cyrilzakka/clinical-trials huggingface dataset:
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition of the abnormal environment of the heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney function after the heart surgery. This is turn can lead to longer times on the ventilator (breathing machine), the need for higher doses of heart medications, a longer stay in the intensive care unit and even death. This is particularly true in infants less than one month of age due to their size and the immaturity of their organs. The appreciation of the post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions directed at its reduction. No therapy has been recognized as the standard of care; however steroid therapy has been applied most often despite unclear evidence of a benefit. This study aims to determine if steroids improve the outcomes of babies undergoing heart surgery.

This study is a multi-institutional randomized double-blind placebo controlled trial of the use of glucocorticoids to improve the clinical course of neonates following cardiac surgery. Cardiopulmonary bypass (CPB) is critical to cardiac surgery, but the pathophysiologic processes engendered by CPB play an important role in post-operative recovery. The use, doses and schedule of glucocortiocoid administration to ameliorate these CPB induced processes is highly variable and without clear data to provide direction. The Primary Aim of this study is to compare the effects of intraoperative methylprednisolone to placebo on a composite morbidity-mortality outcome following neonatal CPB. Secondary Endpoints include: inotropic requirements, incidence of low cardiac output syndrome, fluid balance, ICU stay parameters, levels of inflammatory molecules, neuro-developmental outcomes, and safety parameters. The study will focus on neonates because their post-CPB clinical course is typically more severe, and that high level of severity itself provides a substrate for identifying the positive effects of a particular therapy. Finally, a therapy identified as beneficial has the greatest potential for benefit in this vulnerable population

Eligibility Criteria:
Inclusion Criteria:

* Age \< 1 month
* Male and female patients who are scheduled to undergo cardiac surgery involving CPB

Exclusion Criteria:

* Prematurity: \< 37 weeks post gestational age at time of surgery
* Treatment with intravenous steroids within the two days prior to scheduled surgery.
* Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization.
* Suspected infection that would contraindicate steroid use (eg - Herpes)
* Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (eg - gastrointestinal bleeding).
* Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization.
A Prospective Study of Post-operative Opioid Use in General Surgery Patients

Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills.

Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Patients will be given a patient report form which they will use to record the number of pills they take each day and their daily pain score on a scale of 0-10.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR
* an inpatient on the general surgery service who took at least one oral narcotic

Exclusion Criteria:

* allergic to all narcotics
* chronic opioid use
* history of opioid or benzodiazepine abuse
Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma

Temozolomide provided significant and clinically meaningful benefit in MGMT gene promoter methylation glioblastoma. However, in unmethylated patients, the effect of Temozolomide is limited. The aim of this study is to compare the effect of Cisplatin plus Temozolomide and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma

60 Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.

60 patients were randomly divided into two groups and compared the difference of efficacy between the two groups

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma no cerebrospinal fluid and distant metastatic disease. adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* younger than 18 years; with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities
An Absolute Bioavailability Study in Healthy Participants Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)

The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.


Eligibility Criteria:
Inclusion Criteria

* Within body mass index range 18.5 to 29.9 kilograms per square meter (kg/m\^2)
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
* Clinical laboratory evaluations within the reference range for the test laboratory
* Negative test for selected drugs of abuse at Screening and at each Check-in
* Negative hepatitis panel and anti-hepatitis C virus and negative human immunodeficiency virus (HIV) antibody screens
* Healthy males and females of non-child-bearing potential or who agree to use effective contraception

Exclusion Criteria

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, hernia repair, and cholecystectomy will be allowed
* History or presence of an abnormal ECG
* History of alcoholism or drug addiction prior to period 1 check-in
* Use of any tobacco-containing or nicotine-containing products prior to period 1 check-in
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days or 5 half-lives, whichever is longer, prior to period 1 check-in
* Use of any prescription medications/products, including proton pump inhibitors, within 14 days prior to period 1 check-in
* Poor peripheral venous access
* Any acute or chronic condition that would limit the participants ability to complete and/or participate in this clinical study
* Female participant is pregnant, lactating, or breastfeeding
* Predisposing factors to retinal vein occlusion (RVO)
TelePrEP for At-risk Youth in Colorado

Youth represent the largest proportion of new HIV infections in Colorado, reflective of their inadequate access and uptake of pre-exposure prophylaxis(PrEP)for HIV prevention. Colorado's 2019 HIV/AIDS Prevention Program state-wide review of PrEP barriers showed PrEP eligible individuals do not access PrEP services due to lack of interest, not wanting referral to a navigator, and low estimation of HIV risk. The overall goal is to provide youth at higher risk for HIV with an effective youth informed telemedicine delivery of PrEP (TelePrEP) that addresses PrEP barriers and contributes to ending the HIV epidemic in Colorado. The primary objective will be proportion of youth retained on PrEP 12 months after initiation. The hypotheses are that a TelePrEP model for youth will be acceptable and feasible and will result in successful initiation, persistence and retention on oral PrEP.


Eligibility Criteria:
Inclusion Criteria:

* HIV negative
* Eligible for PrEP using emtricitabine (F)/tenofovir alafenamide (TAF) (F/TAF) (brand name Descovy) based on current CDC guidance
* assigned male at birth
* has had male sex partners in the past 6 months (and not in a monogamous partnership with a recently tested, HIV-negative man) and
* either any sex without a condom in the past 6 months or
* a bacterial sexually transmitted infection
* Consents to TelePrEPvisits
* Willing to use current insurance coverage for clinic and laboratory services OR willing to be assisted to obtain insurance coverage OR eligible for other coverage such as Title X funds or charity care

Exclusion Criteria:

* HIV-infection or concern for acute HIV infection until ruled out
* Pregnancy
* Persons at risk through receptive vaginal sex including cisgender women and transgender men (persons assigned female sex at birth)
* Persons with only injection drug indications for PrEP without sexual risk indications outlined in inclusion criteria
Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study

COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date, no treatment has yet demonstrated Strong efficacy in treating the infectious disease (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy with high potential,due to higher local concentrations and minimal adverse effects. Type I interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19 than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators have a decrease in viral carriage and a rapid reversal. The purpose of this project is to assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen requirements of the addition of inhaled Interferon type I compared to the control arm .


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient with laboratory-confirmed SARS-CoV-2 infection as determined by PCR \< 96 h (at initial diagnosis or persistent carriage \<96 h)
* Hospitalized patient with COVID-19 requiring oxygen therapy

And targeting in phase B :

* Patients under oxygen therapy such as nasal cannula/mask or non-invasive ventilation with paO2/FiO2 \> 200 mmHg.
* Patients hospitalized for less than 7 days.
* Patients with symptoms for less than 10 days or RT-PCR (\<96h) with Cycle Treshold \< 25.
* Social security coverage
* signed informed consent (by patient or their legally authorized representative)

Exclusion Criteria:

* Hypersensitivity to natural or recombinant interferon-ß
* Hypersensitivity to human albumin or mannitol
* Recent suicide attempt
* Decompensation of liver failure
* age \< 18 years
* Pregnant or nursing.
* Patients managed on an outpatient basis (i.e. not initially hospitalized).
* Parenteral IFN treatment. In periode B, addition of new exclusion criteria
* Patients with kidney transplant
* Immunocompromised patients
* Patients with severe systemic disease constantly threatening their vital prognosis (ASA ≥ IV: e.g. severe ARF, advanced cancer pathology, recent myocardial IDM, severe valvular dysfunction, dependence on parenteral nutrition on central line, shock, sepsis, trauma, ...).
* Patients in septic shock.
* Patients with documented fungal infection.
* Patients on mechanical ventilation.
* Patients hospitalized for COVID-19 for more than 7 days.
Effect of Active Release Technique and Abdominal Drawing-Maneuver on Pain and Quality of Life in Patients With Chronic Low Back Pain

To determine the effect of active release technique and abdominal drawing in maneuver on pain and quality of life in patients of chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient with hamstring tightness\[9\]
* Subjects with pain between 4 and 7cm on visual analogue scale\[18\].
* Subjects having 20-40 age group are included in this study\[11\]
* Patients having pain for more than 3 month of mild-moderate intensity\[9\]

Exclusion Criteria:

* Patients with any spine injury\[11\]
* Lumber intervertebral disc fracture\[11\]
* Patients having any surgical history of spine\[11\]
* Spinal stenosis\[11\]
Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS score. These outcomes were measured at baseline, 2 weeks, and 16 weeks

The aim of the study is to test the effect of denervation of the active hip in JIA and compare it with a placebo without changing systemic treatment during the study. Outcome measures included pain, range of motion, SOLAR score, and Harris functional score.

Eligibility Criteria:
Inclusion Criteria:

* patients with JIA with unilateral hip arthritis

Exclusion Criteria:

* hip involvement due to other causes including
* septic arthritis
* other connective tissue diseases
* Avascular necrosis
Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.

The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized high-risk pregnant women in hospital for at least 7 days
* Diagnosed with gestational hypertension
* Diagnosed with preeclampsia (mild to moderate)
* Diagnosed with intrauterine growth restriction
* Single baby
* Expecting twins
* Expecting triplets
* Diagnosed with shortened cervix
* Diagnosed with threatened pre-term labour (not actively contracting)

Exclusion Criteria:

* Diagnosed with symptomatic placenta previa (bleeding)
* Diagnosed with severe pre-eclampsia (immediate delivery)
* Diagnosed with conditions indicating a short term hospital stays of less than 7 days
* Diagnosed with infections
* Diagnosed with heart and renal disease
* Diagnosed with diabetes
* Diagnosed with metabolic bone disease
* Diagnosed with hyper-or-hypo-thyroidism
* Diagnosed with Cushing disease and anemia
* Women carrying more than 3 babies
Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity

This study attempts to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia.

Accurate diagnosis for Greek speaking patients suffering from postoperative delirium is limited by the need for a translation of standardized tools that were investigated for their inter-rater reliability/agreement.

Our primary aim is to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia. Our secondary aim is to estimate the diagnostic accuracy of NuDESK in our population.

This study will provide the first official Greek translation of CAM and Nu-DESC, according to the ISPOR guidelines, and the first evaluation of their inter-rater agreement.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients over 60 years of age
2. an American Society of Anesthesiologists (ASA) physical status I to III
3. undergoing elective non-cardiac surgery under general anaesthesia
4. native speakers of the Greek language
5. eligible to leave the post-anaesthesia care unit
6. an expected in-hospital stay of at least 24 hours following surgery

Exclusion Criteria:

1. refused to participate or sign the informed consent form
2. surgery or anaesthesia within the last 30 day
3. any prior or current history involving an affliction of the central nervous system
4. severe hearing or visual impairment
5. psychiatric disorders
6. sa core less than 5 according the Geriatric Depression Scale (GDS-15)
7. a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
8. alcohol consumption less than 35 units/week
9. drug dependence
10. previous neuropsychological testing
11. haemodynamical instability
12. peri-procedural desaturation (one or more events of SpO2\<80% for more than 2 minutes)
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics

This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments.

Thiazide or thiazide-like diuretics associated hyponatremia (thiazide associated hyponatremia, TAH) has a high prevalence in hospitalized patients. Patients might present either with a hypovolemic hyponatremia due to volume loss as a diuretic effect of thiazide, or with a syndrome of inadequate antidiuresis (SIAD) like hyponatremia in need of fluid restriction. Canonical urine indices are not useful in differential diagnosis, being directly influenced by thiazide itself. Current guidelines suggest the use of a clinical volume status assessment, but this approach has a poor diagnostic performance, with less than 50% of patients being rightly diagnosed thru that. The investigators showed in a retrospective analysis the possible role of strong apparent ion difference (aSID) and of chloride and potassium levels in urine (ChU) in differential diagnosis of TAH. The goal of this study is to investigate prospectively whether implementation of aSID and, in case of inconclusive aSID, ChU, allows a correct differential diagnosis and treatment of TAH.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients presenting at University Hospital Basel
* aged 18 years or older
* able to give informed consent as documented by signature
* with serum sodium level \< 130 mmol/l and serum osmolality \< 300 mOsm/kg
* with treatment with thiazide or thiazide-like diuretic

Exclusion Criteria:

* symptomatic hyponatremia in need of 3% hypertonic solution or intensive care treatment
* inability or contraindications to undergo the trial (i.e., any acute severe cardiovascular event requiring an immediate intervention)
* decompensated liver cirrhosis CHILD C
* decompensated heart failure NYHA III or higher
* severe valve impairment
* untreated adrenal insufficiency
* severe kidney disease in need of dialysis
* pregnancy or breastfeeding
* end of life care
* inability to follow the study procedures (i.e., language problem, dementia or critical illness).
Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients

This study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding.

Enteral feeding has a vital role in the care of critically ill patients. It is considered a routine patients care in intensive care units. Enteral feeding is also a medical treatment as well as a part of nursing care. It is the preferred route of nutritional support in patients who are incapable of volitional intake. Additionally, it helps to stimulate peristaltic movements of the digestive system, improves blood supply, strengthens the immune system, improves recovery, and reduces physiological stress.

There are many complications associated with enteral feeding that can lead to an interruption of the feeding process, including gastrointestinal disorders, mechanical problems, fluid-electrolyte imbalance, and metabolic complications. Feeding intolerance is the most main digestive complication including nausea, vomiting, diarrhea, excess gastric residual volume, abdominal distention, and constipation.

Aspiration is also a significant side effect of delayed gastric emptying and increased GRV among CIPs. The Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition has recognized aspiration as one of the mutual complications of enteral feeding that should be evaluated before and during the feeding process. Consequently, prolonged ICU stays, and increased duration of mechanical ventilation, and mortality rate are side effects of feeding intolerance and aspiration. Additionally, abdominal massage is one of the complementary and alternative medicine which is significantly grown in recent years. Furthermore, it is an inexpensive, non-invasive intervention, and free from harmful side effects. Besides, it can increase the number of intestinal movements and lead to easier food movement along the gastrointestinal tract. In addition, it allows contraction of the diaphragm more fully, increases the capacity of the lung, and strengthens breathing.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are Full Outline of Unresponsiveness (FOUR) score is from 0-14 admitted to the previous ICUs who have nasogastric tube and within the first 24 hours from beginning enteral feeding will be included in the study.
* Age: adult CIPs ≥ 18 years.
* Gender: males and females.
* Negative gastric pH and glucose strip.

Exclusion Criteria:

* Gastric intolerance (delayed gastric empty).
* Patients who suffered from spinal cord injury, could not be properly positioned for massage due to severe trauma.
* Patients receiving prokinetic medications (to avoid interfering with the massage effects).
* Patients who have contraindications to abdominal massage such as ascites, abdominal aortic aneurysm, ileus, diarrhea, recent abdominal surgery, bleeding of GI, abdominal tumor, and undergoing radiotherapy.