Kornimate/medical-research-clean huggingface dataset:
open-label treatment with duloxetine hydrochloride once-daily dosing for evaluation of stabilization dose in patients with major depression

Conditions: Major Depressive Disorder

Summary: the purposes of this study are to determine: the safety of duloxetine and any side effects that might be associated with it. whether duloxetine can help patients with major depression. the safety associated with switching from a medication you may be taking for depression to taking duloxetine. it is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.


Eligibility criteria:
inclusion criteria: * you must be at least 18 years old. * you must have been diagnosed with major depressive disorder. * you must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks exclusion criteria: * you are a woman and are pregnant or breastfeeding. * you have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. * you have had a primary diagnosis of an anxiety disorder within the past 6 months. * you have a history of alcohol or drug dependence or abuse within the past 6 months.

Keywords: depressed blues sadness feelings of guilt hopelessness lack of energy
slagsens (effect of tactile stimulation after stroke)

Conditions: Stroke

Summary: the purpose of this study is to determine whether tactile stimulation for reduced sensibility of the affected extremities after stroke has effect. hypothesis: stimulation of sensibility after stroke will have a significant contribution for improved sensibility. without any stimulation, no signal is sent to the brain and there is no need for the healthy parts of the brain to adapt this function. stimulation of the sensibility over a period of time on both sides of the body, gives the brain signals and the opportunity to compare how the signals should be recognized. new connection will be able to interpret signals correctly.

through stroke rehabilitation, function from damaged areas can be replaced by healthy parts of the brain. it is important for rehabilitation to take advantage of this compensatory qualities whit early intervention and mobilization. only small gains can lead to big improvements. about half of stroke survivors gets reduced sensibility caused bye the stroke, and sensibility is considered to be an important part of rehabilitation of function and activities. a norwegian guideline concludes that the scientific knowledge is to week to recommend this kind of treatment. there is some evidence for improvement of sensibility when specific training and stimulation is given. achievements in sensibility can lead to some improvement in function. the project will be carried out as a randomized controlled trial. in this project, the intervention group receive tactile senses stimulated twice daily over a period of 3 months, while the control group receives standard treatment. the results from both groups are measured before and after treatment.

Eligibility criteria:
inclusion criteria: * patients with impaired tactile sensitivity after stroke kongsberg hospital to undergo rehabilitation course. exclusion criteria: * patients with a history of stroke. * patients with significant symptomatic additional diseases, such as neuropathy. * patients who cannot provide adequate response if they can feel the touch. * terminal and palliative care patients. * patients with cancer. * patients with hypertonic muscles in the current body area. * patients below 18 years of age

Keywords: stroke tactile sensibility stimulation extremities arm leg
study of the effect of sch 900538 on congestion in subjects with seasonal allergic rhinitis (study p05031)(completed)

Conditions: Seasonal Allergic Rhinitis

Summary: this study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. this effect will be compared to placebo and to the decongestant, pseudoephedrine.


Eligibility criteria:
inclusion criteria: * subjects must be 18 to 65 years of age, of either sex, and of any race. * subjects must have a history of sar due to ragweed for the last two consecutive ragweed seasons. * subjects must be skin-test positive for the ragweed pollen allergen used in the environmental exposure unit (pollen chamber at the screening visit or within 12 months prior to the screening visit. * subjects must develop a pre-defined severity of allergy symptoms within 90-minute after entering the pollen chamber during the pollen challenge at the priming visit (visit 2), and prior to dosing (visit 3), in order to qualify for the study. * female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to randomization at the treatment visit. female subjects and female partners of male subjects must be using an acceptable form of birth control during the study. * blood pressure and pulse rate must be within normal ranges. exclusion criteria: * subjects who have had an upper or lower respiratory tract infection within approximately 28 days (4 weeks) before priming (visit 2) and thereafter. * subjects who have a dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator. * subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. * subjects who have used any investigational drugs, including placebo, within 30 days of screening or for the duration of this stud, or who are participating in any other clinical study. * subjects with a history of rhinitis medicamentosa. * subjects with a history of anaphylaxis or severe or serious reaction to skin testing. * subjects who are being medically treated for any of the following conditions: narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy; current treatment with monoamine oxidase (mao) inhibitors. * subjects with a history of a positive test, or are symptomatic, for hiv, tb (not due to vaccination), and hepatitis b (not due to vaccination) or hepatitis c. * subjects with asthma that requires medication other than occasional (\<=3 uses per week) use of an inhaled short-acting b-2 agonist.
genetics of fibromyalgia

Conditions: Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome; Depression

Summary: the fibromyalgia family study identifies and collects blood samples from families with two or more members affected with fibromyalgia syndrome (fms). the primary goal of the study is to identify genes that predispose people to fms and/or symptoms related to fms; identifying these genes may lead to a better understanding of the disease and more effective treatments.

fms predominantly affects women and is characterized by chronic widespread musculoskeletal pain, fatigue, sleep disturbance, and multiple tender points on physical examination. the pathophysiological mechanisms underlying fms are not clearly understood, but neuroendocrine factors seem to be of major importance. studies of familial association suggest that genetic factors play a role in fms. this study will establish patterns of genetic linkage in families with fms. participating family members will undergo a brief physical exam (including tender point exam), donate a blood sample, and complete a detailed questionnaire that includes experience with pain, fatigue, depression, bowel symptoms, headache, anxiety, and physical limitations. measurements of serum serotonin and related compounds will also be obtained. to detect genetic factors, a genome-wide linkage scan using 405 microsatellite markers will be performed.

Eligibility criteria:
inclusion criteria * diagnosed with fibromyalgia according to the criteria of the american college of rheumatology * have at least one living family member who has also been diagnosed with fibromyalgia * no other major rheumatological disease

Keywords: pain fatigue sleep depression irritable bowel syndrome chronic fatigue syndrome
value of capsular repair for latarjet

Conditions: Shoulder Pain

Summary: the purpose of the study is to evaluate the occurrence of osteoarthritis (yes/no) by radiography.

this is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study. this study will validate preliminary results on a technique associating capsular repair with abutment according to latarjet in the treatment of shoulder instabilities. it may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.

Eligibility criteria:
inclusion criteria: * patient, male or female, over the age of 18 * patient with shoulder instability with risk factors for recurrence (isis score \> 3), requiring surgical stabilization by abutment * affiliated patient or beneficiary of a social security scheme * patient having been informed and having given his free, informed and written consent. exclusion criteria: * patient with history of surgery for instability of the same shoulder * patient presenting contraindications to the realization of a postoperative scanner * patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant * patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant, breastfeeding or parturient woman * patient hospitalized without consent.
electroacupuncture for sciatica due to intervertebral disc displacement

Conditions: Sciatica Due to Intervertebral Disc Disorder

Summary: this multicenter randomized controlled trial (rct) will evaluate the therapeutic effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus traction, electroacupuncture plus traction and medication.

this is a multicenter rct with 3 groups to determine the effectiveness and health economic evaluation of the electroacupuncture for sciatica due to intervertebral disc displacement in a population of adults aged 18-65. 324 participants who meet the inclusion criteria will be randomly allocated into 3 different groups, namely electroacupuncture group, electroacupuncture \& traction group, electroacupuncture \& traction \& oral medication group. all participants will receive six-week treatment, the participants in electroacupuncture group will receive electroacupuncture only, electroacupuncture \& traction group will receive both electroacupuncture and traction, and in electroacupuncture \& traction \& oral medication group all of the three therapies are adopted. the statistical analysis will be conducted by a third party who is masked to the allocation of participants.

Eligibility criteria:
inclusion criteria: * patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement; * male or female, aged 18-65; * have completed informed consent form. exclusion criteria: * patients with sciatica caused by diseases such as piriformis syndrome, thickening of ligamentum flavus, acute lumbar strain, contusion, congenital spina bifid, lumbar and sacrum deformity, lumbar sacral vertebra joint disorder or proliferative osteoarthrosis; * patients with urinary and fecal incontinence caused by acute lumbar disc herniation, huge or central type lumbar disc herniation sufferer in need of surgery; * patients who fail to finish the basic treatment course, or have poor adherence; * patients having a poor state, particularly unconsciousness, psychopath, severe osteoporosis, concurrent infection or bleeding susceptibly, or accompany with primary diseases in cardiovascular, digestion or hemopoietic systems and viscera as kidney, liver; * pregnant or lactating women; * patients in other clinical research.

Keywords: sciatica electroacupuncture intervertebral disc displacement
safety study of bms-844421 for treatment of hypercholesterolemia

Conditions: Atherosclerosis; Hypercholesterolemia

Summary: the purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (ldl) cholesterol of single and multiple subcutaneous and intravenous doses of bms-844421 in healthy subjects (sad) and in subjects with elevated cholesterol (mad).


Eligibility criteria:
inclusion criteria: * healthy subjects (sad) * healthy subjects (mad) with untreated elevated cholesterol * body mass index (bmi) of 18 to 30 kg/m² inclusive * women who are not of childbearing potential and men, ages 18 to 45 exclusion criteria: * any significant acute or chronic medical illness * history of liver or renal disorders * prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration
short chain fatty acid metabolism and energy metabolism

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. the role of gut-derived short-chain fatty acids (scfa), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. at the present time, our understanding of the effects of scfa on human metabolism (in gut or systemically) is still limited. the investigators hypothesize that the differential availability of scfa impacts human metabolism differently. in this placebo controlled, double-blind, randomized crossover pilot study the investigators will validate in overweight/obese healthy male volunteers whether rectal administration of scfa is a good model for studying the acute metabolic effects of scfa. for this, it will be investigated if site of administration (in distal or proximal colon) of scfa differentially affects parameters of substrate and energy metabolism and to test the duration of short-term effects of scfa administration.


Eligibility criteria:
inclusion criteria: * overweight, obese men exclusion criteria: * athletes * diabetes mellitus
mechanical ventilation on hippocampus

Conditions: Mechanical Ventilation Complication; Brain Injuries

Summary: ventilator-associated brain injury (vabi) frequently occurs in icu patients. although animal studies indicate the hippocampus as a key target of vabi, its relevance in human patients remains uncertain. in this study, the investigators aim to monitor hippocampal eeg activity during the weaning process of patients off mechanical ventilation, and also exploring the coupling between breathing patterns and hippocampal activity.

\[rational\] although mechanical ventilation (mv) is crucial for saving lives, the high incidence of ventilator-associated brain injury (vabi) in icu patients, affecting up to 80% of cases, raises significant clinical concerns. vabi not only increases mortality and morbidity rates but also strains healthcare resources. despite abundant evidence from preclinical studies, the precise impact of mechanical ventilation on humans remains largely unknown. understanding these effects is crucial for uncovering the mechanisms behind vabi and subsequently preventing and treating this complication. \[methods\] patients with drug-resistant epilepsy scheduled for stereoelectroencephalography (seeg) exploration as part of their pre-surgical assessment will undergo eligibility screening. during the study, seeg signals and respiratory data will be simultaneously collected from the hippocampus and other relevant limbic structures under various mechanical ventilation scenarios. these scenarios include controlled ventilation at different levels of positive end-expiratory pressure (peep, 5cmh2o vs. 10cmh2o) and respiratory rates (rr, 10 vs. 20 bpm), assisted ventilation, and natural breathing phases. following the discontinuation of mechanical ventilation, patients will be monitored for up to 7 days to evaluate the occurrence of delirium. additionally, simultaneous intracranial eeg recordings from relevant cortical and subcortical regions will be conducted. \[aims\] the current study aims to investigate the effects of mechanical ventilation, including variations in rr and peep, on neurophysiological electrical oscillations within the hippocampus, as well as the relationship between breathing patterns and hippocampal activity. furthermore, the investigators will explore the impact of mechanical ventilation on other cortical areas involved in breathing, depending on electrode positioning, and examine the interactions between these brain regions and the hippocampus.

Eligibility criteria:
inclusion criteria: * age: ≥ 18 years * asa: i - ii * w/ electrode inside hippocampus (≥ 1 contacts) * singed consent form exclusion criteria: * seizure occurrence ≤ 36 hours before op. * structural brain damage * history of using: opioids, enzyme-inducing medications, sleep aids, or excessive alcohol consumption * history of mechanical ventilation (\>24h) * cognitive impairment * operation within 6 months * participate in other clinical trials in the last four weeks * pregnant or breastfeeding

Keywords: ventilator associated brain injury hippocampus oscillation mechanical ventilation
a study of insulin degludec/insulin aspart biosimilar (22011) compared with insulin degludec/insulin aspart(ryzodeg) in participants with type 2 diabetes in china

Conditions: Diabetes

Summary: the purpose of this study is to see if insulin degludec/insulin aspart (22011) compared to insulin degludec/insulin aspart (ryzodeg) is similar in safety and effect in participants with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. * male or female, age at least 18 year-old and no more than 75 year-old at the time of signing informed consent. * type 2 diabetes mellitus (t2d). * body mass index (bmi) higher than 18.0, but below or equal to 35.0 kg/m\^2. * current treatment for at least 3 months prior to screening with basal insulin/premixed insulin once a day or twice a day with/without oral anti-diabetic drugs (oads): metformin, alpha-glucosidase inhibitors, dimethylphenylpenicillin dipeptidyl peptidase 4 (dpp-4) inhibitors, sodium-dependent glucose transporter 2 (sglt-2) inhibitors . for above or equal to 3 months prior to screening subjects should be on a stable dose. * hba1c from 7-11.0% both inclusive at screening confirmed by central laboratory analysis. exclusion criteria: * have a diagnosis of type 1 diabetes (t1d), or specific type of diabetes other than t2d, for example, injured pancreas, diseases of acromegaly-induced diabetes. * have a history of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. * have had severe hypoglycemia episodes within 6 months prior to screening.
effect of andecaliximab on fev1 in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the primary objective of this study is to evaluate the effect of andecaliximab (gs-5745) on pre-bronchodilator forced expiratory volume in 1 second (fev1) % predicted in adults with cystic fibrosis (cf) after 8 weeks of treatment. there will be 2 parts to this study. in part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. in part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. part 2 will be initiated after completion of part 1.


Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of cf as determined by the 2008 cystic fibrosis foundation consensus report criteria * must have a body weight of \> 40 kg (88.2 lb) at study screening * pre-bronchodilator fev1 ≥ 40% and ≤ 80% of predicted at screening * two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 criteria: * the relative difference of fev1(l), calculated as the absolute value of \[(first fev1 - second fev1) / first fev1\] x 100 should be \< 12% and * the absolute difference in fev1 should be \< 200 ml * negative sputum investigation/history of any mycobacterium spp. or burkholderia spp. per specified protocol-defined time periods * clinically stable with no evidence of significant respiratory symptoms that would require administration of iv antibiotics, oxygen supplementation, or hospitalization within 30 days of baseline. * on stable cf chronic medical regimen for at least 30 days prior to baseline and expected to remain stable through the completion of the study. this includes but is not limited to: chronic azithromycin use, inhaled bronchodilators, inhaled corticosteroids, inhaled dornase alpha, inhaled hypertonic saline, inhaled mannitol, ivacaftor, and/or ivacaftor/lumacaftor. key exclusion criteria: * concurrent use of oral antibiotics (excluding chronic azithromycin use) or iv antibiotics within 30 days of baseline. prophylactic and chronic doxycycline use is prohibited during the study. * hospitalization for a respiratory event within 30 days of baseline * current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of baseline * current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 l/minute at night (subject would not meet this exclusion criterion if supplemental oxygen is used for comfort only) * history of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list note: other protocol defined inclusion/exclusion criteria may apply.