cyrilzakka/clinical-trials huggingface dataset:
Music Based Caregiving in Patients With Pain and Dementia

The main objective of this study is to evaluate the pain-relieving effect of a well-characterized non-pharmacological treatment program, music-based caregiving (MBC), to patients in nursing homes with dementia and pain. Patients with dementia disease will be recruited from nursing homes in Trondheim and Oslo, and each ward at the nursing homes will be cluster randomized into intervention - or control wards. Then the health care personnel in the intervention wards will receive education in MBC and perform the intervention during eight weeks. The hypothesis is that this non-pharmacological intervention will reduce pain intensity and improve general activity, as well as reduce other symptoms in nursing home patients with dementia and pain compared to baseline.

This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes.

1. About 12 nursing homes are selected to participate in Trondheim and in Oslo.
2. All patients at the included nursing homes will be screened with respect to dementia and pain (see screening tools later). If patients have dementia and report pain (≥3 on MOBID 2) they will be included in the intervention part of the study (n=240).
3. The included patients will then have a clinical examination of pain and pain management by expert physicians (see below). Evaluation of the use of analgesics and psychopharmacological medication will be performed. Inappropriate medication (both too much and too little) will be corrected in collaboration with the nursing home doctor.
4. In addition to the clinical examination of pain, the investigators will measure total daily physical activity, ADL, QOL, and neuropsychiatric symptoms on all included patients.
5. After the pre-test - a randomization of the wards into intervention wards or control wards will be performed.
6. About five staff members at each of the wards randomized to the intervention group will receive education in the MBC before intervention.
7. A post-test just after the intervention has ended, pain, total daily physical activity, ADL, QOL, and neuropsychiatric symptoms will be measured.

Eligibility Criteria:
Inclusion Criteria:

* All patients living in one of the included nursing homes in Oslo or Trondheim will be included in the first descriptive phase
* Patients will be included in the intervention part if they report moderate pain or more (≥3 on MOBID) and mild dementia or more (≥1 on CDR).

Exclusion Criteria:

* They will not be included if they have lived in the nursing home less than four weeks, have short (less than eight weeks) expected lifetime (judged by the nurses),or if they do not understand the Norwegian language.
Effect of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy

This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy.

Cerebral palsy is one of the most common congenital (existing at or before birth) disorders of childhood.Spastic cerebral palsy causes stiffness and movement difficulties.There is no cure for the disease now.

This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy. hAEC will be intrathecal transplanted. Functional status is determined by Gross Motor Function Measure-66 and Fine Motor Function Measure. Spasticity is evaluated by using modified Ashworth scale(MAS).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent document;
* Gross Motor Function Classification System (GMFCS) levels III-V;
* Parents accepted voluntarily cell therapy for their children and followed-up.

Exclusion Criteria:

* Have a history of severe allergic;
* Serological tests such as AIDS, hepatitis B, syphilis, etc;
* Hereditary metabolic diseases of nervous system;
* Tumor or Hematological diseases.
Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Established CVD defined as one of the following:

  * History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
  * History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
  * Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia

Exclusion Criteria:

- Patients currently enrolled in clinical studies with investigational drugs
Mirror Feedback, Augmented Task-Specific, Impairment-Oriented Therapy, Home Practice, Stroke Rehabilitation

In this study, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

Stroke is one of the major causes of long-term disability. Most stroke survivors suffer from arm paresis even in the chronic phase. There is a need to develop novel strategies to augment therapeutic efficacy in stroke rehabilitation. One potential method to enhance treatment efficacy is through the "priming" technique. Among all priming techniques, mirror therapy (MT) has been proposed to be a promising method to augment effects of motor re-training. The investigators propose a 3-year research project to determine the effects of MT-priming on augmenting stroke interventions. The investigators select two types of evidence-based neurorehabilitation, the task-specific training and the impairment-oriented training, to be primed by MT based on their unique treatment benefits on restoring arm ability. In addition, the investigators will provide customized home practice corresponding to each type of interventions. Specifically, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

Eligibility Criteria:
Inclusion criteria:

* A first ever-stroke≧3 months
* Baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56 (Fugl-Meyer et al. 1975)
* No excessive muscle spasticity of the affected arm (Modified Ashworth Scale \< 3 at any joints of the affected arm) (Bohannon \& Smith 1987)
* Able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22) (Folstein et al. 1975)
* No participation in any other experimental rehabilitation or drug studies during period of this project

Exclusion criteria:

* Concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation of this project
* Epilepsy within three months
A Study of R547 in Patients With Advanced Solid Tumors.

This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced or metastatic solid tumors;
* measurable or evaluable disease.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
* prior history of CNS metastases with disease progression;
* patients taking strong inhibitors and/or inducers of CYP3A4.
Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric

Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate parents and patients, public health entities and physicians give informational handouts in various forms. However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. Few, if any, studies have analyzed the relationship between influenza vaccine attitudes and intention with actual vaccine receipt in the pediatric population. These results will help to understand the relationship between parent's vaccine perception and the intent to vaccinate versus the child's receipt of the influenza vaccine, as well as to optimize educational information given to families regarding the influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 6 months

Exclusion Criteria:

* Receipt of influenza vaccination that season
Cognitive Health Promotion Project in the Community

This study was based on baseline data derived from a large prospective study called the Suwon Project (SP), a cohort comprising random clustering samples of elderly people, all of whom are ethnic Koreans aged over 60 years.

There is growing evidence supporting the protective effect of health behaviors against cognitive decline and dementia in older persons. With this increasing evidence and a better understanding of the underlying mechanisms, lifestyle modification is likely to be increasingly promoted as a convincing strategy for maintaining cognitive health in later life.

The study protocol included cognitive screening through the Korean version of the Mini-Mental State Examination (K-MMSE), which has been validated for the Korean-speaking population ({YW, 1997 #88}Kang YW et al., 1997), recording of the subject's medical history. A Korean study in the community defined the cut-off point of K-MMSE score during the screening of dementia as 17/18 points; the sensitivity and specificity of the findings were 91% and 86%, respectively ({YW, 1997 #88}Kim et al., 2003). Based on these results, we defined cognitive impairment (CI) as the group that had a K-MMSE score lower than 17, and not cognitive impairment (NCI) was defined as the group that had a K-MMSE score higher than 18.

Eligibility Criteria:
Inclusion Criteria:

* more than 60 years old

Exclusion Criteria:

* those with a history of significant hearing or visual impairment that rendered participation in the interview difficult
* those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or active epilepsy)
* those with psychiatric illness (e.g., schizophrenia, mental retardation, severe depression, or mania)
* those taking psychotropic medications, or those with significant alcohol and other substance abuse.
Ovarian Reserve and Embryo Implantation

Compare, in young patients with In vitro fertilization (IVF), the rate of embryo implantation by early culture transfer (J2-J3) between 2 groups of patients: "normo responders" vs. "poor responders".


Eligibility Criteria:
Inclusion Criteria:

* IVF patient managed with or without ICSI between 01/01/2014 and 30/06/2015 in one of the two study centres
* Age \< 35 years old
* Fresh transfer of at least one embryo between D2 and D6
* patients who have already received one or more transfer attempts.

Exclusion Criteria:

* No fresh transfer (Freeze All, segmentation failure, stimulation failure)
* Double successive embryo transfer (e. g. J3-J5). We did not retain these cases because if only one of the 2 embryos is implanted, it is not possible to know which transfer it corresponds to.
* Maternal serum FSH determination \< 4 IU/ml at D3 in the baseline balance sheet (hypogonadotropic hypogonadism)
Maintenance Treatment for Abstinent Smokers

The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.

The goal of this study was to assess relapse prevention outcomes among individuals able to stop smoking when pharmacotherapy is extended beyond the standard duration of treatment. We hypothesized that maintenance treatment with prolonged bupropion use and/or "as needed" use of nicotine gum will reduce relapse to smoking. Participants were recruited through advertisements on radio, television, newspapers, the Internet, and various community outlets. Respondents were pre-screened by telephone using a standard interview. The first participant entered the OLT phase in February 2001; the final NTFU visit took place in October 2005.

The study was multi-phased consisting of: 1) eight-week open-label treatment (OLT) with bupropion and nicotine patch; 2) randomized double-blind assignment of OLT successes to 16 weeks of placebo-controlled maintenance treatment (MT); and 3) 24 weeks of non-treatment follow-up (NTFU). Participants received $25 compensation for completing the NTFU visits at Weeks 36 and 48. The Institutional Review Board of the New York State Psychiatric Institute approved the study. The study was performed at the Columbia University Medical Center Smoking Cessation Clinic in New York City.

Eligibility Criteria:
Inclusion Criteria:

* Patients who smoke at least 10 cigarettes daily and have attempted to quit smoking at least once

Exclusion Criteria:

* Seizure History
* Unstable Blood Pressure
* Current major depression
* Current alcohol/drug abuse or dependency
* Lifetime psychotic illness
* Current use of psychotropic drugs
* Unstable medical condition
Flow veRsus OxygeNaTion In acutE ReSpiratory Failure

High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately high oxygen concentration should be avoided as there is increasing evidence that the production of oxygen free radicals can lead to lung damage. This pilot dose finding study will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with respiratory failure requiring low, medium or high oxygen concentration from conventional low flow devices. An assessment will also be made of comfort and compliance with HFNO2.

The study will recruit a total of between 180 and 270 patients across three hospital sites mainly from high dependence units.

The patients recruited will be stratified into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high).

All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.

End points:

Minimal FiO2 required to maintain saturation above 94% for patients with low, medium and high recruitment oxygen requirements for 30 litres, 45 litres and 60 litres per minute. Use Kruskal Wallis to compare the median FiO2 requirements of those patients who recruited with low, medium and high O2 requirement.

Obtain dose response curve 02 saturation against FiO2 for 3 different flow rates for each of the recruitment 02 requirements and use regression modelling to find best fit dose FiO2 response O2 saturation curves

Patient satisfaction scores and number of patients unable to tolerate the three flow rates in each of the three starting groups and flow rates.

Eligibility Criteria:
Inclusion Criteria:

Patient aged 18-80 at time of recruitment to study) Able to give their own consent (4 "A" Test score of 0 if capacity questionable) Acute respiratory failure but no significant deterioration in the previous hour Receiving conventional oxygen therapy (Hudson, Venturi, non-rebreathing mask or equivalent) up to a maximum of 90% Oxygen saturation ≥ 94% and respiratory rate ≤30

Exclusion Criteria:

Type II respiratory failure (chloride ≤95 and bicarbonate ≥35, on an arterial blood gas or venous sample within 4 weeks) Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V) Pregnancy Heart failure (NYHA Grade III or IV) Decreased GCS Cardiovascular instability (systolic BP ≤90 or heart rate ≥130) Pulmonary embolism Unable to give informed consent Contraindication to receiving high flow nasal oxygen

* Nasal obstruction
* Previous bleomycin administration
* Base of skull fracture
Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients

The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is:

• Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft?

You will:

* Undergo debridement surgery
* Receive artificial skin graft as an alternative to autologous skin graft
* Undergo biopsy procedure of burn area

If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process

Burn caused by working accidents occurs mostly in the male population of productive age (68.68%). Up to this date, the only treatment for grade 2B-3 burns patients in Indonesia is skin transplantation taken from their own body (autologous skin graft). This treatment has several drawbacks in which repeated surgery is sometimes necessary, the source of skin in patients with wide area of burn is limited, and patients that are in the elder age and have comorbidities have high mortality risk.

In order to find an alternative for autologous skin graft therapy, a combination of tissue engineering and stem cell therapy is used to invent an artificial skin graft. The present study attempts to evaluate the efficacy of artificial skin graft seeded with autologous keratinocyte and stem cells towards wound healing in burn patients. The artificial graft used in this study is amnion bilayer; a graft that was decellularized to remove donor's cells and then layered to form into 3-D.

To evaluate the efficacy, biopsies are taken from the burn area of patients to evaluate the histoarchitecture of patients' tissue by histological staining (H\&E and Movat's pentachrome, IHC collagen I, collagen III, vWF, and alpha-SMA) and measure the relative gene expression by qPCR. For clinical data, burn area calculation using Rule of 9 method and thermography measurement using FLIRONE. Furthermore, systemic evaluation of patients are done by monitoring the procalcitonin, lactate, mean arterial pressure, gradation of wound, and sensory of burn area. The evaluation and measurement mentioned above are then compared to patients treated with the current available therapy; autologous skin graft. The artificial skin graft is hoped to result in equal, if not better, wound healing in burn patients compared to autologous skin graft. The investigators hope that artificial skin graft can be an option, other than autologous skin graft, in treating burn patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 55
* Area of burn \<50%
* Acute phase burn (\<120 hrs)
* Have not undergo any surgery for burn treatment

Exclusion Criteria:

* Immunocompromised
* Have comorbidities
A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* HER2-negative metastatic breast cancer
* candidates for taxane-based chemotherapy;
* ECOG performance status of 0 or 1.

Exclusion Criteria:

* previous chemotherapy for metastatic breast cancer;
* prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
* prior radiotherapy for treatment of metastatic disease;
* chronic daily treatment with aspirin (325 mg/day) or clopidogrel(\>75mg/day).
Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.

The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.


Eligibility Criteria:
Inclusion Criteria:

* Has at least 1 year history of migraine (with or without aura)
* Females of child bearing potential must use acceptable contraception throughout trial.

Exclusion Criteria:

* Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
* Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
* Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
* Has a history of cancer within the last 5 years.