Kornimate/medical-research-clean huggingface dataset:
effects of instrument assisted soft tissue mobilization and bowen technique in fibromyalgia

Conditions: Fibromyalgia; Low Back Pain

Summary: to compare the effects of bowen's and graston technique in patients of chronic low back pain for reducing pain, enhancing lumbar range of motion and physical functioning and reducing depression.

fibromyalgia is a chronic disease of idiopathic etiology, which is estimated to affect 2-4% of the population. it causes pain, stiffness, and tenderness in muscles, tendons, and joints, as well as sleep disturbances, fatigue, anxiety, depression, and alterations in intestinal functions. chronic low back pain is a pain of more than 12 weeks limited to the lower area of the back .the chief complaint of a patient with fibromyalgia is widespread musculoskeletal pain which is bilateral and involves both upper and lower parts of the body. the pain may be localized initially, commonly in the neck and shoulders. the predominant description of the pain is muscle pain, but the patients may complain of joint pain as well . grastοn technique is an instrument assisted soft tissue treatment method (іastm) derived from the cyriax1 cross-friction massage. physіοtherapist strikes stainless steel instrument in a longitudinal dіrectіοn and in circular patterns at the treatment site. many iastm instruments including astym, fascial abrasion technique and graston technique etc. facilitates the healing process through increased fibroblast proliferation and increased collagen synthesis, maturation, and alignment. bowen therapy is a dynamic fascial and muscle release approach, consisting of gentle cross-fiber movements applied to the fascia, muscles, tendons, muscle insertions, muscle septa, ligaments and viscera. it is named after tom bowen, who created a form of bodywork in geelong, australia and addresses the body as a whole unit rather than just the presenting symptoms. the rationale for the use of these techniques is to identify the effects of iastm and bowen therapy in chronic low back pain of fibromyalgia and to analyze the additional effects of these techniques by reducing the hyperalgesia and excitability in central nervous system by working on the descending pain modulation system and to identify the most time effective treatment for chronic low back pain in fibromyalgia.

Eligibility criteria:
inclusion criteria: * age between 30 and 65 years * both genders * patients with fibromyalgia were included in the study if they fulfilled criteria of the american college of rheumatology for fibromyalgia. * patients having chronic mechanical low back pain of more than three months exclusion criteria: * patients with tumor, infection and major trauma to the spine causing fracture or disruption of spine. * patients with cauda equina syndrome * any neurological disorder * any previous spinal fusion surgery or spinal cord stimulation. * pregnant females

Keywords: bowen technique instrument assisted soft tissue mobilization
pharmacokinetics and pharmacodynamics of cilofexor in adults with normal and impaired hepatic function

Conditions: Nonalcoholic Steatohepatitis (NASH); Primary Sclerosing Cholangitis (PSC)

Summary: the primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.


Eligibility criteria:
key inclusion criteria: cohort 1: * individuals with mildly impaired and normal hepatic function. * individuals with mild hepatic impairment must have a score of 5-6 on the child-pugh-turcotte (cpt) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period. cohort 2: * individuals with moderately impaired and normal hepatic function. * individuals with moderate hepatic impairment must have a score of 7-9 on the cpt classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period. cohort 3: * individuals with severely impaired and normal hepatic function. * individuals with severe hepatic impairment must have a score of 10-15 on the cpt classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period. note: other protocol defined inclusion/exclusion criteria may apply.
descriptive and risk factors analysis of all-cause postoperative death in patients undergoing cardiovascular surgery

Conditions: Postoperative Death

Summary: the investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery. the investigators identify all patients treated with cardiovascular surgery, between 2000 and 2020, within the wuhan union hospital and all collaborators. the surgical patient cohort will be matched with the national death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. logistic regression analysis for prediction of postoperative death adjusted for different covariates. the model was externally validated in the remaining 40% patients.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiovascular surgery exclusion criteria: * patients with incomplete electronic medical record information

Keywords: postoperative death cardiovascular surgery prediction model
injection of dorsal scapular n at different levels, dose it make difference?

Conditions: Pain, Chronic

Summary: dorsal scapular nerve (dsn) entrapment syndrome is an under-recognized cause of neck and shoulder pain. dsn injuries can be the origin of a well-defined chronic pain syndrome, often referred to as dsn syndrome. dsn syndrome is often characterized by a dull ache along the medial border of the scapula.

dorsal scapular nerve syndrome typically presents with a weakness of the levator scapulae and the rhomboid muscles, and results in a winged scapula. a winged scapula is where the scapula protrudes from the patient's back and can affect the ability to lift objects or pull and push. the winging of the scapula seen with dorsal scapular nerve syndrome is not as severe as seen as injury or paralysis of the serratus anterior muscle. dorsal scapular nerve entrapment is a very under-recognized cause of neck and shoulder pain. the scapular winging may be subtle, and the symptoms are easily mistaken for other problems. a careful history and physical exam, along with a high index of suspicion, are necessary for accurate diagnosis and therefore appropriate treatment. injection of the dorsal scapular nerve under ultrasound guidance can be diagnostic as well as therapeutic.

Eligibility criteria:
inclusion criteria: * scapular pain exclusion criteria: * cervical radiculopathy
ak104 for recurrent or metastatic vulvar cancer

Conditions: Vulvar Cancer

Summary: this is a multicenter, open-label, phase ii clinical study, aiming to the evaluate the efficacy and safety of ak104 (an anti- pd-1 and ctla-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.


Eligibility criteria:
inclusion criteria: age \>=18 and \<=80. ecog of 0 or 2. life expectancy ≥ 3 months. histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy. for cohort a, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy. at least one measurable tumor lesion per recist v1.1. adequate organ function as assessed in the laboratory tests. female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception exclusion criteria: subjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc. systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration. previous treatment with immune checkpoint inhibitors (e.g., anti-pd-1 antibody, anti-pd-l1 antibody, anti-ctla-4 antibody, etc.). active or potentially recurrent autoimmune disease.

Keywords: pd-1/ctla-4 vulvar cancer
early intervention for minors in possession of alcohol/drugs: a feasibility study

Conditions: Substance Use Disorder; Delinquency

Summary: the purpose of this study is to evaluate two brief, sustainable interventions for a sample of 280 adolescents charged with an initial drug-related offense: motivational enhancement therapy (met) intervention for youth and the parenting wisely (pw) intervention for parents. families are assessed for adolescent substance use, hiv-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning. it is expected that the combined met+pw interventions will be more effective than a treatment-as-usual intervention (drug education group) for adolescents with parents not participating in pw.

illicit substance use and related problems among adolescents has been consistently high over the past decade and remains one of the most pressing public health concerns in the united states. the objective of this study is to conduct a pilot investigation of the feasibility and effectiveness of two brief empirically based treatments for adolescent substance abuse when implemented as early interventions for youth arrested and charged with first- or second-offense possession of alcohol or drugs. the two examined interventions are motivational enhancement therapy (met) and parenting wisely (pw). over a one-year period, 280 adolescents and their parents will be referred to the study by the juvenile justice centers in two oregon counties within the portland metro area. families will be randomized to one of four intervention conditions; youth will receive either met or a drug education intervention (educ), and the pw intervention for parents is present or absent. participants will be assessed for adolescent substance use, hiv-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning at intake and at 3- and 6-month follow-ups.

Eligibility criteria:
inclusion criteria: 1. 13 - 17 years of age 2. referral for a 1st or 2nd minor in possession (alcohol) or less than an ounce (marijuana) offense 3. adolescents living at home with at least one parent willing to participate in the study 4. adolescents with sufficient english-language ability to permit participation in the interventions 5. parent(s) with sufficient english- or spanish-language ability to complete the english- or spanish-language versions of pw and the assessment exclusion criteria: 1. evidence of psychotic or organic state of sufficient severity to interfere with understanding study procedures 2. danger to self and/or services other than outpatient treatment are required

Keywords: teens parenting substance abuse treatment efficacy
evaluation of the efficacy of the hydroxychloroquine-azithromycin combination in the in the prevention of covid-19 related sdra

Conditions: Sars-CoV-2, Community-Acquired Pneumonia,COVID-19

Summary: since end of december, a new coronavirus, close to the 2002 sars coronavirus, cause serious pneumonias throughout world. there is currently no strong evidence of an efficient specific treatment. hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. it has shown efficacy against sars-cov-2 in vitro. some studies showed that hydroxychloroquine might improve the clinical status of sars-cov-2 infected patients. azithromycin is a macrolide antibiotic, with immunomodulatory properties. adding azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. this study wants to evaluate the clinical impact of adding azithromycin to hydroxychloroquine in the treatment of sars-cov-2 pneumonia


Eligibility criteria:
inclusion criteria: * age \> 18 years old * positive sars-cov-2 rt-pcr on nasopharyngeal swab * ct scan suggestive of sars-cov-2 pneumonia exclusion criteria: * negative sars-cov-2 rt-pcr on nasopharyngeal swab * known hypersensitivity to hydroxychloroquine, azithromycin or a macrolide family member * long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin) * retinopathy or maculopathy * porphyria * severe renal failure (gfr less than 30 ml/min/m²) * dyskaliemia, (ie less than 3,5 mmol/l or more than 5,5 mmol/l) * hypomagnesiemia, ie less than 0,7 mmol/l * severe cholestasis, cirrhosis or severe hepatic failure * known cardiac medical history of congestive heart failure or myocardial infarction * bradycardia less than 50 beats per minute * prolonged corrected qt interval, (ie cqt more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders * blood disorders with history of hematopoietic stem cells allograft * known history of g6pd deficiency * pregnancy * breastfeeding * subject protected by law under guardianship of curatorship * inability to take oral medications
study of intralesional injection of m4n in patients with refractory malignant tumors of the head and neck

Conditions: Head and Neck Neoplasms

Summary: the purpose of this study will be to determine the safety and tolerability of intratumoral m4n. patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. the design is a phase 1 dose escalation study of m4n administered intratumorally once weekly, initially for three weeks. dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor volume and then, new patient cohorts will have their schedule extended to weekly m4n for 4 weeks. dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks.

study data collected will include pre-study demographics and measurements, treatment compliance, efficacy determined by tumor measurements, m4n levels in blood for pharmacokinetics, serum and biochemical determinations, hematology determinations, and patient vital signs.

Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years of age. * patients with documented histologic evidence of head and neck cancer with clinically measurable disease. head and neck cancer could have been recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy. * measurable tumor by direct inspection, photography, or by imaging (ct scan or mri). * life expectancy of at least 3 months in the investigators' opinion. * negative pregnancy test if in women of childbearing potential within 1 week of starting therapy. * patients had provided written informed consent to participate in study. * ecog performance status of 0, 1, or 2. * absolute neutrophil ≥ 1500/ul, hemoglobin ≥ 8 gm%, platelets ≥ 50,000/ul, * alt/ast ≤ 3 x uln (upper limit of the normal range), bilirubin ≤ 1.5 x uln and creatinine ≤ 1.5 x uln, pt and ptt within normal limits. exclusion criteria: * women who were pregnant or nursing. * women of child bearing potential who were unwilling to use an adequate method of contraception during the course of the study. * treatment with prior investigational agent within 30 days of entering the study. * patients who are unable to comply with the study requirements. * patients with known sensitivity to any of the study medication components. * patients not consenting to photography. * patients with tumors that have enveloped the carotid artery or whose anatomy had been distorted such that in the investigator's opinion present high-risk of perforation or compromise during injection. * prior chemotherapy, radiation therapy, or surgery for the primary carcinoma within 30 days of dosing and/or had not recovered from prior therapy toxicities.
lamazym aftercare study fr designed to provide treatment for french patients

Conditions: Alpha-Mannosidosis

Summary: the overall objective of this trial is to provide aftercare treatment with lamazym and to evaluate the safety of repeated lamzede i.v. treatment of subjects with alpha-mannosidosis.

this trial provide aftercare treatment with lamzede to french patients.

Eligibility criteria:
inclusion criteria: * the subject must have participated in previous lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17 * subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities * the subject and his/her guardian(s) must have the ability to comply with the protocol exclusion criteria: * presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the investigator, would preclude participation in the trial * any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the trial * pregnancy. pregnant woman is excluded. before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception * psychosis; any psychotic disease, also in remission, is an exclusion criteria * planned major surgery that, in the opinion of the investigator, would preclude participation in the trial * adult patients who, in the opinion of the investigator, would be unable to give consent, and who does not have any legal protection or guardianship * total ige \> 800 iu/ml * known allergy to the imp or any excipients (sodium-phosphate, glycine, mannitol)
portico and navitor india clinical trial

Conditions: Aortic Valve Stenosis; Aortic Valve Failure; Aortic Insufficiency; Aortic Stenosis

Summary: the objective of this clinical trial is to collect data on procedural safety and device performance of the portico and navitor devices and flexnav delivery system to treat patients with severe aortic stenosis in the indian population.

the objective of this phase iv clinical trial is to characterize the procedural safety and device performance of the portico valve, the navitor valve, the flexnav delivery system and flexnav or navitor loading system to treat patients with severe aortic stenosis.

Eligibility criteria:
inclusion criteria: 1. subject must provide written informed consent prior to any clinical investigation-related procedure. 2. are \>60 years of age in host country, have severe symptomatic (nyha class ≥ ii) aortic stenosis (as), at high or extreme surgical risk and have been identified as a candidate for a portico or navitor valve implant. 3. subjects must have a society of thoracic surgeons (sts) score of ≥7% or documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the sts score. exclusion criteria: 1. have tested positive for the corona virus disease 2019 (covid-19) virus at any time and currently have residual signs or symptoms associated with the covid-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.) 2. have sepsis, including active endocarditis 3. have any evidence of left ventricular or atrial thrombus 4. have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 5. have a non-calcified aortic annulus 6. have congenital bicuspid or unicuspid leaflet configuration 7. are unable to tolerate antiplatelet/anticoagulant therapy 8. are pregnant at the time of signing informed consent 9. are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)
study of regn2810 (anti-pd-1) in patients with advanced malignancies

Conditions: Advanced Cancer; Advanced Malignancies

Summary: this is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply). 2. at least 1 measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1 criteria for response assessment (certain exceptions may apply) 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 key exclusion criteria: 1. ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (iraes). the following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment. 2. prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (pd-1/pd-l1 pathway) (certain exceptions may apply) 3. prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. examples of immune modulating agents include blockers of ctla-4, 4-1bb (cd137), ox-40, therapeutic vaccines, or cytokine treatments. 4. untreated brain metastasis(es) that may be considered active. patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply). 5. immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab the information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial, therefore not all inclusion/ exclusion criteria are listed.

Keywords: advanced cancerous growth