Kornimate/medical-research-clean huggingface dataset:
effects of laying on of hands in fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia is conceptualized as non-inflammatory syndrome with manifestation in the musculoskeletal system associated with chronic generalized pain, fatigue, mood and sleep changes. laying on of hands therapies are intended to prevent injuries, promote health recovery and harmony between the physical, mental and spiritual dimensions. the aim of this study is to evaluate the effects of laying on of hands with and without a spiritual connection on the mental and physical health, well-being and quality of life of women with fibromyalgia. 72 patients will be divided into 3 groups: control - without imposition of hands, imposition without spiritual presence with the intention of healing and imposition with spiritual presence through the spiritist passe.

this is a triple-blind, randomized, controlled clinical trial of 10 weeks, with a minimum sample of 72 participants, to be carried out at the center for integrative and complementary practices of the hospital de clínicas da uftm. participants will be informed about the research objectives, their voluntary participation and anonymity. then, they will be randomly placed in one of the groups: control, imposition by volunteers with healing intent (gim) and spiritist passe. all participants will lie on a stretcher for about 5 minutes, then vital signs (blood pressure and heart rate and pain assessment by vas) will be measured before, immediately after the intervention on days d1, d8 and d10. during the laying on of hands, they will receive the following verbal command: "mentalize relief of pain and improvement of symptoms". after the end of the intervention, they will receive systemic acupuncture: the acupuncture application method will be standardized in all participants, insertion of a systemic needle 0.20 x 0.40 perpendicularly in the following points: pericardium 6, heart 7, spleen, pancreas 6, large intestine 4, liver 2, stomach 36 bilaterally and will remain for about 20 minutes. participants will receive interventions lying on stretchers in a room prepared for this purpose. the eyes will be blindfolded with a visor made for the study.

Eligibility criteria:
inclusion criteria: * women with fibromyalgia * up to 18 years * diagnosis of fibromyalgia according to acr 2010 criteria exclusion criteria: * pregnant women * treatment for cancer * inability to understand the questionnaires * refusing to sign the informed consent

Keywords: laying on of hands therapeutic touch pain c
a study with tocilizumab [roactemra/actemra] monotherapy or in combination with methotrexate in patients with rheumatoid arthritis (picture)

Conditions: Rheumatoid Arthritis

Summary: this single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[roactemra/actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (ra). patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (dmard). patients received 8 mg/kg tocilizumab \[roactemra/actemra\] as an intravenous infusion every 4 weeks for a total of 6 infusions. the anticipated time on study treatment was 24 weeks. the target sample size was 50-200 patients.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age * moderate to severe rheumatoid arthritis (ra) for at least 6 months (defined as a disease activity score (das28) \> 3.2 at screening) * patients with active ra after more than 12 weeks of treatment with dmards * patients with inadequate response to a stable dose of non-biologic dmard exclusion criteria: * autoimmune disease other than ra. patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (mtx) and patients with sjögren's syndrome and ra are permitted * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment * prior history of or current inflammatory joint disease other than ra
niemann-pick type c treatment with adrabetadex for symptoms of brain and nervous system

Conditions: Niemann-Pick Type C Disease

Summary: this study was amended from expanded access to a clinical trial. information will be collected about long-term safety and effectiveness of adrabetadex shots in the spine every 2 weeks. participants who were already taking adrabetadex will receive their stable dose. participants who have not ever taken it will start by receiving 400 mg. participants will receive treatment every 2 weeks until their doctor finds it does not help them anymore, they withdraw, or the study is stopped for any reason. participants will not receive additional study treatment after their participation in this protocol.


Eligibility criteria:
inclusion criteria: to be included in the study, a participant must meet the following criteria: * is male or female and at least 4 years of age at time of screening. * has a confirmed diagnosis of npc and exhibits neurologic symptoms. * has written informed consent/assent to participate. * has the ability to undergo lp and it drug administration. * if taking miglustat (zavesca®), must have been on a stable dose for the past 6 weeks and be willing to remain on a stable dose for the duration of participation in the study, or discontinue miglustat use at least 6 weeks before entry into the study (day 1). * if has a history of seizures, the condition is adequately controlled as per protocol requirements. * agrees to discontinue any investigational treatments (other than adrabetadex) for at least 1 month before first dose on day 1. * if engaging in heterosexual sex, agrees to use a protocol-defined method of contraception throughout the study, and until 30 days after completing the study. * has a responsible adult who the investigator determines is able and willing to comply with study requirements and a parent/guardian who will accompany the participant to study visits. exclusion criteria: participants will be excluded from the study if they meet any of the following criteria: * weighs less than 15 kg. * has a history of hypersensitivity reactions to any product containing 2-hydroxypropyl-β-cyclodextrin (hp-β-cd) or has a history of hypersensitivity reactions or allergy to anesthesia/sedation. * has received treatment with any investigational product (other than adrabetadex) within 1 month prior to day 1 of treatment. * is pregnant or nursing. * has systemic infection or uncontrolled psychosis. * has known history of a bleeding disorder. * has used anticoagulants within 2 months of entry into the study. * per protocol, or in the opinion of the investigator: 1. has laboratory values that would preclude participation 2. has suspected infection of the central nervous system (cns) 3. has a spinal deformity that could impact performance of repeated lps 4. has a serious skin infection in the lumbar region or evidence of obstructive or normal pressure hydrocephalus 5. is unable to comply with the study requirements 6. has a medical condition that might increase the risk of participation

Keywords: niemann-pick npc npc type 1 (npc1)
close obstructive sleep apnea (osa) trial

Conditions: Obstructive Sleep Apnea; Patent Foramen Ovale

Summary: the aim of this study is to evaluate the benefits of patent foramen ovale (pfo) closure on patients with obstructive sleep apnea (osa) and persistent hypoxia despite optimal therapy.


Eligibility criteria:
inclusion criteria: 1. individuals diagnosed with severe osa, defined as an apnea-hypopnea index (ahi) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography. 2. individuals need to have a patent foramen ovale documented by echocardiography. exclusion criteria: 1. individuals unable to take aspirin, clopidogrel, and/or ticagrelor. 2. pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
a study of xeloda (capecitabine) in combination with oxaliplatin in patients with metastatic colorectal cancer.

Conditions: Colorectal Cancer

Summary: this single arm study will investigate possible pharmacokinetic interactions between xeloda and oxaliplatin, and assess whether the pharmacokinetics of xeloda and/or oxaliplatin is influenced by the addition of avastin. all subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. in cycles 1 and 2 patients will receive a treatment regimen containing xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 avastin (7.5mg/kg iv) will be added to the regimen. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * adenocarcinoma of colon or rectum, with metastatic or locally advanced disease. exclusion criteria: * previous systemic treatment for advanced or metastatic disease; * previous treatment with oxaliplatin or avastin.
a phase i study of nk042 cell injection in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a single-arm, open-label, multi-center phase 1 clinical study designed to evaluate the safety and preliminary efficacy of nk042 cell injection in patients with advanced solid tumors.

this study is divided into two phases: phase ia and phase ib. dose-escalation and expansion: * phase ia: this dose-escalation phase involves both single-dose and multiple-dose administrations of nk042 in patients with advanced solid tumors. * phase ib: this multiple-dose cohort-expansion phase will focus on solid tumor indications that demonstrated preliminary efficacy in phase ia.

Eligibility criteria:
inclusion criteria: 1. voluntary signing of a written informed consent form. 2. age between 18 and 70 years. 3. histologically or cytologically confirmed locally advanced or metastatic solid tumor patients who are not amenable to surgical resection, with no standard treatment options, or who have relapsed or progressed after standard treatment, or are resistant or intolerant to standard treatment. 4. at least one assessable tumor lesion according to response evaluation criteria in solid tumors, version 1.1 (recist 1.1). 5. eastern cooperative oncology group (ecog) performance status score of 0-1. 6. expected survival ≥12 weeks. 7. must have adequate bone marrow, liver, and renal function. exclusion criteria: 1. insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy. 2. participation in another clinical trial and use of investigational drugs within 28 days before the first dose. 3. requirement for anticoagulation therapy. 4. symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment. 5. active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis. 6. uncontrolled active infections. 7. uncontrollable massive pleural effusion, ascites, or pericardial effusion. 8. previous receipt of other cellular therapies. 9. planned concurrent participation in other anti-tumor treatments during the study. 10. pregnant or breastfeeding women.

Keywords: car-nk advanced solid tumors early-phase clinical trial cell therapy
a phase 2b study of csl112 in subjects with acute myocardial infarction.

Conditions: Acute Myocardial Infarction

Summary: this is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of csl112 compared with placebo in subjects with acute myocardial infarction (ami).


Eligibility criteria:
inclusion criteria: * men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type i (spontaneous) acute myocardial infarction (ami), in the last week. exclusion criteria: * ongoing hemodynamic instability * evidence of hepatobiliary disease * evidence of chronic kidney disease (ckd) (stage iii, iv, or v), defined as moderate or severe renal impairment or if subject is receiving dialysis * evidence of unstable renal function * history of acute kidney injury after previous exposure to an intravenous contrast agent. * known history of allergies, hypersensitivity or deficiencies to csl112 or any of its components * other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study
influence of early standing training on icu patients

Conditions: Pulmonary Disease

Summary: influence of early standing training on icu patients

objective: to study the effect of early standing training on icu patients.background: early severe rehabilitation is of great significance for patients, which can help patients withdraw from mechanical ventilation as soon as possible, improve pulmonary ventilation, and promote early walking.however, patients on mechanical ventilation are more prone to delirium, muscle weakness, ventilator dependence and other problems. early standing training can significantly improve patients' lower limb muscle strength, improve diaphragm function, improve the prognosis of patients, and reduce the length of hospital stay.methods: selecting stable hemodynamics in icu patients with mechanical ventilation, randomly divided into two groups, a group of routine rehabilitation training, another group stand for regular rehabilitation and early training, with the aid of electric beds, on the first day of patients, to evaluate the seventh day, the 14th day, and collect the basic information for patients and strength assessment, blood gas analysis, the diaphragm of the bed and ultrasound and muscle ultrasound, and record the patient's mortality within 28 days, the incidence of delirium, decannulation rate, etc., recorded in patients with mechanical ventilation time and the time required to walk independently and icu stay time.

Eligibility criteria:
inclusion criteria: * the age is ≥ 18 years old; * the hemodynamics is stable; * 50 \< heart rate \< 120 beats / min ; * 90 \< systolic blood pressure \< 200mmhg ; * 55 \< mean arterial pressure \< 120mmhg; * do not increase the dose of pressor drugs for at least 2 hours; * intracranial pressure is stable and there are no seizures within 24 hours; * the respiratory state is stable; * the patient's finger pulse oxygen saturation ≥ 88%; * oxygen concentration less than 60%； * terminal positive expiratory pressure\<12cmh2o； * 10 \< respiratory frequency \< 35 beats / min. exclusion criteria: * pregnancy; * acute cardio-cerebrovascular events; * spinal or limb fractures; * active bleeding.
self-administered relaxing acupressure to reduce fatigue in adolescent and young adult cancer survivors

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial tests the feasibility of self-administered relaxing acupressure on fatigue in adolescent and young adult (aya) cancer survivors. acupressure, a type of complementary or alternative medicine, is the application of pressure or localized massage to specific sites on the body to control symptoms. relaxing acupressure has been shown to improve cancer-related fatigue (crf) in adults, however, less is known about the impact of relaxing acupressure on crf in aya cancer survivors."

primary objective: i. determine the feasibility of implementing a randomized controlled trial of a six-week, self-administered relaxing acupressure intervention in aya cancer survivors with clinically relevant crf. secondary objective: i. explore participants' perspectives of acceptability and satisfaction with the six-week acupressure interventions using semi-structured interviews. exploratory objective: i. determine the preliminary efficacy of a six-week, virtual, self-administered relaxing acupressure intervention on clinically significant changes in crf in post-treatment aya cancer survivors. outline: patients are randomized to 1 of 2 arms. arm i: patients receive access to an acupressure mobile application and an acuwand on study and self-administer relaxing acupressure to 9 acupoints over 27 minutes once daily (qd) for 6 weeks. arm ii: patients receive access to an acupressure mobile application and an acuwand and self-administer sham acupressure to non-acupressure point locations over 27 minutes qd for 6 weeks.

Eligibility criteria:
inclusion criteria: * 15 - 39 years old * at least three months post cancer treatment (e.g., surgery, radiation or chemotherapy). participants receiving maintenance hormonal or targeted therapies will be allowed to enroll as determined by the study investigator * report clinically relevant fatigue in the past seven days (patient reported outcomes measurement information systems \[promis\] fatigue 4a scores ≥ 55) * speak / read english * crf started at or after the diagnosis of cancer * completed cancer treatment within the past five years exclusion criteria: * diagnosis of untreated anemia, mood disorder, or hypothyroidism * plan to begin new pharmacological, psychological, or other treatments (i.e., physical therapy or dietary supplements) for crf during the study. although, participants may continue usual treatments for crf if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed * plan to become pregnant or lactating during the study period * received acupressure or acupuncture in the past year
effect of ventilation tubes in otitis-prone children

Conditions: Recurrent Acute Otitis Media

Summary: the purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. by drawing lots, young children with recurrent ear infections will be assigned to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. the study participants will be followed until they are 7 years old.

children who fulfil the criteria of recurrent acute otitis media (aom) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). due to the nature of the intervention, blinding will not be possible. children randomised to are randomised to active monitoring and continue to have frequent recurrences will be given the opportunity to cross between groups. children will be followed by the study doctors every third month until the age of two years, and after this yearly. in addition to planned visits, the families will be advised to contact the study doctors whenever they suspect that their child has a new episode of aom. otomicroscopy and nasopharyngeal cultures will be performed at every visit; cultures from the external ear canal will be taken when applicable. it will also be noted whether there is any perforation of the tympanic membrane, whether ventilation tubes are still in place, whether there is an ongoing episode of aom or of otitis media with effusion (ome). at each planned visit, a parental quality of life questionnaire for children with ear disease will be completed. it will be noted how many aom episodes the child has had since the last planned visit, how many times the patient has been prescribed oral antibiotics (also for reasons other than aom), and if the family has seen a doctor elsewhere. at each emergency visit, it will be noted if the child has aom or not, whether the child has fever, any signs of complications to aom, a spontaneous perforation and whether the child´s general well-being is affected. at the ages of 4 and 7 years and, if a hearing impairment is suspected on any other occasion, hearing tests will be performed.

Eligibility criteria:
inclusion criteria: at inclusion, children should be under 1 year of age and fulfil the internationally accepted definition of recurrent aom, ie have had 3 episodes of aom during the last 6 months, or 4 during the last 12 months. - exclusion criteria: chromosomal aberrations, cleft palate or severe immune deficiency -

Keywords: ventilation tubes prevention quality of life antibiotic treatment otitis media with effusion audiometry watchful waiting tympanic membrane perforation
study with quadrivalent recombinant influenza vaccine (riv4) compared with egg-based quadrivalent influenza vaccine (iiv4) in participants aged 3 to 8 years

Conditions: Influenza Immunization

Summary: the purpose of this study was to demonstrate the non-inferior hai immune response of quadrivalent recombinant influenza vaccine (riv4) vs licensed egg-based quadrivalent influenza vaccine (iiv4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of riv4 compared to iiv4 in participants aged 3 to 8 years.

participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either riv4 or iiv4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.

Eligibility criteria:
inclusion criteria: * aged 3 to 8 years on the day of inclusion * assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations exclusion criteria: * known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * thrombocytopenia * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the investigator's judgment * personal or family history of guillain-barre syndrome (gbs) * personal history of clinically significant development delay (at the discretion of the investigator), neurologic disorder, or seizure disorder note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
treatment of acetabular fracture: the contribution of the 3d impression

Conditions: Acetabular Fracture

Summary: acetabular fracture are common in elder patients and high energy trauma in younger one. however, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. anatomic reduction and osteosynthesis of these fracture are technically difficult . 3d printing ease the process of operating planification or implant fabrication. the 3d impression allows to obtain a model on the scale of the pond of the patient allowing to pre mold plates on the anatomy of the patient before he is operated with the aim of decreasing the surgical time and improving the quality of the reduction.


Eligibility criteria:
inclusion criteria: * age \>18 * acetabulum fracture within one month * anterior access or double access exclusion criteria: * acetabulum fracture more than one month