linjc16/ctgov huggingface dataset:
MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems

Study Overview
=================
Brief Summary
-----------------
Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.

Detailed Description
-----------------
This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.

Official Title
-----------------
Long-Term Effectiveness Trial for AMS Sling Systems

Conditions
-----------------
Stress Urinary Incontinence in Women

Intervention / Treatment
-----------------
* Device: MiniArc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise. Exclusion Criteria: Unwilling or unable to sign ICF Unable to understand the study or has a history of non-compliance with medical devices Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses Pelvic prolapse greater than grade 3 Is, in the investigator's opinion, otherwise unsuitable for the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MiniArc|sling system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress urinary incontinence in Women
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD

Study Overview
=================
Brief Summary
-----------------
Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.

Official Title
-----------------
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD

Conditions
-----------------
Dry Age-related Macular Degeneration, Detachment of the Posterior Hyaloid

Intervention / Treatment
-----------------
* Device: ultrasound
* Device: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry MD Age over 50 years Exclusion Criteria: Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole) Prior vitrectomy or buckle surgery Uveitis posterior, multifocal chorioiditis Pathologic myopia Diabetic retinopathy Visualization of the macula not possible (dens cataract, vitreous haemorrhage)

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Dry AMD<br>male or female persons aged over 50 years with dry age-related macular degeneration | Device: ultrasound<br>* A-scan and B-scan ultrasound at baseline and month 6,12,24<br>Device: OCT<br>* Volume scans of spectralis OCT at baseline and month 6,12,24<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance acuity |  | 24 months | 
| Age |  | 24 months | 
| Smoking |  | 24 months | 
| Obesity |  | 24 months | 
| Lesion classification (AREDS) |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macular degeneration, detachment of the posterior hyaloid, AMD
Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop fecal tests that will determine the extent of radiation exposure in patients undergoing radiation treatment for cancer. This project will determine whether fecal biomarkers can be used to diagnose exposure to radiation.

Detailed Description
-----------------
Patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have feces collected for use in the validation and refinement of new methods for rapid radiation biodosimetry. The stool samples will be collected before, and at defined times after TBI. Stool sampling will occur in the same manner that it does during routine patient care during HSCT.

Official Title
-----------------
Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Conditions
-----------------
Total-body Irradiation, Hematopoietic Stem Cell Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All races are eligible 2 years to 21 years old Must be undergoing hematopoietic stem cell transplantation (either autologous or allogeneic) in conjunction with a conditioning regimen that includes total-body irradiation (TBI) (single or multiple fraction).

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 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 |
| --- | --- |
| TBI prior to stem cell transplantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe changes in gene expression associated with exposure to radiation | Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces | prior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal biomarkers, Radiation biodosimetry, Total-body irradiation (TBI), Hematopoietic stem cell transplantation, Gene expression profiles, Fecal metabolites
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients

Study Overview
=================
Brief Summary
-----------------
This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.

Detailed Description
-----------------
Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.

Official Title
-----------------
A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

Conditions
-----------------
Leukemia, Lymphoma, Tumor Lysis Syndrome, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Rasburicase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of hematologic malignancy. Existing hyperuricemia or high risk of developing hyperuricemia of malignancy. The treating clinician plans to treat the patient with rasburicase. A patient is only eligible for RASALL if the clinician has already decided to use rasburicase. Rasburicase should not be given in order to make a patient eligible for this non-therapeutic observational study. No prior exposure to rasburicase or other urate oxidase. A history of asthma or significant allergy. Exclusion Criteria Wheezing or an active hypersensitivity reaction at entry. Hypersensitivity to Aspergillus proteins.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Drug: Rasburicase<br>* Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 3 or 4 allergic reactions |  | Within 30 days of last treatment administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leukemia
Naltrexone Augmentation of Nicotine Patch Therapy - 1

Study Overview
=================
Brief Summary
-----------------
Naltrexone Augmentation of Nicotine Patch Therapy

Detailed Description
-----------------
This double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. Eligible participants will receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.

Official Title
-----------------
Naltrexone Augmentation of Nicotine Patch Therapy

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Willingness and ability to give written consent Smoking 20 cigarettes per day for at least 1 year At least one prior attempt to stop smoking Baseline expired carbon-monoxide level of at least 10 ppm Weigh at least 100 lbs. English speaking One person per household Exclusion Criteria: Pregnant or nursing women or women who do not use a reliable form of birth control Unstable cardiac disease History of dermatoses Current alcohol dependence Current use of opiates A urine drug screen that is positive for opiates Serious current neurologic, psychiatric or medical illness Chronic pain conditions necessitating opioid treatment Evidence of significant hepatocellular injury as evidence by SGOT or SGPT >3 x normal or elevated bilirubin Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naltrexone|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
-----------------
nicotine dependence
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Study Overview
=================
Brief Summary
-----------------
Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal findings of improvement of hair appearance after PRFM injection in the scalp suggest that PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density will be assessed by comparing pre- and post-treatment photographs and non-invasive measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.

Official Title
-----------------
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Biological: PRFM treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18- 75 years old frontal and/or crown alopecia Exclusion Criteria: bleeding disorder

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

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

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

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: Treatment with PRFM<br>Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject. | Biological: PRFM treatment<br>* Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Density Change After Three Treatments | Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer. | 6 months after initial visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alopecia
Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.

Official Title
-----------------
Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician Patient willing to sign informed consent Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels Exclusion Criteria: Subjects with diagnosed type 1 diabetes mellitus Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits) Subjects with hypersensitivity to Levemir® or to any of the ingredients Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.

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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.<br>* Other names: NN304;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | after 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5% |  | after 12 weeks and 24 weeks | 
| Change in FPG (Fasting Plasma Glucose) |  | after 12 weeks and 24 weeks | 
| Change in body weight |  | after 12 weeks and 24 weeks | 
| Change in waist and hip circumference |  | after 12 weeks and 24 weeks |
Acupuncture for Infectious Mononucleosis Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate feasibility issues related to conducting an acupuncture study in a population of adolescents and young adults with infectious mononucleosis. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Detailed Description
-----------------
This study examines the feasibility of treating adolescents and young adults diagnosed with infectious mononucleosis with acupuncture. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Official Title
-----------------
Acupuncture for Infectious Mononucleosis Trial

Conditions
-----------------
Infectious Mononucleosis

Intervention / Treatment
-----------------
* Procedure: traditional Chinese acupuncture
* Other: standard medical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mono diagnosis confirmed by lab test 21 days or less between start of symptoms and diagnostic test presence of fatigue of at least 4/11 (by Chalder Fatigue Questionnaire) no other illnesses present meets residency requirement Exclusion Criteria: insufficient communication in English unable to begin acupuncture within 21 days of diagnostic test acupuncture use currently or in the preceding 3 months currently under the care of a TCM practitioner unwilling to be randomized

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 25 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Traditional Chinese acupuncture in conjunction with standard medical care | Procedure: traditional Chinese acupuncture<br>* 10 treatments over 6 weeks<br>|
| Active Comparator: Standard medical care<br>standard medical care | Other: standard medical care<br>* standard care as provided by primary physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chalder Fatigue Questionnaire |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOS SF-36 |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infectious mononucleosis, mono, acupuncture