cyrilzakka/clinical-trials huggingface dataset:
Criteria and Potential Predictors of Severity in Patients With COVID-19

This is an observational cross sectional study included 202 patients diagnosed to have COVID-19. The study was conducted at Zagazig University Isolation Hospitals from the period of March 2020 to June 2021. The study was approved by Zagazig University Ethics Committee (number 9229). A written informed consent was obtained from all participants.

Inclusion criteria:

The study includes laboratory confirmed COVID-19 patients (confirmed by real-time polymerase chain reaction) admitted l during the period of the study.

The patients were classified into two groups, group A included mild/moderate cases, group B included severe/critical cases according to the following criteria.

Severity of COVID-19 was graded as follows: mild; mild clinical symptoms, no pneumonia on lung CT; moderate: fever, cough and lung CT with pneumonia; severe: respiratory distress (respiratory rate \> 30 /min, oxygen saturation (O2Sat) ≤ 93 percent at rest and/or ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤300 mmHg (PaO2/FIO2); and critical: aforementioned criteria of respiratory failure receiving mechanical ventilation, shock, and/or organ failure other than lung and/or intensive care unit (ICU) hospitalization.

All participants were subjected to full history taking including smoking history and comorbidity profile. Clinical symptoms including: fever, cough, dyspnea, myalgia, hemoptysis, sore throat, diarrhea, loss of smell and anorexia were recorded. Radiological assessment by initial chest x ray then CT chest as possible and appropriate. Routine laboratory investigations: Complete blood count (CBC), coagulation profile, serum biochemical tests (including renal and liver function, and electrolytes), laboratory investigation to assess severity of COVID-19: lactate dehydrogenase (LDH), myocardial enzymes (CPK-MB), serum ferritin, D dimer and arterial blood gases analysis. Patients were followed up for the need for ICU and mechanical ventilation (MV), duration till conversion, total length of stay and final outcome whether survived or died were recorded.


Eligibility Criteria:
Inclusion Criteria:

* laboratory confirmed COVID-19 patients (confirmed by real-time polymerase chain reaction) admitted during the period of the study.

Exclusion Criteria:

* age less than 18
* refusal to participate
* referral to other hospital within 24 hours of admission
* missing data registry
Closed-loop Fluid Administration System: Pilot Study to Evaluate Feasibility

The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.

The optimization of the cardiac output is an important goal during anesthesia to decrease the postoperative morbidity, mortality and the care costs.

We want to test if the closed-loop fluid administration is feasible.

Two groups will be compared. In all cases:

* anesthesia will be provided by a closed-loop which aim is to maintain bispectral index between 40 and 60 using propofol and remifentanil. This method permits to have similar depths of anesthesia in all cases.
* cardiac output will be continuously monitored by LidCO. In one group, fluid replacement is decided by the physician; in the other, fluid replacement is automated using a closed-loop system.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-75 years
* Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
* Consenting to participate in the study

Exclusion Criteria:

* Pregnant, breast feeding women
* Allergy
* Pacemaker
* Psychiatric disease, dementia, brain disease
* Contraindication to hydroxyethyl starch
* Inability to measure pulse pressure variability : arrhythmia, spontaneous breathing, or tidal volume \< 7 ml/Kg
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation

Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF defined as a sweat chloride value greater than or equal to (\>=)60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis.
* Heterozygous for the F508del-CFTR mutation and with a second CFTR mutation that is not likely to respond to VX-661 and/or ivacaftor therapy, genotype to be confirmed via assessment at the Screening Visit.
* Forced Expiratory Volume in 1 Second (FEV1) \>=40 percent (%) and less than or equal to (\<=)90% of predicted normal for age, sex, and height at Screening Visit.

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug).
* History of solid organ or hematological transplantation.
* Ongoing or prior participation in an investigational drug study or use of commercially available CFTR modulator within 30 days of screening.
* Pregnant or nursing females.
NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization

The contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for CIN by their antioxidant effects.There have been no study to compare these two antioxidant.

N-acetylcysteine and ascorbic acid may prevent the CIN in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of these two antioxidant. We studied to find which of the two antioxidants is more beneficial in prevention of CIN

Eligibility Criteria:
Inclusion Criteria:

* Stable Angina pectoris patients
* Patients who required the coronary catheterization
* Creatinine clearance rates =\<60 mL/min using the Cockcroft-Gault formula
* Age of 19 or over 19

Exclusion Criteria:

* Pregnancy
* Lactation
* Having received contrast media within 7 days of study entry
* Emergent coronary angiography
* Acute renal failure
* End-stage renal disease requiring dialysis
* History of hypersensitivity reaction to contrast media
* Cardiogenic shock
* Pulmonary edema
* Multiple myeloma
* Mechanical ventilation
* Parenteral use of diuretics
* Recent use of N-acetylcysteine
* Recent use of Ascorbic acid
* Recent use of statin
* Use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.
Dendritic Cell Vaccine for Head and Neck Cancer

This research study is testing a new treatment of cancer of the head and neck.

Purpose

This research study is being done to:

1. Test the safety of the experimental cancer vaccine made of dendritic cells. An experimental vaccine is one that is not approved by the Food and Drug Administration (FDA).
2. To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer.
3. To learn if the vaccine will stimulate your body's white blood cells, which are part of your immune system (your body's natural defense system).

White blood cells are part of the body's defense system. Sometimes when you have cancer, your body does not know that the cancer cells are making you sick. We hope to teach your white blood cells to find and destroy your cancer cells with a vaccine. The vaccine will be made from a special kind of blood cell called a dendritic cell. This is the cell that will carry the information about your cancer to your white blood cells in your body.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma of the head and neck in patients with unresectable recurrent disease or distant metastasis or patients who fail conventional radiation therapy and/or chemotherapy and refuse surgical salvage.
* Presence of cervical metastasis that is able to be accessed for injection
* Biopsy accessible tumor (metastatic or primary)
* \>18 years of age.
* The following laboratory values obtained ≤14 days prior to registration:

  * ANC ≥1500
  * PLT ≥100,000
  * Hgb ≥ 9.0 g/dL
  * Alkaline phosphatase ≤3 x UNL
  * AST ≤3 x UNL
  * Creatinine ≤1.5 x UNL
* Life expectancy ≥6 months.
* ECOG performance status 0, 1, or 2.
* No chemotherapy for prior 4 weeks.

Exclusion Criteria:

* Pregnant women.
* Nursing women.
* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device {IUD}, abstinence.)
* Known HIV infection.
* Concurrent use of systemic immunosuppressants.
* Other immunocompromising condition that in the opinion of the physician renders the patient a poor candidate for this trial.
* Other active cancer requiring therapy to control the disease.
* Unwillingness to return for follow-up evaluations over a period of up to 2 years following completion of protocol therapy.
* Other intercurrent medical problems that, in the opinion of the investigator, would make participation in the study hazardous for the patient
* Patients in whom the otolaryngologist, radiation oncologist, and medical oncologist can not agree on a consensus node to treat.
* Patients with CNS metastasis or involvement of sites where an inflammatory response would constitute an immediately life threatening situation.
Effects of Therapeutic Tapping in Primary Dysmenorrhea

Dysmenorrhea is more common among women of reproductive age, as it affects their quality of life and limit their daily activities and normal functioning. The estimates of dysmenorrhea from research conducted all around the world varied widely, from 20% to 90%. This study is planned to determine the effects of KT on clinical symptoms, QOL and academic performance of students with Primary dysmenorrhea.

Literature suggested that kinesio tape technique, one of the effective physiotherapy technique, used for Primary dysmenorrhea, to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. This will be a randomized controlled trial, with three groups.

Participants in the experimental group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament with general physical therapy session. Sham group (ST) group will receive sham taping with general physical therapy session. Participants in Control group (CG) will receive only general physical therapy session.

All groups will be assessed at baseline, at 8th week and 12th week for clinical symptoms, QOL and academic performance.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women with Primary dysmenorrhea
* Aged between 18 and 25 years.
* Having a regular menstruation cycle (28 ± 7 days)
* Severity of menstrual pain on VAS: 4 and over in the previous 6 months.

Exclusion Criteria:

* Secondary dysmenorrhea
* Childbirth, pelvic surgery, use of an intrauterine device,
* Malignant condition
* Chronic medication; antidepressants or oral contraceptives for at least 6 months prior to study
* Not volunteering to participate in the study
* Having an allergy to K.
Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study

This study evaluates biofeedback delivered through a smartphone as a treatment for migraine in adolescents. Three out of four participants will receive treatment as smartphone delivered biofeedback training, and one out of four participants will receive treatment as a sham-biofeedback app.

Biofeedback is a behavioral treatment without known side effects. In biofeedback patients learn control over bodily reactions through feedback visualised on a screen. Typical bodily reactions that are displayed is heart rate and muscle tension. Biofeedback has for decades been considered as effective preventive treatment of migraine among children and adolescents. In spite of that, it is not available to most patients in need. This is most likely because it requires specialised stationary equipment and a trained therapist.

In this project, the researchers have developed a new smartphone biofeedback app connected to wearable, wireless sensors measuring muscle tension, finger temperature and heart rate. The app and sensors will be used to deliver biofeedback treatment to adolescents suffering for migraine. The goal of the study is to investigate the effect of the biofeedback treatment and the sham-biofeedback treatment on migraine headaches.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of migraine with or without aura according to ICHD-3
* two to eight migraine attacks per month
* written informed consent signed by guardians, or by adolescent if age between 16-18 years.

Exclusion Criteria:

* participant not speaking Norwegian
* reduced sensibility, hearing or vision to a degree that impairs proper use of the app
* serious psychiatric or neurologic disease and
* currently using migraine prophylaxis.
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.

PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.

OBJECTIVES:

* Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
* Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
* Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
* Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
* Determine the cost effectiveness of this regimen in these patients.

OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral dutasteride once daily on days 1-14.
* Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.

After completion of study procedures, patients are followed at 1 day.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Suspected prostate cancer due to 1 of the following criteria:

  * Prior abnormal digital rectal exam
  * Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days
  * PSA velocity \> 0.75 ng/mL/year
* Must be planning to undergo a transrectal ultrasound with biopsy

PATIENT CHARACTERISTICS:

* Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy
* Must not be clinically unstable, severely ill, or moribund

PRIOR CONCURRENT THERAPY:

* More than 30 days since prior biopsy of the prostate
* More than 1 week since prior acetylsalicylic acid or blood thinner
* More than 30 days since prior participation in a clinical trial involving an investigational drug
* No prior therapy for prostate cancer
* No other concurrent 5-alpha reductase inhibitor
Community Active and Healthy Families

To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using pre/post design will be conducted.

The hypothesis is that children participating in Community-AHF will demonstrate a reduction in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with pre-intervention

To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using a pre/post design will be conducted.

As this is a pilot study, the study will not be powered to detect statistically significant differences pre- and post- intervention. The investigators will measure the average change in %BMIp95 between baseline and completion of the Community-AHF active phase. Without a counterfactual (control group) the investigators will not be able assign responsibility to Community-AHF for any observed improvements. Change in %BMIp95 across the study period will provide data to test our hypotheses and will inform statistical power analyses for a subsequent trial. This pre- and post-intervention data is ideal for generating sample size estimates for a larger randomized control trial in the same population.

The investigators will conduct within-individual analyses for each outcome of interest. The investigators will only analyze participants who contribute pre and post measures in order to avoid biases that can occur when analyses are conducted with all available data. For each outcome for which a participant contributes pre and post measurements, the investigators will calculate pre and post means, standard deviations, differences in means and the p-value of the difference. The investigators will conduct preliminary analyses of outcomes according to subgroups defined by rate of attendance at intervention sessions. If adequate data are available, the investigators will explore the possibility of a nonresponse analysis.

Eligibility Criteria:
Inclusion Criteria:

* Child age 5-12 years with Parent/Caregiver age of 18 or more years
* Child BMI \>/= 85th percentile for age
* Parent is foreign-born, self identifies as Latino/Hispanic and speaks Spanish
* Parental commitment to participate in a 4-month intervention

Exclusion Criteria:

* Child health condition that prevents diet modification or engaging in physical activity
* Child BMI \>40kg/m2
Optimizing Cognitive Remediation Outcomes in Schizophrenia

The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.

The purpose of this study is to explicitly and aggressively drive an optimal response to neuroplasticity- based cognitive remediation in schizophrenia in order to maximize treatment response. We will investigate factors that have generally been ignored in computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless we fully understand and harness these factors, we will not achieve meaningful treatment gains for individuals with schizophrenia.

Our specific aims are:

1. To perform an RCT in which 100 schizophrenia subjects are assigned to either 60 hours of neuroplasticity- based computerized targeted cognitive training (TCT) that focuses exclusively on "cold cognition" (a program which trains early sensory processing, attention, working memory and cognitive control in auditory and visual domains), or to 60 hours of training that combines the TCT program with 20 minutes per day of adaptive computerized social cognition training (SCT) exercises.
2. To compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome.
3. To assess subjects six months after the intervention to determine the durability of training effects.
4. To identify changes in brain activation patterns in key neural regions as a result of TCT alone vs. TCT+SCT: during reward anticipation, and during emotion recognition.

The timeliness of this approach is supported by recent evidence demonstrating only weak associations between traditional cognitive remediation approaches and functional outcome in schizophrenia, but a strong, direct relationship between social cognition and functional outcome. Thus we must now examine the clinical, functional, and neural effects of a well-designed state-of-the-art cognitive training program that combines neurocognition with social cognition training.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia or schizoaffective disorder
* Between 18-65 years of age
* Clinically stable
* Fluent in English

Exclusion Criteria:

* Recent hospitalization, in the past 3 months
* History of traumatic brain injury
* Neurological disorders
* Inability to participate in the study soberly