linjc16/ctgov huggingface dataset:
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

Official Title
-----------------
Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proved adenocarcinoma Unresectable and recurrent colorectal cancer Age20 ≤ at enrollment Performance status 0 or 1 (ECOG) No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded Adequate hematologic, hepatic and renal functions At least one measurable lesion by RECIST criteria Exclusion Criteria: Serious drug hypersensitivity Pregnant or nursing Bleeding from gastrointestinal tract Diarrhea Simultaneously active double cancer Serious illness or medical condition Brain metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 1<br>S-1 plus LV | Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)<br>* S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) |  | During chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | During chemotherapy | 
| Progression free survival (PFS) |  | Until progression | 
| Disease control rate(DCR) |  | During chemotherapy | 
| Time to treatment failure (TTF) |  | Until progression | 
| Overall survival (OS) |  | Over two years from registration | 
| Feasibility |  | During chemotherapy | 
| Pharmacokinetics |  | During chemotherapy |
Modifying Exercise for the COPD Patient

Study Overview
=================
Brief Summary
-----------------
This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the Nustep elliptical. The main outcome of participation will be measured by the number of exercise sessions the patient is able to complete during their pulmonary rehabilitation program. In addition, distance walked in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both groups. It is believed that the new machine will provide better overall outcomes compared to the traditional machine.

Detailed Description
-----------------
A Prospective cohort study of 25 COPD patients with osteoarthritis undergoing an exercise plan in a pulmonary rehab program. Patient pain level, clinical outcomes, and ultimately, quality of life outcomes will be assessed in order to assess whether future compliance for COPD arthritic patients will occur in an exercise rehabilitation program.

Official Title
-----------------
Modifying Exercise for the COPD Patient With Arthritic Limitations to Improve Compliance in a Pulmonary Rehab Program

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Arthritis, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Patient Osteoarthritic limitations in upper or lower extremities, or spine Forced Expiratory Volume (FEV)1 less than 70% Forced Expiratory Volume/Forced Vital Capacity (FEV/FVC) ratio less than 70% Exclusion Criteria: Patients with rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Exercise Method<br>Patients attend exercise 80 minute exercise sessions of which 30 minutes includes aerobic exercise on a NuStep and Biodex elliptical machine. Patients pain levels are scored when using the NuStep then when using the Biodex and these scores are compared to determine which machine give the best outcome for pain management | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Exercise Sessions Attended |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Walked |  | 6 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, Pain, Arthritis, Dyspnea, Exercise, Aerobic
Evaluation of Tests Performance on a New Digital Orthoptic Platform

Study Overview
=================
Brief Summary
-----------------
This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.

Detailed Description
-----------------
The demography of ophthalmologists is becoming weaker, many tasks are now performed by orthoptists. To optimize the achievement of orthoptic exams and thus make reliable screening in a shorter time, digital tools are developed. They attempt to renew the orthoptic screening equipment that is still made up of numerous tests, often with old designs that must be handled and adapted to each patient which constitutes a significant loss of time. It therefore appeared necessary for us to develop a platform of digital tools that integrates major tests used for diagnostic purposes, especially a visual acuity test, a stereoscopic vision test, a fusion test and a digital synoptophore enabling a detailed analysis of disorders of binocular vision. The purpose of the study is to evaluate this new tool, avoiding the mobilization of patients , and quantify whether this platform is precise, reliable, fast, comfortable and allow the realization of a safe examination for the patient and for orthoptics.

Official Title
-----------------
Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques

Conditions
-----------------
Binocular Vision Disorder, Visual Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with less than or equal to 16 ocular deviation prism diopters, without or with slight amblyopia (maximum difference of 2 logarithmic visual acuity lines) and performing an orthoptic exam at ophthalmology department of Brest University Hospital. Exclusion Criteria: monophthalmic Medium and deep amblyopic patients Patients with not normal ocular motility Patient who underwent surgery at the head and neck during the previous three months Children under 7 years old.

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
| Correlation of Ocular Convergence as Measured by the Two Machines |  | through study completion, an average of 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Orthoptic Platform, Vision test
Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Study Overview
=================
Brief Summary
-----------------
We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.

Official Title
-----------------
A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Conditions
-----------------
Diaphragm Injury

Intervention / Treatment
-----------------
* Drug: Tofacitinib 10 MG [Xeljanz]
* Drug: Placebo to match Tofacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing esophagectomy Exclusion Criteria: Patients with more than mild pulmonary dysfunction Patients with any neuromuscular disease that might compromise diaphragm function Patients with abnormal liver or kidney function Patients taking any immunosuppressant medication (including prednisone) or antifungal medications History of tuberculosis Weight loss of >5% of body weight over previous 6 months Pregnancy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofacitinib<br>Patient will receive two days treatment with tofacitinib prior to the surgery. | Drug: Tofacitinib 10 MG [Xeljanz]<br>* administered twice daily for two days<br>* Other names: XELJANZ;|
| Placebo Comparator: Placebo<br>Patient will receive two days treatment with placebo prior to the surgery. | Drug: Placebo to match Tofacitinib<br>* administered twice daily for two days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition | Change in the force deficit that develops between the first and second muscle biopsies in the drug-treated vs. placebo groups | 5-6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in muscle strength due to JAK inhibition | Difference in force generated by muscle biopsies taken at time point 1 (pre-mechanical ventilation) from the drug-treated vs placebo groups | 4-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilator-induced Diaphragm Dysfunction
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity

Study Overview
=================
Brief Summary
-----------------
In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. however, the epidural technique often causes more drop of blood pressure, especially in dehydrated patients. The investigators designed the trial to see if the benefit weigh out the potential risk of epidural in isolated hypertensive patients.

Official Title
-----------------
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and morbidity---a Prospective, Randomized Study

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Drug: remifentanil(Ultiva)
* Drug: epidural infusing 2% lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - adults aged 50-70 with isolated systolic hypertension . Exclusion Criteria: age < 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 < 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine > 50% or liver enzymes > 50% upper limit of normal values)

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with isolated systolic hypertension<br>patients combined with isolated systolic hypertension undergoing abdominal surgery | Drug: remifentanil(Ultiva)<br>* remifentanil (TCI, Ce 3 ng /ml)for intra-operative analgesia<br>Drug: epidural infusing 2% lidocaine<br>* epidural infusing 2% lidocaine 4ml bolus followed by 6-18ml/hr for intra-operative analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay |  | 5 weeks | 
| cardiovascular morbidity |  | 2 weeks | 
| respiratory morbidity |  | 2 weeks | 
| postoperative renal failure |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remifentanil, isolated systolic hypertension, morbidity, epidural combined general anesthesia
Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?

Study Overview
=================
Brief Summary
-----------------
Accumulation of iron in patients with beta thalassemia major causes free radical formation which leads to damage of biological membranes. Sperm DNA damage may result from these generated antioxidants. We aimed at investigating the current DNA damage in the sperms of adult patients with beta thalassemia major and the effect generated by giving antioxidant treatment for 6 months.

Official Title
-----------------
Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?

Conditions
-----------------
Endocrine Disease, Fertility Decreased Male, DNA Damage

Intervention / Treatment
-----------------
* Drug: L-Carnitine and N-acetyl cysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pubertal patients with beta thalassemia major Exclusion Criteria: Associated endcrinopathy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| Other: Antioxidant treatment<br> | Drug: L-Carnitine and N-acetyl cysteine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA fragmentation index |  | 6 months |
Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy .

Study Overview
=================
Brief Summary
-----------------
Insulin injection in carpal tunnel compared with dexamethsone in diabetic patients

Detailed Description
-----------------
Trial to decrease median nerve entrapement neuropathy recurrence using insulin co-injection

Official Title
-----------------
Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy .

Conditions
-----------------
Pain, Neuropathic

Intervention / Treatment
-----------------
* Drug: insulin injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diabetic patients with carpal tunnel syndrome Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: dexamethasone<br>dexamethasone with local anesthetics injected for carpal tunnel relief | |
| Active Comparator: Insulin group<br>insulin with local anesthetics and dexamehtasone injected for carpal tunnel relief | Drug: insulin injection<br>* Carpal tunnel syndrome sonagraphic injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief | consumption analgesics | 12 weeks |
DePuy Revision TKA Implant 5yr Survivorship

Study Overview
=================
Brief Summary
-----------------
This will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients are seen clinically for a minimum of five years after surgery to answer: What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients? What patient factors are associated with the need for re-operation after revision TKA among patients receiving DePuy implant components? How do clinical outcomes change from baseline over the five-year follow-up after revision TKA surgery? Data collection will include patient-reported and clinician-reported measures.

Official Title
-----------------
Clinical Outcome and 5-year Implant Survival Rate Among Adult Revision Total Knee Arthroplasty Patients With DePuy Implant Components

Conditions
-----------------
Complications; Arthroplasty, Mechanical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received a Revision TKA (must have been initial revision) --Received J&J/DePuy implant components for initial revision Procedure performed at New England Baptist Hospital Exclusion Criteria: 2nd Revision TKA on knee Received femoral or tibial components not of DePuy manufacture

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Procedures, Elective
Effect of Folate Acid on Offspring Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.

Official Title
-----------------
Mechanism of Folate Acid in Influencing Offspring Obesity During Pregnancy

Conditions
-----------------
Pediatric Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy women children Chinese Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| The level of folate acid of pregnancy women at first trimester |  | 12 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of folate acid of pregnancy women at second trimester |  | 20-24 weeks of pregnancy | 
| The level of folate acid of pregnancy women at third trimester |  | 28-40 weeks of pregnancy | 
| The birth weight, fat content and metabolism related hormone secretion of their offspring |  | At birth | 
| The weight, fat content and metabolism related hormone secretion of their offspring at one year old |  | One years old | 
| The weight, fat content and metabolism related hormone secretion of their offspring at 3 years old |  | 3 years old | 
| The weight, fat content and metabolism related hormone secretion of their offspring at 5-7 years old |  | 5-7 years old | 
| The weight, fat content and the secretion of metabolism related hormone of offspring at 18 years old |  | 18 years old |
Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

Study Overview
=================
Brief Summary
-----------------
Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System

Detailed Description
-----------------
Multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of IMRT following implantation of the BioProtect Balloon Implant System.

Official Title
-----------------
Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has previously participated in the BP-007 clinical study and completed their IMRT treatment. Subject agrees to complete all required follow-up visits. Subject provides written Informed Consent prior to any study related procedure Exclusion Criteria: Subject who completed 48 months of follow-up in the BP-007 study. Subjects who are receiving at the time of the study, any other investigational agents/ devices. Subjects unwilling and/or unable to comply with the provisions of the study protocol.

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Long Term Rectal And Urinary Toxicity and Quality of Life | Long-term safety as assessed by incidence of urinary and bowel toxicities. | 48 months |