linjc16/ctgov huggingface dataset:
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.

Study Overview
=================
Brief Summary
-----------------
The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact. Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible. In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases. LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm

Detailed Description
-----------------
reconstruction of oral , head and neck defects with Lateral Arm Free Flap

Official Title
-----------------
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.

Conditions
-----------------
Oral Cancer

Intervention / Treatment
-----------------
* Procedure: Lateral Arm Free Flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients post glossectomy. Patients post maxillectomy with malignant maxillary swelling with no distant metastases. All patients which defect after surgery for head and neck neoplasia. Exclusion Criteria: 1. Small defect post excision can be closed directly 2. medically unfit patients

Ages Eligible for Study
-----------------
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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Lateral Arm Free Flap|Primary Reconstruction of intraoral defects by use of Lateral Arm Free Flap.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early detection of recurrence | reconstruction of defects in head and neck post surgical excision by lateral arm free flap and early detection of recurrence by CT neck. | 3 month |
Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

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

Intervention / Treatment
-----------------
* Drug: NIM-1324
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects; Adult males and females, 18 to 64 years of age (inclusive) at screening; Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions. Key Exclusion Criteria: History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant; Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications; COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIM-1324<br>Once daily oral tablet | Drug: NIM-1324<br>* Once daily oral tablet<br>|
| Placebo Comparator: Placebo<br>Once daily oral tablet | Drug: Placebo<br>* Once daily oral tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 1 to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK |  | 24 hours |
Effect of Allopurinol Treatment on Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.

Conditions
-----------------
Hyperuricemia, Prediabetes, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: allopurinol 300 mg./day
* Other: No intervention
* Drug: Normouricemic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 30 Serum uric acid level ≥7mg/dL Glomerular filtration rate ≥60 ml/min Exclusion Criteria: presence of Diabetes Mellitus history of gout history of allopurinol use body mass index ≥35 kg/m2 proteinuria ≥ 1gr/ day presence of autoimmune disease rheumatology associated disease presence of hypothyroidism or hyperthyroidism presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Uric acid ≥7 mg/dL<br>This arm will receive allopurinol treatment. 50 subjects will be recruited. | Drug: allopurinol 300 mg./day<br> <br> |
| Active Comparator: Uric acid ≥6 and <7<br>This arm will not receive allopurinol. 50 subjects will be recruited. | Other: No intervention<br> <br> |
| Placebo Comparator: Normouricemic<br>This arm is healthy controls. 30 subjects will be recruited. | Drug: Normouricemic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin resistance (HOMA-IR) |  | baseline and 3 months |
Study of Optimal Treatment Plan in Hypertensives With Anti-AT1-Receptor Autoantibody

Study Overview
=================
Brief Summary
-----------------
The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in patients with hypertension. ATR-AA which can blocked by ARB may play a role in the pathogenesis of hypertension. The present study is to explore whether AT1 receptor blocker has superior anti-hypertensive effect in patients with positive ATR-AA hypertension. Patients with 2 grade hypertension were recruited and ATR-AA was assayed by ELISA. A study was carried out and the efficacy of anti-hypertension was compared between candesartan cilexetil and ACE inhibitor imidapril.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: candesartan cilexetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension (2 grade) Exclusion Criteria: Secondary hypertension Known sensitivity or intolerance to an angiotensin II receptor antagonist or ACE inhibitor Pregnancy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: candesartan cilexetil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. To see if patients feel better while taking pemetrexed plus Gemcitabine.

Official Title
-----------------
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase II Clinical Trial

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: pemetrexed
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy Have received no prior chemotherapy for Non-Small Cell Lung Cancer Have at least one measurable lesion Have an adequate performance status Sign an informed consent Exclusion Criteria: A female who is pregnant or breastfeeding Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed Treatment with radiation therapy within the last 1-2 weeks Brain metastasis that is uncontrolled Active infection or other serious condition

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

| Intervention/Treatment |
| --- |
|Drug: pemetrexed|nan|
|Drug: gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure time-to-event efficacy variables including: |  |  | 
| time to objective tumor response for responding patients |  |  | 
| duration of response for responding patients |  |  | 
| time to treatment failure |  |  | 
| time to progressive disease |  |  | 
| progression-free survival |  |  | 
| overall survival |  |  | 
| To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population. |  |  |
Comprehensive Assessment of Risks for Miscarriage.

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion

Detailed Description
-----------------
To study the added value (if any) of combining serum markers, immunologic factors, and ultrasound parameters in comprehensively evaluating the risk for spontaneous abortion.

Official Title
-----------------
Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.

Conditions
-----------------
Spontaneous Abortion

Intervention / Treatment
-----------------
* Diagnostic Test: Markers of ultrasound
* Diagnostic Test: Immunologic factors
* Diagnostic Test: Serum factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: visualized fetal structures in utero & heart pulsations until 8th week of gestation normal THS/T4 levels no uterine malformations BMI < 27 signed informed consent Exclusion Criteria: fetal structures in utero & heart pulsations not visualized until the 8th week of gestation elevated THS/T4 levels uterine malformations BMI > 27

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Monitoring of pregnancy, including data on: maternal age and other demographic characteristics; ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL) | |
| sFlt-1, Doppler and NK cells types group<br>Monitoring of pregnancy, including data on: maternal age and other demographic characteristics; ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL), uterine arteries PI, and other parameters; measurement of serum sFlt-1, PLGF, and glycodelin-A levels, as well as other parameters; measurement of CD16+, CD56+, and other subpopulations of NK cells; | Diagnostic Test: Markers of ultrasound<br>* CRL, HR, and other ultrasound measurements.<br>Diagnostic Test: Immunologic factors<br>* Measurement of NK cells subpopulations types in the maternal serum<br>Diagnostic Test: Serum factors<br>* Measuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of a spontaneous abortion | Absent heart rate pulsations on an ultrasound scan | Up to 24 weeks of gestation |
The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients

Study Overview
=================
Brief Summary
-----------------
To study the safety and efficacy of four different doses of Wobenzym (an enzyme combination consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and rutin) in patients with HIV infection whose CD4 count is between 250 and 400 cells/mm3. To evaluate the effect of Wobenzym on certain surrogate markers associated with progression of HIV disease.

Official Title
-----------------
A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Wobenzym


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV seropositivity with CD4 counts between 250 and 400 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to hydrolytic enzymes such as Wobenzym. Known sensitivity to lactose. Presumption that the patient will not comply with the dosing schedule or follow-up appointments. Concurrent Medication: Excluded: Concurrent use of immunosuppressive therapy or steroids.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Wobenzym|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
-----------------
Wobenzym, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hydrolases
Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.

Official Title
-----------------
A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Gemcabene 900 mg
* Drug: Simvastatin 80 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females >18 years of age Body weight 45 kg or greater Exclusion Criteria: If female, of childbearing potential or lactation History of significant adverse reaction to any fibrate lipid-lowering agent or HMG-CoA reductase inhibitor

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

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcabene 900 mg<br>Gemcabene 900 mg | Drug: Gemcabene 900 mg<br>* 3x300 mg Gemcabene tablets orally once daily (QD) for 15 days<br>Drug: Simvastatin 80 mg<br>* 2x40 mg Simvastatin tablets orally once daily (QD) for 15 days<br>|
| Active Comparator: Simvastatin 80 mg<br>Simvastatin 80 mg | Drug: Simvastatin 80 mg<br>* 2x40 mg Simvastatin tablets orally once daily (QD) for 15 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Cmax | 15 days | 
| Pharmacokinetics | Area Under the Curve (AUC) | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 57 days | 
| Clinical Laboratory - hematology, chemistry, urinalysis | Clinical Laboratory Abnormalities | 57 days | 
| ECG | Clinically Significant Changes | 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Lipid Regulator
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to investigate the safety and effectiveness of EYLEA

Detailed Description
-----------------
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study. The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

Official Title
-----------------
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: Aflibercept (Eylea, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who start EYLEA treatment for Diabetic Macular Edema (DME) Exclusion Criteria: Patients who have already received EYLEA treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aflibercept (Eylea,BAY86-5321)<br>Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert | Drug: Aflibercept (Eylea, BAY86-5321)<br>* Administration by intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants of Adverse Events |  | Up to 12 months | 
| Number of participants of Serious Adverse Events |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity from baseline to 12 months |  | Baseline to 12 months | 
| Mean change in retina thickness from baseline to 12 months |  | Baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aflibercept, anti-VEGF