linjc16/ctgov huggingface dataset:
Phentermine/Gastric Band Weight Loss Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.

Official Title
-----------------
Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Phentermine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult age 18-65 BMI 35-55 Approved for gastric band operation Exclusion Criteria: A known allergy to Phentermine Take medications for Attention Deficit Disorder (ADD) Monoamine oxidase inhibitors (MAOI)for depression Selective serotonin reuptake inhibitor (SSRIs)for depression History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias Hyperthyroidism Glaucoma Psychosis History of drug abuse Uncontrolled hypertension (diastolic >85)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure | Other: Placebo<br>* daily for one year<br>|
| Experimental: Phentermine<br>Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure | Drug: Phentermine<br>* Subjects will receive Phentermine 37.5mg everyday for one year<br>* Other names: Adipex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes are total weight loss and excess weight |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes is resolution of preoperative comorbidities |  | one year |
Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.

Official Title
-----------------
A Phase 2/3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Adalimumab in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was age 20 or older and in good health (Investigator discretion) with a recent stable medical history. Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis Exclusion Criteria: Subject had previously received anti-TNF therapy. Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVA, UVB or PUVA phototherapy Subject is taking or requires oral or injectable corticosteroids Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with clinical response relative to Baseline PASI score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoLs |  |  | 
| Clinical response indicators |  |  | 
| Safety parameters |  |  |
Study of Low Bone Mass in Premenopausal or Perimenopausal Women

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo physical examination and complete history with emphasis on risk factors for osteoporosis and screening for occult secondary causes of osteoporosis through blood serum and 24 hour urine collection. Patients with more than 6 months since prior bone mineral density measurements or who did not receive measurements at participating center, undergo dual energy x-ray absorptiometry over 30 minutes for bone mineral density measurements.

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Low bone mass (T score less than -2.0) with no secondary cause on routine exam Premenopausal OR Perimenopausal --Prior/Concurrent Therapy-- Chemotherapy: No prior or concurrent chemotherapeutic agents Endocrine therapy: No prior or concurrent glucocorticoids or suppressive doses of thyroid hormone Other: No prior or concurrent anticonvulsants --Patient Characteristics-- Hematopoietic: No multiple myeloma Other: No hyperparathyroidism No thyrotoxicosis No anorexia nervosa No Paget's disease of bone No rheumatoid arthritis No Cushing's syndrome No malabsorption syndrome No type I diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 54 Years

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

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
-----------------
disease-related problem/condition, osteoporosis, rare disease
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Study Overview
=================
Brief Summary
-----------------
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

Detailed Description
-----------------
A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Official Title
-----------------
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Drug: Stannous Fluoride Toothpaste
* Drug: Colgate fluoride toothpaste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female volunteers aged 18-70 years In good general health, ASA I No clinical signs of gingival inflammation at >90% sites observed Probing Depth (PD) < 3.0 mm Attachment Loss (AL) = 0 mm No periodontal disease history Non-smokers Fluent in English Exclusion Criteria: Presence of orthodontic bands. Presence of partial removal dentures. Tumour(s) of the soft or the hard tissues of the oral cavity. Cavitated carious lesions requiring immediate restorative treatment. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study. Participation in any other clinical study or test panel with a one month period prior to entering the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stannous fluoride test toothpaste<br>Currently marketed as the new Colgate Total SF containing Stannous Fluoride | Drug: Stannous Fluoride Toothpaste<br>* 0.454% stannous fluoride toothpaste<br>* Other names: Colgate Total SF;|
| Placebo Comparator: Colgate flouride toothpaste<br>Colgate Dental Cream containing Stannous Sodium Fluoride | Drug: Colgate fluoride toothpaste<br>* 0.76 % Sodium MonoFluorophosphate (MFP)<br>* Other names: Colgate Dental Cream;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Index (BOP) and Oral Inflammatory Load | BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses | during patient visit over the 9 weeks |
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the influence of the use of different types of phototherapy on different lymphocytes subsets CD4 and CD8 in the treatment of hyperbilirubinemia in neonates.

Official Title
-----------------
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia

Conditions
-----------------
Neonatal Hyperbilirubinemia, Phototherapy Complication

Intervention / Treatment
-----------------
* Device: phototherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term neonates with a gestational week higher than 37weeks, according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns are determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present. Clinically significant indirect hyperbilirubinemia requiring phototherapy in the first week of life. No pathologic etiological factors for hyperbilirubinemia Exclusion Criteria: Total bilirubin level of >20 mg/dl. Prematurity. Sepsis. Congenital anomaly. Elevation in direct bilirubin level. History of immune deficiency the family. History of preeclampsia or any other diseases or drug use of the mother

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional phototherapy<br>neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy | Device: phototherapy<br>* estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy<br>|
| Active Comparator: LED phototherapy<br>neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy | Device: phototherapy<br>* estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets | Detection of CD4 and CD8 absolute counts(x10³/uL) : was done before and 48 hours after phototherapy and for controls at time of examination using monoclonal antibodies and measured by flow cytometry | 2 days |
Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

Study Overview
=================
Brief Summary
-----------------
Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective evidence for such conclusion is lacking. There is no study comparing swallowing and voice after total and partial arytenoidectomy.

Detailed Description
-----------------
Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy

Official Title
-----------------
The Comparison of Voice and Swallowing Parameters After Endoscopic Total and Partial Arytenoidectomy Using Medially Based Mucosal Advancement Flap Technique for Bilateral Abductor Vocal Fold Paralysis: A Randomized Trial

Conditions
-----------------
Airway Obstruction, Vocal Cord Paralysis

Intervention / Treatment
-----------------
* Procedure: Total arytenoidectomy
* Procedure: Partial arytenoidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral vocal fold paralysis Exclusion Criteria: Previously operated patients

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total arytenoidectomy<br>Endoscopic total arytenoidectomy was performed on patients. | Procedure: Total arytenoidectomy<br>* Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis<br>|
| Experimental: Partial arytenoidectomy<br>Endoscopic partial arytenoidectomy was performed on patients. | Procedure: Partial arytenoidectomy<br>* Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decannulation | Preoperative examinations were repeated 1 year after surgery. | From the day of operation until 52 weeks after arytenoidectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation | The duration of operation was measured in minutes at the day of operation. | At the day of operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vocal cords, Vocal cord paralysis, Arytenoid cartilage
Reactive Neuromuscular Training Effects on Side Bridge Endurance Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of reactive neuromuscular training on muscular endurance test.

Conditions
-----------------
Balance

Intervention / Treatment
-----------------
* Device: Rehabilitation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants with no history of balance problems, ages 20 - 40. Exclusion Criteria: Lower extremity injury, surgery, visual, or vestibular condition that would effect balance? Unstable joints of the lower extremity infections, injuries or other malignancies affecting the lower extremity?

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Rehabilitation device|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
-----------------
Rehabilitation, Side Bridge test, Muscular endurance
Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV. Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure; Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay; Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.

Official Title
-----------------
The Value of Electrocardiographic Autonomic Nervous System Function Measures for Predicting Cardiopulmonary Recovery of Mechanically Ventilated Patients in Intensive Care

Conditions
-----------------
Disorders of the Autonomic Nervous System, Cardiovascular Abnormalities, Respiratory Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving mechanical ventilation in medical-surgical intensive care unit; Eighteen years of age or older; Expectation of receiving initial spontaneous breathing trial within the next 24 hours. Exclusion Criteria: Pregnant; Expectation of non-survival when ventilator is discontinued; Cardiac rhythm of atrial fibrillation; Paced cardiac rhythm.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
Heart rate variability, mechanical ventilation, weaning,, spontaneous breathing trial
Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD

Official Title
-----------------
Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)

Conditions
-----------------
Age-Related Macular Degeneration (ARMD)

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 50 years of age or greater who have provided written informed consent Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320) Willing to return for all scheduled visits Exclusion Criteria: - Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters) Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 50 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: ranibizumab|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
-----------------
ARMD, ranibizumab, verteporfin