linjc16/ctgov huggingface dataset:
Neuroimaging Studies of Depression in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment.

Detailed Description
-----------------
Depression is a common and potentially serious complication of Parkinson's disease (PD). Studies show that approximately 40 percent of PD patients are depressed. There is evidence that these patients have deficits in neuropsychological function relative to non-depressed PD patients. Despite the widespread toll on emotional health posed by PD, few studies have undertaken a comprehensive examination of the neural underpinnings of Parkinsonian depression. In this project, we will compare depressed versus non-depressed Parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (MRI). To investigate possible effects of anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients will be tested both off and on Parkinsonian medications.

Official Title
-----------------
Neuroimaging Studies of Depression in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right-handed willing/able to undergo magnetic resonance imaging (MRI) Exclusion Criteria: history of neurological condition other than Parkinson's disease history of psychiatric condition other than depression history of substance abuse/dependence

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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 |
| --- | --- |
| 1<br>Patient Group | |
| 2<br>Control Group | |

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
-----------------
Parkinson's Disease, Magnetic Resonance Imaging (MRI), neuropsychological assessment
Trial of Enhanced Pre-Consent Discussion

Study Overview
=================
Brief Summary
-----------------
Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients > 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.

Official Title
-----------------
Trial of Enhanced Pre-Consent Discussion

Conditions
-----------------
Pediatric Crohn's Disease

Intervention / Treatment
-----------------
* Other: Enhanced Pre-Consent Discussion
* Other: Standard Pre-consent Discussion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965) Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965) Exclusion Criteria: Non-English speaking

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Pre-consent Discussion<br>Standard pre-consent discussion for a clinical trial. | Other: Standard Pre-consent Discussion<br>* Standard pre-consent discussion for a clinical trial<br>|
| Experimental: Enhanced Pre-consent Discussion<br>The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff. | Other: Enhanced Pre-Consent Discussion<br>* The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge Related to Trial Participation | Number correct on 5-item Knowledge Related to Trial Participation survey | prior to consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of enrollment |  | at consent | 
| Support subscale of decision conflict scale |  | prior to consent |
Lorlatinib - PF-06463922

Study Overview
=================
Brief Summary
-----------------
Lorlatinib expanded access program

Intervention / Treatment
-----------------
* Drug: Lorlatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, Senior Exclusion Criteria: -

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


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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lorlatinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel

Study Overview
=================
Brief Summary
-----------------
Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. The purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that is carried out in the population of northern Israel. The results can be useful in order to institute universal screening for sickle cell anemia in northern Israel.

Official Title
-----------------
Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel- An Observational Study

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Procedure: Medical history and basic laboratory analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients that were diagnosed as having sickle cell disease in the specific village and all the population screened for hemoglobinopathies in the same location
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients diagnosed as having abnormal hemoglobin like hemoglobin S and thalassemia in a bedouin village | Procedure: Medical history and basic laboratory analysis<br>* Medical history and basic laboratory analysis<br>|

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
-----------------
Sickle cell disease, Sickle cell thalassemia, Population screening
VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita

Study Overview
=================
Brief Summary
-----------------
VALO-2 is a multicenter, open-label extension (OLE) study enrolling patients with genotyped keratin mutations KRT6A, KRT6B and KRT16 who were previously treated with investigational PTX-022 during the VALO study. The purpose of the OLE study is to investigate long term exposure to investigational PTX-022 and evaluate safety and efficacy data. A sub-study is included to evaluate safety and efficacy of patients with genotyped keratin mutations of KRT6C and KRT17 not previously treated with investigational PTX-022.

Official Title
-----------------
VALO-2: A Multicenter, Phase 3b, Open-Label Treatment Extension Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita

Conditions
-----------------
Pachyonychia Congenita

Intervention / Treatment
-----------------
* Drug: PTX-022


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Adult patients 18 years or older, Previously completed the VALO protocol, or VALO-2 K6C/17 sub-study, and received meaningful benefit from investigational PTX-022 as determined by the clinician. Key Exclusion Criteria: Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label treatment arm<br>PTX-022 QTORIN | Drug: PTX-022<br>* Safety and Efficacy of PTX-022 in the Treatment of Adults with Pachyonychia Congenita<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events |  | 18 Months | 
| Changes in vital sign measurements from baseline |  | 18 months | 
| Changes in weight measurements from baseline |  | 18 months | 
| Changes in clinical laboratory measurements from baseline |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment of Activities Scale |  | 18 Months | 
| Pain at its worst as assessed by NRS |  | 18 months | 
| PROMIS Pain Interference Short 6A as assessed by likert scale |  | 18 months | 
| PROMIS Physical Function as assessed by likert scale |  | 18 months | 
| Patient Global Impression of Severity as assessed by likert scale |  | 18 months | 
| Clinician Global Impression of Severity as assessed by likert scale |  | 18 months |
Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)

Study Overview
=================
Brief Summary
-----------------
It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.

Detailed Description
-----------------
The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Cytokine group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients Exclusion Criteria: above 40 years old

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cytokine plus Hyalurinan embryo transfer arm<br>To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium. | Other: Cytokine group<br>* Testing the efficacy of adding Cytokine to embryo transfer medium<br>|
| No Intervention: Hyalurinan embryo transfer group<br>To transfer the embryos using a Hyaluronan enriched medium only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate ( % ) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate ( % ) |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, implantation, Cytokine
Thromboelastography During and After Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish reference values for thromboelastography (TEM-A) in healthy pregnant women during labor and 2 hours and 24 hours after delivery.

Detailed Description
-----------------
Previous, preliminary investigations by using thromboelastography, confirmed that pregnancy is a hypercoaguable state which remains in the first 24 hours postdelivery. Unfortunately results obtained by the existing studies that attempted to establish reference values for TEG suffer considerable bias. The aim of this study will be to determine the range values for thomboelastography in pregnant women. Since there is no available information on the expected distribution of the outcome, a sequential design will be used. The main endpoint of the analysis will be a reliable estimate for the outcome expected in healthy women after labor. The investigators will state their target estimate as being reliable when the ratio between the estimate and its standard error is smaller than 2. During labor, 2 hours after delivery and 24 hours postpartum, a venous blood sample will be taken from eligible women for thromboelastographic determination. Whole blood nonadditive TEM will be performed on the TEM-A automated thromboelastometer (Framar Biomedica,Rome, Italy) to obtain the four classical TEM parameters: reaction (R) time, k time, alpha angle and maximum amplitude (MA). Inclusion criteria Healthy parturients in labor Exclusion criteria parturients who will eventually had: operative or instrumental vaginal delivery, estimated blood loss greater than 500 mL, the occurrence of II and III degree perineal lacerations, any coagulation disorder or anticoagulant therapy

Official Title
-----------------
Determination of Thromboelastography Values in Pregnancy and After Delivery

Conditions
-----------------
Delivery Uterine

Intervention / Treatment
-----------------
* Device: Thromboelastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy parturients in labor Exclusion Criteria: parturients with coagulation defects or anticoagulant therapy

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thromboelastography|Thromboelastography during labor and after delivery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy | To determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period. | 24 hours postpartum |
The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.

Official Title
-----------------
The Effects of Resistance Type Exercise Training and Protein Supplementation on Skeletal Muscle Mass, Strength, and Muscle Characteristics in Healthy Elderly Men and Women

Conditions
-----------------
Muscle Loss in Elderly

Intervention / Treatment
-----------------
* Dietary Supplement: Protein drink
* Dietary Supplement: placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 65 years healthy men and women Exclusion Criteria: cardiovascular disease COPD Parkinson rheumatoid arthritis musculoskeletal/orthopaedic disorders cognitive impairment subjects with metal implants

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein drink<br>protein drink | Dietary Supplement: Protein drink<br>* total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks<br>|
| Placebo Comparator: Placebo drink<br>Placebo drink | Dietary Supplement: placebo drink<br>* subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass measured by DXA-scan and CT-scan |  | 0, 12 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, sarcopenia, protein drink, resistance training
Drug Interaction With Metformin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Official Title
-----------------
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

Conditions
-----------------
Healthy Male and Female Subjects

Intervention / Treatment
-----------------
* Drug: Dapagliflozin
* Drug: Metformin
* Drug: Dapagliflozin + Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2 Exclusion Criteria: Unwilling to use acceptable method of birth control current or recent (within 1 month) smoker abnormal liver function tests presence of edema history of diabetes mellitus history of heart failure or renal insufficiency history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections history of Hepatitis C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: 1<br> | Drug: Dapagliflozin<br>* Tablets, Oral, 20 mg, once daily single dose<br>|
| Active Comparator: 2<br> | Drug: Metformin<br>* Tablets, Oral, 1000 mg, once daily, single dose<br>|
| Active Comparator: 3<br> | Drug: Dapagliflozin + Metformin<br>* Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment |  | measures taken daily throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment |  | measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes,NOS