cyrilzakka/clinical-trials huggingface dataset:
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet

A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 21 and 64 inclusive. For female subjects only: Female subjects will be included if they are post-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 4 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening.
* Good health on the basis of pre-study history and physical examination, vital signs and the results of blood chemistry, hematology, and urinalysis
* Good binocular visual acuity, corrected or uncorrected
* Possession of valid driver's license for 3 years or more
* Driving experience at least 3000 km/year
* Signed informed consent

Exclusion Criteria:

* A history of drug addiction or drug or substance abuse, including alcohol abuse, within the past 12 months
* Has a history of restless legs syndrome, sleep apnea, narcolepsy or other primary sleep disorder
* A known hypersensitivity to zolpidem or zopiclone
* Has undergone oral surgery, tooth extraction or piercing of the lip/tongue within 60 days prior to screening
* Has used any medication to promote sleep, including herbal medications, within 14 days (or 5 half-lives of the drug, whichever is longer) prior to screening
* Prescription medications for other health conditions are allowed as long as the subject has been on a stable dose at least 30 days prior to screening
* Has taken any drugs known to induce hepatic drug metabolism (i.e., rifampin) within 30 days prior to screening
* BMI \> 29 Kg/M\^2
* Current use of medication that affects driving performance
* Smokes more than 10 cigarettes/day
* Uses tobacco products during periods of nighttime awakening
* Consumes more than 6 cups of coffee/day
* Consumes more than 21 glasses of alcohol/week
* Has received an investigational drug within 60 days or 5 half-lives (whichever is longer) prior to screening
* Has any additional condition(s) that in the Investigator's opinion would:

  * Affect sleep/wake function
  * Prohibit the subject from completing the study
  * Not be in the best interest of the subject to participate in the study
Evaluation of a Video Game for Adolescents and Young Adults With Cancer

The purpose of this study is to determine the effects of playing the interactive video game, Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care behaviors, quality of life, stress, communication, control, and knowledge.

POPULATION: Approximately 340 patients will be enrolled in this study. Patients will be 13 to 29 years of age with any cancer (original diagnosis or relapse), currently receiving treatment and expected to be on treatment for at least 4 - 6 months following Baseline assessment, and able to communicate effectively in English, Spanish, or French. Approximately 170 patients will be enrolled in each of the two treatment groups. Each group will receive either the "Re-Mission" video game and a popular interactive video game, or just the popular interactive video game.

DESIGN: This is a multi-center, randomized trial, with patients randomized to one of two groups. One group (50% of patients) will receive the active intervention, which is the psycho-educational video game module called Re-Mission and a popular video game (hereafter "RE-MISSION") and another group (50 % of patients) will be in a game control group and receive a popular video game only (hereafter "GAME CONTROL. The games in the RE-MISSION and GAME CONTROL groups are delivered on identical mini, personal computers (hereafter "Mini-PC").

INTERVENTION: Each patient in the RE-MISSION group will be asked to play "Re-Mission" along with the popular video game for at least one hour a week for a period of ten to fourteen weeks. "Re-Mission" presents a 3-D environment in which the player can manipulate a humanoid character inside the virtual body of a patient with cancer. Game-play consists of guiding the character to destroy cancer cells and other "enemies" in the body (e.g., bacteria) while avoiding injury or weakness. During the process of playing the game and guiding the character through a series of missions, the player learns about chemotherapy and other medical treatments, health-promoting self-care behaviors, infections, and pain management. In addition, the game has also been designed to facilitate the patient's ability to share knowledge and concerns with others.

DURATION OF STUDY: 9 -12 months

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient 13 to 29 years of age with a cancer diagnosis.
2. Patient who is currently receiving treatment and is expected to remain on treatment for at least 4 - 6 months.

Exclusion Criteria:

1. Patient who has a history of seizures due to photosensitivity.
2. Patient who has been determined by the investigator to be incapable of following the study schedule or study directions for any reason.
3. Patient who can not communicate effectively with study personnel in English, Spanish, or French.
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting

This randomised, controlled clinical trial aims to evaluate the safety and efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring surgical revascularization. The main questions to answer are:

* Does cardiac shockwave therapy, in addition to CABG surgery, improve left ventricular ejection fraction?
* Is cardiac shockwave therapy in addition to CAGB surgery safe?

Participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.

This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).

Eligibility Criteria:
Inclusion criteria

* Male or female patients between 21 and 90 years of age undergoing primary coronary artery bypass grafting
* Presentation with reduced left ventricular function, defined as LVEF ≤ 40% measured by cardiac MRI
* Presentation with regional left ventricular wall motion abnormalities
* Written informed consent from the patient for participation in the study

Exclusion criteria

* Significant concomitant aortic valve disease requiring surgical treatment (other than significant aortic valve disease not detected in preoperative cardiac ultrasound but detected during surgery)
* Serious radiographic contrast allergy
* Patient in cardiogenic shock or presenting with acute myocardial infarction (STEMI or NSTEMI)
* Patient with a contraindication for cardiac MRI
* History of significant ventricular arrhythmia, other than MI-associated arrhythmia
* Comorbidity reducing life expectancy to less than one year
* Presence of a ventricular thrombus
* Presence of a cardiac tumour
* Pregnancy
Coherence Imaging of the Cervical Epithelium

The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.


Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

* pregnant
* using an intrauterine device (IUD)
* have a current gynecological infection or discharge
* have had any cervical surgery
* had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
* currently enrolled in any research studies involving the application of vaginal formulations
* employed or supervised by the study investigators
* have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study
Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)

The study will examine the resting energy need (REE) in patients suffering from brain damage. For the measurement of REE will be used a metabolic computer (which with continuous recording of breath-to-breath volume (Vt), respiratory rate (RR) of ventilation per minute volume (MV) ), of inhaled and exhaled gases (O2 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ.

This is a retrospective observational study concerning patients suffering from brain damage.

All the patients suffering from brain damage are monitored in order to examine their resting energy needs (REE). For the measurement of REE the metabolic computer (Medical Graphics, Ultima CCM, Minneapolis, USA) is used.

The main purpose of this study is to reveal the (REE) changing in patients with brain death semiology and examine if the REE changes could be related to the outcome of a patient with intracranial pathology. Moreover the study will examine if the changes in REE measurement are related to changes in flow velocities in the midbrain.

Any measurement shall be preceded by calibration of the metabolic computer pneumotachograph with a 3-liter syringe with an acceptable error of less than 9 ml / lit. The metabolic unit is calibrated for VO2 measurements with two calibration cylinders containing 21% and 12% O2 and for VCO2 measurements with calibration gases containing 5% and 0% CO2 respectively.

The measurement of flow velocities in the middle cerebral artery will be done with the transcranial Doppler using a low frequency (2 MHz) ultrasound head After their final diagnosis (brain death or not) the patients' characteristics will be compared according to the categorization as "brain dead" or not.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients entering the ICU
* Age 18-90 years old
* Clinical Diagnosis of brain damage
* GCS \<=8

Exclusion Criteria:

* Patients \<18 years old and \>90 years old,
* Past history CNS disease (alzheimer's disease, multiple sclerosis, brain tumor, aneurysm) in the last 3 years
* Past history of cachexia due to cancer
Cerebrospinal Fluid Congestion in Spinal Stenosis Patients

The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.


Eligibility Criteria:
Inclusion Criteria:

* neurogenic claudication more than 3months
* relief neurogenic claudication by lumbar flexion
* spinal stenosis symptom by physical exam.
* who can walk more than 30 min.

Exclusion Criteria:

* vascular claudication by physical exam.( ABI \<0.9)
* structural change in vertebral ( tumor, congenital deformity)
* operation history at spinal bone
* metallic foreign body
* peripheral polyneuropathy
Allocating Resources for Cancer Care in Times of the Sars-CoV-2 Outbreak. Health Care Research

The focus on treatment of COVID19 patients during the Sars-CoV-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-COVID19 patients. Medical care of cancer patients is a particularly sensitive area. To draw holistic conclusions, it is necessary to analyze the provision of healthcare as broadly as possible with regard to the dimensions of access, processes and outcome during the Sars-CoV-2 pandemic. This will be implemented exemplarily for the early detection, diagnosis and treatment of colorectal cancer (CRC) and pancreatic cancer (PaCa) in Saxony. Patients with diagnosis, treatment or early detection measures for type 2 diabetes (T2D), coronary heart disease (CHD) and multiple sclerosis (MS) serve as comparison groups.

For a realistic assessment, the situation will be compared with the situation before the Sars-CoV-2 pandemic while considering confounders and effect modifiers. The evaluation is based on pseudonymised routine statutory health insurance (SHI) data of the AOK PLUS for Saxony.

As data sources, SHI data of the AOK PLUS Saxony for the period 2015 to 4th quarter 2020 and publicly available data on COVID19 are used. The differentiation between incidence and prevalent diseases is based on a 4-year washout period, so that the health care situation can be compared between 2019 (pre-period) and 2020 (post-period). Patients with confirmed diagnoses of CRC and PaCa or early detection measures regarding CRC are investigated. These will be contrasted to patients with confirmed diagnoses of T2D, CHD, and MS or early detection measures regarding T2D.

The differentiation of subgroups as confounders or effect modifiers is taken into account. Subgroups are considered with respect to the factors age groups, gender, Elixhauser comorbidities, metastasis y/n, residential regions (postal code 3 digits), characteristics of the treating institution and possibly seasonal effects.

Aims:

Analysis of the differences in the health care provision situation during the Sars-CoV-2 outbreak compared to the time before.

Research questions:

1. (How) did the situation of health care for cancer patients change due to the outbreak of Sars-CoV-2? Which changes could be observed in the dimensions access to care, quality or guideline adherence in medical care and outcome?
2. Did the focus on COVID19 patients have an impact on the diagnosis or early detection of cancer in Saxony?
3. Are the observed effects differential with respect to the diseases, especially when comparing CRC and PaCa with the control group regarding T2D and CHD?

Eligibility Criteria:
Inclusion Criteria:

* Resident of Saxony, Germany with health insurance coverage provided by AOK PLUS
* Diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis between in 2019 or 2020 according to ICD-10

Exclusion Criteria:

* Change of health insurance provider between 2015 and 2020
* Born after 2014
* Deceased between 2015-2018
Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients

Clinically significant portal hypertension (CSPH) is defined as HVPG \>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \<12 mm Hg or reduction to \>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study

To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients.

• To determine the best cut off to define acute hemodynamic response in ACLF patients

Primary outcome - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF

Secondary outcome -

(1) Complications \[PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect\] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week

(b) Methodology

Study population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria

Baseline parameters that will be recorded:

1. Baseline characteristics:
2. History and etiology of liver disease
3. Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc)
4. Clinical and demographic profile
5. Endoscopy

Stopping rule of study:

1. Progression to exclusion criteria
2. In case of hypotension(\<90/60mmHg) or Heart Rate \<60 after carvedilol
3. Potential liver transplant within 90 days

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 yrs
2. ACLF diagnosis (AARC criteria)

Exclusion Criteria:

1. Contraindications to NSBB (Heart rate \< 65 /min, BP \< 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na \< 125meq/l)
2. PVT
3. HCC
4. BCS
5. HE grades 2-4
6. NSBB therapy within 5 days
7. Pregnancy
8. Lactation
9. Planned for LT in the next 12 weeks
10. No consent.
Protonics Knee Brace Versus Hamstring Resisted Exercise (HRE) on Individuals With Patellofemoral Pain Syndrome

ProtonicsTM Knee brace has been suggested as an intervention for patients with patellofemoral pain syndrome (PFPS). However, the effectiveness of this knee brace compared to traditional conservative methods knee rehabilitation is lacking. The objective of this randomized controlled trial was to compare the effect of ProtonicsTM knee brace vs. sports cord on knee pain and function in patients with PFPS.

The purpose of this graduate student research study was to compare the effect of ProtonicsTM knee brace vs. sports cord on knee pain and function in patients with PFPS.

Design: Randomized controlled trial.

Setting: Loma Linda University.

Participants: Subjects with patellofemoral pain will participate in the study.

Intervention: Subjects will be randomized to one of two treatment groups, the ProtonicsTM knee brace or the sport cord to complete a series of resistance exercises over the course of 4 weeks.

Main Outcome Measures: Both groups will be evaluated according to the following clinical outcomes: Anterior pelvic tilt (APT), hip internal/external rotation, and iliotibial band flexibility. The following functional outcomes were also assessed: Global Rating of Change (GROC) scale, the Kujala score, the Numeric Pain Rating Scale, and the lateral step-down test.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be males and females who have Patellofemoral pain symptoms for more than 1 month, have pain level ≥ 3 on a Numeric Pain Rating Scale, and pain during at least 2 activities, such as squatting, ascending/descending stairs, and/or running.

Exclusion Criteria:

* Subjects will be excluded if they have previous traumatic injuries to the knee joint/lower limbs, sign, and symptoms of meniscus tear or ligamentous-related pathology, neurological disorders and being on pain medication."
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.

After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus

Exclusion Criteria:

* children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy

Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today.

The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy.

Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In group I; propofol was discontinued during the dural closure. After the propofol was discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery. Time to awakening and extubation time, adverse events, total remifentanil and propofol consumptions and side effects were recorded. Heart rate and blood pressure were recorded during this period.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologist physical status I-II
* Glasgow Coma Scale score of 15 points
* Elective supratentorial craniotomy for tumor resection
* Supine position

Exclusion Criteria:

* Obese patient
* Brain tumor greater than 30 mm in diameter
* Postoperative cranial drainage
* Hypertension
* Diabetes mellitus
* Reoperation
* Pregnant
* Breast feeding
* Allergy to the study medications
* History of cranial radiotherapy
* Frontal bone flap
* Intraoperative neuromonitoring
Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients

This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients.

Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and nonpharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.

Eligibility Criteria:
Inclusion Criteria:

* Their age will ranging from eight to forty years.
* All cases participated in this study will from both sexes.
* All cases receiving chemotherapy as primary treatment, postoperative surgical removal of tumors or with conjunction with radiotherapy
* All cases have polyneuropathy caused by chemotherapy.

Exclusion Criteria:

* Patient with osteoporosis.
* Patient with DVT.
* Patient have a Pacemaker fitted
* Uncooperative patients