linjc16/ctgov huggingface dataset:
Far Infrared Irradiation for Managing, Control and Treatment of Huntington's Disease (HD)

Study Overview
=================
Brief Summary
-----------------
Huntington's disease (HD) is a fatal disease with profound neurological and behavioral features. HD is typically characterized by uncontrollable movements and psychological disturbances. This study will investigate the use of far infrared radiation for control, management and treatment of HD.

Detailed Description
-----------------
Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells. It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have HD.

Official Title
-----------------
Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Control, Management and Treatment of HD

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with HD Exclusion Criteria: None
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Radiation: Far Infrared Radiation (5μm to 20μm wavelength) | Radiation: Far Infrared Radiation<br>* Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.<br>* Other names: Far Infrared Radiation (5μm to 20μm wavelength);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of people with HD |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation of people with HD |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Akinetic-Rigid Variant of Huntington Disease, Chorea, Chronic Progressive Hereditary (Huntington), Chronic Progressive Hereditary Chorea (Huntington), Huntington Chorea, Huntington Chronic Progressive Hereditary Chorea, Huntington Disease, Akinetic-Rigid Variant, Huntington Disease, Juvenile, Huntington Disease, Juvenile-Onset
Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

Study Overview
=================
Brief Summary
-----------------
To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)

Official Title
-----------------
An 8 Week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients who are eligible and able to participate in the study Exclusion Criteria Severe hypertension History or evidence of a secondary form of hypertension History of hypertensive encephalopathy or cerebrovascular accident Other protocol-defined exclusion criteria may apply.

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 |
| --- |
|Drug: aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 8 weeks |  |  | 
| Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks |  |  | 
| Blood pressure < 140/90 mmHg |  |  | 
| Change from baseline in standing diastolic blood pressure after 8 weeks |  |  | 
| Change from baseline in standing systolic blood pressure after 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, hydrochlorothiazide (HCTZ).
Patient Perception of Visual Distortions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.

Conditions
-----------------
Cataract, Astigmatism

Intervention / Treatment
-----------------
* Other: Administration of patient self-assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal astigmatism of at least 0.75 diopters Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes At least one month postoperative from second-eye surgery Ability to understand, read and write English to give consent and complete study questionnaire Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Other protocol-defined inclusion criteria may apply Exclusion Criteria: Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms Patient is pregnant or is lactating Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Pseudophakic implanted with toric IOL<br>Subjects bilaterally implanted with toric IOL | Other: Administration of patient self-assessment<br> <br> |
| Pseudophakic implanted with non-toric IOL<br>Subjects bilaterally implanted with non-toric IOL | Other: Administration of patient self-assessment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Distortion Symptoms | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. | Baseline | 
| Visual Distortion Symptoms | Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3. | 1 week |
Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to assess the influence of the administration of low dose hCG on the endometrium. The study is a randomised trial where 2 groups of patients, undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization, are studied. In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.

Official Title
-----------------
Influence of Ovarian Stimulation With 200 IU of hCG, (Administered in the Late Follicular Phase Among ICSI Patients Undergoing a GnRH-antagonist Protocol), on the Endometrium on the Day of Oocyte Pick-up

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: human menopausal gonadotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 36 years on day of randomisation FSH < 12 in the early follicular phase Normal ultrasound scan BMI between 18 and 29 (both inclusive) Randomisation at outpatient clinic Exclusion Criteria: Endometriosis ≥ grade 3 PCO syndrome Poor responder Endocrine or metabolic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recombinant FSH<br>Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins. Histology and gene expression is studied on the endometrium. | Drug: human menopausal gonadotropin<br>* 200 IU per day in the late follicular phase<br>|
| Experimental: human chorionic gonadotropin<br>Patients undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins. Histology and gene expression is studied on the endometrium | Drug: human menopausal gonadotropin<br>* 200 IU per day in the late follicular phase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes |  | 2 weeks after start of the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, ICSI, hCG, infertility treatment
Studding the Implementation of ERAS Protocols in Pediatric Surgery

Study Overview
=================
Brief Summary
-----------------
this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols, in pediatric surgery and evaluate the feasibility and effectiveness of implementing these protocols

Official Title
-----------------
Enhanced Recovery After Surgery in Pediatric Surgery in Jordan: A Retrospective Cohort Study in a Tertiary University Hospital

Conditions
-----------------
ERAS, Pediatric Disorder, Appendicitis, Hydrocele

Intervention / Treatment
-----------------
* Other: Observational study, non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution Exclusion Criteria: patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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 |
| --- | --- |
| pediatric surgery patients<br>all pediatric surgery patients, aged from 6 months up to 18 years, underwent surgery between January 2017 to December 2018 | Other: Observational study, non-interventional<br>* observational study for the ERAS protocols in pediatric surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Hospital stay, |  | retrospectively studied. data collection done at least 1 year after surgery | 
| Total Hospital expenses |  | retrospectively studied. data collection done at least 1 year after surgery | 
| readmission within 30 days |  | retrospectively studied. data collection done at least 1 year after surgery | 
| reoperation within 90 days |  | retrospectively studied. data collection done at least 1 year after surgery | 
| post op ER visits |  | retrospectively studied. data collection done at least 1 year after surgery | 
| Pain control, according to a scale from 0-10, post-operative pain after implementation of ERAS protocols |  | retrospectively studied. data collection done at least 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enhanced recovery after surgery (ERAS), enhanced recovery protocol, fast-track surgery, pediatric surgery
The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.

Official Title
-----------------
The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: Equistasi
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple Sclerosis affected Spasticity EDSS (Expanded Disability Status Scale) 0 - 5,5 Patients able to sign informed consent Exclusion Criteria: Age less than 18 years old and more than 65 years old Pacemaker Pregnancy Comorbidities as: cancer, hypertension not controlled by drugs concurrent therapies with antidepressant or corticosteroids

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Equistasi Group<br>arm treated with application of devices | Device: Equistasi<br> <br> |
| Placebo Comparator: Placebo Group<br>arm treated with application of inactivated devices | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Velocity | evaluation of gait velocity in m/s | one year | 
| First step length | first step length in cm | one year | 
| Swing phase | swing phase measured in seconds | one year | 
| Stance phase | stance phase measured in seconds | one year | 
| Double support time | double support time measured in seconds | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H/M ratio | evaluation of neurophysiological modifications in treated patients vs placebo group, as ratio between H max and M max in tibial posterior nerve, in Unit | one year | 
| Berg Balance Scale | Evaluation of balance with a self administered scale, measured in Unit | one year | 
| Modified Fatigue Scale | evaluation of fatigue with a self administered scale, measured in Unit | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focal Vibrations, Neurorehabilitation, Spasticity, Multiple Sclerosis
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes

Study Overview
=================
Brief Summary
-----------------
Partial Nephrectomy is the standard care for small (<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods

Conditions
-----------------
Tumor, Nephrectomy, Laparoscopy

Intervention / Treatment
-----------------
* Procedure: Laparoscopic partial nephrectomy
* Procedure: Open partial nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients referred to partial nephrectomy Exclusion Criteria: Contra-indication for laparocopic surgery Complexed , large tumors, single kidney, chronic renal failure

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 |
| --- | --- |
| Laparoscopic partial nephrectomy<br> | Procedure: Laparoscopic partial nephrectomy<br>* Laparoscopic partial nephrectomy<br>|
| Open Partial nephrectomy<br> | Procedure: Open partial nephrectomy<br>* Open partial nephrectomy<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
-----------------
Renal tumor, RCC, Partial nephrectomy, Laparoscopy
Study Evaluating ReFacto in Hemophilia A

Study Overview
=================
Brief Summary
-----------------
To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).

Official Title
-----------------
Factor VIII Mutation Testing Program in Previously Untreated Patients (PUPs) With Hemophilia A Participating in ReFacto® Study

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: BDDrFVII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation. The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed. A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories. Exclusion Criteria: Any condition which, in the investigator's opinion, places the patient at undue risk.
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: BDDrFVII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface antigen or hepatitis C antibody.

Official Title
-----------------
A Phase 1B, Multi-center, Open Label, Dose Escalation Study of Mapatumumab ([HGS1012], a Fully-human Monoclonal Antibody to TRAIL-R1) in Combination With Sorafenib as a First Line Therapy in Subjects With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Biological: mapatumumab
* Drug: sorafenib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate liver disease Test positive for hepatitis B surface antigen or hepatitis C antibody Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma Age 18 years or older Exclusion Criteria: Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma. Received radiation therapy within 4 weeks before randomization Major surgery within 4 weeks before randomization Minor surgery within 2 weeks before randomization Systemic steroids within 1 week before randomization Hepatic encephalopathy, per the investigator's evaluation History of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization Known brain or spinal cord metastases History of other cancers within 5 years before enrollment Pregnant or breast-feeding women Known HIV infection

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: A<br>mapatumumab and sorafenib | Biological: mapatumumab<br>* 3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle<br>Drug: sorafenib<br>* 400 mg orally, twice a day continuously in each cycle<br>* Other names: Nexavar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, frequency, and severity of adverse events. |  | Until disease progression or unacceptable toxicity develops | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Cancer