linjc16/ctgov huggingface dataset:
Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

Study Overview
=================
Brief Summary
-----------------
Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).

Official Title
-----------------
Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group

Conditions
-----------------
Autoimmune Diseases, Checkpoint Inhibitor, Immunotherapy

Intervention / Treatment
-----------------
* Drug: Checkpoint inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Patients with cancer Patients with autoimmune disease Treated at HeCOG-affiliated Departments of Oncology Early-stage or metastatic Exclusion Criteria: diagnosis of the autoimmune disease after initiation of immunotherapy

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

| Intervention/Treatment |
| --- |
|Drug: Checkpoint inhibitor|Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | Through the completion of the study, for an average of 6 months |
Impact Evaluation of the Reducing the Risk Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.

Official Title
-----------------
Impact Evaluation of the Reducing the Risk Program

Conditions
-----------------
Sexual Behavior

Intervention / Treatment
-----------------
* Behavioral: Reducing the Risk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 9th grader Attends participating school
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reducing the Risk<br>An eight-lesson (approximately eight-hour) version of Reducing the Risk | Behavioral: Reducing the Risk<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Initiation |  | 2-years post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Initiation |  | 1-year post intervention | 
| Contraceptive use |  | 1-year post intervention | 
| Contraceptive use |  | 2-years post intervention | 
| Number of sexual partners |  | 1-year post intervention | 
| Number of sexual partners |  | 2-years post intervention |
Study of Sensory Deficits in the Upper Limb After Stroke

Study Overview
=================
Brief Summary
-----------------
The overall aim of the project is to gain insight in sensory deficits and recovery patterns in the upper limb post stroke and its association with brain lesion localisation. Furthermore, the investigators will identify associations of deficits in sensory modalities with upper limb impairments, activities and participation at different time points after stroke. Identification of the sensory deficits, along with further insights in their relation with objective neurophysiological and neuroanatomical measures will contribute to the amelioration of goal-setting for the rehabilitation of upper extremity function after stroke. These functions are indispensable during several daily activities as well in different sports and leisure activities. This project is an important step towards a better delineating of treatment interventions for the upper limb and to a better guiding of individual needs for post-stroke treatment in the future.

Official Title
-----------------
Prospective Longitudinal Study: Sensory Deficits in the Upper Limb After Stroke.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first-ever stroke as defined by WHO ≤ 5 days post stroke motor impairment and/or a sensory impairment ≥ 18 years old sufficient cooperation to execute evaluations Exclusion Criteria: other neurological impairments such as previous stroke, head injury or multiple sclerosis (these might affect sensory ability independently of the stroke) stroke-like symptoms caused by subdural hematoma, tumour, encephalitis or trauma no informed consent pre-stroke Barthel Index < 95 out of 100 points (to be able to distinguish between pre-existing disabilities and disabilities resulting from the stroke)

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 |
| --- | --- |
| study participants<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensory function in upper limb from baseline up to 6 months post stroke |  | 6 months post stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor function in upper limb from baseline up to 6 months post stroke |  | 6 months post stroke |
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.

Official Title
-----------------
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: MK-0431/ONO-5435
* Drug: Placebo, MK-0431/ONO-5435


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy Exclusion Criteria: Patients with Type 1 Diabetes Mellitus

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br> | Drug: MK-0431/ONO-5435<br>* Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.<br>|
| Placebo Comparator: P<br> | Drug: Placebo, MK-0431/ONO-5435<br>* Double-blind period (12 wks); placebo QD. The double-blind period will be followed by a 40 wk open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability |  | 12 weeks and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks | 
| 2-hour postmeal glucose |  | 12 weeks | 
| Fasting plasma glucose |  | 12 weeks |
Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment

Study Overview
=================
Brief Summary
-----------------
Port-wine stain is a congenital, progressive vascular malformation of human skin involving post-capillary venules that occurs in an estimated 0.3% of children and can alter personality development and psychological in children.

Detailed Description
-----------------
The researchers at University of California, Irvine and Washington University in Saint Louis are collaborating in this project and developes new multiple imaging devices call photoacoustic microscopy and optical coherence tomography imaging technologies can be use to evaluate the response of port-wine stain from Pulse Dye Laser treatment.

Official Title
-----------------
A Pilot Study of Photo Acoustic Microscopy and Optical Coherence Tomography Imaging Technologies to Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment.

Conditions
-----------------
Port-wine Stain

Intervention / Treatment
-----------------
* Device: Photo Acoustic Microscopy and Optical Coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All age with diagnosis of Port-wine stain Exclusion Criteria: No diagnosis of Port-wine stain
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 |
| --- | --- |
| Port-wine stain<br>Photo Acoustic Microscopy and Optical Coherence tomography | Device: Photo Acoustic Microscopy and Optical Coherence tomography<br>* Photo Acoustic Microscopy and Optical Coherence tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the port-wine stain birthmark | pulsed dye laser treatment | up to 12 months |
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.

Official Title
-----------------
A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: ibandronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Ambulatory, postmenopausal women who are diagnosed with osteoporosis. Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole. Exclusion criteria: Have been treated with other bisphosphonates or using chronic steroids within the past 6 months. Have a history of major upper GI diseases or have severe kidney dysfunction. Have a spine fracture (identified on x-ray).

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibandronate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year. |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between biomarkers and changes in bone quality for one year. |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, bisphosphonates, bone
Expanded Access for CC-10004

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-10004.

Official Title
-----------------
Expanded Access for CC-10004

Conditions
-----------------
Bechet's Disease

Intervention / Treatment
-----------------
* Drug: CC-10004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC-10004|CC-10004 will be administered orally|

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
-----------------
Expanded Access, Compassionate Use
Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise.

Detailed Description
-----------------
As above

Official Title
-----------------
Biomarkers in the Diagnosis and Assessment of PAH

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of PAH, based on currently accepted gold standard for Right Heart Catheterization. Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary capillary wedge pressure less than 18mm Hg on right heart catheterization. Exclusion Criteria: Significant left heart disease or renal insufficiency (serum creatinine > 1.5 mg%).

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with Pulmonary Arterial Hypertension | Other: Blood draw<br>* Venous and Arterial Blood draw samples; 6 Minute Walk test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the correlation of plasma/arterial BNP and MIF levels pre/post with the 6 Minute walk test distance and echocardiographic parameters as surrogate markers of severity of PAH. |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAH, Biomarkers, MIF, BNP, 6 Minute Walk (6MW)
The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The purpose of this study is to investigate the remifentanil effect on renal function during robot assisted prostatectomy.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages > 19 years and < 85 years the patients undergoing a general anesthesia for robot assisted prostatectomy Exclusion Criteria: incomplete record history of opioid or steroid using solitary kidney history of kidney transplantation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| robot assisted prostatectomy<br>robot assisted prostatectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury incidence based on Acute Kidney Injury Network criteria | Acute kidney injury incidence based on Acute Kidney Injury Network criteria was defined as increase in serum creatinine from baseline of ≥ 0.3 mg/dl within a 48-hour period. Acute kidney injury is evaluated at POD 1. | 24 hours after end of surgery |
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome (IBS)

Intervention / Treatment
-----------------
* Drug: GW427353
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain) Exclusion Criteria: Subjects not meeting the Rome II criteria for the diagnosis of IBS Subjects with no stool for 7 days during the screen

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW427353|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion of questionnaires by the subject, determining the average adequate relief rate |  | during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of GW427353 |  | Week 1, 13 | 
| Questionnaire |  | Weeks 1, 6, 12, 18, 24 | 
| ECG, vital signs, adverse events |  | each visit | 
| clinical lab tests |  | Weeks 1, 6, 12, 18, 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tolerability, GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), efficacy, pharmacokinetics
Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database

Study Overview
=================
Brief Summary
-----------------
Analysing ths spread of COVID-19 epidemics in a timely manner is key to implementing public health control strategies. The investigators propose to analyse a large set of laboratory SARS-CoV-2 RT-PCR data to explore potential links between Ct values and epidemic parameters.

Official Title
-----------------
Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database : CovPCR

Conditions
-----------------
Covid-19, SARS-CoV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - A SARS-Cov2 RT-PCR result with a known sampling date Exclusion criteria: - Patient refusing to participate in research
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 |
| --- | --- | --- |
| Detecting co-factors associated with Ct values | Detecting co-factors associated with Ct values | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting associations with epidemic spread | Detecting associations with epidemic spread | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-Cov2 infection, Tested for SARS-Cov2 infection with RT-PCR test, CT, epidemiology, reproduction number