linjc16/ctgov huggingface dataset:
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Official Title
-----------------
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
* Drug: Esterified estrogens 1.25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg<br>* ESTRATEST® administered orally QD<br>|
| Active Comparator: 2<br> | Drug: Esterified estrogens 1.25 mg<br>* Esterified estrogens 1.25 mg administered orally QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total score of the Menopause Rating Scale (MRS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the domain and individual item scores of the MRS |  | 12 weeks | 
| Change from baseline in the domain scores of the MENQOL |  | monthly for 3 months | 
| Comparison of changes in hormone levels and correlation with changes in the MRS |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause; Postmenopause; Estrogen; Hormone Therapy
Voice Acoustic Properties in People With Obstructive Sleep Apnea Syndrome (OSAS)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine whether voice acoustic properties has an influence on sleep apnea. Sleep apnea syndrome is defined as a sudden stop of more than ten seconds multiple times during sleep. The syndrome is common especially among men and occurs in 2%-4% of the population aged 30-60. The syndrome diagnosis is performed by an ENT (Ear, Nose and Throat) physician. The diagnosis is based on evaluation of anatomical structures in the sound path (nose and throat, jaw, pharynx and oral cavity) and a Polysomnography (PSG) test which quantifies the number and duration of breathing pauses during night sleep and additional parameters that monitor sleep. The syndrome has many negative consequences for those who suffer from it, including fatigue , lack of concentration, hypertension, diabetes ,heart disease, stroke and even death. Therefore, early diagnosis is important.

Official Title
-----------------
Voice Acoustic Properties in People With OSAS (Obstructive Sleep Apnea Syndrome)

Conditions
-----------------
Obstructive Sleep Apnea of Adult

Intervention / Treatment
-----------------
* Diagnostic Test: Patients suffering from Sleep apnea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older men who meet the criteria for disorders such as apnea. 18 years old men and older who meet the criteria of snores based on screening questionnaires. 18 years old men and older who don't suffer from disorders such as apnea and do not suffer from snoring. Exclusion Criteria: Smoking Patients or smoked in the past. Having neurological disorders. Having swallowing trouble. Having Respiratory problems. Having Neuroendocrine problems. Having Voice disorders. Patients who were previously head or/and neck operated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 30 men suffering from apnea<br> | Diagnostic Test: Patients suffering from Sleep apnea<br>* PSG test<br>|
| 15 men defined as snorers<br> | Diagnostic Test: Patients suffering from Sleep apnea<br>* PSG test<br>|
| 15 men without complaints<br> | Diagnostic Test: Patients suffering from Sleep apnea<br>* PSG test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare differences in acoustic properties of phonetics i,a,u, n,m | Subjects will be recorded in a variety of positions expressing the phonetics i,a,u, n,m. and the results will be documented and compared. | half hour |
Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to explore the mechanism of Yisui Granule(YSG) in the treatment of myelodysplastic syndrome(MDS) through demethylation. Under the same condition of basic western medicine treatment, the treatment group used the same traditional Chinese medicine decoction pieces as YSG, and the control group was given placebo. Through a randomized controlled clinical study, we focused on observing the effects of MDS patients on clinical symptoms (including single symptom), fatigue relief, quality of life, peripheral blood picture, blood transfusion interval and blood transfusion volume, and measured the expression of DNMTs, the expression and methylation level of Wnt3a、β-catenin、SFRP and other indicators, as well as cytokines, were used to explore the mechanism of YSG in the treatment of MDS through demethylation.

Official Title
-----------------
Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation

Conditions
-----------------
MDS

Intervention / Treatment
-----------------
* Drug: Yisui granule
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
A. Diagnosed as myelodysplastic syndrome, IPSS score 0-1; B. It meets the syndrome standard of deficiency of both qi and yin, internal resistance of blood stasis; C. Newly diagnosed cases or no application of other Chinese and western medicines or treatment schemes in the past month; D. Take the test voluntarily and sign the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br> | Drug: Yisui granule<br>* Yisui granule<br>|
| Placebo Comparator: control group<br> | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylation index |  | 8 weeks |
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
This is a single center,prospective,no-controlled clinical trial

Detailed Description
-----------------
The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

Official Title
-----------------
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

Conditions
-----------------
IgA Nephropathy

Intervention / Treatment
-----------------
* Drug: Prednisone or Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male patients aged between 18 to 65 years Renal biopsy was used to diagnose IgA nephropathy Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L Exclusion Criteria: Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2 urine RBC > 1 million/ml Patients who have received treatment of enough steroids for more than 12 weeks patients with secondary IgA Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2

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 |
| --- | --- |
| Experimental: Prednisone or Prednisolone<br> | Drug: Prednisone or Prednisolone<br>* daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day<br>* Other names: Prednisone, prednisolone, corticosteroids;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h urinary protein excretion |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enough steroids, MCD, efficacy
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to : to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis; to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital; and to have a method compatible with screening extended to populations at risk.

Official Title
-----------------
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic

Conditions
-----------------
COVID, RT-ddPCR Multiplex

Intervention / Treatment
-----------------
* Diagnostic Test: Saliva collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening Person affiliated to a social security scheme Exclusion Criteria: Person objecting to participation in the research after reading information Person under the protection of justice, Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.) Patient under guardianship or curatorship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with COVID-19 infection suspicion<br>Patient with COVID-19 infection suspicion are tested using standard diagnosis method | Diagnostic Test: Saliva collection<br>* Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive patient using saliva method compared to number of positive patient using standard method |  | One hour | 
| Number of negative patient using saliva method compared to number of negative patient using standard method |  | One hour |
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Licarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling) In need of psychiatric treatment Cooperation and willingness to complete all aspects of the study Exclusion Criteria: Current diagnosis other than bipolar I disorder History of schizophrenia or schizoaffective disorder Drug dependence within 1 month prior to study start or testing positive in a urine drug test Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others Any form of psychotherapy within 1 month prior to study start

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major improvement in anxiety and depression from baseline to endpoint (Week 3) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, manic episode, treatment, licarbazepine
Effect of Flex-a-New on Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an chondroitin sulfate for the symptom modification is knee osteoarthritis

Detailed Description
-----------------
comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an chondroitin sulfate for the symptom modification is knee osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: flex-a-new (food supplement)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee osteoarthritis grade 1 to 3 - Exclusion Criteria: ischemic heart disease with CHF -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: flex-a-new (food supplement)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS KSS |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee osteoarthritis
Antibiotic Resistant Community-Acquired E. Coli

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review patients with E. coli infections at UPMC from January 1, 2004 to December 31, 2005 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community.

Detailed Description
-----------------
The following variables will be followed: age, sex, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization or nursing home admission, receipt of outpatient dialysis or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures.

Official Title
-----------------
Antibiotic Resistant Community-Acquired E. Coli

Conditions
-----------------
E Coli Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ll patients with E. coli infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC-P who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as: Isolation of the organism two or more days after admission for hospitalization OR A history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR Previous isolation of an antibiotic resistant organism
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
-----------------
Infection, Antibiotic resistant
A Pumpkin Seed, Isoflavonoid and Cranberry Mix in LUTS/BPH

Study Overview
=================
Brief Summary
-----------------
The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.

Detailed Description
-----------------
This is a single-arm prospective open-label trial investigating a combination of pumpkin seed, isoflavonoid and cranberry mix in improving LUTS, urological quality of life, and erectile function in BPH patients. The compound will be administered orally two tablets daily for 3 months. Recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated case report form.

Official Title
-----------------
Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Novex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate LUTS due to BPH for at least 6 months at the initial visit no previous therapy or are still symptomatic despite the current use of alpha-blockers Exclusion Criteria: International Prostate Symptom Score (IPSS) > 19 Prostate cancer Urethral stenosis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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: Experimental arm<br>Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally, for 3 months. | Drug: Novex<br>* Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS | Change in IPSS | At 1 and 3 months visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS subscores | Change in IPSS subscores (voiding, filling, nocturia) | At 1 and 3 months visits | 
| uQoL | Change in uQoL | At 1 and 3 months visits | 
| IIEF-5 | Change in IIEF-5 | At 1 and 3 months visits | 
| Rate of ejaculatory dysfunction and orthostatic hypotension | Rate | At 1 and 3 months visits |