linjc16/ctgov huggingface dataset:
Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.

Conditions
-----------------
RECTAL CANCER

Intervention / Treatment
-----------------
* Procedure: RECTAL CANCER RESECTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin) Histology of adenocarcinoma Exclusion Criteria: Locally advanced disease (T4) Emergency surgery Rectal cancer over familial colic polyposis
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 |
| --- | --- |
| Active Comparator: OPEN SURGERY<br> | Procedure: RECTAL CANCER RESECTION<br> <br> |
| Experimental: LAPAROSCOPIC SURGERY<br> | Procedure: RECTAL CANCER RESECTION<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay |  | 1 month |
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring

Study Overview
=================
Brief Summary
-----------------
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?

Detailed Description
-----------------
traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours

Official Title
-----------------
Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension

Conditions
-----------------
Traumatic Brain Injury, Intracranial Hypertension

Intervention / Treatment
-----------------
* Drug: variation of mannitol dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults severe traumatic brain injury intracranial hypertension requiring mannitol administration Exclusion Criteria: impeding neurosurgery hemodynamic or respiratory severe failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mannitol high dose<br>mannitol 20% 0,8 g/ kg on minutes | Drug: variation of mannitol dose<br>* in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes<br>|
| Active Comparator: mannitol low dose<br>mannitol 20% 0,4 g/ kg on minutes | Drug: variation of mannitol dose<br>* in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracranial pressure |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transcranial doppler |  | 2 h | 
| brain PO2 |  | 2h | 
| MAP |  | 2h | 
| Heart Rate |  | 2h | 
| biology (blood gases, natremia, hematocrit) |  | 2h | 
| diuresis |  | 2h | 
| fluid requirement |  | 2h |
A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary hypothyroidism.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Crossover, Phase 2 Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Drug: ST-1891
* Drug: Levothyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary hypothyroidism On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening On a stable daily dose of levothyroxine for the 3 months prior to Screening Willing to give written informed consent for the Study Exclusion Criteria: Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of ST-1891 or levothyroxine Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening Anticipated initiation or change in concomitant medications Concomitant use of prohibited medications Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ST-1891<br> | Drug: ST-1891<br>* ST-1891<br>|
| Active Comparator: Levothyroxine<br> | Drug: Levothyroxine<br>* Levothyroxine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levothyroxine-to-ST-1891 dosing conversion factor |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range |  | Week 52 | 
| Time to TSH normalization |  | Week 52 |
Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-

Study Overview
=================
Brief Summary
-----------------
This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older). To confirm the use in actual clinical settings To confirm the occurrence of adverse events

Detailed Description
-----------------
This study is a multicenter open-label cohort conducted in patients vaccinated with the Product; for which, case report forms will be recorded based on data presented in medical records obtained from day-to-day clinical treatment and diagnosis. Pneumococcal vaccine health study diary will be implemented to collect accurate safety data; to which, vaccine recipients will be asked directly to cooperate.

Official Title
-----------------
PREVENAR13(REGISTRIED) SUSPENSION LIQUID FOR INJECTION DRUG USE INVESTIGATION - ADULTS AGED 65 YEARS OR OLDER

Conditions
-----------------
Adult Not Younger Than 65 Years

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Geriatric patients vaccinated with this product (adult not younger than 65 years) Consent of vaccine recipients [Vaccine recipient (or his/her legally acceptable representative) must sign and date the consent form warranting that the relevant information concerning this Study was appropriately communicated to the recipient]. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Number of Participants With Adverse Reactions | An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence attributed to Prevenar 13 in a participant who received Prevenar 13. A serious adverse reaction was a vaccine-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Prevenar 13 was assessed by the physician. | 28 days |
Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms.

Detailed Description
-----------------
Before and after 8 weeks of mindfulness program, We will measure Y-BOCS scores in OCD patients. As a control program, relaxation and psychoeducation will provided to OCD patients.

Official Title
-----------------
Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder

Conditions
-----------------
Obsessive-compulsive Disorder

Intervention / Treatment
-----------------
* Behavioral: mindfulness meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obsessive-compulsive disorder age 17-55 Exclusion Criteria: currently undergoing Cognitive Behavioral Therapy, psychotherapy other medical disease

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: relaxation with psychoeducation<br>after 8 weeks of relaxation with psychoeducation. subject take part in 8 weeks of the mindfulness meditation program | Behavioral: mindfulness meditation<br>* 8 weeks of mindfulness meditation specified for OCD patient<br>|
| Experimental: meditation<br>8 weeks of mindfulness meditation | Behavioral: mindfulness meditation<br>* 8 weeks of mindfulness meditation specified for OCD patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive compulsive scores |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive profile (emotion-memory task) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obsessive-compulsive disorder, mindfulness, meditation
Detection of K14 in Bladder Cancer With a Non Invasive Technique

Study Overview
=================
Brief Summary
-----------------
By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.

Official Title
-----------------
K14 in Urothelial Cells as a Pronostic and Diagnostic Marker in Bladder Cancer Patients Using a Non Invasive Technique.

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bladder cancer Exclusion Criteria: Inability to sign the 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder cancer<br>Patients who suffered a bladder cancer | |
| Control group<br>Patients with urologic diseases of non tumoral origin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratin 14 |  | At the time of study entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, Keratin 14, Pronostic marker, Diagnostic marker, Noninvasive technique
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).

Detailed Description
-----------------
Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.

Official Title
-----------------
Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

Conditions
-----------------
Autoimmune Thrombocytopenic Purpura

Intervention / Treatment
-----------------
* Drug: Doxil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes. Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids. Platelet count of 30,000 or less. Performance status score of 2 or less. Adequate organ function: *bilirubin< 2; *AST < 3 times normal; *creatinine < 2. No prior treatment with anthracycline or chemically related drugs. Exclusion Criteria: Pregnant or lactating women. Presence of a malignancy other than basal cell carcinoma of the skin.

Ages Eligible for Study
-----------------
Minimum Age: 0 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: Doxil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the primary outcome would be a platelet response, with a return of platelet count to normal |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune Thrombocytopenic Purpura
Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the genetic profile of families in British Columbia with HME.

Detailed Description
-----------------
The purpose of this study is to establish the genetic make-up of families and patients with HME. This will occur as the patient presents to a regular clinic visit. Dr. Alvarez will be introduced to interested patients and their parent(s) and a brief discussion about the project will occur. If the patient and their direct family are interested they will be entered into the study. This will involve interviewing the patients and their direct family. This interview will take about 1 hour. We are interested in identifying all affected family members as far up the family tree as possible. We ask that the idea of the study be introduced to extended family members by the participating family members and then have them call Dr. Alvarez to set up an appointment. Each available member will be interviewed and a physical exam done to determine the location of osteochondromas. In addition, Xrays will be done to determine the location of all osteochondromas. All Xrays will be reviewed. No new ones will be taken unless it is part of the patient's routine care. To complete the genetic work up DNA analysis will be done on all available family members. This will entail obtaining a blood sample from each family member willing to partake in the study. These blood samples will be used only for the purpose of identifying abnormalities in the genes related to osteochondromas. The blood samples will be taken at British Columbia's Children's Hospital and processed there. DNA samples will be kept confidential.

Official Title
-----------------
Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC

Conditions
-----------------
Exostoses, Multiple Hereditary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with HME
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA sequencing, EXT genes, Hereditary Multiple Exostoses,, also known as Multiple Hereditary Exostoses,, also known as Hereditary Multiple Osteochondromas
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)

Official Title
-----------------
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria). Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy. Exclusion Criteria: Evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years. Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib). Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Lumiracoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks. |  |  | 
| Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks. |  |  | 
| Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8. |  |  | 
| Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. |  |  | 
| Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13. |  |  | 
| Patient's health status using the Short Form-36 (SF-36), at week 13. |  |  | 
| Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors