linjc16/ctgov huggingface dataset:
Pharmacokinetic Study Of EPZICOM Tablet

Study Overview
=================
Brief Summary
-----------------
This study was designed to explore the drug levels in the blood in Japanese HIV-infected patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total of 8 subjects.

Official Title
-----------------
Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Lamivudine / Abacavir Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning (00:00 to 12:00) at least for 2 weeks prior to administration of the study drug. A patient who agrees to abstain from alcohol from 48 hours prior to administration of the study drug until completion of blood sampling for pharmacokinetic analysis. Exclusion criteria: A patient developing AIDS (Patients who developed AIDS in the past but have no symptoms or findings that may serve as indicators at screening may be eligible for the study.) A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: Lamivudine / Abacavir Sulfate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following pharmacokinetic parameters of plasma lamivudine and abacavir Maximum plasma concentration(Cmax), Time to the maximum plasma concentration(tmax), Elimination half-life(t1/2), Area under the plasma concentration-time curve(AUC) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events occurring during the study period) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EPZICOM, Lamivudine, Abacavir, pharmacokinetics, Japanese
Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis

Study Overview
=================
Brief Summary
-----------------
Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.

Official Title
-----------------
Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis

Conditions
-----------------
This Study Describes the Different Causes of Death in 237 FL Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FL patients patients recorded as deceased Exclusion Criteria: -Other diagnosis than FL

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 |
| --- | --- |
| LP: Lymphoma Progression<br> | |
| TRM: Treatment Related Mortality<br> | |
| NHM: Non hematologic malignancy<br> | |
| OC: Other Cause<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | OS length was calculated from the date of diagnosis to the date of death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Follicular lymphoma; death, rituximab, treatment related toxicity
Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

Study Overview
=================
Brief Summary
-----------------
The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy. In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established. The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy

Official Title
-----------------
Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

Conditions
-----------------
Ovarian Function Insufficiency

Intervention / Treatment
-----------------
* Procedure: Salpingectomy or Fimbriectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause Exclusion Criteria: Menopause known or suspected malignancy
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Hysterectomy<br>Hysterectomy without oophorectomy or salpingectomy | |
| Experimental: Hysterctomy with salpingectomy or fimbriectomy<br>Salpingectomy or Fimbriectomy | Procedure: Salpingectomy or Fimbriectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian function | ovarian function measured by FSH , AMH and follicule count on ultra-sound | 60 days post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian function, Hysterectomy, Salpingectomy, Anti mullerian hormone
Open Label Clinical Trial of Vitamin D in Children With Autism

Study Overview
=================
Brief Summary
-----------------
Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients. The study will determine if initial safety and effect estimates predict that a double blind randomized control trial (RCT) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of ASDs. Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.

Detailed Description
-----------------
data is still being collected

Official Title
-----------------
Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism

Conditions
-----------------
Autism, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Liquid Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Autism from DSM-IV TR and ADOS Moderate but less than severe on CGI-Severity scale IQ > 40 ZRT 25(OH)D blood spot test < 30 ng/ml Age 3-8 years old Exclusion Criteria: Developmental delays prior to 12 months of age history of head trauma seizure in the past year bleeding disorder history of kidney or liver disease clinically significant low white blood cell count PDD-NOS, Rett's syndrome, Childhood Disintegrative Disorder or Fragile X syndrome current supplementation with Vitamin D, Vitamin A or cod-liver oil

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid Vitamin D<br> | Drug: Liquid Vitamin D<br>* 300 IU/Kg/day not to exceed 10,000 IU/day.<br>* Other names: Ddrops;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale - Improvement (CGI-I) | Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved. | Baseline and 12 weeks from Baseline |
Eruption Status of Primary Teeth in Low Birth Weight Children in Comparison to Normal Birth Weight Childern

Study Overview
=================
Brief Summary
-----------------
determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight

Detailed Description
-----------------
Timing of eruption of primary teeth is an urgent question for every mother especially in low birth weight children. Although, the timing of eruption of primary teeth and their sequence of eruption shown to be under the genetic control , pre-natal maternal conditions, early childhood metabolic and nutritional factors along with socioeconomic states have been associated with the timing of eruption of primary teeth. Many factors may affect the timing of eruption. Literature showed that factors like gender, race and physical growth may influence emergence of tooth in child mouth but there is scarce information on Egyptian children .

Official Title
-----------------
Eruption Status of Primary Teeth and BMI in Low Birth Weight Children in Comparison to Normal Birth Weight Children

Conditions
-----------------
Eruption Statues of Primary Teeth in LBW Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children. Children aged from 6 to 36 month. Exclusion Criteria: Refusal of participation from the parents. Medically compromised children. Major illness. The child had special needs. Any systemic disease. Any congenital deformity that may affect teeth eruption.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

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 |
| --- | --- |
| group A<br>low birth weight children | |
| group B<br>normal birth weight children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| status of eruption of primary teeth | clinical examination | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child physical growth | weight in kilograms height in centimeter weight and height will be combined to report BMI in kg/m^2 | 1 year |
10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)

Study Overview
=================
Brief Summary
-----------------
10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast cancer patients taking aromatase inhibitors.

Official Title
-----------------
10-year CHD Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer Patients Taking Aromatase Inhibitors

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early Breast Cancer patients Postmenopausal Status patients taking Aromatase Inhibitor as adjuvant treatment no longer than 6 months Exclusion Criteria: Advanced Breast Cancer patients(stage iii, iv) Patients who are hard to be analysed by limitation of chart record according to investigators discretion patients who already have been registered in this study

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

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

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 |
| --- | --- | --- |
| The primary objective of this study is to define 10-year CHD risk according to Framingham risk score in postmenopausal early breast cancer patients who are taking aromatase inhibitors as an adjuvant treatment. |  | 1 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe 10-year CHD risk comparing to the historical data of 10-year cancer-specific mortality in breast cancer |  | 1 Visit | 
| To analyse CHD management patterns according to defined 10-year CHD risk categories |  | 1 Visit | 
| To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk |  | 1 Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHD-Risk, Breast Cancer, Aromatase Inhibitors, postmenopausal early breast cancer
Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

Study Overview
=================
Brief Summary
-----------------
Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established. In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.

Official Title
-----------------
Comparing Timing and Number of Endometrial Biopsies in IVF Treatment and Identifying Biochemical Markers to Predict Endometrial Receptivity

Conditions
-----------------
Infertility, Recurrent Implantation Failure

Intervention / Treatment
-----------------
* Procedure: endometrial biopsy/ies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal menstrual cycle between 1-6 previous failed IVF cycles normal hormonal profile Exclusion Criteria: intrauterine procedure in last 3 months hydrosalpinx intrauterine lesion /malformation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no treatment<br> | |
| Experimental: one biopsy, proliferative phase<br> | Procedure: endometrial biopsy/ies<br>* performing office endometrial biopsy with a disposable sterile catheter<br>|
| Experimental: one biopsy, secretory phase<br> | Procedure: endometrial biopsy/ies<br>* performing office endometrial biopsy with a disposable sterile catheter<br>|
| Experimental: two biopsies<br> | Procedure: endometrial biopsy/ies<br>* performing office endometrial biopsy with a disposable sterile catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rates |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rates |  | 3 years |
The Effect of Nasal Hair on Nasal Obstruction

Study Overview
=================
Brief Summary
-----------------
Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many studies have been performed quantifying and describing the impact of a number of factors on symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory causes. Despite this scrutiny, no attention has been paid to the nasal vibrissae as a potential anatomical contributor to nasal obstruction. The proposed study intends to elucidate that contribution, if any exists.

Official Title
-----------------
The Effect of Vibrissae on Subjective and Objective Measures of Nasal Obstruction

Conditions
-----------------
Nasal Obstruction

Intervention / Treatment
-----------------
* Procedure: Vibrissae trimming
* Drug: Application of oxymetazoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of nasal vibrissae Able to tolerate rhinomanometry Exclusion Criteria: Anatomical or other obvious cause of obstruction Claustrophobia with rhinomanometry mask

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrissae trimming<br>Patients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae. | Procedure: Vibrissae trimming<br>* Patients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement.<br>Drug: Application of oxymetazoline<br>* Afrin will be administered to minimize the impact of erectile mucosal tissue on obstruction.<br>* Other names: Afrin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal airflow/pressure | Objective measures include airflow and pressure as assessed by Rhinomanometry. | Participants will undergo assessment over a 30 minute period, no follow-up | 
| Subjective Nasal Obstruction | Subjective measures will be assessed via the modified version of the NOSE outcome instrument-a validated test of subjective nasal obstruction | Participants will undergo assessment over a 30 minute period, no follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal obstruction, Vibrissae, Nasal hair
Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Detailed Description
-----------------
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Official Title
-----------------
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 1, Mesenchymal Stem Cells, Umbilical Cord

Intervention / Treatment
-----------------
* Biological: umbilical cord mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks. Ability to provide written informed consent from patients or Child guardian. Exclusion Criteria: diabetic ketoacidosis. evidence of retinopathy at baseline. Body Mass Index >30. Severe or acute organ damage. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection. Severe psychiatric disorder. Presence of malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 35 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: umbilical cord mesenchymal stem cells<br>Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells | Biological: umbilical cord mesenchymal stem cells<br>* Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.<br>* Other names: mesenchymal stem cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C peptide release test |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exogenous insulin dose |  | 3 months | 
| blood glucose |  | 3 months | 
| glycosylated Hemoglobin A1c |  | 3 months | 
| Number of severe and documented hypoglycemic events |  | 3 months | 
| Immunologic reconstitution parameters |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 1, mesenchymal stem cells, Umbilical cord