Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of empagliflozin or semaglutide in overweight/obese patients with type 1 diabetes

Conditions: Diabetes

Summary: type 1 diabetes (t1dm) is a disease characterised by immune mediated destruction of the insulin-producing pancreatic beta cells. overtime, obvious insulin deficiency develops which requires insulin therapy. t1dm accounts for about 5% to 10% of diabetes cases in europe and united states. currently, worldwide incidence is estimated to be around 15 per 100,000 people per year. despite the advancement that has occurred in the field diabetes therapy, patient with t1dm still suffer from managing their disease as well as continuing to face diabetes related complications. the american diabetes association (ada) recommend a goal of glycated haemoglobin (hba1c) of \< 7%. however, only 21% of adults in the united states has achieved this recommended goal. once again, a multinational, multicentre study shows that only 24.3% of participants achieved the glycaemic target of hba1c less than 7.0 %. unfortunately, intensifying the insulin therapy in order to reach the targeted hba1c can result in serious adverse effects of hypoglycaemia and weight gain which is in its turn is known risk factor for cardiovascular disease.


Eligibility criteria:
inclusion criteria: * patients diagnosed with type 1 diabetes for more than 1 year. * age 18-65 years. * bmi ≥ 27 kg/m². * hba1c 7.5-10 % (58-86 mmol/mol) * inadequately controlled despite treatment with multiple daily injections of insulin for at least 1 year. exclusion criteria: history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (men 2) syndrome; family history of multiple endocrine neoplasia, type 2a (men 2a), medullary thyroid cancer, or familial medullary thyroid cancer. * insulin pump treatment. * any prior use of glp-1 ras or dipeptidyl peptidase-4 inhibitors, any medication (except insulin) that could interfere with glycemic control or affect a subject's safety. * an estimated glomerular filtration rate ≤ 30 ml/min/1.73 m2. * liver disease with raised alanine aminotransferase (ast), aspartate transaminase (alt) or alkaline phosphatase (alp)more than three times the upper normal range. * history of pancreatitis. * gastroparesis. * pregnancy or lactation. * history of alcohol or drug misuse, or any medical or psychological disorder that made the patient unsuitable for study participation. * acute symptomatic urinary tract infection or genital infection; chronic or recurrent (≥3 annual episodes) cystitis. * hypoglycaemia that required hospitalization or emergency treatment in the 3 months. * dka that required hospitalization or emergency treatment in the past 12 months. * treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen leading to unstable body weight (based on investigator's judgement) for the last 3 months.
a phase ii study on recombinant botulinum toxin type a (yy001) for injection in the treatment of upper limb spasticity in adults

Conditions: Upper Limb Spasticity

Summary: this is a randomized, double-blind, dose escalation, placebo- and active-controlled parallel-group multi-center phase ii study to evaluate the efficacy and safety of recombinant botulinum toxin type a (yy001) for injection in the treatment of upper limb spasticity in adults


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender. 2. weight ≥ 50 kg. 3. subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity. 4. subjects with disability assessment scale score of at least 2 on the principal target of treatment (one of four functional domains: hygiene, dressing, limb position and pain). 5. if taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment. 6. if the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment. exclusion criteria: 1. history of allergy to any component of the experimental drugs. 2. previous use of any botulinum toxin within 6 months prior to randomized enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study. 3. fixed contractures of the studied limb. 4. any medical condition that may increase the risk to the subject when using botulinum toxin type a. 5. need for treatment with drugs that interfere with neuromuscular function during the study. 6. plan or anticipate to use new antispasticity drugs during the study. 7. history of epilepsy. 8. pregnant or breastfeeding women. participation in other drug/device clinical trials within 1 month prior to randomized enrollment.

Keywords: yy001 recombinant botulinum toxin type a botulinum toxin upper limb spasticity
to investigate safety, tolerability, and pharmacokinetics of treatment with bi 660848 rising single doses (from 2 mg to 600 mg) administered as oral drinking solution (powder in bottle).

Conditions: Pain; Healthy

Summary: as a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of bi 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of bi 660848 in the indication of neuropathic pain.


Eligibility criteria:
inclusion criteria 1. healthy male based upon a complete medical history, including the physical examination, regarding vital signs (bp, pr), 12 lead ecg measurement, and clinical laboratory tests. there is no finding deviating from normal and of clinical relevance. there is no evidence of a clinically relevant concomitant disease. 2. age 21 and 50 years 3. bmi 18.5 and \<30 kg/m2 (body mass index) 4. signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation exclusion criteria 1. any finding of the medical examination (including bp, pr, and ecg measurements) deviating from normal and of clinical relevance 2. evidence of a clinically relevant concomitant disease 3. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. history of relevant orthostatic hypotension, fainting spells or blackouts 6. chronic or relevant acute infections 7. history of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator 8. intake of drugs with a long half-life (24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation 9. use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation 10. participation in another trial with an investigational drug within 2 months prior to randomisation 11. smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) 12. inability to refrain from smoking on trial days as judged by the investigator 13. alcohol abuse (more than 30 g alcohol a day) 14. drug abuse 15. blood donation (more than 100 ml blood within 4 weeks prior to randomisation or during the trial) 16. excessive physical activities within 1 week prior to randomisation or during the trial 17. any laboratory value outside the reference range that is of clinical relevance 18. inability to comply with dietary regimen of the study centre
the longitudinal impact of ses and the cnds on recovery from sud

Conditions: Substance Use Disorders

Summary: the goal of this study is to provide a scientific understanding of the impact of socioeconomic status (ses) on the recovery trajectory (psychosocial functioning, relapse/remission status, and neurocognitive mechanisms).

the study will characterize the effect of ses (subjective and objective indicators) on long-term trajectories of recovery and neurocognitive functioning. by using an accelerated longitudinal design, the investigators will examine the association between baseline ses, changes in cnds, and changes in psychosocial functioning (e.g., quality of life) and relapse. moreover, the investigators will use computational modeling to capture underlying changes in components of cnds functioning related to ses and sud recovery.

Eligibility criteria:
inclusion criteria: 1. be ≥18 yrs old 2. meet lifetime dsm-5 sud criteria 3. have a recovery initiation date less than 3 years prior to the time of enrollment 4. be able to read independently 5. be free of legal problems that could limit participation 6. reside in the u.s. 7. anticipate continued internet access (to ensure ongoing contact and data collection) 8. be a registrant of the international quit and recovery registry (iqrr) exclusion criteria: 1. minors will not be included 2. prisoners will not be included. if participants become incarcerated during this study, they will not be contacted to complete assessments during their incarceration. if the incarceration ends during the study, they may be contacted to participate in assessments. 3. adults who are not capable of consenting on their own behalf
adipose tissue and inflammation in coronary heart disease

Conditions: Coronary Heart Disease

Summary: the aims of the present project are to study possible differences in inflammatory gene expression and protein secretion in various compartments of adipose tissue being exposed during open cardiac surgery in patients with coronary heart disease undergoing coronary artery bypass surgery.

the present study is observational with biochemical end-points to disclose inflammatory mechanisms in various compartments of adipose tissue in patients with coronary heart disease (chd) compared to patients without significant chd. fifty patients with chd undergoing coronary artery bypass surgery with open chest procedure will be included and 20 patients with valve disease without overt chd undergoing open valve surgery will serve as a control group. no specific restrictions to inclusion other than lack of consent to participate after written and oral information are listed. in patients undergoing open heart surgery for chd, representative peri-operative biopsies from epicardial, pericardial and subcutaneous fat will be gathered, carefully processed and deep-frozen to 80 degrees of frost for later analyses on histological/cellular components and on messenger ribonucleic acid for selected inflammatory variables. simultaneously, blood samples (arterial blood at start of operation) will be collected, processed and deep-frozen at 80 degrees of frost for later analyses of relevant circulating inflammatory variables to correlation analyses with tissue samples, possibly also paxgene tubes for messenger ribonucleic acid in circulating leukocytes. the study will be conducted according to the declaration of helsinki, and in accordance with approval from the regional ethics committee.

Eligibility criteria:
inclusion criteria: * patients with coronary heart disease undergoing coronary artery bypass surgery exclusion criteria: * none

Keywords: adipose tissue inflammatory mediators gene expression
trial of pegasys® in patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to investigate the efficacy and safety of pegasys® 180μg for subcutaneous (s.c.) injection in interferon (ifn)-treated or ifn-untreated chronic hepatitis c patients except for those infected with genotype 1b of hepatitis c virus (hcv) and a high viral load (≥ 100 kiu/ml). in addition, this study will explore the efficacy and safety of pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in ifn-untreated chronic hepatitis c patients.


Eligibility criteria:
inclusion criteria: * quantitative serum hcv-rna is positive except for high viral load of genotype 1b (≥ 100 kiu/ml) * observation of serum alt elevation above upper limit of normal * chronic hepatitis is evaluated as the negative result (\< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis." exclusion criteria: * observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dl. * observation of the following situations and disease: severe renal disease, hepatitis b co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant
manual lymphatic drainage in fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: there are limited studies on the use of manual lymphatic drainage (mld) in fibromyalgia syndrome. considering the possible mechanisms of action of mld and the pathophysiology of fibromyalgia, more studies are needed to fully determine the effect of mld on this syndrome. the aim of this study was to investigate the effectiveness of manual lymphatic drainage on symptom severity, pain intensity, pressure pain threshold and anxiety about pain in fibromyalgia syndrome.

fibromyalgia syndrome (fms) is a syndrome of unknown cause, characterized by numerous symptoms such as chronic widespread pain, fatigue, insomnia, joint stiffness, depression, concentration and memory problems, myofascial pain and tender points. the prevalence of fms in the general population is 2%, and it is a common syndrome. there are studies showing that there is dysfunction in the connective tissue or fascia in fms that triggers peripheral nociceptor stimulation. any change in fascial tissue motility can cause an imbalance between body fluids leading to tissue hardening and accumulation of toxins. by stimulating the lymph vessels, metabolic waste products can be eliminated, excess fluid can be reduced, blockages can be removed and the immunological system can be regulated. pharmacological and non-pharmacological methods are used in the treatment of fms. exercise, manual therapy techniques, cognitive behavioral treatments, patient education and other physiotherapy modalities are the non-pharmacological methods that are frequently used. manual lymphatic drainage (mld) was developed in 1965 by dr. it is a manual therapy technique that consists of slow, rhythmic, superficial and repetitive movements defined by vodder. many effects that mld can reveal locally and systemically are discussed. mld; it stimulates the lymphatic and parasympathetic system, reduces pain, helps regulate the immune system, clears blockages, eliminates metabolic wastes and toxins in the body, and reduces excess fluid. there are limited studies on the use of mld in fibromyalgia syndrome. considering the possible mechanisms of action of mld and the pathophysiology of fibromyalgia, more studies are needed to fully determine the effect of mld on this syndrome. the aim of this study was to investigate the effectiveness of manual lymphatic drainage on symptom severity, pain intensity, pressure pain threshold and anxiety about pain in fibromyalgia syndrome.

Eligibility criteria:
inclusion criteria: * have fibromyalgia as defined by the criteria of the 2016 acr * have turkish as their native language * between 18 and 65 years of age exclusion criteria: * having cognitive impairment * receiving routine physiotherapy and/or manual therapy, alternative/complementary therapies * illiterate people * diagnosed with endocrine, neuromuscular, infectious and inflammatory diseases * diagnosed severe mental and psychological disorders * having malignancy * pregnant or people who breastfeed

Keywords: fibromyalgia pain manual lymphatic drainage
effects of gastric bypass surgery and calcium metabolism and the skeleton

Conditions: Obesity, Morbid; Gastric Bypass

Summary: obesity is a chronic illness of staggering proportions. because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including roux-en-y gastric bypass. gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. because of the serious consequences of osteoporosis and fracture, this is of great concern. this study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology.


Eligibility criteria:
inclusion criteria: scheduled to undergo gastric bypass surgery. please note that to be eligible, one must already be working with a bariatric surgeon and with plans in place to undergo gastric bypass. this study is unable to arrange or pay for gastric bypass surgery. exclusion criteria: * perimenopausal women * known intestinal malabsorption * prior bariatric surgery * use of medications known to impact bone and mineral metabolism * disease known to affect bone * illicit drug use or alcohol use \>3 drinks/day * serum calcium \>10.2 mg/dl * calculated creatinine clearance \<30 ml/min * weight \>350 pounds * wrist circumference \>12 inches or calf circumference \>17 inches

Keywords: obesity, morbid bariatric surgery gastric bypass calcium metabolism disorders vitamin d bone density body composition weight loss
evaluation of cloumella strut effect in tip rotation

Conditions: Nose Deformities, Acquired

Summary: the role of strut in rhinoplasty has been debated for many years and many research has been made over this problem but there is no significant data for descision of surgeon, so this study was designed to evaluate the effect of columellar strut in tip projection and rotation.

in selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.

Eligibility criteria:
inclusion criteria: * rhinoplastic patients exclusion criteria: * revision surgery, * incomplete strip, * facial anomaly

Keywords: rhinoplasty ,esthetic surgery
topotecan in treating patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.

objectives: * determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy. * determine the safety of this regimen in these patients. outline: this is a dose-escalation study. patients receive oral topotecan twice daily for 21 days. treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression. patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. the maximum tolerated dose is defined as the dose tolerated by the majority of the patients. patients are followed every 2 months for at least 6 months. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer * stage iiib, iiic, or iv * surgically staged and debulked * complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria: * no evidence of cancer by history or physical examination * ca 125 no greater than 35 units/ml * no evidence of residual cancer on ct scan of the abdomen/pelvis and chest x-ray * must have received at least 5 courses of first-line chemotherapy patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * not specified hematopoietic * granulocyte count at least 1,200/mm\^3 * platelet count at least 90,000/mm\^3 hepatic * bilirubin normal * alt and ast less than 1.5 times upper limit of normal (uln) * alkaline phosphatase less than 1.5 uln renal * creatinine clearance at least 60 ml/min prior concurrent therapy: biologic therapy * no concurrent immunotherapy chemotherapy * see disease characteristics * at least 3 weeks since prior first-line chemotherapy * at least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer) * no other concurrent chemotherapy endocrine therapy * no concurrent hormonal therapy radiotherapy * no prior abdominopelvic radiotherapy * no concurrent radiotherapy surgery * see disease characteristics * no concurrent surgery other * no other concurrent antitumor therapy

Keywords: stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer
ultrasound-guided technique for thoracic epidural insertion

Conditions: Pain

Summary: thoracic epidural analgesia and anesthesia are effective in improving the quality of intraoperative and postoperative pain relief during thoracic and abdominal surgical procedures. conventional epidural techniques have significant limitations. due to the anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the insertion requires a more technically challenging paramedian approach. the safety and feasibility of bedside ultrasonography for the lumbar spine has already been established and it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia

• the feasibility and the reliability of us imaging for the thoracic spine has been proven by comparing the findings of ultrasound scans to mri measurements, which is the standard imaging technique for the depiction of the spine. pre-puncture us assessment may contribute to the safety and efficacy of the thoracic epidural technique. the purpose of this study is to compare the ultrasound-guided thoracic epidural insertion technique with the conventional anatomic landmarking technique of contacting bone and walking-off the lamina

Eligibility criteria:
inclusion criteria: * age \> 18 years old. * elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia. * consent to participate and signed consent form. exclusion criteria: * contraindication to epidural anesthesia. * marked spinal deformities or a history of spinal instrumentation * emergency surgery. * inability to communicate in english. * bmi\>35 kgm-2

Keywords: thoracic epidural epidural anesthesia ultrasound palpation thoracic spine
different strategies for preventing severe acute malnutrition in niger

Conditions: Malnutrition

Summary: options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. finding the most appropriate strategy is essential to prevent child malnutrition in countries like niger with annual hunger gaps. here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.


Eligibility criteria:
inclusion criteria: * resident in selected villages * height between 60 and 80 cm. exclusion criteria: * refusal to participate

Keywords: pediatrics ready-to-use supplementary food corn soy blend cash transfer prevention of malnutrition niger