linjc16/ctgov huggingface dataset:
Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America

Study Overview
=================
Brief Summary
-----------------
Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.

Official Title
-----------------
Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America

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

Intervention / Treatment
-----------------
* Drug: antiresorptive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a diagnosis of osteoporosis of at-Risk Have a medical indication to receive Ibandronate+Vitamine D+Calcium Exclusion Criteria: Osteoporosis due to secondary causes

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients on antiresorptive therapy<br>Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day | Drug: antiresorptive therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | 6 months | 
| Health-Related Quality of Life |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, ibandronate, vitamine D, calcium, bone mineral density, health-related quality of life
A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).

Official Title
-----------------
Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia/Hypochondroplasia Enrolled in the GH-1941 Study [Follow-up Survey]

Conditions
-----------------
Genetic Disorder, Achondroplasia

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Norditropin®<br> | Drug: somatropin<br>* Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy |  | At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor the patients to see if they undergo lower limb lengthening |  | At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age |
Pharmacologic Intervention for Postcessation Weight Gain

Study Overview
=================
Brief Summary
-----------------
To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum and phenylpropanolamine (PPA).

Detailed Description
-----------------
BACKGROUND: Despite the potential importance of weight gain to smoking relapse, in 1991 there had been virtually no success in eliminating, or even reducing, the weight gain following smoking cessation. Two promising pharmacologic methods for reducing postcessation weight gain were nicotine gum and an over-the-counter drug, phenylpropanolamine gum ([PPA]. However, the relative efficacy of these two drugs had never been evaluated and the mechanisms of action of both drugs on weight gain were unknown. DESIGN NARRATIVE: The investigators determined the efficacy of nicotine gum and phenylpropanolamine (PPA) gum relative to a placebo in the reduction of postcessation weight gain throughout a 13-week combined behavioral and pharmacologic treatment program. Following cessation of the drugs at the end of treatment, they monitored long-term effects of these drugs on body weight at both a 6- and a 12-month follow-up. They also determined the mechanism of action of both nicotine gum and PPA gum (viz., changes in dietary intake, physical activity, or metabolic rate) on change in weight during the course of treatment and evaluated withdrawal symptoms of smoking cessation as they were moderated by either nicotine gum or PPA gum use during the course of treatment. Finally, they investigated whether PPA and nicotine gum produced an incremental effect on smoking cessation (relative to placebo gum) in a sample of female smokers who were at high risk for postcessation weight gain at posttest and at a 6- and 12-month follow-up.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor

Study Overview
=================
Brief Summary
-----------------
Gimatecan® is sigma-tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound, when given as a capsule, rather than by intravenous injection.

Official Title
-----------------
Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

Conditions
-----------------
Solid Malignancies

Intervention / Treatment
-----------------
* Drug: Gimatecan® (ST-1481)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically/cytologically proven advanced solid tumors Life expectancy of at least 3 months with normal hematological, liver and renal function Exclusion criteria: Pregnant and lactating patients Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy Gastrointestinal dysfunction that could alter absorption or motility

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gimatecan® (ST-1481)|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
-----------------
Solid Tumor, Camptothecin, Pharmacokinetics
Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Endothelial function and vascular reactivity are impaired not only in white adults with type 2 diabetes but also in those at risk for the disease by virtue of having impaired glucose tolerance or parental history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The investigators plan to assess the endothelial function and vascular reactivity in young Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging to a minority population.

Conditions
-----------------
Obesity, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: Age between 18-40 years; Hispanic (we will consider a subject being Hispanic if both parents are reported as Hispanics when asked the following question: What ethnic group do you consider that you belong to?); History of type 2 diabetes in one or both parents; BMI above 27; Not have participated in any exercise program for the 6 months prior to the beginning of the study. Group 2: Age between 18-40 years; Hispanic (same criteria as above ); No history of type 2 diabetes in any first degree relative; BMI under 25; Not have participated in any exercise program for the 6 months prior to the beginning of the study. Exclusion Criteria: diabetes, glucose intolerance, pregnancy, smoking, cardiovascular disease, uncontrolled hypertension, renal disease, proteinuria, cancer, infectious diseases, severe GI diseases, lung disease, electrolyte abnormalities, anemia, endocrine disorders, severe dyslipidemia, peripheral vascular disease, medications: beta-blockers, any diuretic, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adults at risk<br>Latino adults with family history of type 2 diabetes | |
| controls<br>Latino adults without family history of type 2 diabetes and normal glucose tolerance | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers of endothelial activation, coagulation and inflammation |  | cross sectional evaluation |
Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects

Study Overview
=================
Brief Summary
-----------------
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects

Official Title
-----------------
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects

Conditions
-----------------
Pharmacology

Intervention / Treatment
-----------------
* Drug: HM15912
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures. Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit Exclusion Criteria: Subject with a history or presence of clinically significant active diseases. Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM15912<br> | Drug: HM15912<br>* The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of HM15912 after single subcutaneous (SC) doses |  | after single subcutaneous (SC) doses for 44 days |
Observational Study on the Efficacy and Safety of NovoSeven® During Real-life Usage in Germany

Study Overview
=================
Brief Summary
-----------------
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

Official Title
-----------------
Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia

Conditions
-----------------
Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Acquired Bleeding Disorder, Acquired Haemophilia

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication Exclusion Criteria: Due to the non-interventional observational character of the study, there are no exclusion criteria.
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: eptacog alfa (activated)<br>* A NON INTERVENTIONAL OBSERVATIONAL STUDY: Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: activated recombinant human factor VII;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved |  | within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven® | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time proportion of acute bleeding treatments resulting in effective pain relief |  | within 9 hours after initiation of treatment with NovoSeven® | 
| Proportion of patients experiencing one or more re-bleeds |  | within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding) |
Combined Agent Randomized Trial of Induction of Labor

Study Overview
=================
Brief Summary
-----------------
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.

Detailed Description
-----------------
This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: >36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score <6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery <24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.

Official Title
-----------------
Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.

Conditions
-----------------
Labor Induction, Cervical Ripening

Intervention / Treatment
-----------------
* Drug: dinoprostone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or = to 36 weeks of gestation Singleton fetus Cephalic presentation Intact membranes and an unripe cervix (Bishop score <6) Exclusion Criteria: Multifetal gestation Rupture of membranes Ripe cervix (Bishop score >6) Active labor Contraindication to vaginal delivery Previous uterine surgery Non-cephalic presentation Fetal macrosomia

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of vaginal delivery <24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomization to delivery interval |  |  | 
| Rate of cesarean delivery for non reassuring fetal status |  |  | 
| Rate of uterine hyperstimulation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor, Labor induction, Cervical ripening, Dinoprostone, Fetal safety, Oxytocin, Cesarean delivery
Combined Approach to Resection of Glioblastoma (GBM) by 5-Aminolevulinic Acid (5-ALA) and Intraoperative Magnetic Resonance Imaging (MRI)

Study Overview
=================
Brief Summary
-----------------
In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually considered a a first step of effective therapy. Radical resection of the tumor is highly beneficial to the patient as measured in progression-free survival and overall survival. At the same time eloquent areas of the brain have to remain intact to preserve quality of life. Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor tissue and thereby to improve precision of GBM-Resection. We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases the number of sites where tumor tissue can be detected. - Trial with surgical intervention

Detailed Description
-----------------
Precision of GBM-Resection Intraoperative marking of tumor tissue Combination of 5-ALA fluorescence and intraoperative MRI

Official Title
-----------------
Combined Approach to GBM-resection by 5-ALA and Intraoperative MRI

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Procedure: diagnostic 5-ALA and MRI for tumor resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients with Glioblastoma multiforme (GBM) no other tumor types or metastases Exclusion criteria: Allergy against 5-ALA or Porphyrin Porphyria Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: diagnostic 5-ALA and MRI for tumor resection|diagnostic 5-ALA and MRI for tumor resection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |