Kornimate/medical-research-clean huggingface dataset:
global patient registry to monitor long-term safety and effectiveness of increlex® in children and adolescents with severe primary insulin-like growth factor-1 deficiency (spigfd).

Conditions: IGF1 Deficiency

Summary: the increlex® global registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. the main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving increlex® therapy for spigfd according to the locally approved product information.

this registry is a post-authorisation safety study called the increlex® global registry which is intended primarily to monitor the safety of increlex® therapy in children and adolescents with severe primary igf-1 deficiency and secondly to follow the effectiveness of this treatment. patients who have already started increlex® therapy before entering this registry may be included and data will be collected retrospectively. the countries participating in this registry are austria, france, germany, italy, poland, spain, sweden, united kingdom and the usa

Eligibility criteria:
inclusion criteria: * for us : patients starting or planning to start or currently receiving treatment with increlex® therapy for severe primary igf-1 deficiency as defined by the us increlex® prescribing information or for growth hormone (gh) gene deletion who have developed neutralizing antibodies to gh.for eu : patients starting or planning to start or currently receiving treatment with increlex® therapy according to the locally approved product information. * parents or legally authorized representatives if applicable must give signed informed consent before any registry-related activities are conducted. assent from the subject should also be obtained as appropriate exclusion criteria: * subject currently participating in an increlex® clinical trial * subject currently participating in any clinical trial for growth retardation * patient with any contraindication to increlex® or any condition subject to special warning as per the locally approved label * for us patients, these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia and patients with closed epiphyses. * for eu patients: these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia or any condition or medical history which increases the risk of benign or malignant neoplasia and patients with closed epiphyses
neuroendocrine brake for type 2 diabetes mellitus

Conditions: Diabetes

Summary: evaluation to determine the safety of two laparoscopic procedures to control t2dm.


Eligibility criteria:
inclusion criteria: 1. - male and female between 18 and 65 years. 2. bmi 25.1 - 34.9. 3. type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment. 4. diagnosis of t2dm for at least 3 years. 5. patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years. 6. hba1c \>/ 7.5 documented for at least 3 months. 7. stable weight (nor significant weight change (\>3%) over the 3 months prior to enrollment. 8. stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment. 9. ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments. exclusion criteria: 1. prior abdominal surgery, except laparoscopic cholecystectomy. 2. taking appetite suppressant. 3. severe eating disorders. 4. severe pulmonary, renal or cardiac disease. 5. obese due to a clinically diagnosed endocrine disorder. 6. subjects with impaired liver function. 7. history of peptic ulcer disease. 8. history of malignant disease. 9. use of prescription, over the counter or herbal weight loss products. 10. pregnant or planning on pregnancy while enrolled in study.
a study of the telerehabiliation intervention effect of the tai chi exercise on elderly with sarcopenia

Conditions: Sarcopenia

Summary: sarcopenia is an age-related disease characterized by a progressive decrease in skeletal muscle content and loss of muscle function. tai chi exercises have been shown to improve skeletal muscle mass in elderly people suffering from sarcopenia. however, offline interventions are a very labor- and financial-intensive approach. therefore, researchers designed an artificial intelligence-assisted program and tai chi exercise format to investigate whether a remote rehabilitation approach could replace face-to-face interventions


Eligibility criteria:
inclusion criteria: (1) patients between the ages of 60-75 years; (2) who meet the screening criteria for sarcopenia in asia established by awgs 2019; (3) who have a computer at home (4) who can use a computer or was accompanied by family number who can use a computer. exclusion criteria: (1) participants taking medications that significantly impact musculoskeletal function (2) participants suffering from respiratory failure or other bodily problems; (3) participants with mental disorders or neurological disorders; (4) patients who participate in other training programs on a regular basis.

Keywords: sarcopenia human pose
a phase 2 study of eik1001 in combo with pembrolizumab and chemotherapy in patients with stage 4 nsclc

Conditions: NSCLC

Summary: this study is for patients with advanced/metastatic non-small cells lung cancer (nsclc) who have not received any treatment through the vein for the advanced disease.

this is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of eik1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous nsclc who have not received prior systemic therapy for the advanced disease. the study includes dose finding and evaluates adverse events and efficacy.

Eligibility criteria:
inclusion criteria: 1. be ≥ 18 years of age on the day of signing of informed consent. 2. confirmed stage 4 nsclc (squamous or non-squamous) and be considered for standard of care. 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy). 4. have at least 1 lesion with measurable disease at baseline according to recist 1.1 as determined by the local site investigator/radiology assessment. 5. have not received prior systemic treatment for advanced/metastatic nsclc. 6. have an ecog performance status of 0 to 1. 7. have adequate organ function. exclusion criteria: 1. does not have predominantly squamous cell or non-squamous cell histology nsclc. mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of eik1001. 3. prior to the first dose of eik1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose). 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration. 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years. 6. has an active infection requiring therapy.

Keywords: squamous nonsquamous metastatic
effects of soft tissue mobilization and pelvic floor muscle exercises on pelvic adhesions

Conditions: Pelvic Adhesions; Post Hysterectomy Pain

Summary: adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. they are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and hemostasis/inflammatory phase. adhesions are typically the body's defense mechanisms against various triggers of inflammation, including physical, chemical, and infections. these triggers can have unfavorable consequences, including chronic pain, obstruction (particularly bowel), functional impairment, and infertility. this may cause adjacent structures to lose their flexibility and mobility. the nonsurgical treatment of symptoms thought to be associated with adhesions has centered on several methods of soft tissue scar removal.

this study will be randomized controlled trial and will be conducted in hanif medical center and poly clinic and lady willingdon hospital. the total duration of treatment will be 10 week. non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. the subjects will be divided into two groups. group a will receive soft tissue mobilization of pelvic area with pelvic floor muscle exercises and group b will receive soft tissue mobilization of pelvic area without pelvic floor muscle exercises after heating for 10 minutes as baseline treatment. the tools that will be used are numeric pain rating scale (nprs), female sexual function index (fsfi) and functional status questionnaire (fsq). after data collection data will be analyzed by using spss version 25.

Eligibility criteria:
inclusion criteria: * married women * age 40-60 years * bmi below 30 (13) * women with post-operative pelvic adhesions (14) * women after hysterectomy (3 months after surgery) exclusion criteria: * women with any other surgery * women with failed pelvic surgery (14) * post-operative women with open wound (unhealed suture site) (14) * women with uncontrolled hypertension, thrombophlebitis, hematoma, osteomyelitis, myositis ossificans and malignancy
shen hai long capsule for male asthenospermia

Conditions: Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men

Summary: to evaluate the efficacy and safety of shen hai long capsule in the treatment of mild to moderate asthenospermia in men.

to evaluate the efficacy and safety of shen hai long capsule in the treatment of mild to moderate asthenospermia in men: 1) efficacy index (1) main efficacy indexes forward motile sperm ratio (pr) (2) secondary efficacy indexes 1. sperm survival rate; 2. sperm concentration; 3. normal morphology rate of sperm; 4. seminal malondialdehyde (mda) 5. seminal superoxide dismutase (sod) 2) safety indicators (1) vital signs; (2) liver and kidney function; (3) blood routine; (4) electrocardiogram; (5) adverse events.

Eligibility criteria:
inclusion criteria: 1. age range from 22 to 50 years old; 2. patients with mild to moderate asthenospermia, that is, at least two normative semen analyses indicated that 10%≤pr percentage \< 32% and the total number of pr sperm ranged from 5 million to 20 million; 3. at least two standard semen analyses indicated that sperm concentration ≥15×106 /ml; sperm normal morphology rate ≥4%; 4. no other chinese and western drugs for the treatment of oligospermia, weak and malformed spermia have been taken in the past 3 months; 5. the subject voluntarily participates and signs the informed consent. exclusion criteria: 1. varicocele, ejaculatory duct/seminal vesicle cyst, anti-sperm antibody (+); 2. genital tract infection: seminal plasmic elastase \> 1000ng/ml or leukocyte semen disease (peroxidase positive cell concentration in semen more than 1×10\^6/ml); 3. erectile dysfunction, ejaculation disorders; 4. suffer from mental disorders, immune system diseases; severe impairment of liver and kidney function (serum transaminase ≥2× upper limit of medical reference value, creatinine clearance ≤40ml/min or active stage of chronic kidney disease); 5. patients with allergic history or constitution to therapeutic drugs; 6. patients who have taken drugs affecting the study within 3 months, such as antitumor and antiepileptic drugs, etc.

Keywords: efficacy safety
comparison of chs-0214 to enbrel (etanercept) in patients with chronic plaque psoriasis (pso)

Conditions: Plaque Psoriasis

Summary: this is a two part study comparing chs-0214 to enbrel in patients with chronic plaque pso who have not yet received any biologic therapy for any indication (other than insulin or hormones).

pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. the primary end point is 75% improvement from baseline according to the psoriasis area and severity index (pasi-75). comparing chs-0214 to enbrel for efficacy and safety at a dosage of 50mg subcutaneous (sc) twice weekly. pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where chs-0214 and enbrel dosage is reduced to 50mg sc weekly for maintenance.

Eligibility criteria:
inclusion criteria: * male or female adults * pso diagnosis for 6 months * active disease: pasi greater than or equal to 12, physician's static global assessment (psga) score greater than or equal to 3 (based on a scale or 0-5), * body surface area (bsa) involved with pso greater than or equal to 10% * dermatology life quality index (dqli) greater than or equal to 10 * previously received phototherapy or systemic non-biologic therapy for pso exclusion criteria: * forms of psoriasis other than pso * drug induced psoriasis * positive quantiferon-tuberculosis (tb) gold test * presence of significant comorbid conditions * chemistry and hematology values outside protocol specified range * major systemic infections

Keywords: pso
innovative methods to reduce emissions and health impacts of deep-frying

Conditions: Inflammation

Summary: cooking oil fume (cof) is a significant source of pm2.5 for poorly ventilated space indoors and in urban streets near restaurants or night markets. modern chinese cooking produces high concentration of cof especially from deep-frying foods and stirred frying. emission from high-temperature frying has been classified by the iarc as group 2a carcinogen. cooks are at high risk of exposure to toxic compounds from cooking fumes. however, more of the cof-related studies focused on the home kitchen and less addresses the problems in the restaurants. studying health hazards and biomarkers of cooks may provide opportunities to understand biological mechanisms and to search and test efficacy for measures to overturn such risks. the investigators will recruit 80 cooks who handle deep-frying and stirred frying on daily basis. the 80 cooks will be randomized to 4 groups: (1) control, (2) vegetable and fruits extract (v\&f) group, (3) fish oil group, and (4) v\&f-fish oil group will be provided to the participants for 2 months v\&f capsules (equivalent to 4 servings a day) and fish oil capsules (1\~1.5 serving a day) and placebos of the same appearance. heart rate variability (hrv), pulmonary functions, bio-markers, oxylipins and metabolomics profile will be measured as outcomes.


Eligibility criteria:
exclusion criteria: 1. acute diseases in the past 2 weeks 2. taking anti-oxidant supplements in the past month 3. taking steroid or non-steroidal anti-inflammatory drugs (such as aspirin and panadol) in the past week 4. under hormone replacement therapy 5. cancer and other severe diseases
valsartan/amlodipine as compared to losartan treatment in stage 2 systolic hypertension

Conditions: Stage 2 Systolic Hypertension

Summary: this study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmhg).


Eligibility criteria:
inclusion criteria: * male or female outpatient of 18 years of age or greater * stage 2 systolic hypertension defined as office mean sitting systolic blood pressure (mssbp) greater than or equal to 160 and \< 200 mmhg at randomization * patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed. exclusion criteria: * office systolic blood pressure \>200 and/or mean sitting diastolic blood pressure (msdbp) greater than or equal to 110 mmhg at visit 1. * use of four (4) or more antihypertensive medications within 30 days of visit 1. * refractory hypertension, defined as blood pressure \>140/90 mmhg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (therapy with a fixed-dose combination of two active medications represents two drugs). * inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension combination therapy valsartan cardiovascular diseases
dextromethorphan as an augmentation agent in treatment-resistant schizophrenia

Conditions: Treatment Resistant Schizophrenia

Summary: dextromethorphan acts as n-methyl-d-aspartate (nmda) antagonist. in treatment resistant schizophrenia(trs) the efficacy of treatment response by clozapine is only around 40%. numerous augmentation agent have been tried which includes antipsychotics, anticonvulsants, antidepressants and nmda antagonist. the nmda antagonist such as riluzole and memantine have shown good efficacy in trs. therefore we are evaluating nmda antagonist, dextromethorphan in trs. the dextromethorphan or placebo will be administered along with clozapine in trs patients. the study is randomized double blind placebo controlled group sequential trial.


Eligibility criteria:
inclusion criteria: * schizophrenia patients who are diagnosed as treatment-resistant schizophrenia (trs) defined as having been tried and not responded to any two antipsychotic medication for a duration of 6 weeks with dose equivalent of 600 mg of chlorpromazine and initiated on clozapine for the treatment of the same. * the patients who are on stable dose of clozapine. * patients of either sex with age \>18 years. * patients for whom legally authorized representative (lar) are willing to give informed consent. exclusion criteria: * patients with significant medical comorbidity. * patients with significant psychiatric comorbidity. * patients having active substance abuse history during the time of screening. * female patients who are pregnant or in reproductive age not using contraception. * female patients who are breast feeding
effectiveness of aquatic therapy in children with duchenne and becker muscular dystrophy

Conditions: Duchenne or Becker Muscular Dystrophy

Summary: the purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with duchenne and becker muscular dystrophy.

duchenne and becker muscular dystrophy is the most common type of muscular dystrophy in childhood caused by a mutation of the dmd gene. progressive muscle weakness is the main symptom, as muscle fiber degeneration is the primary pathological process. weakness selectively affects the proximal before the distal limb muscles and the lower before the upper limbs. the affected child therefore has difficulty running, jumping, and walking up steps. although there is currently no treatment method that eliminates the disease, exercise practices significantly improve the quality of life of children. there are not enough studies in the literature evaluating whether the addition of aquatic therapy to conventional physical therapy helps to improve balance skills, functionality and quality of life in children with muscular dystrophy. the purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with duchenne and becker muscular dystrophy. our study will include children aged 5-18 years and complete a 10 -m walk without assistance/support who are diagnosed with duchenne or becker muscular dystrophy by a neurologist and followed up in the muscular diseases unit of gaziosmanpaşa training and research hospital in follow-ups, patients who are planned to receive aquatic therapy will be listed according to their application dates. in addition to the exercises home programme, patients at the top of the list will receive aquatic treatment 3 days a week for a total of 5 weeks with a physiotherapist. patients at the bottom of the list will form the control group and will receive home programme exercise while waiting in line for aquatic therapy after 5 weeks, the initial assessments will be repeated and recorded

Eligibility criteria:
inclusion criteria: * diagnosed with duchenne muscular dystrophy or becker muscular dystrophy by a neurologist * between the ages of 5-18, with ongoing ambulation * co-operating with the physiotherapist's practices exclusion criteria: * those who will not be able to perform the evaluation parameters * have a serious systemic disease that may interfere with exercise * injury and/or surgery in the last 6 months * receive gene therapy * in the presence of contraindications to aquatic therapy such as excessive fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wound, acute systemic disease, epilepsy, tracheotomy, permanent drain, immunodeficiency

Keywords: aquatic exercise therapy muscular dystrophy life quality functional status balance control