Kornimate/medical-research-clean huggingface dataset:
to investigate the efficacy and mechanism of zbp powder product in the treatment of osteopenia in patients with pain.

Conditions: Osteopenia

Summary: this study investigates the efficacy and mechanism of traditional chinese medicine formula power product in the treatment of osteopenia in patients with pain. half of participants will receive chinese medicine formula power product, while the other half will receive a placebo.

osteoporosis is a major public health problem, resulting in potentially pain and increasing risk of fracture. treatment of osteoporosis consists of pharmacotherapy, lifestyle measures, dietary changes, mineral supplementation. traditional chinese medicine is a major component of health care in taiwan and provides one treatment alternative for osteoporosis. investigators investigate the efficacy and mechanism of traditional chinese medicine formula powder product in the treatment of osteopenia patients with pain.this trial is a 12 weeks' randomized, placebo-controlled study. the study was approved by the wan fang hospital, and signed informed consent was obtained from each participant. 80 osteopenia participants with pain were enrolled in this study. there were 80 participants aged 50 years or older included. before random assignment to treatment, participants were at least moderate pain during 2 weeks as identified by visual analogue scale (vas) for more than 4. bone mineral density (bmd) of all participants was -2.5 or below without diabetes, hyperthyroidism, hypoparathyroidism, liver or kidney function disorder, ovariectomy, rheumatoid arthritis, bone cancer, ever used hormone agent within 6 months before assignment to treatment, ever used steroids more than 3 week before assignment to treatment, primary outcome measures were the change of vas scale, oswestry disability index and whoqol-bref taiwan at week 1 and 12. secondary outcome was the genetic loci associated with a susceptibility to osteoprosis treated by traditional chinese medicine formula powder product. result : to provide evidence of the efficacy and mechanisms of zbp powder product in the treatment of osteoporosis patients with pain.

Eligibility criteria:
inclusion criteria: 1. aged 50 years or older. 2. vas score≧4.0 in a week. 3. bone mineral density (bmd) of all participants was -2.5 or below. exclusion criteria: 1. diabetes. 2. thyroidism function disorder. 3. parathyroidism function disorder. 4. liver or kidney function disorder. 5. ovariectomy 6. rheumatoid arthritis. 7. bone cancer. 8. ever used hormone agent within 6 months before assignment to treatment. 9. ever used steroids more than 3 months before assignment to treatment. 10. ever used analgesics, excepted acetaminophen, more than 1 week before assignment to treatment.
impact of visceral osteopathic treatment on meconium evacuation in preterm infants

Conditions: Meconium Ileus

Summary: timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. the time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours). obstruction of the gastrointestinal tract by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage recent data support the concept that complete rapid evacuation of meconium plays a key role in feeding tolerance . if duration to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and hospital stay of the infant prolongates. previously two prospective trials focusing on the problem of delayed meconium evacuation in preterm with different therapeutic pharmacological approaches were published by our group. none of the applied therapies appeared to be effective or had a beneficial effect- quite the contrary one agent (gastrografin) was supposed to have severe negative side effects. therefore we were looking for an alternative, non-invasive, holistic solution for the problem of delayed meconium excretion. osteopathic treatment with the emphasis on the relationship of the structural and functional integrity of the body and with its variety of therapeutic manual techniques seemed to be remedy. treating the abdomen of premature infants with visceral osteopathic techniques might be more effective to mobilize meconium from small bowel and deep parts of the colon. therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.


Eligibility criteria:
inclusion criteria: * premature infants with a birthweight 1500 gram exclusion criteria: * major congenital malformations * known gastrointestinal abnormalities

Keywords: premature infant visceral osteopathy alternative medicine meconium passage enteral feedings hospital stay
an evaluation of the erchonia laser as a non-invasive treatment to improve the appearance of skin laxity

Conditions: Skin Laxity

Summary: the purpose of this clinical study is to determine the effectiveness of the erchonia® gvs in improving the appearance of skin laxity on the abdominal region.

this clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the erchonia® gvs laser in improving the appearance of skin laxity on the abdominal region. participants will receive 8 treatments over the course of 4 weeks.

Eligibility criteria:
inclusion criteria: * subject has signed a written informed consent form. * male or female 22 to 70 years of age, inclusive. * desire to undergo treatment for skin laxity of the abdomen. * subject's score on the skin laxity scale for skin on the abdomen is 1 (mild) or 2 (moderate). * subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in diet, exercise or medication routine during the course of the study. * subject agrees to refrain from taking any medication(s) or supplements(s), whether prescription or otc, or undergo any procedures indicated for weight loss, or for fat reduction or improving the appearance of the skin in the abdominal area (e.g. liposuction, ultrasound therapy) for the duration of participation in the clinical study. * willing to have research photos taken of treatment areas. * understands, and is able and willing to comply with all study visits, treatments and evaluations schedules and requirements. * females are at least 9 months post-partum. * females are post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study and agree to continue to do so for the duration of study participation. exclusion criteria: * skin laxity resulting from genetic disorders, including but not limited to ehlers-danlos syndrome. * history of undergoing a fat reduction procedure (e.g., liposuction, bariatric surgery, abdominoplasty). * botulinum toxin or other aesthetic drug injections within the abdomen area within the past 6 months. * history of any major prior surgery in the abdominal area * implanted medical prostheses (such as clips, pins or plates) in or adjacent to the area of intended treatment. * active implanted device such as a pacemaker, defibrillator, or drug delivery system. * any clinical and significant dermatological skin condition(s) in the intended abdominal treatment area, such as skin infections or rashes, extensive scarring, psoriasis, etc.. * tattoo or former tattoo at the treatment area. * current moderate to heavy tobacco use, defined as smoking 10 or more cigarettes per day (or equivalent use of other nicotine-containing products such as cigars, pipes, chewing tobacco, or e-cigarettes) within the past 6 months * history of chronic drug or alcohol abuse. * pregnant or intending to become pregnant in the next 6 months. * currently enrolled in a clinical study of an unapproved investigational drug or device.
a study to investigate the effect of protein in infant formula on insulin response in adults

Conditions: To Compare the Metabolic Effects of Different Infant Milks

Summary: it has been established that the consumption of a diet that causes a low rise in blood insulin levels is beneficial in terms of risk for diabetes and heart disease. furthermore, it is known that certain nutrients contained within a food play an important role in the insulin response of that food. for example, the type and quantity of protein has been shown to affect the insulin response to particular foods. different types of infant formula exist, containing different levels and types of protein, yet the impact of these different infant formulas on blood insulin levels is not known. using a randomized, double blind, cross-over study design, the insulin response to four test milks was compared in healthy adults. the four test milks were as follows: i) infant formula containing partially hydrolyzed protein; ii) infant formula with intact protein; (iii) infant formula with a higher energy and protein content compared to (i) and (ii); and (iv) human breast milk (in a small sub-group). the aim of the study was to show that the insulin response to the partially hydrolyzed formula is similar to that of an infant formula with intact protein.


Eligibility criteria:
inclusion criteria: * healthy males and females aged 20-50 years at time of the enrollment * normal body weight. bmi 19-25 kg/m2 * having obtained his/her signed informed consent exclusion criteria: chronic or acute diseases affecting metabolism (diabetes, renal insufficiency, cvd, liver disease), dyslipidemia, as checked using the medical questionnaire and based on a biochemical blood analysis (glucose, triglycerides, cholesterol, transaminases and gamma-gt, crp in fasting * anemia (erythrocytes \< 4,6 t/l (male) or \< 4,2 t/l (women); hemoglobin hb \< 13 g/dl (male) or hb \< 12 g/dl (women); hematocrit ht \< 40% (male) or ht \< 37% (women); sera iron \< 0,6 mg/l or plasma ferritin \< 120 μg /l (male) or \< 60 μg/l (non menopaused women) * recent major surgery (3 months) * history of cancer within the past year * significant weight loss during the last 3 months (more than 5% of bw) * regular intensive physical activity of more than 3 times of 45 min per week * food allergy, lactose intolerance * under chronic medications (except contraceptive pills) have a regular higher alcohol consumption than 1 drink/day or occasional 1-2 drinks during week end * consumption of illicit drugs, as checked by a urinary testing * smoking (more than 5 cigarettes a day) * women pregnant or lactating * special weight reduction program /diet * blood donation of at least 300ml during the last 3 months or planned blood donation before the end of the study * subject who cannot be expected to comply with the study procedures, including consuming the test products (600 ml of milk within 10 minutes) * currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Keywords: infant formula intact protein partially-hydrolyzed protein glucose insulin metabolic response
safety and efficacy study of autologous bone marrow aspirate concentrate for no-option critical limb ischemia

Conditions: Critical Lower Limb Ischemia; Type-2 Diabetes Mellitus

Summary: the aim of the presented clinical trial is to evaluate a hypothesis, that bmac prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type ii., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of no-cli. another aim of the study is to find out differences among three different therapeutic types of bmac application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.

secondary hypothesis assumes, that the intravenous application of bmac in patients with t2dm older than 30 years of age, with a dose of insulin exceeding 0.7 u/kg/day or 50u/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glychba1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of bmac.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * diagnosis of critical limb ischemia * non-healing defect on the study limb * abi value \< 50 mmhg or abi\< 0.4 * tbi value \< 40 mmhg or tbi \< 0.4 * tcpo2 \< 20 mmhg in supine position * no other suitable surgical or re-vascularization procedure * age \> 18 years * signed informed consent exclusion criteria: * non-signing of the informed consent * anticipated life expectancy \< 6 months * history of bone-marrow disease * renal failure or dialysis dependency * known malignant disease * health risks excluding the possibility of general anaesthesia or sedation * life-threatening ischaemic heart disease * vast necrosis of the index limb * active infectious disease, or atb treatment * treatment with immunosupressives * pregnancy, breastfeeding

Keywords: ischemia diabetes mellitus bone marrow aspirate concentrate (bmac)
ibi112 in moderate to severe plaque psoriasis with randomized withdrawal and re-treatment

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of ibi112 in the treatment of participants with moderate to severe psoriasis


Eligibility criteria:
inclusion criteria: 1. have a diagnosis of plaque-type psoriasis for at least 6 months; 2. psoriasis area and severity index (pasi) score of 12 or greater, and static physician's global assessment (spga) score of 3 (moderate) or greater; psoriasis covering at least 10% of body surface area; 3. must be a candidate for either systemic therapy or phototherapy for psoriasis. exclusion criteria: 1. has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments 2. participants who have ever received ibi112 or il-23 inhibitor 3. history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances 4. has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant 5. is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug
pathophysiological effects of persistently colonized microbiome on irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (ibs) patients. the main questions it aims to answer are: question 1: the microbiome difference of the biofilm between ibs and healthy patients. question 2: the metabolic product patterns between ibs and healthy patients. participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will be collected during the examination. researchers will compare the ibs and healthy control groups to see if there was the disease-specific pattern in the microbiome and metabolic product of the biofilm.


Eligibility criteria:
inclusion criteria: * ibs patients with iv type; no abdominal surgery; exclusion criteria: * age \<18 y; * major disease; * alcoholic addicted; * antibiotic use in past 3 months; * severe gastrointestinal disease * severe cardiac disease; * pregnant; * icu in past 1 year; * vegeterian; * immune disease (sle etc.) * mental disease;
study to evaluate the safety and efficacy of oral cr845 (difelikefalin) in patients with primary biliary cholangitis (pbc) and moderate-to-severe pruritus

Conditions: Cholestatic Pruritus

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (bid) oral cr845 1.0 mg in patients with pbc with moderate-to-severe pruritus. the study includes a 16-week treatment period.

this study will consist of a screening visit, a 7-day run-in period, a 16-week treatment period, and a follow-up visit (approximately 7-10 days after the last dose of study drug). informed consent will be obtained prior to performing any study-specific procedures. the screening visit will occur within 7 to 28 days prior to randomization to assess eligibility. day 1 of the treatment period will be defined as the day of the administration of the first dose of study drug. if patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day run-in period, they will be randomized in a 1:1 ratio to receive either placebo or cr845 tablets at a dose of 1.0 mg orally bid for 16 weeks.

Eligibility criteria:
key inclusion criteria: to be eligible for inclusion into the study, a patient must meet the following criteria: * confirmed diagnosis of pbc; * if currently taking ursodeoxycholic acid (udca), should be on stable dose for \>12 weeks prior to screening and plan on continuing to take udca throughout the study; * if previously taking udca, should have discontinued its use \>12 weeks prior to screening; * self-reports experiencing daily or near-daily pruritus during the month prior to screening; * prior to randomization has a mean baseline wi-nrs score indicative of moderate to severe pruritus. key exclusion criteria: a patient will be excluded from the study if any of the following criteria are met: * presence of child-pugh class c decompensated cirrhosis at screening; * itching secondary to biliary obstruction; * history or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis; * current placement on liver transplantation list with anticipated liver transplant during the course of the study or current model for end-stage liver disease (meld) score ≥15; * alanine aminotransferase or aspartate aminotransferase \>5 × upper limit of normal at screening, or within 2 months prior to screening; * anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the treatment period; * new or change of treatment with antihistamines and corticosteroids (oral, intravenous, or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates within 14 days prior to screening.

Keywords: primary biliary cholangitis pruritus cr845 chronic itch difelikefalin itch itching generalized pruritus
pancreatitis - microbiome as predictor of severity

Conditions: Acute Pancreatitis

Summary: this study is a multicentric prospective study initiated and coordinated from the university medical centre goettingen. the study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis.

this prospective translational study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis. from each patient one buccal and rectal swab is collected within 72 h after hospital admission. microbial composition will be determined by 16s and metagenomics oxford nanopore sequencing (ont) and correlated with the revised atlanta classification as the primary endpoint. secondary endpoints are the correlation of microbiome signatures with the length of hospital stay, numbers of interventions and mortality. to this end, alpha and beta diversity of microbiota are determined and compared between mild, moderately severe and severe acute pancreatitis.

Eligibility criteria:
inclusion criteria: patients with acute pancreatitis (2 out of 3 following diagnostic criteria: lipase \>3x of upper limit, abdominal pain, and imaging modalities (computed tomography, magnetic resonance imaging or ultrasound). \< 72 hours after hospital admission. exclusion criteria: pregnant women patients \< 18 years; patients who are incapable of giving consent
pre-hospital and intra-hospital temporal delays in patients requiring emergent trauma craniotomy

Conditions: Brain Injuries, Traumatic

Summary: the investigators aim to retrospectively map the delays in the acute care of traumatic brain injury patients necessitating emergent craniotomies.

despite the high incidence of traumatic brain injury (tbi) and the high numbers of emergent craniotomies for tbi performed worldwide, publications reporting on temporal delays in these patients are very scarce. to the best of the investigators' knowledge, there are only 3 publications providing data on the intra-hospital delay and no publications on pre-hospital delay specifically for tbi patients undergoing emergent craniotomies. the aim of the present study is to retrospectively map delays between the emergency call of the national emergency telephone dispatch to the hospital's medical emergency service (ec) and the surgical skin incision in emergent tbi craniotomies in the investigators' level 1 trauma center and to propose possible measures to improve performance.

Eligibility criteria:
inclusion criteria: * every patient undergoing 1 of 3 surgical procedures ('removal of epidural hematoma'; 'removal of acute subdural hematoma'; and 'decompressive craniectomy'), performed between february 1, 2010 and january 31, 2016, as recorded in the surgical database of our institution. exclusion criteria: * who had a delayed clinical or radiological deterioration as a surgical indication; * who did not have traumatic brain injury as the origin of the intracranial abnormalities; * in whom not all aforementioned temporal or clinical data were readily available from the electronic patient file; and/or * who were not admitted via our emergency department.
core temperature in patients with ohca

Conditions: Out-Of-Hospital Cardiac Arrest; Accidental Hypothermia; Temperature Change, Body

Summary: a prospective observational study aiming to monitor core temperature via an esophageal probe in out of hospital cardiac arrest during transport and until arrival in hospital. insertion of an esophageal temperature probe will be done on scene during ongoing resuscitation manoeuvres based on european resuscitation council guidelines 2015 (or newer). environmental temperature influence and hypothermia prevention interventions will be monitored.

prospective observational study to evaluate the body temperature difference in patients in out of hospital cardiac arrest on site and at arrival at the hospital. if the patient fulfills the inclusion criteria and after establishment of cpr measures according the erc resuscitation guidelines (2015 or newer) an esophageal probe will be inserted and bodytemperature is measured; on site ambiental temperature will also be measured. weather conditions, altitude on site, activity of the patient and hypothermia protection (eg. clothes) will bei documented. on arrival in hospital the body temperature will be measured with the esophageal probe;

Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest * patients transferred to hospital * \> 18 years exclusion criteria: * obvious signs of death * obvious lethal injury/injuries incompatible with life * confirmation of death on scene * \< 18 years

Keywords: out-of-hospital cardiac arrest accidental hypothermia core temperature