Kornimate/medical-research-clean huggingface dataset:
autologous bone marrow transplant in chronic insulin dependent diabetic patients

Conditions: Diabetes Mellitus Progression; Diabetes Complications

Summary: diabetes, recently declared a pandemic by the world health organization, is a risk factor for increased mortality and morbidity. its multi-functional complications, in the short and long term, are a serious problems for the global public health. millions of patients, the world over, suffer diabetes, a chronic and degenerative disease without treatments today. america, and particularly the caribbean and central america region, is seriously affected despite the efforts of the public health systems. caribbean region presented nearly twice the incidence and prevalence of type 1 and type 2 diabetes when compared with the rest of the americas. today stem cells are emerging as a valid alternative of treatment. in vitro experiments with adult stem cells demonstrated their ability to migrate and differentiate into cells of different lineages. the bone marrow stem cells are safe, effective and have a lot of scientific evidence that supports the carrying out of clinical research in phases ii and iii. our protocol is an autologous bone marrow stem cell transplantation, without immune suppression or cell cultures. our hypothesis is that the stem cells will act as immune modulators, angiogenic and in a regenerative way stimulating quiescent stem cells and improving the metabolic control by endogenous secretion of insulin.

our clinical trial, authorized and controlled by the government of bahamas, offer safety data and effectiveness that encourage continued research. we will divide the patients into a treatment group and into a control group. we will control insulin daly dose, c peptide, a1c glycated hemoglobin and specific antibodies. follow up two years.

Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic insulin dependent type 1 or 2 diabetes, with negative specific antibodies (islets, gad, e2) and low basal c peptide (using c-peptide measurement (nv 0.9 mg / dl). men and women, between 16 and 70 years old, derived voluntarily by their family doctors. exclusion criteria: -

Keywords: diabetes mellitus bone marrow transplant
op2c : prialt® observatory in clinical practice

Conditions: Refractory Pain

Summary: ziconotide is a strong analgesic marketed since 2005 in europe and reserved for the intrathecal route. its efficacy has been proven in particular by 3 randomized clinical studies. it is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. in addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. however, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. this toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration). in recent years, the use of intrathecal ziconotide has become a pertinent option. indeed, it is recommended as first-line among the intrathecal treatment options. however, there is a lack of data on the current use of ziconotide in current practice. the objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * severe refractory chronic pain requiring intrathecal analgesia * candidate for intrathecal analgesia treatment with ziconotide * patient informed about the study and agreeing to take part in. exclusion criteria: * contraindications to ziconotide

Keywords: intrathecal analgesia ziconotide
clincal study of reduced target radiotherapy in nasopharyngeal carcinoma

Conditions: Toxicity Due to Radiotherapy; Nasopharyngeal Carcinoma

Summary: to determine whether subtractive radiotherapy can significantly reduce the acute side effects of radiotherapy and improve the quality of life of patients on the basis of ensuring the existing curative effect.


Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., who type ii or type iii). 2. the clinical stage is tanyn2-3m0, iii-iva (ajcc 8th edition stage). 3. patients who have not received radiation therapy before. 4. after induction chemotherapy, cr or pr were evaluated by radiography. 5. age 18-65 years old. 6. ecog score of 0-1. 7. good organ function 8. the patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs. exclusion criteria: 1. patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (who type i) is excluded. 2. patients with relapsed and distant metastases. 3. the metastatic lymph nodes are located in the target area (ib zone, the lateral group of the retropharyngeal lymphatic drainage area (vii), and the cervical lymphatic rainage area the medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.the triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain). 4. nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx. 5. severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3). 6. those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment. 7. those who have participated in clinical trials of other drugs within 3 months before treatment. 8. pregnant or lactating women. 9. patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.

Keywords: reduced target nasopharyngeal carcinoma radiotherapy
fitness training after traumatic brain injury

Conditions: Craniocerebral Trauma

Summary: the aim of this project is to compare the efficacy of two different fitness exercise programmes on improving fitness and psychosocial functioning in a traumatic brain injured population. we hypothesize that a supervised fitness-centre based exercise programme, compared to an unsupervised home-based exercise programme will show significant improvements in cardiorespiratory fitness, depression and community integration.

the objective of this project is to compare a three-month supervised fitness centre-based exercise programme to a 3-month unsupervised home-based exercise programme on discharge from inpatient rehabilitation on improving cardiorespiratory fitness and psychosocial functioning in a traumatic brain injured population. we plan to carry out a multi-centre, assessor blinded, randomised controlled trial with a parallel group design to compare the two interventions. we hypothesise that the supervised fitness-centre based programme will provide significantly better outcomes, and that these gains will not only be evident on completion of the programme, but will be maintained on follow-up, thereby demonstrating that investment in a supervised exercise programme can provide beneficial long-term effects.

Eligibility criteria:
inclusion criteria:patients who have sustained a traumatic brain injury who have completed their inpatient rehabilitation at either of the three sydney metropolitan brain injury units (liverpool, ryde or westmead) will be included in this study if they: * have sustained a very severe or extremely severe traumatic brain injury * have had a hospital admission of \> 1 month * are able to walk independently at \> 1 m/s on discharge * are able to commit 3 hours per week to a fitness programme * live within the area serviced by the 3 units exclusion criteria: * have a concurrent medical condition for which moderate to high intensity exercise is contraindicated * are still in posttraumatic amnesia (pta) * have cognitive or language problems that affect their ability to understand verbal instructions * have behaviour problems not suitable for a fitness centre environment

Keywords: 'traumatic brain injury' 'head injury' 'brain injuries' 'exercise therapy' 'physical fitness'
enoxacin for amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the study will assess the safety of the drug enoxacin at specific dose levels in adults with als.

participants will be randomized to one of three doses of enoxacin (200, 400, or 600mg twice daily) for 30 days. on day 1, 7, 14, 21, and 30 of treatment and at a follow-up visit 14 days after the last dose, participants will be assessed for safety measures and blood will be collected to assist with the determination of enoxacin pharmacokinetics (pk) and pharmacodynamics (pd). on day 1 and day 30 of dosing, participants will only take one dose of study medication (the morning dose) to assist with determination of enoxacin single dose pk over a 24-hour period. a lumbar puncture (lp) to collect cerebrospinal fluid (csf) for pd assessments will occur on day 1 and day 30.

Eligibility criteria:
inclusion criteria: * diagnosis of familial or sporadic als * fvc of ≥ 50 percent predicted * if female, is not breastfeeding and is not pregnant * has been on a stable dose of riluzole, or has not taken riluzole, for at least 30 days prior to screening * if taking concomitant edaravone at study entry, must have completed at least one cycle of edaravone therapy prior to screening * not currently taking and has not taken for at least 30 days prior to screening any theophylline containing medications, clozapine, or duloxetine * no active infection in the 30 days prior to randomization * has not taken any fluoroquinolone antibiotics for at least 30 days prior to screening exclusion criteria: * hypersensitivity/allergy to fluoroquinolones * diagnosed with another neurodegenerative disease * significant pulmonary disorder not attributed to als, central nervous system disorder associated with seizures, myasthenia gravis, active rheumatologic disease, tendinopathy, or any severe uncontrolled medical condition (other than als) * severe renal impairment or impaired liver function * baseline prolongation of qt interval/corrected qt interval (qtc) at screening, treatment with any agent that may prolong qt/qtc interval, or history of any other at-risk other cardiac condition * currently enrolled in another clinical trial involving an experimental drug or device

Keywords: enoxacin
methylene blue in patients with acquired methemoglobinemia

Conditions: Acquired Methaemoglobinaemia

Summary: this is an open label, uncontrolled, phase 4 study including 10 patients who present in hospital/urgent care setting with acquired methemoglobinemia. the population may include pediatric and adult patients (males and females of all ages are included). the study will run in both the eu and the us. the aim of the study is to confirm safety and efficacy of provaybluetm for the treatment of acquired methemoglobinemia and has been requested by the us-fda as a post-marketing requirements.


Eligibility criteria:
inclusion criteria: * pediatric or adult patients (males and females of all ages are included) diagnosed with acquired methemoglobinemia and receiving treatment with provayblue™ as per the treating physician's diagnosis and hospital standard of care. acquired methemoglobinemia is defined as a level of methemoglobinemia \>30% or ≤30% in case of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.). * written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments. exclusion criteria: * known severe hypersensitivity reactions to methylene blue or any other thiazine dye; * known deficiency in glucose-6-phosphate dehydrogenase (g6pd) due to the risk of hemolytic anemia as well as lack of therapeutic effect; * known deficiency in nicotinamide adenine dinucleotide phosphate hydrogen (nadph) reductase. * known use of selective serotonin reuptake inhibitors (ssris), serotonin and norepinephrine reuptake inhibitors (snris), monoamine oxidase (mao) inhibitors or drugs metabolised via cyp isoenzymes anticipated during the treatment phase of the study. * women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of provaybluetm.

Keywords: acquired methaemoglobinemia methylene blue
raising well at home

Conditions: Obesity

Summary: the purpose of this pilot study was to test the feasibility and efficacy of a balanced lifestyle intervention for caregivers and their children with obesity, conducted in partnership with envolve, inc., a family of comprehensive health solutions and wholly owned subsidiary of centene corporation.

this pilot study employed a pretest-posttest design to assess the feasibility and efficacy of the raising well at home pilot intervention delivered by peer coaches on weight (caregiver/child), behaviors (eating, walking), and the home environment. the raising well at home intervention was delivered via home visits with additional support via text or phone over 6 months, beginning after completion of the baseline assessment. this study was implemented in partnership with the parent raising well programs located in three states: florida, louisiana, and missouri. the caregiver and the child's height and weight were measured by trained staff in the home with the same scale and stadiometer at the pre- and post-intervention time points. measures were completed on a paper survey with the same caregiver pre and post intervention delivery.

Eligibility criteria:
inclusion criteria: * caregivers had to be at least 18 years old, live in one of the states offering the raising well program, and be the primary caregiver to at least one child 2-17 years old served by an envolve medicaid health plan with international classification of diseases, ninth revision (icd-9) coding for overweight or obesity. caregivers had to be able to give informed consent. if more than one child within a household was eligible to participate, all children were invited to participate. exclusion criteria: * unable to speak english or spanish
the role of mucosal microbiome in recurrence of clostridioides difficile infection

Conditions: Clostridioides Difficile Infection

Summary: the study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for c. difficile infection to determine if there are features associated with recurrent disease.

patients who have recently been diagnosed with c. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. participants will also complete surveys, blood draw and stool collection. overall goals are to identify whether c. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.

Eligibility criteria:
inclusion criteria: * adults aged 18 and over * confirmed c. difficile infection based on positive c. difficile toxin pcr testing and clinical evidence of diarrhea exclusion criteria: * known pregnancy * prior diagnosis of c. difficile infection within 2 months of this diagnosis * other known active gastrointestinal infectious process * known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions * vulnerable adults * any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
"the effect of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients"

Conditions: Type 2 Diabetes

Summary: evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients

patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are: * changing the meal plan (individual and group counseling, assistance in developing menus and determining the calorie intake, keeping a food diary) * individually dosed physical exercises using specific exercise program; * comprehensive training (course of interactive lessons, self-control training). the program included group sessions with a team of specialists: nutritionist, endocrinologist, physical therapy doctor and included 3 sessions per week for 24 weeks. each visit included teaching patients in a group format and in an interactive form (classes with specialists alternated), performing physical exercises using the specific exercise program under the supervision of a physiotherapy physician, evaluating medical indicators, and a self-control diary. patients in the control group will not participate in group sessions, but they had the opportunity to receive non-pharmacological care provided in the framework of free outpatient care. their indicators will be recorded during a routine visit to the doctor at the baseline, after 12 and 24 weeks.

Eligibility criteria:
inclusion criteria: * medically diagnosed with type 2 diabetes mellitus * hba1c result of ≤7.0% within the past 2 months * body mass index (bmi) of ≥26 kg/m\^2 * hypoglycemic therapy: metformin only exclusion criteria: * pregnancy * the use of other hypoglycemic drugs * the use of medication for weight loss * cardiovascular diseases (heart attack or cardiac procedure within the past 3 months) * had stroke or history of treatment for transient ischemic attacks in the past 3 months * had chronic renal failure or were on dialysis * any conditions that do not allow the patient to perform the complex of the proposed physical exercises

Keywords: type 2 diabetes mellitus non-pharmacological treatment lifestyle intervention structured program
electroencephalograph for detection of acute ischemic stroke

Conditions: Stroke

Summary: the purpose of this study is collecting data for an electroencephalograph based algorithm for detection of onset and deterioration of acute ischemic stroke by comparison to nihss.

inclusion criteria study population age \> 18 years old. acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible. acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by nihss) and including patients treated by t-pa exclusion criteria study population primary intracranial hemorrhage on admission by ct. significant movement disorder. previous major hemispheric stroke. local skull or skin affliction which prevents electrodes application. any known condition which in the opinion of the investigator may interfere with the protocol implementation. inclusion criteria control population age \> 18 years old. exclusion criteria control population primary intracranial hemorrhage on admission by ct. significant movement disorder. previous major hemispheric stroke. local skull or skin affliction which prevents electrodes application. migraine any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Eligibility criteria:
inclusion criteria: * age \> 18 years old. * acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible. * acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by nihss) and including patients treated by t-pa exclusion criteria: * primary intracranial hemorrhage on admission by ct. * significant movement disorder. * previous major hemispheric stroke. * local skull or skin affliction which prevents electrodes application. * any known condition which in the opinion of the investigator may interfere with the protocol implementation

Keywords: stroke
a study of avastin (bevacizumab) in patients with non-squamous non-small cell lung cancer (nsclc)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this 3 arm study will evaluate the efficacy and safety of adding avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (nsclc) who have not received prior chemotherapy. the anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * documented inoperable, locally advanced, metastatic or recurrent non-squamous nsclc; * adequate liver and kidney function; * women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment. exclusion criteria: * prior chemotherapy or treatment with another systemic cancer therapy; * surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment; * brain metastasis or spinal cord compression; * fertile men, and women of childbearing potential, not using adequate contraception; * treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.