cyrilzakka/clinical-trials huggingface dataset:
Nintendo Wii Virtual Reality Application In Dementia

•This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD.

The aim of the present study is to investigate the effect of the virtual reality application on muscle strength and fall in individuals with Alzheimer' Dementia (AD).

Purpose: This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD.

Method: The study included a total of 32 volunteers between the ages of 65-80, with mild or moderate AD diagnosed. These individuals were divided into 2 groups as a training group and control group. The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes. Mini-Mental State Test, Knee Extension Muscle Strength, Timed Up and Go Test, Tinetti Falls Efficacy Scale results of individuals were recorded in the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* included volunteers between the ages of 65-80 with mild or moderate AD diagnosis,
* who did not have any difficulty or problems in communicating,
* who did not have any neurological diseases that disrupt balance and coordination such as a cerebrovascular event, Parkinson's disease, Multiple Sclerosis, and neurological disorder,
* who obtained a score of 18 - 24 points in the Mini-Mental State Test (MMST)

Exclusion Criteria:

* Patients diagnosed with rapidly progressing dementia (infection, vascular, hematologic diseases),
* Those who could not be contacted during the follow-up period or who did not participate in the training session, those who experienced cardiac and cerebrovascular events, endocrine disorders, fluid-electrolyte imbalance and infection,
* Those with malignancy and those who received chemotherapy and radiotherapy that causes malignancy, delirium or depression and malignant sensory loss (those with the Semmes-Weinstein monofilament thickness of 4.56 and above),
* Those with a lower or upper extremity amputation at any level
Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy

The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in study TR002 but have not yet commenced dosing

Exclusion Criteria:

* None; no criteria additional to TR002 exclusion criteria are applicable to this study
Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto.

A total of 38 Spanish-speaking, Latinx smokers with high anxiety sensitivity (AS) will be recruited for this project. Eight (8) participants will complete user interviews in Spanish and thirty (30) participants will participate in a randomized controlled trial (RCT) for smoking cessation. Participants will be randomized to receive either the Impacto mobile app or a generic, Spanish language, smoking cessation, mobile app control (Dejar de Fumar Asistente).

Eligibility Criteria:
Inclusion Criteria:

1) 18 to 55 year of age, 2) current smoker (i.e., at least 6 cigarettes/day), 3) not currently engaged in smoking cessation treatment, 4), high anxiety sensitivity (AS) score defined as an ASI-III score of ≥ 23, 5) motivation to quit \> 5 on a 10 pt. scale, 6) Spanish speaking, and 7) currently own an Android-compatible mobile phone.

Exclusion Criteria:

1) use of other tobacco products (including e-cigarettes), 2) current non-nicotine substance dependence and/or current or intended participation in a concurrent substance abuse treatment, 3) ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression, or 4) active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis
Large Head X3 Study

The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who is a candidate for primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
2. Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
3. Patient whose age is 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 45.
4. Patient who is or may be pregnant female.
5. Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.
Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer

This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.

Androgen receptor(AR) is closely related to molecular type, treatment and prognosis in breast cancer. Over 70% of breast cancer expressed androgen receptor. And in some estrogen receptor positive breast cancer cells which are resistant to Aromatase inhibitors can change androgen receptor dependent. So AR may be a new target in the treatment of breast cancer. Bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the ER-/AR+ metastatic breast cancer. This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER+/AR+/HER- metastatic breast cancer patients who have disease progression after treatment of an AI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
* Metastatic or unresectable locally advanced disease
* Age over 18 years
* Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
* Patient must have disease progression after treatment of an Aromatase inhibitor.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2
* Life expectancy over 3 months.
* Measurable disease according to RECIST version 1.1 or only bone metastasis
* Adequate hematological, hepatic function.
* Voluntarily signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

* Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
* Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
* History of other primary malignancy
* Resistant to steroidal or nonsteroidal aromatase Inhibitor
Samsca Post Marketing Surveillance Study

This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011\~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.

This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

  1. Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level \< 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction
  2. Patients who are prescribed Samsca® treatment as per investigator's medical judgment
  3. Patients who gave written authorization to use their personal and health data
  4. Patients starting Samsca® treatment after agreement is in place Investigators will refer to the product market authorization (label) for inclusion criteria.

Exclusion Criteria:

* Subjects presenting with any of the following will not be included in the study:

  1. Patients who have been treated with Samsca®
  2. Patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug
  3. Patients requiring urgent intervention to raise serum sodium acutely.
  4. Inability of the patient to sense or appropriately respond to thirst.
  5. Hypovolemic hyponatremia
  6. Concomitant use of strong CYP3A inhibitors
  7. Anuric patients
  8. Volume depletion patients
  9. Hypernatremia patients
  10. Women who are pregnant or possibly pregnant and lactation
  11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Investigators will refer to the product market authorization (label) for exclusion criteria.
Implementing & Testing Assessment and Referral Technologies in Juvenile Justice

1. Assess the impacts of implementing a juvenile assessment, referral, placement, and treatment planning (J-ARPP) protocol, and of different strategies for transferring J-ARPP technology, on service utilization of youth entering the juvenile justice system.
2. Assess the impacts of implementing J-ARPP, and of different strategies for transferring J-ARPP technology, on measures of organizational readiness and motivation, and staff attitudes about assessment and service.
3. Assess the impacts of implementing J-ARPP, and of different strategies for transferring J-ARPP technology, on measures of systems integration.
4. Assess fidelity to the J-ARPP protocol and the relationship between fidelity to the J-ARPP protocol and service utilization of youth entering the juvenile justice system.


Eligibility Criteria:
Inclusion Criteria:

* all offices
Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.

In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patients (over 18 years of age), without any systemic complication.
* Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is \< 6 mm.
* Non smokers or patients who smoked less than 11 cig/day Will be included.

Exclusion Criteria:

* Uncontrolled systemic diseases which affect bone healing.
* Presence of any pathology in the site of operation.
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease

The Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY) study is a pragmatic prospective, open-label, randomised controlled trial. CLARITY aims to examine the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of people who tested positive for COVID-19 disease.


Eligibility Criteria:
Inclusion Criteria:

Potential participants must satisfy all of the following:

1. Laboratory-confirmed\* diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 infection within 10 days prior to randomisation
2. Age ≥ 18 years
3. a) Systolic Blood Pressure (SBP) ≥ 120 mmHg OR b) SBP ≥ 115 mmHg and currently treated with a non-Renin Angiotensin Aldosterone System inhibitor Blood Pressure (BP) lowering agent that can be ceased
4. Participant and treating clinician are willing and able to perform trial procedures.
5. Either Intended for hospital admission for management of COVID-19, or (In Australia Only) Intended for management at home with one or more of the following criteria:

   1. Age≥60 years
   2. Body Mass Index ≥30kg/m2 (derived from the patient's self-report of their height and weight where these are not measured directly)
   3. Diagnosis of diabetes defined as HbA1c ≥7% and/or the consumption of glucose lowering medication
   4. History of cardiovascular disease
   5. History of chronic respiratory illness
   6. Currently treated with immunosuppression

Exclusion Criteria:

1. Currently treated with an angiotensin-converting enzyme inhibitor, Angiotensin Receptor Blocker or aldosterone antagonist, aliskiren, or angiotensin receptor-neprilysin inhibitors (ARNi)
2. Serum potassium \> 5.2 mmol/L or no potassium testing within the last 3 months
3. For those intended for hospital admission, an estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.73m2 or no eGFR testing within the last 3 months, or For those intended for management at home (Australia only), an eGFR \<45ml/min/1.73m2 or no eGFR testing within the last 3 months
4. Known symptomatic postural hypotension
5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) - see Table below
6. Intolerance of ARB
7. Pregnancy or risk of pregnancy, defined as;

   1. (In Australia only) Women younger than 51 years who have not had a negative pregnancy test during the past 3 days and/or who do not agree to use adequate contraception
   2. (In India Only) Women who are pregnant
8. Women who are currently breastfeeding
9. Individuals who are not able to take medications by mouth at enrolment, or who are not expected to be able to take medications by mouth during the first 48 hours after randomisation
Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery

Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* age 0 to 18 years submitted to heart surgery
* parent approval

Exclusion Criteria:

* previous oral intubation
* previous or present pneumonia
* parent refusal
* death during surgery
EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

This study will evaluate efficacy and safety for monthly ranibizumab 0.5 mg intravitreal injections in Asian patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Asian patients 50 years of age or greater.
* Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or active occult lesions with no classic component.
* Patients who have a BCVA score between 73 and 24 letters (approximately 20/40 to 20/320 Snellen equivalent), inclusively, in the study eye.
* Total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area
* Total lesion area must be \<= 12 disc areas

Exclusion Criteria:

* Patients who have in the fellow eye a Snellen equivalent below 20/200
* Presence of angioid streaks, presumed ocular histoplasmosis syndrome, myopia (exceeding -8 diopters), or CNV secondary to causes other than AMD in the study eye
* Subfoveal fibrosis or atrophy in the study eye
* Total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area
* Total lesion area must be \<= 12 disc areas
* Vitreous hemorrhage, retinal tear or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
* Active, or history of, ocular inflammation or infection in the study eye within the last 30 days prior to screening.
* Uncontrolled glaucoma in the study eye
* Treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy within 30 days prior to screening
* Previous treatment with anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, corticosteroids, protein kinase C inhibitors, squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD in the study eye. Treatment of the fellow eye is permitted if administered \> 30 days before screening.
* History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery more than 60 days prior to screening
* History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers

Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ....)
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration
Feasibility Study of the My Health Coach App for Adults With FASD

The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older
* Have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
* Have conversational fluency in English
* Own an smartphone

Exclusion Criteria:

* Unable to complete measures or interviews in English
* Do not have a smartphone
* Under 18
* Do not have an FASD or history or prenatal alcohol exposure