Kornimate/medical-research-clean huggingface dataset:
a study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of repeated dosing of ro5459072 in volunteers with celiac disease

Conditions: Celiac Disease

Summary: a randomized, double-blind, placebo-controlled, two treatment, parallel group study to investigate the effects of ro5459072, a cathepsin s inhibitor, on the immune response to a gluten challenge in volunteers with celiac disease. volunteers with previously diagnosed celiac disease will be randomized to receive either 100 milligrams (mg) ro5459072 or placebo twice daily with food for 28 days (days 1 to 28).


Eligibility criteria:
inclusion criteria: * volunteers with a biopsy confirmed diagnosis of celiac disease * human leukocyte antigen (hla) serotype dq 2.5 and hla-dq 8 haplotypes * maintaining a gluten-free diet for at least one year. compliance will be assessed by serology, compatible responses to a self-reported assessment of gluten-free diet adherence and the absence of typical celiac disease symptoms * able to participate and to comply with the study restrictions including the requirements of the gluten challenge exclusion criteria: * a diagnosis of non-celiac gluten sensitivity * a personal history of food intolerance other than to gluten, or diagnosis of galactosemia, lactose, galactose or fructose intolerance * a personal history of severe acute symptomatic reaction to sporadic gluten ingestion * a diagnosis of refractory celiac disease or presence of severe complications of celiac disease * diagnosed or suspected immunoglobulin a (iga) deficiency * acute inflammatory bowel disease (ulcerative colitis, crohn's disease), gastrointestinal obstruction or sub-occlusive syndromes, digestive perforation or risk of digestive perforation, painful abdominal syndromes of undetermined cause * a history of stomach or intestinal surgery or resection. appendectomy and hernia repair are acceptable * any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple allergies (non-active hay fever is acceptable) * immunocompromised or with reduced immune function considered to be clinically significant by the investigator * immunization within 30 days before the screening visit or planning vaccination during the study * women who are pregnant or lactating, or who are of child-bearing potential and do not agree to comply with requirements for contraceptive use. men who do not agree to comply with requirements for contraceptive use and restrictions on sperm donation * participation in an investigational drug or device study within the three months preceding the screening visit
a comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy.

Conditions: Vulvovaginal Atrophy

Summary: the goal of this observational study isto compare the effect hyaluronic acid and estradiol in vulvo-vaginal atrophy.hyaluronic acid and estrogen were equally effective in vaginal treatment. hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or who wish to receive non-hormonal therapy.

this randomized, controlled, monocentric, prospective, comparative (before/after) study was conducted at koru ankara hospital between april 2023 and september 2023. patients were randomized into 2 groups. a total of 300 patients, 150 in each group, were included in the study. informed written consent was obtained from the volunteers who willingly participated in the study. group i received 25 µg vaginal estrodiol (vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks. group ii received 5 mg of vaginal hyaluronic acid every day for 14 days, then 2 days a week for the next 2 weeks. hyaluronic acid gel for vaginal use was supplied by orthogen®. the treatment period lasted 1 month in both groups. before receiving treatment, patients who consented to participate in the study were examined by a gynecologist, and vaginal health index (vhi)12 score was determined. after the end of the treatment period, the patients were re-evaluated by the same physician, and the vhi score was obtained again. the vhi is the most common score based on vaginal elasticity, secretions, ph, presence of petechiae on the epithelial mucosa, and hydration assessment. the score can range from 5 to 25, and \<15 is considered an atrophic vagina index. vaginal ph was measured by placing ph paper on the anterior wall of the vagina. a value \>5 ph was defined as decreased estrogen activity13. the effect on the primary outcome vhi index was investigated.

Eligibility criteria:
inclusion criteria: - age over 40 years, fsh value above 25 pg/ml, lh value above 20 pg/ml, e2 value below 15 pg/ml, endometrial thickness of 5 mm or less, and absence of menstruation for 12 months. exclusion criteria: * patients receiving hormone replacement therapy (hrt), genital organ malignancy, breast cancer, patients with vaginal bleeding of unknown cause, history of thrombophlebitis and thromboembolism, thrombophilia, acute or chronic cardiovascular diseases, estrogen and hyaluronic acid allergy, vaginal infection, acute or chronic cardiovascular diseases, and liver diseases. patients eligible to participate in the study were required to report at least one of the following symptoms: vaginal dryness, burning or irritation, lack of lubrication during intercourse, sexual discomfort or pain during intercourse, dysuria, or recurrent urinary tract infection.

Keywords: vulvovaginal atrophy hyaluronic acid estradiol
capsule colonoscopy in crohn's disease and its correlation with conventional colonoscopy and faecal calprotectin

Conditions: Crohn's Disease

Summary: aims: * to study the feasibility of capsule colonoscopy in patients with crohn's disease (cd). * to compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing. * to correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy. * to document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy. project design: cross sectional, prospective, comparative study methodology: patients of the royal melbourne hospital (rmh) and other associated speciality clinics with an established diagnosis of cd who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy on the same day after undergoing bowel preparation. the images of both the conventional and capsule colonoscopies will be recorded. in addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day. professor macrae and the scholarly selective student researcher will assess the recorded images obtained from capsule colonoscopies once the images have been deidentified. to assess the level of mucosal disease they will use the simple endoscopic score for cd (sescd). the results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.


Eligibility criteria:
inclusion criteria: * adults with established diagnosis of cd with ileal, colonic or ileo-colonic disease aged 18-75 years. gender: both male and female * patients of rmh ibd clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes: patients who have had anti tnf induction therapy 6-12 months prior to commencement of this study and/or patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings. exclusion criteria: patients must not: * have known/suspected gastrointestinal obstruction * have swallowing disorder * have a known oesophageal stricture * have severe gastroparesis * have dementia * have a cardiac pacemaker or other implanted medical device * have sever cardiac or renal insufficiency * have a previous allergy or contraindication to bowel preparation * be pregnant * prior major abdominal surgery * colonoscopy is contraindicated
pharmacokinetics of megace f and megace os under fasting and fed conditions in healthy male volunteers

Conditions: Cachexia; Anorexia

Summary: phase i study of megace f will be conducted to investigate pharmacokinetics and safety compared to megace os. phase i study divided into 3 parts written as belows. part 1 megace f in fasting volunteers vs megace f in fed volunteers part 2 megace f vs megace os in fed volunteers part 3 megace f vs megace os in fasting volunteers


Eligibility criteria:
inclusion criteria: age: 20-55 years body weight: greater than 50kg written informed consent exclusion criteria: known allergy to megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study
cost-consequence analysis of parenchymal stapling device versus hand-sewing for pulmonary lobectomy in lung disease

Conditions: Malignant Neoplasm of Bronchus or Lung, Unspecified

Summary: the purpose of this study is to compare the efficacy and cost difference of using a parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with lung disease (mass or others).

there are many lung diseases that need surgical treatment including malignancy lesion or benign lesions such as lung bleb or bullae, lung cyst, benign tumor, infection (necrotizing pneumonia, lung abscess, aspergilloma) etc. one of the most common procedure is pulmonary lobectomy. the surgical method for dividing parenchyma when performing lobectomy was divided in two methods. in the past, the investigators used hand-sewn technique but this procedure was time-consuming, high risk of air leakage, infection and re-operation, long length of hospital stay and high total cost of treatment. in the present time, the investigators use stapling device which has been used worldwide in various field of surgery since 1995. many studies proved that using stapling devices can reduce post-operative complication, length of hospital stay and total cost of treatment and also became the standard instrument for lung surgery. in thailand, these devices have been used for at least 5 years but they were not included in all of health insurance of thai government. many patients had to pay for these devices by themselves, approximately 323-484.5 usd. therefore, the investigators try to prove the hypothesis that using stapling devices for lung surgery would reduce the cost of treatment, post-operative air leakage, re-operative rate, length of hospital stay and time of surgery. the result of this study may effect the decision for including these devices in the health insurance of thai government.

Eligibility criteria:
inclusion criteria: * patients who diagnosed lung diseases that need to perform pulmonary lobectomy exclusion criteria: * patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.

Keywords: stapling device lobectomy cost utility
a 24-week single-blind trial of prevention of hand eczema in cleaners

Conditions: Hand Eczema

Summary: this study aims to investigate the effectiveness of picture-based prevention education among professional hospital cleaners in relation to hand eczema. this is a single-blinded randomized clinical trial including hospital cleaners at three different hospitals.


Eligibility criteria:
inclusion criteria: * professional hospital cleaners ≥ 18 years old * sufficient danish skills * written informed consent exclusion criteria: * insufficient danish skills * pregnancy * other skin diseases on the hands * receiving immunomodulatory therapies

Keywords: prevention occupational picture cleaning
revofit™ system evaluation on residual limb pain in amputee patients

Conditions: Amputation; Adult Disease

Summary: at the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. in most cases, the volume of residual limb is constant from 12 to 18 months after surgery. however, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. the goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.

with the " multiple n-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.

Eligibility criteria:
inclusion criteria: * patients aged 18 years old and above * above knee or below knee amputation (irrespective of etiology and time from amputation) * residual limb pain * prosthetic with classic fitting * fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting ...) * recipients or registered with a social security scheme * informed consent form signed beforehand exclusion criteria: * patient with peripheral neuropathies contraindicating the use of revofit system * pregnant woman, nursing mother or parturiant * patient in detention by judicial or administrative decision * patient undergoing psychiatric compulsory care * patient in a health or social institution for purposes other than research * legally protected person * patient unable to express their consent

Keywords: residual limbs pain adjustable socket
osteopathic manipulative treatment for constipation in people with rett syndrome

Conditions: Rett Syndrome

Summary: constipation consists of bowel symptoms characterized by difficulty or infrequency passage of stool, stiff stool, or a feeling of incomplete evacuation. however, its impact goes far beyond this definition. constipation negatively impacts the quality of life (qol) of children and adults suffering from this condition, affecting mental and physical-related qol. additionally, a negative impact of constipation on qol was found in parents carrying children with constipation, affecting family functioning. people with an intellectual disability present a constipation rate of over 33%. rett syndrome (rtt) is a complex neurodevelopmental disorder affecting about 1/10,000 females and a few males worldwide. chronic constipation is persistent in people with rtt, with a reported prevalence higher than 74%. specific recommendations for constipation management in rtt were developed, including behavioral, pharmacological, and surgical considerations. recently, the literature has been enriched with papers describing the osteopathic treatment efficacy in reducing constipation. emerging literature reported the efficacy of omt in reducing constipation symptoms and improving qol in typically developed people, as well as in children with disability. the present study aims to evaluate the efficacy of a specific omt for managing chronic constipation in people with rtt and its impact on primary caregivers' quality of life. research questions: * can an omt improve the constipation of people with rtt, increasing the frequency of bowel movements? * can the effects of an omt aimed at reducing the constipation symptoms in people with rtt positively impact the participants' parents' constipation-related qol? twelve individuals with rtt and their families will be recruited to participate in this single-blind parallel group-randomized study. participants will be randomly divided into an experimental group (eg) and a control group (cg). after the preliminary evaluations, each participant will undergo eight omt carried out weekly for eight weeks. the omt will aim to facilitate bowel movements by increasing blood flow through the abdomen. at the end of the treatment, the participants will repeat the evaluation conducted before the omt, and the collected data will be analyzed.


Eligibility criteria:
inclusion criteria: * diagnosis of classic rett syndrome with a mutation of the mecp2 gene; * matching the rome iv criteria for constipation; exclusion criteria: * the presence of specific severe heart and cardiovascular diseases; * the presence of amenorrhea.
quality of life in children with psychiatric disorders and parental well-being: effects of group cbt

Conditions: Quality of Life

Summary: this study examines the immediate and long-term effectiveness of a group cognitive behavioral therapy intervention (gcbt) in improving health-related quality of life (hrqol) in children treated for mixed psychiatric disorders in naturalistic child psychiatric outpatient settings. the effects of a treatment-as-usual condition (tau) is also examined. further, the study aims to explore the associations among children´s hrqol dimensions and parental well-being, and how gcbt may influence these associations.

the effectiveness of gcbt and tau at the different time points are measured using nonparametric tests, such as friedman tests and wilcoxon tests. the associations among children´s hrqol dimensions and parental well-being variables at different time points are explored using a network analysis approach.

Eligibility criteria:
inclusion criteria: * child psychiatric outpatient care * sufficient skills to participate in group sessions exclusion criteria: * child psychiatric inpatient care * acute suicidality * excessive physical aggression

Keywords: quality of life health-related quality of life children cognitive behavioral therapy group cognitive behavioral therapy parental wellbeing
pethidine analgesia on labor duration

Conditions: Labor Pain

Summary: although opioid analgesics are used to treat labor pain, there are still concerns about their side effects. the researchers in this study; aimed to evaluate the effect of pethidine on active phase duration of labor, labor pain and maternal-neonatal. 50 mg pethidine will be administered intramuscularly to the cases to be included in the study group. the patients in the control group will be given placebo injections. vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60 minutes. pain will also be assessed by visual analogue scale (vas) before injection and at the 1st and 2nd hour after injection. delivery times, maternal side effects, neonatal apgar scores and fetal findings will be recorded.


Eligibility criteria:
inclusion criteria: * nullipar-multiparous patients; * singleton pregnancies 37- 41 weeks (by the last menstrual period). exclusion criteria: * maternal respiratory rate \< 8 /min, * maternal bradycardia (\<60 bpm), * major fetal congenital anomalies, * uterine scar presence from previous pregnancies, * malpresentation, * antepartum hemorrhage, * multiple pregnancy, * labor induction, * chronic systemic disease, * rupture fetal membranes, * epidural analgesia.

Keywords: analgesia labor pethidine active phase
randomized clinical trial of bococizumab (pf-04950615; rn316) in subjects with primary hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events

Conditions: Hyperlipidemia

Summary: this study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of bococizumab (pf-04950615; rn316) in subjects with hyperlipidemia receiving background statin therapy.


Eligibility criteria:
inclusion criteria: * treated with a statin * fasting ldl-c \>=100 mg/dl and triglyceride \<= 400 mg/dl * high or very high risk of incurring a cardiovascular event exclusion criteria: * pregnant or breastfeeding females * cardiovascular or cerebrovascular event or procedure within 90 days * congestive heart failure nyha class iv * poorly controlled hypertension

Keywords: primary hyperlipidemia or mixed dyslipidemia high risk of cardiovascular events multiple cardiovascular disease risk factors.
stereotactic body radiotherapy for oligometastases from colorectal cancer

Conditions: Colorectal Cancer

Summary: single arms prospective phase ii study of sbrt for oligometastatases from colorectal cancer

single arms prospective phase ii study of sbrt for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.

Eligibility criteria:
inclusion criteria: * 18-75 years * eastern cooperative oncology group (ecog) performance score ≤ 1 * diagnosis by pathological examination * primary lesion is under control by surgery * adequate blood counts: * white blood cell count ≥3.5 x 109/l * haemoglobin levels ≥100g/l * platelet count ≥100 x 109/l * creatinine levels ≤1.0× upper normal limit (unl) * urea nitrogen levels ≤1.0× upper normal limit (unl) * alanine aminotransferase (alt) ≤1.5× upper normal limit (unl) * aspartate aminotransferase (ast) ≤1.5× upper normal limit (unl) * alkaline phosphatase (alp) ≤1.5× upper normal limit (unl) * total bilirubin (tbil) ≤1.5× upper normal limit (unl) exclusion criteria: * primary lesion is not under control * pancreatic carcinoma * oligometastases could not be located * pregnancy or breast feeding * symptoms or history of peripheral neuropathy

Keywords: stereotactic boday radiotherapy, oligometastases
deposition - decreasing postoperative blood loss by topical vs. intravenous tranexamic acid in open cardiac surgery

Conditions: Bleeding; Surgical Blood Loss; Seizures

Summary: the aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (txa) versus the usual intravenous txa in patients undergoing on-pump cardiac surgery.

postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. it results from the blood thinners that are needed for use. intravenous tranexamic acid (txa) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. although intravenous txa is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. this is due to the similarity between txa and the brain tissues. the aim is to eliminate the risk of seizures but to maintain the protection against bleeding. when txa is used directly on the tissues (topically) for other type of surgeries (joints), txa is effective to reduce blood loss and transfusions. the aim is to prove that direct application of txa on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (cabg), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (cpb) and median sternotomy 3. provide written informed consent exclusion criteria: 1. allergy to tranexamic acid 2. undergoing minimally invasive surgery 3. fulfill any of the following transfusion risk factors (a-d): a. emergency surgery b. history of bleeding disorder c. inherited thromboembolic or hemorrhagic disease d. infective endocarditis (active) 4. history of previous cardiac surgery 5. estimated glomerular filtration rate \<30 ml/min (ckd-epi equation) or on dialysis 6. pre-operative hemoglobin \> 170 g/l or \<110 g/l 7. pre-operative thrombocytopenia (\<50,000 platelets per µl) 8. expected circulatory arrest 9. pregnancy or breast feeding 10. previously enrolled in the deposition trial 11. refusal of blood products 12. pericardiectomy

Keywords: tranexamic acid on-pump cardiac surgery