Kornimate/medical-research-clean huggingface dataset:
concepts for analgosedation during placement of regional anaesthesia before operations.

Conditions: Knee Arthropathy; Hip Arthritis; Fractures, Closed

Summary: aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view. in this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (emla salve) or placebo (nacl 0,9% i.v. and skin protection salve).

in this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. this assessement includes nrs, patients' satisfaction and wellbeing. the tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (emla salve). the fifth combination will be the control group with only placebo medication. we expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field.

Eligibility criteria:
inclusion criteria: * adult patients planed electively for orthopedic surgery exclusion criteria: * missing patient's consent * intolerance against study medication
melatonin for prevention of metabolic side effects of olanzapine

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.

atypical antipsychotics including olanzapine are associated with significant metabolic side effects. animal studies have suggested that melatonin might prevent some of the olanzapine-associated side effects. melatonin is safe and is widely used as a sleep-promoting complement, and is not associated with side effects seen with other used drugs such as metformin.

Eligibility criteria:
inclusion criteria: * age 18-65 year * first episode schizophrenia (dsm-iv-tr) * ability to take medicine orally * eligible for starting olanzapine exclusion criteria: * married women who are at reproductive age * history of taking olanzapine in the recent 3 months * history of allergy or intolerance to olanzapine * history of significant head trauma ( causing loss of consciousness more than 5 minutes or neurological or cognitive sequels) * liver, kidney, cerebrovascular or cardiovascular disease * diabetes, metabolic syndrome * cancer * using antiepileptic (other than benzodiazepines for sleep) , antihypertensive, anticoagulant, anti-platelet drugs * using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil) * delirium * need for administration of other antipsychotics * substance abuse

Keywords: melatonin olanzapine metabolic side effects psychosis hyperlipidemia hyperglycemia weight gain diabetes
two doses of ghb04l1 for pandemic influenza prophylaxis in healthy adults

Conditions: Influenza, Avian

Summary: this study evaluates safety, tolerability and immunogenicity of two doses of ghb04l1, a liquid formulation of the replication- deficient influenza a/vietnam/1203/04(h5n1)-like ∆ns1 virus in healthy adults. subjects are randomised at a ratio of 2:1 for ghb04l1 (6.8 log10 or 7.5 log10 tcid50/dose/volunteer) or placebo.

ghb04l1 is intended to provide a novel treatment approach for influenza virus h5n1 infection. based on preclinical data from ferrets that demonstrated protection against challenge with wild-type virus following treatment with various dose levels of ghb04l1, vaccination with ghb04l1 might protect humans from influenza a (h5n1) virus infection. due to the lack of the ns1 protein, the δns1 virus replicates efficiently in interferon-deficient cells but has lost its ability to grow in normal hosts and organisms. immunisation with δns1 mutant virus can cause only an abortive replication cycle in the nasal mucosa of vaccinated individuals. this allows development of replication-deficient intranasal vaccines with genetic stability of the attenuated phenotype and without virus shedding.

Eligibility criteria:
inclusion criteria: * male or female healthy volunteers, 18-50 years of age * seronegative for h5n1 (with antibody titres \<1:10 detected in hai assay) * seronegative for h1n1 (with antibody titres ≤1:20 detected in hai assay) * written informed consent to participate in this study exclusion criteria: * acute febrile illness (\>37.0°c) * positive influenza immunoassay at baseline * signs of acute or chronic upper or lower respiratory tract illnesses (sneezing, cough, tonsillitis, otitis, etc.) * history of severe atopy * influenza vaccination 2006/2007 and/or later * known increased tendency of nose bleeding * volunteers with clinically relevant abnormal paranasal anatomy * volunteers with clinically relevant abnormal laboratory values females with positive urine pregnancy test prior to vaccination * simultaneous treatment with immunosuppressive drugs incl. corticosteroids (≥ 2 weeks) within 4 weeks prior to study medication application * clinically relevant history of renal, hepatic, gi, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases * history of leukaemia or cancer * hiv or hepatitis b or c seropositivity * volunteers who had undergone rhino or sinus surgery or surgery of another traumatic injury of the nose within 30 days prior to application of study medication * volunteers who had received antiviral drugs, treatment with immunoglobulins or blood transfusions or an investigational drug within four weeks prior to study medication application * volunteers who had received anti-inflammatory drugs 2 days prior to study medication application * volunteers who were not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
substance misuse to psychiatric disorders for cannabis

Conditions: Cannabis Use Disorder; Depressive State; Anxiety State; Depression; Anxiety Disorders; Pharmacotherapy

Summary: with the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic disabling dependence or co-morbid state.


Eligibility criteria:
inclusion criteria: • cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms exclusion criteria: * age \<16 years old * unable to read english or chinese * unable to give informed consent * had been diagnosed to have intellectual disabilities (dsm-5) or mental retardation * had history of primary psychotic episode * had been diagnosed to have substance-induced mood disorder, other than cannabis * had been diagnosed to have mood disorders or anxiety disorders * had been taking maintenance therapeutic dose of antidepressant continuously \>= 6 months and with depressive symptom or anxiety symptom being in remission * had known hypersensitivity to vortioxetine * had known history of serotonin syndrome * pregnant * mother currently breast-feeding * currently taking warfarin and/or having poorly controlled bleeding disorder * had history of prolonged qtc ≥500ms and/or known unstable or untreated cardiology disease

Keywords: cannabis depression anxiety medication
a study of bms-986171 in healthy people to assess safety, to measure blood levels of drug, and to find out what the drug does to the body

Conditions: Liver Fibrosis/NASH

Summary: the purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * age 21 to 55 years (part a,b, and c) * bmi 30-40 (part a or part b); bmi 20-35 (part c). bmi = weight (kg)/ \[height (m)\] exclusion criteria: * any significant medical illness * cannot tolerate subcutaneous injections, or having blood samples taken * smoking more than 10 cigarettes/day * history of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics. * hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. * pregnancy
nutritional habits among people with and without diabetes in upper egypt

Conditions: Diabetes Mellitus

Summary: type2 diabetes is a serious chronic disease associated with numerous complications. it is pandemic disease due to worsening of diatery habits and westernization of diet. these complications contribute to nearly half (46.1%) of deaths occurring in adults under 60, the working-age population. with this alarming increase, and in order to decrease complications and diabetes-related mortality, this health problem requires a comprehensive management plan where patients should be educated to make informed decisions about diet, exercise, weight, and medications, as recommended by the american diabetes association (ada). the aim of the study is -to detect nutritional habits in our locality among diabetic patients comparing to non diabetics.

recent analysis has reported that for the management of diabetes, only pharmacologic approaches are not sufficient. the management of diabetes is a multifactorial process involving life style and dietery factors that influence the treatment outcomes. there are also patient-related factors, such as self-care behaviors, that have a strong influence on glycemic intolerance. diabetes management necessitates both medication and lifestyle adjustments, which are associated with a decreased risk of death. people with t2dm find dietary advice confusing, contradictory, and report that understanding and making healthy eating choices are the most challenging parts of living with the condition. therefore, national guidelines recommend that all patients with t2dm should receive individualized, ongoing dietary advice from a health professional with expertise in nutrition. the role standing of diet in controlling of diabetes is considered imperative; still, diabetes patients are unaware of how they should approach this issue to ensure good glycaemiccontrol .in egypt no sufficient screening about diatery habits .hypothesis:there is difference in diatery habits between patients with and without diabetes

Eligibility criteria:
inclusion criteria: * adults participant whose age \> 18or older . * type 2 dm exclusion criteria: * patients who have stroke patients who have dementia. ckd patients (as it affects appetite and diet)

Keywords: nutritional habits
the effect of cervical physical therapy treatment in patients with somatic tinnitus

Conditions: Tinnitus, Subjective

Summary: this study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. this study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions. these inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.


Eligibility criteria:
inclusion criteria: * patients with subjective tinnitus (tinnitus functional index between 25 and 90 point) in combination with self-reported neck complaints (neck bournemouth questionnaire \> 13 points) are included in case one of the following is present: * tinnitus and neck complaints increase and decrease together * tinnitus is low-pitched and increases during inadequate neck postures exclusion criteria: * tinnitus related to ménière's disease, clear otological or neurological causes * serious depression * contra-indications for cervical spine treatment * patient already received cervical physical therapy in the past 2 months

Keywords: somatic tinnitus
efficacy and safety of prophylactic use of an antibiotic for medical thoracoscopy

Conditions: Pleural Effusion; Pleurisy; Empyema

Summary: this is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g iv for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.

this is a prospective randomized study to assess the efficacy and safety of a single dose of cefazolin 2g iv for the prophylaxis of surgical site and pleural space infections during medical thoracoscopy. consecutive patients who are planned to undergo a medical thoracoscopy (rigid or semirigid) will be enrolled in the study if they satisfy the inclusion and exclusion criteria. one hundred patients will be randomized in 1:1 ratio to receive either of the following: (a) a single dose of intravenous cefazolin 2 gms dissolved in 100 ml of normal saline administered over 10 minutes, between 15 and 30 minutes before the incision, or (b) 100 ml normal saline administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. thoracoscopy will be performed in the bronchoscopy suite on a spontaneously breathing subject (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Eligibility criteria:
inclusion criteria: 1. age ≥12 years 2. medical thoracoscopy being performed for a pleural effusion for any of the three indications: diagnosis, pleurodesis, or adhesiolysis exclusion criteria: 1. age ≥80 years 2. pao2/fio2\< 300; 3. hemodynamic instability 4. myocardial infarction or unstable angina in the last 6 wk 5. lack of pleural space due to adhesions 6. uncorrected coagulopathy 7. failure to provide informed consent 8. patients already taking any antibiotic due to any reason

Keywords: thoracoscopy pleuroscopy antibiotic prophylaxis pleural effusion
diagnostics and pharmacotherapy for severe forms of tb (dmid 15-0100)

Conditions: Tuberculosis

Summary: major research aim: to study novel molecular diagnostics and the pharmacokinetic variability among a spectrum of tb disease states, including severe forms of tb like disseminated tb, tb meningitis and drug resistant tb, among adults and children from multiple international sites.

aim 1. measure pharmacokinetics to anti-tuberculosis (tb) medications in severe tb syndromes (including multidrug-resistant tb, pediatric tb, tb sepsis and tb meningitis) from diverse geographies (including tanzania, uganda, bangladesh, and siberia) and correlate these findings to tb treatment outcome (tb treatment failure: death/ default/ relapse/ further acquired drug resistance). aim 2. decipher mechanisms of pharmacokinetic variability to tb drugs, particularly malabsorption due to concurrent gastrointestinal disease. aim 3. deployment of quantitative susceptibility testing (minimum inhibitory concentration-mic) and rapid mic-informed molecular methods (e.g., taqman array card-tac) for m. tuberculosis. in addition to the stated aims, the primary elements of capacity building requisite for this project include the training in and deployment of the fieldable molecular diagnostic platforms, onsite pharmacokinetic monitoring, and a broad strengthening of longitudinal cohort management for clinical research.

Eligibility criteria:
inclusion criteria: patients admitted to one of the study site hospitals with at least one of the following: 1. clinical suspicion for tb in a child, as defined by nih consensus case definitions for tb research in children, and started on tb treatment 2. clinical suspicion for tb meningitis, as defined by the international tb meningitis workshop consensus case definitions for tb meningitis 3. clinical suspicion for tb sepsis, as defined by the uganda/prism-u definitions 4. microbiologic evidence of mdr-tb from a respiratory specimen within the past 6 months exclusion criteria: 1. pregnant women-self reported 2. patient unable per treating physician discretion to undergo sample collection 3. patient or representative/guardian unable to sign written informed consent 4. patient unable to return for follow-up or be contacted by phone for follow-up
impact of joint crisis plan

Conditions: Mental Disorders

Summary: for some patients in department psychiatric, isolation measures are put in place. but the measures is not pleasant for the patient or for the care team. that's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated. one of the solutions is called the joint crisis plan. a joint crisis plan is a personalized procedure for a patient. it describes the attitude, the care, the measures in case of crisis with the patient and his family. patients indicate their wishes regarding their care. however, there is no real scientific proof of the effectiveness of this joint crisis plan, especially to reduce isolation measures.

the primary objective of this study is to evaluate efficacy of the joint crisis plan.

Eligibility criteria:
inclusion criteria: * patients \>18 years * patients having had at least one isolation, restraint or forced hospitalization measure in the 24 months before inclusion * followed by nurses of a mobile team of psychiatry sector saint etienne * social security affiliation * signed informed consent exclusion criteria: * patient having already had a joint crisis plan for less than 6 months. * patient does not speak french * pregnant and lactating women

Keywords: joint crisis plan internalized stigma of mental illness (ismi) isolation physical restraint psychiatry
long-term evaluation of nasopharyngeal airway in hypotonia

Conditions: Hypotonia, Muscle; Obstructive Sleep Apnea; Nasal Airway Obstruction

Summary: this research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssnpa") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * children with hypotonic upper airway obstruction (huao) that took part in the original study (hum00189669/nct04846400 or hum00220966/nct05527652 trials) * willingness to continue device usage. * confirmed diagnosis of osa (apnea/hypopnea index; ahi \&gt; 10 or ahi \&gt;5 with lowest oxygen level ≤75%) * at least one symptom of osa (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors) * previous adenotonsillectomy (unless tonsillectomy not possible) * tonsil size 2+ or smaller exclusion criteria: * participants that were non-compliant with the self-supporting nasopharyngeal airway (ssnpa) device during participation in the parent study listed above * any medical reason why ssnpa therapy may not be suitable * active covid 19 infections moderate/severe tracheobronchomalacia * need for anticoagulative therapy * bleeding disorder * restrictive thoracic disorders

Keywords: self-supporting nasopharyngeal airway (ssnpa) sleep study difficulty breathing obstructive sleep apnea cerebral palsy down syndrome trisomy 21
effects of korean red ginseng on male infertility

Conditions: Male Infertility

Summary: objective: several in vitro studies report positive effects of ginseng on spermatogenesis. however, no controlled human clinical study of the effect of korean red ginseng (krg) on spermatogenesis has been performed. this study was performed to investigate the effects of krg on semen parameters in male infertility patients in a randomized, double-blind, placebo-controlled study. methods: a total of 80 male infertility patients with varicocele were recruited from april 2011 to february 2012. the subjects were then divided into the following four groups: non-v + p group, placebo; v + p group, placebo and varicocelectomy; non-v + krg group, 1.5-g krg daily; v + kgr group, 1.5-g krg daily and varicocelectomy. semen analysis was performed and hormonal levels were measured in each treatment arm after 12 weeks.


Eligibility criteria:
inclusion criteria: * patients should be males, 25 - 45 years of age * complained of infertility for at least 12 months * no history of surgical or medical treatments for infertility * increased retrograde flow in the internal spermatic vein with venous diameter \> 3 mm during the valsalva maneuver on scrotal ultrasonography was used as an indicator of varicocele.13 varicocele was graded according to the criteria presented by lyon et al.14: grade i, palpable only with the valsalva maneuver; grade ii, palpable without the valsalva maneuver; grade iii, visible from a distance. exclusion criteria: * the exclusion criteria were as follows: * a history of vasectomy or obstructive azoospermia * chromosomal abnormalities * hypogonadism or pituitary abnormalities * anatomical abnormality of the genitals * significant hepatopathy (liver enzymes elevated 2 - 3-fold higher than the normal range) * renal insufficiency (serum creatinine level \> 2.5 mg/dl) * medical treatment for infertility during the past 4 weeks
comparison of maintenance ect versus clozapine in treatment-resistant schizophrenia

Conditions: Treatment Resistant Schizophrenia

Summary: the proposed study will be conducted to compare the efficacy of maintenance ect (m-ect) vs clozapine in treatment resistant schizophrenia (trs) in terms of change in psychopathology measures and cerebral hemodynamics.

the proposed study is a prospective, randomized clinical trial in patients suffering from treatment-resistant schizophrenia (trs) and will be conducted in the department of psychiatry, aiims, bhubaneswar, over a period of 16 months. sixty patients with trs (trrip consensus criteria, 2017), fulfilling the inclusion and exclusion criteria will be recruited for the study. written informed consent will be taken after explaining the objectives and procedure of the study in detail. the detailed history, relevant social-demographic and clinical data will be collected in a structured case record form (crf). at baseline, panss will be administered to determine the severity of positive symptoms, negative symptoms, and general psychopathology, global assessment of functioning (gaf), and cgi to determine the baseline severity of the illness and improvement with treatment and moca to assess change in cognitive impairment. before starting the treatment, brain spect-ct will be done to measure baseline regional brain blood perfusion. the study cohort will be randomized into two treatment groups by computer-generated random numbers, each group comprising 30 patients. one group will receive maintenance ect (m-ect) following acute treatment of bilateral ect of six sessions along with ongoing antipsychotic and the other group will be treated with clozapine monotherapy. panss, gaf, cgi, moca will be re-administered at 6 weeks, 3 months, and 6 months follow-up visits to compare the changes within each group and between the groups. post-treatment spect-ct of the brain will be done at the end of 6 months to document changes in the regional cerebral blood perfusion.

Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with treatment-resistant schizophrenia (trs) (trrip consensus criteria). * patients aged 18-60 years of either sex. * patients giving voluntary written consent for participation in the study exclusion criteria: * patient already on clozapine or ect. * history of psychoactive substance abuse or dependence. * co-morbid psychiatric, major medical, or neurological disorders. * history of organicity or significant head injury. * pacemaker or metal in any part of the body excluding the mouth. * pregnant and breastfeeding females.

Keywords: m-ect clozapine psychopathology cerebral perfusion