cyrilzakka/clinical-trials huggingface dataset:
Comparison of Depression Interventions After Acute Coronary Syndrome

Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI\>=15 or BDI\>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.

The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for ACS defined as unstable angina or MI
* BDI greater or equal to 10 and \< 15 2-6 months post-ACS on each of 2 occasions, or BDI greater than 15 on one occasion
* Age at least 35 years
* Fluent in English or Spanish
* Able to complete baseline assessment within 2-6 months of index ACS event
* Able and willing to provide informed consent

Exclusion Criteria:

* Presence of non-cardiac condition likely to terminate fatally within 1 year
* Inaccessibility for intervention or follow-up (e.g., plans to move from the area)
* Cognitive impairment
* Need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours)
* Suicidal ideation
* Major psychiatric co-morbidity (current or by history) including active psychosis, bipolar disorder, or overt personality disorder
* Active substance abuse or dependency
* Chronic renal failure (receiving chronic dialysis treatment, or estimated glomerular filtration rate"...\[eGFR\] \< 30 ml/min/1.73 m2) or moderate/severe liver disease (e.g., esophageal varices, portal hypertension, encephalopathy, GI bleeding)
* Participation in another clinical trial for the treatment of depression.
Cranial Cup Use for Correction of Head Shape Deformities

The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.

The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows with the infant and maintains proper body alignment while promoting normal head shape development. While the cranial cup is not yet FDA approved, it is considered a non-significant medical device and it has successfully corrected asymmetric positional head shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis of a prospective randomized controlled trial currently underway suggests that the cranial cup may be useful in prevention of positional head shape deformity in a cohort of hospitalized infants of varying gestational ages. However, the cranial cup has never been used for correction of the most common form of positional head shape deformity in hospitalized premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to provide information on the feasibility of using the cranial cup in a small sample of prematurely born infants with dolichocephaly during the convalescent phase of their hospitalizations. Information obtained from this descriptive study will be used to determine if a larger investigation using the cranial cup is warranted in this specific patient population.

Eligibility Criteria:
Inclusion Criteria:

* Born at \< or equal to 35 weeks gestation
* Cleared for participation by healthcare team
* Estimated minimum length of stay \>14 days
* Weight \>1000 grams (at enrollment)
* Dolichocephalic head shape deformity

Exclusion Criteria:

* Unable to maintain airway patency (anatomical problem)
* Craniofacial anomaly or scalp device, drain or shunt
* Craniosynostosis
* Severe parturitional head shape deformity
Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma

Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.

We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patients admitted to the ABC Medical Center.

Eligibility Criteria:
Inclusion Criteria:

Donors:

1. Age: \>18 and \<60 years
2. Body weight : \>60 kg
3. Confirmed previous SARS CoV-2 infection
4. negative SARS CoV-2 test result
5. 21 day without symptoms from the negative SARS CoV2 negative test
6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
7. Positive COVID-19 IgG antibodies
8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
9. Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.

Patients/recipients:

1. Age: \>18 years
2. Admitted to the ABC Medical Center facility for the treatment of COVID-19
3. Patients with severe or critical COVID-19
4. Informed consent provided by the patient or healthcare proxy

Exclusion Criteria:

Patients/recipients:

1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy 4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease

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Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae

The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve chordae.

Summary: This study compares the efficacy and the safety of two surgical procedures for the treatment of mitral valve prolapse due to degeneration of the mitral valve: chordae replacement and the translocation of secondary mitral valve chordae.

In our study, researchers used the loop method proposed by von Oppel and Mohr in 2000. The main principle of the method of prosthetic chordae is the preservation of the native anatomy of the mitral valve. This principle is achieved by the implantation of artificial chordae made of ePTFE Gore-Tex threads.

The chordae replacement method essentially involves five stages:

1. Measuring the required length of the chordae.
2. Forming the loops.
3. Fixation of the group of loops to the papillary muscles.
4. Fixation of the chordal loops to the free edge of the valve.
5. Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse.

Chordae translocation is the alternative method, which does not require measurement and selection of chordae lengths. Chordae replacement is technically easier (less aortic clamping time) with comparable results.

The technique of translocation of secondary chordae essentially consists of three stages:

1. Selection of the secondary chordae.
2. Fixation of secondary chordae to the free edge of the valve.
3. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.

Eligibility Criteria:
Inclusion Criteria:

1. Isolated type II mitral valve insufficiency by A. Carpentier
2. Mitral regurgitation degree \>2
3. Age \>18 years
4. Signed informed consent to participate in the study

Exclusion Criteria:

1. Any other cardiac surgeries
2. Age \<18 years
3. Multiple organ failure
4. ReDo procedure
5. Persistent atrial fibrillation
6. Acute infective endocarditis
7. Refusal to sign informed consent
Divided Attention Steering Simulator Alertness Test

Driving simulator programmes are used under a wide range of conditions, and a correlation of driving performance and real accident risks in patients with obstructive sleep apnoea syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today there are no reference levels with regards to sex and age in existence. To define the boundaries of normality age and sex reference values are to be generated and compared to values of patients with OSAS.

50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as well. A better differentiation of pathologic driving performance and response times of OSAS patients should be possible with new reference levels.

The DASS programme records several data, including mean and absloute errors and standard deviations from centre and curve.

Additionally the response time to a randomly appearing target number is recorded (divided attention).

The standard deviation (curve) is the difference between the steering angle and the road angle. Standard deviation (centre) is the standard deviation of the centre of the car from the centre of the road.

Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.

The secondary task of the divided attention test is to respond to a randomly appearing target number at the sides of the monitor while trying to keep the car in the centre of the road.

Average Reaction time is the average time (in seconds) it takes the subject to respond to the target numbers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects

   * capability of giving consent
   * ESS (Epworth Sleepiness scale) score less than 9
   * Holding a driving license
2. Patients

   * diagnostic OSAS
   * capability of giving consent
   * Holding a driving licence

Exclusion Criteria:

1. Healthy subjects

   * suspected OSAS, any observed sleep disorders or snoring
   * acute cardial, pulmonal oder neurological disease
2. Patients - acute cardial, pulmonal oder neurological disease
Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.


Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
2. The coronary angiogram/cardiac catheterization/PCI procedure is elective.
3. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

Exclusion Criteria:

1. The procedure is an emergency and/or the patient is unstable. -
Jedi Grip Versus Double Operator Technique For Ultrasound Guided Infraclavicular Block

The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique.

Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind observer, the block characteristics were evaluated and recorded .

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective hand, wrist and forearm surgery

Exclusion Criteria:

* hepatic or renal failure
* serious cardiac or pulmoner disease
* local or systemic infection
* sepsis
* coagulation disorder
* neurological, muscular or psychiatric disease
* body mass index (BMI) below 18.5 or above 35
* drug and substance abuse
* pregnancy
* refusal of regional anesthesia
* history of allergy to local anesthetics
* mental-motor retardation (inability to consent or assess the visual analog scale(VAS) pain score)
* preoperative long-term NSAIDs or opioid use.
Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants

Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.

Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).

Eligibility Criteria:
Inclusion Criteria:

* Children who participated in NOVA study and are of school age

Exclusion Criteria:

* Children who participated in NOVA study but deceased post discharge
Extended Use of Sodium Bicarbonate in Patients With Cancer

This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may inhibit the spread of the tumor to other parts of the body (metastases) and improve survival.

PRIMARY OBJECTIVES:

I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is feasible and well tolerated as measured by the proportion of subjects with first evidence of adherence failure.

SECONDARY OBJECTIVES:

I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is safe for long term consumption (90 days) as measured by blood pressure, resting pulse rate, and basic metabolic panels to assess metabolic alkalosis.

OUTLINE:

PHASE I (RUN-IN/ADJUSTMENT): Patients receive sodium bicarbonate orally (PO) dissolved in water thrice daily (TID) or twice daily (BID) on days 1-10. The dose may be adjusted as necessary.

PHASE II (LONG TERM): Patients continue to receive sodium bicarbonate PO TID or BID for a total of 90 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Any cancer patient enrolled in the study must have a written approval from their oncologist that a notation will be made in the patient's chart for their study participation
* Subject without known cognitive impairment, central nervous system (CNS) metastasis, overt psychosis, major depression, or delirium as noted in the oncology medical record
* Subject with a Karnofsky performance status scale of 80% or greater at time of consent
* Subject has completed initial adjuvant therapy and is not currently receiving or waiting to receive chemotherapy during the next 120 days
* Breast cancer subjects may be enrolled if they are receiving hormonal blockade therapy
* Subject is not enrolled in any other clinical trials
* Subject has a valid working phone number to be contacted with during the study
* Subject must be willing to provide urine specimen for pH measurements during scheduled clinical visits
* Subject must be willing to provide a 3 mL blood sample for metabolic panels during scheduled clinical visits
* Subject does not have uncontrolled hypertension (systolic pressure \> 140, diastolic pressure \> 90) despite maximal anti-hypertensive therapy
* Subject has healthy renal function: creatinine clearance: 88-128 mL/min; glomerular filtration rate (GFR): \> 90 mL/min/1.7m\^2 based on standard care results no older than 2 weeks; if no data exist, the subject will need to consent to a blood draw for a basic metabolic panel (which measures creatinine) for verification
* Subject must be informed of the investigational nature of this study and must sign and written informed consent in accordance with institutional and federal guidelines
* Subject is not pregnant or breastfeeding at time of consent; a pregnancy test will be conducted from urine sample on day of consent in premenopausal women
* Subject agrees to use medically approved contraception (ie. condoms, oral contraceptive) if premenopausal
Post Market Clinical Follow-Up KeriFuse®

The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years,
* Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.

Exclusion Criteria:

* Pregnant or nursing women,
* Patients with intellectual disabilities who cannot follow the instructions of their surgeon,
* Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®,
* Patients with acute or chronic infections, local or systemic,
* Patients with sensitivities or allergies to the implant components (Nickel, Titanium).
Hypothermia to Prevent High Intracranial Pressure in Patients With Acute Liver Failure

Treatment options in patients with high intracranial pressure due to acute liver failure are limited. This study intends to evaluate the effect of prophylactic hypothermia on preventing high intracranial pressure and compromised cerebral oxidative metabolism.

Acute liver failure (ALF) is associated with a high mortality. With severe hepatic encephalopathy and elevated arterial ammonia concentration (\< 200 micromol/L) more than 50% of the patients will develop high intracranial pressure (ICP) and risk cerebral incarceration and death. The therapeutic options are limited in treating and preventing this condition and new interventions are much sought after. As in hypothermia used for patients after cardiac resuscitation it could be speculated that hypothermia and the reduced cerebral metabolic rate would contribute to neuroprotection and reduce the risk of cerebral hypertension in patients with ALF. We have designed this open, randomized and unblinded study in order to evaluate the effect of prophylactic hypothermia on ICP, cerebral hemodynamics and oxidative metabolism. Patients are randomized to standard medical treatment (SMT) or SMT and hypothermia 33° C for 72 hours using a cooling mattress (Blanketrol II, Cincinnati Sub-Zero). All patients will receive mechanical ventilation, antibiotics, inotropic support and monitored with invasive and non-invasive equipment in accordance to local guidelines. In Copenhagen monitoring cerebral hemodynamics includes:

Placement of a intracranial pressure measuring catheter (Camino (R), Integra) for monitoring ICP. Furthermore, a microdialysis catheter (CMA-70) placed in brain cortex is used for monitoring brain metabolism. Finally, cerebral perfusion can be monitored by measuring mean flow velocity using transcranial doppler and/or oxygen saturation in blood from the jugular vein.

Ethical considerations:

The Helsinki II declaration will be followed and informed consent is mandatory for enrollment. In any patient where hypothermia is believed or suspected to be harmful the study should be stopped and the primary investigator should be notified immediately. All adverse effects will be recorded and published together with the full paper.

Eligibility Criteria:
Inclusion Criteria:

* acute liver failure
* and hepatic encephalopathy stage 3 or 4
* and informed and written consent by closest relative(s)
* and arterial ammonia concentration above 150 micromol/L or clinical suspicion of cerebral edema
* and an ICP-measuring device

Exclusion Criteria:

* no or withdrawn informed consent
* pregnant or breast feeding women
* uncontrollable infection
* hemodynamically instable patients
* active bleeding
Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.

Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase the incidence of arrythmia, especially in cardiac patients. We postulated that dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia during cardiac surgery. Furthermore, dexmedetomidine have been reported to have cardioprotective effect with previous animal studies.

Therefore, the aim of the present study is to investigate whether the intraoperative dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also trying to compare these effects with those of remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* Those undergoing off-pump coronary artery bypass graft during March, 2012 \~ February, 2013 in Samsung Medical Center
* Age between 20 and 70 yrs old

Exclusion Criteria:

* Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
* Patients with recent exogenous steroid administration or previous diuretics therapy