linjc16/ctgov huggingface dataset:
Nutrition and Resistance Training in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
To test the effects of nutrition versus nutrition with resistance exercise on muscle mass loss, fatigue and outcomes of concurrent chemo radiation.

Official Title
-----------------
Randomized Trial of Specialized Nutrition Therapy (SNT) Versus SNT Plus Resistance Training (RT) in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation Therapy (CCR)

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

Intervention / Treatment
-----------------
* Other: Tailored Nutrition Intervention
* Behavioral: Nutrition plus Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 3 or 4 HNC Exclusion Criteria: Previous Cancer

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B1<br>Nutrition | Other: Tailored Nutrition Intervention<br>* Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements<br>|
| Experimental: B2<br>Nutrition plus Exercise | Behavioral: Nutrition plus Exercise<br>* Nutrition plus Exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue |  | 6 months |
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg

Study Overview
=================
Brief Summary
-----------------
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

Official Title
-----------------
Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers

Conditions
-----------------
Contraceptives, Postcoital

Intervention / Treatment
-----------------
* Drug: Levonorgestrel Emergency Pill (BAY86-5028)
* Drug: Postinor 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis. Exclusion Criteria: History of illnesses or any organic abnormalities that could affect the results of the study. History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs. Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levonorgestrel Emergency Pill (BAY86-5028)<br>* Single dose of 1.5 mg coated tablet<br>|
| Active Comparator: Arm 2<br> | Drug: Postinor 2<br>* Single dose of 1.5 mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least square estimator of average maximum plasmatic concentration (log transformed) |  | After 2 months | 
| Least square estimator of area under the pharmacokinetic curve (log transformed) |  | After 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which maximum concentration is reached |  | After 2 months | 
| Area under the pharmacokinetic curve from time=0 to last blood sample |  | After 2 months | 
| Half life of plasmatic concentration of study drug |  | After 2 months | 
| Clearance constant of plasmatic concentration of study drug |  | After 2 months | 
| Adverse events collection |  | Up to 8 weeks |
Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective, Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA concomitantly treated with MTX during the Core Study Period.

Official Title
-----------------
Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1987) for at least 6 months prior to randomization. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL or an ESR ≥28 mm/hour. Exclusion Criteria: Patient is unresponsive or intolerable to more than 2 biologic agents. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.

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 |
| --- | --- |
| Active Comparator: MabThera<br>rituximab | Biological: rituximab<br>* 1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.<br>|
| Active Comparator: CT-P10<br>rituximab | Biological: rituximab<br>* 1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK in terms of Cmax | maximum serum concentration | Up to Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA, Biosimilar
Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a website that allows patients and providers to maintain contact via the website. We will compare RMS users on a number of different variables with the goal of identifying which variables are associated with optimal outcomes (larger weight losses) at one year (and potentially beyond). The study has two primary objectives. The first is to assess changes in body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that frequent users will achieve significantly greater reductions in weight at 6 and 12 months (and beyond) than infrequent users. The second objective is to assess changes in body weight at postoperative year 1 in persons who use different features of the RMS site. We hypothesize that persons who, on a regular basis, record their food intake, track their physical activity and make specific behavioral goals will experience significantly greater reductions in weight beginning 6 months after surgery as compared to those who do not use these features of the RMS site.

Official Title
-----------------
Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

Conditions
-----------------
Bariatric Surgery, Obesity, Weight Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old BMI between 40-70 kg/m2 (or 35-70 kg/m2 in the presence of co-morbidities) Have registered in the Realize Mysuccess Systema and have logged into the system at least once postoperatively. Exclusion Criteria: We will be receiving/analyzing a data set based on the inclusion criteria, therefore there is no set exclusion criteria for our research.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Assess changes in body weight in frequent v. infrequent RMS users |  | 12 months |
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.

Detailed Description
-----------------
Material and Method: This study falls in two fields: First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated. 280 overweight (body mass index [BMI] > 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly. Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.

Official Title
-----------------
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Behavioral: physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 kg/m2 BMI < 45 kg/m2 Healthy Over 18 years of age No earlier preterm delivery (before 37) Singleton pregnancy 14 weeks +/- 1 week of gestation Exclusion Criteria: BMI > 45 kg/m2 Earlier preterm delivery (before 37) Not singleton pregnancy Medically treated diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: physical activity|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perinatal mortality |  |  | 
| congenital malformations and preeclampsia |  |  | 
| gestational hypertension and gestational diabetes mellitus (GDM) |  |  | 
| preterm delivery |  |  | 
| too large infants (> 2 standard deviation [SD]) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery by caesarian section |  |  | 
| induction of labour |  |  |
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.

Official Title
-----------------
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Drug: L-MTP-PE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible. Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma L-MTP-PE is deemed to be of potential benefit by the treating investigator Willing and able to understand and sign informed consent and assent as appropriate Life expectancy > 6 weeks Adequate organ function as follows: Adequate bone marrow function defined as: absolute neutrophil count (ANC) ≥ 750/mm^3 platelet count ≥ 30,000/ mm^3 hemoglobin ≥ 8 g/dl Adequate renal function defined as: Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m^2 OR Serum creatinine ≤ 2x the upper limit of normal based on age/gender Adequate liver function defined as: Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant Exclusion Criteria: Use of chronic steroids of other immunosuppressive agents Pregnant or breast feeding
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-MTP-PE|L-MTP-PE will be administered at a dose of 2mg/m2 (maximum dose 4 mg), twice weekly for 12 weeks and weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks.|

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
-----------------
L-MTP-PE, Expanded Access, 20-324
PPI Sequencing Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Official Title
-----------------
A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI)

Conditions
-----------------
Gastro-Oesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Procedure: Physical exam
* Procedure: Pregnancy test if applicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor Informed consent Over 18 years of age Exclusion Criteria: Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study; More than 1 other course of PPI treatment in the previous 12 month; Previous use of esomeprazole; Presence of alarm symptoms.

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: Esomeprazole|nan|
|Procedure: Physical exam|nan|
|Procedure: Pregnancy test if applicable|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry |  |  | 
| Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heartburn, reflux, proton pump inhibitor, GERD, GORD
Radiofrequency Ablation of Uterine Fibroids

Study Overview
=================
Brief Summary
-----------------
This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. We are doing this to look for a less invasive method of treatment for patients with uterine fibroids. One method that is being used in other areas of the body to treat masses is radiofrequency electrocautery. This method may be performed for the treatment of uterine fibroids by placing a small diameter needle through the wall of the vagina into the fibroid guided by an ultrasound probe. An optional approach is to place the needle through the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating. This would be done before hysterectomy (removal of the uterus). We are trying to test to see if this type of treatment can be applied to uterine fibroids. We are trying to develop radiofrequency electrocautery as one of the methods to treat fibroids without surgery.

Official Title
-----------------
Radiofrequency Ablation of Uterine Fibroids

Conditions
-----------------
Uterine Fibroids

Intervention / Treatment
-----------------
* Procedure: radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Diagnosed with uterine leiomyomas (fibroids) Patient will undergo surgical hysterectomy Patient is willing to sign informed consent form Exclusion Criteria: Patients with acute infection Patients with bleeding disorders Patients who are not candidates for surgery or general anesthesia

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

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

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 |
| --- |
|Procedure: radiofrequency ablation|Intraoperative RFA of uterine fibroids|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Following the hysterectomy, the study pathologist will perform a histological examination of the treated fibroid specimen to determine the size and volume of the ablation that was created with radiofrequency electrocautery. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine fibroids