Kornimate/medical-research-clean huggingface dataset:
upper limb robot-assisted therapy in patients with guillain-barré syndrome

Conditions: Guillain Barré Syndrome

Summary: guillain-barré syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. the aim of this double-blind randomized controlled trial with a sham control group is to evaluate the effects of robot-assisted therapy, integrated with conventional therapy, on upper limb motor recovery in patients with gbs.

guillain-barré syndrome is a leading cause of acute flaccid paralysis, presenting with limb weakness and hyporeflexia or areflexia. guillain-barré syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. this study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with guillain-barré syndrome. a double-blind randomized trial will be conducted, where the experimental group will undergo actual robotic rehabilitation sessions, while the control group will perform sessions in which the robot will carry out simple mobilization, comparable to traditional interventions. this approach will help maintain participant blinding. patients will be evaluated before and after treatment, and with two follow-up assessments 60 and 90 days after therapy initiation. evaluations will include muscle recruitment and autonomy in daily living activities.

Eligibility criteria:
inclusion criteria: 1. diagnosis of guillan-barré syndrome; 2. ul motor impairment (0-4 in the medical research council scale); 3. sub-acute phase (until 180 days); 4. patients able to maintain the sitting position. exclusion criteria: 1. concomitant neurological, orthopedic, metabolic, and oncological diseases; 2. cognitive impairment assessed with the mini mental state examination (score under 24 points); 3. visual deficit; 4. hearing disorders.

Keywords: polyradiculopathy chronic inflammatory demyelinating polyradiculoneuropathy polyradiculoneuropathy exoskeleton device robotic rehabilitation
cytokine profile of conjunctivitis, performed through tears analysis among patients treated with dupilumab

Conditions: Conjunctival Diseases; Atopic Dermatitis; Side Effect

Summary: this study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with dupilumab


Eligibility criteria:
inclusion criteria: * patients with severe atopic dermatitis resistant to main immunosuppressive drugs * treated with dupilumab * with or without conjunctivitis * postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception exclusion criteria: - pregnant or breastfeeding women
gabapentin and neural mobilization pain reduction effect compared to only gabapentine

Conditions: Carpal Tunnel Syndrome

Summary: in the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

the present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral gabapentin treatment, to those effects produced by a gabapentin (only) treatment. additionally, effects over the functionality of the affected upper limb will be evaluated and compared. subjects will be invited to participate and randomly allocated to 2 different groups.

Eligibility criteria:
inclusion criteria: * participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings). * full understanding of written and spoken spanish (language). * participants must freely consent to participate. * the presence of positive phalen an tinel sings. * the presence of carpal tunnel syndrome signs and symptoms exclusion criteria: * the lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive)

Keywords: gabapentin median nerve neural mobilization pain
laryngopharyngeal reflux and proton pump inhibitor (ppi) treatment

Conditions: Laryngopharyngeal Reflux

Summary: this study proposes to investigate prospectively, the presence of molecular markers for inflammation in laryngopharyngeal reflux (lpr) patients and to study the effect of a proton pump inhibitor (aciphex) on these molecular markers. the investigators will be evaluating a group of patients before and after treatment. this group will be patients that have untreated laryngopharyngeal reflux diagnosed by laryngoscopic assessment and a 24-hour probe.

objectives: this study proposes to investigate prospectively, the presence of molecular markers for inflammation in lpr patients and to study the effect of a proton pump inhibitor on these molecular markers. this study will provide important data regarding the etiology of lpr. it will also provide vital information about the present standard treatment for lpr and why it is not universally successful. patient selection criteria: the subject group will consist of 25 subjects who have untreated lpr diagnosed by laryngoscopic assessment and 24-hour ph probe. design: the presence of proinflammatory cytokines will be measured at the gene and protein expression levels from pl biopsies with gene specific semiquantitative reverse transcription-polymerase chain reaction and western blot analysis. statistical methods, data analysis, and interpretation: null hypothesis: there will be no difference in cytokine expression in the posterior larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with aciphex, a proton pump inhibitor. alternative hypothesis: there will be a difference in cytokine expression in the posterior larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with aciphex, a proton pump inhibitor. effect size = 30% (based upon review of the literature for cytokines in inflammatory states) standard deviation = 30 standard effect size = effect size/standard deviation = 30/30 = 1 with an alpha of 0.05, power 0.1 (90% power), sample size should be 22. therefore we have chosen 25 subjects in case of error in molecular studies. paired t-tests will be utilized to compare differences between cytokine levels for experimental group initiation and completion of medication.

Eligibility criteria:
inclusion criteria: * the subject group will consist of 25 subjects who have untreated lpr diagnosed by laryngoscopic assessment and 24-hour ph probe.
safety and efficacy of a single subretinal injection of jwk002 gene therapy in subjects with x-linked retinoschisis(xlrs)

Conditions: X Linked Retinoschisis

Summary: this trial is to evaluate the safety and efficacy of jwk002 treatment of x-linked retinoschisis(xlrs). this study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of jwk002.


Eligibility criteria:
inclusion criteria: 1. fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the informed consent, and be able to cooperate with the testing required in various studies according to the requirements of the program; 2. male, ≥5 years old and \< 18 years old (subject to the date of signing the informed consent); 3. clinically diagnosed xlrs, identified by genetic testing as rs1 gene mutation, and do not carry other mutations causing ophthalmic genetic diseases; 4. best corrected visual acuity (bcva) of the study eye ≤63 letters (equivalent to snellen 20/63); best corrected visual acuity (bcva) ≥34 letters (equivalent to snellen 20/200). exclusion criteria: 1. carbonic anhydrase inhibitor treatment within 3 months; 2. the presence of other conditions in the study eye that may cause vision loss (e.g., atrophy of the optic nerve, advanced glaucoma, uveitis, the presence of vesicular splitting chambers or vesicular retinal detachment that may affect the subretinal injection operator); 3. those who study the retinal observation and examination caused by lens, cornea or other refractive interstitial turbidity; 4. there are eye conditions affecting subretinal injection or eye conditions affecting the determination of the study endpoint; 5. patients who had undergone internal eye surgery within 6 months; 6. patients with aav8 neutralizing antibody titer ≥1:1000; 7. have previously received any gene therapy or cell therapy; 8. fertile subjects are unwilling to use contraception; 9. the presence of any of the following: an active infection that the investigator believes may affect the patient's participation in the study or affect the study results that requires systematic treatment; hepatitis b surface antigen positive, hepatitis b virus deoxyribonucleic acid (hbv dna) copy number \> uln; hepatitis c virus (hcv) antibody positive and hcv-rna copy number \>uln; treponema pallidum antibody positive; positive for human immunodeficiency virus (hiv) antibodies; 10. malignant tumors (basal cell or squamous cell skin cancer) were diagnosed within 5 years prior to screening; 11. has or has had a systemic immune system disease; 12. laboratory values considered to be clinically significant were abnormal: alanine and/or aspartate transaminase \>2.5×uln, total bilirubin \>1.5×uln, serum creatinine \>1.5×uln, prothrombin time ≥1.5×uln, activated partial thromboplastin time ≥1.5×uln; (13) have a severe allergy or a known allergy to the drugs used in the treatment or examination in the study protocol, including the investigational drug allergy; (14) other situations that the investigator considers inappropriate for participation in this study.

Keywords: x linked retinoschisis
auto-allo tandem stem cell transplantation for patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the present study will be a multicenter, prospective phase ii-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma and age of \>_60 years, followed by maintenance therapy with low-dose thalidomide and donor lymphocyte infusions.


Eligibility criteria:
inclusion criteria: * multiple myeloma stage ii or iii acc. to salmon and durie * patient's age 18-60 years * patient's written informed consent * women and men capable of reproduction must agree to use adequate contraceptive measures (condom, iud, oral contraceptives) until three months after termination of treatment * a maximum of eight chemotherapy cycles prior to registration (cr/ pr/ mr/ or pd) exclusion criteria: * more than eight chemotherapy cycles prior to registration * severe irreversible renal, hepatic, pulmonary or cardiac disease, such as * total bilirubin, sgpt or sgot \> 3 times upper the normal level * left ventricular ejection fraction \< 30 % * creatinine clearance \< 30 ml/min * dlco \< 35 % and/or receiving supplementary continuous oxygen * positive serology for hiv * pregnant or lactating women * participation in another trial at the time of registration * preceding autologous stem cell transplantation * age \> 61 years

Keywords: multiple myeloma stem cell transplantation thalidomide dli
triple therapy convenience by the use of one or multiple inhalers and digital support in chronic obstructive pulmonary disease

Conditions: Copd; Adherence, Medication

Summary: tricolon is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the netherlands. the primary objective is to investigate in copd patients if single-inhaler triple therapy (sitt) is superior to multi-inhaler triple therapy (mitt) in terms of adherence to inhaled corticosteroids (ics) therapy and to investigate if sitt with e-health support is superior to mitt and sitt without e-health support.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd for at least 1 year before the screening visit * aged 40 years and older * an indication for triple therapy according to the treating physician (following the gold guideline 2021(2)). could be step-up from dual therapy or currently receiving triple therapy (both mitt and sitt). * owner of mobile device compatible with e-device app with access to internet (android or ios) * willing to provide written informed consent * current or ex-smoker exclusion criteria: * inability to comply with study procedures or with study treatment * insufficiently skilled in the dutch language to be able to read and understand the app. help by third party (family members) is allowed * asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed * use of e-health application for copd in the past six months * patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion) * use of nebulized bronchodilators, for example via pari boy * pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive * patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order * patients without the capability to complete the questionnaires
biomechanical taping on low back pain with increased foot pronation

Conditions: Low Back Pain; Foot Posture; Taping; Functional Mitral Regurgitation

Summary: it is stated that abnormal lower extremity posture and biomechanics are effective in the development and progression of low back pain (lbp). exercise, electrotherapy, insoles, and orthoses are used for the prevention and treatment of low back pain.the use of orthosis, insoles, and taping techniques stands out in the correction of foot posture and dysfunctions, which are stated to cause lbp. in studies examining the application of taping to improve foot posture and biomechanics, it is stated that taping is effective in improving foot posture and biomechanics in the short term. biomechanical taping has been used in the treatment of musculoskeletal disorders in recent years. it is aimed to correct the impaired joint biomechanics by reducing the load on the joint, supporting strength, and providing movement modification.

in this study, it is assumed that correction of "increased foot pronation" with dynamic taping will result in the recovery of increased internal rotation and decreased shock absorption during weight-bearing, which is stated to cause pain. the study aims to investigate the effects of biomechanical tapping in combination with a home exercise program on lbp. participants with a diagnosis of lbp and bilateral increased flexible foot pronation will divide into two groups (biomechanical taping (bt) group or placebo taping (pt) group). tape applications will repeat twice per week, for 4 weeks. and also a home-based exercise program will apply to both groups.

Eligibility criteria:
inclusion criteria: * mechanical low back pain for at least 6 months * age between 18-65 years * increased, bilateral, flexible pronation of the feet (foot posture index-6 score\> 0) exclusion criteria: * rigid pes planus, pes cavus, equinus deformity, hallux valgus, hallux rigid or calcaneal epin in the feet * lower extremity injury or surgery in the last 6 months * radicular type back pain (patients with leg pain\> low back pain) * body mass index (bmi)\> 30, * use of analgesics * pregnancy * presence of symptoms related to a history of spinal surgery in the last 5 years. * neurological impairment or cognitive dysfunction (stroke, dementia, etc.) * rheumatological diseases * peripheral vascular diseases * difference in length between extremities

Keywords: biomechanical-taping mechanical low back pain foot posture function
progressive esophageal dilation for benign strictures: a randomized controlled trial

Conditions: Benign Esophageal Stricture

Summary: a randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation compared to conservative esophageal dilation in patients with severe benign esophageal strictures.

a randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation (up to 6mm) compared to esophageal dilation according to the rule-of-3 in patients with severe benign esophageal strictures. patients will be followed up for 6 months. when recurrent dysphagia occurs within 6 months the patients will be dilated according to the previously allocated strategy.

Eligibility criteria:
inclusion criteria: * dysphagia due to benign esophageal stricture (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) requiring esophageal dilation * requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter) * no history of esophageal endoscopic dilations for benign strictures the past 6 months * dysphagia for solid, semisolid or liquid food (dysphagia score ≥ 2 \[ogilvie\]16, and dysphagia score ≤ 21 \[dakkak and bennett\]19, see appendix) * written informed consent exclusion criteria: * patient \< 18 years old * patient is unwilling or unable to sign and date the informed consent * patient is unwilling or unable to comply with the follow-up schedule * patient is unable to understand informed consent and fill in the questionnaires due to a language barrier * patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month * patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study * previous esophageal dilation for benign stricture within the past 6 months * patient with a life expectancy \< 12 months * patient with a known eosinophilic esophagitis or motility disorder (such as achalasia) * patients with a known malignant esophageal stricture * patients with a benign stricture due to a previous performed laryngectomy endoscopic exclusion criteria: * benign strictures in the upper part of the esophagus too close to the cricopharyngeal muscle (for the purpose of this protocol, within 1½ cm of the upper esophageal sphincter) * patients with stricture ≥ 10 cm in length * patients with an active esophageal perforation, leak, fistula, or varices * stricture within necrotic chronically bleeding tumors * highly suspected esophageal malignancy * stricture within polypoid lesions * known or strongly suspected dysmotility esophageal disorder * patient with high suspicion for an esophageal web, schatzki ring, eosinophilic esophagitis, or motility disorder (such as achalasia)
study to investigate the effect of balovaptan on the qtc interval in healthy subjects

Conditions: Healthy Volunteers

Summary: this was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the qtc interval in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects. healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemistry, urinalysis, and serology. * body mass index of 18 to 30 kg/m2, inclusive. * for women of childbearing potential: agreement to use at least 1 acceptable form of contraception during the entire study and for 90 days following last dose of study drug. * for men: vasectomized, agreement to remain abstinent or use of a condom during intercourse. must also agree to refrain from donating sperm. * fluent in english. exclusion criteria: * if female, a positive pregnancy test at screening or prior to day 1 of any treatment period. * lactating women. * any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator or designee.
effectiveness of the optifast program compared with a reduced-energy food based diet plan on body weight

Conditions: Obesity

Summary: compare percent change in loss of body weight between the optifast program and a food-based energy-deficit program


Eligibility criteria:
inclusion criteria: * adult males and females between 18 and 70 years * obese (bmi \> 30 kg/m2 and 55 kg/m2) * non-smokers or smoking cessation \> 6 months * \< 14 alcoholic beverages per week * willing and able to give informed consent exclusion criteria: * active participation in any weight loss program within previous 3 months * weight changes of \> 5% body weight within previous 3 months * participated in an optifast program within prior 5 years * prior bariatric surgery or liposuction * use of any medication prescribed for weight loss in the past 3 months * current major disease or gi disease that is poorly controlled (crohn's, ulcerative colitis) * type 1 dm * current esrd * current copd * any major or active hepatic disease requiring inpatient or outpatient treatment * history of acute pancreatitis in the past year * active cancer treatment in the past 2 years other than non-malignant skin cancers * uncontrolled hypertension (blood pressure 160/100 or greater) * hemoglobin a1c \> 10% * recent cv event in past 6 months * pregnancy, childbirth, or nursing within prior 6 months * eating attitudes test (eat-26) \> 30 * current major depressive disorder with center for epidemiological studies depression scale-revised (cesd-r) score \> 16 * schizophrenia, history of bipolar disorder * recent hospitalization for psychiatric illness in past 6 months * dependence on alcohol or sedative-hypnotic drugs * intolerance or allergy to optifast product * unable to read/speak english * orthopedic limitation preventing participation in regular physical activity * untreated thyroid disease, abnormal tsh, non on stable dose of hormone replacement for hyperthyroidism * major surgery defined as any surgical procedure that might require prolonged convalescence or limit participation in the program in any way * inability to complete the 7-day run-in satisfactorily