linjc16/ctgov huggingface dataset:
fMRI of Active DBS Stimulation in Epilepsy

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to incorporate a process known as Functional MRI (fMRI) scanning to reveal a pattern in brain activity during Deep Brain Stimulation (DBS), which will correlate to possible seizure freedom.

Official Title
-----------------
fMRI of Active DBS Stimulation in Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Diagnostic Test: Functional MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy Exclusion Criteria Contraindication to MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation subjects<br> | Diagnostic Test: Functional MRI<br>* A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DBS Stimulation | The primary endpoint of this feasibility study is detection of functional MRI activation related to DBS stimulation. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Brain Stimulation
Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA), and to determine the composition of immune cells present in the microenvironment of individuals with SEA after initiation of mepolizumab.

Official Title
-----------------
Exploratory Investigation of Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

Conditions
-----------------
Eosinophilic Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. Diagnosis of SEA by a health care provider History of an absolute eosinophil count ≥ 300/mm^3 Prescription for mepolizumab provided during course of routine clinical care but mepolizumab not yet started Exclusion Criteria: Age < 18 years old. Pregnancy. Currently using or have used within 3 months of the initial baseline visit any biologic or immunomodulatory therapy with the exception of #3. Currently using or any prior use of rituximab. History of upper/lower respiratory tract infection or asthma exacerbation within the previous four weeks of the first baseline visit. Any prior history of malignancy, autoimmune disease, or immune deficiency. Any other significant medical issue as determined by the principal investigator.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expressed gene transcripts | RNA sequencing will be performed from collected peripheral blood mononuclear cells (PBMCs) at four time points to compare changes in expressed gene transcripts. | Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab | 
| Composition of immune cell subsets | CyTOF mass cytometry (50 test immune phenotype panel including cell surface markers, transcription factors, and cytokines) will be performed on PBMCs isolated from peripheral blood at four time points. | Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab |
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

Official Title
-----------------
Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Conditions
-----------------
Infant, Gastrointestinal Intolerance

Intervention / Treatment
-----------------
* Other: Experimental Hydrolyzed infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant is 0 to 180 days of age Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate Infant has not consumed an extensively hydrolyzed infant formula Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted Infant is not receiving steroids. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study. Parent(s) confirm their intention not to administer vitamin or mineral during the study Exclusion Criteria: • Participation in another study

Ages Eligible for Study
-----------------
Maximum Age: 180 Days

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: Hydrolyzed infant formula<br>Hydrolyzed infant formula to be fed ad libitum | Other: Experimental Hydrolyzed infant formula<br>* Experimental hydrolyzed infant formula to be fed ad libitum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight maintenance |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula volume intake |  | 14 days |
Effect of Phacoemulsification on Ocular Blood Flow in Human

Study Overview
=================
Brief Summary
-----------------
To investigate ocular haemodynamics after phacoemulsification surgery To evaluate the influence in people with different autoregulation of ocular blood flow

Official Title
-----------------
To Investigate Ocular Haemodynamics After Phacoemulsification Surgery

Conditions
-----------------
Cataract, Hypertension, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age-related cataract no complications during surgery Exclusion Criteria: complications during surgery have other complications

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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 |
| --- | --- |
| patients with active-fluidics system<br>patients who underwent phacoemulsification surgery using active-fluidics system | |
| patients with gravity-fluidics system.<br>patients who underwent phacoemulsification surgery using gravity-fluidics system | |

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
-----------------
blood flow
Neurobehavioral Consequences of Sleep Apnea in Children

Study Overview
=================
Brief Summary
-----------------
To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.

Detailed Description
-----------------
BACKGROUND: The study is in response to a Request for Applications (RFA) on Obstructive Sleep Apnea in Children. NHLBI issued the RFA in December, 1997, with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development. DESIGN NARRATIVE: This cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in Massachusetts enrolled in the on-going Infant Care Practices Study. Stratified sampling was used to assemble a cohort of 250 children with habitual snoring (> 3 nights/week), 100 children with occasional snoring (<3 nights/week), and 100 non-snoring children. These children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation, in order to test the hypothesis that, after adjusting for potential confounding variables, both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains: immediate attention, sustained attention, working memory, and symptoms of hyperactivity. These data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old children. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in healthy female volunteers.

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

Intervention / Treatment
-----------------
* Drug: RGB-10
* Drug: Teriparatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult female subjects 18-55 years of age (inclusive) BMI must be between 18.5 and 27 kg/m2 (inclusive) Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: RGB-10<br> | Drug: RGB-10<br> <br> |
| Active Comparator: Forsteo<br> | Drug: Teriparatide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | 0-4 hours | 
| Peak Plasma Concentration (Cmax) |  | 0-4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female, volunteers
Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears

Study Overview
=================
Brief Summary
-----------------
To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.

Detailed Description
-----------------
Autologous platelet-rich matrices may aid in post surgical patients by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Official Title
-----------------
PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail

Conditions
-----------------
Achilles Tendon Tear

Intervention / Treatment
-----------------
* Biological: PRGF
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A complete tear of Achilles tendon Age 18-50 years old Exclusion Criteria: under 18 year of age pregnancy physical or mental disabilities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PRGF | Biological: PRGF<br>* injection of 6cc into injured area of tendon<br>* Other names: platelet-derived preparation rich in growth factors;|
| Placebo Comparator: 2<br> | Biological: placebo<br>* injection of 6 cc of saline into injured area<br>* Other names: saline 0.9% nacl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of symptoms / disease progress |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles tendon
High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

Detailed Description
-----------------
There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Official Title
-----------------
High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Procedure: High-Dose Chemo with Autologous BMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of breast cancer Age 18-70 Breast cancer at first clinical evidence of metastatic disease Must have objectively measurable or evaluable disease or be in complete remission Exclusion Criteria: Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer) CNS involvement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: 1<br> | Procedure: High-Dose Chemo with Autologous BMT<br>* Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur. |  | Undetermined | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes |  | Undetermined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Cancer Treatment, Breast Cancer Treatment
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

Detailed Description
-----------------
Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.

Official Title
-----------------
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary cadaver or non-HLA identical living donor kidney transplant. - Exclusion Criteria: HIV HCV Pregnancy Age < 18 years Malignancy -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and graft survival |  |  | 
| Biopsy proven acute rejection |  |  | 
| Serum creatinine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperlipidemia |  |  | 
| post-transplant diabetes |  |  | 
| wound infections |  |  | 
| lymphoceles |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation, immunosuppression, sirolimus, Thymoglobulin
Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

Study Overview
=================
Brief Summary
-----------------
At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized between study and control group.In the control group no additional intervention takes place on the embryos to be transferred,in the study group, embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo.

Official Title
-----------------
Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

Conditions
-----------------
IVF, ICSI

Intervention / Treatment
-----------------
* Procedure: laser assisted hatching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and above Female Exclusion Criteria: No exclusion criteria, except not possible to give informed consent

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo. | Procedure: laser assisted hatching<br>* Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo<br>|
| No Intervention: 2<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical implantation per transferred embryo |  | fourteen days after transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy and birth per transfer |  | resp. 12 weeks and 38 weeks after transfer |