linjc16/ctgov huggingface dataset:
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Study Overview
=================
Brief Summary
-----------------
Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences. Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity. Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery

Official Title
-----------------
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Conditions
-----------------
Perinatal Morbidity

Intervention / Treatment
-----------------
* Drug: induction of labor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Routine ultrasound scan and delivery at St.Olav's Hospital Ability to speak Norwegian Singleton pregnancy Gestational age 289 +/- 2 days Cephalic presentation Exclusion criteria: - prelabor rupture of membranes
Sexes Eligible for Study
-----------------
Female

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Induction<br>induction of labor at gestational age 289(41 weeks+2 days) | Drug: induction of labor<br>* Misoprostol, Dinoprostone, amniotomy, Oxytocin<br>|
| No Intervention: expectant management<br>expectant management at gestational age 289(41 weeks+2 days) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal morbidity |  | peri- en postnatal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal complications |  | peri- and postnatal | 
| Mode of delivery |  | at birth | 
| women's view |  | postpartum | 
| Women's experiences |  | perinatal | 
| Hormone levels |  | perinatal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asphyxia neonatorum, Birth Injury, Meconium Aspiration Syndrome
Effective Volemia in Older Adults

Study Overview
=================
Brief Summary
-----------------
Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults. The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients. The secondary objectives are to assess the variability of measurements between decubitus and sitting position.

Detailed Description
-----------------
This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.

Official Title
-----------------
Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study

Conditions
-----------------
Orthostatic Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 70 years and older Orthostatic hypotension or venous insufficiency Affiliated to a social security or beneficiary Exclusion Criteria: Refusal to participation to the study Cognitive disorder Unable to keep sitting posture for up to 30 minutes Foreign patients under french AME scheme

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| Duration of recording during positional echography | Feasibility of positional echography assessed by - Duration of recording (minutes) | 3 months | 
| Feasibility of positional echography | Feasibility of positional echography assessed by - Number of good quality imaging (out of 5 pre specified views : parasternal long axis view, parasternal short axis view, apical views 4 and 5 chamber, subxiphoid view, inferior vena cava view) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac ultra sound parameters: left ventricle diastolic diameter | - Left ventricle diastolic diameter mm/m2 | 3 months | 
| Cardiac ultra sound parameters: left ventricle ejection fraction | - Left ventricle ejection fraction (%) | 3 months | 
| Cardiac ultra sound parameters: E and A waves velocity | - E and A waves velocity (cm/sec) (mitral Doppler) | 3 months | 
| Cardiac ultra sound parameters: Inferior vena cava size and compliance | - Inferior vena cava size (mm) and compliance (%) | 3 months | 
| Cardiac ultra sound parameters: left atrial size | - Left atrial size (cm2) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
older, orthostatic hypotension, volemia, clinical sonography
Surveillance of Fungal Infections During Construction Activity

Study Overview
=================
Brief Summary
-----------------
Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported. However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively. To answer this question, we will monitor our immunosuppressed patients' health status, as well as fine dust and aspergillus spore contents in the air during a three year construction activity period in our hospital.

Conditions
-----------------
Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplantation Chronic hemodialysis treatment

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Hemodialysis patients<br> | |
| Renal transplant patients<br> | |

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
-----------------
aspergillus infections, immunosuppression, kidney transplantation, hemodialysis, galactomannan test, fine dust, construction activity, airborne aspergillus spores
Statin Eligibility Prior to Myocardial InfarCtion

Study Overview
=================
Brief Summary
-----------------
The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is Cross sectional Non interventional One encounter per patient. No follow up. It addresses a major issue of primary prevention in Jordanians especially the young population, namely the issue of lipid lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of patients who sustained MI were not eligible to statins had they been evaluated before the heart attack. It is largely unknown if a larger percentage of Middle Eastern patients who sustain a heart attack would be eligible to receive lipid lowering agents. The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.

Detailed Description
-----------------
Statins, when use as primary cardiovascular prevention strategy, have been shown to lower future acute cardiovascular events, especially myocardial infarction. However the use of statins in this context (i.e., primary prevention) is governed by guidelines that limit the use of statins to four high risk populations: (1) hose with known cardiovascular disease, (2) those with low-density lipoprotein cholesterol (LDL-C) levels 190 mg/dl or above, (3) diabetics with LDL-C levels 70-189 mg/dl, and (4) those with an estimated 10-year atherosclerotic cardiovascular disease risk score of 7.5% or more. Unfortunately, some individuals are still at risk of sustaining MI despite the fact that they do not fit into one of these four high risk groups eligible for statins. StainEPIC will enroll consecutive patients admitted with MI who are not on statins to examine their eligibility for these medications based on the AHA/ACC guidelines.

Official Title
-----------------
Statin Eligibility Prior to Myocardial InfarCtion in Jordanians

Conditions
-----------------
Myocardial Infarction, Statins

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults admitted with MI, age 30 to 75 known lipid profile Exclusion Criteria: on statin before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention. Collection of data on statin eligibility in patients admitted with MI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligible patients for statin therapy | The primary outcome is to calculate the percentage of enrolled patients who do meet the AHA/ACC Guidelines for receiving statins as a primary prevention measure. | Within 24 hour of enrollment |
The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children

Study Overview
=================
Brief Summary
-----------------
No studies have reported the effect of pre-meal snacking on raisins compared to other commonly consumed snacks on energy intake in children. Therefore, the objective of the current study was to examine appetite and energy intake following consumption of ad libitum snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on appetite and food intake 30 min later in 8 - 11 y old normal weight children. The investigators hypothesized that raisins would lower subsequent energy intake in children and reduce hunger.

Official Title
-----------------
The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children

Conditions
-----------------
Food Intake Regulation

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy boys and girls between 8-11 y Exclusion criteria: learning and behavioral problems

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snack foods: raisins<br>children were given ad libitum access to raisins for 15 min | Other: Dietary intervention<br> <br> |
| Experimental: Snack foods: grapes<br>children were given ad libitum access to grapes for 15 min | Other: Dietary intervention<br> <br> |
| Experimental: Snack foods: a mix of almonds with raisins<br>children were given ad libitum access to a mix of almonds with raisins for 15 min | Other: Dietary intervention<br> <br> |
| Experimental: Water control<br>children were given ad libitum access to water | Other: Dietary intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ad libitum snack intake (kcal) |  | 15 min | 
| ad libitum pizza intake (kcal) |  | at 30 min after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective appetite |  | 0-105 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
raisins, grapes, snacks, appetite, food intake
Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:

Study Overview
=================
Brief Summary
-----------------
Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Official Title
-----------------
Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.

Conditions
-----------------
Pain, Neuropathic

Intervention / Treatment
-----------------
* Drug: hyalase group
* Drug: midazolam group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months . Exclusion Criteria: Diabetic patients Pregnant population . Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hyalse group<br>ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5% | Drug: hyalase group<br>* bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.<br>* Other names: Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%;|
| Active Comparator: midazolam group<br>ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5% | Drug: midazolam group<br>* 2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%<br>* Other names: Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston questionnaire | symptom severity ... function severity | 6 months | 
| median nerve sonogrphy | cross sectional area | 6 months | 
| Nerve electrophysiology | sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest | 6 months |
Development and Implementation of Evidence-Based Family-Oriented Support for Young Carers and Their Families in Germany

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and implement evidence-based and family-oriented support for young carers and their families in Germany. Hypothesis is that families' own support mechanisms, combined with externally provided support that is determined by the families' specific needs, will help to overcome their burden and enable families to live in the way they wish to despite chronic illness. This will lead to a measurable increase in HRQOL of children concerned.

Official Title
-----------------
Improved Health-Related Quality of Life for Young Carers and Their Families in Germany on the Basis of Evidence-Based Family-Oriented Support

Conditions
-----------------
Chronic Illness

Intervention / Treatment
-----------------
* Other: support service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children of mentally ill parents (chronic illness) children of somatically ill parents (chronic illness) Exclusion Criteria: children of drug addicted parents

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>intervention group | Other: support service<br>* professional partners for communication befriending with other families concerned information and education (about illness, symptoms, first aid, caring) free-time activities and time out homework assistance administrative advise support for everyday life<br>|
| No Intervention: 2<br>waiting group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related Quality of Life in children |  | study start and after 5 month of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
young carers, family support, children (up to the age of 18) of chronically ill parents
Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery

Study Overview
=================
Brief Summary
-----------------
Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).

Official Title
-----------------
Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery

Conditions
-----------------
Coronary Artery Occlusive Disease

Intervention / Treatment
-----------------
* Drug: ulinastatin, saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighty high risk patients undergoing OPCAB (High risk patients: Euro score ≥ 6 , acute coronary syndrome, preoperative CK-MB increased over 5 times than normal value and high sensitivity CRP ≥2.0) Exclusion Criteria: The patients who receive additional operations, the patients who don't agree to participate in this trial, the patients who has a past hypersensitive experience on Ulinastatin

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ulinastatin<br> | Drug: ulinastatin, saline solution<br>* the ulinastatin group receiving ulinastatin (300,000 unit after anesthesia induction and another 300,000 unit during Y- graft anastomosis, n = 40), the control group receiving the same volume of saline solution(n = 40)<br>|
| Active Comparator: saline solution<br> | Drug: ulinastatin, saline solution<br>* the ulinastatin group receiving ulinastatin (300,000 unit after anesthesia induction and another 300,000 unit during Y- graft anastomosis, n = 40), the control group receiving the same volume of saline solution(n = 40)<br>|
| Placebo Comparator: Sugar pill<br> | Drug: ulinastatin, saline solution<br>* the ulinastatin group receiving ulinastatin (300,000 unit after anesthesia induction and another 300,000 unit during Y- graft anastomosis, n = 40), the control group receiving the same volume of saline solution(n = 40)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulinastatin | The purpose of this study was to evaluate whether ulinastatin significantly affect on coagulation and blood loss in high risk patients undergoing off-pump coronary bypass surgery (OPCAB). - thrombin-antithrombin complex (TAT), prothrombin fragment 1+2(F1,2), platelet factor-4 (PF-4) , hemoglobin, platelet count, white blood cell differential count, prothrombin time (PT), partial prothrombin time (aPTT), amount of blood loss, transfusion, urine output and intravenous fluid input | 24 hours after surgery |
Efficacy of PD-1 Blockade Plus Platinum-based Chemotherapy in Patients With EGFR Sensitive Mutated NSCLC

Study Overview
=================
Brief Summary
-----------------
In this study, the investigator retrospectively collected patients who were continuously treated with immunosuppressive agents or chemotherapy after EGFR-TKI resistance. To analyze the efficacy of immunosuppressive agents in patients with EGFR mutations in the posterior line in a real-world setting.

Official Title
-----------------
Efficacy of PD-1 Blockade Plus Platinum-based Chemotherapy in Patients With EGFR Sensitive Mutated NSCLC Who Progressed From EGFR-TKI Therapy: A Multiple Center Retrospective Comparison Study

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18， non Small Cell Lung Cancer Confirmed by Histopathology patients who are EGFR-TKI resistant without subsequent driver gene mutations and given chemotherapy combined with ICIs or platinum-based chemotherapy Exclusion Criteria: Patients with contraindication of chemotherapy and ICIs Pregnant or breast feeding women

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival time | January 2018 to September 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | January 2018 to September 2021 | 
| ORR | Objective response rate | January 2018 to September 2021 |