linjc16/ctgov huggingface dataset:
Ranibizumab for Diabetic Traction Retinal Detachment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

Official Title
-----------------
The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment

Conditions
-----------------
Diabetic Retinopathy, Retinal Detachment

Intervention / Treatment
-----------------
* Drug: Ranibizumab
* Other: Sham injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy. Exclusion Criteria: Massive vitreous hemorrhage preventing from detailed posterior pole examination; Previous intra-ocular surgery other than cataract surgery Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin Prothrombin time, partial thromboplastin time or platelet count without normal limits History of previous thromboembolic events

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RANI/PPV<br>Preoperative intravitreal ranibizumab and pars plana vitrectomy | Drug: Ranibizumab<br>* Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy<br>* Other names: Lucentis;|
| Placebo Comparator: PPV<br>Sham injection and pars plana vitrectomy | Other: Sham injection<br>* Simulation of intravitreal injection one week before pars plana vitrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of intraoperative intra-ocular bleeding | amount of intra-ocular bleeding that occurred during pars plana vitrectomy | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Preoperative Ranibizumab, pars plana vitrectomy
the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy

Study Overview
=================
Brief Summary
-----------------
early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice ,so we design this trial to answer the priority of each options.

Detailed Description
-----------------
early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice as part of quality of life ,so we design this clinical randomised trial to answer the priority of each options.

Conditions
-----------------
Voice Quality

Intervention / Treatment
-----------------
* Procedure: surgery
* Radiation: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early laryngeal cancer Exclusion Criteria: No history of radiotherapy and collagen vascular disease
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiotherapy<br>patients receive radiotherapy | Radiation: radiotherapy<br> <br> |
| Experimental: surgery<br>Patients undergo surgery | Procedure: surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of voice |  | 3 to 6 month after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 6 month later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngeal cancer, RADIOTHERAPY, Voice Quality
Health Related Quality of Life of Youth and Young Adults With Hemophilia A

Study Overview
=================
Brief Summary
-----------------
The relevance of the study will be in establishing whether Health Related Quality of Life (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant changes in health or personal circumstances related to the transition from youth to adulthood. This may support the future use of HRQoL measures as part of routine care in order to identify important changes that are not detectible by other clinical means.

Official Title
-----------------
A Prospective Non-Interventional Study to Describe Health Related Quality of Life of Youth and Young Adults With Moderate or Severe Hemophilia A Using Recombinant Factor VIII (Helixate FS).

Conditions
-----------------
Hemophilia A

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate or severe Hemophilia A (factor level ≤5%) Receiving Helixate FS as on-demand treatment or prophylaxis therapy at time of informed consent Patient age 14 to 29 years at the time of recruitment Complete informed consent process and documentation; (Patients under age 18 must assent in addition to consent of legal guardian) Willing/able to follow study protocol, including keeping a bleeding and treatment diary Able to communicate clearly in either English or French - both written and verbal communication is essential. Exclusion Criteria: Known inhibitor at time of recruitment (> 0,5 Bethesda units) or immune tolerance therapy at time of recruitment HIV positive Symptomatic Hepatitis B or C infection or active treatment for hepatitis B or C Inability to comply with study protocol Hypersensitivity to Helixate FS or to any ingredients in the formulation or component of the container Hypersensitivity to mouse or hamster protein Unsuitable to participate in study for any other reason as assessed by investigator

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who have moderate or severe Hemophilia A, living in Canada and who are using Helixate FS either on-demand or prophylaxis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (HRQoL) |  | Every 6 months over 2 to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of HRQoL measures to significant life events |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, HRQoL, Hemophilia A, Helixate FS
Chronic Stress as a Risk Factor in the Etiology of Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
To conduct a prospective, longitudinal, analysis of the psychophysiological effects of chronic exposure to environmental stress. The study took advantage of a unique, naturally occurring experiment caused by the relocation of a major international airport.

Detailed Description
-----------------
DESIGN NARRATIVE: Studies were conducted on blood pressure and the neuroendocrine effects of noise resulting from the relocation of the Munich International Airport. At the former airport site the investigators monitored people exposed to high levels of noise and then tracked these same individuals as their ambient environment became normal following the shutdown of the airport. At the new airport site, the opposite situation occurred: Individuals living in normal, quiet ambient conditions became exposed to loud aircraft noise. At both sites, control groups were formed who were not exposed to aircraft noise. The study piggybacked onto a German sponsored grant. NIH funds covered the costs of cardiovascular and psycho-physiological data analysis. Measures included biochemical assays of chronic neuroendocrine markers of stress, resting blood pressure, and reactivity of blood pressure during cognitive tasks. Perceptions of community noise levels were also assessed as possible mediators of the stressful effects of chronic exposure to ambient, environmental noise. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted We investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.

Detailed Description
-----------------
There are many studies on the preventive use of Antibiotics or povidone iodine to Cardiovascular implantable electronic device (CIED) infections. But, studies of prophylactic use of hydrogen peroxide is still limited. We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.

Official Title
-----------------
Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Procedure: Hydrogen peroxide pretreatment group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for cardiac devices Implantation Exclusion Criteria: under the age of 18 Hydrogen peroxide allergy take an antibiotic History of infection within 30 days

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrogen peroxide pretreatment group<br>Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze. | Procedure: Hydrogen peroxide pretreatment group<br>* Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.<br>|
| No Intervention: Control group<br>No intervention group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom of cardiac device-related infection | check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG | 1 year after precedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac devices, prevention, infection
Interaction Between Fluvoxamine and Sildenafil

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Detailed Description
-----------------
In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).

Official Title
-----------------
Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males

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

Intervention / Treatment
-----------------
* Drug: sildenafil, fluvoxamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, male individuals, age: 18-45. Able and willing to give written informed consent Exclusion Criteria: Hypotension ( 65 mmHg diastolic and  100 mmHg systolic blood pressure) Bleeding disorders in medical history Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking) Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie's disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia) Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case) alcohol (>30 g/d) or drug abuse Acute or chronic illness Blood donation within the preceding 2 months Participation in clinical trial within 2 month before the study Drug and/or alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sildenafil, fluvoxamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-induced changes of hand vein compliance |  |  | 
| Drug-induced changes of pharmacokinetic parameters |  |  |
Breast Cancer During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.

Official Title
-----------------
Observational Study of Breast Cancer Diagnosed During Pregnancy

Conditions
-----------------
Pregnancy, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with breast cancer diagnosed during pregnancy Exclusion Criteria: Patients who refuse informed consent

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject study<br>Patients with breast cancer during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal results | Gestational age, weight, Apgar, blood tests | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal outcome | Over all survival, disease free survival | 5 year and 10 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Breast Cancer, Chemotherapy, Surgery, Obstetric managment
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Study Overview
=================
Brief Summary
-----------------
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

Official Title
-----------------
Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)

Conditions
-----------------
Adult Acute Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Asparaginase
* Drug: Vincristine
* Drug: Daunorubicin, Adriamycin
* Drug: Cyclophosphamide
* Drug: Ifosfamide
* Drug: Cytarabine
* Drug: Mitoxantrone
* Drug: Methotrexate
* Drug: 6-Mercaptopurine
* Drug: 6-Thioguanine
* Drug: VM26
* Drug: Dexamethasone / Prednisolone
* Procedure: CNS Irradiation
* Procedure: Mediastinal Irradiation
* Procedure: Stem Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Lymphocytic Leukemia Age 15 - 65 years Exclusion Criteria: Serious secondary diseases which may compromise intensified chemotherapeutical treatment Serious psychiatric diseases, which may compromise compliance with therapy HIV-1 or HIV-2 Infection Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids Patients without central diagnosis who cannot be allocated to a risk group

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Asparaginase|nan|
|Drug: Vincristine|nan|
|Drug: Daunorubicin, Adriamycin|nan|
|Drug: Cyclophosphamide|nan|
|Drug: Ifosfamide|nan|
|Drug: Cytarabine|nan|
|Drug: Mitoxantrone|nan|
|Drug: Methotrexate|nan|
|Drug: 6-Mercaptopurine|nan|
|Drug: 6-Thioguanine|nan|
|Drug: VM26|nan|
|Drug: Dexamethasone / Prednisolone|nan|
|Procedure: CNS Irradiation|nan|
|Procedure: Mediastinal Irradiation|nan|
|Procedure: Stem Cell Transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate, disease free survival, overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death in induction, toxicity, time and dose compliance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL, Treatment, De Novo, Adult
Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)

Study Overview
=================
Brief Summary
-----------------
A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.

Official Title
-----------------
Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma

Conditions
-----------------
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides

Intervention / Treatment
-----------------
* Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher) Age: over 18 years of age Have the ability to swallow capsules. You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment. Patients also require adequate heart, liver, and kidney function. Exclusion Criteria: Pregnant and nursing women and those with known allergy to the study drug are excluded from this study. Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy. Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate in patients with progressive, persistent, or recurrent disease. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CTCL