linjc16/ctgov huggingface dataset:
Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF

Study Overview
=================
Brief Summary
-----------------
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage.

Detailed Description
-----------------
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage (SAH). 1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory factors and cogulation factors. 2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients will be used for Mass Spectrometry

Official Title
-----------------
Inhibition of Caspase-1 Reduces Pyroptotic Neuroinflammation and Tissue Factor-Induced Cerebrospinal Fluid Circulation Impairment After Subarachnoid Hemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
-----------------
* Diagnostic Test: Lumbar puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SAH patients with modified Fisher Scale 3-4. Exclusion Criteria: Patients with history of CNS disease (e.g., stroke, traumatic brain injury, CNS infection) or accompanied by serious comorbidities before SAH onset (e.g., severe coagulation disorders, malignant tumor, uncontrollable heart disease, and hypertension) or other organ dysfunctions within 6 months were excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| subarachnoid hemorrhage<br>Patients with subarachnoid hemorrhage | Diagnostic Test: Lumbar puncture<br>* Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test<br>|
| Control<br>patients with non-neurological diseases | Diagnostic Test: Lumbar puncture<br>* Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of hospital stay | evaluated 1day after discharge | 
| modified Rankin Scale | modified Rankin Scale (mRS) at discharge. mRS ranging from 0-5, higher represents worse | evaluated 1day after discharge | 
| Glasgow Outcome Scale | Glasgow Outcome Scale (GOS) at discharge, GOS ranging from 0-5, higher represents better | evaluated 1day after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subarachnoid hemorrhage, coagulation, inflammation
An Online System to Improve Diabetes Self-Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).

Detailed Description
-----------------
Patient portals are online programs that can provide a number of functions for patients, among them: Ability to request appointments, referrals, and medication refills; Ability to send secure electronic messages to medical staff, and to receive replies; Access to the medical record; Disease management We are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. Self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. Chart review will be used to assess measures of diabetes-related health.

Official Title
-----------------
D-STAR (Diabetes-System To Access Records): An Online Patient Portal to Improve and Sustain Diabetes Self-Care

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Access to online patient portal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Type 2 diabetes mellitus Has access to Internet Has e-mail address Established patient at one of four participating practices at University of Colorado Hospital Exclusion Criteria: Non-English speaking

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Access to online patient portal|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure |  | Surveys at baseline, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative assessment of the program by patients and medical staff |  | Interviews after 9 months of deployment | 
| Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol) |  | Incidentally obtained over 9 months of care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disease management, Patient access to records, Medical records systems, computerized, Questionnaires, Physician-patient relations, Medical records
CAR-T Cells in the Treatment of Malignant Hematological Tumors

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Detailed Description
-----------------
Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Official Title
-----------------
Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor

Conditions
-----------------
Lymphoma, B-Cell, Leukemia, B-cell, Leukemia, T-Cell, Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: CAR-T


Participation Criteria
=================
Eligibility Criteria
-----------------
With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis; Age 14-70 (including boundary value), both male and female; Subjects with a physical status of 0 2 in the American Eastern Oncology Collaboration Group (ECOG); The results of treatment related antigens were positive; The expected life span is more than 3 months from the date of signing the informed consent;

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR-T<br>Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg | Biological: CAR-T<br>* Patients will receive CAR-T treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence and severity of adverse events | The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period | 24 months post CAR-T cells infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T cells
Observational Study of NovoNorm® in Subjects With Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to review the safety and efficacy of Novonorm® (repaglinide) in post-marketing use.

Official Title
-----------------
NovoNorm Post Marketing Surveillance Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Repaglinide<br> | Drug: repaglinide<br>* Prescription with NovoNorm® 0.5mg, 1mg or 2mg tablets according to product labelling in daily clinical practice at the discretion of the physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 
| 2 hours postprandial blood glucose (2-hr PPBG) |  |  | 
| Fasting blood glucose (FBG) |  |  | 
| Body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  |
Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes an increase in plasma volume, total plasma protein concentration, and albumin concentration. This is an important step in understanding the effects of OLT, specifically its effects on fluid in the body. The primary role of the lymph system is the return of fluid and proteins lost from the blood vessels. Despite this, no research has been done to see what effects an OLT has on fluid and protein levels in the blood.

Official Title
-----------------
The Short-Term Effect of Osteopathic Lymphatic Treatment on Blood Cell Count, Plasma Protein, and Blood Pressure: A Pilot Study in a Cross-Over Design

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: OLT maneuver
* Other: Sham OLT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy volunteers Males Age 20 to 40 years Exclusion Criteria: History of cardiovascular, kidney, or liver disease. Cannot have taken medication or drugs or have been ill at the time of the study or for two weeks prior.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: A<br>OLT administration | Other: OLT maneuver<br>* direct myofascial release for the thoracic inlet for 30 seconds, supine rib raising for 1 minute on each side of the body, thoracic pumping for one minute, thoracic vacuum for 30 seconds, doming of the abdominal diaphragm for 30 seconds, abdominal pumping for 1 minute, pedal pumping for 1 minute, a second thoracic pump for 1 minute, a second thoracic vacuum for 30 seconds, and a final direct myofascial release for the thoracic inlet lasting 30 seconds<br>|
| Sham Comparator: B<br>placebo-OLT | Other: Sham OLT<br>* Therapeutic massage performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline blood pressure |  | 15 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma proteins |  | 15 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteopathic, lymphatic, treatment, OLT, normal
Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions

Official Title
-----------------
A Single Dose, 2-Period, 2-way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: protriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Protriptyline or any comparable or similar product.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: protriptyline|10 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | baseline, 2-period, 28 day washout |
DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute lymphoblastic leukemia.

Detailed Description
-----------------
OBJECTIVES: Identify the transcriptional signatures associated with the presence of NOTCH1 mutations in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide microarrays. Characterize the global changes on gene expression resulting from the inactivation of NOTCH signaling in human T-ALL lymphoblasts. OUTLINE: This is a multicenter study. Frozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by microarray analysis and activated NOTCH1 protein by western blot analysis. PROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study.

Official Title
-----------------
Molecular Mechanisms of NOTCH Induced Transformation in T-ALL

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: microarray analysis
* Genetic: mutation analysis
* Other: immunologic technique


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Confirmed diagnosis of T-cell acute lymphoblastic leukemia Frozen lymphoblast samples available NOTCH1-mutated or wild type sample available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: microarray analysis|nan|
|Genetic: mutation analysis|nan|
|Other: immunologic technique|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptional signatures associated with NOTCH1 mutations in T-cell acute lymphoblastic leukemia (T-ALL) cells | Mutational analysis | 1 month | 
| Global changes on gene expression resulting from inactivation of NOTCH signaling in T-ALL cells | Gene expression | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T-cell adult acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission
Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.

Conditions
-----------------
Cervical Dystonia

Intervention / Treatment
-----------------
* Biological: MT10109
* Biological: BOTOX(Registered trade mark)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 75 Have no clinically significant medical condition Cervical dystonia Exclusion Criteria: Pregnant or lactation Subjects who have been administered the following drugs within the previous 1 month

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 |
| --- | --- |
| Active Comparator: BOTOX (registered trade mark)<br> | Biological: BOTOX(Registered trade mark)<br>* Botulinum toxin type A<br>|
| Experimental: MT10109<br> | Biological: MT10109<br>* Botulinum toxin type A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Day 30 |
Bariatric Surgery and Pharmacokinetics of Atomoxetine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on atomoxetine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Atomoxetine: BAR-MEDS Atomoxetine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- |
|Drug: Atomoxetine|Patients are tested for their normal prescription atomoxetine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atomoxetine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Atomoxetine hydrochloride
Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study

Study Overview
=================
Brief Summary
-----------------
This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.

Official Title
-----------------
A Prospective, Randomized, Comparison of Total Knee Arthroplasty With the Triathlon® CS Tibial Insert vs. the Triathlon® PS Tibial Insert.

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

Intervention / Treatment
-----------------
* Device: Stryker Triathlon® CS Tibial Insert
* Device: Stryker Triathlon® PS Tibial Insert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ages 20-80 years old Body mass index <40 Undergoing primary total knee arthroplasty for osteoarthritis of the knee Exclusion Criteria: Inflammatory arthritis Revisions Other criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Cruciate Substituting Tibial Insert<br> | Device: Stryker Triathlon® CS Tibial Insert<br> <br> |
| Posterior Stabilized Tibial Insert<br> | Device: Stryker Triathlon® PS Tibial Insert<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes, Knee Society Score | Clinical outcomes to include overall success, failure rate, revison rate, clinical scores (Knee Society Score), range of motion, pain, stability, radiographic success | Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Total Knee Replacement, TKA, Knee, PS, CS