linjc16/ctgov huggingface dataset:
Prevalence Of Microalbuminuria Among Children Suffering From Sickle Cell Nephropathy and Sickle Cell/Beta-Thalassemia

Study Overview
=================
Brief Summary
-----------------
Sickle cell nephropathy is a known complication of sickle cell anemia (SCA) manifested by increase in glomerular filtration rate (glomerular hyperfiltration) and results in proteinuria and chronic renal failure. Our goal is to examine the prevalence of proteinuria and microalbuminuria as an early predictive factor of glomerular injury, among young people who suffer from SCA as well as those who suffer from combined sickle cell/beta-thalassemia.

Conditions
-----------------
Sickle Cell Anemia, Beta-Thalassemia, Microalbuminuria

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with sickle cell anemia Patients diagnosed with combined sickle cell anemia/beta-thalassemia Exclusion Criteria: Diabetes mellitus Hypertension Reduced renal mass (single kidney) Overweight History of UTIs

Ages Eligible for Study
-----------------
Maximum Age: 25 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 |
| --- | --- |
| Sickle cell beta<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer. PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

Detailed Description
-----------------
OBJECTIVES: To compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples). OUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia.

Official Title
-----------------
Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1 PATIENT CHARACTERISTICS: Previously consented to biologic studies PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression levels between DS AMKL and non-DS AMKL patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia in remission, childhood acute myeloid leukemia/other myeloid malignancies, childhood acute megakaryocytic leukemia (M7)
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.

Official Title
-----------------
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy

Conditions
-----------------
Glottic Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment with exclusive radiotherapy or exclusive surgery. patients treated for these cancers at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017. Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors. Exclusion Criteria: -

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 |
| --- | --- |
| Surgery<br> | |
| Radiotherapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice Handicap Index | The VHI is a self-administered questionnaire that provides a score ranging from 0 to 120 points validated in France and internationally based on the declarative answers to 30 items of the questionnaire. A high score corresponds to a voice felt to be of poor quality. This is a subjective assessment made by the patient. | At 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Phonation Time | The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible. | At 5 years | 
| Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score) | This score is obtained from an internationally and nationally validated hetero-assessment. It consists in the attribution by a listening jury made up of two people of a mark ranging from 0 to 3 for each of the 6 items: Grade, Roughness, Breathiness, Asthenia, Strain, Instability. A high score is associated with a voice perceived as bad by the audience. | At 5 years | 
| Acoustic Analysis by Vocalab software | short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community. | At 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glottic Squamous Cell Carcinoma, Surgery, Radiotherapy, Voice
Predicting Outcome in Cervix Carcinoma: a Prospective Study

Study Overview
=================
Brief Summary
-----------------
The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.

Official Title
-----------------
Predicting Outcome in Cervix Carcinoma: a Prospective Study

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological or cytological proven cervical cancer informed consent according to national rules Exclusion Criteria: no histological or cytological proven cervical cancer no informed consent according to national rules

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1:surgery<br>treatment = surgery only | |
| group 2: radiotherapy<br>treatment = radiotherapy only | |
| group 3: RT and CT, and/or hyperthermia<br>treatment= radiotherapy combined with chemotherapy and/or hyperthermia | |
| group 4: stage IVb , any treatment<br>cervical cancer stage IV b, treatment = any systemic or radiation therapy and supportive care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| five-year overall survival rate | assessment of the overall survival 5 years after treatment | 5 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| three-year distant disease free survival | assessment of distant disease free survival, 3 years after treatment | 3 years | 
| three-year local disease free survival | assessment of local disease free survival, 3 year after treatment | 3 years | 
| five-year distant disease free survival | assessment of distant disease free survival,5 years after treatment | 5 years | 
| five-year local disease free survival | assessment of local disease free survival, 5 years after treatment | 5 years | 
| number of participants with early adverse events as a measure of safety and tolerability |  | 2 months | 
| number of participants with late adverse events as a measure of safety and tolerability |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer
FST-100 in the Treatment of Acute Viral Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Viral Conjunctivitis

Conditions
-----------------
Acute Viral Conjunctivitis

Intervention / Treatment
-----------------
* Drug: FST-100
* Drug: FST-100 Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye Exclusion Criteria: Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FST-100<br> | Drug: FST-100<br>* FST-100<br>|
| Placebo Comparator: FST-100 Vehicle<br> | Drug: FST-100 Vehicle<br>* FST-100 Vehicle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical resolution of acute viral conjunctivitis |  | 6-7 days |
A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
A total balanced fluid replacement strategy is a promising concept for correcting hypovolemia. The effects of a balanced fluid management including a new balanced hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.

Official Title
-----------------
Phase 4 Study of a Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Conditions
-----------------
Elderly, Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Balanced HES 130/0.42
* Drug: Balanced HES 130/0.42
* Drug: 6% HES 130/0.4 prepared in saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged >80 years Exclusion Criteria: Chronic kidney dysfunction requiring dialysis Myocardial infarction within the previous 3 weeks Liver insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid | Drug: Balanced HES 130/0.42<br>* Volume is administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) was <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg<br>Drug: Balanced HES 130/0.42<br>* Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg<br>|
| Active Comparator: B<br>Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate | Drug: 6% HES 130/0.4 prepared in saline solution<br>* Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is postoperative renal function |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other organ function (myocardial function, endothelial function, degree of inflammation) |  | Postoperative period |
Chemotherapy Combined With Immunotherapy or Chemotherapy Combined With Immune Checkpoint Inhibitor Plus Bevacizumab in 5'-ALK NSCLC

Study Overview
=================
Brief Summary
-----------------
This study was designed to explore the efficacy and safety of Alectinib as a first-line treatment for advanced NSCLC with ALK rearrangement positive mutation in the real world. On the basis of the hypothesis that the 5' partner influences the intrinsic properties of the fusion protein, immune surveillances that impact oncogenic potential, and sensitivity to ALK TKIs, the investigators investigated the clinical impact of the detection of non-reciprocal/reciprocal ALK translocations in ALK-rearranged NSCLC patients receiving alectinib as first- or subsequent-line therapy. The investigators also performed whole transcriptomic analysis by RNA sequencing and translated proteins identification by proteomics using tissue samples from patients with non-reciprocal/reciprocal ALK translocations and 3'-ALK fusion to identify certain differentially expressed genes or proteins and their signaling pathways.

Official Title
-----------------
Chemotherapy Combined With Immune Checkpoint Inhibitor or Chemotherapy Combined With Immune Checkpoint Inhibitor Plus Bevacizumab in 5'-ALK Rearranged Advanced NSCLC Patients

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Alectinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology ALK Arranged Positive ALK Arranged Detection Method is NGS Treatment Plan is Alectinib 600mg po bid Exclusion Criteria: Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

| Intervention/Treatment |
| --- |
|Drug: Alectinib|Alectinib Cap 600 mg po bid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression survival time | may 2017- may 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | over survival time | may 2017- may 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alectinib, Non-small Cell Lung Cancer, ALK Rearranged
Fertilix Supplements and Assisted Reproductive Technology

Study Overview
=================
Brief Summary
-----------------
This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)

Conditions
-----------------
Spermatozoa

Intervention / Treatment
-----------------
* Dietary Supplement: Fertilix
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with a sperm sample containing 8-OHdG levels > 15% and must be capable of producing an ejaculate containing >10million sperm upon study enrollment. Male is between 20-55 years of age seeking treatment for infertility with his partner at URA and who is a candidate for an IUI, IVF or IVF-ICSI (excluding donor egg) procedure. Female is between 20-42 years of age Female exhibits tubal patency on hydrosonogram or hysterosalpingogram (HSG) Female exhibits normal uterine cavity by hysteroscopy, hydrosonogram or hysterosalpingogram (HSG). Exclusion Criteria Subjects with initial semen analysis of an ejaculate containing < 10 million sperm. Men who have been taking nutraceuticals, vitamins or other compounds known to have antioxidant activities within4 weeks of the study. No other supplements may be taken with Fertilix. Men who have hypersensitivity or an allergy to any of the ingredients in Fertilix®. Men who have been treated with a chemotherapeutic agent known to cause sterility, such as cyclophosphamide. Men who have taking anabolic steroids or testosterone replacement within 4 months of the study. Men currently being treated with a Ca++ channel blocker or other medical treatment known to adversely affect sperm production or function. Men with HIV, hepatitis B and C.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fertilix<br>Fertilix supplementation | Dietary Supplement: Fertilix<br>* daily supplementation<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in sperm DNA damage |  | 2 years |
A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)

Study Overview
=================
Brief Summary
-----------------
This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.

Official Title
-----------------
Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)

Conditions
-----------------
Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung, Small Cell Lung Carcinoma, Triple Negative Breast Carcinoma, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Atezolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are administered with atezolizumab for the locally approved indications Exclusion Criteria: Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants who Receive Atezolizumab<br>Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years. | Drug: Atezolizumab<br>* Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.<br>* Other names: Tecentriq;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |  | Approximately 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |  | Approximately 6 years | 
| Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1 |  | Approximately 6 years | 
| Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1 |  | Approximately 6 years | 
| Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1 |  | Approximately 6 years |