linjc16/ctgov huggingface dataset:
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Study Overview
=================
Brief Summary
-----------------
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.

Detailed Description
-----------------
20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.

Official Title
-----------------
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: aspirin
* Drug: warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months. Exclusion Criteria: Any contraindication to aspirin or warfarin.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin<br> | Drug: aspirin<br> <br> |
| Experimental: warfarin<br> | Drug: warfarin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stroke by one year. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent dissection by one year. |  | 1 year | 
| Incidence of TIA by one year. |  | 1 year | 
| Incidence of major and minor bleeding episodes by one year. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervicocephalic Arterial Dissection
Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.

Official Title
-----------------
A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke

Conditions
-----------------
Severe Upper Limb Hemiplegia

Intervention / Treatment
-----------------
* Drug: HC-58
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe upper limb hemiplegia after stroke Within 28 days after stroke at enrollment Exclusion Criteria: Patients with sensory loss between shoulder and hand on paralyzed side Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HC-58 low dose<br>Low dose | Drug: HC-58<br>* once or more / week<br>|
| Experimental: HC-58 high dose<br>High dose | Drug: HC-58<br>* once or more / week<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* once or more / week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of shoulder hand syndrome | The incidence rate of shoulder hand syndrome | 12 weeks | 
| Change from Baseline in the modified Barthel index (MBI) and MBI efficiency | MBI efficiency means MBI gain divided by period of administration | 12 weeks | 
| Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency | FMA efficiency means FMA gain divided by period of administration | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score by numeric rating scale |  | 12 weeks | 
| Swelling asymmetry between hands |  | 12 weeks | 
| Discolouration of the skin of the hand |  | 12 weeks | 
| Difference in skin temperature between hands |  | 12 weeks | 
| Decreased range of motion |  | 12 weeks | 
| Radiographic finding of bone |  | 12 weeks | 
| Bone metabolic marker |  | 12 weeks |
Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Detailed Description
-----------------
Correct

Official Title
-----------------
Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: lipitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-90 Male or female Type 2 diabetes Exclusion Criteria: Known pregnancy or nursing. Females of child bearing potential must have been surgically sterilized or be post menopausal. Smoking Known vascular disease Inability to complete MRI scan Symptoms of claudication Use of a nitrate medicine Use of any cholesterol-lowering agent LDL < 70 Acute illness Liver disease Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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 |
| --- | --- |
| Experimental: High-Dose Statin<br>80 mg atorvastatin daily for 3 weeks | Drug: lipitor<br>* 80 mg everyday (QD) for 3 weeks<br>* Other names: atorvastatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Low Density Lipoprotein (LDL) | Serum LDL, mg/dL (baseline LDL-follow-up LDL) | Change from baseline to follow-up, up to 5 weeks | 
| Change in Endothelial Function as Measured on MRI in the Arms |  | chance from baseline to end of study, up to 5 weeks | 
| Change in Endothelial Function as Measured on MRI in the Legs |  | chance from baseline to end of study, up to 5 weeks |
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.

Official Title
-----------------
A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Decitabine
* Drug: Rapamycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction OR Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML ECOG performance status <3 (Appendix 1) Exclusion Criteria: Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2) Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal Active systemic infection Known chronic liver disease Known diagnosis of human immunodeficiency virus infection (HIV) Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin Pregnant or breast feeding female subjects

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Decitabine<br>* 20 mg/m2 IV, Days 1-5<br>Drug: Rapamycin<br>* Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine. |  | 6 months |
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program for eligible participants and is designed to provide access to omaveloxolone for the treatment of unresectable or metastatic melanoma to patients who previously participated in the 408-C-1401 (REVEAL) study. To be considered for expanded access, a Principal Investigator from the REVEAL trial should submit a request to Reata Pharmaceuticals on behalf of the individual patient.

Detailed Description
-----------------
This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: omaveloxolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: omaveloxolone|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
-----------------
melanoma, omaveloxolone, expanded access
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study

Study Overview
=================
Brief Summary
-----------------
The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.

Official Title
-----------------
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study

Conditions
-----------------
Tooth Extraction

Intervention / Treatment
-----------------
* Device: Axiostat
* Device: Cotton Gauze


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5) If present, sugar level should be under control Exclusion criteria Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axiostat<br>Size: 1 x 1 cm Chitosan based haemostatic dressing | Device: Axiostat<br>* Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site. Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.<br>* Other names: Chitosan haemostatic dressing;|
| Active Comparator: Cotton Gauze<br>Size: 1 x 1 cm | Device: Cotton Gauze<br>* Size: 1 x 1 cm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve haemostasis | Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain & Healing Scale | Patients comfort level as assessed by verbal inquiry after completion of procedure. | Upto 1 Day |
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

Study Overview
=================
Brief Summary
-----------------
The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.

Official Title
-----------------
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

Conditions
-----------------
Inguinal Hernia, Postoperative Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of inguinal hernia Patient undergo operation under daycare basis ASA I-II Written consent Exclusion Criteria: ASA > II Allergic reaction against gabapentin and/or pregabalin History of recurrent hernia repair. Patient who has taken analgesia prior to the surgery Liver failure Renal failure Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin Group<br>The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction. | Drug: Pregabalin<br>* The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.<br>* Other names: Lyrica 150mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3. | Efficacy: To compare the VAS score for pain after operation between the group at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiod Sparing | Total amount of rescue medication requires | 3 days | 
| Side effect of medication | Severity of Post operative nausea and vomiting (PONV) graded with mild, moderare and severe(Vomiting) Side effect of medication includes headache, giddiness, visual disturbance, and difficulty in walking. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical diagnosis of inguinal hernia, Patient undergo operation under daycare basis, ASA I-II, Written consent
Colchicine Has Anti-diabetic Effect

Study Overview
=================
Brief Summary
-----------------
Colchicine has antidiabetic effect and may be an option for type 2 diabetes management

Detailed Description
-----------------
Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years. The aim of this study was to evaluate colchicine effect on A1C of newly diagnosed type2 diabetes compared to the metformin and control group on diet only. The first group patients received colchicine 0.5twice daily for 6 months, the second group received metformin 1gm twice daily, the third group patients were on diet only. During the period of treatment, the investigators followed the patients if there were side effects of the drugs used. No side effects were monitored during the period of treatment except for gastric upset in some patients using metformin

Official Title
-----------------
Colchicine Has Anti-diabetic Effect and May be an Option for Type 2 Diabetes Management

Conditions
-----------------
Treatment Adherence

Intervention / Treatment
-----------------
* Drug: Colchicine Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes newly diagnosed age 35- 55 years Exclusion Criteria: severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1 on cochicine<br>The first group patients received colchicine 0.5 twice daily for 6 months | Drug: Colchicine Tablets<br>* colchicine tabletes for 6 months<br>|
| group 2 on glucophage 1 gm twice daily<br>second group received glucophage 1gm twice daily for 6 months | Drug: Colchicine Tablets<br>* colchicine tabletes for 6 months<br>|
| group 3 control<br>the third group patients were on diet only for 6 months | Drug: Colchicine Tablets<br>* colchicine tabletes for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colchicine for treatment of type diabetes patients | colchicine tablets .5 mg twice daily for 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, colchicine, inflammatory markers
Treatment Effect According to Timing of Administration of DWP14012 40 mg

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Detailed Description
-----------------
Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy.

Official Title
-----------------
A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis

Conditions
-----------------
Erosive Esophagitis

Intervention / Treatment
-----------------
* Drug: DWP14012
* Drug: DWP14012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between 19 and 75 years old based on the date of written agreement Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days Exclusion Criteria: Those who have undergone gastric acid suppression or gastric, esophageal surgery Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fed state group<br>just after a meal | Drug: DWP14012<br>* DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks<br>* Other names: fed state;|
| Experimental: fasted state group<br>before a meal | Drug: DWP14012<br>* DWP14012 40 mg, orally, once daily before a meal up to 4 weeks<br>* Other names: fasted state;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing rate at week 4 | Cumulative healing rate of erosive esophagitis at week 4 by endoscopy | up to 4 weeks |