linjc16/ctgov huggingface dataset:
Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.

Official Title
-----------------
Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: CDP870


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male/female, 18-75 years old, inclusive diagnosis of adult-onset RA had active disease had received methotrexate on a stable dose of folic acid Exclusion Criteria: contraindication for methotrexate or anti-TNF

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CDP870|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology (ACR)-20 responder rate at Week 24 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability every 4 weeks |  | Every 4 weeks | 
| effect of CDP870 on health outcomes measures |  | 24 weeks | 
| systemic exposures and immunogenic profile of CDP870 |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDP870, Certolizumab Pegol
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

Study Overview
=================
Brief Summary
-----------------
This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
An Open-label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-experienced Patients With HIV-1 Infection

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: ARV regimen
* Drug: enfuvirtide [Fuzeon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults or adolescents at least 16 years of age; HIV-1 infection; clinically stable, treatment-experienced; evidence of HIV-1 replication despite ongoing antiretroviral therapy; CD4 + count greater than 50 cells/mm3. Exclusion Criteria: previous use of Fuzeon and/or T-1249; active, untreated opportunistic infection; inability to self-inject, unless a reliable caregiver is available to inject.

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ARV regimen<br>* As prescribed<br>Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL (MOS-HIV)\n |  | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HIV-RNA |  | Week 12 | 
| Change from baseline in CD4 count |  | Week 12 |
Dengue Seroprevalence Study in Blood Donors in the French West Indies

Study Overview
=================
Brief Summary
-----------------
Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.

Detailed Description
-----------------
Principal objective: To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies. Secondary objective: To specify the serotypic specificity of the anti-dengue antibodies detected during the study.

Official Title
-----------------
Dengue Seroprevalence Study in Blood Donors in the French West Indies

Conditions
-----------------
Blood Donors, Dengue

Intervention / Treatment
-----------------
* Other: Biological sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for blood donation following the French legislation, Resident in Martinique /Guadeloupe for at least one year Consent signed Exclusion Criteria: Not Eligible for blood donation following the French legislation, Not Resident in Martinique / Guadeloupe for at least one year Consent not signed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Biological sample collection|Blood (serum) sample collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or not of dengue virus-specific immunoglobulin G antibodies |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of dengue virus serotype-specific IgG | Characterization of dengue virus serotype-psecific IgG whendengue virus serotype-specific immunoglobulin G antibodies Test is positive | 1 day |
Ribavirin, Its Dosing Regime

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

Detailed Description
-----------------
The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily. The pharmacokinetics of ribavirin at different dosage regimes is investigated.

Official Title
-----------------
Ribavirin, Its Dosing Regime

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anti-HCV positivity > 6 months Positive HCV-RNA genotype 1 or 4 Liver biopsy within one year before the start of therapy Intention to be treated and participate treatment body weight at or above 75 kg Exclusion Criteria: HIV positive

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Ribavirin<br>* different dosing regimes of Ribavirin<br>|
| Experimental: 2<br> | Drug: Ribavirin<br>* different dosing regimes of Ribavirin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph |  | within 24 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The tolerability of the treatment at different dosage regimes of ribavirin |  | 24 weeks of treatment | 
| The antioxidant capacity in plasma and erythrocytes at different dosing regimes |  | 24 weeks of treatment | 
| The effect of ribavirin on the hemolysis |  | 24 weeks of treatment | 
| The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes |  | 24 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, Ribavirin, Dosage, Pharmacokinetics
Efficacy and Safety of JAK Inhibitors in Systemic Sclerosis-associated Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis. Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis. The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.

Official Title
-----------------
Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease

Conditions
-----------------
Systemic Sclerosis, Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic sclerosis according to 2013 ACR/EULAR criteria Patients with interstitial lung disease affecting at least 10 % of the lungs on HRCT chest, FVC of at least 40 % of the predicted value and DLCO between 30 % and 90 % of the predicted value Use of JAK inhibitors Exclusion Criteria: Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities) Patients with pulmonary arterial hypertension defined on right heart catheterization

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 |
| --- | --- |
| SSc-ILD patients with JAK inhibitors<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative change in FVC after 12 months of JAK inhibitor | relative change in %predicted FVC after 12 months of JAK inhibitor | at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative change in DLCO after 12 months of JAK inhibitor | relative change in %predicted DLCO after 12 months of JAK inhibitor | at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation | 
| relative change in skin fibrosis after 12 months of JAK inhibitor | relative change in modified Rodnan skin score after 12 months of JAK inhibitor | at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation |
Evaluation of Patient's Knowledge of Their NACO Treatment

Study Overview
=================
Brief Summary
-----------------
More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant . The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect

Official Title
-----------------
Evaluation of Patient's Knowledge of Their NACO Treatment

Conditions
-----------------
Anticoagulant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with AOD treatment capable to answer to questionnaire with or without antivitamin K Exclusion Criteria: dementia cognitive trouble refusing participation

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 |
| --- | --- | --- |
| questionnaire score >80% | it's a questionnaire about anticoagulant treatment ; each question has a score ans for the study investigators calculate the total | Day 1 |
The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

Study Overview
=================
Brief Summary
-----------------
Currently, a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited. This BSGM provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency, amplitude, velocity, and pattern, in high spatiotemporal detail. The system is also capable of providing a novel meal response metric, which might correlate with the gastric emptying time. The system includes an App for tracking patient-reported symptoms throughout the test.The aim of the present study is to assess and compare BSGM and breath-based gastric emptying parameters and to study the relation between BSGM and presence or severity of individual symptoms and clinical features.The investigators will perform a study in 100 subjects to record gastric bioelectrical activity by non-invasive multi-channel body-surface electrode arrays during gastric emptying breathing test.

Official Title
-----------------
The Relationship Between Body Surface Gastric Mapping (BSGM) and Gastric Emptying Rate

Conditions
-----------------
Motility Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged >18 years old; Male or female patients; Patients planned GEBT; Negative PCR on nasopharyngeal swab 24 or 48 hours prior to the test; Signed informed consent. Exclusion Criteria: Females who are pregnant or lactating. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions Fragile skin vulnerable to skin tears. Damaged epigastric skin (open wounds, rash, inflammation) Patients unable to remain in a relaxed reclined position for the test duration
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of body surface gastric mapping for delayed gastric emptying | The correlation of electrogastrography abnormality (in percentage) and delayed gastric emptying (t 1/2, minutes) will be determined employing a regression method. | 30 minutes before the meal and 4 hours after having meal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess correlation between electrogastrography abnormality and upper gastrointestinal symptoms. | Visual analogue scale (VAS) score for gastrointestinal symptoms, including pain, nausea, vomiting, bloating and flatulence will be recoded during recording gastric electrophysiological activity. The correlation of electrogastrography abnormality (in percentage) and upper gastrointestinal symptoms severity will be determined employing a regression method. | 30 minutes before the meal and 4 hours after having meal. |
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

Study Overview
=================
Brief Summary
-----------------
This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.

Official Title
-----------------
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects

Conditions
-----------------
Huntington Disease, Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Dextromethorphan
* Drug: Dimebon + Dextromethorphan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult subjects. Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype. Exclusion Criteria: Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects. Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception. Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Regimen A (Reference)<br> | Drug: Dextromethorphan<br>* Dextromethorphan HCl 30 syrup single dose<br>|
| Experimental: Regimen B (Test)<br> | Drug: Dimebon + Dextromethorphan<br>* Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone |  | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms) |  | Day 15 | 
| Dextrorphan (the metabolite of dextromethorphan) exposure |  | Day 12 |
The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures

Study Overview
=================
Brief Summary
-----------------
With the expected rise of patients with osteoporosis-induced fractures, it has become increasingly urgent to design and use specialized health education materials aimed at easing pain and improving bodily functions

Detailed Description
-----------------
This study designed web-based dynamic pain relief instructions for women with spinal compression fractures. We collected patients' pain rating data the day before, one month after, and three months after providing the instructions.

Official Title
-----------------
National Taipei University of Nursing and Health Science

Conditions
-----------------
Back Pain Lower Back Chronic

Intervention / Treatment
-----------------
* Device: web app healthcare instructions for relieving back pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women Exclusion Criteria: postmenopausal women

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| control<br>regular nursing care instructions | Device: web app healthcare instructions for relieving back pain<br>* This study designed web-based dynamic pain relief instructions for women with spinal compression fractures.<br>|
| Expirement<br>web app healthcare instructions for relieving back pain | Device: web app healthcare instructions for relieving back pain<br>* This study designed web-based dynamic pain relief instructions for women with spinal compression fractures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of back pain, and qualitative of life between groups | Follow-up observations of the control and experimental groups one month after the f intervention, as well as a significant difference between the data collected prior to the intervention and two months after the intervention | 3 months |