: Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks. Patients who have received previous (BCG) or chemotherapy. Patients with evidence of invasive, locally advanced or metastatic bladder cancer (greater than or equal to T2 disease; stage greater than or equal to B1) or patients with upper urinary tract disease.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: mitomycin C|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the tumor recurrence rate at 12 months after TUR in patients with intermediate risk superficial bladder cancer treated with intravesical Gemcitabine or Mitomycin C. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor recurrence rate in 6 months |  |  | 
| disease free interval |  |  | 
| Toxicity profile (local and systemic) |  |  |
Screening of Instability of the Spinal Column With Spinal Mouse® and X-ray

Study Overview
=================
Brief Summary
-----------------
The SpinalMouse is a computer-assisted medical device that measures and graphically reports on posture and range of motion of the axial spine. The data has shown to be highly valid and reproducible while compared to x-ray film. The aim of the study is to evaluate if the Spinal Mouse is a reliable clinical diagnostic device to screen those patients having instability in the lumbar area.

Official Title
-----------------
A Comparison of Spinal Mouse® and X-ray Film to Measure a Instability of Lumbar Spine

Conditions
-----------------
Instability of Lumbar Spine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: supposed instability of lumbar spine Exclusion Criteria: not willing to participate to 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 |
| --- | --- |
| Back pain<br>Persons with back pain and supposed instability of lumbar spine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sagittal spinal range of motion |  | One measurement before or after x-ray film | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain; pain drawing, VAS |  | Once in the same day with range of motion measurements | 
| Oswestry Disability Questionnaire |  | Once in the same day with range of motion measurements | 
| Questionnaire; socio-demographic variables, back/leg trouble history |  | Once in the same day with range of motion measurements | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal sagittal range of motion, Intersegmental range of motion, Spinal Mouse