linjc16/ctgov huggingface dataset:
The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent of patients. Since in vitro data have suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in a subsequent protocol.

Official Title
-----------------
Combination Therapy With 9-(1,3-Dihydroxy-2-Propoxymethyl) Guanine (DHPG) and Interferon Beta for the Prevention of Relapse of Cytomegalovirus Retinitis in Patients With the Acquired Immunodeficiency Syndrome

Conditions
-----------------
Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b
* Drug: Ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must fulfill the CDC criteria for the diagnosis of AIDS. In addition, patients must have a typical clinical picture of cytomegalovirus (CMV) retinitis, a positive CMV culture from any site, and no other possible explanation for the retinal findings (e.g., toxoplasmosis infection). Patients with AIDS in whom CMV retinitis is suspected will be examined by an ophthalmologist and, if, retinal lesions are seen, shall have a complete set of retinal photographs taken. CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained. Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed. Exclusion Criteria Co-existing Condition: Patients not meeting inclusion criteria are excluded. Patients not meeting inclusion criteria are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon beta-1b|nan|
|Drug: Ganciclovir|nan|

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
-----------------
Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Interferon Type I
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing. At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.

Official Title
-----------------
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: naloxone versus placebo
* Drug: intravenous injection of normal saline or naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD Ability to exercise Ability to computer mouse to provide ratings > 10 pack-years smoking Baseline dyspnea index < 9 Exclusion Criteria: Clinically significant comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A: naloxone; B: normal saline<br>Arm A: IV naloxone Arm B: IV normal saline | Drug: naloxone versus placebo<br>* 10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits<br>Drug: intravenous injection of normal saline or naloxone<br>* Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slope of oxygen consumption - dyspnea during treadmill exercise. |  | throughout exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise duration |  | 10-14 minutes | 
| Peak ratings of breathlessness |  | at end of exercsie - 10-15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspnea; leg discomfort; exercise duration
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials

Official Title
-----------------
An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Crohn's Disease Who Have Completed Previous Spesolimab Trials

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Spesolimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years Has completed all treatments (placebo or active treatment) and the end of treatment (EOT) visit in the parent induction trial in fistulising Crohn's Disease (CD) and is willing and able to continue treatment in 1368-0007 Has obtained an individual health benefit, per investigator judgement (such as fistula response or remission or other clinical improvement), from treatment in the parent trial Signed and dated written informed consent for 1368-0007 in accordance with GCP and local legislation prior to admission into the trial Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information Exclusion Criteria: Have experienced treatment-limiting adverse events during induction treatment with study drug Have developed any condition which meets the exclusion criteria from the original induction study Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spesolimab arm<br> | Drug: Spesolimab<br>* Spesolimab<br>* Other names: BI 655130;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) |  | Up to week 336 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with perianal fistula remission |  | Up to week 336 | 
| Proportion of patients with perianal fistula response |  | Up to week 336 |
Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance?

Study Overview
=================
Brief Summary
-----------------
The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified

Official Title
-----------------
Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance? Pilot Study to Guide Probabilistic Antibiotic Regimens of Community-acquired Urinary Tract Infections

Conditions
-----------------
Urinary Tract Infection Empiric Antibiotic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: national health insurance card available community acquired urinary tract infection Exclusion Criteria: incapacity to accept an inform consent hospitalized acquired urinary tract infection national health insurance card non available

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| Frequency of antibiotic resistant organisms | Frequency of antibiotic resistant organisms in patient with urinary infection | One year |
Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement.

Detailed Description
-----------------
Blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. Therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. Furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. However, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure. Aim: To test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy.

Official Title
-----------------
Impact of Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance in Medical Outpatients: The Hyper-ABC Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: 24 hour blood pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncontrolled hypertension (office BP >139/89mmHg AND 24h BP >129/79mmHg) Exclusion Criteria: Severe concomitant illness including heart failure, significant valvular heart disease or malignancy

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 24 hour blood pressure measurement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour systolic blood pressure from baseline to 1 year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour diastolic blood pressure from baseline to 1 year |  |  | 
| Primary outcome measure in patients with treated hypertension at baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Ambulatory blood pressure monitoring, Blood pressure, Risk assessment
Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Venous thrombosis is a potentially serious complication after PTH and PTG, justifying various prophylactic measures. In France, aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event. More recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. While this molecule is potentially less effective than LMWHs or ADOs, it could decrease the risk of iatrogenic hemorrhage. The introduction of enhanced recovery procedures after surgery (RAAC) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current French recommendations when The operated follows such a protocol.

Official Title
-----------------
Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement. Comparison With Baseline Low Molecular Weight Heparin Prophylaxis

Conditions
-----------------
Hip and Knee Prosthesis Implantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥ 18 years old); Patient operated on for a first-line total hip or knee replacement by the principal investigator; Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion criteria: - Subject having expressed opposition to participating in the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the postoperative thromboembolic complications after implantation of hip and knee prostheses |  | Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip prosthesis implantation, Knee prosthesis implantation, Aspirin thromboprophylaxis, Heparin prophylaxis, Thromboembolic complications, Bleeding complications
A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration

Study Overview
=================
Brief Summary
-----------------
Chlorhexidine gluconate (CHX), as an anti plaque agent, is commonly used with a variety of products. In this study we, the investigators at Hadassah Medical Organization, intend to examine the efficacy of a single dip in CHX of provisional restoration prior to oral cementation. If the protocol is effective, we intend to calibrate it and recommend clinical use of the protocol. The examination of biofilm formation will be both with electron microscope and confocal scanning laser microscope.

Official Title
-----------------
Examination of the Immersion of Provisional Crown Material in Chlorhexidine Gluconate on Dental Plaque Formation in Vivo

Conditions
-----------------
Dental Plaque

Intervention / Treatment
-----------------
* Procedure: saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any volunteer without systemic condition Exclusion Criteria: Intake of antibiotic drug three months prior to experiment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calibration of a preventative protocol for biofilm formation measured by confocal scanning laser microscope and scanning electron microscope |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chlorhexidine gluconate, polymethylmethacrylate, Anti-Bacterial Agents
Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia However, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. This highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal. This study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in Egyptian patients.

Official Title
-----------------
Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients

Conditions
-----------------
Acute Coronary Syndrome, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Beta-blockers naïve patients Patients been on beta-blocker therapy for at least 4 weeks. Age (18-75) Years old. Exclusion Criteria: Non-Egyptians. Kidney failure of any stage. Liver failure of any stage. Malignancy. Pregnancy. HR < 55 beats/min (in the absence of b-blocker therapy). Presence of a cardiac pacemaker.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| beta blocker navie patients with acute coronary syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adrenergic receptors genes and blood pressure response to beta-blocker | Investigate the association of the adrenergic receptor polymorphisms with reduction in blood pressure (expressed in units of millimeters of mercury mmHg ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy. | Three months | 
| Adrenergic receptors genes and heart rate response to beta-blocker | Investigate the association of the adrenergic receptor polymorphisms with reduction in heart rate (expressed as beats per minute BPM ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy. | Three months |
Subcutaneous Amifostine Safety Study

Study Overview
=================
Brief Summary
-----------------
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Official Title
-----------------
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Conditions
-----------------
Head and Neck Cancer, Lung Cancer, Lymphoma

Intervention / Treatment
-----------------
* Drug: Amifostine administered subcutaneously


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Institutional criteria for administration of amifostine Radiation therapy ECOG PS of at least 2 No distant mets Granulocyte count greater than 2000 Platelet count greater than 100,000 Creatinine less than 2.0 Exclusion Criteria: Allergy to amifostine Life expectancy less than 6 mos Investigational drug within last 4 weeks

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amifostine administered subcutaneously|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nausea/vomiting |  |  | 
| Incidence of hypotension |  |  | 
| Incidence of generalized skin rash |  |  | 
| Incidence of injection-site skin toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amifostine, Mucositis, Nausea, Hypotension, Rash