linjc16/ctgov huggingface dataset:
Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent

Official Title
-----------------
Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III, IV SCCHN Completed curative treatment Exclusion Criteria: Prior chemotherapy or radiotherapy Recurrent disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Erlotinib<br>* 150 mg per day orally until disease progression occurs, up to a maximum of 12 months<br>* Other names: Tarceva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One Year Disease Free | Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squamous cell cancer of head and neck, SCCHN
The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare the sensitivity and specificity of a new system for analyzing the electrocardiogram (ECG) to the sensitivity and specificity of a conservative treadmill test in asymptomatic subjects, classified by Framingham score as moderate to high risk. Subjects will perform a routine exercise test with the addition of another set of electrodes to record high resolution ECG. All subjects will perform a stress echocardiography. The result of the routine ECG analysis will be compared to the new system and to the echocardiography results.

Official Title
-----------------
The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient referred to annual screening check Classified as being at intermediate or high risk for the development of cardiovascular disease by the Framingham score. Signed an Informed Consent Form Exclusion Criteria: A subject who cannot or should not perform an exercise test.
Sexes Eligible for Study
-----------------
All

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

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
-----------------
Asymptomatic subjects, Moderate to high risk for cardiovascular event
Liver Glycogen Dynamics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores

Official Title
-----------------
Liver Glycogen Dynamics and Substrate Oxidation in Lean Healthy Volunteers

Conditions
-----------------
Hepatic Glycogen

Intervention / Treatment
-----------------
* Behavioral: Overnight fasting duration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are able to provide signed and dated written informed consent prior to any study specific procedures Caucasian (people will be excluded when having a ≥50% racial African/Asian background) Participants should have suitable veins for cannulation or repeated venipuncture Women are post-menopausal (defined as at least 1 year post cessation of menses) Men and women aged ≥ 45 and ≤ 75 years at the start of the study Body mass index (BMI) 18.5 - 25 kg/m2 Stable dietary habits (no weight loss or gain >3kg in the past 3 months) Sedentary lifestyle (not more than 3 hours of vigorous sports per week) Exclusion Criteria: Type 2 Diabetes Mellitus Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other) Any contraindication for MRI scanning Alcohol consumption of >2 servings per day Regular smoking No use of medication interfering with investigated study parameters (as determined by responsible physician) Participants who do not want to be informed about unexpected medical findings, or do not wish that their physician

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short overnight fast<br>Overnight fasting duration intervention: Participants will receive their last evening meal at 11 pm and stay overnight fasted afterwards for (9.5h). | Behavioral: Overnight fasting duration<br>* Subjects will adhere to overnight fasting protocol for 1 day<br>|
| Experimental: Long overnight fast<br>Overnight fasting duration intervention: Participants will receive their last evening meal at 4.30 pm and stay overnight fasted afterwards for (16h). | Behavioral: Overnight fasting duration<br>* Subjects will adhere to overnight fasting protocol for 1 day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic glycogen content | Measured with 13C-MRS | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substrate oxidation | Measured as RQ | 14 hours |
Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fasting Conditions

Conditions
-----------------
Hypertension, Chronic Stable Angina, Vasospastic Angina

Intervention / Treatment
-----------------
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Twenty-one day washout |
Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment

Study Overview
=================
Brief Summary
-----------------
14 patients having recent anterior mandibular fracture divided into two groups. Group A has 6 patients and treated using Herbert bone screw, and group B has 6 patients and treated using lag screw. Clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. In addition, a radiographic investigation was performed after twelve weeks to estimate the mean bone density across the fracture line.

Official Title
-----------------
Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)

Conditions
-----------------
Mandibular Fractures

Intervention / Treatment
-----------------
* Other: Herbert screw
* Other: Lag screw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients suffering from recent, uninfected anterior mandibular fracture. Adult patients from 20-60 years old with no gender predilection agreed to present for follow-up visits for a minimum postoperative period of 3 months. Fracture that demands open reduction and internal fixation. Exclusion criteria Medically compromised patients contradicting operations. Existence of infection at the fracture line. Pathological fracture. An old fracture. Completely edentulous patient

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Herbert screw<br> | Other: Herbert screw<br>* Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion and application of Herbert screw<br>|
| Active Comparator: Lag screw<br> | Other: Lag screw<br>* Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion. Application of either lag screw according to Champy's osteosynthesis lines.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone density | By using digital orthopantomogram bone density was evaluated | baseline and 3 months | 
| change in pain scores | assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) | 24 hours, 1 week , 4 Weeks and 6 weeks | 
| presence of Intra-fragmentary mobility | assessed by bi-manual palpation across the fracture site | 24 hours |
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.

Official Title
-----------------
Addressing HIV Risk in Young Unhealthy Alcohol Drinkers in the Emergency Department With Rapid HIV Testing and Brief Intervention

Conditions
-----------------
Alcohol Consumption, Sexual Risk Behaviors

Intervention / Treatment
-----------------
* Behavioral: Counseling intervention with rapid HIV testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years old; engaged in at least one sexual risk behavior in past 90 days; alcohol consumption greater than NIAAA guidelines for at-risk drinking; unknown or negative HIV status and willing to be tested; able to provide contact information for follow-up; able to provide written informed consent. Exclusion Criteria: known HIV positive status; medically or psychiatrically unstable.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Behavioral: Counseling intervention with rapid HIV testing<br>* Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | number of patients enrolled and retained at 2 months. | baseline and 2 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol consumption | As assessed by the Time Line Follow Back, change in alcohol consumption. | baseline vs. 2 month follow-up | 
| Sexual risk behaviors | As assessed by an adapted HIV Risk Behaviors Scale, change in sexual risk behaviors. | baseline vs. 2 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol consumption, sexual risk behaviors, young, unhealthy drinkers
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

Study Overview
=================
Brief Summary
-----------------
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.

Official Title
-----------------
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

Conditions
-----------------
Ureteral Stent Discomfort

Intervention / Treatment
-----------------
* Drug: Alfuzosin Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Undergoing unilateral retrograde ureteroscopy with ureteral stent placement Exclusion Criteria: Significant ureteral trauma Concomitant ESWL or other secondary surgical procedure than may impact patient comfort Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets. Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study Undergoing bilateral ureteral stenting Undergoing antegrade ureteral stenting Undergoing simultaneous extracorporeal shockwave lithotripsy Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis) Primary bladder dysfunction that would impact ability to void without a catheter Neurologic dysfunction that would impair pain sensation History of chronic pain or substance abuse Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased Other alpha-blockers Phosphodiesterase type 5 inhibitors for erectile function Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study.

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfuzosin Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of study medication on urinary symptoms and quality of life |  |  | 
| usage of analgesics/narcotics |  |  |
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety, tolerability and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during the treatment of osteoporosis in men and postmenopausal women.

Official Title
-----------------
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or postmenopausal women who are osteoporotic Exclusion Criteria: Vitamin D deficiency Other disease of bone or mineral metabolism Digestive disease causing malabsorption Other significant medical conditions that are not adequately treated

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment. |  |  |
Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

Study Overview
=================
Brief Summary
-----------------
This study investigate the progression of labour in 144 normal weight pregnant women (BMI <30) and 144 obese pregnant women (BMI >30) , not in labor admitted for induction of labor. These women are to be investigated for success of induction of labor.

Detailed Description
-----------------
This prospective study will be conducted for 144 obese and 144 non obese ), post date (>41 wks), not in labor. Woman is classified as obese if BMI >=30. Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation. First informed consent will be obtained. Determination of gestational age Proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score. And obstetric U/S scan will be done and by which the following data will be obtained : Fetal biometry Fetal heart activity Presentation Localization of the placenta. Amount of amniotic fluid. Exclude multifetal pregnancy. Induction of labor will be done using vaginal misoprostol according to the estimated Bishop score.

Official Title
-----------------
Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

Conditions
-----------------
Obesity, Induced; Birth

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman. Post date >= 41 weeks. Absent onset of labor. Patient acceptance to join the study after signing an informed consent. Exclusion Criteria: Placenta previa and or vasa previa. Previous caesarean section(CS). Multiple gestation Any patient who will refuse to be a part of the study. Intra- uterine fetal death (IUFD).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non obese<br>BMI<30. Misoprostol is given for induction of labour according to Bishop score | Drug: Misoprostol<br>* Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups<br>|
| obese<br>BMI>30. Misoprostol is given for induction of labour according to Bishop score | Drug: Misoprostol<br>* Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| route of delivery vaginal or caesarean section. | Partogram is used to access the progress of labour | 48 hours from the start of induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal haemorrhage | Calculating number of soaked pads | 48 hours from the start of induction |