linjc16/ctgov huggingface dataset:
GI Complications in Cancer Immunotherapy Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.

Detailed Description
-----------------
Primary objective To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy Secondary objective Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy

Official Title
-----------------
GI Complications in Cancer Immunotherapy Patients

Conditions
-----------------
Malignant Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of cancer Currently undergoing or have undergone immunotherapy Exclusion Criteria: History of a total colectomy History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease) History of colitis on chemotherapy

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 |
| --- | --- |
| Cancer immunotherapy patients - no GI side effect<br>Cancer immunotherapy patients who do not develop GI side effects. | |
| Cancer immunotherapy patients - develop GI side effects<br>Cancer immunotherapy patients who develop GI side effects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI disease activity | To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms. | 12 weeks | 
| Biospecimen collection | To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer immunotherapy, Ipilimumab
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Study Overview
=================
Brief Summary
-----------------
Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods

Detailed Description
-----------------
This multicenter study aims to evaluate the performance of QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel with another validated comparator method.

Official Title
-----------------
Clinical Performance Evaluation Study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on Positive Blood Culture and Pure Colony Isolates From Subjects With Signs and Symptoms of Bloodstream Infection

Conditions
-----------------
Blood Disease

Intervention / Treatment
-----------------
* Device: QIAstat-Dx® BCID GN and GPF Plus AMR Panels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU. Residual and de-identified specimens. Specimen from subject who has not previously been enrolled. Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity. Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity. Minimum 1.5 mL volume available In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales. Exclusion Criteria: Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids) Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected). Frozen specimens which are unable to be cultured after thawing. Specimen from subject previously enrolled
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: QIAstat-Dx® BCID GN and GPF Plus AMR Panels|The performance of QIAstat-Dx® BCID GN and GPF Plus AMR Panels will be evaluated in comparison with another validated comparator method, using residual specimens of positive blood culture. Pure colonies derived from the residual positive blood culture specimens will also be tested|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPA | positive percentage agreement | 6 moths | 
| NPA | negative percentage agreement | 6 moths |
A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel

Study Overview
=================
Brief Summary
-----------------
xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs). The objective of this study is to establish diagnostic accuracy of the xTAG RPP.

Official Title
-----------------
A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection

Conditions
-----------------
Respiratory Tract Infection, Bronchitis, Bronchiolitis, Pneumonia

Intervention / Treatment
-----------------
* Device: xTAG RPP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specimen is a nasopharyngeal swab. The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility. The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia. Exclusion Criteria: The specimen is not a nasopharyngeal swab. The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blinded, Pre-selected Arm<br>For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested. | Device: xTAG RPP<br> <br> |
| Blinded, Prospective Arm<br>Diagnostic accuracy for the more prevalent targets will be evaluated in prospectively collected, de-identified, left-over, clinical specimens accrued during the 2012/2013 flu season. | Device: xTAG RPP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target. | Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by xTAG RPP. | Within the first year after sample extraction |
Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers. Objectives: to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo to establish SNX-001 pharmacokinetic profile.

Detailed Description
-----------------
This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.

Official Title
-----------------
Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers

Conditions
-----------------
Safety

Intervention / Treatment
-----------------
* Drug: SNX-001
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females Physically and mentally healthy subjects Body weight >60 kg and body weight ≤ 100 kg Exclusion Criteria: Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities History of general malignant diseases Evidence of myasthenic weakness Acute infection or any other febrile illness

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNX-001<br> | Drug: SNX-001<br>* 3.6, 7.2, or 10.8 mg single dose or t.i.w.<br>* Other names: MSF;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Same volumes and frequency as active.<br>* Other names: Oil vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of clinical safety measurements to dose | Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration | Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of dose on pharmacokinetic (PK) parameters | Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg) | After single (Day 1) and multiple (Day 12) doses |
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: doxycycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Healthy patients with rosacea Males and females ≥18 years of age 10 to 40 papules and pustules and ≤2 nodules Score of 2 to 4 on the IGA Presence of telangiectasia Moderate to severe erythema Main Exclusion Criteria: Use of topical acne treatments or topical or systemic antibiotics Use of systemic retinoids within 90 days of baseline Use of an investigational drug within 90 days of baseline Pregnant or nursing women Women of childbearing potential not using an adequate form of contraception Change in method of contraception within 4 months of baseline Known hypersensitivity to tetracyclines Surgeries that bypass or exclude the duodenum or achlorhydria

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total inflammatory lesion count |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in erythema scale scores |  |  | 
| change from baseline in the investigator's global assessment (IGA) score |  |  | 
| proportion of patients being clear or near-clear at endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosacea, acne rosacea
Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

Study Overview
=================
Brief Summary
-----------------
Women who naturally deliver a singleton will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. The pattern of involution will be analyzed.

Detailed Description
-----------------
Women who naturally deliver a singleton in the Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. Transabdominal or transvaginal approach will be at the examiner's discretion. Uterine volume will be measured with 3-dimensional sonographic technologies. Ovaries will also be assessed, along with Doppler flow in several vessels in the pelvis. The pattern of involution will be analyzed.

Official Title
-----------------
Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who deliver a singleton vaginally will be invited to participate the study. Exclusion Criteria: Women who deliver multiple gestation. Women who deliver by Cesarean section Women who have puerperal complications eg. postpartum hemorrhage or infection
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postpartum women<br>Women who deliver a singleton vaginally | Other: Ultrasound examination<br>* Sequential three-dimension sonographic examination for the uterine size after vaginal delivery. The examination will be performed once a week, until the completion of 7 weeks after delivery.<br>* Other names: postpartum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To create the uterine involution curve after vaginal delivery |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery |  | 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum, involution, three-dimension sonography, size of the uterus
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

Study Overview
=================
Brief Summary
-----------------
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls. The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.

Official Title
-----------------
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

Conditions
-----------------
Electromagnetic Interference

Intervention / Treatment
-----------------
* Device: Hand-held metal detector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for routine pacemaker or cardioverter defibrillator control appropriate PM/ICD function Exclusion Criteria: atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters low battery status of the device such as elective replacement indicator (ERI) intrinsic heart rate > 120 beats per minute (bpm)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hand-held metal detector<br>Exposure to two hand-held metal detectors | Device: Hand-held metal detector<br>* 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromagnetic Interference | inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function | time during exposure to hand-held metal detector (2x 30 sec) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electromagnetic interference, hand-held metal detector, pacemaker, cardioverter-defibrillator
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Study Overview
=================
Brief Summary
-----------------
Patients who completed Study ISEE2008 (GATHER2) and consent to participate will be administered monthly avacincaptad pegol 2 mg.

Detailed Description
-----------------
Approximately 400 patients who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham) and consent to participate will be administered monthly avacincaptad pegol 2 mg from Month 1 through Month 17 (maximum 17 total doses); or until avacincaptad pegol is commercially available. All patients will have a final follow up visit at Month 18.

Official Title
-----------------
An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

Conditions
-----------------
Geographic Atrophy, Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Avacincaptad pegol 2 mg intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment. Patient must provide new written informed consent for this OLE trial prior to participation. Patient must have the ability to return for all trial visits for the duration of the 18-month trial. Exclusion Criteria: Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham), Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible. Patient did not enroll into this OLE trial within the 90 day enrollment period. Patient who is pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Avacincaptad pegol 2 mg<br>Avacincaptad pegol 2 mg administered monthly from Month 1 to Month 17 | Drug: Avacincaptad pegol 2 mg intravitreal injection<br>* Avacincaptad pegol is a complement C5 inhibitor<br>* Other names: ARC1905;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham). | Month 18 |