linjc16/ctgov huggingface dataset:
Resistance Training in Lung Cancer Patients on Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.

Official Title
-----------------
Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy

Conditions
-----------------
Inflammation, Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically diagnosed with lung cancer Stage I, II, or III Eligible for chemotherapy with curative intent 21 years of age or older Approval to participate in study by treating oncologist or family physician Exclusion Criteria: Unstable cardiac disease Untreated bone or brain metastases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance training<br>Group assigned to complete resistance training during duration of chemotherapy. | Behavioral: Exercise<br>* Resistance training with resistance bands.<br>|
| No Intervention: Control<br>Usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammation measured by c-reactive protein. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy completion |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammation, chemotherapy, lung cancer
Phase I Study to Investigate the Alcohol Interaction of DA8159

Study Overview
=================
Brief Summary
-----------------
This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers

Official Title
-----------------
A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers

Conditions
-----------------
Healthy Volunteers, Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Udenafil
* Dietary Supplement: Alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 19 to 55 years at screening. Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9. Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. Exclusion Criteria: Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis. Subjects with hypotension or hypertension. Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study. Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil<br>Udenafil 200mg | Drug: Udenafil<br>* 200mg Single Oral Dose of<br>|
| Active Comparator: Udenafil + Alcohol<br>Udenafil 200mg + Alcohol | Drug: Udenafil<br>* 200mg Single Oral Dose of<br>Dietary Supplement: Alcohol<br>* Alcohol 39g / 240ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC and Cmax) |  | 48 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DA-8159, Udenafil, Alcohol
Use of a Gamma-IFN Assay in Contact Tracing for Tuberculosis in a Low-Incidence, High Immigration Area

Study Overview
=================
Brief Summary
-----------------
After exposure to an active case of tuberculosis (TB), close contacts may be infected. They are then considered as having latent tuberculosis infection (LTBI). Detecting LTBI is the main goal of contact tracing procedures after exposure to TB. Until recently, the only test available for detecting LTBI was the tuberculin skin test (TST). More recent tests are now available (Interferon-gamma release assays: IGRA), which are more specific and sensitive than the TST. This study compares the TST and an IGRA in the routine activity of contact tracing in our area.

Detailed Description
-----------------
Setting: A TB clinic in Geneva, Switzerland, a low incidence area for TB with a high immigrant population. Aim of study: to compare results of an IGRA test (T-SPOT.TB, Oxford Immunotec, UK) and the TST, and their correlation with exposure scores in subjects exposed to cases of contagious TB. Methods: Prospective study of all contacts screened in our area, and accepting to be included. Simultaneous recording of age, gender, origin, history of recent travels or exposure, BCG vaccination status, infectiousness of index case, 5 different exposure scores, TST, and result of the T-SPOT.TB blood test. Univariate and multivariate analysis.

Official Title
-----------------
Production of Gamma-Interferon by Circulating Lymphocytes Exposed to Antigens Specific of Mycobacterium Tuberculosis: Contribution to the Identification of Latent Tuberculosis Infection in Contact Tracing

Conditions
-----------------
Tuberculosis, Latent Tuberculosis Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exposure to a case of contagious TB Willingness to participate in study Exclusion Criteria: Known HIV infection Known previous TB or treatment for LTBI

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 |
| --- | --- | --- |
| Correlation between results of TST and IGRA tests and exposure scores |  | 2 months after exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Latent tuberculosis infection, Interferon gamma release assay, Contact tracing
CT-Angiography Prior to DIEP Flap Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).

Official Title
-----------------
CT-Angiography Prior to DIEP Flap Breast Reconstruction a Randomized Controlled Trial

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Preoperative CT angiography
* Other: No Preoperative Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planning breast reconstruction with DIEP flap Age 18 to 75 years Exclusion Criteria: Mild to moderate loss of kidney function (Estimated Glomerular Filtration Rate (eGFR) < 60) Decisionally challenged Pregnant Hepatic failure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative CT Angiography<br>Patients will receive preoperative CT angiography to map the blood vessels potentially used for reconstruction | Other: Preoperative CT angiography<br>* Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction<br>|
| Active Comparator: No Imaging Preoperatively<br>No preoperative vessel mapping will be done | Other: No Preoperative Imaging<br>* No imaging will be done to map blood vessels prior to surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Operative Time | Time required to perform breast reconstruction with DIEP flap | Time of incision to incision closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DIEP flap, Deep inferior epigastric artery perforator flap
Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

Official Title
-----------------
Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

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

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Written informed consent History of persistent bronchial asthma for at least 6 months Good health with the exception of asthma Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Smoking history with ≥10 cigarette pack years Pregnancy Intention to become pregnant Breast feeding Lack of safe contraception Previous enrolment into the current study

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC |  |  | 
| morning and evening PEF from diaries |  |  | 
| asthma symptom score |  |  | 
| use of rescue medication |  |  | 
| number of patients with an asthma exacerbation |  |  | 
| time to the first asthma exacerbation |  |  | 
| percentage of days on which patient perceived asthma control |  |  | 
| percentage of nocturnal awakening-free days |  |  | 
| percentage of rescue medication-free days |  |  | 
| percentage of asthma symptom-free days |  |  | 
| adverse events |  |  | 
| physical examination |  |  | 
| vital signs |  |  | 
| standard laboratory work-up |  |  | 
| 8 am serum cortisol. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Ciclesonide
Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.

Detailed Description
-----------------
This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.

Official Title
-----------------
A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

Conditions
-----------------
Intraductal Papillary Mucinous Neoplasm

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed as IPMN; without other malignant tumor; agree to sign informed consent. Exclusion Criteria: with mental disorders which can affect cognition and cooperation; with serious blood diseases or taking drugs that can affect peripheral blood

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Prospective IPMN cohort<br>Multi-omics analysis of 5000 prospectively collected samples. | Other: Observation<br>* This is an observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of IPMN malignant transformation |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the probability of IPMN malignant transformation |  | Up to 10 years | 
| rates of surgical resection |  | Up to 10 years | 
| survival after surgery |  | Up to 10-15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraductal papillary mucinous neoplasm, biomarkers, prospective cohort
A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects. The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).

Official Title
-----------------
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects

Conditions
-----------------
Pharmacology

Intervention / Treatment
-----------------
* Drug: HM15136
* Drug: Placebo of HM15136


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg Exclusion Criteria: with personal or family history of hypercoagulability or thromboembolic disease has had treatment with any incretin therapy has FPG < 70 or > 110 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM15136<br> | Drug: HM15136<br>* 10 mg/mL as protein in prefilled syringes<br>|
| Placebo Comparator: Placebo of HM15136<br> | Drug: Placebo of HM15136<br>* Placebo in prefilled syringes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Incidence of adverse events | Day 30 |
Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety and tolerability of maintenance therapy with BGB-290(Pamiparib) versus placebo in Chinese participants with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy

Official Title
-----------------
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With BGB-290 Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer

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

Intervention / Treatment
-----------------
* Drug: Pamiparib capsule
* Drug: Placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin) Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Ability to be randomized ≤8 weeks after last dose of platinum Key Exclusion Criteria: Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor Progressive disease (PD) as per CA-125 criteria before randomization Diagnosis of myelodysplastic syndrome (MDS) Known history of intolerance to the excipients of the Pamiparib capsule NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br> | Drug: Pamiparib capsule<br>* 60 mg twice daily (BID), orally (per os-PO)<br>* Other names: BGB-290;|
| Placebo Comparator: Placebo arm<br> | Drug: Placebo capsule<br>* 60mg BID, PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to 3 years | 
| Objective response rate |  | up to 2 years | 
| Duration of response |  | up to 2 years |
An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.

Official Title
-----------------
Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months Patients with chronic renal anemia with stage V CKD on dialysis No contraindication to ESA treatment Exclusion Criteria: Uncontrolled hypertension Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage/schedule of Mircera treatment in clinical practice |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment |  | approximately 3 years | 
| Change in Hb levels |  | from baseline to Month 12 |