linjc16/ctgov huggingface dataset:
Genetic Epidemiology of Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
To determine if hereditary susceptibility predisposes African Americans to sarcoidosis and to identify sarcoidosis susceptibility genes in African Americans.

Detailed Description
-----------------
BACKGROUND: Sarcoidosis is a multisystem, granulomatous inflammatory disease of unknown etiology. Hereditary susceptibility to sarcoidosis is suggested by reports of familial clustering and a higher prevalence in certain ethnic groups, particularly African-Americans. Over four hundred kindreds been reported in the medical literature and these investigators have recently described 101 families and shown that African Americans have a higher prevalence rate of familial sarcoidosis than Caucasians (19 percent vs. 5 percent). The reasons why sarcoidosis clusters in families or the role of genetic factors in this disease are not known. DESIGN NARRATIVE: The study was carried out in African American families ascertained through 400 African American sarcoidosis patients evaluated at the Henry Ford Health System. They were tested for association of sarcoidosis with markers for candidate genes using the affected family-based control method and tested for possible environmental risk factors and genetic mechanisms of disease transmission by performing a segregation analysis in African American families. A strong association of one or more of the candidate genes with sarcoidosis or an indication of major gene segregation for the disease, provided the basis for future linkage studies. Investigating the hereditary susceptibility of sarcoidosis was best done in African Americans, because of the greater severity and occurrence of disease in this population. Once the reasons for familial aggregation of sarcoidosis are determined, the etiology of this disease will be better understood and it should be possible to design new approaches to prevention and treatment. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) recor

Conditions
-----------------
Lung Diseases, Sarcoidosis

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 |
| --- | --- | --- |
Evaluation of ClearLLab Leukemia and Lymphoma Panels

Study Overview
=================
Brief Summary
-----------------
Multi-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up.

Detailed Description
-----------------
Multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping as part of their standard of care for hematological diseases work-up. Residual specimens will be tested using the ClearLLab Panels to determine the presence or absence of an abnormal phenotype and compare results to clinical impression (hematological malignancy or non-malignancy).

Official Title
-----------------
Evaluation of ClearLLab Leukemia and Lymphoma Panels

Conditions
-----------------
Leukemia-Lymphoma

Intervention / Treatment
-----------------
* Diagnostic Test: Flow Cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residual samples from patients with hematological abnormalities being evaluated by Flow Cytometry for the presence or absence of an abnormal population associated with a hematological malignancy. All subjects of any ethnicity, age and racial background will be included. Exclusion Criteria: Specimens and/or spent samples that are visibly hemolyzed Specimens and/or spent samples that are visibly clotted Specimens and/or spent samples collected in K2EDTA anticoagulant older than 24 hours from time of collection Specimens and/or spent samples collected in Heparin or ACD anticoagulant older than 48 hours from time of collection Samples with insufficient volume to complete the protocol tests
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Flow Cytometry|Immunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologically Malignant or Non-Malignant | Presence or absence of an abnormal phenotype detected using the ClearLLab Panels vs. the clinical outcome of Hematologically Malignant or Hematologically Non-Malignant from the same subject | Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematological diseases
Long-Term Follow-up Safety Study of Human Central Nervous System Stem Cells in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine the long-term safety and possible benefits of transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term follow-up study.

Official Title
-----------------
Long-Term Follow-up Study of the Phase I/II Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration, Geographic Atrophy

Intervention / Treatment
-----------------
* Biological: Human Central Nervous System Stem Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have completed Study CL-N01-AMD Must be able to provide written informed consent prior to any study related procedures Agree to comply in good faith with all conditions of the study and to attend all required study visits Exclusion Criteria: Inability to comply with study procedures or visits Since enrolling in Study CL-N01-AMD, have entered, or are about to enter another investigational study that, in the opinion of the Principal Investigator (PI), might confound study interpretation. Received off-study immunosuppressive agents in the lead-in study or are receiving any immunosuppressive agents since completing the lead-in study

Ages Eligible for Study
-----------------
Minimum Age: 51 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Human Central Nervous System Stem Cells|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and types of serious adverse events |  | At each of 11 visits over a period of 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and types of adverse events |  | At each of 11 visits over a period of 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD
Role of Salbutamol and Furosemide in TTN

Study Overview
=================
Brief Summary
-----------------
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn

Official Title
-----------------
Role of Salbutamol and Furosemide in Transient Tachypnea of Newborn

Conditions
-----------------
Transient Tachypnea of the Newborn

Intervention / Treatment
-----------------
* Drug: Furosemide Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all newborn babies with clinically diagnosed TTN Exclusion Criteria: babies less than 34 weeks babies with congenital malformations and CHD

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 7 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with salbutamol<br> | Drug: Furosemide Injection<br>* efficacy of salbutamol and furosemide in TTN<br>* Other names: salbutamol inhalation;|
| Experimental: with furosemide<br> | Drug: Furosemide Injection<br>* efficacy of salbutamol and furosemide in TTN<br>* Other names: salbutamol inhalation;|
| Experimental: both furosemide and salbutamol<br> | Drug: Furosemide Injection<br>* efficacy of salbutamol and furosemide in TTN<br>* Other names: salbutamol inhalation;|
| No Intervention: no inervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of oxygen requiremment in neonates having TTN. | neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed. | upto 6 months |
Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.

Detailed Description
-----------------
Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis. Following admission, all patients underwent complete clinical examination and detailed medical history was obtained. A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).

Official Title
-----------------
Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility

Conditions
-----------------
Infertility, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regular cycles. normal thyroid function, prolactin and androgen levels. normal semen analysis of the partner. normal hysterosalpingography. normal transvaginal ultrasound examination. Exclusion Criteria: possible uterine malformations or pathologies. presence of infections, including hepatitis, human immunodeﬁciency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma. presence of anti-sperm antibodies in serum. Male factor infertility.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| unexplained infertility patients<br>44 patients diagnosed to have unexplained infertility | |
| Fertile women<br>44 fertile women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Helicobacter Pylori IgG Assay in Serum | calculation of quantitative Helicobacter pylori IgG assay in serum | 24 hours |
Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience

Study Overview
=================
Brief Summary
-----------------
Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain. In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks. However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties. In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program Rafael until they are 7 years old. The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7. At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.

Official Title
-----------------
Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program

Conditions
-----------------
Neurodevelopmental Abnormality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all children prematurely born between 24 and 33 completed week during 2012 and involved in the Lorraine Perinatal Follow-up program at 7 years old Exclusion Criteria: Children not able to respond to the EDA evaluation

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 8 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 |
| --- | --- | --- |
| EDA score (Evaluation Des fonctions cognitives et des Apprentissages) | Evaluation of learning ability by a standardized score (ranging from 15 in maths to 65 in reading, the higher score being the better) | 7 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAFAEL follow-up questionnaire reply of parents | Questionnaire on parents feelings (with 4 levels from no impact to heavy disturbances of the family life) | 8 years old |
Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in conjunction with thorough visual function testing. Methods: 28 patients with uveitis-associated CME were examined before intravitreal triamcinolone injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection. Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading speed using a standardized German-language test (Radner Reading charts), contrast sensitivity using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time were compared to the respective outcome of visual function.

Official Title
-----------------
Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema

Conditions
-----------------
Uveitis Related Cystoid Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intraocular inflammation able to read > 18 years old Exclusion Criteria: cataract amblyopia dyslexia already applicated intravitreal triamcinolone for current cystoid macular edema

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Cystoid macular edema, microperimetry, functional visual acuity, intravitreal triamcinolone
Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether esophageal dysmotility and dilatation is an important complication in the long term follow-up following laparoscopic gastric banding for morbid obesity.

Detailed Description
-----------------
Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.

Official Title
-----------------
Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.

Conditions
-----------------
Esophageal Motility Disorders

Intervention / Treatment
-----------------
* Procedure: Laparoscopic surgery
* Procedure: gastric banding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI more than 40 Exclusion Criteria: BMI below 40

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgery<br> | Procedure: Laparoscopic surgery<br>* Gastric banding<br>Procedure: gastric banding<br>* laparoscopic gastric banding<br>* Other names: morbid obesity;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| esophageal dilatation | esophageal dilatation or dysfunction | yearly follow-up over 12 year period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, adjustable gastric banding, morbid obesity, esophageal motility, esophageal dilatation
Long-term Cardiovascular Risk Following Successful Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.

Official Title
-----------------
The Prevalence of Cardiovascular Risk Factors in Patients More Than 10 Years Following Successful Renal Transplant.

Conditions
-----------------
Renal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered in the Norwegian Renal Registry Documented elevated iPTH at Tx and 10 weeks post-tx Well functioning transplant 10 years following tx Signed informed consent Exclusion Criteria: Lack of ability to comply with the protocol Refused written informed consent

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 |
| --- | --- |
| eGFR >=60ml/min/1.73m2<br>Patients with an estimated glomerular filtration rate of >=60 ml/min/1.73m2. | |
| eGFR 45-60ml/min/1.73m2<br>Patients with estimated glomerular filtration rate >=45 ml/min/1.73m2 and <60ml/min/1.73m2. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibroblast growth factor 23 (FGF23) | To evaluate the long-term effect of a successful renal transplant on this biomarker. | More than 10 years after successful renal transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intact parathyroid hormone (iPTH) | To evaluate the long-term effect of a successful renal transplant on this biomarker. | More than 10 years after successful renal transplantation | 
| Klotho | To evaluate the long-term effect of a successful renal transplant on this biomarker. | More than 10 years after successful renal transplantation | 
| Neutrophil gelatinase-associated lipocalin (NGAL) | To evaluate the long-term effect of a successful renal transplant on this biomarker. | More than 10 years after successful renal transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Successful transplantation, Long-term observation