cyrilzakka/clinical-trials huggingface dataset:
Nurse Case Manager Model on Neuroblastoma Caregiver's Uncertainty

Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the survival rate in Western countries, the treatment in Taiwan needs more efforts to improve. According to the report from the Childhood Cancer Foundation ROC, several children with neuroblastoma did not complete their treatment and or not received the protocol. In addition to the efforts in improving protocol, the reasons for those who drop-out and do not receive complete treatment need the investigators more attention to think of.

Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on caregivers' adaptation of disease uncertainty about then child with neuroblastorna.

Methods: A longitudinal and prospective design will be used to perform this study. Questionnaire survey and chart review will be the means of data collection for the part of quantative analysis. The qualitative method , semi-structural interview , also will be used to collect data regarding caregiver's perception of social support and adaptation at the same time of self-report of questionnaires survey .There are five points of time to collect data: Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible subjects agree to participate in the study.

Subjects: The study will use a convenience sample. Once the caregiver's child is on has been diagnosed with neuroblastoma will be recruited in this study.

Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the self-reported socio-demographic questionnaire will be used to collect data. Process recording will be typed once finishing interview for further analysis.

Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The data will be analyzed using descriptive statistics and inferred statistics. Content analysis and theme formation will be categorized to assist the interpretation of quantitative results.

Implication: The findings of this study will be expected of the effects of nurse care manager model on children with newoblastoma cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Care giver of Neuroblastoma Children

Exclusion Criteria:

* NA
Red Cell Distribution Width as a Predictor of Mortality in Acute Methanol Poisoning

The study aimed to investigate the association between RDW and in-hospital mortality in methanol poisoning.

RDW values have been found to be an independent predictor of the prognosis among patients with heart diseases, stroke,community-acquired pneumonia (CAP), pulmonary embolism, chronic obstructive pulmonary disease (COPD), septic shock, and acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

All patients aged ≥18 years who were admitted to emergency departments from January 2019 to January 2020 on account of acute methanol intoxication.

Exclusion Criteria:

Incomplete data, Malignancy, Severe anaemia, History of erythrocyte transfusion last 6 weeks

-
Effect of Whole-Body Vibration on Plasma Sclerostin Level

The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.

Fifteen healthy young adult women are planned to include in this study. All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. Training duration will be short at the beginning but progressed slowly.

The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The subjects will be asked to report negative side effects or adverse reactions in their training diary.

Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels will be measured by human sclerostin ELISA kit.

Whole-body vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates the osteocytes.

Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.

The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women,
* Women with ages varying between 20 and 40 years
* Right-handed women

Exclusion Criteria:

* Lower extremity problems

  1. Orthopedic problems: shortness of legs, congenital anomalies, etc.
  2. Joint disease (arthritis, joint prosthesis, etc.)
  3. Other painful pathologies in the lower extremities (fractures, tendinitis,bursitis, etc.)
  4. Circulation problems in the lower extremities
* Dorsolumbar diseases: Vertebral fract, disc hernias, spondylodiskitis, etc.
* Systemic disease cases

  1. Systemic bone disease: osteoporosis, osteomalacia, Paget's disease
  2. Hypertension (\>135 mmHg systolic, \>85 mmHg diastolic)
  3. Heart dis.(coronary dis, conduction/rhythm prob, cardiac pacemaker)
  4. Infectious diseases
  5. Endocrine diseases (Diabetes mellitus etc)
* Neurological diseases (CNS problems, peripheral neuropathy)
* Menstrual cycle disorders, amenorrhea, lactation, oral contraceptive use
* Cases during the ovulatory period (11-16th day of menses)
* Obesity (BMI \>30 kg/m2) or low BMI (BMI \<20 kg/m2)
* Vertigo
* Cognitive function disorders
* Women whose blood samples were not taken in the time planned
* Women whose blood samples hemolyzed
Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers

Family therapy is considered an empirically supported treatment approach for adolescents and adults with eating disorders. One family based approach, Expert Carers Helping Others (ECHO) is based on evidence that suggests family environment, e.g., carer criticism, can influence an individual's eating disorder symptoms. ECHO aims to improve carer coping, reduce expressed emotion and manage eating disorder symptoms, and has been associated with reduced carer distress, caregiver burden, and an increase in general well being. The current pilot study seeks to evaluate a new condensed version of the ECHO intervention that is delivered entirely in a 2 ½ hour self-help DVD format (ECHOs). Sixty patients and their carers will be recruited from the Capital Health Eating Disorders Service and randomized into either a treatment as usual group (TAU) or a TAU+ECHOs group. Both carers and patients will be assessed along a variety of dimensions including psychiatric symptoms, family functioning, and carer and patient collaboration, at pre-intervention, four weeks later at post-intervention, and then three-months post-intervention. ANOVAs will be used to compare the primary outcomes between the two groups over time. This pilot study will be the first evaluation of ECHOs, which may ultimately boost the efficacy of current treatment for adults with eating disorders and reduce carer distress.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an ED (AN, BN, EDNOS) according to DSM-V criteria (American Psychiatric Association, 2013) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist.
* Patients age of \>17y.o.
* Carers can include parents/partners/siblings/extended family who provide unpaid help and support. Peers and roommates could also be included in circumstances within which they play a significant role in the person's life and meet the following criteria:
* Live with or have regular, current contact with the patient (at least 7 hours/week) throughout the duration of the trial (approximately 6months).
* Interact with the patient in some meaningful manner regarding their ED (e.g. provide support, eat meals together, discussions about behaviours).
* Consent from patient and at least one carer

Exclusion Criteria:

* ED comorbid with severe psychiatric or physical comorbidity: e.g. current psychotic illness (inc. bipolar disorder), severe alcohol/drug abuse, significant metabolic or gastrointestinal problems (i.e. treatment interfering) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist.
* Family in a concurrent treatment trial.
* Either patient or carer has insufficient knowledge of English.
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy

The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
* Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
* Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
* Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) \> Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Exclusion Criteria:

* Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
* Pregnant or breastfeeding female
* Ongoing or active infection.
Cryolipolysis for Jawline Contouring

The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with Cryolipolysis.


Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Treatment area skin fold thickness \> 1cm (measured by caliper).
* Sufficient treatment area requiring at least 2 cooling cycles.
* No weight change exceeding 5% of body weight in the preceding month.
* Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject has signed a written informed consent form.

Exclusion Criteria

* Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
* Prominent platysmal bands at rest which may interfere with assessment of treatment area.
* Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
* Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
* Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the treatment area (below the mandible) within the past 6 months.
* Botulinum toxin or other aesthetic drug injections within the treatment area in the past 6 months.
* History of facial nerve paresis or paralysis (such as Bell's palsy).
* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
* History of prior neck surgery, or prior surgery in the area of intended treatment.
* Current infection in and adjacent to treatment area.
* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 6 months.
* Lactating or has been lactating in the past 6 months.
* Unable or unwilling to comply with the study requirements.
* Currently enrolled in a clinical study of an unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.


Eligibility Criteria:
Inclusion Criteria:

1. 16 years of age or older
2. Surgery at least 6 weeks after injury to allow for a return of full range of motion, minimize swelling, and offset strength deficits due to pain/swelling14,28
3. ACL reconstruction with a bone-patellar tendon-bone autograft

Exclusion Criteria:

1. Previous or concomitant reconstruction of any knee ligament to either knee
2. Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
3. Professional athletes or workers' compensation patients
4. Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
5. Patients without access to local physical therapy services
Paravertebral Calcitonin in Thoracotomy

This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.

Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.

Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.

Using calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, we conducted this study as we hypothesize that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.

In both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* American society of anesthesiology (ASA) physical status of I-III
* scheduled for elective thoracotomy

Exclusion Criteria:

* Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy.
* Pregnancy
* History of cardiovascular and gastro-esophageal surgery
* Preexisting pain syndrome or psychological disorders
* Severe hepatic, cardiovascular, or renal disorders
* Allergy to calcitonin
* Patients who will be re-operated and who will report infections
Biomarker Study in Pancreatic Neuroendocrine Tumours

The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed consent
* WHO performance status ≤2
* Progressive disease (as defined by the local investigator) or newly diagnosed disease (defined as prior to medical or oncological intervention except for somatostatin analogue treatment).
* Pathology confirmed diagnosis of pancreatic or duodenal neuroendocrine tumour WHO G1-G3.

  o Exception: In newly diagnosed patients with high suspicion of PNET based on clinical and radiological parameters where tissue sample have not yet been obtained. These patients may be included and subsequently excluded if pathology cannot confirm NET.
* Biopsy procedure not associated with inappropriate risk as determined by the responsible physician.

Exclusion Criteria:

* Patient does not consent
* Permanent risk factors for biopsy

  * Long term treatment with anticoagulant that cannot be temporarily paused without unacceptable risk.
  * Permanent coagulation disorder
* Pregnancy or no contraceptive in fertile women.
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

Post-menopausal osteoporosis and the resulting fractures are an important cause of disability and loss of independence. They also increase the risk of morbidity and mortality.

Given potential side effects, hormone replacement therapy is no longer recommended for menopausal women with risk of becoming osteoporotic. The very significant decrease in the use of these treatments is suspected of contributing to a resurgence in the incidence of osteoporotic fractures, particularly in women before the age of 70. There is a need for prevention of osteoporosis.

Mother-of-pearl is a candidate for long-term use due to the combination of its effects: calcium supplementation, anti-resorptive activity and osteoanabolic activity.

Our hypothesis is that powdered mother-of-pearl supplementation limits bone loss in postmenopausal women with risk of becoming osteoporotic.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (50-65y) with risk of becoming osteoporotic
* T-score between -1 and -3
* Absence of fragility fractures history

Exclusion Criteria:

* absence of parathyroid glands (phospho-calcic regulation)
* presence of kidney stones
* patients who follow a treatment that could interfere with bone metabolism (corticotherapy, menopausal hormonal therapy, anti-oestrogen treatment, non-controlled hyperthyroiditis, hyper- and hypothyroiditis)
* bone diseases (Paget'disease, osteomalacia)
* chronic alcoholism
Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults

The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 years old or older, up to 60 years old.
* Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
* Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)

Exclusion Criteria:

* Any clinically unstable medical condition
* Clinically significant abnormal baseline laboratory values
* Mental retardation (I.Q. \<75) or Organic brain disorders
* Seizure disorder
* Patients with a history or an eating disorder including anorexia or bulimia nervosa
* Pregnant or nursing females
* Patients with current bipolar disorder
* Psychotic disorder of any type
* Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)
* Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)
* Patients demonstrating active withdrawal from substance abuse
Computer-Assisted Fixation of Trochanteric Femur Fractures

The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.

This will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. Patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis.

The primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. Secondary outcomes will be position of the lag screw as described by Cleveland et al, operative time, fluoroscopy time, and number of Kirschner wire passes prior to final placement of the lag screw. Additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.

Eligibility Criteria:
Inclusion criteria:

1. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device

Exclusion criteria:

1. Patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma)
2. Patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon
3. Patients less than 18 years of age