linjc16/ctgov huggingface dataset:
CLL Therapy Approaches in Russia

Study Overview
=================
Brief Summary
-----------------
This is going to be a non-interventional study (NIS). Assessment of variables will be carried out using data on patient's treatment in real-life clinical setting. Patients should be enrolled into study after evaluation of eligibility criteria by the investigator. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. Evaluation of efficacy and safety of any approaches used for CLL/SLL treatment is not the primary objective of this study, though there is no treatment of interest. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance). It is planned to enroll approximately 6000 patients (suggested number of patients on WW 1000 pts, 1L 2750 pts, RR 2250 pts) During the course of study's prospective part, it is planned to carry out at approximately 5 visits: (if unscheduled visit performed - the information should be filled on nearest visit). Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site. Interim Visits (CRF will be filled every 6 months for therapy receiving patients and every 12 months for WW patients; if a patient transitions from WW to therapy, his/her CRF will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis). Final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update).

Official Title
-----------------
Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Ability and willing to sign the ICF Diagnosed CLL/SLL (including watch and wait stage of disease) according to Russian clinical guides Exclusion Criteria: Patients without CLL/SLL diagnosis Age <18 years Patients who refused/did not sign the ICF

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 |
| --- | --- | --- |
| Sex |  | Baseline | 
| Date of diagnosis for CLL/SLL |  | Baseline | 
| Comorbidities |  | Up to 2 years | 
| ECOG status (0-1/≥2) |  | Up to 2 years | 
| Rai staging (0-IV) |  | Up to 2 years | 
| Cytogenetic tests | TP53 gene mutation status IGHV gene mutation status complex karyotype del13q status | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic lymphocytic leukemia
Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Observational study of the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma.

Official Title
-----------------
Observational Study of the Clinical Practice in Patients With Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma in Greece

Conditions
-----------------
Pancreatic Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or advanced) Patients that are alive and under treatment or follow up Signed informed consent (ICF) Exclusion Criteria: Presence of other primary tumors Pancreatic adenocarcinoma due to metastasis from other primary tumor(s) Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma Patients who refuse to provide informed consent

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 |
| --- | --- | --- |
| clinical practice-treatments |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression Free Survival |  | 2 years | 
| Overall Survival |  | 2 years |
A Study of Radiotherapy Planning System Software ---- Zeus Cloud

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of Zeus Cloud TPS in the design of photon intensity modulated radiation therapy (IMRT) plan for tumors in various parts of the body.

Detailed Description
-----------------
This is a self-control, multi-center non-inferiority study. Subjects meeting inclusion criteria have radiation treatment plans designed by Zeus Cloud TPS and Eclipse treatment planning software from Varian, respectively. The qualities of two plans are compared. This is a observational study as the two plans are not executed.

Official Title
-----------------
A Multicenter Study on the Feasibility of a Radiotherapy Treatment Planning System (TPS) Software---Zeus Cloud

Conditions
-----------------
Radiotherapy

Intervention / Treatment
-----------------
* Other: Zeus Cloud TPS V1.0
* Other: Eclipse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer; The medical imaging data (CT) of the subjects were complete and available; Between 18 and 75 years old, regardless of gender; Exclusion Criteria: The patients had metal implants; Not suitable for clinical trials judged by investigators.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eclipse<br> | Other: Eclipse<br>* Eclipse TPS of Varian company is used to design the radiotherapy plan for the subjects and the plan is evaluated.<br>|
| Zeus Cloud TPS V1.0<br> | Other: Zeus Cloud TPS V1.0<br>* Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The qualification rate of treatment plans based on dosimetry |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The conformability index of radiation dose to the target |  | 2 months | 
| single-field pass rate |  | 2 months | 
| composite-field pass rate |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Planning System
Intracranial Pressure Waves Via Lumbar Puncture

Study Overview
=================
Brief Summary
-----------------
Patients are subjected to simultaneous intracranial and lumbar puncture pressure measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial pressure amplitude is reflected by lumbar puncture pressure amplitude.

Official Title
-----------------
Are Intracranial Pressure Waves Measurable Through Lumbar Puncture?

Conditions
-----------------
Idiopathic Normal Pressure Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Idiopathic Normal Pressure Hydrocephalus Exclusion Criteria: Known cause of hydrocephalus

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 78 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 |
| --- | --- | --- |
Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.

Official Title
-----------------
A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: E2006


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Healthy males or females, ages 18 to 55 years Body mass index (BMI) &gt; 18 and 32 kg/m2 at Screening Exclusion: Female subjects who are nursing Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006 Subjects with a known history of clinically significant drug or food allergies Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: E2006 2.5 mg<br> | Drug: E2006<br>* 2.5 mg, 10 mg, and 25 mg E2006 tablets<br>|
| Other: E2006 10mg<br> | Drug: E2006<br>* 2.5 mg, 10 mg, and 25 mg E2006 tablets<br>|
| Other: E2006 25 mg<br> | Drug: E2006<br>* 2.5 mg, 10 mg, and 25 mg E2006 tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of E2006 of tablet vs. capsule formulations |  | up to 336 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | 36 days |
Gum Acacia and Blood Glucose

Study Overview
=================
Brief Summary
-----------------
This study will provide needed insight on the satiety and blood glucose and l effects of the soluble fiber gum acacia at 20g and 40g doses.

Detailed Description
-----------------
This is a randomized, single-blind, crossover, intervention study testing the satiety and blood glucose effects of the soluble fiber gum acacia.

Official Title
-----------------
The Effect of Gum Acacia on Satiety, Glycemic Response and Gastrointestinal Tolerance

Conditions
-----------------
Diet Modification

Intervention / Treatment
-----------------
* Other: Low Fiber
* Other: High Fiber
* Other: Placebo/Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18 and 29 kg/m2 Exclusion Criteria: distaste for bagels and cream cheese, orange juice or cheese pizza; current smoker; restrained eating habits; recent weight change; any history of disease or significant past medical history; are vegetarian; do not normally eat breakfast or lunch; pregnant or lactating; irregular menstrual cycles.

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: subjects will consume 0, and 2 doses of acacia gum
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0 fiber<br>0 grams fiber added to orange juice | Other: Placebo/Control<br>* No acacia gum will be added to orange juice.<br>|
| Experimental: low fiber<br>20 grams of acacia gum added to orange juice | Other: Low Fiber<br>* 20 g of acacia gum will be added to orange juice<br>|
| Experimental: high fiber<br>40 grams of acacia gum added to orange juice | Other: High Fiber<br>* 40 g of acacia gum will be added to orange juice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose levels | Blood will be taken via finger stick | 0, 30, 60, 120, 180, and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment | 
| Appetite Sensation | Subjective visual analog scale (VAS) will be utilized to assess hunger, fullness and desire to eat | 15, 30, 45, 60, 90, 120, 180 and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment |
Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.

Official Title
-----------------
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

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

Intervention / Treatment
-----------------
* Drug: Oral salmon calcitonin, salmon calcitonin nasal spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical history and symptoms of knee osteoarthritis Exclusion Criteria: Any other disease or medication affecting the bone or cartilage. Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Ages Eligible for Study
-----------------
Minimum Age: 52 Years
Maximum Age: 75 Years

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

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: Oral salmon calcitonin, salmon calcitonin nasal spray|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Urine CTX-I and CTX-II |  |  | 
| Changes in serum osteocalcin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.

Official Title
-----------------
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: Blood draw within 12 hours of injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Subject is at least 18 years of age at screening. The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force. The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent. The venous blood sample is collected no later than 12 hours from the time of head injury. The Subject is competent and willing to undergo the Informed Consent process Exclusion Criteria: Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable). Time of suspected head injury cannot be determined. Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)). Blood transfusion after head injury, and prior to study blood draw Blood donation within 1 week of study enrollment. The subject is a female who is pregnant or lactating. The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected traumatic brain injury<br> | Other: Blood draw within 12 hours of injury<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of biomarkers | Measurement of UCH-L1 and GFAP using Philips Minicare | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic brain injury, Head injury
A Study Of BOTOX For The Treatment Of Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines

Conditions
-----------------
Glabellar Lines

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Drug: sodium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment. Exclusion criteria: Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible. Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Injection | Drug: Botulinum Toxin Type A<br>* botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg<br>|
| Placebo Comparator: B<br>Injection | Drug: sodium chloride<br>* sodium chloride 0.9 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigator's rating of Glabellar line severity at maximum frown |  | Day 30 after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations. |  | Day 7, 30, 60, 90, 120 after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Botulinum Toxin Type A, safety, efficacy, glabellar lines