Kornimate/medical-research-clean huggingface dataset:
randomized study evaluating the efficacy of low intensity transcranial electrical stimulation (tdcs) for the relief of dyspnea

Conditions: Dyspnea; Mechanical Ventilation Complication

Summary: nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. this respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. physiopathological mechanisms of dyspnea are beginning better understood and have analogies with those of pain. like pain, dyspnea often persists despite appropriate treatment of the cause, because of perceptual dysfunction related to changes in cortical excitability and neuronal plasticity and requires specific treatments. studies have shown that transcranial stimulation by low current (tdcs) was able to modulate the perception of acute pain induced and chronic pain. the tdcs modulates the functioning of a whole set of brain structures including the anterior cingulate gyrus, the prefrontal cortex, the thalamus and the brain stem, some of which have an established role in the central integration of pain and dyspnea. the investigators have recently demonstrated that the application of tdcs on the primary cortical motor area reduces the excitability of the central neurological pathways dedicated to the respiratory muscles in healthy subjects. the investigators therefore hypothesize that tdcs could relieve dyspnea in intensive care. in this research project, the investigators propose to evaluate the efficiency of tdcs on dyspnea in patients admitted to intensive care unit, having sepsis and mechanically ventilated.


Eligibility criteria:
inclusion criteria: * adult patient, hospitalized in intensive care unit, presenting a sepsis, having required a mechanical ventilation since at least 24h. * non-sedated or showing good wake up (richmond agitation-sedation scale score (rass)\> -3 at inclusion (sessler et al., 2002)) within 48 hours after cessation of sedation * patient able to answer by "yes" or "no" to simple questions * showing significant dyspnea (level ≥ 4) on the a1 sub-scale of the multidimensional dyspnea profile (mpd-a1 ≥ 4). * signature of informed consent by the patient or his relative. exclusion criteria: * patient under guardianship, * wake up delay, coma (gcs ≤ 8), or severe agitation. * chronic respiratory pathology * respiratory pathology, neuromuscular or neuro-sensory disability (auditory or visual). * cranioplasty * language barrier, refusal to participate in the study or to sign the informed consent, * pregnant or nursing woman, * no affiliation to a social security scheme.
intermittent oro-esophageal tube feeding on cerebral small vessel disease patients with dysphagia

Conditions: Cerebral Small Vessel Diseases

Summary: nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. compared to ngt, ioe, as an enteral nutrition support mode, in csvd patients with dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, adl, qol, pneumonia, and adverse events, which should be considered as the preferred approach.

nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. this was a randomized controlled study with 60 csvd patients with dysphagia who received comprehensive rehabilitation therapy. patients enrolled were randomly divided into the observation group (with ioe, n=30) and the control group (with ngt, n=30). at admission and after treatment, video fluoroscopic swallowing study (vfss) and functional oral intake scale (fois), body mass index (bmi), serum albumin (alb), and hemoglobin (hb), modified barthel index (mbi) and world health organization quality of life assessment instrument brief version (whoqol-bref) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (adl) and quality of life (qol). the incidence of pneumonia was recorded and compared.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of csvd, confirmed by mri; * must be able to cooperate with treatment and questionnaire investigation, (generally with a mini-mental state examination (mmse) score ≥ 24) ; * clinical diagnosis of dysphagia through the functional oral intake scale (fois) and video fluoroscopic swallowing study (vfss); * age between 40 and 70 years; * enteral nutrition support was required and feasible. * no history of prior stroke. exclusion criteria: * dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * complicated with severe liver and kidney failure, tumors, or hematological disorders; * simultaneously need to undergo other therapy that might affect the outcomes of this study; * unable or unwilling to undergo vfss; * pregnant or nursing females.

Keywords: cerebral small vessel disease enteral nutrition. intermittent oro-esophageal tube feeding
liberate - liposomal bupivacaine versus adjuncts in total shoulders

Conditions: Post-operative Pain; Total Shoulder Arthroplasty; Osteoarthritis of the Shoulder; Pain Management

Summary: this will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and pf dexamethasone in patients undergoing primary shoulder arthroplasty. primary endpoint will be total opioid consumption in the first three post-operative days.


Eligibility criteria:
inclusion criteria: * patient age \>18 years; * lack of language barrier; * informed consent obtained; * presenting for primary total shoulder arthroplasty (tsa), both anatomic and reverse, by a specialty-trained surgeon; * american society of anesthesiology (asa) physical status score i- iii exclusion criteria: * presence of a language barrier; * inability to complete telephone and/or paper questionnaire; * lack of consent; * allergy to local anesthetic; * chronic pain syndrome and/or preoperative opioid use \> 50 mme per day (including extended-release formulations and methadone); * preoperative consultation to chronic pain service; * history of (\<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the office of disease prevention and health promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men); * baseline peripheral neuropathy of the brachial plexus; * contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent american society of regional - - -anesthesiology (asra) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site; * severe chronic obstructive pulmonary disease (copd) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy; * weight \< 45 kg, given concern for local anesthetic toxicity at dosages given for the study; asa score iv-v; * revision arthroplasty; * anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block; * pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery

Keywords: brachial plexus liposomal bupivacaine dexamethasone interscalene bupivacaine shoulder arthroplasty regional anesthesia exparel
pegasys® plus ribavirin in thalassemic patients with hepatitis c virus infection

Conditions: Hepatitis C; Thalassemia

Summary: antiviral treatment of hcv in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. blood transfusion in thalassemic patients are a known high risk for acquiring hepatitis c. the investigators are trying the pegasys (peginterferon alpha-2a(40 kd)) plus ribavirin in thalassemic patients with hcv.

patients with thalassemia receive chronic blood transfusions and have an increased prevalence of chronic hepatitis c virus (hcv) infection, particularly if transfused before hcv serological testing became available. the investigators enrolled 300 patients into the study. the patients received pegasys (peginterferon alpha-2a(40 kd)) 180 microgram per week plus copegus (ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. follow up period is 6 months after treatment. the patients are visited every 4 weeks with biochemistry lab tests. the patients are checked with quantitative hcv rna (ribonucleic acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. the patients with undetectable hcv rna are considered as responders.

Eligibility criteria:
inclusion criteria: * hcv rna positive * age older than 12 years exclusion criteria: * ongoing pregnancy or breast feeding * history (hx) of hepatocellular carcinoma (hcc) * hx of alcoholic liver disease * hx of bleeding from esophageal varices * hx of hemochromatosis * hx of autoimmune hepatitis * hx of suicidal attempt * hx of cerebrovascular dis * hx of severe retinopathy * hx of severe psoriasis * hx of scleroderma * hx of metabolic liver disease * hx of systemic lupus erythematosus (sle)

Keywords: hepatitis c thalassemia pegasys ribavirin
ph 2 open label study of gc4419 to reduce som associated with chemoradiotherapy for head and neck cancer

Conditions: Head and Neck Cancer; Oral Mucositis

Summary: gti-4419-202 is a phase 2 open-label study of the effects of gc4419 (iv) when administered in combination with imrt and cisplatin to up to subjects with head and neck cancer, who are at high risk for severe oral mucositis (som)

subjects will receive 90 mg gc4419 per day (60 min iv infusion to complete within 60 minutes prior to imrt), concurrent with daily fractions of imrt (2.0-2.2 gy) to a total of 60-72 gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (investigator's choice). all subjects will be assessed twice weekly for oral mucositis (om) per who grading criteria until 28 days post end of study treatment period (last day of imrt).

Eligibility criteria:
inclusion criteria: 1. pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent imrt. 2. treatment plan to receive a continuous course of imrt delivered as single daily fractions of 2.0 to 2.2 gy with a cumulative radiation dose of 60-72 gy. 3. patients who have had prior surgery may be eligible, 4. treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses). 5. age 18 years or older 6. ecog performance status ≤ 2 7. adequate hematologic function 8. adequate renal and liver function alkaline phosphatase ≤ 2.5 uln exclusion criteria: 1. metastatic disease 2. prior radiotherapy to the region of the study cancer or adjacent anatomical sites 3. prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with imrt 4. planned concurrent chemotherapy other than single agent cisplatin 5. receiving any approved or investigational anti-cancer agent 6. concurrent participation in another interventional clinical study 7. inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures 8. complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline 9. malignant tumors other than head and neck cancer (hnc) within the last 5 years 10. active infectious disease excluding oral candidiasis 11. presence of oral mucositis at baseline. 12. known history of human immunodeficiency virus (hiv) or active hepatitis b/c 13. female patients who are pregnant or breastfeeding 14. known allergies or intolerance to cisplatin and similar platinum-containing compounds 15. requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
pocket echocardiography system (pes) for detection of pda in neonates

Conditions: Patent Ductus Arteriosus

Summary: this is a single-center, feasibility study involving all neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. parents will be approached and provided a description of the study. no written consent will be requested, but parents have the option of opting out. each patient will have a 5 minute pocket echocardiography system scan followed by a full echo performed on a traditional full featured echo system. the objective is to assess if the current food and drug administration (fda) approved pocket echocardiography system (pes) can detect patent ductus arteriosus (pda) in neonates as comparable to traditional full featured echo systems (ffes) and/or physical exam alone.

all newborns admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation will be included in this study. parents will be approached and provided a description of the study. no written consent will be requested, but parents have the option of opting out. if parents agree to be part of this study, a 5-minute pes scan will be performed first so as to not bias the sonographer. then, a full echocardiogram study will be performed on a traditional ffes. the scans will be performed at the bedside. the images will be reviewed and compared by fellow and/or attending and by experienced sonographer. the scans will include short axis view, ductal view and arch view. the objective of the study is to assess if the current fda approved pes can detect pda in neonates as comparable to traditional full featured echo systems and/or physical exam alone. using pes for pda diagnosis will be an accessible, economic and effective way of complementing the findings in our physical exam by increasing diagnostic accuracy, and detecting pda's at the bedside comparable to a full size traditional echocardiographic system.

Eligibility criteria:
inclusion criteria: * all newborn infants with orders for cardiac echocardiography evaluation in clinically stable condition exclusion criteria: * known congenital heart disease. * clinically unstable (meaning by unstable patients: those patients that need cardiopulmonary resuscitation, or in maximum ventilatory or inotrope support and in immediate need for extracorporeal membrane oxygenation or major surgery or whenever the physician attending responsible for the clinical care of the patient considers that a traditional echo needs to be done urgently)

Keywords: pda echo pes handheld echo system
effects of corrective exercise training for improving neuropathic pain and function in knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: patients with neuropathic pain had longer duration of symptoms increased severity of pain, functional limitation and disability as compare to the patient with general knee osteoarthritis. objective: to find out the effects of corrective exercise training for improving neuropathic pain and function in knee oa patients.

this study was a quasi experimental study. it was conducted at horizon hospital johar town lahore. the study was completed in six months. consecutive sampling technique was used to collect the data. the sample size of 16 patients was taken in this study to find out the effects of corrective exercises training for improving neuropathic pain and function in patients with knee osteoarthritis. for descriptive analysis we used frequency, percentages and charts. for quantitative measure. repeated measured anova was used.

Eligibility criteria:
inclusion criteria: * acr criteria for osteoarthritis * neuropathic pain * age over 65 * dn4 cut off value is 4/10 * less than 30 minutes of morning stiffness * grade i and ii * crepitus on active motion * bony tenderness * bony enlargement * no palpable warmth of synovium exclusion criteria: * knee complain that require urgent medical attention (fracture and infection) * diabetes mellitus * patients with malignancies * neurological disorders * systematic musculoskeletal diseases (parkinson's, rheumatoid arthritis etc) * incapability of understanding implication of participants

Keywords: knee osteoarthritis
a prospective, open, non-randomized phase i/ii study of therapeutic angiogenesis in diabetic patients with critic ischemia of lower limbs while administering positive cd133 mobilized with g-csf

Conditions: Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF

Summary: the primary objective is to analyze the safety and efficacy of cd133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs. the secondary objectives are: * to determine the safety of the intramuscular administration of cd133+ cells that have been mobilized from peripheral blood. * to determine the cd133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs. * to evaluate the patient global health condition using the notified results of the sf-36 questionnaires completed by patients

a total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. patients will be administered with cd133+ cells, that previously have been obtained of their peripheral blood after mobilization with g-csf the study is divided in three phases: pre-treatment (previous 4 weeks of cd133+ cells mobilization). treatment (cells mobilization, cd133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) follow-up (9 and 12 months after transplant visits)

Eligibility criteria:
inclusion criteria: * according to the investigator opinion, patient is able to carry out with all the clinical trial requirements * patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention * age 18 to 75 * a diagnosis of chronic critic ischemia of the lower limbs * diabetes mellitus active * iii or iv stages (fontaine classification): resting pain, ulcer or minor gangrene with no major amputation * general contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria * if female reproductive potential, negative pregnancy test exclusion criteria: * pregnant or currently breast feeding women * acute myocardial infarction within the last 3 years * non re-vascular unstable angina pectoris * history of ischemia stroke within the last 3 years * neoplasia at the time of inclusion or chemotherapy or radiotherapy treatment in the last 5 years * chronic renal insufficiency * g-csf contraindication * a non well controlled serious concomitant disease * history of serious thrombotic episodes within the past 3 years * patients who have received other investigational therapy within 30 days previous to the study inclusion * patients currently in other clinical trial or receiving any other investigational agent

Keywords: cellular therapy cd133+
a study of efruxifermin in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis (nash) (symmetry)

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a multi-center evaluation of efruxifermin (efx) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven f4 compensated nash.


Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent. * main study only: previous history or presence of type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose). * main study only: biopsy-proven compensated cirrhosis due to nash. * cohort d only: diagnosis of type 2 diabetes * cohort d only: use of glp-1r agonist for at least 90 days * cohort d only: biopsy-proven liver fibrosis stages 1, 2, or 3 exclusion criteria: * main study only: weight loss \> 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer. * type 1 diabetes or uncontrolled type 2 diabetes * cohort d only: weight loss \> 5% in the 90 days prior to screening * cohort d only: presence of cirrhosis on liver biopsy other inclusion and exclusion criteria may apply
sexuality of women with pelvic cancer

Conditions: Sexual Behavior; Pelvic Cancer

Summary: this study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

the representations associated with sexuality and cancer seem antinomic: wellbeing / death, and yet combine in the experience of cancer. the latter has an impact on sexuality in terms of satisfaction or sexual activity and on the relationship in terms of support. in addition, various studies show the psychological impact of treatments on the couple's relationship or the body image of women with cancer. their abilities to seduce are affected and explain the decrease of their sexual activity during the treatments: a communication, valuing the femininity, would it then facilitate the relations of couple? there is no work that considers sexuality in a systematic way (sexual act and verbal and non-verbal communication) and apprehends its link with the evolution of the relationship, from the diagnosis of cancer to the end of treatments. this study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * life in a couple or single with a regular partner for at least 3 months * cancer of the cervix or uterine body or ovarian cancer, in first diagnosis and treatment * whatever the stage of cancer * curative treatment * support in one of the participating centers * possible follow-up of all stages of the research exclusion criteria: * presence of metastases * history of other cancer * history of severe psychiatric illness