linjc16/ctgov huggingface dataset:
Fixed Inclination Humeral Cut

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.

Official Title
-----------------
Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial

Conditions
-----------------
Shoulder Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Anatomical cut
* Procedure: Cutting guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients 18 years or older primary glenohumeral osteoarthritis intact rotator cuff primary anatomic shoulder arthroplasty Exclusion Criteria: revision arthroplasty reverse shoulder arthroplasty candidates cognitive or behavioral problems which would preclude informed consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anatomically-matched cut<br> | Procedure: Anatomical cut<br>* Surgeon-derived cut based on patient's anatomy<br>|
| Active Comparator: Cutting guide<br> | Procedure: Cutting guide<br>* Angle cut at 132.5 degrees based on cutting guide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radriographic measurements | x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement | x-rays taken day of surgery |
Assessment of Quality of Life in Hemophiliac Patients

Study Overview
=================
Brief Summary
-----------------
Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation factor VIII (in hemophilia A) or factor IX (in hemophilia B). The deficiency is the result of mutations of the respective clotting factor genes.

Detailed Description
-----------------
Hemophilia is rare, with only about 1 instance in every 10,000 births (or 1 in 5,000 male births) for hemophilia A and 1 in 50,000 births for hemophilia B. According to the World Federation of Hemophilia, 400 000 people worldwide & 5,307 people in Egypt are suffering from hemophilia. Hemophilia A is more common than hemophilia B, representing 80-85 % of the total hemophilia population. Signs and symptoms of hemophilia vary according to the level of clotting factors, mild, moderate and sever. Unexplained excessive bleeding from cuts or injuries Epistaxis without a known cause Many large or deep bruises Hamoarthritis Hematuria and Melena. Intracranial hemorrhage and death In infants, unexplained irritability it is subjective representation of health, including not only physical,mental and social, but also emotional and everyday life dimensions in terms of well-being. Several definitions of QoL have been provided, the definition of the WHO viewing QoL as 'individuals perceptions of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectation standards and concerns'

Official Title
-----------------
Assessment of Quality of Life in Hemophiliac Patients

Conditions
-----------------
Improvement of Quality of Life of Hemophiliac Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Hemophilia A & B Different age groups (pediatric - adolescence - adult ) Home or hospitalized treatment complications such as joint swelling , spontaneous bleeding, etc…. Exclusion Criteria: - 1- Other causes of bleeding tendency such as liver failure, DIC, anticoagulant drugs, etc.. 2- Diseases that affect joints such as osteoarthritis, SLE , etc.. 3- Mentally retarded patients.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation and improvement of quality of life of hemophiliac patients | by questionnaire | one year |
Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of training and testim on Hypogonadism.

Detailed Description
-----------------
The effect of testim and training in hypogonadal men.

Official Title
-----------------
The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men

Conditions
-----------------
Hypogonadism, Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Testim
* Behavioral: Strength training
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 65-78 Bioavailable testosterone < 7.3 nmol/L Waist > 94 cm Exclusion Criteria: Haematocrit > 0.50 Known c. prostate or PSA > 3 Myg/L Known malignant disease Alcohol or drug abuse BMI > 40 kg/m2 Use of 5 alpha reductance inhibitors Plan to father children

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 78 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>testim | Drug: Testim<br>* 50 mg/dose7day<br>* Other names: testosteron;|
| Experimental: 2<br>placebo | Drug: placebo<br>* placebo<br>* Other names: gel;|
| Experimental: 3<br>training | Behavioral: Strength training<br>* three times a week<br>* Other names: training;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass |  | january 2008-january 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone |  | january 2008-january 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body composition, Physical activity, Metabolic syndrome
Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Detailed Description
-----------------
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Official Title
-----------------
Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: rosiglitazone
* Drug: inhaled human insulin
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with OAD(s) for more than or equal to 2 months Body mass index of (BMI) less than or equal to 40.0 kg/m2 HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy Exclusion Criteria: Recurrent major hypoglycaemia Current smoking or smoking within the last 6 months Impaired hepatic or renal function Cardiac disorders Uncontrolled hypertension Proliferative retinopathy or maculopathy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, inhalation.<br>* Other names: NN1998;Drug: metformin<br>* Tablets, 2000 mg/day.<br>|
| Active Comparator: B<br> | Drug: rosiglitazone<br>* Tablets, 4 mg once or twice daily.<br>Drug: metformin<br>* Tablets, 2000 mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment difference in HbA1c |  | After 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | For the duration of the trial | 
| Body weight |  | For the duration of the trial | 
| Lung function |  | For the duration of the trial | 
| Blood glucose |  | For the duration of the trial | 
| Hypoglycaemia |  | For the duration of the trial |
Use of a New Stapling Device in General Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

Detailed Description
-----------------
A prospective study was conducted with 80 consecutive thoracic cases. Stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.

Official Title
-----------------
Use of a New Stapling Device in General Thoracic Surgery

Conditions
-----------------
Thoracic Cancer

Intervention / Treatment
-----------------
* Device: AEON Endostapler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing planned VATS or open lung resection surgery (lobectomy or wedge resection) Exclusion Criteria: Active bacterial or fungal infection Prior history of VATS or open lung surgery Use of staple line reinforcement material (buttress) Patients under the age of 18 on the date of the surgery Any female patient who is pregnant Scheduled concurrent surgical procedure other than lobectomy or wedge resection (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AEON Endostapler<br>Stapling performed with AEON Endostapler | Device: AEON Endostapler<br>* Surgery with AEON Endostapler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Product Malfunction | Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended. | Within surgery, up to 8 hours | 
| Number of Participants With Intraoperative Staple Line Bleeding | Number of participants with intraoperative staple line bleeding | Within surgery, up to 8 hours | 
| Number of Participants With Reported Device-related Adverse Events | Number of participants with reported device-related adverse events | Within 30-day post-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Hospital length of stay (days) | Following hospital admission, up to discharge | 
| Chest Tube Removal | Time before chest tube removal (days) | Following surgery, up to chest tube removal |
Single Dose Bronchodilatory Study in Asthma

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.

Official Title
-----------------
A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Zileuton extended release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma for at least 5 years FEV1 of 50-85% predicted Reversible airway obstruction Exclusion Criteria: Pregnant/nursing females Liver function tests greater than upper limit of normal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Other: Zileuton extended release<br>Oral, 1200 mg (2 x 600 mg tablets) | Drug: Zileuton extended release<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FEV1 |  | 12 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) |  | 72 Hours | 
| Number of Subjects With Adverse Events |  | 72 Hours |
Hyaluronic Acid and Vaginal Distress

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid in menopause women with vaginal distress for treatment vaginal distress.

Official Title
-----------------
Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study

Conditions
-----------------
Vaginal Disease

Intervention / Treatment
-----------------
* Other: hyaluronic acid pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopause vaginal distress no other therapy Exclusion Criteria: vaginal infection Sjogren Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hyaluroni acid pill<br> | Other: hyaluronic acid pill<br>* pill, 220 mg, once a day, three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of the oral somministration hyaluronic acid in menopause women with vaginal distress |  | three months |
The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

Study Overview
=================
Brief Summary
-----------------
Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic agents result in prolongation of the duration of the sensory and motor blockade induced by hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on the low-dose spinal anesthesia for the transurethral surgery.

Official Title
-----------------
The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

Conditions
-----------------
Transurethral Prostatectomy

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I or II Elective transurethral prostatectomy aged > 20 Exclusion Criteria: Coagulation deficiency infection on the back Congestive heart failure or arrythmia Chronic alcoholic disease Antidepressants therapy

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br>0.5% bupivacaine 1.2 mL + normal saline 0.8 mL = total 2 mL | Drug: Dexmedetomidine<br>* Dexamedetomidine intravenous injection (1 ㎍/kg )<br>* Other names: (generic name : Dexmedetomidine);|
| Placebo Comparator: saline<br> | Drug: Dexmedetomidine<br>* Dexamedetomidine intravenous injection (1 ㎍/kg )<br>* Other names: (generic name : Dexmedetomidine);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy

Study Overview
=================
Brief Summary
-----------------
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.

Official Title
-----------------
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy

Conditions
-----------------
Kidney Transplantation, Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-coated Mycophenolate sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney or liver transplanted patients Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events Exclusion Criteria: Recent graft rejection before the study Other pre-existing conditions that may cause gastro-intestinal complaints Use of other drugs known to cause gastro-intestinal complaints Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: Enteric-coated Mycophenolate sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-intestinal adverse events before switch versus 3 months after switch |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first biopsy-proven rejection after conversion. |  |  | 
| Severity of biopsy-proven rejections after conversion. |  |  | 
| Proportion of patients who had graft loss after conversion. |  |  | 
| Frequency of adverse events |  |  | 
| Frequency of infections |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enteric coated mycophenolate sodium, transplantation, gastrointestinal adverse events, Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment
Asthma, Missed Immunizations, and Vitamin D Deficiency in Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Atopic dermatitis is a chronic skin disease with pruritus as one of its main features. Because of the symptomatic nature of their condition, pediatric patients with atopic dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling behind in visits to their primary care provider. This cross-sectional study in patients attending the Dermatology Clinic at Children's Hospital of Wisconsin will screen for common conditions associated with atopic dermatitis and subsequently treat or refer patients for appropriate care. The investigators hypothesize that Milwaukee County pediatric patients with atopic dermatitis will have a high prevalence of asthma needing treatment, missed immunizations requiring catch-up, and vitamin D deficiency necessitating replacement therapy.

Official Title
-----------------
The Atopic Dermatitis Clinic as an Entry Point for Community Outreach in Asthma, Missed Immunizations, and Vitamin D Deficiency

Conditions
-----------------
Atopic Dermatitis, Vitamin D Deficiency, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with atopic dermatitis by a Children's Hospital of Wisconsin (CHW) pediatric dermatologist Age 1- 18 years old Primary residence in Milwaukee County Exclusion Criteria: Other chronic, systemic diseases other than asthma or environmental allergies Hyperimmunoglobulin E or Job syndrome Ichthyosis disorder other than ichthyosis vulgaris Prior systemic therapy or phototherapy for atopic dermatitis Ongoing or prior treatment for known Vitamin D deficiency On chronic systemic corticosteroids for asthma

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Atopic dermatitis<br>Pediatric patients ages 1-18 years old with atopic dermatitis | |

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
-----------------
Missed immunizations