linjc16/ctgov huggingface dataset:
PreTerm RNA in Maternal Serum

Study Overview
=================
Brief Summary
-----------------
Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation. The incidence of preterm birth in Israel in the last years is around 7-8%. Despite various diagnostic modalities as well as newly therapeutic approaches the incidence of preterm birth remains unchanged and is considered to be the leading cause of neonatal morbidity and mortality. In the last decade, small RNAs have emerged as an important player in both physiological and pathophysiological responses. These single strands, non-coding regulatory RNA molecules are responsible for post transcriptional regulation of target genes. Hence, may provide a new opportunity for biomarkers discovery in the field of preterm birth. The main objective of this study is to identify a distinctive expression profile of maternal circulating RNAs that will be used as biomarkers for preterm birth.

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with singleton pregnancy at 26-32 week of gestation with no clinical symptoms of preterm labor. Women with singleton pregnancy 24-34 week of gestation who present to the labor suite with symptoms suspected for preterm labor. Women with singleton pregnancy in term active labor (weeks 37-40). Exclusion Criteria: Exclusion criteria will include: multiple gestation, major fetal anomalies, IUFD, severe preeclampsia, chronic steroid or immunosuppressive drug use, active immunological illness, and/or pregestational and gestational DM.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| pregnant women not in active labor<br> | Other: observation<br>* observation<br>|
| pregnant women in preterm labor<br> | Other: observation<br>* observation<br>|
| pregnant women in term labor<br> | Other: observation<br>* observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women with preterm labor that present a unique RNA cluster |  | 2 years |
Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy

Study Overview
=================
Brief Summary
-----------------
Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral.

Detailed Description
-----------------
Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral

Official Title
-----------------
Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy

Conditions
-----------------
Lung Cancer, Liver Cancer, Stomach Cancer, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years old; The patient whose tumor (tissue or cell) was first diagnosed by pathology; Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy; Have relevant indications for treatment and have no contraindications; Exclusion Criteria: Severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases, etc.); Other circumstances considered inappropriate by the researcher to participate in the study;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Raman spectra | Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum | the 1st day before operation | 
| Raman spectra | Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum | the 1st day after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | through study completion, an average of 1 year | 
| overall survival |  | through study completion, an average of 1 year | 
| objective response rate |  | through study completion, an average of 1 year |
Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer (MBC)

Study Overview
=================
Brief Summary
-----------------
The investigators want to know the role of Peripheral hematopoietic stem cell infusion in avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with Drug Induced Liver Injury.

Detailed Description
-----------------
The researcher investigate the incidence and the cause of Drug Induced Liver Injury in MBC. Patients having a complete clinical history and physical examination, receive routine chemotherapy. Venous blood Sample(4 ml)is collected before and after each cycle according to the planning time. Genomic DNA,RNA and upper serum is isolated. ELISA、rt-PCR or PCR-direct sequencing is used to detect the protein or gene expression associated with liver function.

Official Title
-----------------
Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms, Neoplasm Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be histologically confirmed with metastatic breast cancer; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Normal cardiac, hepatic, renal and bone marrow functions; Life expectancy ≥3 months; Exclusion Criteria: previous history of other malignancies; Central nervous system metastases; Serious or uncontrolled concurrent medical illness.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protective effection of peripheral hematopoietic stem cell infusion for DILI | Patients receiving PHSC infusion after chemotherapy will have lower incidence of DILI. PHSC infusion may improve the liver function. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNPs genotyping associated with Drug Induced Liver Injury | Some SNPs will be find to associated with DILI. | 3 months | 
| Change of cytokines | Changes of cytokines in periphral blood related with liver function with be observed. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast neoplasm, Neoplasm Metastasis, Stem Cells, Drug-Induced Liver Injury
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.

Official Title
-----------------
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

Conditions
-----------------
Incontinence, Urinary

Intervention / Treatment
-----------------
* Device: Coloplast Test Catheter
* Device: Coloplast Speedicath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent and signed letter of authority Be at least 18 years of age and have full legal capacity Be a male Willing to refrain from using analgetics up to 24 hours prior to catheterization visits Have a negative urine multistix - erythrocytes (Microscopic haematuria) Have a negative urine multistix: Leukocytes Nitrite Or if positive, subsequent negative for bacterial growth in urine culture Exclusion Criteria: Abnormalities, diseases or surgical procedures performed in the lower urinary tract Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation Known hypersensitivity toward any of the test products -

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Coloplast Test catheter; then Speedicath catheter<br>The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter | Device: Coloplast Test Catheter<br>* Newly developed intermittent catheter<br>Device: Coloplast Speedicath<br>* Marketed Coloplast Speedicath catheter<br>|
| Experimental: First Speedicath catheter; then Coloplast Test catheter<br>The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter | Device: Coloplast Test Catheter<br>* Newly developed intermittent catheter<br>Device: Coloplast Speedicath<br>* Marketed Coloplast Speedicath catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | The VAS scale is used to measure the pain experienced by the subjects at catheterisation | 1 day |
Wearable Blood Pressure Monitoring

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.

Detailed Description
-----------------
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.

Official Title
-----------------
Verenpaineen Seuranta Paineanturi-matriisilla

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: sphygmomanometer, SpyghmoCor, CNAP500


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written concent from the participant Exclusion Criteria: pace maker, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| blood pressure<br>blood pressure is measured from the participants, by using two methods. A new developed device and a reference device. The new device measures, using oscillometry, the blood pressure from the finger tip. The reference device is a standard sphygmomanometer. | Device: sphygmomanometer, SpyghmoCor, CNAP500<br>* blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of new blood pressure measurement technology. | the accuracy of new developed blood pressure measurement technology is validated against existing gold standard method by comparing systolic and diastolic blood pressure values between the two. | up to 12 weeks |
Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Visanne (SH T00660AA , BAY86-5258)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with endometriosis-associated pelvic pain Exclusion Criteria: Pregnant or lactating women History or suspicion of hormone dependent tumor Therapy resistant endometriosis or need for primary surgical treatment Any other conditions which forbid the participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: Arm 1<br> | Drug: Visanne (SH T00660AA , BAY86-5258)<br>* Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment of the drug |  | 12-18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (reduction of pelvic pain) |  | 12-18 months |
Relatives Visit Prior to Hospital Admission & Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.

Official Title
-----------------
Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Family in an Intensive Care Unit

Conditions
-----------------
Care Unit Syndrome, Anxiety, Depression

Intervention / Treatment
-----------------
* Other: Family visit prior to hospital admission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family of a patient for hospital admission for surgery Exclusion Criteria: Cognitive impairment

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Receiving one family visit prior to hospital admission | Other: Family visit prior to hospital admission<br>* Family receiving one visit prior to hospital admission for surgery<br>|
| No Intervention: Control group<br>Without receiving one family visit prior to hospital admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hospital Anxiety and Depression Scale | Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety). | Change from Baseline anxiety and depression at 90 days |
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics

Study Overview
=================
Brief Summary
-----------------
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.

Official Title
-----------------
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (Patients With Severe Persistent Asthma)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Spiriva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients diagnosed with severe persistent bronchial asthma Patient aged >= 15 years Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS (Inhaled corticosteroids) treatment. Exclusion criteria: Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat Patients who have been enrolled this study before.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Spiriva<br>Patients with severe persistent asthma | Drug: Spiriva<br>* 60 puffs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Asthma Control Status at Week 52 | The effectiveness was determined based on the change of asthma control status from baseline at Week 52 which is the secondary endpoint in the surveillance. The asthma control status was rated on a 3-point scale of well controlled, insufficiently controlled and poorly controlled based on asthma symptoms (in the daytime or at night), use of reliever and limitation of activities including exercise (based on Asthma prevention and management guideline). Well-controlled=WC, Insufficiently-controlled=IC, Poorly-controlled=PC, Unknown=Unk, Missing=Miss, Baseline=BL, Week 52=W52 | Baseline and Week 52 |
Validation of the Telematic Version of the Fugl-Meyer Scale

Study Overview
=================
Brief Summary
-----------------
Stroke is one of the most prevalent pathologies worldwide and its consequences require long-term treatment. The current situation caused by the Sars-cov-2 virus has collapsed health systems and has delayed these patient's treatment. The proposed alternative is telerehabilitation: a treatment system that has already proved its effectiveness. However, the difficulty to assess the stroke patient's functional status is the great problem. For this reason, a Fugl Meyer Assessment Scale adaptation, one of the most widely used (in research and in clinic), is proposed to be carried out remotely. The objective of our study is to validate this scale in stroke patients.

Official Title
-----------------
Validation of theTelematic Spanish Version of the Fugl-Meyer Assessment of Motor Recovery After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Telematic evaluation of motor function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being older than 18-years-old Diagnosis of stroke Exclusion Criteria: Another neurological or orthopedic problem different than stroke that will affect functionality and balance

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 |
| --- | --- |
| Single Group<br>Scale validation in stroke patients | Diagnostic Test: Telematic evaluation of motor function<br>* Validation of the Telematic Spanish Version of the Fugl Meyer Assessment Scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Assessment of sensorimotor function |  | baseline | 
| Fugl-Meyer Assessment Upper Extremity (FMA-UE) |  | Baseline | 
| Fugl-Meyer Assessment Lower Extremity (FMA-LE) |  | Baseline | 
| Fugl Meyer Assessment of sensorimotor function (Short Form) |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Validation Study, Patient Outcome Assessment