linjc16/ctgov huggingface dataset:
Inflammation, Polyphenols, and Genetics

Study Overview
=================
Brief Summary
-----------------
Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.

Detailed Description
-----------------
A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.

Official Title
-----------------
Inflammation, Polyphenols, and Genetics: A Pilot Study in Overweight and Obese Adult Males to Determine Whether Black-Raspberry Consumption Affects Markers of Inflammation in Study Participants Fed a High-Fat, High-Calorie Challenge Meal

Conditions
-----------------
Overweight, Obese

Intervention / Treatment
-----------------
* Dietary Supplement: Blackraspberry Slurry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult males over 55 years of age overweight or obese Exclusion Criteria: history of adverse reaction to berries or berry products history of adverse reaction to high-fat, high-calorie challenge meal significant liver or renal insufficiency significant cognitive impairment

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blackraspberry slurry, washout, water<br>Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days | Dietary Supplement: Blackraspberry Slurry<br>* Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.<br>|
| Experimental: Water, washout, Blackraspberry slurry<br>8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days | Dietary Supplement: Blackraspberry Slurry<br>* Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IL-6 | Area Under the time-concentration Curve (AUC) of IL-6 | acute (0-12 hours) after inflammation-causing challenge meal |
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia

Official Title
-----------------
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: AquaBeam System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 50 - 80 years Moderate to severe BPH Subjects who have failed standard medical therapy Exclusion Criteria: Size and width of prostate Medical condition or co-morbidities where BPH intervention would be contraindicated

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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: Single Arm<br>AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH | Device: AquaBeam System<br>* Aquablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Device Performance Endpoint | The primary device performance endpoint is completion of the intended surgical procedure. | 6 months | 
| Primary Safety Endpoint of the study is the perioperative complication rate. | The primary safety endpoint of the study is the perioperative complication rate | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aquablation, AQUABEAM, BPH, LUTS
The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation

Study Overview
=================
Brief Summary
-----------------
Single Blinded, Randomized-control tiral, Multicenter clinical trial

Official Title
-----------------
The Clinical Efficacy of Hip Protection Orthosis for The Protection of Hip Dislocation in Patients With Severe Cerebral Palsy, Single Blinded, Randomized-control Trial, Multicenter Clinical Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Hip protection orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GMFCE level IV or V in the Cerebral palsy age from 1 to 10 Exclusion Criteria: History of hip joint surgery Botulinum toxin injection to hip muscle past 3 months or expected in our study duration

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Device: Hip protection orthosis<br>* Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration index | Hip AP radiography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cobb's angle (') | using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value. | 6 months | 
| Range of motion of hip joint (') | Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value. | 6 months | 
| Visual analog scale | measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain. | 6 months | 
| Likert scale (score) | measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction. | immediately after wearing orthosis | 
| Child Health Index of Life with Disabilities (CPCHILD) | measure the quality of life expressed by score from 0 to 100. The higher the quality of life. | 6 months |
Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective research in order to compare and analysis the risk factor, clinical manifestation and efficacy of albicans candidemia by pulling medical records. We hope that this retrospective research will let us understand the method of treatment and prevention of albicans candidemia in order to improve the quality of healthcare.

Official Title
-----------------
Retrospective Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation

Conditions
-----------------
Non-albicans Candidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 20 years old hospital patients albicans candidemia patients Exclusion Criteria: pregnant patients or patients under 16 years old liver cirrhosis and Child C

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-albicans candidemia
Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.

Detailed Description
-----------------
After written informed consent, the nerves supplying the facet joints - lumbar dorsal rami and its medial branches, will be harvested when they are exposed during spinal surgery. These nerves will be fixed, washed and further dissected to enable smaller sections. The cut section will be stained and subjected to analysis of overall cross-sectional area and presence of connective tissue sheaths under light microscope.

Official Title
-----------------
Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch

Conditions
-----------------
Lumbar Facet Arthrosis, Nerve Degeneration

Intervention / Treatment
-----------------
* Procedure: Spinal surgery
* Other: Histology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be aged 18 or over be able to give informed consent scheduled to undergo lumbar spinal surgery Exclusion Criteria: Children under 18 years old Vulnerable adults Adults with incapacity Inability to provide informed consent History of previous spinal surgery history of previous RF ablation for low back pain has COVID-19 or displaying symptoms of COVID-19

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 |
| --- | --- |
| Active group<br>Patients who are scheduled to undergo lumbar spinal surgery and fulfill the inclusion and exclusion criteria | Procedure: Spinal surgery<br>* In participants who undergo elective lumbar spinal surgery and consented for research, the medial branch and dorsal rami will be harvested for histological analysis.<br>Other: Histology<br>* The harvested nerves will be fixed, cut into smaller sections. Analysis of macroscopic and light microscopic sections will be carried out<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve Histology | Percentage of nerves containing more than 50% sensory fibres in lumbar dorsal rami/medial branches to assess whether they are sensory or motor nerves | one year |
Gut Microbiota Pilot Study

Study Overview
=================
Brief Summary
-----------------
Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.

Detailed Description
-----------------
Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.

Official Title
-----------------
Anaylsis of Gut Microbiota in ICU

Conditions
-----------------
Microbiota, Metabolism

Intervention / Treatment
-----------------
* Biological: Gut Microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 17 years old Every patients who are admitted to ICU Exclusion Criteria: With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome With history of immunosuppressive agents. Initial systolic blood pressure <100 Initial pulse rate > 100 Need emergent operation at brain or torso Need vasopressor, transfusion

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 |
| --- | --- |
| Stable patient<br>Stable patients who admitted to ICU for observation. | Biological: Gut Microbiota<br>* Status of microbiota<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stuatus of gut microbiota in stable patient | Result of next generation sequencing | 1 Month |
A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

Conditions
-----------------
Solid Cancers

Intervention / Treatment
-----------------
* Drug: MNRP1685A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease) Exclusion Criteria: Inadequate hematologic or organ function Anti-cancer therapy within 4 weeks prior to initiation of study treatment Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava Active infection or autoimmune disease Known human immunodeficiency virus (HIV) infection Pregnancy or breast feeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MNRP1685A|Escalating intravenous dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of dose-limiting toxicities (DLTs) |  | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total exposure (AUC) |  | Length of study | 
| Maximum and minimum serum concentrations |  | Length of study | 
| Clearance |  | Length of study | 
| Volume of distribution |  | Length of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuropilin-1, NRP1, anti-NRP1, anti-angiogenic
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)

Study Overview
=================
Brief Summary
-----------------
This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.

Official Title
-----------------
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)

Conditions
-----------------
Primary Sclerosing Cholangitis, Cholangiocarcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: MR/MRCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PSC by MR/MRCP Life expectancy >1 year Informed consent Exclusion Criteria: Liver transplantation or on the waiting list Secondry SC Diagnosis of CCA

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: MR/MRCP|MR/MRCP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholangiocarcinoma | cholangiocarcinoma | 10 yrs f-up | 
| liver transplatation | liver transplatation | 10 yrs f-up | 
| death | death | 10 yrs f-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary dysplasia | biliary dysplasia | 10 yrs f-up |
Surveillance Study of NovoRapid® for New Drug Re-examination

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.

Official Title
-----------------
Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IAsp<br> | Drug: insulin aspart<br>* Subjects who had a first drug date on NovoRapid® were prescribed to inject insulin aspart using vial, FlexPen, NovoLet or Penfill devices. Injected subcutaneously (s.c., under the skin) immediately before meals for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose (FBG) |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  | 
| Adverse events: Serious and non-serious |  |  |
Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia

Study Overview
=================
Brief Summary
-----------------
The study aims at determining the best biometry calculation formula to be used in IOL calculation of cataract patients how previously underwent laser refractive correction surgery

Detailed Description
-----------------
Patients undergoing laser refractive surgery will will be investigated in means of Pentacam testing and IOL master biometry both preoperative and 6 weeks postoperative to determine which IOL calculation formula is the nearest and most accurate to preoperative records in different refractive sittings.

Official Title
-----------------
Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia

Conditions
-----------------
Cataract, Refractive Errors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patient undergoing laser refractive surgery Exclusion Criteria: previous ophthalmic surgery previous trauma ocular pathology other than refractive error
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 |
| --- | --- | --- |
| Best Selected IOL calculation formula |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LASIK, Intraocular lens, Biometry, IOL master