cyrilzakka/clinical-trials huggingface dataset:
Tuned App Self-Fitting vs. Professional Fitting

The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females, 18 years and older.
* Mild to moderate sensorineural hearing loss.
* Own and able to use a smart phone (Android or iOS).
* Able to read and understand Hebrew.

Exclusion Criteria:

* Conductive mixed hearing loss.
* Unilateral hearing loss.
* Any external or inner ear malformations.
* Symptoms of ear disease or excessive cerumen.
A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People

This five arm feasibility study aims to promote self-management in strength and balance exercises among community-living older people. The research process, implementation strategies and procedures, acceptability of the exercise programs, perceived benefits of the programs, and the ecological validity, acceptability and ability to detect change of possible outcome measurements will be evaluated before a future randomized controlled trial. A comparison of two exercise programs will be performed; a) Safe Step, a mobile technology based exercise program with motivational strategies, developed by researchers in collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises presented in a booklet. The older participants will be free to select either of the intervention programs and the selection process and outcome will be studied as part of the process evaluation.

The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be recruited through advertisements in local papers and through posters and meetings at senior citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants will be recruited from health care centres and their registered professionals with experience of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10 participants in each, will be exercising for four months and will undergo testing at baseline, after two and four months and they will be asked to keep an exercise diary (digital or paper format) during the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Independently living
* Able to rise from a high chair
* Able to stand without support
* Experience an impaired balance

Exclusion Criteria:

* Progressive disease that impairs mobility
* Dementia diagnosis
* Intense exercising more than 3 hours / week
Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury

The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . It is Whether the best amount of replacement fluid for Chinese people, it is unclear. Especially,there is little evidence about the optimal dose from randomized trials in Cardiac surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14 days, 28 days, 90 days survival and renal function.

Acute kidney injury (AKI) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. However, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with Cardiac surgery-associated acute kidney injury (CSA-AKI) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg／h),The primary study outcome was death from any cause within 14, 28 and 90 days.

Eligibility Criteria:
Inclusion Criteria:

* \> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery

Exclusion Criteria:

* \< 18 years old,
* with chronic kidney disease,
* dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,
* all causes kidney damage (pathology, hematuria, and radiographic abnormalities)\> = 3 months or glomerular filtration rate \< 60ml/min for 3 months or more.
High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER) and Weight Loss

This study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.

Increasing the protein consumption promotes weight loss through several mechanisms. Diets high in protein promote energy expenditure through increased postprandial thermogenesis, increase total daily expenditure and increase satiety as compared to carbohydrate. The present study aims to evaluate the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.

Eligibility Criteria:
Inclusion Criteria

* Age 25 to 60 years
* Body mass index (BMI) ≥ 25 kg/m2 to 40 kg/m2
* Subjects who have stable weight, i.e. who have not had more than ± 3 kg variation in their weight level in the 3 months prior to screening for this study.
* Absence of significant disease or clinically significant medical history or physical examination during screening in the view of the investigator.
* Subjects willing to provide written inform consent to participate in the study.

Exclusion Criteria

* Body mass index (BMI) \> 40 kg/m2
* Any patient taking/requiring drugs known to effect insulin resistance, lipids, vascular reactivity, during the intervention period would be excluded from the study
* Patients on any drugs that change the weight or in conditions where dietary protein supplementation is contraindicated
* Subjects who are consuming a high protein diet on randomization, to be excluded
* Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc
* Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs
* Pregnancy \& lactation
* Patients having diagnosed with any of the following:

  * Type 2 diabetes mellitus
  * Cushing's disease
  * Severe end organ damage
* Unwillingness to give written informed consent for participation in the study
Pre vs Post Block in Total Knee Arthroplasty (TKA)

The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee arthroplasty can be observed with the substitution of a post operative adductor canal block for a preoperative adductor canal block in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).


Eligibility Criteria:
Inclusion Criteria:

1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent

Exclusion Criteria:

1. All patients under the age of 18
2. Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women planning on becoming pregnant in the next year, and women who think they might be pregnant.
3. Patients with prior surgery or history of infection on the joint of interest.
4. Patients on steroid preoperatively.
5. Inability to provide medical consent.
6. Patients with a history of significant unmitigated pain in parts of their body not including the knee the procedure is to be performed or a history of pain catastrophizing (the tendency to magnify the threat value of the pain stimulus and to feel helpless in the context of pain, and by a relative inability to inhibit pain-related thoughts in anticipation of, during or following a painful event) regarding pain anywhere in the body.
7. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
8. Allergy to local anesthetic or any medication used in the standard protocol for joint replacement.
A Study of Ranolazine in ALS

The purpose of this study is to evaluate safety, effect on cramps, function and quality of life of ranolazine versus placebo for the treatment of ALS.

A prospective, multi center, double-blind, placebo-controlled, parallel group study of 2 doses of ranolazine (500 mg and 1000 mg twice daily) compared to placebo in patients with ALS.

Approximately 72 adults with ALS will be enrolled into the study in the United States at approximately 7 ALS treatment sites.

Participants will take oral ranolazine or placebo twice daily, attend a minimum of 5 onsite research visits, and 4 remote research visits.

The study is estimated to last 28 weeks for each participant.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with clinically definite, possible, probably, or lab-supported probable ALS per revised El Escorial criteria
* Breathing assessment called forced vital capacity (FVC) greater than or equal to 50%.
* Able to swallow pills at the start of the study and expected to for the length of the study.
* If on ALS modifying medications must be on a stable dose at least 30 days.
* Experiencing 4 or more cramps per week during a 2-week screening period.

Exclusion Criteria:

* Disease duration \< 5 years
* Tracheostomy invasive ventilation, or noninvasive ventilation of more than 12 hours/day
* Pregnant or lactating, adults unable to consent, and prisoners
* Taking ranolazine or investigational drug or has received an investigational drug within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening
* Medically uncontrolled comorbidities (heart, liver, kidney disease)
* Baseline QTc interval prolongation \>450 ms for men/ \>470 ms for women, history of long QT syndrome, or medications which prolong the QT interval
* Participation in an experimental drug trial less than 30 days before screening
* Patients have to be on a stable dosage of any medications used to treat muscle cramps for ≥30 days or have been off these medications ≥30 days prior to randomization.
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma

This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.


Eligibility Criteria:
Inclusion Criteria:

* \< 21 years of age at original diagnosis
* histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
* evidence of tumor recurrence or progression by MRI or contrast CT
* Karnofsky and Lansky performance status of 0,1 or 2
* life expectancy of greater than or equal to 2 months
* adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
* absolute neutrophil count (ANC)\> 1000/uL
* platelet count \> 100,000/uL (transfusion independent)
* serum creatinine \< 1.5 x normal for age
* written informed consent signed by subject and/or subject's parent/legal guardian

Exclusion Criteria:

* not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
* chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
* less than 7 days since the completion of therapy with a biologic agent
* less than 2 months since cranial/spinal radiation
* receiving a stable dose of dexamethasone for less than one week
Meditation and Youth Mental Health

Youth is a crucial time of life when physical and mental well-being is critical. Students are vulnerable due to academic and pandemic stresses. Meditation research has been showing effects on improved parameters of mental health (sleep quality, attention, memory, and concentration), emotional wellbeing (reduced stress and anxiety), and physiological parameters (better metabolism, circulation, immunity, etc.), which influence the life and academic performance of students. This study is designed to examine the feasibility of conducting a meditation intervention among students of a small liberal arts university in Pakistan. Future larger and longer randomized controlled clinical trials on high-risk youth may be planned at a later stage to see the impact on academic performance and career progression.


Eligibility Criteria:
Inclusion Criteria:

* Healthy students

Exclusion Criteria:

* Students suffering from a serious illness
* Students already meditating regularly
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis Generalized Anxiety Disorder
* HAM-A score \>=18 and HAM-D (item 1) score \>=2 at screening and baseline
* Needs pharmacological treatment

Exclusion Criteria:

* Current or past diagnosis of any other DSM IV Axis I disorders
* A history of failed treatment with a benzodiazepine
* Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following

The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.


Eligibility Criteria:
Inclusion Criteria:

* ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
* CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
* Geographically stable patients who are available for follow-up at a study centre
* Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

* Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
* Patients currently requiring dialysis
* Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
* Enrolled in any concurrent study
* Patients implanted with the following leads which will not be abandoned:
* Atrial or right ventricular unipolar leads
* Patch defibrillation leads
* Non-compatible defibrillation leads (e.g. 5/6mm)
Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study

The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.

Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.

Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.

Research design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure \>140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.

Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.

Discussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.

Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension subjects, aged 18-70 years, blood pressure \> 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.

Exclusion Criteria:

* Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.
Assisted Exercise in Prematurity; Effects and Mechanisms

Briefly our study is looking at the effects of 4 weeks of assisted exercise on the body composition and neurological/behavioral development of healthy growing premature infants enrolled between the ages of 30-33 weeks. It is a blinded study where the active group gets the exercise intervention and the control group is cuddled for the same amount of time -approximately 20 minutes. We get baseline data using muscle ultrasound, bone speed of sound and DEXA. We also get baseline blood samples to look at inflammatory mediators and growth hormone. Video of each subject is recorded an hour at two time points during the study to assess the babies for spontaneous activity. Nutritional intake information is collected daily and in the 4th week of the study assessments made for total energy expenditure using doubly labeled water. At this point in the study we repeat the ultrasounds and DEXA for comparison. Finally in the period just before discharge we do a complex neurological exam using the Brazelton NBAS assessment.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at post menstrual ages of 23-33 weeks gestation Enrollment occurs at post menstrual age of 30 to 35 weeks.if their projected stay based on standard clinical criteria is four weeks after enrollment
* Enrollment occurs at post menstrual age of 30 up to 35 weeks, if their projected stay based on standard clinical criteria is 4 weeks after enrollment.
* Birth weight appropriate for gestational age (AGA) using current CDC growth charts. AGA is defined as plus or minus 2 standard deviations above the mean or above the third percentile.
* Tolerating full enteral feeds at greater than or equal to 100kcal/kg/day

Exclusion Criteria:

* Evidence of chromosomal or other major genetic abnormalities
* Existence of current diseases or syndromes including:

central nervous system or other neurological abnormalities chronic lung disease of prematurity requiring chronic use of corticosteroids, musculoskeletal diseases

* positive infant toxicology screen(urine) for drugs or alcohol
* Both parents are under the age of 18 years
* Babies with tracheostomy
* Babies receiving ventilator assistance with breathing
* Babies receiving IV fluids
The Efficacy of Scalp Block in Craniotomy

The aim of the study is to compare the effectiveness and safety of scalp block versus intravenous fentanyl in pain control intraoperatively in craniotomy patients. Most of the previous studies compared the effect of scalp block versus fentanyl or opioids in postoperative pain

The history will be obtained from patient. The patients fasting 8 hours preoperatively will be examined and assessed, especially neurologically, to exclude any neurological deficit that may affect the results. Pre-operative laboratories will be reviewed for all patients as (complete blood picture, renal function tests, liver function tests, and coagulation profile) .

Patients will be assigned randomly by using a computer -generated table of random numbers, placing them in sealed envelopes, into two groups:

* Group A: (n= 10): patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr)
* Group B (control group): (n= 10): patients will receive general anesthesia then receive scalp block In the operating room, the monitor will be connected to track pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and heart rate (HR). A second recording will occur after induction. An IV cannula will be inserted, and an electrocardiogram (ECG) obtained.

Pre-oxygenation with 100% oxygen will last 3 minutes, followed by IV induction with Propofol (2 mg/kg), Atracurium (0.5 mg/kg), and Fentanyl (1 mcg/kg). The patient will be placed on inhaled Isoflurane, and smooth intubation will be performed. Invasive blood pressure monitoring will be set up via the non-dominant radial artery, and a central venous line will be inserted in the internal jugular vein using ultrasound.

A scalp block will be done blindly for group B, while group A will receive Fentanyl (1 mcg/kg/hr) prior to Mayfield placement and skin incision. Throughout the operation, continuous monitoring of Electrocardiogram, Heart rate, invasive blood pressure (IBP), oxygen saturation and urine output will occur.

The scalp block will be performed under aseptic conditions by qualified personnel, with the patient in the supine position, using a landmark technique to target the relevant nerves for the blockage in group A.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60
* Physical status: ASA I and II
* Elective operation, under general anaesthesia,

Exclusion Criteria:

* ASA above ll
* Patients with known uncontrolled comorbidities such as hypertension or Diabetes Mellites
* Coagulopathy, use of anti-coagulant or anti-platelet therapy.
* Known allergies to drugs used (Bupivacaine)
* Infection at the site of injection
* History of cranial nerve affection
* Emergency craniotomy.