linjc16/ctgov huggingface dataset:
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-ascending-dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RG1511


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-65 years of age; type 2 diabetic patients; naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment. Exclusion Criteria: type 1 diabetes mellitus; clinically significant cardiovascular disease.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG1511<br>* Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.<br>|
| Experimental: 2<br> | Drug: RG1511<br>* Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.<br>|
| Experimental: 3<br> | Drug: RG1511<br>* Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, vital signs. |  | Throughout study | 
| Glucose AUC |  | Days -1, 1 and 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin, C-peptide, glucagon and GLP-1 AUC |  | Days -1, 1 and 8 | 
| 24h glucose |  | Days -1, 1 and 8 | 
| Lipid profiles |  | Days -1 and 8 | 
| Pharmacokinetic parameters |  | Days 1 and 8 |
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Detailed Description
-----------------
Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.

Official Title
-----------------
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Topotecan
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histologically-confirmed ovarian cancer relapse within 6 month after primary therapy primary therapy with platin and taxan ECOG 0-2 >= 18 years leukocytes >= 3.000/ µl platelet >= 100.000/ µl neutrophil >= 1.500/ µl written informed consent Exclusion Criteria: earlier topotecan therapy simultaneous or planned radiotherapy secondary malignancy

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

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

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: A<br> | Drug: Topotecan<br>* Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.<br>|
| Experimental: B<br> | Drug: Topotecan<br>* Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CR and PR in each arm |  | every 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of topotecan treatment |  | after each cycle | 
| Progression-free survival of both arms |  | every 12 weeks |
Arthroscopy Simulator Training vs OR Training Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare between two groups of residents with basic arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee arthroscopic simulator in a lab, and the second group will perform diagnostic knee arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy surgeon in the operating room based on selected competencies following the Global Rating System.

Official Title
-----------------
The Benefit of Arthroscopic Simulator Training Versus Operating Room Training in Diagnostic Knee Arthroscopy for Residents With Basic Arthroscopic Skills

Conditions
-----------------
Knee Arthroscopy Skills

Intervention / Treatment
-----------------
* Other: Training knee simulator
* Other: OR Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthopedic residents Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: simulator training<br>Training knee simulator in Lab | Other: Training knee simulator<br>* Training in a lab on a virtual reality knee arthroscopy simulator<br>|
| Other: OR training<br>Training in the OR - 2 knee arthroscopies. | Other: OR Training<br>* Training on diagnostic knee arthroscopy in the OR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global rating scale | About 3 months will be needed for both study arms to complete the training in the arthroscopy lab and in the OR. Then, both will be assessed by the global rating scale for arthroscopy. | completion of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| simulator parameters | Secondary outcome measures are technical parameters provided by the simulator for each trainee. At the end of the training sessions, about 3 months from the beginning of the study, this parameters can be collected. | Completion of training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroscopy skills, Knee, Virtual reality, Simulator
Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain

Study Overview
=================
Brief Summary
-----------------
Depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice

Official Title
-----------------
Observational and Cross-sectional Study to Assess the Sociodemographic and Clinical Characteristics of Patients Treated With RIVAROXABAN in the Context of Routine Clinical Practice of Spanish Haematologists, Cardiologists and Internists (HEROIC Study)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years Patients with atrial fibrillation Patients in treatment with rivaroxaban for stroke prevention in atrial fibrillation at least 3 months previous to inclusion period in study Exclusion Criteria: Patients in treatment after start of study Patients treated with other anticoagulant treatment

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 |
| --- | --- |
| Rivaroxaban<br>Patients with Atrial fibrillation treated with Rivaroxaban | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Patients treated by Physicians under approved local prescriptions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Data |  | At recruitment visit | 
| Medical History |  | At recruitment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess regional differences among the different Spanish autonomous communities on the management of patients with rivaroxaban treatment during the routine clinical practice | By use of Informe de Posicionamiento Terapéutico (Spanish Questionnaire) | At recruitment visit | 
| Adherence to rivaroxaban treatment | By use of Morisky-Green questionnaire | At recruitment visit | 
| Assess the satisfaction of rivaroxaban treatment | By use of Anti-Clot Treatment Scale (ACTS) questionnaire | At recruitment visit | 
| Assess the quality of life in patients | By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire | At recruitment visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke prevention on Atrial Fibrillation, Prevention and Control, Stroke
Prospective Observation of Wound Healing With Prevena Incision Management System

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

Detailed Description
-----------------
The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.

Official Title
-----------------
Prospective Observation of Wound Healing With Prevena Incision Management System

Conditions
-----------------
Scarring

Intervention / Treatment
-----------------
* Device: Prevena
* Procedure: Standard of Care Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abdominal procedure with incision >20cm must be >18 years of age Exclusion Criteria: <18 years of age history of allergy or reaction to adhesives pregnant or anticipated pregnancy within 6 months

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevena<br>Incision with prevena device overlying | Device: Prevena<br>* Device will be applied at end of procedure over closed incision<br>|
| Active Comparator: Standard of Care dressing<br>Prevena device is not used | Procedure: Standard of Care Dressing<br>* Dressing applied as Standard of Care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scarring | Assess quality of scar: hypertrophy, hyperpigmentation, etc | 0-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevena, negative pressure wound therapy, Incisional wound vac
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

Study Overview
=================
Brief Summary
-----------------
Patients presenting a deterioration of the general state (performance status [PS] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.

Detailed Description
-----------------
Arm A Iressa 250 mg daily PROG/TOX --> Taxotere 75 mg/m² d1 (d1=d22) Arm B Gemzar 1250 mg/m² d1 & d8 (d1=d22) PROG/TOX --> Iressa 250 mg daily Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --> Iressa 250 mg daily

Official Title
-----------------
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: gemcitabine
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IIIB/IV NSCLC patients with performance status 2 or 3.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Gefitinib | Drug: Gefitinib<br>* 250 mg/day, until progression<br>|
| Experimental: B<br>Gemcitabine | Drug: gemcitabine<br>* 1250 mg/m² D1 and D8 (D1=D28, until progression)<br>|
| Experimental: C<br>Docetaxel | Drug: Docetaxel<br>* 75 mg/m² D1 (D1=D22, until progression)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) |  | week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIB/IV NSCLC, patients with performance status 2 or 3.
Terminal Latency Index, Residual Latency and Median Ulnar F Latency Difference in Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Terminal latency index, residual latency and median ulnar F latency difference in carpal tunnel syndrome are specific parameters for the diagnosis

Detailed Description
-----------------
Carpal tunnel syndrome is the most common compression neuropathy. This study was performed to determine the value of terminal latency index, residual latency and median ulnar F latency difference to investigate their sensitivity and specificity in the diagnosis of this syndrome. We retrospectively determined the 160 patients. We evaluated the nerve conduction studies of patient and healthy arms. We recorded all nerve conduction study values.

Official Title
-----------------
Role of Terminal Latency Index, Residual Latency and Median Ulnar F Latency Difference in Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Other: nerve conduction study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had gone to electrodiagnostic study and diagnosed as carpal tunnel syndrome Exclusion Criteria: any history of hereditary polyneuropathies acquired polyneuropathies surgery or local steroid injections for upper limbs or effect the study any history of fracture at the sites of stimulation or recording

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| 1<br>affected arms of patients who had gone to electrodiagnostic study and diagnosed as carpal tunnel syndrome | Other: nerve conduction study<br>* nerve conduction study<br>|
| 2<br>healthy arms of patients who had gone to electrodiagnostic study and diagnosed as carpal tunnel syndrome in the other arms | Other: nerve conduction study<br>* nerve conduction study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nerve conduction studies |  | one month |
Individual Patient Expanded Access-Glembatumumab Vedotin

Study Overview
=================
Brief Summary
-----------------
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to glembatumumab vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.

Conditions
-----------------
Metastatic gpNMB Expressing Triple Negative Breast Cancer

Intervention / Treatment
-----------------
* Drug: glembatumumab vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is 18 years of age or older. The patient has histologically confirmed, gpNMB expressing, metastatic triple-negative breast cancer Overexpression of gpNMB in at least one tumor sample as determined by a Sponsor approved laboratory using IHC methods The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive glembatumumb vedotin. The patient is not eligible for or cannot access ongoing glembatumumab vedotin clinical trials The patient does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for triple negative breast cancer. The patient is able to read and understand, and has signed a patient informed consent form, which outlines the nature of the proposed treatment and the anticipated benefits and risks of treatment with glembatumumab vedotin. Exclusion Criteria: History of allergic reactions attributed to compounds of similar composition to glembatumumab vedotin, MMAE, dolastatin or auristatin. Pregnant or breast-feeding women, and women or men who are not willing to use effective contraception during the time from signing of informed consent through two months after the last dose of glembatumumab vedotin treatment. The patient was previously treated with glembatumumab vedotin or previously enrolled on the METRIC trial (regardless of which arm they were randomized to). Any underlying medical condition that, in the investigator's or Sponsor's opinion, will make the administration of Glembatumumab vedotin hazardous to the patient, or would obscure the interpretation of adverse events.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glembatumumab vedotin|nan|

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

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