cyrilzakka/clinical-trials huggingface dataset:
VR-based Remote Rehabilitation for Pediatric ABI

The primary objective of this study is to evaluate the feasibility and effectiveness of an at-home program of VR-based vestibular and oculomotor rehabilitation on improving postural stability, ocular motility and activities of daily living for children with mild to severe ABI


Eligibility Criteria:
Inclusion Criteria:

* They are ALYN patients undergoing physiotherapy for mild to severe ABI;
* They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility;
* They are between the ages of 8 and 18;
* The time since injury/event is between 10 days and 1 year after the injury/event;
* They are able to maintain stable and dynamic positioning of the head;
* They able to walk with or without assistive equipment, or use a wheelchairs with no need for head support, defined by a LSS (level of sitting scale) score of 3 or greater (scale range: 1-8);
* Are able to understand basic instructions;
* Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.

Exclusion Criteria:

* Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures;
* Untreated benign paroxysmal positional vertigo (BPPV);
* Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak);
* Hearing impairment.
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Males or female patients ≥ 55 years of age
* LVH as confirmed by echocardiogram
* Patients with high risk hypertension, currently treated or already taking antihypertensive medication

Exclusion Criteria:

* Renal artery stenosis
* Symptomatic heart failure or known ejection fraction \< 40%
* Myocardial infarction or stroke within 6 months
* Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
* Pregnant or lactating females
* Cancer within the last 5 years
Implementation of PrEP Care Among Women in Family Planning Clinics

This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants include ciswomen presenting at a PPIL health center with a positive STI test (syphilis, gonorrhea, or chlamydia) and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling.

Exclusion Criteria:

- Participants will be excluded if they are not PrEP eligible, have a negative STI test, or are not identified in the EHR.
Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria
* Participants resistant to or intolerant of hydroxyurea
* Participants with a phlebotomy requirement
* Participants with splenomegaly (palpable or non-palpable) and a spleen volume, as measured by MRI (or CT in applicable participants ), of greater than or equal to 450 cubic centimeters
* Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

* Women who are pregnant or nursing
* Participants with inadequate liver or renal function
* Participants with significant bacterial, fungal, parasitic, or viral infection requiring treatment
* Participants with an active malignancy within the past 5 years, excluding specific skin cancers
* Participants with known active hepatitis or HIV positivity
* Participants who have previously received treatment with a JAK inhibitor
* Participants being treated with any investigational agent
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids

This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables


Eligibility Criteria:
Inclusion Criteria:

* uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.

Exclusion Criteria:

* significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.
Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors

The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients.

Among the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.

Randomized controlled clinical study. All patients who survived COVID-19 and discharged from the intensive care unit of the Lecco hospital will be enrolled if present: chronic pain, anxiety, depression and/or insomnia in pharmacological therapy A group of patients will be observed during 12 months and evaluated with rating scales for chronic pain, anxiety, depression and insomnia.

The second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy

Eligibility Criteria:
Inclusion Criteria:

* Intensive care survivors
* Surviving COVID-19 patients
* Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy

Exclusion Criteria:

* Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
* Patients not hospitalized in intensive care for COVID-19
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity

The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.

One hundred pregnant women with obesity who are otherwise healthy will be studied from early pregnancy until approximately 2 weeks postpartum. Major assessments will occur at baseline (13-16 weeks gestation), 27-29 weeks gestation, 35-37 weeks gestation, and approximately 2 weeks postpartum. Safety assessments will be collected every 4 weeks after enrollment. Participants will be randomized within site (approximately 50 individuals at Pennington Biomedical Research Center and approximately 50 individuals at California Polytechnic University) and obesity to either: Provider Directed Group or Weight Maintenance Group.

Eligibility Criteria:
Inclusion Criteria:

* Are pregnant less than or equal to 15 weeks gestation at screening
* Have a body mass index between 31.0 and 55.0 inclusive
* Have a confirmed viable singleton gestation
* Willing to receive randomization to either group
* Willing and able to eat the study foods
* Willing to enroll infant for study measurements after birth
* Receive clearance from the prenatal care provider for participation

Exclusion Criteria:

* Smoking, drug, or alcohol use
* Have a known fetal anomaly
* Have a non-pregnancy related illness
* Have pre-existing diabetes
* Have pre-existing hypertension
* Have severe anemia
* Have current mental health issue or eating disorder
* Short inter-pregnancy interval (\<6 months since last pregnancy)
* Use of assisted reproductive technology
* Use of medications with known effects on body weight including over the counter medications and supplements for weight loss
* History of pre-eclampsia, prior small for gestational age infant, bariatric surgery
* Planning to move out of the area in the next 12 months
Determine the ED50 of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction

Dexmedetomidine can be used as a co-induction agent to facilitate laryngeal mask airway (LMA) insertion with minimal effect on respiratory function. The purpose of the study was to determine the median effective dose (ED50) of dexmedetomidine to facilitate LMA insertion during anaesthesia induction with propofol 2.0 mg/kg.

Dexmedetomidine is a highly selective α2 receptor agonist, which produces sedative, anxiolytic and analgesic effects without causing clinically significant respiratory depression. Dexmedetomidine also reduces the propofol requirement for sedation and anaesthesia induction. Therefore, dexmedetomidine may be a useful co-induction agent to facilitate LMA insertion with minimal effects on respiratory function. A recent study showed that dexmedetomidine administration prior to propofol induction provided similar conditions for successful LMA insertion, as does fentanyl without respiratory depression. The purpose of this study was to determine the median effective dose (ED50) of dexmedetomidine required for successful LMA insertion during induction with propofol of 2 mg/kg .

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.5～25

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA

Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed OSA (AHI ≥20/h)
* Patient is willing to start CPAP therapy
* ESS \> 10 points
* 18 years or above

Exclusion Criteria:

* Moribund or severe disease prohibiting protocol adherence
* Use of oxygen therapy or home ventilation
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR \< 15 mL/min)
* Pregnant patients
Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

This is the second phase of a study designed to determine the immunological effects of long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis (phase 2). The results indicate that six months of moderate intensity exercise reduces bone resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood mononuclear cells.

In a before and after trial involving 43 healthy adults the investigators measured the effect of six months of supervised exercise on the spontaneous and phytohemagglutinin-induced production of osteoclastogenic cytokines (interleukin-1α, tumor necrosis factor-α), anti-osteoclastogenic cytokines (transforming growth factor-β, interleukins 4 and10), pleiotropic cytokines with variable effects on osteoclastogenesis (interferon-γ, interleukin-6), and T cell growth and differentiation factors (interleukins 2 and 12) by peripheral blood mononuclear cells. The investigators also measured lymphocyte phenotypes, and serum markers of bone formation (osteocalcin), bone resorption (C-terminal telopeptides of Type I collagen), and bone homeostasis (estradiol, vitamin D2, testosterone, parathyroid hormone, insulin-like growth factor).

Eligibility Criteria:
Inclusion Criteria:

* Normal exercise treadmill test

Exclusion Criteria:

* Any medical condition that would prevent participation in a six month exercise program
Prevalence of Anatomical Variants of Dural Sinuses by MRV Evaluation in Sohag

The purpose of this study is to use the MRV to depict the prevalence of anatomical variants of dural venous sinuses in Sohag population, which can help to avoid potenital pitfalls in the diagnosis of dural venous sinus thrombosis, venous infarcts and venous hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.

Exclusion Criteria:

* Having the diagnosis of cerebral venous sinus thrombosis, congential or acquired intracranial abnormalities, ischemic or hemorrhagic stroke, intracranial hypertension, intracranial space occuping lesion, and previous head injury or neurosurgery, also patients with absolute or relative contraindications for imaging including claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder

Definition of the efficacy of NET compared with "treatment as usual" in the treatment of patients with complex traumatic disease (borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews. Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process of the specific therapy compared to treatment as usual.

Experimental intervention:

Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.

Control intervention:

Treatment as usual.

Follow-up per patient:

3 follow-up assessments- 4 weeks, 6 months,12 months and 24 months after end of experimental/ control intervention

Duration of intervention per patient:

Both treatment types will be conducted for 10-14 sessions of 60-90 min in length.

Additionally 5 sleep laboratory investigations (1 pre- and 4 post- intervention (4 weeks, 6 months, 12 months, 24 months after treatment)) will be carried out. Additionally the cortisol level in the hair and epigenetic markers will be recorded. The estimated observation time is 2 years.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV -TR Diagnosis axis II: borderline personality disorder; axis I: posttraumatic stress disorder
* stable medication
* age 18-45 years, gender female
* legal competence
* sufficient cognitive function
* sufficient knowledge of the German or English language

Exclusion Criteria:

Known severe internal, neurological, musculoskeletal, endocrinological or sleep disorders with organic origin (clinical examination during the screening visit, judged by the investigator)

* gravidity (positive ß-HCG test)
* continuing and not interruptible exposure to sexual or physical abuse
* acute suicidal tendency
* positive drug-screening in urine toxicology test
Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.


Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years;
2. Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
3. Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
4. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
5. Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.

Exclusion Criteria:

1. Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers);
2. Pure non-urothelial carcinoma histology.
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)

Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Specifically , infants will be investigated by sleep studies in order to test this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

1. Polysomnographically diagnosed OSA
2. Age is 2-24 months
3. Clinical suspicion of milk allergy due to findings in the medical history or physical exam

Exclusion Criteria:

1. Congenital defects in the pulmonary and gastrointestinal systems
2. Family history of genetic diseases or familial syndromes
3. Infantile asthma.
PS150 Total Knee Arthroplasty Outcomes Registry

This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.


Eligibility Criteria:
Inclusion Criteria:

* Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant.
* Signed Informed Patient Consent

Exclusion Criteria:

* There are no exclusion criteria for this registry.
Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial

The aim of this project is to assess the effect of cold water immersion on knee joint re-positional sense in healthy subjects. Cryotherapy, in the form of cold water immersion, had previously been shown to improve athletic performance however, debate exists within the existing literature regarding whether proprioception, in the form or joint position sense, is effected post treatment.

Null hypothesis (H0): Water immersion has no effect on joint position sense (JPS).

Alternate hypothesis (H1): Water immersion has an effect on joint position sense.

This was a prospective, randomised, cross-over design where volunteers acted as their own controls. The volunteers were immersed at two temperatures (detailed below) and these sessions were separated by six to ten days. The order of the testing was randomly assigned using a random number generator. Ethical approval of the design of this trial was gained from the University of Limerick's Research Ethics Committee and signed informed consent was gained from each participant before any data collection took place.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between the ages of 18 and 40 who complete both a Par-Q test and sign an informed consent form.

Exclusion Criteria:

* Potential subjects who do not complete a Par-Q questionnaire or provide written consent. Subjects with any ankle or knee injuries in the past twelve months.
* Students who have a recent history of ear or vestibular conditions.
* Subjects who will not be available to attend all sessions.
* Subjects who are under the age of 18 or over the age of 40.
* Subjects who aren't comfortable with being blind-folded or videotaped during testing.
* Those who are sensitive to cold exposure or show signs of a contraindication to cryotherapy.
Bio-equivalence Study

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, aged between 20 and 40 years
* Normal body weight and height (18.5 kg/m2 \< BMI \< 30 kg/m2)
* Stable body weight (weight gain or loss \< 3 kg in past 3 mo)
* Written consent to take part in the study
* Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria:

* Abuse of drugs and/or alcohol
* Use of vitamin supplements containing vitamin K
* Soy allergy
* Pregnancy
* a history of) metabolic or gastrointestinal diseases including hepatic disorders
* Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
* Use of oral anticoagulants
* Corticoid treatment
* Subjects with anaemia or subjects who recently donated blood or plasma
* Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)