linjc16/ctgov huggingface dataset:
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.

Official Title
-----------------
A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: AVP-923


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: 18 to 80 years of age, inclusive Confirmed diagnosis of ALS or probable ALS Clinical history of pseudobulbar affect If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study If female, must have been practicing an established method of birth control for at least the prior month (oral contraceptive tablets, hormonal implant device, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal Must be willing to not take any prohibited medications during participation in the study Exclusion: Known sensitivity to quinidine or opiate drugs (codeine, etc.) On any anti-depressive medication Recently (within two months) diagnosed with ALS Currently participating in, or who within the past 30 days have participated in, the study of another investigational new drug Previously received treatment with co-administration of dextromethorphan and quinidine History of substance abuse within the past two years Women who are pregnant or likely to become pregnant during the course of the study

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AVP-923|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
-----------------
AVP-923, Dextromethorphan, Quinidine, Pseudobulbar Affect
Stroke and MI in Users of Estrogen/Progestogen

Study Overview
=================
Brief Summary
-----------------
To estimate the relative risks of acute myocardial infarction (MI) and of stroke in postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative risks of MI and of stroke in users of estrogen alone.

Detailed Description
-----------------
BACKGROUND: Post-menopausal hormone use is becoming increasingly widespread based on evidence of the benefits of estrogen use for bone and the heart. However, because estrogen alone substantially increases the risk of endometrial cancer, estrogen users who have not undergone a hysterectomy are frequently also placed on a progestogen (E/P), a strategy that reduces the likelihood of endometrial cancer when compared with use of estrogen alone. In 1991, there were almost no data on the risk of cardiovascular disease in post-menopausal women who used E/P combinations. DESIGN NARRATIVE: The study had a case-control design, Cases were women hospitalized with MI or stroke in any of nine participating Northern California Kaiser Permanente hospitals in a 36 month period. For each case, one control, matched by year of birth, was selected at random from among members of the Kaiser Permanente Health Plan who were expected to use the same nine hospitals for their medical care. Information about use of estrogen, E/P combinations, past use of oral contraceptives, menopause, hysterectomy and oophorectomy, demographics, general health status, preventive health care, and cardiovascular risk factors were collected in interviews done of the subjects or, for fatal cases, a surrogate. Information about then current use of estrogen and E/P combinations were also gathered by reviewing medical records. The investigators used conditional logistic regression analysis to estimate the relative risks of MI and of stroke in users of E/P combinations, taking into account prior oophorectomy and other potential confounders. They also estimated the risks of acute MI and of stroke in users of estrogen alone, accounting for prior oophorectomy and potential confounders. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident, Myocardial Infarction, Postmenopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Correlations Phenotype / Genotype in Down Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to correlate phenotype and genotype of Down syndrome patients in order to identify the biochemical reactions involved in their mental retardation and their other phenotypic characteristics.

Official Title
-----------------
Epidemiological Study of Trisomy 21 With Research of Correlations Between Phenotype (Physical, Psychometrical) and Genotype (Genome, Transcriptome, Proteome)

Conditions
-----------------
Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Down syndrome patients age: 8years and older assessment by the psychometric tests possible blood tests Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 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
-----------------
Down Syndrome, phenotype, genotype, patient family
Antithrombotics and Complications in Skin Grafts

Study Overview
=================
Brief Summary
-----------------
Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Detailed Description
-----------------
Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Official Title
-----------------
Complications in Skin Grafts When Continuing Antithrombotic Therapy Prior to Cutaneous Surgery Requiring Skin Grafting: an Observational Study

Conditions
-----------------
Skin Graft Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium - Exclusion Criteria: Patients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5 -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Postoperative bleeding |  | 5-7 postoperative day |
Managing Chronic Kidney Disease in Eastern North Carolina

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease.

Detailed Description
-----------------
The Division of Nephrology within the Brody School of Medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern North Carolina. It is estimated that more than 40 million Americans have or at risk for CKD. The estimate for CKD in eastern North Carolina is exacerbated by poor access to health care. The mission of the East Carolina University Center for the Study and Treatment of Kidney Disease (ECCKD) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with CKD in eastern North Carolina.

Official Title
-----------------
Management of Chronic Kidney Disease in Eastern North Carolina (MARKER)

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

Intervention / Treatment
-----------------
* Behavioral: Chronic Kidney Disease Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care clinics in eastern North Carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Chronic Kidney Disease Education|Instituting teaching programs to manage hypertension, diabetes, anemia, proteinuria and cardiovascular disease in patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina. |  | every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the rate of reduction of CKD in patients in Eastern North Carolina. |  | every 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Cardiovascular Disease, Hypertension, Anemia
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.

Official Title
-----------------
LY333531 Treatment of Symptomatic Peripheral Neuropathy in Patients With Diabetes

Conditions
-----------------
Diabetic Neuropathies, Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: Ruboxistaurin mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have type I or type II Diabetes Mellitus. Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months. Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be insulin therapy. Must be 18 years or older. Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study. Exclusion Criteria: History of significant liver problems. Have poor kidney function. Drink an excess of alcohol or abuse drugs. Have recently participated or currently participating in a Medical study in which you receive an experimental drug. Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ruboxistaurin mesylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in neuropathic symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change |  |  |
Detection of Bone Marrow Changes: Comparison of MRI and DECT

Study Overview
=================
Brief Summary
-----------------
Prospective study where magnetic resonance imaging is compared to dual-energy computed tomography for the detection of bone marrow changes.

Conditions
-----------------
Bone Marrow Changes

Intervention / Treatment
-----------------
* Other: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with bone marrow changes Exclusion criteria: Pregnacy Age below 18 ys old Contraindications for MRI

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: magnetic resonance imaging|magnetic resonance imaging is compared to dual-energy computed tomography for the detection of bone marrow changes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male volunteers.

Detailed Description
-----------------
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days second.

Official Title
-----------------
A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Anplag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 55 years of healthy volunteers Exclusion Criteria: Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DP-R202<br>Multiple oral administration for 3 days | Drug: Anplag<br>* Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days<br>* Other names: Anplag : 0007-1;|
| Active Comparator: Anplag<br>Multiple oral administration for 3days | Drug: Anplag<br>* Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days<br>* Other names: Anplag : 0007-1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pharmacokinetics | Cmax, ss, AUCτ | comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pharmacokinetics | tmax,ss, t1/2, Cav,ss, PTF, AI, Cmin,ss | comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h |
Vitamin D Supplementation for Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.

Official Title
-----------------
Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression

Conditions
-----------------
Bipolar Disorder, Bipolar Depression

Intervention / Treatment
-----------------
* Drug: Vitamin D3, Cholecalciferol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18years old Bipolar disorder (I,II or NOS), MADRS Score>7 (mild), 25(OH)D level <30ng/ml (insufficient). able to take the prescribed vitamin D by mouth Exclusion Criteria: Systemic diseases such as: liver and kidney diseases, known parathyroid disorder, disorders of vitamin D metabolism, taking vitamin D replacement therapy, fat digestion disorder, diabetes mellitus, gi surgery If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency: active suicidality, acute psychosis, active substance use<6mo or pregnant or nursing females

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: Vitamin D3<br>Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks | Drug: Vitamin D3, Cholecalciferol<br> <br> |
| Placebo Comparator: Placebo<br>methylcellulose po qday for 12weeks | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Åsberg Depression Rating Scale | Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. | baseline and at 12 week completion |
Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare prepuce tissue samples from healthy male children who applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1), androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene expression in the prepuce is planned to investigate via polymerase chain reaction (PCR) method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and collagen protein is planned to investigate via immunohistochemical examination.

Official Title
-----------------
Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces

Conditions
-----------------
Hypospadias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group. To have isolated hypospadias for study group. Exclusion Criteria: To have genitourinary surgery before.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study<br>Children with isolated hypospadias | |
| Control<br>Children with planned circumcision | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic analysis 1 | Androgen receptor (AR) gene PCR analysis | 1 year | 
| Genetic analysis 2 | Estrogen receptor 1 (ER1) gene PCR analysis | 1 year | 
| Genetic analysis 3 | FGFR2 gene PCR analysis | 1 year | 
| Genetic analysis 4 | TGF beta gene PCR analysis | 1 year | 
| Genetic analysis 5 | HOXA13 gene PCR analysis | 1 year | 
| Immunohistochemical study 1 | Mucosal vessel density is planned to determine via CD34 | 1 year | 
| Immunohistochemical study 2 | Mucosal nerve density is planned to determine via PGP 9.5 | 1 year | 
| Histological study 1 | Laminin is planned to determine in extracellular matrix via light microscope | 1 year | 
| Histological study 2 | Collagen is planned to determine in extracellular matrix via light microscope | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypospadias, prepuce, HOXA13, FGFR2, TGF beta