linjc16/ctgov huggingface dataset:
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar

Study Overview
=================
Brief Summary
-----------------
There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients. Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct training for medical and nursing staff. After the training, ETCP will be measured every 8 hours. The aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal ETCP.

Official Title
-----------------
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar

Conditions
-----------------
Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated, Ventilator-Induced Lung Injury

Intervention / Treatment
-----------------
* Other: traning seminar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated patients intubated in a medical intensive care unit Exclusion Criteria: Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will include patients staying in the intensive care unit, requiring ventilation of the artificial airways in the form of endotracheal or tracheostomy tube. Patients will be over 18 years of age.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: once a day<br>Cuff pressure checks once a day. | Other: traning seminar<br>* There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.<br>|
| Active Comparator: three times a day<br>Cuff pressure checks three times a day | Other: traning seminar<br>* There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitoring of cuff pressures | The effectiveness of pressure monitoring in various time intervals | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preventing complications of incorrect pressure in tracheal cuff | preventing of an VAP or airway damage | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal tube cuff pressure, Ventilator-Induced Lung Injury, traning
Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay

Detailed Description
-----------------
Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.

Official Title
-----------------
Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Conditions
-----------------
Ileostomy - Stoma, Ileostomy; Complications, Stoma Ileostomy, Ileus Paralytic

Intervention / Treatment
-----------------
* Procedure: efferent limb stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with loop ileostomy Barium transit throught the efferent limb without leaks Exclusion Criteria: Chemotherapy at the moment Ileostomy closure at the same admission than the ileostomy creation
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Ambispective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non stimulated<br>Prospective data obtained from non stimulated patients | |
| Experimental: Stimulated<br>Prospective data obtaied from stimulated patients | Procedure: efferent limb stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative ileus | Need for a nasogastric tube | during the admission for the ileostomy closure | 
| bowel movement | day of hospital stay whe stool or flatus begins | during the admission for the ileostomy closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | days | during the admission for the ileostomy closure |
Sildenafil Citrate and Intrapartum Fetal Distress

Study Overview
=================
Brief Summary
-----------------
Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress

Official Title
-----------------
Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor

Conditions
-----------------
Fetal Distress

Intervention / Treatment
-----------------
* Drug: Sildenafil 50 mg
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy. Pregnant ≥ 37 weeks gestation. Fetus with longitudinal lie and vertex presentation. Healthy fetus with EFW>2500 gm Exclusion Criteria: Patients with previous cesarean delivery or uterine surgery. Antepartum hemorrhage. Cephalopelvic disproportion. Category II or III non-stress test. Medical disease as hypertension, cardiac, renal and hepatic disorders Intrauterine fetal death. Fetal growth restriction. Fetuses with major congenital malformations. Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>50 mg oral sildenafil citrate tablet | Drug: Sildenafil 50 mg<br>* 50 mg oral Sildenafil tablet<br>|
| Placebo Comparator: placebo group<br>placebo tablets of the same shape, color and size of sildenafil citrate tablets | Drug: Placebo oral tablet<br>* placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of cesarean section for intrapartum fetal distress | Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present | 24 hours |
Examining Endogenous Antioxidant Levels in Well Trained Cyclists

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.

Official Title
-----------------
The Effects of Habitual Antioxidant Supplementation on Endogenous Antioxidants and Oxidative Damage in Well Trained Cyclists

Conditions
-----------------
Oxidative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, BMI 18.8 29.9 kg/m2 cycle 3-7 times a week for durations longer than 60 minutes cycled for a minimum of 3 years accustomed to exhaustive cycling protocols healthy (no known cardiovascular or metabolic disease) Exclusion Criteria: answering NO to any question on the general health questionnaire would result in exclusion from the study current participation in another clinical study current or recent smoker (last 30 days) prescription or non-prescription of anti-inflammatory use >30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Supplemented<br>The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months | |
| Non-supplemented<br>The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2) | To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations | Protein concentrations will be measured at baseline only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endogenous antioxidants, Antioxidant supplements, Vitamin Supplements, Exercise adaptations, Oxidative stress, Redox regulation, Cycling - exercise
Vitamin A and Response to Endotoxin

Study Overview
=================
Brief Summary
-----------------
Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses.

Detailed Description
-----------------
Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system, we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. This will be done in an established model using infusion with endotoxin to male human volunteers. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses. Furthermore, we hypothesise that it reduces oxidative stress and injury.

Official Title
-----------------
The Effect of Vitamin A on the Response to Endotoxin

Conditions
-----------------
TNF-alfa, Endotoxin Levels

Intervention / Treatment
-----------------
* Drug: Vitamin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamin A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotoxin levels |  |  | 
| TNF-alfa levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of oxidative injury and stress |  |  | 
| Retinol and beta-caroten levels |  |  | 
| Haematological values |  |  | 
| Clinical markers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin A, Endotoxin, TNF-alfa
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

Study Overview
=================
Brief Summary
-----------------
Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity. Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.

Detailed Description
-----------------
A topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. Non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. No method is applied to the control group during the examination for retinopathy of prematurity

Official Title
-----------------
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: non-nutritive sucking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having an examination for retinopathy of prematurity for the first time, age was between 28-35 weeks Exclusion Criteria: - having no congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 36 Weeks

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

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

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: Intervention Group<br>The non-nutritive sucking is applied to the group during the examination for retinopathy of prematurity | Other: non-nutritive sucking<br>* intervention group received a sterile gloved finger during the examination for retinopathy of prematurity<br>|
| No Intervention: Control Group<br>The non-nutritive sucking is not applied to the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Infant Pain Profile | The primary outcome of the study is to evaluate the pain relief efficacy of non-nutritive sucking during examination for retinopathy of prematurity Premature Infant Pain Profile (PIPP). | 1 minute |
Screening for Memory Studies

Study Overview
=================
Brief Summary
-----------------
We hope to recruit participants into various clinical trials and research projects.

Detailed Description
-----------------
The purpose of this protocol is to advertise, recruit, and do a preliminary screen for various clinical trials. Anonymous information collected will be entered in a database available to researchers connected with the Stanford/VA Aging Clinical Research Center, located at VA Palo Alto Health Care System, Palo Alto Division.

Official Title
-----------------
Screening for Memory Studies

Conditions
-----------------
Memory Loss, Memory Deficits, Dementia

Intervention / Treatment
-----------------
* Behavioral: Memtrax Memory screening test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 or over. Exclusion Criteria: Major psychiatric problems. Major medical problems. Aversion to test-taking.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Older Adults<br>Persons over age 60 Participants will complete the Memtrax memory screening test | Behavioral: Memtrax Memory screening test<br>* Memory Screening test<br>* Other names: Memory screening;|

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
-----------------
Memory Loss
Identification of Novel Targetable Kinases in SR-a GvHD

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to identify novel targetable kinases in SR-a GvHD patient samples and investigate their role in different immune cell subtypes.

Detailed Description
-----------------
Corticosteroids are the first-line treatment of a GvHD, however many patients do not respond to corticosteroids. Patients with steroid-refractory a GvHD (SR-a GVHD) have a low 1-year survival rate. In this study, the investigators aim to identify and validate novel targetable kinases in SR-a GvHD patient peripheral blood mononuclear cells (PBMCs) by using a kinase-specific proteomic approach, and thereafter to investigate the role of the identified kinases in different immune cell subtypes by analyzing biopsies taken from SR- a GvHD patients.

Official Title
-----------------
Investigation of Novel Targetable Kinases in Steroid-refractory Acute Graft-versus-host Disease

Conditions
-----------------
Graft Versus Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: allo-transplanted confirmed diagnosis of a GvHD age ≥ 18 years peripheral blood samples and biopsies available written informed consent ability to understand the nature of the study and the study-related procedures and to comply with them Exclusion Criteria: age < 18 years lack of informed consent patients that cannot be classified in one of the 2 groups (steroid-refractory, steroid-responsive)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Steroid-refractory a GvHD<br>Analysis of peripheral blood and intestinal biopsies of patients suffering from steroid-refractory a GvHD | |
| Steroid-responsive a GvHD<br>Analysis of peripheral blood and intestinal biopsies of patients suffering from steroid-responsive a GvHD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of differentially regulated kinases | Bead-based Kinase Assay enrichment (Knet beads) of PBMC lysates | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of protein expression | Analysis of PBMC lysates by western blot | 3 years | 
| Analysis of immune cell subtype | Immunohistochemistry of intestinal biopsies | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Steroid-refractory GvHD, Myeloid cells, Allogeneic hematopoietic cell transplantation (allo-HCT)
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

Study Overview
=================
Brief Summary
-----------------
To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).

Official Title
-----------------
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: CD4 Antigens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-1 seropositivity. Diagnosis of AIDS or AIDS related complex (ARC). Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy. The ability to sign a written informed consent form prior to treatment. A willingness to abstain from all other experimental therapy for HIV infection during the entire study period. A life expectancy of at least 3 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Serious active opportunistic infections. Malignancies other than Kaposi's sarcoma. Concurrent Medication: Excluded: Zidovudine (AZT). Corticosteroids. Nonsteroidal anti-inflammatory agents (NSAI). Other experimental therapy. Patients with the following are excluded: Serious active opportunistic infections. Malignancies other than Kaposi's sarcoma. Prior Medication: Excluded within 3 weeks of study entry: Zidovudine (AZT). Chemotherapy. Immunomodulators. Other experimental therapy.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CD4 Antigens|nan|

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
-----------------
Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex