cyrilzakka/clinical-trials huggingface dataset:
Wheelchair Backs That Support the Spinal Curves

The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when using a solid backrest in individuals with spinal cord injury (SCI).

A properly fit wheelchair and seating system can have a profound impact on the daily life of people with spinal cord injury (SCI). A backrest that supports the natural spinal curves is thought to enhance posture, functional mobility, and comfort for manual wheelchair (MWC) users. In fact, therapists routinely prescribe after-market posture-backs based on clinical reasoning. However, there is little research comparing the efficacy of an after-market posture-back to the standard upholstery back, and it is becoming increasingly difficult to justify these to group insurance payers.

Based on this, investigators performed a pilot study to investigate whether there were postural and/or functional differences between using a standard upholstery WC back and an after-market solid posture-back. The results of that study have been presented at the American Congress of Rehabilitation Medicine (ACRM) annual conference in November 2019 and the Combined Sections Meeting (CSM) of the American Physical Therapy Association (APTA) in February 2020, and were also published in the Journal of Spinal Cord Medicine in 2020.

Although the results of that study demonstrated clinical relevance and statistical trends for improvements in postural alignment and functional outcomes when using a solid back, there was not enough power to establish statistical significance. It also did not evaluate the effect of backrest height and position or depth of contour in order to inform clinical practice. The overall objective of this fully powered clinical trial is to further investigate if using a solid backrest on MWC will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest; and to explore the impact of overall back height, seat gap, and contour when using a solid backrest.

Eligibility Criteria:
Inclusion Criteria:

* Full time manual wheelchair users
* Motor complete SCI from C6-T4
* Age 18-70 at time of testing
* Time since injury \> 3 month at time of testing

Exclusion Criteria:

* Weight \>250 pounds
* Current pressure ulcer at time of testing
* Significant shoulder pain that precludes independent mobility at time of testing
* Insufficient range of motion to achieve neutral pelvis and spine at time of testing
* Orthopedic restrictions requiring a brace that would impact functional outcome measures
* Shoulder flexion range of motion \<120 degrees at time of testing
* PSIS-to-Inferior Angle of scapula measurement less than 8 inches or greater than 16 inches
* Cognitive deficits or visual impairment that would impair ability to give informed consent or to follow simple instructions during testing
* Children, pregnant women and prisoners will not participate in this study
A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain

This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health.

Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN.

From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association
* Age greater than 21 years according to the Kuwaiti law.
* History of plantar heel pain for greater than one month.
* Walking 50 meters without any support
* Having MTPs on initial physical examination on plantar and calf muscles
* Accepting to be treated by a male physiotherapist.
* Capacity to understand the study and the informed consent, as well as having signed the document.

Exclusion Criteria:

* - Needle phobia
* Allergy from needles or hypersensitivity to metals
* Presence of coagulopathy or use of anticoagulants
* Presence of peripheral arterial vascular disease
* Pregnancy
* Dermatological disease with the dry needling area
* The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy.
* Treatment of plantar heel pain with needling or acupuncture during last 4 weeks.
* A history of injection therapy in the heel in the previous three months.
* Previous history of foot surgery or fracture.
Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule.

Subjects will be placed in a group to receive either the drug enbrel, or a placebo. The radiation therapy treatments are as they would be given if the person was not on a research study. The selection of the group a patient is in is done by random, like flipping a coin. The doctor is not able to influence which group anyone is selected for. As is done routinely, radiation therapy is given Monday through Friday for about 4 to 6 weeks.The injections of enbrel or placebo are given two times a week. The enbrel or placebo is given as an injection directly under the skin with a small needle.

Eligibility Criteria:
Inclusion Criteria:

* Advanced lung, prostate, or bony metastasis for cancer
* Performance status (PS) of 3 or less
* Good lab test results with albumin of at least 2.5
* Radiation therapy of at least 4000Gy in 4 weeks

Exclusion Criteria:

* Poor PS
* Planned radiation therapy for less than 4 weeks or 4000Gy
* Limited disease
Management of Eczema by Specific Probiotic Strains

To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).

Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. The disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma later in childhood.

Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. There is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. Modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease.

Clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical trials (about treatment of AD by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for AD; however, there is great heterogeneity between studies since many different probiotic strains are used. Because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others.

Better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.

Eligibility Criteria:
Inclusion Criteria:

* children 0-15 months with mild to moderate eczema (SCORAD score 15-50 or equally EASI score) for at least two weeks

Exclusion Criteria:

* use of topical steroids class II or higher (which means treatment for severe eczema),
* use of oral steroids or treatment with antibiotics prior to inclusion.
* severe comorbidity
* lack of knowledge of the Dutch language
Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment

The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.

* open label,randomized, multicenter
* Experiment duration: 12 weeks.
* 05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization).
* evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

* Adults male or female aged ≥ 18 years old;
* Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
* Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
* Patient who accept the discontinuation of previous hypertension therapy.

Exclusion Criteria:

* Patients with blood pressure ≥ 180/100 mmHg;
* Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics;
* Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine\> 1.5 mg / dL);
* Patients with hypo or hyperkalemia (serum potassium outside normal range);
* Patients with ALT greater than 2.5 the upper limit of normal or active liver disease;
* Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period;
* Patients on drug or alcohol abuse in the last two years;
* Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome);
* Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation;
* Refusal or inability to provide the Informed Consent Term.;
* Refusal to discontinue the anti-hypertensive medication.
* Patients at the discretion of the investigator does not have indication for discontinuing the current medications;
Prevent Exposure to Tobacco Smoke at Home [Gesunde Atemluft zu Hause]

Background: Infants are at risk for tobacco-attributable diseases by being exposed to environmental tobacco smoke (ETS). International literature has shown that a home smoking ban can reduce ETS. The purpose of this study is to examine whether a brief feedback about urinary cotinine in infants and a counselling session about the consequences of ETS leads to a reduction of ETS.

All families with children up to an age of three years in the study region will be contacted by mail and asked for participation in this study. They will be randomised into an intervention and one control group. The intervention group will receive a ETS counselling session and detailed analysis of urinary cotinine (a biomarker of ETS) at their home. They will further receive written feedback approx. 2 weeks later. The control group will be visited and will answer a questionnaire and will receive brochures about ETS. They will receive a standard analysis feedback of urinary cotinine. There will be oine further assessment/ visit 12 months later. The outcome of this study is an anlysis of urinary cotinine and smoking behaviour and changes in cotinine and smoking behaviour.


Eligibility Criteria:
Inclusion Criteria:

* born in 2005, 2006 or 2007,
* being exposed to environmental tobacco smoke at home by at least one parent, living in the study region of west pommerania

Exclusion Criteria:
Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.

This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).

Eligibility Criteria:
Inclusion Criteria:

1) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:

1. Head CT scan showing diffuse axonal lesion.
2. CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
3. Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
4. Admission less than 8 hours of trauma.

Exclusion Criteria:

1. History of drug or narcotic abuse.
2. Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
3. Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
4. Psychiatric disorders.
5. Injury severity score ≥3, according to the Abbreviated Injury Scale
Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

Mixed methods study with focus groups interviews and a prospective observational cohort study aimed to investigate the impact of advanced home care on transplant specific outcomes and quality of life in recipients of allogeneic hematopoietic stem cell transplantation

Study of advanced home care after allogeneic haematopoietic stem cell transplantation (allo-HSCT). The main objective is to investigate the impact of home care on transplant specific variables and quality of life (QoL). The main hypothesis is that home care patients will home care patients will have significantly better measured QoL than patients receiving in-hospital care during the first 6 weeks after allo-HSCT. The study will be conducted as part of routine care at the departement of haematology, Oslo University Hospital.

There are qualitative and quantitative aspects to the study. The qualitative part involves focus groups interviews with patients that have been treated with allo-HSCT and have recieved home care and their caregivers.

In the prospective observational cohort study data will be collected to compare patients receiving home care and patients treated in-hospital (control group). Patients in both groups wil answer the questionnaire EORTC QLQ-C30 once weekly for 6 weeks. In addition transplant- and treatment-specific variables will be collected and compares between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Consent competency and written informed consent to participation
* Age ≥18
* Understanding and willing to comply with written and oral instructions in Norwegian
* Planned treatment with allo-HSCT
* ECOG performance status 0-2
* Caregiver (age ≥18) present 24 hours a day during the aplastic phase
* Travelling distance from residence to the hospital must be less than one hour.

Exclusion Criteria:

* Not meeting inclusion criteria
* Uncontrolled infection or other medical condtion unsuitable for out patient care
Kinematic-based BoNT-A Injections for Bilateral ET

The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected utilizing kinematically-based injection parameters for the treatment of upper extremity essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment tools in determining injection parameters and to study the composition of tremor using kinematics.


Eligibility Criteria:
Inclusion Criteria:

* Consenting male and female participants
* Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
* Stable ET medication management for the 3 month duration prior to their enrollment in the study
* Participants who are botulinum toxin naïve for tremor management
* Patients will be screened for pregnancy by the physician

Exclusion Criteria:

* History of stroke
* Muscle weakness or any related compartmental muscle syndrome
* Smoking
* History of ALS or Myasthenia Gravis
* Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol)
* Persons prescribed zonisamide
* History of allergic or side effect reaction to botulinum toxin
* Contraindications per the Xeomin® drug monograph
* Women reporting that they are pregnant
PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the patient's response to treatment.

PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in evaluating response to treatment in patients undergoing radiofrequency ablation for lung metastases.

OBJECTIVES:

Primary

* Determine the accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA) in patients with lung metastases.

Secondary

* Determine the agreement between observers analyzing PET/CT scan results.
* Determine the outcome of these patients.
* Determine the false-positive rate and false-negative rate of PET/CT scan at 1 and 3 months in these patients.
* Determine the optimal time for obtaining a negative PET scan.
* Determine the sensitivity, specificity, positive predictive value, and negative predictive value of PET/CT scan at 1 and 3 months.
* Determine the morbidity associated with RFA.
* Determine the disease-free survival after RFA and the factors predicting recurrent disease in these patients.

OUTLINE: This is a multicenter study.

Patients undergo positron emission tomography (PET) and CT scan at baseline. Patients then undergo radiofrequency ablation (RFA) for lung metastases. PET/CT scan is repeated at 1 week, 1 month, and 3 months after RFA.

After completion of RFA, patients are followed by clinical examination and conventional scanning at 6, 9, and 12 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cancer
* Radiologically suspected pulmonary metastases

  * May be confirmed histologically or by specific markers
  * Less than 6 lesions
  * Lesions \< 40 mm
  * Prior positron emission tomography shows 1 hyperfixation (standard uptake variable \> 3) at the level of lesions to be treated
  * Lesions must not be attached to or next to major mediastinal structures
* Radiofrequency ablation planned as treatment

PATIENT CHARACTERISTICS:

* Life expectancy \> 6 months
* No uncontrolled medical condition, including any of the following:

  * Psychiatric condition
  * Infection
  * Coronary insufficiency
  * New York Heart Association class III-IV heart disease
* No other serious condition
* No contraindication to general anesthesia
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* At least 30 days since prior participation in an investigational study
* At least 30 days since prior chemotherapy
* No other concurrent investigational agents
Restricted Reporting for Positive Urine Cultures

Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Eligibility Criteria:
Inclusion Criteria:

* positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.

Exclusion Criteria:

* pregnancy,
* antibiotic treatment at the time of urine collection,
* collection from an indwelling catheter,
* admission to long term care facility.