linjc16/ctgov huggingface dataset:
Seroquel Long-Term NIS for Schizophrenia Patients

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder

Official Title
-----------------
24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR The patient is between 18 and 65 years old(extremes included) On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation Exclusion Criteria: The patients who have known hypersensitivity to quetiapine

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?
-----------------
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
-----------------
Schizophrenia, Schizoaffective, quetiapine, long-term efficacy, Naturalistic, Observational
A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain

Study Overview
=================
Brief Summary
-----------------
A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.

Official Title
-----------------
A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: 0.9% NaCl (sodium chloride)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has signed the informed consent form prior to screening Age 18-74 years at screening (both included) Exclusion Criteria: Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit Previous participation in this trial. Participation is defined as having received at least one injection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-diabetes medication<br>Insulin | Other: 0.9% NaCl (sodium chloride)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injection pain |  | within 24 hours after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variability of injection pain |  | within the first 24 hours after injection |
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula

Study Overview
=================
Brief Summary
-----------------
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.

Official Title
-----------------
Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Device: reinforce soft tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent primary or recurrent trans-sphincteric anal fistula Exclusion Criteria: Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure Fistula with multiple tracts Recto-vaginal fistula Active infection in the anal fistula Physical allergies or cultural objections to porcine products Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician Previous diagnosis of collagen disorder History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region

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 |
| --- | --- |
| LIFT+Biodesign<br> | Device: reinforce soft tissue<br>* reinforce soft tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of the anal fistula |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of the anal fistula |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal fistula, Ligation of the intersphincteric fistula tract, LIFT, Tissue graft
Allergic Transfusion Reactions in Plasma Transfusion

Study Overview
=================
Brief Summary
-----------------
Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.

Detailed Description
-----------------
Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. Samples from patients and plasma units will be investigated. Samples frozen until investigation. To assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire . In-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.

Official Title
-----------------
Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion

Conditions
-----------------
Allergy, Transfusion Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving plasma transfusion Exclusion Criteria: - Patients not able to complete sampling procedure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| plasma transfusion<br>Patients receiving plasma transfusion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in concentration of allergen specific Immunoglobin E antibodies | Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated daily during hospital stay (anticipated up to 14 days), and 4, 6 and/or 8 weeks after transfusion. | Baseline and up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in basophil reactivity measured by flow cytometry | Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated during hospital stay, and 4, 6 and/or 8 weeks after transfusion. | Baseline and up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasma transfusion, allergic transfusion reaction, transfusion reaction, blood transfusion, Solvent detergent plasma
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Primary: To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently. Secondary Objectives: To describe the safety and tolerability at this dose and schedule

Official Title
-----------------
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Conditions
-----------------
Urologic Neoplasms

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients: Who are 18 years of age and older Who have histologically documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure Exclusion Criteria:Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an orchiectomy Any patient with painful bone metastases Who have received chemotherapy for prostate cancer Who have a abnormal serum creatine >2.5 Receiving any investigational drug within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded History of non compliance to medical regimens or unwillingness to return for medical visits

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

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

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: Zoledronic Acid with Intermittent Hormonal Therapy<br> | Drug: zoledronic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the safety and tolerability at this dose and schedule |  |  |
Pre-flight Titration of Supplemental Oxygen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if supplemental oxygen during air travel can be reliably titrated using a Hypoxia-altitude simulation test (HAST). Also, the effect of oxygen supplementation given with the various oxygen equipment allowed for air travel is studied.

Detailed Description
-----------------
International guidelines recommend supplemental oxygen if PaO2 < 6.7 kPa (50 mmHg) during air travel. Hypobaric chamber exposure is the ideal test but is not widely available. In clinical practice, the HAST has been recommended as the preferable test for pre-flight evaluation, and is used with increasing frequency. The oxygen dose during air travel has been recommended titrated during HAST. In the study, supplemental oxygen titration during hypobaric chamber exposure is compared to oxygen titration during HAST, to evaluate if HAST can be used with confidence to titrate the amount of supplemental oxygen needed during air travel.

Official Title
-----------------
COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen

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

Intervention / Treatment
-----------------
* Other: Pre-flight test with supplemental oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients who have performed a Hypoxia-altitude simulation test with a PaO2 < 6.7 kPa Exclusion Criteria: exacerbation or pneumothorax within the previous six weeks LTOT anemia pulmonary disease other than COPD cerebrovascular or symptomatic cardiovascular disease claustrophobia inability to equalize pressure in the middle ear

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

| Intervention/Treatment |
| --- |
|Other: Pre-flight test with supplemental oxygen|The Hypoxia-altitude simulation test, which is established in clinical practice, is compared to the gold standard of hypobaric chamber while giving supplemental gaseous oxygen without and with oxygen conserving device, and with oxygen concentrator.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 obtained from oxygen titration during HAST vs hypobaric chamber |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxygen, Hypoxemia, Air travel
Transplantation of Ovarian Cortex to Restore Fertility

Study Overview
=================
Brief Summary
-----------------
Ovarian transplantation has been shown to restore fertility.

Detailed Description
-----------------
The investigators transplant ovarian cortex previously collected from the patient prior to cancer treatment.

Official Title
-----------------
Transplantation of Ovarian Cortex to Restore Fertility

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Procedure: ovarian transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who froze ovarian tissue Exclusion Criteria: malignant cells in ovary

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 54 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fertility restoration by transplantation<br>fertility restoration by transplantation of ovarian cortex slivers that were cryopreserved prior to chemotherapy | Procedure: ovarian transplantation<br>* ovarian transplantation<br>* Other names: frozen thawed ovarian cortex transplantation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy | we will start IVF within 3 months | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovary, cortex, transplantation
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy. PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

Detailed Description
-----------------
OBJECTIVES: Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis. OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy. PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.

Official Title
-----------------
A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis

Conditions
-----------------
Radiation Fibrosis

Intervention / Treatment
-----------------
* Drug: pirfenidone


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities) At least moderate impairment in at least 1 of the following principal functional abilities: Range of motion Strength Edema Swallowing Prior radiation for cancer received more than 6 months ago No evidence of recurrent or metastatic cancer No history of collagen vascular disease No positive antinuclear antibody PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Hepatitis B and C negative Renal: Not specified Other: HIV negative No evidence of second primary cancer No life-threatening situation requiring rehabilitation intervention Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy Chemotherapy: No concurrent anticancer chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: See Disease Characteristics No concurrent anticancer radiotherapy Surgery: Not specified Other: No other concurrent anticancer investigational agents Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed

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: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pirfenidone|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
-----------------
radiation fibrosis
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring: changes in brachial artery flow-mediated dilatation (FMD) and changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period. HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.

Official Title
-----------------
Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Dehydroepiandrosterone (DHEA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Member of the Michigan Lupus Cohort Meet the American College of Rheumatology (ACR) criteria for SLE Premenopausal Exclusion Criteria: Smoker Diabetic Prednisone dose > 10 mg

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dehydroepiandrosterone (DHEA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery reactivity, by flow mediated dilatation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in biomarkers of SLE |  |  | 
| Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic Lupus Erythematosus, Dehydroepiandrosterone (DHEA), DHEA, SLE, Lupus