linjc16/ctgov huggingface dataset:
Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Study Overview
=================
Brief Summary
-----------------
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.

Official Title
-----------------
A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Drug: YM087


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum sodium levels 115 to < 130mEq/L Euvolemic or Hypervolemic hyponatremia Exclusion Criteria: Clinical evidence of volume depletion or dehydration Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

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: YM087|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
euvolemic, hyponatremia, hypervolemic, vasopressins, YM087
Influencing Factors in Uveitis

Study Overview
=================
Brief Summary
-----------------
Environmental factors possibly influencing uveitis are evaluated.

Detailed Description
-----------------
Smoking, nutrition, BMI, education

Official Title
-----------------
Evaluation of Influencing Factors in Uveitis

Conditions
-----------------
Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Uveitis Exclusion Criteria: Children under 18 years

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

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 with non-infectious Uveitis | |
| 2<br>Patients with scleritis | |

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
-----------------
influencing factors (smoking, nutrition, education)
Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

Study Overview
=================
Brief Summary
-----------------
Open-label treatment with MPC-7869 for participants in a previous randomized study.

Official Title
-----------------
Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: MPC-7869


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in a previous MPC-7869 randomized protocol Have had a diagnosis of probable Alzheimer's disease. Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility). Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study. Female subjects must be surgically sterile or postmenopausal for > 1 year. Subjects must have a reliable caregiver who can read, understand and speak English or Spanish. Exclusion Criteria: History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor. Chronic or acute renal, hepatic or metabolic disorder. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Label Arm<br>Treatment is open-label | Drug: MPC-7869<br>* 800 mg BID Oral dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety |  | For study duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's, Dementia, Dementia of Alzheimer Type
Study of PTPN22 C1858T Polymorphism in Children and Adolescents of Greek Origin With T1DM

Study Overview
=================
Brief Summary
-----------------
The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene encodes a lymphoid-specific phosphatase (LYP) which is an important downregulatory factor of T cell activation. A PTPN22 polymorphism, C1858T, was found associated with T1DM in different Caucasian populations. In this observational case-control study, we aimed at confirming the role of PTPN22, C1858T polymorphism in T1DM predisposition in a Greek population.

Official Title
-----------------
Study of Protein Tyrosine Phosphatase Non-receptor Type 22 (PTPN22) C1858T Polymorphism in Children and Adolescents of Greek Origin With Type 1 Diabetes Mellitus (T1DM)

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the patients Diagnosis of T1DM according to American Diabetes Association (ADA) Criteria as well as according to International Society for Pediatric and Adolescent Diabetes (ISPAD) Guidelines Unrelated male and female subjects 1-20 years of age Come from Greece (At least 3 grandparents are Greek) At least one year post onset of T1DM Sign written informed consent Inclusion Criteria: For the controls Unrelated nondiabetic male and female subjects with no family history of T1DM Equal to or greater than 18 years of age Come from Greece (At least 3 grandparents are Greek) Be screened by a questionnaire to ensure the absence of any diagnostic evidence of autoimmune diseases or family history (first- or second-degree relatives) of T1DM Sign written informed consent Exclusion Criteria: For the patients •Subjects who do not meet the criteria above Exclusion Criteria: For the controls •Subjects who do not meet the criteria above

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 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 |
| --- | --- |
| T1DM<br>Children and adolescents with T1DM | |
| Unaffected Population<br>Population not known to be affected by T1DM | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The association between PTPN22 C1858T polymorphism among patients and gender |  | 3 years | 
| • The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM) |  | 3 years | 
| • The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies |  | 3 years |
CD0104 VEST II Post Marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.

Detailed Description
-----------------
The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.

Official Title
-----------------
A Post-market Prospective Study of the VGS VEST (Venous External Support), Supporting Saphenous Vein Grafts for Coronary Bypass Graft Surgery in Patients With Severe Coronary Heart Disease

Conditions
-----------------
Coronary Artery Bypass Surgery

Intervention / Treatment
-----------------
* Device: VEST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for on-pump CABG on clinical grounds At least one vein graft bypass indicated for right coronary artery and LIMA indicated for the LAD on clinical grounds Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed, as assessed from the pre-operative cardiac angiography. Exclusion Criteria: Concomitant non-CABG cardiac procedure Prior cardiac surgery Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP) Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta) Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before VEST implantation. Prior debilitating stroke less than 1 year before surgery Severe renal dysfunction (Cr>2.0 mg/dL) Concomitant life-threatening disease likely to limit life expectancy to less than 2 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: VEST<br> | Device: VEST<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein graft patency by CT angiography |  | 3-6 monthws | 
| MACCE | Major adverse cardiac and cerebral events | 3-6 months |
Aneuploidy Rates of in Vitro Matured Oocytes

Study Overview
=================
Brief Summary
-----------------
In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Detailed Description
-----------------
Under controlled ovarian stimulation, patients with normal functional ovarian reserves produce a good number of oocytes at retrieval. However, in addition to quantity, oocyte maturity is an important variable for the success of reproductive technologies. In general, nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). Due to the limited expectations held for in vitro maturation in said stimulated cycles, the rescue of immature oocytes is not widely used in current clinical practice and these oocytes are usually discarded due to the possibility of abnormal embryonic development or an increased rate of abortion. The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Official Title
-----------------
Aneuploidy Rates of in Vitro Matured Oocytes

Conditions
-----------------
Aneuploidy

Intervention / Treatment
-----------------
* Other: Non intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-35-year-old women BMI: >18 and < 30 kg/m2 Normal female karyotype Normal uterus and ovaries at transvaginal ultrasound Exclusion Criteria: > 35 years PCO syndrome carriers Null follicle aspiration History of chemotherapy or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non intervention|Non|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneuploidy rate | Aneuploidy rate of the PB | The moment that the PB is extruded (between 1 hour and 50 hours after the denudation) |
Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

Detailed Description
-----------------
The objective is to collect product safety and performance data for Medtronic CE (Conformitè Europëenne )-Marked Cardiac Surgery, including perfusion (CS) products. The main goals of this data collection are as follows: Identification of any (new) device-related complications including events which were not anticipated or documented in the Instructions For Use (IFU), or Risk Management Plan, or Clinical Evidence Evaluation report, or Design Failure Modes and Effect Analysis Evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies Evaluation of general device performance when applicable Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital. Inclusion Criteria: Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating Registry hospital. Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used. Exclusion Criteria: • Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry Data collection includes, for example: Demographics Product performance information Safety Events

Official Title
-----------------
SYMBIOSIS Post-Market Registry

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital. Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used. Exclusion Criteria: Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
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 |
| --- | --- | --- |
| Device Safety | Procedure- , device-related events and device deficiencies | Procedural | 
| Device performance | Device Success | Procedural |
A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1, subjects were screened, and if qualified, were randomly assigned to one of two following treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.

Official Title
-----------------
A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Kemstro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable dose of baclofen Exclusion Criteria: not stable dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Study Overview
=================
Brief Summary
-----------------
This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

Detailed Description
-----------------
Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid rescue general anesthesia that occur in 20-40 % of patients with plain bupivacaine.

Official Title
-----------------
Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Conditions
-----------------
Spinal Anesthesia, Neonates

Intervention / Treatment
-----------------
* Drug: clonidine
* Drug: clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns less than 60 weeks old post-conceptional, former premature or not Newborns requiring inguinal hernia or lower limbs surgery, infants needing no more critical care assistance Informed consent of parents Exclusion Criteria: Spinal malformation, Coagulopathy, critical hemodynamics, uncontrolled neurologic or metabolic pathology. infection at injection point.

Ages Eligible for Study
-----------------
Maximum Age: 60 Weeks

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 |
| --- | --- |
| Placebo Comparator: prematurely born, bupivacaine, placebo<br> | Drug: clonidine<br>* equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia<br>|
| Experimental: prematurely born, bupivacaine, clonidine<br> | Drug: clonidine<br>* addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia<br>|
| Placebo Comparator: term neonate, bupivacaine, placebo<br> | Drug: clonidine<br>* equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia<br>|
| Experimental: term neonate, bupivacaine, clonidine<br> | Drug: clonidine<br>* addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of rescue general anesthesia |  | end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea and desaturation occurrence |  | during 24h | 
| duration of spinal anesthesia |  | during 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal anesthesia, neonates, clonidine, post operative apnea
Outcome and Related Factors of Necrotizing Fasciitis of the Limb

Study Overview
=================
Brief Summary
-----------------
Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and prevent limb loss.

Detailed Description
-----------------
Patients that are admitted to hospital with the diagnosis of necrotizing fasciitis of a limb will be entered to this study. A questionnaire will be completed for each patient included demographic data, admission and diagnosis date, treatment onset, medical history for diabetes mellitus, HIV infection, use of immunosuppressor drugs, peripheral vascular disease, cancer, renal disease, intravenous drug abuse, and disease outcome that can be recovery, amputation or death.

Conditions
-----------------
Necrotizing Fasciitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Necrotizing fasciitis of the limb
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
-----------------
Necrotizing fasciitis