linjc16/ctgov huggingface dataset:
Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Critically ill patients are frequently transfused with red blood cell (RBC) units with the predominant intention to increase arterial oxygen content and thus oxygen delivery to the tissues. To date, RBC transfusions have been proven effective in patients with profound anaemia or circulatory shock. However, the impact of the storage process and the so-called storage lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding tissue oxygenation are much debated at present. Alterations of RBC physiology have been comprehensively described ex vivo. Reduced deformability, increased adhesiveness and aggregability of stored RBC impair their rheological properties; anaerobic cellular metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP) increases oxygen affinity and impairs oxygen release to the tissues. This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might require RBC transfusion. The monitoring is continued for the time of transfusion and the hours afterwards.

Official Title
-----------------
Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients

Conditions
-----------------
Effect of RBC Transfusions on Cerebral Oxygen Saturation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: expected requirement of RBC transfusion 18 yrs and older Exclusion Criteria: severe traumatic brain injury (Glasgow coma scale < 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage cerebral ischaemia active bleeding patients necessitating ongoing resuscitation deficient signal of rSO2 impeding its proper valuation

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 |
| --- | --- | --- |
| regional cerebral oxygen saturation (rSO2) | Regional cerebral oxygen saturation (rSO2) will be measured before, during and after RBC transfusion. As the decision to transfuse is multifactorial and the condition of critically ill patients often instable, time frames before, during and after transfusion may vary. | 24-48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, NIRS, Near Infrared Spectroscopy, RBC transfusion, critical ill, regional cerebral oxygen saturation, tissue oxygenation
Lonafarnib for Patients With Hutchinson-Gilford Progeria Syndrome or Progeroid Laminopathy

Study Overview
=================
Brief Summary
-----------------
This treatment IND protocol will allow patients with HGPS and progeroid laminopathies access to lonafarnib, the only compound shown to have an effect on the HGPS disease process resulting in improved outcomes (Gordon et al, 2018). There are no approved treatments for HGPS and progeroid laminopathies.

Official Title
-----------------
A Treatment IND (Investigational New Drug) Protocol for EAP (Expanded Access Program) for the Use of Lonafarnib in Patients With Hutchinson-Gilford Progeria Syndrome (HGPS) or Progeroid Laminopathy

Conditions
-----------------
Progeria, HGPS

Intervention / Treatment
-----------------
* Drug: Lonafarnib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HGPS or progeroid laminopathy by qualified medical doctor (based on common phenotype as described in Gordon 2015 and Merideth 2008). Confirmation with genetic testing is preferred but not required. Adequate hepatic function as defined by SGPT (ALT) and SGOT (AST) ≤ 5 times upper limit of normal range for age Exclusion Criteria: Taking medications or foods that are known to be moderate or strong inducers or inhibitors of CYP3A4 or sensitive CYP3A substrates; or if a patient is taking one of these drugs and cannot safely discontinue or take an alternative drug, the dose of the inhibitor/inducer must be adjusted per the treating physician Taking digoxin, a P-gp substrate with a narrow therapeutic window. Severe renal impairment (GFR < 30 mL/min/1.73m2). Uncontrolled infection. Presence of any active clinically relevant medical condition that in the opinion of the treating physician would preclude patient from safely participating in the program. Pregnant or breast-feeding or plan to become pregnant while on therapy.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lonafarnib|Farnesyl transferase inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

Study Overview
=================
Brief Summary
-----------------
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.

Official Title
-----------------
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

Conditions
-----------------
Supratentorial Neoplasms

Intervention / Treatment
-----------------
* Procedure: Scalp Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years), presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia Exclusion Criteria: history of allergic reactions on local anesthetics; ASA status ≥ 3; depressed consciousness in pre- or postoperative period; aphasia (as investigators were not able to obtain VAS score).

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Scalp Block|standard practice of controll the pain after surgery. Block of the nerve emergences.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale score at 24 h after surgery | Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain), | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale score at 0 | Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain) | Baseline | 
| Visual Analogue Scale score at 2 hours | Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain) | up to 2 hours | 
| Visual Analogue Scale score at 6 hours | Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain) | up to 6 hours | 
| Visual Analogue Scale score at 12 hours | Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain) | up to 12 hours | 
| time first request of a patient for rescue analgesia |  | during surgery | 
| intraoperative anesthetics | (and opioids consumption) | during surgery time | 
| awakening time |  | time from the end of surgery to awekening | 
| changes in hemodynamics at mayfiled headfraom positioning | changes in term of blood pressure | surgery | 
| changes in hemodynamics at mayfiled headfraom positioning | changes in heart rate | surgery |
Cost-Effectiveness of Lung Volume Reduction Surgery

Study Overview
=================
Brief Summary
-----------------
Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Detailed Description
-----------------
Background: Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS. Objectives: Evaluate cost-effectiveness of LVRS compared to current therapy for COPD. Methods: This is a case control study in which veterans undergoing LVRS at VA Puget Sound Health Care System (VAPSHCS) are compared to patients with a similar severity of disease at Boise VAMC who are not undergoing LVRS. Changes in health related quality of life are being evaluated using three instruments: the SF-36, the St. George�s Respiratory Questionnaire, and the Quality of Well-Being Scale, the latter to calculate utility associated with different health states. Costs will be determined using utilization data on outpatient visits, medications, oxygen use, inpatient days, radiology tests, laboratory tests, and emergency room visits are being collected for the twelve months before and after surgery. Costs will be calculated according to VA and community standards. Status: Complete.

Official Title
-----------------
Cost-Effectiveness of Lung Volume Reduction Surgery

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Emphysema

Intervention / Treatment
-----------------
* Procedure: Effectiveness of Lung Reduction Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of >165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease Exclusion Criteria:

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Procedure: Effectiveness of Lung Reduction Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Coronary Artery Disease (CAD) in Women Marathon Runners

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effects of extreme fitness in women. The incidence of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will be compared with age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners. Life style, training volume and risk factors will be assessed.

Detailed Description
-----------------
Single-center, non-randomized, prospective, observational study. The study population will be up to 100 female athletes who are competitive long distance runners, and have been so for a minimum of 10 years. Multi-slice computed tomography (MSCT) will be used to characterize the amount, severity and type of atherosclerotic lesions. MSCTA will be performed per usual practice using a minimum X-ray dose protocol. The study will determine whether moderate to high intensity, long term athletic training and competition is associated with enhanced coronary artery disease in women. Each participant will complete a life-style, training volume and risk factor questionnaire. These participants will be compared to an age, gender and risk factor matched cohort.

Official Title
-----------------
Coronary Atherosclerosis in Women Athletes: Asymptomatic Twin Cities Marathon Women Studied by MSCT Angiography

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female athletes who have run marathons competitively for a minimum of 10 years. Age > 40 years old Agree to participate and sign an informed consent form Exclusion Criteria: Allergy to X-ray contrast Creatinine ≥ 2.0 Pregnant Female Has run a marathon within the past 2 weeks

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Extreme fitness<br>Female competitive long distance runners | |
| Control<br>Age and Risk matched controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of coronary artery disease confirmed by Multislice Computed Tomography |  | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MSCTA, Marathon runners
Pre-ESRD Syndrome in High Risk African Americans

Study Overview
=================
Brief Summary
-----------------
Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Detailed Description
-----------------
Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Official Title
-----------------
Pre-ESRD Syndrome in High Risk African American Young Adults

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

Intervention / Treatment
-----------------
* Drug: Potassium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-35, healthy volunteers, African American Exclusion Criteria: Active medical conditions, prescription drug therapy other than birth control

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Potassium Chloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

Official Title
-----------------
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Dose of Albinterferon Alfa 2b (Alb-IFN), Recombinant Human Albumin-interferon Alfa Fusion Protein in Japanese Chronic Hepatitis C Patients.

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Biological: Albinterferon alfa 2b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period. Age 20 to 69 years Have compensated liver disease results on screening laboratory assessment Exclusion Criteria: Evidence of decompensated liver disease and/or liver cirrhosis. Body weight < 50 kg. A history of immunologically mediated disease. A history or other clinical evidence of interstitial lung disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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: 1<br>Open-label treatment with albinterferon alfa 2b escalating single dose | Biological: Albinterferon alfa 2b<br>* recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability after single dose |  | 5 weeks after single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation |  | 5 weeks after single dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in European patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Detailed Description
-----------------
Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Official Title
-----------------
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimetrexate glucuronate
* Drug: Leucovorin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry. Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, OR a documented history of such intolerance during a prior episode. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Patients with the following prior conditions are excluded: History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimetrexate glucuronate|nan|
|Drug: Leucovorin calcium|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
-----------------
Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome