linjc16/ctgov huggingface dataset:
Mantle Irradiation for Hodgkin's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study it to evaluate the effectiveness of radiation therapy limited to above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.

Detailed Description
-----------------
Eligble patients will receive a course of radiation therapy directed to above the diaphragm only. Patients would have bloodwork and chest x-rays performed 4 times per year for the first two years, 3 times per year for the third year, and 2 times per year for the fourth and fifth years. After five years, yearly check-ups are performed. In addition to the above follow-up, patients will receive, once or twice a year for the first 5 years, an abdominal-pelvic CT scan and/or gallium scan.

Official Title
-----------------
Mantle Irradiation for Selected Hodgkin's Disease Patients With Stage IA-IIA Disease

Conditions
-----------------
Hodgkin's Disease

Intervention / Treatment
-----------------
* Procedure: Mantle irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically Stage IA-IIA Hodgkin's disease A negative staging laparotomy including splenectomy, biopsies of liver, paraortic nodal biopsies and palpitation of upper pelvic nodes 18 years of age or older Exclusion Criteria: Patients with large mediastinal adenopathy Patients with LD histology Patients with B symptoms Positive laparotomy Subcarinal, hilar, or cardiac lymph node involvement

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 |
| --- |
|Procedure: Mantle irradiation|Limited to above the diaphragm|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin's Disease Stage IA-IIA, mantle irradiation
Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if oxytocin administration is able to blunt LPS induced increase of cytokines (TNF-α) and if there is a change in the endocrine response after lipopolysaccharide administration in humans.

Official Title
-----------------
Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 18 years or older with no disease history Written informed consent Exclusion Criteria: Receiving any medication Probands who suffer from infectious disease

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha |  | six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACTH, cortisol, procalcitonin, IL-1ra, IL-4, IL-6, MIP-1alpha, MIP-1 beta, MCP-1, IP-10, VEGF, body temperature, BNP, Ghrelin, |  | six hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, tnf, sepsis, lps
H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.

Official Title
-----------------
Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial

Conditions
-----------------
Ulcer

Intervention / Treatment
-----------------
* Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
* Drug: Lansoprazole (proton pump inhibitor), placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 - 75 years old Early gastric cancer (< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (< 3 cm in size) Helicobacter pylori positive Exclusion Criteria: Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound) History of Helicobacter pylori eradication History of gastric surgery or other cancers Major comorbidities Medication of ASA, NSAIDS, steroids, anti-coagulants

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eradication<br>Helicobacter pylori eradication | Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin<br>* Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg<br>|
| Placebo Comparator: No eradication<br>No eradication for Helicobacter pylori | Drug: Lansoprazole (proton pump inhibitor), placebo<br>* Lansoprazole, Amoxicillin placebo, Clarythromycin placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer healing rate by endoscopic assessment |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer reduction rate by endoscopic assessment |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic mucosal resection, iatrogenic
An Evaluation of Appearance-based Interventions for the Promotion of Sleep

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy of appearance-based interventions in promoting healthy sleep. One group of participants will receive standard information about sleep (control group), while the other group will receive information about how sleep affects their physical appearance (intervention group).

Conditions
-----------------
Sleep Habits, Healthy

Intervention / Treatment
-----------------
* Behavioral: Appearance-based intervention
* Other: Pamphlets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-24 years <7 hours of sleep routinely Exclusion Criteria: per-existing medical, sleep, or psychiatric conditions; history of substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard information<br>In this arm, participants will receive standard information pamphlets about the benefits of good sleeping habits. | Other: Pamphlets<br> <br> |
| Experimental: Appearance-based information<br>In this arm, participants will receive information about how sleep modifies their physical appearance. This will involve a computer transformation that morphs their face according to hours of sleep obtained. | Behavioral: Appearance-based intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep duration | Measured through actigraphy | Up to 1 month after the intervention | 
| Self-reported sleep hygiene | Measured through the Sleep Hygiene scale (total score: higher score corresponds to poorer sleep hygiene) | Up to 1 month after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality | Measured through the Pittsburgh Sleep Quality Index (global score: higher score corresponds to poorer sleep quality) | Up to 1 month | 
| Insomnia-related cognition | Measured through the Dysfunctional Beliefs and Attitudes about Sleep scale (total score: higher score corresponds to more dysfunctional beliefs and attitudes) | Up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
participants
Electrocardiogram (ECG) Recordings in Paediatric Population

Study Overview
=================
Brief Summary
-----------------
The primary goal of this protocol is to collect ECG signals from paediatric patients using 4 surface electrodes placed in the configurations proposed for the Cameron Health, Inc. subcutaneous implantable defibrillator (S-ICD) system. These signals will then be used to test the S-ICD system for future use in paediatric patients.

Detailed Description
-----------------
The surface ECGs collected from pediatric patients in normal sinus rhythm and a variety of ventricular and atrial arrhythmias will be used as test signals for the development of the S-ICD system. These signals will be collected from patients undergoing electrophysiology (EP) study, transvenous defibrillator implantation or ablation procedures

Official Title
-----------------
ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Procedure: EP
* Procedure: ICD
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients < 18 years of age Patient scheduled for an EP study, implantation of an ICD or for an ablation procedure Exclusion Criteria: Patients whose parents/guardians do not sign an informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: EP|nan|
|Procedure: ICD|nan|
|Procedure: Ablation|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
-----------------
S ICD, ICD, Ablation, EP study, Paediatric, ECG
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.

Detailed Description
-----------------
Doppler Ultrasound will be performed 2-6 weeks after surgery.

Official Title
-----------------
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT

Conditions
-----------------
Number of Deep Venous Thrombosis (DVT)

Intervention / Treatment
-----------------
* Procedure: Doppler Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral partial knee replacement Postoperative anticoagulation with aspirin 325 twice daily Regional anesthesia Inflatable garments worn during hospitalization Exclusion Criteria: -Bilateral partial knee replacement
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DVT<br>Doppler Ultrasound | Procedure: Doppler Ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep venous thrombosis |  | 2-6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index |  | at date of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DVT
Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery

Study Overview
=================
Brief Summary
-----------------
Pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery. The investigators found that pregabalin is equivalent to gabapentin for relief of post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.

Official Title
-----------------
Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.

Conditions
-----------------
Intervertebral Disc Prolapse

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Gabapentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30-60 years age Any gender elective micro discectomy for intervertebral disc prolapse Exclusion Criteria: micro discectomy at two or more vertebral levels, Instrumentation i.e. pedicle screw fixation, hooks etc., history of steroids or alcohol use, Multiple co-morbids i.e. renal failure, chronic liver disease, use of anticonvulsant drugs, Spinal deformity, Obesity (BMI >30), 8) inability to understand and respond VAS and 9) patients with known allergy to GABA analogues.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gabapentin<br> | Drug: Gabapentin<br>* Gabapentin 200 mg twice daily per oral<br>|
| Active Comparator: Pregabalin<br> | Drug: Pregabalin<br>* Pregablin 75 mg per oral two times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, Pregabalin, gabapentin, microdiscectomy
Assessing Continuous Glucose Monitors in Healthy Children

Study Overview
=================
Brief Summary
-----------------
Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.

Detailed Description
-----------------
The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate. The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Official Title
-----------------
DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitoring System (CGMS)
* Device: GlucoWatch G2TM Biographer (GW2B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Weight >= 16.0 kg (35 lbs) Body mass index between the 10th to 90th percentile for age and sex HbA1c within normal limits Hematocrit within normal limits Exclusion Criteria History of diabetes History of positive islet cell antibody testing Family history of Type 1 or Type 2 diabetes in a sibling or parent Medication use of any type in the 7 days prior to study entry Skin abnormalities contraindicating device use

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous Glucose Monitoring System (CGMS)|nan|
|Device: GlucoWatch G2TM Biographer (GW2B)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the GlucoWatch G2 Biographer and CGMS sensors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous Glucose Monitoring Devices, Blood glucose profiles in normal children, Blood glucose profiles in non-diabetic children
Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and that have no other available treatment options.

Official Title
-----------------
A Treatment Use Protocol of Entecavir in Subjects With Chronic Hepatitis B Infection Who Have Failed or Who Are Intolerant of Available Therapies

Conditions
-----------------
Hepatitis B, Chronic Disease

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis B Early Access Program

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Entecavir|Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

Official Title
-----------------
Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Diclofenac sodium gel 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion criteria: • Osteoarthritis of the hand Key Exclusion Criteria: Other rheumatic disease, such as rheumatoid arthritis Active gastrointestinal ulcer during the last year Known allergy to analgesic drugs

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Diclofenac sodium gel 1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OA pain intensity in target hand at Week 4 and 6 |  |  | 
| Total AUSCAN score in target hand at Week 4 and 6 |  |  | 
| Global rating of disease activity by patient at Week 4 and 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 |  |  | 
| AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 |  |  | 
| OA pain intensity in target hand and use of rescue medication recorded in diary |  |  | 
| Global evaluation of treatment at final visit |  |  | 
| Treatment responder rate according to OARSI criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand osteoarthritis, Topical NSAID, Diclofenac sodium