linjc16/ctgov huggingface dataset:
Effect of Capecitabine on the Pharmacokinetics of BMS-247550 and BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the body.

Official Title
-----------------
Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

Conditions
-----------------
Advanced Solid Tumors, Neoplasms

Intervention / Treatment
-----------------
* Drug: Ixabepilone
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recovery from surgery or radiation therapy Measurable or non-measurable disease Available for follow-up Exclusion Criteria: Neuropathy Uncontrolled pulmonary or cardiovascular disease Known history of 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Ixabepilone<br>* Solution, I.V. infusion, 40 mg/m2, Cycles 1-18: once per cycle (Day 1) cycles 2-18 (6-54 weeks) depending on response.<br>* Other names: Ixempra;|
| Experimental: B<br> | Drug: Capecitabine<br>* Tablets, Oral, 1000 mg/m2, Cycle 1: Once (Day 1) Cycle 2: Twice daily (Days 1-5) Cycles 3-18: None, 2 cycles (6 weeks).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of capecitabine on the pharmacokinetics of BMS-247550 and to assess the effect of BMS-247550 on the pharmacokinetics of capecitabine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Tumor response |  |  |
Prevention of Alcohol Intolerance

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.

Conditions
-----------------
Alcohol Sensitivity

Intervention / Treatment
-----------------
* Drug: Broccoli Sprout Extract
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old, sensitive to alcohol on the skin, Japanese Exclusion Criteria: recent skin abnormalities /tanning

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Broccoli Sprout Extract<br>Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. | Drug: Broccoli Sprout Extract<br>* 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge<br>|
| Placebo Comparator: Placebo<br>Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. | Drug: Placebo<br>* 80% acetone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Area of Skin Erythema (Skin Redness) | For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported. | mean up to 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Broccoli sprouts, alcohol sensitivity, sulforaphane, alcohol metabolism, in the Asian Community
Effects of Exercise Training in Bariatric Patients

Study Overview
=================
Brief Summary
-----------------
Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.

Official Title
-----------------
Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index ≥ 35 kg/m2 not engaged in physical activity programs without any physical limitation that could preclude exercise participation Exclusion Criteria: body mass index < 35 kg/m2 regular participation in physical activities programs cancer or any other disease that could limit participation in exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Subjects will undergo bariatric surgery and no exercise training will be prescribed. | |
| Experimental: exercise training<br>Subjects will undergo bariatric surgery and exercise training will be prescribed. | Other: Exercise training<br>* Exercise training will comprise aerobic and strength exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity as assessed by surrogates of insulin sensitivity |  | 6 months | 
| body composition as assessed by densitometry (DEXA) | bone mass, lean mass and fat mass | 6 months | 
| profile of cytokines |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity level as assessed by accelerometry |  | 6 months | 
| quality of life as assessed by questionnaires (composite) |  | 6 months | 
| muscle function as assessed by a battery of tests | timed-stands test, timed-up-ang-go test, maximal strength tests | 6 months | 
| risk of cardiovascular events as assessed by questionnaires (composite) |  | 6 months | 
| aerobic conditioning as assessed by a cardiopulmonary test. |  | 6 months | 
| depression and anxiety as assessed by questionnaires (composite) |  | 6 months |
Treatment of Psoriasis With Parathyroid Hormone

Study Overview
=================
Brief Summary
-----------------
This is a clinical study in two phases. The first phase compares the effect of an ointment containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment without PTH) on psoriasis lesions. Neither the study participants nor the researchers will know who is receiving PTH ointment and who is receiving placebo until the end of this first study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to find out how long the effects last.

Detailed Description
-----------------
Patients with active plaque psoriasis will be withdrawn from systemic and topical medications. After washout, we will select active psoriatic lesions of at least 25 square cm in size to receive either placebo ointment or a proprietary ointment containing PTH for 8 weeks. We will see the patients every 2 weeks. We will evaluate the lesions by examination and digital photography at each visit and measure parameters of calcium metabolism periodically during the 8 weeks. At the conclusion of the 8 weeks, we will obtain punch biopsies from the treated lesions and from one lesion without treatment. If the patients elect, we will transition them into an open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism.

Official Title
-----------------
Evaluation of the Therapeutic Efficacy & Safety of Topical Administration of Parathyroid Hormone (PTH) in Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Parathyroid hormone ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active plaque psoriasis at least 10 percent BSA (body surface area) Age 18-70 Exclusion Criteria: Abnormalities of calcium metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parathyroid hormone ointment|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
-----------------
Parathyroid hormone, Psoriasis, Lesions, Topical medications, Ointment, Calcium metabolism, Skin biopsy
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.

Official Title
-----------------
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training

Conditions
-----------------
TBI (Traumatic Brain Injury)

Intervention / Treatment
-----------------
* Other: Robotic gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age traumatic brain injury at least 6 months prior to study Exclusion Criteria: currently receiving outpatient therapy medically unstable body weight > 150 kgs

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: Single Arm Study<br>This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training. | Other: Robotic gait training<br>* Robotic gait training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Gait Outcomes | Gait speed will be assessed using a gait mat. | Change from baseline gait speed to post-test up to 6 weeks following the intervention. | 
| Change in Endurance | Endurance will be assessed using the 6-minute walk test. | Change from baseline distance covered to post-test up to 6 weeks following the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in balance | Balance will be assessed using the Berg Balance Scale. | Change from baseline balance to post-test up to 6 weeks following the intervention. |
Short-term Perfusion Angiography Pilot Study (SPA)

Study Overview
=================
Brief Summary
-----------------
The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on device performance in a real-world setting.

Detailed Description
-----------------
This clinical study is designed to collect pre and post procedural imaging data using 2D Perfusion (2DP) software in patients receiving an endovascular intervention.

Official Title
-----------------
Short-term 2D Perfusion Angiography Pilot Study

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age. Subject or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent Subject has appropriate femoral arterial access Subject presents with a Rutherford classification of 4 to 6. Planned DSA with endovascular intervention below the knee on one or both limbs. This may include patients who undergo: Above the knee (ATK) and below the knee (BTK) intervention during the same procedure. Only BTK intervention. ATK intervention with staged future BTK intervention within 6 weeks of the initial procedure. Exclusion Criteria: Subjects whose ATK intervention is limited to only the common femoral or iliac arteries Subject is unwilling or unable to comply with the protocol including all follow-up visits Subject with active atrial fibrillation at time of procedure Critical limb ischemia due to acute arterial occlusion. Subject with documented ejection fraction < 40% and/or prolonged bradycardia (< 60 beats per minute) Inability to collect toe pressure on index limb from subject Subjects with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated or any other condition that precludes an endovascular intervention and DSA Female subject of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to enrollment), or plans a pregnancy during study period, Subject life expectancy < 3 months, Subject is participating in a potentially confounding device or drug clinical trial that interferes with this study Investigator considers subject to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented) )

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Safety (Freedom from Major Adverse Device Effects) | Freedom from Major Adverse Device Effects through 30 day visit. | 30 days |
Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2

Study Overview
=================
Brief Summary
-----------------
This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2) for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).

Detailed Description
-----------------
Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.

Official Title
-----------------
Clinical Study to Evaluate Efficacy and Safety of Inject BMP(Beta-TCP Containing rhBMP-2) for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.

Conditions
-----------------
Alveolar Bone Preservation, Bone Graft

Intervention / Treatment
-----------------
* Device: Inject BMP
* Device: ExcelOS-inject


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons without periodontal disease Exclusion Criteria: Women who are pregnant or plan to be pregnant within study period

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inject BMP<br>ExcelOS-inject containing rhBMP-2 | Device: Inject BMP<br>* Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.<br>|
| Active Comparator: ExcelOS-inject<br>ExcelOS-inject without rhBMP-2 | Device: ExcelOS-inject<br>* Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compared the changed height and standard height by computed tomography. |  | at 12 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project

Study Overview
=================
Brief Summary
-----------------
Cancer Survivor Registry: The Breast Cancer M.A. P. (Mind Affects the Physical M.A.P.) Project to identify and help us understand the emotional and social needs of breast cancer survivors.

Detailed Description
-----------------
The Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project was the first registry of its kind to look at the emotional and social needs of individuals diagnosed with breast cancer and track how their needs changed throughout their cancer journey. Data will raise awareness and help develop programs to address the needs of breast cancer survivors. Findings from the Registry are disseminated online at www.CancerSupportCommunity.org/RegistryIndexReport2017

Official Title
-----------------
Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project

Conditions
-----------------
Cancers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having received a cancer diagnosis Exclusion Criteria: None

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 |
| --- | --- |
| Cancer Survivors<br>This is a broad observational study conducted online at www.cancerexperienceregistry.org, or via pen and paper survey obtained by calling the cancer support helpline at 888-793-9355 Any individual who has ever received a cancer diagnosis, regardless of disease type, stage, treatment, and time since diagnosis, can take part in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported quality of life measures |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, cancer survivorship, psychosocial needs, cancer experience, metastatic breast cancer, breast cancer, caregiver
Cerebrovascular Registry

Study Overview
=================
Brief Summary
-----------------
Patients with stroke were registered based on the WHO/ MONICA protocol and were followed-up for 28 days, starting in 2015 in PROVE Registry

Detailed Description
-----------------
PROVE program started in 2015, the registration of stroke continued but followed the WHO Stepwise method instead of WHO/MONICA .Patients are followed up for two years. The corresponding questionnaire covered the patients' demographic data, medical history upon hospital admission, history of comorbidities, medications used prior to the treatment, history of drug abuse, heart and brain imaging, history of blood tests and blood diseases, hospital treatments received, hospitalization complications, medications prescribed at the time of discharge, discharge status and the definite diagnosis of type of stroke according to CT or MRI. The patients were followed-up over the phone or in person from the 1st, 3rd and 12th months to two years. The patients' disabilities were measured using the Barthel Index and the Modified Rankin Scale (MRS). The reliability and validity of these two questionnaires have already been investigated in Persian. In addition, secondary prevention measures, rehabilitation status and the incidence of new cardiovascular events were also examined in the follow-up. The stroke registration personnel received an initial training of three two-hour sessions and monthly one-hour retraining sessions. They visited the archives of various hospitals on a daily basis and registered the data contained in the records

Official Title
-----------------
Prove/Cerebrovascular Registry

Conditions
-----------------
Cerebrovascular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * patients with acute Stroke (Hemorrhagic and Non Hemorrhagic) Exclusion Criteria: patients who do not agree to continue cooperation patients with incomplete documents

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| disability | the Barthel Index | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rehabilitation | Ashworth Scale | 3 months | 
| rehabilitation | Modified Ashworth Scale | 12 months |