linjc16/ctgov huggingface dataset:
ABCB1 SNPs as Predictors of PIPN

Study Overview
=================
Brief Summary
-----------------
The study aim is to determine the allele frequencies of 1236 G>A and 3435 G>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.

Official Title
-----------------
ABCB1 Single Nucleotide Polymorphism Genotypes as Predictors of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer

Conditions
-----------------
Paclitaxel Adverse Reaction, Neuropathy;Peripheral, Breast Cancer

Intervention / Treatment
-----------------
* Genetic: Real-Time PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian females ≥18 years of age. Histologically confirmed Breast Cancer. Receiving conventional neoadjuvant or adjuvant weekly paclitaxel. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL). No major neurological disease or symptoms prior to the start of paclitaxel therapy. neither subjective nor objective evidence of metastatic disease. Exclusion Criteria: Pregnancy. Patients with recurrent or metastatic (local or distant) breast cancer. Neuropathic at the time of recruitment. History of neuropathy prior to recruitment. Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates. Patients currently receiving dose-dense biweekly taxane-containing regimens.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Real-Time PCR|Genomic DNA was extracted from 2 ml of venous blood. ABCB1 1236 G>A and 3435 G>A were genotyped using predesigned TaqMan SNP genotyping assays on a stepOne PCR instrument in accordance with the manufacturer's protocol.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 2 or higher peripheral neuropathy | Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0) | 12 weeks |
Family-based Genetic Long-term Study of Brain Function in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to find out possible susceptible gene(s) in schizophrenic patients with family history and 5-year period functional changes of brain among the members of family, in order to further analysis factors and their interactions.

Detailed Description
-----------------
Schizophrenia is a serious mental disease, highly family inheritable inclination. By means of traditional psychiatry diagnosis, genetics and long term brain change researches will help to unveil the secret of schizophrenia and other factors. The advantage of comparative gene hybridization is that chromosome copy number alterations can be detected; this technique has been widely applied in many researches, such as cancer, mental retardation screening and autism. As we known, we are the first one use this technique in chromosome abnormality research for family history schizophrenic patient, this study also is the first one to track the relationship of long term brain function alteration and chromosome abnormality in Taiwan.

Official Title
-----------------
The Genetic Study of Longitudinal Brain Function Among Schizophrenic Patients With Family History

Conditions
-----------------
Schizophrenia, Blooddraw, MRI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Psychiatry doctor diagnosed who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder, family history, age older than 15 will be recruited for participation in this study. Participants agree and sign informed consent forms will eligible to participate this experiment. 2.10-20c.c blood will be drawn from the participants. 3.Participants need to understand procedures and assays of this experiment. 4.At least one psychiatry doctor interview needed, participants and their family voluntarily join this interview, approximately 30-45min. Exclusion Criteria: Participant can not understand procedures and assays of this experiment. Participant has another major mental disease other than the inclusion criteria. Participant has material abuse history, it could seriously influence diagnosis. Participant has combination diseases, it could seriously influence diagnosis. Psychopathy or psychosis can not be categorized in defined group. Other considerations: Participants, age fewer than 20 needs to their deputy guardians (parents) and their own consent altogether. Participants who are inability needs to their deputy guardians (parents) and their own consent altogether.
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
-----------------
Schizophrenia, DNA, MRI
Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

Study Overview
=================
Brief Summary
-----------------
Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in reducing high cholesterol.

Detailed Description
-----------------
Hypercholesterolemia is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). The National Cholesterol Education Program estimates that 65 million Americans with hypercholesterolemia could be treated with diet and exercise alone. Flaxseed is a potential component of cholesterol-reducing diet regimens. Flaxseed contains significant amounts of soluble fiber and is a rich source of both alpha-linolenic acid and phytoestrogenic ligands, which have been implicated in the prevention of ASCVD. However, flaxseed's phytoestrogenic ligands may have undesirable hormonal effects. This study will systematically evaluate the safety and efficacy of ground flaxseed ingestion in both men and women with hypercholesterolemia. Participants will be randomized to receive flaxseed or a matching wheat bran control. The test dose of flaxseed will be 40 grams administered in baked products (muffins, bread, or bars). The first 6 study weeks are a diet stabilization phase, followed by a 10-week study phase in which participants are expected to eat two servings of the test food daily. Blood and urine are collected for analysis, which will include measurement of low density lipoprotein cholesterol (LDL-C), post-prandial triglycerides, and urinary isoprostane secretion.

Official Title
-----------------
A Double Blind, Randomized, Placebo Controlled Trial of Flaxseed in Patients With Hypercholesterolemia

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

Intervention / Treatment
-----------------
* Behavioral: Flaxseed-supplemented diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men over 45 and post-menopausal women LDL cholesterol > 130 mg/dl Exclusion Criteria Established heart, kidney, or liver disease Diabetes Cancer

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Flaxseed-supplemented diet|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
-----------------
Flaxseed, Cholesterol
Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Genexol-PM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who aged 18 years or older Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required. Subjects with no other malignancy diagnosed within past five years except for: Cured non-melanoma skin cancer Cured cervical intraepithelial neoplasia (CIN) Cured In-situ cervical cancer (CIS) Subjects who are ECOG performance status of ≤ 1

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: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2 | Drug: Genexol-PM<br>* Cremophor EL-free polymeric micelle of paclitaxel<br>|
| Experimental: Cohort 2<br>Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2 | Drug: Genexol-PM<br>* Cremophor EL-free polymeric micelle of paclitaxel<br>|
| Experimental: Cohort 3<br>Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2 | Drug: Genexol-PM<br>* Cremophor EL-free polymeric micelle of paclitaxel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine |  | 1 year | 
| The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (complete response (CR) + partial response (PR)) |  | 1 year | 
| Time to tumor progression |  | 1 year | 
| Progression free survival |  | 1 year | 
| Safety profiles |  | 1 year |
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.

Detailed Description
-----------------
To determine mean change in visual acuity at 6 and 12 months

Official Title
-----------------
Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months

Conditions
-----------------
Wet AMD

Intervention / Treatment
-----------------
* Drug: Lucentis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age greater then and equal 50 years Patients with active neovascular AMD Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months If the patient has bilateral disease and qualifies for the study, both eyes may be included Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: Pregnancy or lactation Premenopausal women not using adequate contraception. Participation in another simultaneous medical investigation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0<br> | Drug: Lucentis<br>* 0.5mg Lucentis every four months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity at 6 and 12 months |  | one year |
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.

Official Title
-----------------
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Conditions
-----------------
Memory Functions

Intervention / Treatment
-----------------
* Drug: Cinacalcet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy normotensive native or fluent German-speaking caucasian (European ancestry) BMI between 19 and 27 kg/m2 Exclusion Criteria: acute or chronic psychiatric or somatic disorder pathological ECG Low serum calcium known hypersensitivity to the IMP pregnancy breast-feading long-term medication within last 3 months smoking more than 3 cigarettes per day seizures in participants and first degree relatives concurrent participation in another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinacalcet<br> | Drug: Cinacalcet<br>* single administration, 90mg<br>|
| Placebo Comparator: Sugar pill<br> | Drug: Cinacalcet<br>* single administration, 90mg<br>Drug: Placebo<br>* single administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of attention functions under cinacalcet |  | two study days within 10 days | 
| Change of memory functions under cinacalcet |  | two testing days within 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of emotional state under cinacalcet |  | two study days within 10 days |
ARIpiprazole in Anorexia NErvosa

Study Overview
=================
Brief Summary
-----------------
Evidence is lacking on the effects of different psychotropic drugs in the treatment of anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a placebo.

Official Title
-----------------
Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial

Conditions
-----------------
Anorexia Nervosa

Intervention / Treatment
-----------------
* Drug: aripiprazole
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 12 and 18 diagnostic criteria for anorexia Nervosa (DSM-IV-TR (includes BMI below 17.5kg/m2 and above 14 kg/m2) confirmed by a Psychiatrist and validated by K-SADS-PL interview severity criteria requiring Hospital admission Consent given by parents and patients Exclusion Criteria: psychotic illness antipsychotic therapy at inclusion pregnancy and breastfeeding antipsychotic drug allergy prior head trauma, malignant neuroleptic syndrome or epilepsy relevant comorbidities requiring therapy detection of abuse drugs in urine test treatment with neuroleptic, antidepressant or mood stabilizers during 2 weeks prior to randomization (4 weeks in case of fluoxetine) suicidal or homicidal thoughts IQ below 70

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aripiprazole<br> | Drug: aripiprazole<br>* 10 mg QD during 26 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* QD during 26 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Inventory-2 |  | 6 months | 
| Eating attitudes test (EAT) |  | 6 months | 
| Brown Assessment of Beliefs Scale (BABS) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Body mass index | 6 months | 
| BDI | Beck Depression Inventory | 6 months |
Knowledge Attitudes Beliefs and Practices Regarding HIV Among Teenagers in French Guiana

Study Overview
=================
Brief Summary
-----------------
French Guiana is the French territory where the prevalence of HIV is highest. in order to determine the knowledge attitudes, beliefs, and practices among the target group of teenagers attending the public school system a survey was conducted in 2011. schools and classrooms were randomly selected, and a structured questionnaire was administered. Descriptive statistics were obtained and multivariate logistic regression was used to determine predictors of main outcomes such as age at first sex. the results will be used to guide prevention of HIV and sexually transmitted infections though the school system.

Conditions
-----------------
HIV

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: attending the public school system of french guiana Exclusion Criteria: refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge, attitudes, behaviours, and practices relative to HIV/AIDS and sexually transmitted infections | a structured questionnaire was used. it was administered face to face with usually 5 possible responses. Scores were established using similar questions exploring related areas of HIV. | when the interview was conducted |
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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

Intervention / Treatment
-----------------
* Drug: Comparator: sitagliptin 100 mg
* Drug: Comparator: sitagliptin 200 mg
* Drug: Comparator: placebo
* Drug: Comparator: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus Exclusion Criteria: Younger than 18 years of age or older than 75 Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin 100 mg<br>Sitagliptin 100 mg | Drug: Comparator: sitagliptin 100 mg<br>* sitagliptin 100 mg oral tablet once daily for 54 weeks<br>|
| Experimental: Sitagliptin 200 mg<br>Sitagliptin 200 mg | Drug: Comparator: sitagliptin 200 mg<br>* sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks<br>|
| Placebo Comparator: Placebo/Pioglitazone<br>Placebo/Pioglitazone | Drug: Comparator: placebo<br>* placebo oral tablet once daily during Phase A (Weeks 0-18)<br>Drug: Comparator: pioglitazone<br>* pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at Week 18 | Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | Weeks 0-18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG at Week 18 | The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. | Weeks 0-18 | 
| Change From Baseline in A1C at Week 54 | A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent. | Weeks 0-54 | 
| Change From Baseline in FPG at Week 54 | The change from baseline reflects the Week 54 FPG minus the Week 0 FPG. | Weeks 0-54 |