linjc16/ctgov huggingface dataset:
Pilot Study of AdvanStep in Improving Balance in at Risk Elderly

Study Overview
=================
Brief Summary
-----------------
Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.

Detailed Description
-----------------
Feasibility study, assessing usability of the system and receiving feedback from the volunteers. Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests. Reassessment of balance and mobility after completion of 15 treatment sessions. Treatment sessions will be supervised by physical therapists.

Official Title
-----------------
Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls

Conditions
-----------------
Impaired Balance in Elderly

Intervention / Treatment
-----------------
* Other: AdvanStep training program - Turtle Pop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65-80 History of 2 falls in past 5 years, not requiring medical attention No acute orthopedic or neurological disorders No cognitive impairment affecting daily function. Adequate vision and hearing to see the computer screen and follow verbal commands. Unilateral stance test - inability to remain in unilateral stance for 25 seconds Exclusion Criteria: Congestive heart failure or angina that limits physical activity Need for interventional medical treatment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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: Training<br>15 training sessions | Other: AdvanStep training program - Turtle Pop<br>* Balance / mobility exercise program using the AdvanStep in a virtual reality context<br>* Other names: Turtle Pop p/n gw00005 rev. A1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test |  | On completion of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Falls, Balance, Elderly, Aged
Prediction of Outcome in Severe Preeclampsia

Study Overview
=================
Brief Summary
-----------------
this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes

Detailed Description
-----------------
leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.

Official Title
-----------------
Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia

Conditions
-----------------
Leiden Factor V Deficiency,Preeclampsia, Doppler Examination, Palental Pathology

Intervention / Treatment
-----------------
* Diagnostic Test: blood sample , doppler of uterine vessel and placenta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe preeclampsia in 3rd trimester - Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy. -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood sample , doppler of uterine vessel and placenta|blood sample for factor V and doppler examination of uterine arteries , placenta pathology post partum|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature | placental abruption, prematurity, IUGR | within 12 wks from diagnosis of severe preeclampsia | 
| percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator | IUFD, admission to neonatal IUC | from diagnosis of severe preeclampsia till one week after delivery |
AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions

Study Overview
=================
Brief Summary
-----------------
This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin. Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.

Official Title
-----------------
A Phase 1, Open-label Study to Evaluate the Tolerability of 21 Days of Treatment With the AC-OLE-01-VA Formulation of Tricaprilin Under Different Dosing Conditions in Healthy Participants

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

Intervention / Treatment
-----------------
* Drug: AC-OLE-01-VA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive). Exclusion Criteria: History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement. Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products within 3 months prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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 |
| --- | --- |
| Experimental: Arm 1<br>Days 1-3: 5 g BID 4-6: 10 g BID 7-9: 15 g BID 10-21: 20 g BID | Drug: AC-OLE-01-VA<br>* formulation of tricaprilin<br>|
| Experimental: Arm 2<br>Days 1-3: 10 g BID 4-6: 10 g BID 7-9: 10 g BID 10-21: 20 g BID | Drug: AC-OLE-01-VA<br>* formulation of tricaprilin<br>|
| Experimental: Arm 3<br>Days 1-3: 15 g TID 4-6: 10 g TID 7-9: 10 g TID 10-21: 15 g TID | Drug: AC-OLE-01-VA<br>* formulation of tricaprilin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of discomfort of the adverse events nausea, dyspepsia, abdominal pain, abdominal distension, diarrhoea | Discomfort rating from 0 (no discomfort) to 4 (severe discomfort) | 21 days | 
| Incidence of adverse events | Adverse event incidence will be tabulated Adverse event incidence will be tabulated Adverse event incidence will be tabulated | 21 days |
An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.

Official Title
-----------------
A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, age >/=18 years Proven metastatic colorectal carcinoma Patients have measurable disease Patients are eligible to receive first-line Avastin Patients have signed data release form Exclusion Criteria: Contra-indication to receive Avastin according to the local labeling Participation in a clinical study within 30 days prior to enrolment Patients have any other primary cancer Concomitant treatment with other biologics History of other malignant disease in the past 5 years except basal cell carcinoma

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival in a real life setting assessed by computer tomography |  | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate assessed by computer tomography |  | Approximately 2 years | 
| Response of Avastin according to the sites of metastases assessed by computer tomography |  | Approximately 2 years | 
| Chemotherapy regimens used in combination with Avastin |  | Approximately 2 years | 
| Patient demographics eligible to receive Avastin |  | Approximately 2 years | 
| Safety: incidence of adverse events |  | Approximately 2 years |
A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion.

Official Title
-----------------
A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion

Conditions
-----------------
Lumbar Fusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient 18 years of age or older Patients with a minimum follow up of 1 year Patients who have previously undergone TLIF, PLIF,PLF, XLIF procedures Exclusion Criteria: Patients under the age of 18 Any patient with less than 1 year of follow up history at the time of first data analysis Any patient that the primary investigator deems as an unfit candidate

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Actifuse<br>Patients who recieved Actifuse synthetic bone brafting material | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of fusion prior to or at 12 months postoperatively |  | 6 - 12 months year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar fusion rates, Actifuse synthetic bone graft, Baxter Healthcare, Other synthetic bone graft
Psychosocial Screening for Neuroendocrine Tumor Patients

Study Overview
=================
Brief Summary
-----------------
This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.

Official Title
-----------------
Psychosocial Screening for Neuroendocrine Tumor Patients

Conditions
-----------------
Neuroendocrine Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sign written informed consent form; age ≥ 18 years; pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%); Exclusion Criteria: <18 years; Neuroendocrine carcinoma; History of psychiatric or psychologic illness; History of previous cancers or cancer distress; Patients with central nervous system(CNS) disorder； Severe, uncontrolled medical condition that would affect patients' compliance;

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuroendocrine tumors<br>Patients with neuroendocrine tumors will be given access to an application that monitors distress, anxiety, depression, self-perceived burden, and resilience at regular intervals for 3 months lasting for 24 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DT | Distress Thermometer | every 3 month until 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HADS | Hospital Anxiety and Depression Scale | every 3 month until 24 month | 
| SPBS | Self-Perceived Burden Scale | every 3 month until 24 month | 
| CD-RISC | Connor-Davidson Resilience Scale | every 3 month until 24 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DT, HADS, SPBS, CD-RISC, Psychosocial Screening
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.

Official Title
-----------------
Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Conditions
-----------------
Uterine Cervix Cancer

Intervention / Treatment
-----------------
* Radiation: Standard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone. Exclusion Criteria: Presence of another concurrent active invasive malignancy Prior invasive malignancy diagnosed within the last three years except for [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radiochemotherapy followed by brachytherapy<br>Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy | Radiation: Standard<br>* Radiation then brachytherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | deoxyribonucleotide levels | 3 months posttherapy | 
| Biomarker | HPV DNA levels | 3 months posttherapy | 
| Biomarker | Circulating tumor cell count | 3 months posttherapy |
Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.

Official Title
-----------------
Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates

Conditions
-----------------
Medically Complex Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age Birth at <28 weeks gestation Birth weight <1000 grams Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly) Cardiac surgery during first 3 months of life Severe chronic lung discharge defined as the need for mechanical ventilation at 36 weeks post-menstrual age Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at 44 weeks post-menstrual age) Exclusion Criteria: Significant malformations/amputations of the extremities Recovering from a surgical procedure within 4 weeks of the assessment Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| Study Babies<br>Study video at 50-55 weeks gestational age, motor assessments at 24m (+/- 6 months) and again at 4 years (+/- 1 year). | |
| Control Babies<br>Video at 50-55 weeks gestational age, motor assessment at 24 months (+/- 6 months). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of cerebral palsy |  | 24 months (+/- 6 months) and 4 years (+/- 1 year) of age |
Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.

Official Title
-----------------
Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

Conditions
-----------------
Leukemia, Non Hodgkin's Lymphoma, Aplastic Anemia

Intervention / Treatment
-----------------
* Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase. Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible. Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease. Patients must be <age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor. Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%. Patients with serious intercurrent medical illness are not eligible. Patients and their donors must provide written informed consent.

Ages Eligible for Study
-----------------
Maximum Age: 49 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 |
| --- | --- |
| Experimental: Megadose T cell depleted<br> | Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation<br> <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
-----------------
CLL, CML, Lymphoma, AML, ALL, MDS, AA