cyrilzakka/clinical-trials huggingface dataset:
A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.

This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.

Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.

During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18-70 years (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c level between 7.5% and 9.5% (both inclusive)
* Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
* Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening

Exclusion Criteria:

* Type 1 diabetes mellitus
* Known or suspected allergy to the IMPs or related products
* Previous participation in this trial. Participation is defined as randomised.
* Receipt of any medicinal product in clinical development within 60 days prior to this trial.
* Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation screening tests, as judged by the Investigator considering the underlying disease
* Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
* Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.
* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening
* Women of child bearing potential not willing to use contraceptive methods.
Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease

A randomized, controlled, three-arm trial to investigate the effects of warm water footbaths with and without the addition of ginger or mustard powder on psychosocial parameters in patients with an oncological disease and in healthy controls.

A randomized, controlled trial with cross-over design in which the subjects (23 patients with an oncological disease, 13 healthy controls) receive warm water footbaths with added ginger (experimental) or mustard powder (experimental) or without additives (active comparator). The wash-out period between two consecutive footbath interventions is at least one day. Outcome measures are assessed right before (t1), right after (t2) and 10 minutes following the footbath (t3). The main focus is on the change in subjective perception of warmth distribution between t1 and t3. Moreover, the objective skin temperature distribution and psychosocial scores are assessed. The primary outcome measure is analyzed with a linear mixed effects model (after checking for carry-over effects). Secondary outcome measures are described descriptively.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 65 years
* Oncological disorder with at least one chemotherapy or radiation in the treatment history
* Current inpatient treatment in the oncology ward of the Filderklinik (Filderstadt, Germany) with a minimum stay of 4 days

Exclusion Criteria:

* Infectious disease (with more than 38 °C core body temperature)
* Skin lesion on the lower legs or feet
* Hypersensitivity to mustard or ginger products
* Cardiac arrhythmia
* Pregnancy
* Insufficient knowledge of the German language
* Bedriddenness
* Poor general condition (according to the assessment of the attending physicians)
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.

Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Phenytoin.
* Oral hypoglycemics.
* Coumarin-type anticoagulants.
* Cyclosporine.

Patients must have:

* ARC or AIDS.
* Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms.
* Confirmation of diagnosis by microscopic exam and culture of organism.
* Life expectancy of at least 4 weeks.

NOTE:

* Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Unable to tolerate oral medication.
* Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor).

Concurrent Medication:

Excluded:

* Antifungal agents other than study drugs.
* Other experimental medications.

Patients with the following prior conditions are excluded:

Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.

Prior Medication:

Excluded:

* Other antifungal agents within the past 3 days.
Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy

RATIONALE: Mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably.

PURPOSE: This phase II trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

* Determine whether supplemental treatment with mistletoe increases immune function (as determined by total lymphocyte count, eosinophil count, and lymphocyte subset analysis) in patients with stage IIIB or IV non-small cell lung cancer receiving palliative chemotherapy.
* Determine the tolerability of this drug in these patients.
* Correlate immune function and quality of life in patients treated with this drug.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive mistletoe subcutaneously three times a week for 15 weeks.

Dose of mistletoe is increased at weeks 2 and 3 and then every 3 weeks until a maximum response is seen, dose-limiting toxicity occurs, or the study ends.

Quality of life is assessed at baseline and at weeks 3, 6, 9, 12, and 15.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Stage IIIB or IV non-small cell lung cancer

  * Newly diagnosed disease
* Planning to receive standard chemotherapy with either carboplatin plus paclitaxel or cisplatin plus gemcitabine

  * Refused or ineligible to participate in experimental chemotherapy clinical trials

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant
* No AIDS
* Able to self-report quality of life
* No known allergy to Viscum album Linnaeus

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No other concurrent mistletoe products

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* No concurrent steroid or adrenocorticotropic hormone therapy

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No concurrent participation in other clinical trials
* No concurrent mushroom glucan or proteoglycan extracts
* No concurrent thymus extract
* No concurrent non-oncologic immunosuppressive therapy (e.g., therapy for rheumatoid arthritis or after organ transplantation)
Effects of Posterior Parietal Cortex and Cerebellum Anodal tDCS on Ankle Tracking Visuomotor Adaptation

Motor adaptation is guided by state estimation, a dynamic prediction of the interaction consequences between body and environment in the sensorimotor system. Previous studies have shown that the posterior parietal cortex (PPC) and cerebellum are potential candidates for state estimators. However, neither direct evidence linking neural substrates of state estimation and motor adaptation nor the differences in state estimation in these two brain areas was presented. A comparison of neuromodulation effects over PPC and cerebellum in motor adaptation tasks could provide direct evidence to solve the knowledge gap.

Objective: This study aims to provide direct evidence to link state estimation and motor adaptation, and the neuromodulation effects of PPC and cerebellum in motor adaptation by using anodal transcranial direct current stimulation.

This was a single-blind, sham-controlled study. All participants were randomized to the PPC, cerebellum, and sham stimulation group. The ankle tracking system was used to record the ankle tracking visuomotor task during the motor learning phase, motor adaptation phase, and motor re-adaptation phase. Normalized root-mean squared error (RMSE) and RMSE reduction rate were measured as the performance outcome. A 20-minute atDCS at 2 mA anodal tDCS was given during the motor adaptation phase. The immediate effect and after effect of tDCS were seen in the motor adaptation phase and motor re-adaptation phase, respectively.

Eligibility Criteria:
Inclusion Criteria:

* age between 20\~29 years old
* normal ankle range of motion and muscle strength
* intact cognitive function (Mini-mental State Examination (MMSE) \>27)
* corrected vision \> 0.9.

Exclusion Criteria:

* any neurologic or psychiatric disease history
* musculoskeletal disease that interferes lower extremities movement
* severe cardiopulmonary or systematic disease (e.g. unstable angina, severe arrhythmia, heart failure, hypertrophic cardiomyopathy, aortic stenosis, pulmonary embolism, kidney failure)
* paresthesia
* seizure history
* brain surgery, meningitis, encephalitis history
* drainage tube on the head
* metal or other insertion in the brain
* insertion of electric medical device (e.g. pacemaker, cochlear implant)
* pregnancy
* taking central nervous system medication (e.g. antidepressants, anxiolytic)
* alcoholic addiction or drug abuse
* open wound, allergy, rash, or other illness that would affect the placement of tDCS
* headache, disgusting, vomit, or any other severe side effect to the tDCS
Spinal Mobilization and PNF Comparison on Pain, Disability in Patients With Cervical Radiculopathy

As in this modern era of digitalization; mobile phones, touch pads and computers devices use is increasing, neck pain that radiates into upper limb is also becoming common due to such devices long term use in bad postures or positions for more workload. The resulted findings could significantly contribute to the refinement of rehabilitation interventions, offering a more holistic and tailored approach for addressing cervical radiculopathy sensory and motor symptoms, ultimately improving individuals daily living activities and life quality. It will be helpful for physiotherapists to find evidence about comparison of mulligan's spinal mobilization along with arm movement with proprioceptive neuromuscular facilitation technique on pain, disability and range of motion in patients with cervical radiculopathy. It will be beneficial for patients also to improve pain, activities of daily living and working tasks in a comfortable position.

Cervical radiculopathy is a clinical situation in which reflex, motor, and sensory alterations e.g. radicular pain, paresthesia, or numbness might be present and might be increased by neck bad postures and movements. Due to sustained forward head and neck posture and repetitive movements, cervical pain and numbness is becoming common in office, bank and online workers. The cervical radiculopathy new cases report yearly is almost 107.3 per 1 lac for men and 63.5 per 1 lac for women. It is essential to find new efficient methods of cervical radiculopathy physical therapy management.

Males and females of age 21-50 years old added in this study. Screening tests will include upper limb tension tests (ULTT), spurling (compression) test and distraction test. Subjects randomly assigned into two groups by lottery method. Experimental group (N=19) received Mulligan's spinal mobilization with arm movements (SMWAMs) and proprioceptive neuromuscular facilitation (PNF) contract-relax technique and control group (N=19) received Proprioceptive neuromuscular facilitation (PNF) contract-relax technique and standard physical therapy protocol including passive stretching exercises (3 sets of 10 repetitions) and isometric strengthening exercises (2 sets of 10 repetitions). Outcome measures included numeric pain rating scale (NPRS) for pain, neck disability index (NDI) for functional disability and goniometer for range of motion (ROM). Data analyzed by statistical package for social sciences (SPSS 26) software.

Eligibility Criteria:
Inclusion Criteria:

* Both males, females of 21 years to 50 years old
* Patients already diagnosed by orthopedicians
* Patients with positive screening (upper limb tension, spurling \& distraction) tests

Exclusion Criteria:

* History of trauma, fracture and previous surgery
* Any pathological condition, spinal instability and tumor
* VBI (Vertebral-Basillar Insufficiency) and cervical instability/spondylolisthesis
Ramipril Versus Carvedilol in Duchenne and Becker Patients

Data on preventive therapy in Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD) affected individuals without cardiac involvement are very limited and currently lacking regard both ACE-inhibitors and Beta-Blockers in Becker Muscular Dystrophy and for the latter even in Duchenne Muscular Dystrophy patients. Thus, the study aim is to compare the efficacy of carvedilol vs ramipril on myocardial tissue properties and heart function, performing CMR and myocardial Ultrasound Tissue Characterisation analysis.

This protocol represent an open randomized and prospective trial, designed to answer the specific question regarding the role of the cardioprotective therapy in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy patients. In this light, CMR could provide relevant data, reinforcing the scientific background, to start early (particularly in BMD patients in whom this is still a debated question) a cardioprotective treatment with carvedilol or ramipril.Finally,this clinical trial will clarify whether a preventive therapy may be helpful on the clinical outcome, both in reducing myocardial fibrosis and preventing the progression towards the cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Immunohystochemical and molecular diagnosis of Duchenne and Becker muscular dystrophy.
2. Not evidence of clinical cardiomyopathy,normal 2D-echocardiography with normal systolic,WMSI = 1) and diastolic function.
3. DMD patients treated with steroid therapy.
4. All DMD and BMD patients are not treated with cardiological therapy (ACE-inhibitors, ARBs or Beta-Blockers).
5. Written informed consent to study participation (with serial visit, CMR and echocardiographic study) is required from all patients themselves, as well as their parent or guardian and healthy-control subjects.

Exclusion Criteria:

1. Failure to obtain informed consent from patients, parents or guardians.
2. Any controindications to carvedilol or ramipril treatment (bronchial asthma, diabetes, any degree of renal failure (all patients are required to have a normal creatinine level and clearance).
3. in BMD patients ECG changes suggestive of ischemic heart disease, left bundle-branch block, atrial flutter/fibrillation, ventricular arrhythmias, any degree of atrioventricular block and left ventricular (LV) hypertrophy. Aspecific ST changes will be not considered as electrocardiographic exclusion criteria both in DMD and BMD patients.
4. In BMD patients exclusion criteria will be also hypertension and valvular heart disease other than trivial.
5. DMD and BMD patients requiring ventilatory (non-invasive or invasive) assistance.
6. Presence of systolic and/or diastolic dysfunction detected by 2D-Echocardiography.
7. Presence of any contraindications to CMR (including any history of claustrophobia).
8. Patients under the age of 2 years.
9. Renal failure, even mild.
10. Patient unable or unwilling to attend the follow-up and tests, in the opinion of local study principal investigator, (children not willing to perform CMR will not be enrolled).
Sleep Patterns After Total Joint Replacement Surgery

The purpose of this study is to determine sleep patterns and sleep quality following total joint arthroplasty, in order to understand when patients should expect to return to baseline or improved sleep following total joint arthroplasty. Patients prospectively enrolled in this study are to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA). Patients will receive the SleepScore Max device and smart device app to track their sleep patterns starting one week prior to surgery and until six months after surgery. The SleepScore Max device tracks duration of sleep, time to fall asleep, number of nightly awakenings, rapid eye movement sleep, light sleep, deep sleep, and room temperature and light levels. Through the associated application, patients will also record caffeine and alcohol consumption and exercise. In addition to sleep tracking, patients will fill out Pittsburgh Sleep Quality Index (PSQI), PROMIS, Hip Disability and Osteoarthritis Outcome Score (HOOS), and Knee Injury and Osteoarthritis Outcome Score (KOOS) surveys at specified visits. Secondarily, Visual Analog Pain (VAP) scores and opioid consumption measure in milligram morphine equivalents (MME) will be measured during hospital stay and at subsequent post-operative clinic visits. The clinical goal of this study is to better under sleep patterns in patients undergoing TKA and THA and hopefully provide this patient population improved sleep recommendations and interventions.


Eligibility Criteria:
Inclusion Criteria:

* Patient is to undergo ambulatory total hip arthroplasty or total hip knee arthroplasty.
* Patient is 18 years or older.

Exclusion Criteria:

* Patient is unable to give consent
* Non-English speaking patients
* Patients with pre-existing sleep disorders or neurological disorders, including dementia.
* Patients taking hypnotic drugs or other medication that is known to affect sleep.
Improving Sleep Using Mentored Behavioral and Environmental Restructuring

The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.

This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.

Eligibility Criteria:
Inclusion Criteria:

* living in the unit of intervention,
* ability to communicate and follow simple commands,
* English- or Spanish-speaking,
* capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

Exclusion Criteria:

* Does not have capacity and does not show enthusiasm for the research
* Does not have capacity and does not have a proxy.
* obtunded or comatose state,
* inability to communicate verbally,
* inability to consent and without surrogate
* non-English and non-Spanish speaking. In keeping with QI strategies, all residents will be exposed to the environmental aspects of the intervention, as these strategies represent clinically proven non-experimental behavioral strategies with no perceptible harm.