cyrilzakka/clinical-trials huggingface dataset:
Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?

The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.

Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal. There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence. But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises. We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up. Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test. Appropriate post hoc analysis will be done to compare within group and between group differences.

Eligibility Criteria:
Inclusion Criteria:

1. Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
2. Age between 18 to 65 years
3. Male or female
4. All educational backgrounds (educated or uneducated)
5. Pain intensity more than 2/10 on NPRS and
6. Disability of more than 20/100 on NODI

Exclusion Criteria:

1. Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
2. Signs consistent with nerve root compression, this includes any one of the following:

   1. Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
   2. Muscle weakness involving a major muscle group of the lower extremity
   3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
   4. Diminished or absent sensation to pinprick in any lower extremity dermatome
3. Prior surgery to the lumbar spine or buttock
4. Current pregnancy
5. Past medical history of osteoporosis or spinal compression fracture
6. Participants who do not provide informed consent for the study

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A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.

The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants. The CIQoL responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice.

The CIQoL-35 has been translated and adapted from English to French in accordance with the guidelines of Hall and colleagues.

The purpose of the current study is to describe the measurement properties of the French CIQoL-35 questionnaire.

Hall et al recommend that at least 8 patients participate in any qualitative testing of the translation (n=13 in the previous study) and that at least 50 patients participate in a measurement property evaluation (n=50 in the present study).

The aim of this study is not to assess the performance of the device or compare the performance of different devices/brands but to correlate quality of life scores with speech understanding in patients with cochlear implants. The main objective of the study is to validate the translation of the questionnaire, the correlation is a secondary criterion.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) user of at least one cochlear implant system,
* Duration of cochlear experience ≥ 6 months (period from cochlear implant activation to study enrolment),
* Psychological/literacy ability to read, understand, and complete the questionnaire.

Exclusion Criteria:

* Patient who participated in initial validation of the French CIQoL-35 (CIQoL project part 1),
* Patient with a psychological or linguistic inability to understand the information sheet or the questionnaire,
* Patient under legal protection or deprived of liberty,
* Unwillingness or inability to comply with all investigational requirements.
An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

The objective of this proposal is to compare clinical outcomes, implementation metrics (i.e., patient reach and clinician adoption), and clinician preferences of two designs (customized vs. commercial) of a clinical decision support (CDS). Beta blocker prescribing for patients with heart failure will be used as a test case. The best practices in CDS design, including the user-centered design will be incorporated into the customized CDS and compared to a commercially-available CDS in the electronic health record using a cluster randomized trial.


Eligibility Criteria:
Study subjects are providers

Inclusion Criteria:

* Prescribing primary care clinicians at University of Colorado Health (UCHealth) who provide care for patients with heart failure and reduced ejection fraction

Exclusion Criteria:

* None
Genistein Stimulates Insulin Sensitivity Through Gut Microbiota

There is evidence that genistein present in soy can improve insulin resistance in rodents and humans with metabolic syndrome (MetS). However, it is not known if this improvement is associated with changes in the gut microbiota. In the present study, the investigators show that the consumption of genistein for 2 months could have an effect on insulin resistance in subjects with MetS. This effect will be accompanied by a modification of the gut microbiota taxonomy. As a consequence, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of fatty acid oxidation in skeletal muscle.

The investigators included 45 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of MetS, HOMA index greater than 2.5, BMI ≥30 and ≤ 40 kg / m2 and who signed the consent letter. Patients who had any added pathology, pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. These individuals were advised to consume the recommended diet for subjects with MetS according to the guidelines of the ATPIII. Participants were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months. In the previsit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile, lipopolysaccharide and serum insulin. Also determined blood pressure, body weight, height, body composition and gut microbiota. The presence of insulin resistance was determined by means of the HOMA-IR index and by an oral glucose tolerance test. After 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then RNA extraction and gene expression microarray assay was performed

Eligibility Criteria:
Inclusion Criteria:

* Adults (men and women) between the ages of 18 and 50.
* Patients with obesity (BMI ≥ 30 and ≤ 40 kg / m2) and with insulin resistance (HOMA - IR Index ≥ 2.5).
* Mexican mestizos (parents and grandparents born in Mexico).
* Patients who can read and write.

Exclusion Criteria:

* • Patients with any type of diabetes.

  * Patients with kidney disease diagnosed by a medical or with creatinine\> 1.3 mg / dL for men and \> 1.1 mg / dL for women and / or BUN\> 20 mg / dL.
  * Patients with acquired diseases that produce obesity and diabetes secondarily.
  * Patients who have suffered a cardiovascular event.
  * Patients with weight loss \> 3 kg in the last 3 months.
  * Patients with any catabolic diseases.
  * Gravidity status
  * Positive smoking
  * Treatment with any medication
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

This is a trial to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of \[S,S\]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race at least 18 years of age
* Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
* Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

Exclusion Criteria:

* Patients with significant hepatic impairment
* Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
* Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
* Amputations other than toes
* A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
* History of transient ischemic attack or stroke
* Myocardial infarction or unstable angina within the past three months
Physical Activity and Work Ability in University Staff

The goal of this observational study is to explore the relationship between leisure-time physical activity (LTPA) and work ability in university staff, with a focus on occupational physical activity (OPA) and gender. The main question it aims to answer is:

How does leisure-time physical activity (LTPA) influence work ability in university staff, considering their occupational physical activity (OPA) and gender?

Participants from the University of Alcalá will complete an online survey, which includes sociodemographic data and validated questionnaires on LTPA, OPA, work ability, musculoskeletal disorders, health-related quality of life, and workload.

Introduction: 39.17% of the population in the Autonomous Community of Madrid (CAM) does not meet the physical activity recommendations set by the World Health Organization, representing a significant public health issue and considerable socioeconomic costs. Sex, gender, and working conditions are key determinants of leisure-time physical activity (LTPA). However, there are few studies aimed at understanding these sociocultural barriers.

Objective: To describe the association between LTPA and work ability, depending on occupational physical activity (OPA), among university staff in CAM, with a gender perspective. Secondly, to describe the relationship between the prevalence of musculoskeletal disorders at work, health-related quality of life (HRQoL), physical and mental workload, functional capacity, and working conditions with the aforementioned association.

Methodology: Cross-sectional descriptive study. The study population will consist of a representative sample of 885 workers from the University of Alcalá (Alcalá de Henares, Madrid), selected by snowball non-probability sampling. Participants will complete an ad hoc form (Microsoft Forms) including sociodemographic data (working hours, type of service, main task, income, menopause, etc.) and validated questionnaires in Spanish. The variables collected through these questionnaires will include LTPA and OPA (Global Physical Activity Questionnaire), work ability (Work Ability Index), prevalence of musculoskeletal disorders at work (Nordic Musculoskeletal Questionnaire), HRQoL (SF-12), and physical and mental workload (NASA Task Load Index).

Discussion: Improving understanding of the social determinants of physical activity in this population could facilitate the design of culturally sensitive interventions, thus making them more effective in reducing the economic and health costs of sedentary behavior.

Eligibility Criteria:
Inclusion Criteria:

* University staff from different departments of the University of Alcalá who are able to understand Spanish.

Exclusion Criteria:

* Individuals with cognitive limitations that hinder their ability to comprehend information, respond to questionnaires, or consent to participation in the study.
* Individuals with neurological impairments or a diagnosis of severe mental illness.
* Individuals with uncontrolled cardiorespiratory diseases or diabetes.
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study

Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?


Eligibility Criteria:
Inclusion criteria

* AO/OTA fracture classification 31(A-B) (1-3).
* Age greater than 18 years old.

Exclusion Criteria

-Less than 18 years old.
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
* Positive serological test for autoantibodies against AChR

Exclusion Criteria:

* History of thymectomy, or any other thymic surgery within 12 months prior to Screening
* Untreated thymic malignancy, carcinoma, or thymoma
* History of Neisseria meningitidis infection
* Pregnancy, breastfeeding, or intention to conceive during the course of the study
Increasing Long-Term Physical Activity After Lumbar Spine Surgery

After recuperating from low back surgery patients often perpetuate a sedentary lifestyle because they are concerned about injury and recurrent pain. The objective of this study is to test the feasibility of a program to increase lifestyle walking starting several months after low back surgery.

The primary objective of this RCT is to compare energy expenditure from walking between an experimental group that receives a multi-component intervention based on the Health Belief Model of Behavior Change versus a control group. Patients who had surgery for a degenerative condition will be randomized postop when their surgeons deem them orthopedically stable to increase walking (at about 3 months).

Eligibility Criteria:
* Inclusion Criteria: Patients will be eligible if they had lumbar surgery for a degenerative condition and their surgeon deems it safe for them to walk more.
* Exclusion Criteria: Patients will be excluded if they had any new cardiopulmonary symptoms since surgery.
Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery

The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.

Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.

Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing venous malformation embolization operation through general anesthesia.
2. aged 18-65 years old.
3. operating time varies 1-4h,and extubation after the operation.

Exclusion Criteria:

1. long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
2. known for dexmedetomidine or other drugs allergy in this study.
3. cannot communicate.
4. preoperative systolic blood pressure \<90 mmHg, or the heart rate \<50/min.
Neuroimage Genome Study of Neuroplasticity Associated With Microgravity

This clinical trial investigates the neuroplasticity and cognitive status changes of the human brain in microgravity. To explore the relationship between cognitive status changes and brain functional activities, gray matter and white matter changes under microgravity exposure, screen and identify representative image markers, so as to provide decision-making information for the cognitive status changes of relevant personnel under microgravity environment.

MRI has the advantage of non-invasive and non-radiation, and imaging the human brain after exposure to microgravity can reveal the neuroplastic changes in the astronaut's brain and discover the characteristics of functional activities behind it. The purpose of this study is to explore the image features and cognitive state related information related to the changes of human brain neuroplasticity under microgravity environment, and to identify the related image markers. At the same time, the pathophysiological mechanism is preliminarily discussed in this study. This study is helpful for us to explore the sensitivity of different brain structures and brain functions to space microgravity environment, so as to further understand the role and influence of space missions on brain health.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 18-60 years
* No mental or other neurological disorders, no history of drug or alcohol abuse
* Generally in good condition, no clear major physical diseases, no hearing disorders
* No metal foreign bodies in the body, no contraindications to MRI scanning
* No claustrophobia
* Agree to participate in the clinical study and sign the informed consent

Exclusion Criteria:

* There are electronic implants or metal foreign bodies, such as cardiac pacemakers
* People with aneurysm surgery and intracranial aneurysm clip
* People who have had heart surgery and used artificial heart valves
* Having family planning
* Uncontrolled epilepsy or mental illness, can't cooperate with MRI examination
* Severe claustrophobia, can't cooperate with magnetic resonance examination
* Other circumstances that the clinical trial personnel consider inappropriate to participate in the study
Study of Families With Melanoma

RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.

PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

OBJECTIVES:

Primary

* Determine what lifestyle factors and which genes govern relapse from melanoma.

Secondary

* Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
* Assess how unusual moles relate to sun exposure and genes that cause melanoma.

OUTLINE: This is a multicenter, cohort study.

Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients\* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).

NOTE: \*Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.

Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.

Patients and healthy participants are followed annually.

Peer reviewed and funded or endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Newly diagnosed primary invasive melanoma (patient group)

    * Lentigo maligna malignant melanoma allowed
    * Rare variants of melanoma allowed, including any of the following:

      * Acral lentiginous
      * Subungual
      * Ear, nose, and throat
      * Oropharyngeal
      * Perineal
      * Vaginal
      * Vulval
      * Rectal
      * Nodal with no known primary
    * Patients undergoing sentinel node biopsy are eligible
    * No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
  * Healthy participant meeting either of the following criteria (control group):

    * Relative of a patient who was diagnosed with melanoma after September 2005
    * Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Clinical Trial Treatment in Lupus Nephritis

The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in both the induction and maintenance with similar results at least to those offered by the classic pattern and possibly with fewer side effects, especially for long term. The association of prednison and mycophenolate has created large expectations to that effect, and is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.

Despite the significant advances that have led to these treatments, the likelihood of complete remission after six months remains, according to the series of 8-13% and partial remission do not exceed 60% in papers published. In the last year, two articles have been published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in poor prognosis of lupus nephritis with hopefully better results than those obtained previously. In this study we try to compare the effectiveness of triple therapy, the therapy is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type III-IV-V

asd

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients diagnosed SLE with renal type III-IV-V confirmed by renal biopsy done in the last 6 months
* Proteinuria \> 2 g/24 hours and hematuria (\> 5 h / field)
* MDRD4 eGFR \> 60 ml/min/1.73m2
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Central nervous system LES involvement or any other vital organ
* Active infection
* Use of mycophenolic acid, mycophenolate mofetil, cyclosporine or tacrolimus in the last 6 months
* No adherence
* Women of childbearing age not using appropriate contraceptive methods.
* Positive pregnancy test
* Anasarca
* Malignancy or cancer history (except basal cell skin carcinomas)
* Patient participating in another study with an investigational drug or have participated within 28 days prior to entry into this study