linjc16/ctgov huggingface dataset:
Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

Study Overview
=================
Brief Summary
-----------------
This is a randomized, inpatient, ascending multiple dose study to assess safety and tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and schizoaffective disorder.

Official Title
-----------------
An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder

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

Intervention / Treatment
-----------------
* Drug: SLV-313 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged 18-50 years old Women, aged 18-50 years old Exclusion Criteria: Non-lactating women, aged 18-50 years old Non-pregnant women, aged 18-50 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SLV-313 SR<br>* sustained release tablets taken once daily for 14 days<br>|
| Experimental: 2<br> | Drug: SLV-313 SR<br>* sustained release tablets taken once daily for 14 days<br>|
| Experimental: 3<br> | Drug: SLV-313 SR<br>* sustained release tablets taken once daily for 14 days<br>|
| Experimental: 4<br> | Drug: SLV-313 SR<br>* sustained release tablets taken once daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe safety and tolerability |  | 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK and PD profile |  | 25 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Schizophrenia
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.

Official Title
-----------------
A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy

Conditions
-----------------
Infection, Human Immunodeficiency Virus I, HIV Infection

Intervention / Treatment
-----------------
* Drug: No intervention; Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003. Must be failing virologically (>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908. Exclusion criteria: Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M. Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI). Have an acute CDC Class C event requiring therapeutic intervention. Are pregnant or lactating. Have any other condition which in the opinion of the investigator would preclude their participation.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: No intervention; Observational study|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
-----------------
protease inhibitor, ritonavir, GW433908, HIV-1, fosamprenavir
Parent Management Training, Oregon

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems.

Detailed Description
-----------------
This project estimates the causal effect of Parent Management Training, Oregon (PMTO) in a Danish context. The study design is an RCT where PMTO is compared to Treatment As Usual (TAU). The target population is parents with children aged 3 and 12 showing behavioral problems. The primary outcome estimates changes in child behavior, and is measured three times: baseline, seven months follow-up, and 19 month follow-up.

Official Title
-----------------
The Effect of Parent Management Training, Oregon, in Denmark

Conditions
-----------------
Child Behavior Problems

Intervention / Treatment
-----------------
* Behavioral: PMTO
* Behavioral: TAU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families with children that are eligible for PMTO and at least one other type of family training program Exclusion Criteria: The family does not want to participate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMTO<br>Parent Management Training Oregon | Behavioral: PMTO<br>* Parent Management Training, Oregon<br>|
| Active Comparator: TAU<br>Other kinds of family treatment | Behavioral: TAU<br>* Other kinds of family training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength and Difficulties Questionnaire (SDQ) | Measuring child behavior | 7 months post baseline | 
| Brief Problem Monitor-Parent Form (BPM-P) | Measuring child behavior | 7 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents Preference Test (PPT) | Parenting skills | 7 months post baseline | 
| Sense of Coherence (SOC) |  | 7 months post baseline | 
| Parental Stress Scale (PSS) |  | 7 months post baseline | 
| Parenting Sense of Competence scale (PSOC) |  | 7 months post baseline | 
| Major Depression Inventory (MDI) |  | 7 months post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parent training, Child behavior, Randomized Controlled Trials
Project Connect Online: An Internet-based Intervention for Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.

Official Title
-----------------
Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Project Connect Online
* Behavioral: PCO PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women at least 18 years of age; first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis; ability to complete the intervention and assessments in English; and willingness to attend in-person PCO workshop; Exclusion Criteria: male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses); local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and use of a personal website to post cancer-relevant material in the past six months

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Connect Online (PCO)<br>Creation of personal website to share breast cancer experience with friends and family | Behavioral: Project Connect Online<br>* Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family<br>|
| Experimental: PCO PLUS<br>Creation of personal website to share breast cancer experience with friends and family, as well as other women diagnosed with breast cancer | Behavioral: PCO PLUS<br>* Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family, as well as other women diagnosed with breast cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of general and cancer-related psychological status | web site self reported | Baseline, 2 months, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall physical health status | web site self reported | Baseline, 2 months, 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women
Effect of Wheat Dextrin on Calcium and Magnesium Absorption

Study Overview
=================
Brief Summary
-----------------
To compare calcium and magnesium absorption within subjects with and without chronic consumption of wheat dextrin.

Official Title
-----------------
Effect of Wheat Dextrin on Calcium and Magnesium Absorption

Conditions
-----------------
Colonic Inertia

Intervention / Treatment
-----------------
* Dietary Supplement: wheat dextrin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects will be generally healthy Caucasian females aged 19 and older with no known abnormalities of gastrointestinal function, and taking no medications that might alter absorptive performance. BMI will be between 19 and 31 kg/m2 -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Control cookies will contain no wheat dextrin and will be taken 3 times daily for 2 weeks. | Dietary Supplement: placebo<br>* cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks<br>|
| Experimental: wheat dextrin<br>wheat dextrin (formulated according to the supporter's established method), will be baked in cookies providing three doses per day (≈5 gram of wheat dextrin in each dose)for 2 weeks. | Dietary Supplement: wheat dextrin<br>* 5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium Absorption | The calcium load to be tested will be 300 mg calcium from calcium and vitamin D fortified TropicanaTM orange juice extrinsically labeled with ≈3-7 μCi of 45Ca. The labeled orange juice will be ingested as part of a light meal, served as breakfast, after an overnight fast. | within 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnesium absorption | The magnesium load to be tested will be from calcium and vitamin D fortified TropicanaTM orange juice extrinsically labeled with 30 mg 26Mg. The labeled orange juice will be ingested as part of a light meal, served as breakfast, after an overnight fast. | within 2-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fiber, calcium, magnesium
Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women

Study Overview
=================
Brief Summary
-----------------
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women. Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.

Detailed Description
-----------------
Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV-infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants. No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.

Official Title
-----------------
Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure Parent or guardian willing to provide informed consent Exclusion Criteria: Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perinatal Transmission, Mother-to-Child Transmission
A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if administration of supplemental chloride in the form of lysine chloride to patients with congestive heart failure will affect their neurohormonal profile as well as response to diuretics.

Detailed Description
-----------------
This prospective pilot pre-post study was designed to determine if supplementation of sodium free chloride ion as a lysine chloride to patients with heart failure could improve parameters of neurohormonal status and diuretic responsiveness. Volunteers will receive Lysine Chloride 7 grams three times daily for three days. At baseline and then again post lysine chloride patients will undergo sampling of venous blood for determination of neurohormonal parameters in addition to formal diuretic responsiveness testing.

Official Title
-----------------
Prospective Pre-post Pilot Study on the Effects of Dietary Chloride Supplementation on Neurohormonal and Diuretic Function in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: Lysine Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Fluency in English Heart failure requiring loop diuretic therapy Loop diuretic dose ≥ 80mg/day furosemide equivalents Stable volume status and diuretic requirement as assessed by treating physician Exclusion Criteria: Unstable heart failure renal replacement therapy or an estimated GFR < 30 ml/min/1.73m2 Significant bladder dysfunction History of hepatic failure Pregnancy History of hyperinsulinemia/hyperlysinuria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lysine Chloride<br> | Dietary Supplement: Lysine Chloride<br>* Administration of 21g of lysine chloride (7g three times daily) for a period of time of 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma renin activity following lysine chloride administration |  | 3 days | 
| Change in urinary renin level following lysine chloride administration |  | 3 days | 
| Change in diuretic response following lysine chloride administration | Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lysine Chloride
Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients

Study Overview
=================
Brief Summary
-----------------
One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM. Questionnaires were administered to document demographic and clinical characteristics. Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10 was measured by ImmunoCAP.

Detailed Description
-----------------
Background: The role of specific IgE (sIgE) against Der p 1and Der p 2 in Chinese patients with house dust mite (HDM)allergy has not yet been well investigated.Methods: One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM. Questionnaires were administered to document demographic and clinical characteristics. Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10 was measured by ImmunoCAP.

Official Title
-----------------
Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients

Conditions
-----------------
Asthma, Allergic Rhinitis, Conjunctivitis, Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HDM-allergic patients reporting allergic rhinitis, conjunctivitis, asthma and/or atopic dermatitis and who had never undergone immunotherapy, were enrolled if they were sensitized to Dp as judged by ImmunoCAP ( ≥ 1 kU/l) and/or skin reaction index (SRI)by skin-prick test (SPT, a wheal diameter ≥ 0.5 mm). Exclusion Criteria: Patients who refused to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Demographic Characteristics | Describe the patient's basic information in detail, including age, gender, family history, etc | 1 year | 
| Der p 1 Serum IgE | Prevalence of Der p 1 Serum IgE in HDM-Allergic Patients | 1 year | 
| Der p 2 Serum IgE | Prevalence of Der p 2 Serum IgE in HDM-Allergic Patients | 1 year | 
| Dp, Der p 1 and Der p 2 | Relationship between Serum IgE Levels of Dp, Der p 1 and Der p 2 | 1 year | 
| Factors associated with specific IgE against Der p 1 | Study the patient's basic information and identify factors that are clearly associated with specific IgE against Der p 1 | 1 year | 
| Factors associated with specific IgE against Der p 2 | Study the patient's basic information and identify factors that are clearly associated with specific IgE against Der p 2 | 1 year | 
| the Number of Affected Organs | Association of Specific IgE Titers with the Number of Affected Organs | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Der p 1, House dust mite, Der p 2, China