linjc16/ctgov huggingface dataset:
Characteristics of Lyme Arthritis

Study Overview
=================
Brief Summary
-----------------
Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.

Official Title
-----------------
Characteristics of Positive Lyme PCR Arthritis, Data From CNR Borrelia 2011-2016

Conditions
-----------------
Lyme Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Diagnosis of Lyme arthritis confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016 Patient who has agreed to use his medical data for research purposes Exclusion Criteria: - Refusal to participate in the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of clinical and biological data of French patients with Lyme arthritis between 2011 and 2016 |  | The period from 2011 to 2016 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme arthritis, Borrelia burgdorferi, vector tick, Arthritis, joints
Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat

Study Overview
=================
Brief Summary
-----------------
The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous fat is often popularly referred to as Lipodissolve therapy. Despite its attractiveness as an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections might work remain unclear. This study will investigate the hypothesis that injections of PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible for the fat loss will be explored to find out whether fat cells die from toxic effects or are broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the study, including photography and measurement of patients, tissue biopsy, blood tests, and MRI. The study will also record side effects of the treatments as well as patient satisfaction.

Official Title
-----------------
Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat

Conditions
-----------------
Abdominal Subcutaneous Fat

Intervention / Treatment
-----------------
* Drug: phosphatidylcholine and deoxycholate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Body Mass Index (BMI) no greater than 30 Excess fat in the lower abdomen area Exclusion Criteria: Cigarette smoker Diabetes Pregnant or breast feeding Use anticoagulants (blood thinner), aspirin or other non-steroidal anti-inflammatory drugs that cannot be discontinued

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Experimental: 1<br> | Drug: phosphatidylcholine and deoxycholate<br>* 50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional<br>* Other names: Lipodissolve;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous fat thickness with calipers and MRI. |  | Before and 8 weeks after final treatment |
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.

Detailed Description
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.

Official Title
-----------------
Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Biological: ALLO-ASC-CD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1. Subjects who are considered not suitable for the study by the principal investigator.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALLO-ASC-CD injection<br>Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101 | Biological: ALLO-ASC-CD<br>* ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention.<br>* Other names: Allogenic adipose-derived mesenchymal stem cell;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Evaluation of AE | up to 36 months |
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.

Official Title
-----------------
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: nutritional supplementation
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program. Adequately dialyzed (Kt/V > 1.2). Age 18-75 Exclusion Criteria: Pregnant women. Patients unable to perform exercise Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included. Patients hospitalized within the last month prior to the study. Patients with malfunctioning arterial-venous access (recirculation and/or blood flow < 750 ml/min) Patients receiving steroids and/or other immunosuppressive agents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>nutritional supplement plus resistance exercise | Drug: nutritional supplementation<br>* 2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period<br>Behavioral: exercise<br>* resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period<br>|
| Active Comparator: 2<br>nutritional supplement only (resistance exercise will not be performed) | Drug: nutritional supplementation<br>* 2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in net protein muscle balance |  | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in net whole body protein balance |  | 10 hours |
the Patients Journey Through Surgical Admission Ward Versus Emergency Department

Study Overview
=================
Brief Summary
-----------------
Emergency departments are established in 20 hospitals in Denmark in order to improve the quality for the acute patients. A group of acute patients which require timely assessment and plan from a specialist is patients with abdominal pain. the aim of the present study is to evaluate whether the admission of the group of patients to emergency departments reduces the time to doctor, specialist and plan compared to the traditional admission to a surgical acute ward.

Conditions
-----------------
Waiting Time in Emergency Department

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 15 years Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| admitted to emergency department<br> | |
| patients admitted to surgical ward<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in minutes | the time in minutes from the patient is admitted until the patient is seen by a doctor and until a treatment plan is recorded | up to 24 hours after admission |
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).

Official Title
-----------------
A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

Conditions
-----------------
Hodgkin's Lymphomas

Intervention / Treatment
-----------------
* Biological: MDX-1401


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant Bi-measurable disease ECOG Performance Status of 0 - 2 Meet all screening laboratory values Exclusion Criteria: Previous treatment with any other anti-CD30 antibody History of allogeneic transplant Any tumor lesion greater than or equal to 10 cm in diameter Any active or chronic significant infection Underlying medical condition which will make the administration of MDX- 1401 hazardous Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 12 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: MDX-1401<br>MDX-1401 iv at various doses | Biological: MDX-1401<br>* IV weekly for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Profile |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | Day 50 | 
| Tumor response assessment |  | Two year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Hodgkin's, bi-measurable disease, Lymphoma
Dysregulated Tyrosine Kinase Signaling in Leukemia

Study Overview
=================
Brief Summary
-----------------
Dysregulated Tyrosine Kinase Signaling in Leukemia

Detailed Description
-----------------
Purpose: to look at a number of proteins in the abnormal cells in the blood and/or bone marrow. These proteins make a cell grow or prevent the cell from dying

Official Title
-----------------
Dysregulated Tyrosine Kinase Signaling in Leukemia

Conditions
-----------------
Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have newly diagnosed or relapsed leukemia. Patients must sign an informed consent. Patients will not be excluded if they are receiving chemotherapy. Patients with CML, AML, ALL, T/NK leukemia, myelodysplasia, or myeloproliferative disorders will be eligible. Patients must be => 18 years of age.

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
-----------------
leukemia
Personalized CRT - PSR

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

Detailed Description
-----------------
The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

Official Title
-----------------
Personalized CRT - Product Surveillance Registry (PSR)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible CRT device Patient within 30 days of therapy received at the time of their initial PSR platform enrollment Exclusion Criteria: Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/ or device study that may confound results
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT Response | A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits. | Every 3-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatments for CRT non-response | Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives. | Every 3-9 months | 
| Treatment effects for different CRT features in the CRT non-responder population | A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response. | Every 3-9 months | 
| Patient outcome post initial CRT implant | Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death. | Every 3-9 months |
Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)

Study Overview
=================
Brief Summary
-----------------
To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term under the practical use conditions. In this special drug use investigation, the following items shall be handled as the priority investigation items for information collection. Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.

Official Title
-----------------
Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Salmeterol and Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADOAIR must be used for the first time ADOAIR used for a long-term Exclusion Criteria: Patients with hypersensitivity to salmeterol and fluticasone Patients with infection which salmeterol and fluticasone is not effective Patients with deep mycosis

Ages Eligible for Study
-----------------
Maximum Age: 14 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 patients prescribed ADOAIR<br>Pediatric patients with asthma prescribed ADOAIR during study period | Drug: Salmeterol and Fluticasone<br>* Collection of safety data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy for a long term under the practical use conditions. As the priority investigation items, (1)Systemic effects accompanying steroid administration (2) Events related to nervous system, musculoskeletal system and circulatory systems |  | One year |
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Study Overview
=================
Brief Summary
-----------------
Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip [OTSC] clips).

Detailed Description
-----------------
During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.

Official Title
-----------------
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Conditions
-----------------
Gastric Subepitelial Mass

Intervention / Treatment
-----------------
* Procedure: Endoscopic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endosonographically suspicous gastric subepithelial mass <=3 cm. Exclusion Criteria: American Society of Anesthesiologists (ASA) classes IV or V Pregnancy Bleeding disorders Contraindications for endoscopy Endosonographically shown large vessels in the area for resection

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: Study arm<br>Endoscopic resection | Procedure: Endoscopic resection<br>* Endoscopic resection of the gastric subepithelial mass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 Resection | Rate of R0 resections by an endoscopic approach for resection. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Rate of complications | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric subepitelial mass, Endoscopic full thickness resection