linjc16/ctgov huggingface dataset:
Family Involvement in The Treatment Of a Mentally Ill Relative

Study Overview
=================
Brief Summary
-----------------
Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill patients. We assume that the sibling group intervention would be effective in reducing the family burden of the siblings, and that this reduction would be reflected in their replies to the Experience of Caregiving Inventory.

Detailed Description
-----------------
The group for siblings is an intervention which is carried out in the outpatient clinic of Lev HaSharon Mental Health Center in cycles which last eight weeks; Every group cycle will include between 10-14 participants, all siblings of persons with mental illness. The patients themselves (ill siblings) are either hospitalized in Lev HaSharon Mental Health Center, or are outpatients in the Lev HaSharon Mental Health Outpatient Unit, or in the community at large. The group is an ongoing group: short term intensive group intervention in a dynamic orientation. Veteran participants of each cycle are welcome to re-join at following cycles, and at the same time new participants can join at the beginning of each cycle. Participants will be asked to fill the Experience of Caregiving Inventory twice: first time before the first meeting of a particular cycle of sibling group and second time: after the last (eighth) meeting of this group cycle.

Official Title
-----------------
Family Involvement in The Treatment Of a Mentally Ill Relative

Conditions
-----------------
Families of Mentally Ill

Intervention / Treatment
-----------------
* Behavioral: filling the Experience of Caregiving Inventory


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: siblings of persons with mental illness Exclusion Criteria: persons junior then 18 years old

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: filling the Experience of Caregiving Inventory|8 weeks of group therapy for family members|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Experience of Caregiving Inventory following 8 weeks of participation in the group. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family members, Illness burden, Mental Disorders, Family intervention
Angelman Syndrome Video Assessment (ASVA) Source Material Study

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, observational, nonrandomized, fully remote study enrolling approximately 55 participant-caregiver dyads. The study includes no treatments or interventions, and participants will not be asked to change their current treatments. The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.

Official Title
-----------------
Angelman Syndrome Video Assessment (ASVA) Source Material Study

Conditions
-----------------
Angelman Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Caregiver reports that the individual with AS has a laboratory-confirmed diagnosis of Angelman syndrome Individual with AS is at least 1 year old Caregiver is willing and able to provide informed consent for themselves and oversee study participation Caregiver or legal guardian is willing to provide informed consent on behalf of the individual with AS Caregiver is comfortable reading and speaking in English Caregiver has access to a smartphone or tablet that is compatible with the study app OR caregiver has internet access and is willing to use a wi-fi only device to record and upload videos NT-Caregiver dyads will be eligible for inclusion if the: Neurotypical individual is between 1 and 8 years of age Caregiver is willing and able to provide informed consent and oversee study participation and NT individual is willing and able to provide assent, as applicable Caregiver is comfortable reading and speaking in English Caregiver has access to a smartphone or tablet that is compatible with the study app OR caregiver has internet access and is willing to use a wi-fi only device to record and upload videos Participant-Caregiver dyads will be excluded from the study only if they do not meet the inclusion criteria above.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- |
| Ambulatory<br> | |
| Limited Ambulation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Source material collection, Baseline | The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system. | Baseline | 
| Source material collection, Week 12 | The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system. | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angelman Syndrome
Vessel Resection and Reconstruction of Biliary Tract Cancers

Study Overview
=================
Brief Summary
-----------------
To investigate the vessel resection and reconstruction in biliary tract cancer.

Detailed Description
-----------------
The vessel resection and reconstruction of hepatic artery and portal vein in biliary tract cancer surgery is still controversial. In this study, we retrospectively evaluate the diagnostic image, pathology, peri-operative events, recurrence, and prognosis in these patients, as a multi-center surveillance.

Official Title
-----------------
Resection and Reconstruction of Major Vessels in Biliary Tract Cancers

Conditions
-----------------
Biliary Tract Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of vessel resection and reconstruction in biliary tract cancer. Exclusion Criteria:
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 |
| --- | --- | --- |
| Comparison of vascular invasion in diagnostic image and in pathology. |  | 20 years | 
| R0 resection rate |  | 20 years |
Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase Ib study is to determine if Human Central Nervous System Stem Cells(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile neuronal ceroid lipofuscinosis. The study will also measure post-transplantation disease progression.

Detailed Description
-----------------
Participation in this study will involve screening assessments, surgery to implant HuCNS-SC, medication to suppress immune system and a series of follow-up assessments.

Official Title
-----------------
A Phase Ib Study of the Safety and Preliminary Efficacy of Allogeneic Intracerebral Human Central Nervous System Stem Cell Transplantation in Subjects With Non-Refractory Infantile and Late Infantile Neuronal Ceroid Lipofuscinosis

Conditions
-----------------
Neuronal Ceroid Lipofuscinosis

Intervention / Treatment
-----------------
* Biological: HuCNS-SC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 months to 6 years Male or female Clinical diagnosis of Infantile neuronal ceroid lipofuscinosis or late infantile neuronal ceroid lipofuscinosis CLN1 or CLN2 mutation Exclusion Criteria: Previously received an organ, tissue or bone marrow transplantation Previously participated in any gene or cell therapy study Infection with hepatitis virus, cytomegalovirus, Epstein-Barr virus, or Human Immunodeficiency Virus (HIV) Current or prior cancer Bleeding disorder Unable to have an MRI scan

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 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 |
| --- | --- |
| Other: HuCNS-SC<br> | Biological: HuCNS-SC<br>* Surgery to implant human CNS stem cells<br>* Other names: neural stem cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events. | Safety will be measured by number of adverse events and changes in neurological status. | one year following transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with improvement in neurological, neuropsychological development, MRI and MRS |  | one year following transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Batten's disease, INCL, LINCL, Neuronal Ceroid Lipofuscinosis, NCL
Epidemiology of Pediatric Asthma Hospitalization

Study Overview
=================
Brief Summary
-----------------
To study three possible, but yet unproven, influences on pediatric asthma hospitalization rates - diagnostic substitution, different systems of medical care, and asthma medication use.

Detailed Description
-----------------
BACKGROUND: Recent research has shown that asthma admission rates for children vary widely across geographic areas and have increased nationally for the past decade. The results from these studies will have direct relevance to the clinical care and development of public policy for children with asthma. DESIGN NARRATIVE: Specific hypotheses regarding these factors which influence pediatric asthma hospitalization were tested in two different data sets: ecologic studies of trends and area variations of the children residing in the contiguous states of Maine, New Hampshire, and Vermont for 1980 - 1994; retrospective cohort analyses of children enrolled at a staff model HMO, Group Health Cooperative of Puget Sound for 1977 - 1994. These studies utilized detailed information regarding area and individual 'exposure' to differing systems of health care and asthma medications, controlling for socioeconomic status.

Conditions
-----------------
Asthma, Lung Diseases

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 |
| --- | --- | --- |
Circadian Rhythm of Blood Lactate

Study Overview
=================
Brief Summary
-----------------
To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a circadian rhythm

Detailed Description
-----------------
Blood will be drawn fasting and then every hour over a period of 24 hours in 30 healthy probands.

Official Title
-----------------
Circadian Rhythm of Blood Lactate, Lipid Transferproteins and Genetic Markers (PPARs, CLOCK, Bmal1)

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

Intervention / Treatment
-----------------
* Other: Blood Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 40 years old Exclusion Criteria: Inability/unwilling to give written informed consent Chronic disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy probands<br>Healthy probands, age between 18 and 40 years | Other: Blood Sampling<br>* Blood Sampling over 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian rhythm of blood lactate | Blood samples | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian rhythm of Lipid transfer proteins | Blood | 5 months | 
| Circadian rhythm of PPARs, CLOCK and Bal1 | Blood | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PLTP, Blood lactate, Lipid transfer proteins, Lactate, CETP, PPARs, CLOCk, Bal1
12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study. Neither the study subjects nor the physicians will know what treatment an individual subject is receiving. Subjects will be randomly assigned (like flipping a coin) to one of five treatment groups. The treatment groups include four different dosing groups of active study drug and one group of subjects who will receive placebo. A 12 week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction in Hepatitis C viral load.

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: UT-231B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be adults, have a positive Hepatitis C antibody test, and be genotype 1, with a minimum of 100,000 IU of Hepatitis C virus by nucleic acid testing, be non-cirrhotic with a Metavir score of F0-3 (or equivalent) on liver biopsy, and have failed previous therapy with Interferon or Peg Interferon monotherapy, Interferon plus ribavirin, or Peg Interferon and ribavirin. Exclusion Criteria: Diabetics are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: UT-231B|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
-----------------
Hepatitis C
Comparison of Bone Morphogenetic Protein-4 (BMP-4) and 7 Levels Between Control and Polycystic Ovarian Syndrome (PCOS) Patients.

Study Overview
=================
Brief Summary
-----------------
The investigators aim to compare the levels of bone morphogenetic protein-4 and -7 (BMP-4 and 7) in blood, follicular fluid and ovarian organ culture supernatant obtained from healthy subjects and polycystic ovarian syndrome (PCOS) patients.

Detailed Description
-----------------
Female patients at ages 20-35 diagnosed with polycystic ovarian syndrome and age-matched healthy control subjects will be enrolled in this study. Blood samples will be obtained at early follicular phase during doctor's visit from PCOS patients and control subjects.If the patient is amenorrheic at the time of visit, both random blood samples and another sample at early follicular phase after induction of withdrawal bleeding with progesterone. Follicular fluids will be retrieved during oocyte pick-up procedure in patients undergoing assisted reproduction for PCOS and control IVF patients whose infertility is not PCO related. Samples from ovaries will be collected at operation from PCOS patients and control subjects if they already undergo any gynecologic laparotomi operations. Collected samples will be cultured for 7 days and BMP-4 and -7 levels will be measured in the culture fluid of the samples using ELISA method.

Official Title
-----------------
Comparison of Bone Morphogenetic Protein-4 and -7 Levels (BMP-4 and 7) in the Serum, Ovarian Follicle Aspirates and Ovarian Organ Culture Supernatants Between Healthy Controls and Patients With Polycystic Ovarian Syndrome (PCOS).

Conditions
-----------------
Polycystic Ovarian Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects and PCOS patients at ages 20-35 will be recruited for the study. Exclusion Criteria: Those with any metabolic or endocrine problems other than PCOS will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCO<br>Healthy control subjects and patients with polycystic ovarian syndrome will be recruited for the study. | |

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
-----------------
BMP- 4 and 7, polycystic ovarian syndrome
Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Lecozotan SR Administered Orally to Healthy Young and Elderly Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Lecozotan SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Young subjects: Men aged 18 to 45 years. -Elderly subjects: Men and women ≥ 65 years of age. -Body mass index in the range of 18 to 30 kg/m2 and body weight ≥ 50 kg. -Healthy as determined by the investigator. Exclusion Criteria: -History of any neuropsychiatric disorder. -History of drug or alcohol abuse.

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

| Intervention/Treatment |
| --- |
|Drug: Lecozotan SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events and adverse reactions will be calculated. The safety variables (vital signs, ECG parameters, and routine laboratory tests) and PK parameters will be measured throughout study period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic analysis after single and multiple dosing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy young volunteers, healthy elderly volunteers, Alzheimer's disease, 5HT1A antagonist, Health, Pharmacokinetics
Sequential Versus Single O2 Levels on Human Embryo Development

Study Overview
=================
Brief Summary
-----------------
Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.

Official Title
-----------------
5% O2 or Lower is the Ideal Tension for Culturing Human Embryo Development From Day 3 Onward

Conditions
-----------------
Embryo Culture

Intervention / Treatment
-----------------
* Other: Sequential O2 Culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI cycles undergoing their first ICSI attempt Exclusion Criteria: ICSI cycles with a previous failure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential O2 culture (5% then 2.5%)<br>Embryo culture from day 0 to 3 in 5% O2 then split to either 5% or 2.5% O2 until Day 5 or 6. | Other: Sequential O2 Culture<br>* We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)<br>|
| No Intervention: 5% O2 culture<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Implantation rate | number of sacs with a heartbeat after week twelve of gestation | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and ongoing pregnancies | registered pregnancy with fetal heartbeat at week four after transfer and after week twelve of gestation | three months | 
| human embryo development in vitro |  | three months |