Kornimate/medical-research-clean huggingface dataset:
β-cell function in schizophrenic subjects on atypical antipsychotic drugs

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether atypical antipsychotic drugs (commonly prescribed for treating schizophrenia) induce changes in anthropometry and metabolism, including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of metabolic syndrome at enrollment.

atypical antipsychotic drugs (aads) induce weight gain, truncal adiposity and may engender a metabolic syndrome which may progress to ifg/igt or dm. aads effects in lean schizophrenic patients without metabolic syndrome are not documented, especially the relationship between weight gain and changes in insulin sensitivity (s), beta-cell function (β), and circulating adiponectin. we prospectively determined the outcome of 9-month therapy with aads on anthropometrics, metabolism and adiponectin, including homa-modeling of s, β, and βxs (hyperbolic product, assessing individual β adjusted for s)in 36 schizophrenic subjects (m:f 24:12; caucasian n=23; north-african n=12; south-asian n=1) aged 35±9 years (mean±1sd) free of mets (ncep-atpiii).

Eligibility criteria:
inclusion criteria: * age 18-55 years * body mass index \<25.0 kg/m² * waist circumference \<102 (men) and \<88 cm (women) * absence of a metabolic syndrome according to ncep atpiii criteria * normoglycaemic (fasting plasma glucose levels \<100 mg/dl) exclusion criteria: * previous use of antipsychotic drugs * concomitant therapy with drugs known to possess an inherent potential to increase weight and/or to alter glucose metabolism (including antihistaminic drugs, glucocorticoids, β-blockers, antiepileptic drugs and mirtazapine)

Keywords: antipsychotic drugs schizophrenia β-cell function insulin resistance
trial protocol globifer - oral iron repletion

Conditions: Iron Deficiency

Summary: the haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with globifer forte.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 ≤ 60 years of age 2. signed written informed consent 3. hb ≥ 8 ≤ 10g/dl for 4. female exclusion criteria: 1. history of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions). 2. known hypersensitivity to oral iron preparations. 3. diseases, which an iron supplementation is not allowed or contraindicated. 4. patients on current oral or intravenous iron supplementation 5. history of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study. 6. patients who have had iron supplementation within the last 30 days. 7. other reasons which in the investigator's judgment argue against inclusion of the patient into the trial. 8. inability to comprehend study protocol 9. participation in another clinical trial (currently or within the last 30 days)

Keywords: iron, hemoglobin, feritin, erytrocyty. transferin
evaluation of the effect and side effect profile of covid-19 vaccine in cancer patients

Conditions: Covid19; Cancer

Summary: the aim of the study is to evaluate the effects and side effects of inactive covid-19 vaccine in patients with cancer and compare them with the healthy control group.

the aim of the study is to evaluate the effects and side effects of inactive covid-19 vaccine in patients with cancer. patients followed up in medical oncology clinic and healthy volunteers will be enrolled in the study. blood samples of participants will be taken 4 weeks after the second dose of the covid-19 vaccine. after blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different eppendorf tubes and stored at -80 or -20 degrees. the samples will be delivered to the working center in a manner suitable for cold chain transport. covid-19 antibody test will be performed on the blood samples. in addition, volunteers will be questioned in terms of side effects that may develop after vaccination and the information obtained will be recorded in the database together with the clinical data of the patients.

Eligibility criteria:
inclusion criteria: for the patient group : 1. patients with pathological and clinical cancer diagnosis 2. older than 18 years 3. patients two doses of covid-19 vaccine administered 4. volunteering to participate in the study for the control group : 1. no known cancer diagnosis or history 2. older than 18 years 3. two doses of covid-19 vaccine administered 4. volunteering to participate in the study - exclusion criteria: 1. not volunteering to participate in the study 2. \< 18 years 3. not administered two doses of the covid-19 vaccine 4. covid-19 infection history -

Keywords: cancer, covid-19, vaccine
wheelchair positioning and neuromuscular diseases

Conditions: Neuromuscular Diseases

Summary: this database will describe sitting postural control in wheelchair, as well as pw pain, and pressure ulcers associated with sitting, in patients with neuromuscular disease (nmd).

neuromuscular diseases are genetic diseases of the muscle or its innervation (nerve connection) causing respiratory, cardiac and especially motor difficulties which may require use of wheelchair. however there is no standardized positioning protocol, so it seems interesting to us to study wheelchair positioning in neuromuscular diseases). the purpose of this study is to describe sitting posture in the wheelchair in patients with neuromuscular disease, pain associated with using the wheelchair, but also to assess the effectiveness of the recommended equipment making the same evaluations in follow-up consultation (a few months after receipt of the prescribed tap). posture is assessed by the tool: measurement of postural control in seated postural control measure for adults 2.0 (spcma 2.0), which is a validated tool. pain is assessed by a simple verbal scale or by a visual analog scale. this database could allow providing guidelines of good practice, for wheelchair positioning for patients with neuromuscular disease.

Eligibility criteria:
inclusion criteria : * patient with neuromuscular disease * written informed consent (ic) obtained * adult patients (\> 18 years) or * adults under guardianship who has given theirs oral consent and guardian's consent obtained or * childs who has given theirs oral consent and parents' consent obtained * wheelchair user exclusion criteria : • patient not seen in positioning consultation by n. pellegrini and / or e. dupitierr

Keywords: neuromuscular disease postural wheelchair disorders wheelchair positioning pain
a randomized, multicenter pragmatic trial comparing bone pain from a single dose of pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy

Conditions: Early-stage Breast Cancer

Summary: react-5g will compare bone pain from a single dose of pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.

the use of granulocyte colony-stimulating factors (g-csf) significantly reduces febrile neutropenia (fn) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. this is crucial as survival outcomes are significantly impaired if dose intensity are reduced. national and international guidelines recommend the use of g-csf as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. filgrastim (fil) as a g-csf that has been in use since the early 90s. pegfilgrastim (peg) is a long-acting, pegylated version of fil that requires only one injection per chemotherapy cycle instead of daily fil injections for 5 to 10 days per cycle. peg and fil both come at the potential cost of bone pain, the most common side effect. g-csf related bone pain is often severe, leading to refusal or cancellation of g-csf and early discontinuation of chemotherapy. we propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either peg or 5-day-fil with neoadjuvant or adjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring primary febrile neutropenia prophylaxis with g-csf * able to provide verbal consent * able to complete questionnaires in english or french exclusion criteria: * no access to pegfilgrastim or filgrastim prior to randomization * metastatic cancer * known hypersensitivity to filgrastim or pegfilgrastim or one of its components

Keywords: filgrastim pegfilgrastim
efficacy of oropharyngeal exercises for patients with obstructive sleep apnea using mandibular advancement device

Conditions: Obstructive Sleep Apnea of Adult

Summary: combined treatment with mad and oe for adult patients with obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea.

background: obstructive sleep apnea (osa) is a sleeping disorder with recurrent upper airway obstruction during sleep. patients with osa often suffer from daytime sleepiness, snoring, and interrupted breathing during sleep. the etiology of osa can divide into anatomical causes, including narrow, crowded, or easily collapsible upper airway, and non-anatomical causes, including low respiratory arousal threshold, ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control. a mandibular advancement device (mad) is one of the treatment options for mild to moderate osa patients. oropharyngeal exercises (oe) are a novel intervention targeted at internal/external tongue muscle training with significant improvements in the muscle tension and severity of osa. the efficacy of combined treatment with mad and oe has not been investigated. thus, the present study aims to determine the effectiveness of combing mad and oe by assessing the tongue function and severity of osa in patients with osa. methods: a total of 20 participants using mad for osa were included in the study. participants will be divided into two groups: the treatment group with the 12-week oe. oe consists of one to three times 30-minute sessions per day, 3 to 5 days per week for 12 weeks. the weekly clinic visits are required to adjust the intensity of the home exercise program and monitor the training progress. the participants in two groups will receive polysomnography (psg) test, tongue muscle strength, and endurance testing, at baseline and after the intervention. expected results: combined treatment with mad and oe for adult patients with mild to moderate obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea

Eligibility criteria:
inclusion criteria: * osa patients * aged over 20 years old * wearing a mad exclusion criteria: * body mass index (bmi) ≧ 35 * pregnancy * severe obstructive or restrictive lung disease * exercise with high-risk cardiovascular disease * history of central or peripheral neurological disease resulting in an inability to perform exercise prescriptions * musculoskeletal or psychological disorders that prevent the performance of exercise prescriptions * chronic illnesses that are ongoing or not yet controlled

Keywords: obstructive sleep apnea mandibular advancement device oropharyngeal exercises
open label study of botox® (botulinum toxin type a) as headache prophylaxis in chinese patients with chronic migraine

Conditions: Migraine Disorders

Summary: this study is an open-label extension study to evaluate the safety, tolerability and efficacy of botox® as headache prophylaxis in chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.


Eligibility criteria:
inclusion criteria: -has successfully completed the double-blind study (1313-301-008). exclusion criteria: * has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ecg) findings * headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma) * any medical condition that may put the patient at increased risk with exposure to botulinum toxin type a, including diagnosed myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
predictive factors of failure or success of sedation with dexmedetomidine in icu

Conditions: Requiring Sedation in ICU; Adult Patients; Patient Covered by French Health Care System

Summary: research predictive factors of success or failure of a sedation with dexmedetomidine in icu

prospective clinical study in icu with sedated ventilated patients with dexmedetomidine, establishing incidence of success, failure of moderate sedation or failure of dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation

Eligibility criteria:
inclusion criteria: -adult patients ventilated requiring sedation in icu with rass objective more than -2 exclusion criteria: * contraindication: intracranial lesion, hepatic failure * pregnancy

Keywords: sedation dexmedetomidine icu delirium
heart ultrasound by emergency medicine residents as an estimate of heart function

Conditions: Stroke Volume; Cardiovascular Diseases

Summary: the purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.

this research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. results from the two doctors will be compared to see how similar they are. this research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors. the doctors will use ultrasound of the heart to measure e-point septal separation (epss). epss is the distance between two parts of the heart, the mitral valve and the ventricular septum. epss is measured in millimeters (mm). epss can estimate left ventricular ejection fraction (lvef) as a measure of how well the heart pumps blood.

Eligibility criteria:
inclusion criteria: * healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care * age 18 or over * willing and able to provide informed consent exclusion criteria: * pediatrics (age \<18 years old). * no cardiac-altering intervention performed between examiners. * unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root. * transthoracic echocardiogram (tte) more than the next day after epss is performed (for secondary outcome). * female with known pregnancy. * prisoner * prior cardiac surgery
mass treatment t solium community study

Conditions: Intestinal Parasitism

Summary: investigators from cayetano heredia university and johns hopkins university are doing this study. they want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). cysticercus attacks the meat of pigs and the brains of people. in the intestine, the parasite is known as "solitaria". this study is to see how treatment in both people and pigs works to control the disease.

this is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. four villages will be selected to be treated against t solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. the effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.

Eligibility criteria:
inclusion criteria: * all consenting individuals older than two years living in the study villages (6 endemic communities of the northern coast of peru) exclusion criteria: * pregnancy (for antiparasitic treatment only).

Keywords: t solium, cysticercus, pig triquina, solitaria, intestinal parasites, niclosamide, tapeworms, taeniasis
a comparative study for efficacy and safety between 4% hydroquinone cream with or without fractional picosecond 1,064 nm laser for the treatment of dermal or mixed type melasma

Conditions: Picoseconds Laser; Melasma

Summary: a comparative study for efficacy and safety between 4% hydroquinone cream with or without fractional picosecond 1,064 nm laser for the treatment of dermal or mixed type melasma

primary objective: * to compare clinical efficacy by modified masi score between fractional picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone secondary objectives * to compare the clinical endpoints of mexameter melanin index, brownish spot and ultraviolet spots by visiatm complexion analysis, the antera 3d® imaging technology for pigmentation, quality of life by dermatology life quality index and patient's satisfaction between fractional picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone

Eligibility criteria:
inclusion criteria: * female with melasma lesion on bilateral sides * age between 18-65 years * dermal or mixed type melasma, confirming by wood's lamp test * willing to participant in this study and signed in informed consent form exclusion criteria: * pregnancy / lactation * having an activity or working outside the building or unable to avoid heavy uv light * allergic to uv sunscreen, topical anesthetics , topical corticosteroid or hydroquinone treatment with laser or chemical peeling within 3 months * treatment with skin lighting medication / food supplements within 4 weeks * currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks * use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks * uncontrolled medical illness include non-skin cancers, coagulopathy * intra-cardiac device - pacemaker * photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis * currently taking anticoagulant such as warfarin * active skin infection or acute dermatitis at testes skin sites * unable to follow and comply to the study protocol
is preoperative exercise test in morbid obese patients a predictive test for extubation?

Conditions: Morbid Obesity

Summary: the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.


Eligibility criteria:
inclusion criteria: * patients between 18-60 years old * patients with bmi \> 40 * patients undergoing laparoscopic sleeve gastrectomy exclusion criteria: * patients with chronic obstructive pulmonary disease (copd), asthma, * patients with uncompensated heart failure * uncompensated diabetes mellitus * patients who have orthopedic problems that effects the exercise test

Keywords: morbid obesity surgery walk test exercise
sglt inhibitors versus ddp4 inhibitors and prostate in patient with diabetes

Conditions: Diabetes Mellitus; Prostatic Hyperplasia

Summary: the study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus

the study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus the study compares sodium glucose cotransporter 2 inhibitors to dipeptidyl peptidase 4 inhibitors in elderly patients with type 2 diabetes mellitus

Eligibility criteria:
inclusion criteria: * patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either sglt inhibitor or ddp4 inhibitors exclusion criteria: * unable to consent to the blood sampling or ultrasound any other diabetes control measure other than sglt inhibitors or ddp 4 inhibitors
safety and pharmacokinetics of mk-7680 in participants with hepatitis c (mk-7680-003)

Conditions: Hepatitis C

Summary: this is a two-part dose-finding trial of mk-7680 in participants with hepatitis c virus (hcv) infection of genotype (gt)1 (part i) and gt3 (part 2). the primary hypothesis is that daily administration of a safe and well tolerated dose of mk-7680 will produce a decrease in hcv viral load.

parts 1 and 2 will each consist of 4 panels. in the first panel, a 200 mg dose of mk-7680 will be administered. in each of the following 3 panels, higher or lower doses of mk-7680 will be administered. each panel will only begin once the safety and tolerability data from the preceding panel have been evaluated.

Eligibility criteria:
inclusion criteria: * is in good health except for hcv infection * is male or is a female of non-childbearing potential * clinical diagnosis of hcv gt1 or gt3 with no evidence of mixed-gt or non-typeable infection exclusion criteria: * has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting hcv infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease * has a history of cancer * has a history of significant multiple and/or severe allergies * is positive for hepatitis b or human immunodeficiency virus * has had major surgery, donated or lost 1 unit (500 ml) of blood within 4 weeks prior to screening * consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening * has chronic hepatitis not caused by hcv (e.g., nonalcoholic steatohepatitis \[nash\]) * has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis
prospective multicenter trial to compare preformed vs non preformed orbital implants

Conditions: Orbital Floor Fracture; Medial Orbital Wall Fracture

Summary: accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years 2. fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor 3. scheduled for reconstruction surgery with one of the following implants: * matrixmidface preformed orbital plate * custom-made orbital implant * orbital floor mesh plate * synpor titanium reinforced fan sheet 4. at least partial sight in both eyes before the accident 5. willingness and ability to participate in the study follow-up according to the protocol 6. ability to understand and read local language at elementary level 7. signed informed consent exclusion criteria: 1. bilateral orbital fracture 2. fractures of the orbital roof 3. comminuted zygoma fracture 4. more than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure 5. previous dislocated orbital fractures on either side 6. vision or diplopia not assessable 7. injury of the globe 8. neurological diseases with influence on eye motility or sight 9. legal incompetence 10. active malignancy 11. life-threatening condition 12. alcohol and drug abuse