linjc16/ctgov huggingface dataset:
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel

Study Overview
=================
Brief Summary
-----------------
The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the presence or absence of gastrointestinal (GI) pathogens from human stool specimens. The objective of this study is to establish diagnostic accuracy of the xTAG GPP.

Detailed Description
-----------------
The xTAG GPP assay is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify bacterial (and toxins), viral, and parasitic pathogens extracted from human stool specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis. The objective of this study is to establish the diagnostic accuracy of xTAG GPP through a multi-site, method comparison study on prospectively collected, left-over, and anonymized stool specimens. The prospective sample set will also be supplemented with pre-selected archived left-over specimens (for low prevalence targets only). Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each target.

Official Title
-----------------
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel (xTAG GPP) in Patients With Signs and Symptoms of Infectious Colitis and Gastroenteritis

Conditions
-----------------
Infectious, Colitis, Gastroenteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specimen is stool. 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 infectious colitis or gastroenteritis. Exclusion Criteria: The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.
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, Prospective Arm<br>Diagnostic accuracy for higher prevalence targets will be evaluated in prospectively collected, anonymized, leftover, stool specimens. | |
| 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. | |

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
-----------------
Stool, Feces, Gastrointestinal, Pathogen, Panel, xTAG GPP, Infectious colitis, Gastroenteritis, Detection
Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the investigation of the functional and radiological results and subjective patient outcome after the implantation of a hip resurfacing endoprosthesis (Birmingham hip resurfacing).

Detailed Description
-----------------
High volumetric wear of polyethylene was the main factor in periprosthetic bone resorption and failure of historic hip resurfacing prosthesis. Metal-on-metal devices reduce the wear substantially and may solve this problem. The purpose of this study is the investigation of the functional and radiological result and subjective patient outcome after implantation of a hip resurfacing endoprosthesis (Birmingham Hip Resurfacing) during the first two years after surgery.

Official Title
-----------------
Prospective, Non-Randomised, Non-Comparative Multicentric Investigation of the Functional and Radiological Result and Subjective Patient Outcome After Implantation of a Hip Resurfacing Endoprosthesis (Birmingham Hip Resurfacing)

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Device: Birmingham Hip Resurfacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and radiological signs of coxarthritis Implantation of a total hip replacement indicated Informed consent Exclusion Criteria: Osteoporosis Tumor Acute infection Higher grade congenital dysplasia of the hip Pregnancy

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Birmingham Hip Resurfacing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional result |  |  | 
| Radiological result |  |  | 
| Subjective patient outcome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative and postoperative complication rate |  |  | 
| Revision rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Hip, Hip arthroplasty, Hip resurfacing arthroplasty
Study of Value of Dexamethasone Used in Ovulation Induction

Study Overview
=================
Brief Summary
-----------------
This study intends to solve the following problems: whether use dexamethasone can obviously decrease transplant cancelling probability in fresh embryo transplant cycle or not, reduce time and frequency going to hospital repeatedly for patients need frozen embryo transplant or not, and reduce the economic burden for patients or not; By comparing pregnancy rate of single transplant, hope to make clear in IVF-ET treatment for patients progesterone increases to a certain level whether it is a good choice to transfer fresh embryo after dexamethasone treatment, or frozen embryo transplant is better.

Official Title
-----------------
A RCT Study of Value of Dexamethasone Used in Ovulation Induction

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: Dexamethasone Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - female, 18 years old≤age≤35 years old, 18≤BMI≤25, standard patient, menstrual regularity Exclusion Criteria: Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥1.0 cm, and/or endometrial hysteromyoma≤1 cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Dexamethasone group<br> | Drug: Dexamethasone Oral Tablet<br>* Dexamethasone Oral Tablet，0.75mg/tablet<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative pregnancy rate per oocyte retrieval cycle | cumulative pregnancy rate per oocyte retrieval cycle | Until 28 day after embryo transferred |
Pedobarographic Changes After Forefoot Reconstruction

Study Overview
=================
Brief Summary
-----------------
Static pedobarography is routinely used for pre- and postoperative questions regarding plantar foot pressure. This Investigation does insufficiently detect dynamic Forces. Hence, dynamic pedobarography might give some important insights in detecting plantar foot pressure after forefoot reconstruction.

Official Title
-----------------
Dynamic Pedobarography With a New Insole After Forefoot Reconstruction

Conditions
-----------------
Plantar Foot Pressure

Intervention / Treatment
-----------------
* Procedure: Forefoot surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Forefoot surgery for hallux valgus or rigidus planned at out departement Exclusion Criteria: No given consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients undergoing forefoot reconstruction of hallux valgus or hallux rigidus | Procedure: Forefoot surgery<br>* Forefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis)<br>|
| Control group<br>Healthy volunteers (Students) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS-Score (American Orthopedic Foot and Ankle Society) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar Peak Pressure | Measuring will be performed by insole (Fa. Meticon) capable to detect plantar pressure in 80 regions of the sole of the foot | 2 years |
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour after the administration of lapatinib.

Official Title
-----------------
A Phase 1, Open-label Study to Evaluate the Effect of Lapatinib, a BCRP Inhibitor, on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease Receiving Hemodialysis

Conditions
-----------------
Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: JTZ-951
* Drug: Lapatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with end stage renal disease on hemodialysis Post-dialysis body weight >45.0 kg BMI between 18.0 and 40.0 kg/m2 (inclusive) Exclusion Criteria: Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody Subjects with known history of liver failure or liver surgery Subjects with a history or current clinically significant chronic or acute blood loss

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: JTZ-951 and Lapatinib<br>Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5 | Drug: JTZ-951<br> <br> Drug: Lapatinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum concentration) |  | 10 days | 
| tmax (time to reach maximum concentration) |  | 10 days | 
| AUC (area under the concentration-time curve) |  | 10 days | 
| t1/2 (elimination half-life) |  | 10 days | 
| Number of adverse events |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JTZ-951, Lapatinib, Pharmacokinetics
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor

Study Overview
=================
Brief Summary
-----------------
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses. The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.

Official Title
-----------------
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor

Conditions
-----------------
Chronic Leukemia

Intervention / Treatment
-----------------
* Other: Additional biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For cohort A : patient with chronic myelogenous leukemia in chronic phase in deep molecular response (MR4.0) persistent for 2 years or more after end of TKi treatments patient with total cessation of TKi treatment signed written informed consent For cohort B : patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with TKIs (inclusion of patient under TKi treatment after relapse is possible). signed written informed consent Exclusion Criteria (for all patients) : patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed) active autoimmune diseases, HIV, hepatitis C or B virus patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. patient under guardianship, curator or under the protection of justice.

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 |
| --- | --- |
| Experimental: Additional biological samples<br>Blood samples will be realized at inclusion and 6 months after inclusion (optional). Peripheral Blood Mononuclear Cells (PBMC) will be collected. | Other: Additional biological samples<br>* Blood samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCP-specific Th1 responses measured by ELISPOT assay |  | at inclusion |
Peri-procedural Smoking Cessation Program in Patients With Chronic Pain

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.

Official Title
-----------------
Implementation of a Peri-procedural Smoking Cessation Program in Patients With Chronic Pain Undergoing Interventional Pain Management Procedures

Conditions
-----------------
Chronic Pain, Smoking

Intervention / Treatment
-----------------
* Behavioral: Smoking cessation counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Pain of 3 months or greater Scheduled for interventional pain procedure Exclusion Criteria: Cancer related pain Current participation in smoking abstinence program History of schizophrenia or other pyschotic disorder History of dementing illness Pregnant patients Diagnosis of depression or anxiety

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

| Intervention/Treatment |
| --- |
|Behavioral: Smoking cessation counseling|Patients will be given a briefing on the benefits of smoking cessation in the peri-procedural period around their interventional pain procedure. They will also be provided an informational sheet from the American Society of Anesthesiologists promoting cessation. The sheet will contain the 1-800-QUITNOW national hotline phone number. Additional an enrollment folder will provided that contains referral information to Cooper's Tobacco Cessation program. This service, free of charge to Cooper Health patients consists of 5 tobacco cessation counselors who use personalized cessation plans, individual and group counseling cessations, Chantix, and education to promote smoking cessation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual analogue pain score | 6 months |
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.

Official Title
-----------------
A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Device: Quantitative POC TSH Kit
* Device: Qualitative POC TSH Kit
* Device: Third generation TSH Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected hypothyroidism subject Willing to comply with the trial protocol Signed informed consent document Exclusion Criteria: Menstrual period, bleeding hemorrhoids, hematuria Drinking or taking aspirin within 48 hours Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability. Subjects who are unwilling or unable to complete the trial Subjects who do not sign informed consent form
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: POC TSH Kits + Third Generation TSH Kit<br> | Device: Quantitative POC TSH Kit<br>* A drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.<br>Device: Qualitative POC TSH Kit<br>* A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.<br>Device: Third generation TSH Kit<br>* One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Positive and Negative TSH Test Result |  | Day 1 up to Day 5 | 
| Concentration of TSH in Whole Blood |  | Day 1 up to Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypothyroidism, Third generation TSH kit, Quantitative POC TSH kit, Qualitative POC TSH kit
Progressive Muscle Relaxation and Cigarette Craving

Study Overview
=================
Brief Summary
-----------------
Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.

Detailed Description
-----------------
The study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.

Official Title
-----------------
Preliminary Study of Effects of Progressive Muscle Relaxation on Cigarette Craving and Withdrawal Symptoms of Experienced Smokers in Acute Cigarette Abstinence : A Randomised Control Trial

Conditions
-----------------
Addiction

Intervention / Treatment
-----------------
* Behavioral: Progressive Muscle Relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or more Daily cigarette smokers Exclusion Criteria: Hospitalization Participating in cigarette dependency treatment or trying to quit smoking with other methods Uncontrolled blood pressure Current other substance users (except alcohol)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive muscle relaxation<br>Progressive muscle relaxation: single 20-minutes session | Behavioral: Progressive Muscle Relaxation<br>* Comparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time.<br>|
| No Intervention: Reading newspaper of the day<br>Reading newspaper of the day : single 20-minutes session | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving | Craving, a strong desire for using a substance when abstaining from substance, was measured by the Penn Alcohol Rating Scale - adapted (PACS-adapted) and the Visual Analog Scale (VAS). | Immediately after a 20-minutes session of progressive muscle relaxation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette withdrawal-related and non-withdrawal related feelings | Cigarette withdrawal symptoms (i.e., anxious, hungry, feeling bad, restless) and non-withdrawal (i.e., high, stimulated, paranoid, tongue - tied) (59-61), as measured by using the Visual Analog Scale (VAS) | Immediately after a 20-minutes session of progressive muscle relaxation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, Progressive muscle relaxation, Cigarette, Craving