linjc16/ctgov huggingface dataset:
Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.

Official Title
-----------------
A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: K-285
* Drug: Indomethacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study specific evaluation is performed. Subject is a healthy adult male or female aged 18 to 45 years, inclusive. Subject has a BMI of 18 to 30 kg/m2, inclusive. Subject meets all inclusion criteria outlined in the clinical study protocol. Exclusion Criteria: Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1). Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1). Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1). Subject does not meet any exclusion criteria outlined in the clinical study protocol.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>K-285 dose/application method A | Drug: K-285<br>* Topical<br>|
| Experimental: Treatment B<br>K-285 dose/application method B | Drug: K-285<br>* Topical<br>|
| Experimental: Treatment C<br>K-285 dose/application method C | Drug: K-285<br>* Topical<br>|
| Active Comparator: Treatment D<br>Indomethacin capsule | Drug: Indomethacin<br>* Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4 | 
| Area under the plasma versus concentration time curve (AUC) |  | Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | Through study completion approximately 33 to 38 days |
Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

Study Overview
=================
Brief Summary
-----------------
This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases. Primary end point is local progression free survival.

Detailed Description
-----------------
Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.

Official Title
-----------------
The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial

Conditions
-----------------
Colorectal Carcinoma, Liver Metastases

Intervention / Treatment
-----------------
* Procedure: SBRT or RFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adenocarcinoma of the colon or rectum Liver metastases Inoperable (technical or medical) 1-4 metastases Maximum 40 mm in diameter Suitable for both therapies, RFA and SBRT Exclusion Criteria: Uncontrolled extrahepatic disease and uncontrolled primary cancer Liver cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic body radiation therapy<br>Colorectal liver metastases treated by SBRT | Procedure: SBRT or RFA<br>* Patients are allocated to one of the two arms in a 1:1 randomization<br>* Other names: Radiofrequency ablation;|
| Active Comparator: Radiofrequency ablation<br>Colorectal liver metastases treated by RFA | Procedure: SBRT or RFA<br>* Patients are allocated to one of the two arms in a 1:1 randomization<br>* Other names: Radiofrequency ablation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local progression-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 3 years | 
| Survival |  | 3 years | 
| Progression (local or distant) |  | 3 years | 
| Quality of life |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation
Creatine Supplementation and Bone Mass

Study Overview
=================
Brief Summary
-----------------
Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.

Conditions
-----------------
Osteopenia, Osteoporosis

Intervention / Treatment
-----------------
* Dietary Supplement: creatine supplementation
* Other: exercise training
* Other: placebo (dextrose)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteopenia and osteoporosis women older than 60 years old Exclusion Criteria: cardiovascular diseases or muscular disturbances precluding exercise training drugs affecting bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Placebo Comparator: control and exercise<br>this is trained and receives placebo | Other: exercise training<br>* resistance training twice a week for 24 weeks<br>Other: placebo (dextrose)<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>|
| Experimental: creatine<br>this is non-exercise trained and receives creatine supplementation | Dietary Supplement: creatine supplementation<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>|
| Experimental: exercise and creatine<br>this is exercised trained and receives creatine supplementation | Dietary Supplement: creatine supplementation<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>Other: exercise training<br>* resistance training twice a week for 24 weeks<br>|
| Placebo Comparator: placebo<br>this only receives placebo (dextrose) | Other: placebo (dextrose)<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognition |  | six months | 
| physical capacity | including muscle strength, balance and muscle function | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
creatine supplementation, resistance training, osteopenia, osteoporosis, bone mineral density
Laboratory and Clinical Data in Antiphospholipid Patients

Study Overview
=================
Brief Summary
-----------------
To constitute a registry of antiphospholipid antibodies positive-patients

Detailed Description
-----------------
An international web-based application, the REDCap (Research Electronic Data Capture), captures data on patient demographics, aPL-related clinical and laboratory characteristics, and medications. The inclusion criteria are: a) age between 18 and 60 years; and b) persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening; positivity is defined as anticardiolipin antibodies (aCL) IgG/M/A (> 40 GPL/MPL/APL, medium-to-high titer, and/or greater than the 99th percentile), anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A (> 40 units, medium-to-high titer), positive lupus anticoagulant (LA) test based on International Society on Thrombosis and Hemostasis and other current guidelines. Patients are followed every 12 ± 3 months with clinical data and blood collection. Blood drawn is done at inclusion and every year.

Official Title
-----------------
Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides

Conditions
-----------------
Antiphospholipid Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 60 years; persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening Exclusion Criteria: no inform consent impossible follow up pregnancy

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Blood test|Blood test for the identification of biomarkers|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Rate of thrombosis | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Rate of bleeding | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiphospholipid antibodies
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt

Study Overview
=================
Brief Summary
-----------------
Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on structural studies and multiple alignment analysis. By comparing the positive-stranded RNA genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal nucleotide analogue to repurpose for COVID-19 treatment

Official Title
-----------------
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild- moderate COVID-19 confirmed by PCR Exclusion Criteria: Patients on renal dialysis Severe COVID-19 cases Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia). Children < 12 years Pregnant and breast feeding women Exacerbation of hepatitis B

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sofosbuvir / Daclatsvir<br>A drug used in the treatment of HCV infection, given in the same dose 400mg and 60 mg respectively once daily for 14 days | Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg<br>* Giving these two drugs for treatment of COVID patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19. | The study assesses the incidence of resolution of symptoms in COVID patients after taking Sofosbuvir and Daclatasvir for 14 days by doing PCR and the result to be negative | it is estimated to be 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sofosbuvir, Daclatasvir
Cohort Study in South China

Study Overview
=================
Brief Summary
-----------------
Healthy Chinese residents from South China will be recruited and followed up for at least 4 years to evaluate the association between climate, diet and lifestyle and risks for the development of chronic diseases. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of chronic diseases will be investigated during follow-up.

Detailed Description
-----------------
110,000 adult Chinese (35 to 74 years old) without chronic diseases and major disability who have been living in South China including Guangdong, Fujian, Guangxi and Hainan for more than 5 years will be recruited. All participants will be prospectively followed up for the incidence of chronic diseases (stroke, coronary heart disease, malignant neoplasms, chronic obstructive pulmonary diseases, diabetes and hypertension) and their risk factors (impaired glucose tolerance and obesity). Information about socio-demographic, diet, lifestyle, psychological status, medical history and current medication will be collected by questionnaires. Physical examinations including height, weight, waist and hip circumferences, blood pressure, fat mass and vital capacity will be conducted. Besides, blood, urine and fecal samples will be collected for further analysis. Annual meteorological data throughout the study period will also be collected. The associations between climate, diet and lifestyle and risks for chronic diseases will be evaluated.

Official Title
-----------------
Prospective Cohort Study of Chronic Diseases in South China

Conditions
-----------------
Chronic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult Chinese (35-74 years old) who have been living in South China including Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years. Exclusion Criteria: any subject diagnosed with stroke, coronary heart disease, malignancy, chronic obstructive pulmonary disease, diabetes and hypertension. any subject who suffer from major disability and cannot participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 74 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic disease | Incidence of chronic disease, including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for chronic diseases | Incidence of impaired glucose tolerance and obesity | 4 years |
Stroke Prevention in Atrial Fibrillation Patients Between 2004 and 2020

Study Overview
=================
Brief Summary
-----------------
Prevention of thromboembolic complications is an important part in the management of patients with atrial fibrillation (AF). European and American guidelines recommend the use of non-vitamin K antagonist oral anticoagulants (NOACs) over therapy with vitamin K antagonists (VKA) in most AF patients. The number of patients treated with NOACs has increased significantly during the last few years. In the primary randomized controlled trials leading to their approval, compared to warfarin, NOACs were shown to be either noninferior or superior for stroke prevention in AF, with similar or reduced rates of bleeding, especially intracranial haemorrhage. The aim of this study was to assess the frequency of oral anticoagulants using, espescially apixaban, dabigatran, and rivaroxaban, and the predictors of their prescription in a group of hospitalised patients with AF.

Official Title
-----------------
Stroke Prevention in Atrial Fibrillation Patients Between 2004 and 2020

Conditions
-----------------
Atrial Fibrillation; Stroke Prevention

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - non-valvular atrial fibrillation Exclusion Criteria: valvular atrial fibrillation death during hospitalization

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational study|observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral anticoagulant treatment |  | one year |
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Detailed Description
-----------------
Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Official Title
-----------------
Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Drug: Norfloxacin
* Drug: Itopride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cirrhotic patients with ascites who had previous episodes of SBP. Exclusion Criteria: 1. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.
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 |
| --- | --- |
| Active Comparator: Norfloxacin<br>Norfloxacin 400 mg daily | Drug: Norfloxacin<br>* Norfloxacin 400 mg daily<br>* Other names: Epinor;|
| Experimental: Norfloxacin and Itopride<br>Norfloxacin 400 mg daily and Itopride 50 mg three times daily. | Drug: Norfloxacin<br>* Norfloxacin 400 mg daily<br>* Other names: Epinor;Drug: Itopride<br>* Itopride 50 mg three times daily<br>* Other names: Ganaton;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bouts of recurrence during treatment. | The recurrence of infection during treatment. | 6 months |
Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

Study Overview
=================
Brief Summary
-----------------
This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are: Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1) Identification of molecular tumor characteristics in long-term survivors (Focus 2) Assessment of therapy-related parameters, including neuro-toxicity (Focus 3) Immunological studies (Focus 4)

Official Title
-----------------
Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Procedure: Blood drawl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years at diagnosis Histopathological diagnosis of glioblastoma (reference histology available) and Survival >5 years from diagnosis Availability of tumor tissue from initial glioblastoma diagnosis (FFPE or fresh-frozen) to validate the diagnosis centrally. Signed consent form (living patients) or ethics approval for anonymous data collection in case of retrospective analysis of deceased patients Exclusion Criteria: Not applicable

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

| Intervention/Treatment |
| --- |
|Procedure: Blood drawl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1 year from last patient in | 
| Molecular profiling on FFPE samples | Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform | 1 year from last patient in | 
| Molecular profiling on frozen samples | Samples will be subjected to whole exome sequencing | 1 year from last patient in | 
| Molecular profiling on frozen samples | Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing | 1 year from last patient in | 
| Molecular profiling on frozen samples | Samples will be subjected to miRNA sequencing | 1 year from last patient in | 
| Molecular profiling on frozen samples | Samples will be subjected to microarray-based expression profiling | 1 year from last patient in | 
| Proteome profiling | Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry | 1 year from last patient in |