Kornimate/medical-research-clean huggingface dataset:
endocur - modulation of endotoxaemia via curcumin intake in healthy overweight adults

Conditions: Overweight

Summary: chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on the scottish population. obesity and inflammation have strong links to these diseases. one of the mechanisms explaining the relationship between low-grade inflammation and excess weight is "endotoxaemia". we wish to study this phenomenon, when small components coming from our gut bacteria can pass into the bloodstream, raising the body's defences. diet can modulate endotoxaemia. in this study, we propose to use curcumin, in a capsule form, to modulate endotoxaemia. curcumin comes from turmeric, which is widely used as a spice. in this study, we want to test the effect of consuming curcumin extract to the composition of the gut microbiota, post-meal endotoxaemia, and inflammatory markers in blood.


Eligibility criteria:
inclusion criteria: - bmi \> 25 kg/m2. exclusion criteria: * having chronic inflammatory or autoimmune disease, gastrointestinal complaints or known biliary obstruction (past and present) * use of anti-inflammatory drugs 2 weeks before the start of the study * use of antibiotics during the 12 weeks preceding the trial * pregnancy * lactation

Keywords: endotoxaemia, curcumin.
a pilot trial with subcutaneous alemtuzumab and oral fludarabinephosphate for the determination of safety, efficacy and molecular profiling for the prediction of response

Conditions: B-cell Chronic Lymphocytic Leukemia

Summary: open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. in patients with b-cll disease in 1st and 2nd relapse after any primary treatment or with disease refractory to any therapy in 1st or 2nd line (including fludarabine, ). this regimen is preceded by an escalation phase with 3-10-30 mg of alemtuzumab s.c. after the first phase (completed treatment of 7 patients) an interim analysis of safety and efficacy will be performed. in case of a sufficient risk benefit assessment followed by the enrollment of further 21 patients. final analysis of safety and preliminary efficacy will be based on all patients enrolled.


Eligibility criteria:
inclusion criteria: * male or female patients with cd23+, cd5+, cd19+, light chain monoclonal b cll * 1st or 2nd relapse after fludarabine or any other primary treatment regimen or refractory to primary or secondary treatment (including fludarabine) and simultaneously indication for treatment according to the nci workshop criteria 1996 * age 19-75 * who performance score 0-2 * informed consent given by the patient exclusion criteria: * hiv positive or positive for hepatitis b or c * active uncontrolled infection * child bearing age without adequate control of fertility, pregnant or lactating women * intolerance towards any ingredient of either oral fludarabine or alemtuzumab * allergy against foreign proteins * previous treatment with alemtuzumab * treatment with an experimental drug within the previous 2 months * second malignant disease (non cll) * cll in transformation (richter syndrome) * decreased kidney-function with creatinine-clearance \< 30ml/min * severe concomitant diseases or major organ dysfunctions * patients who are unable to comply with the requirements of the protocol

Keywords: b-cll refractory molecular profiling alemtuzumab fludarabinephosphate
the use of teriparatide as an adjunctive therapy for the treatment of jones fractures

Conditions: Fractures

Summary: this randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of jones fractures.


Eligibility criteria:
inclusion criteria: * patients who are at least 18 years of age and who have closed epiphyses. * patients of both genders and all races. * patients with jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation. * patients with a history of an acute injury and an acute jones fracture defined by torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress. * patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks. * patients with a baseline visual analog scale (vas) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight. * patients who are in good general health and who have physical examinations that either are within normal limits or are clinically non-significant as determined by the investigator. * patients with laboratory evaluations that either are within normal limits or are clinically non-significant as determined by the investigator. * patients who have voluntarily signed informed consent forms, including hipaa authorization. exclusion criteria: * patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses. * patients with jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation. * patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures. * patients with prior fifth metatarsal fracture(s). * patients with prodromal symptoms present for more than 2 weeks. * patients with a nonunion or delayed union as defined by the radiographic criteria described by torg et al. * patients who are allergic to any of the individual active ingredients in teriparatide or related compounds. * patients with chronic rheumatologic disease, ankylosing spondylitis or other inflammatory arthropathy. * patients with associated injuries considered by the investigator as to likely interfere with evaluation of the study drug. * patients with a present condition or history of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, endocrine, neurologic, psychiatric, connective tissue, respiratory or other medical disorders. * patients with worker's compensation claim(s) under dispute or mediation. * patients with history of drug or alcohol abuse. * patients who are pregnant or lactating. * patients who are considered by the investigator for any reason to be an unsuitable candidate for receipt of the study drug. * patients who are unwilling or unable to follow the follow-up evaluation schedules. * patients who refuse to voluntarily sign the informed consent form.

Keywords: jones fracture fifth metatarsal fracture teriparatide fracture healing
a study of the pharmacokinetics and safety of bms-663068 administered in subjects with normal renal function and with mild, moderate, severe and end stage renal dysfunction (esrd)

Conditions: HIV Infections

Summary: an oral dose in healthy and renally impaired subjects to determine the drug effect for bms-663068.


Eligibility criteria:
inclusion criteria (for renal impaired subjects): * classification by renal function based on egfr * clinical, ecg, and laboratory findings consistent with renal dysfunction * bmi of 18.0 to 38.0 kg/m2 inclusive * women of child bearing potential (wocbp) and sexually active fertile men with partners who are wocbp must use non-hormonal highly effective birth control * slightly different inclusion criteria are defined in the protocol for healthy subjects exclusion criteria: * history of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening * evidence of rapidly deteriorating renal function, defined as a screening egfr that has decreased from a previous egfr by ≥ 50% within the last 3 months * current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug * any major surgery within 4 weeks of study drug administration. * other protocol defined exclusion criteria could apply
study on the myocardial protective effect of upper limb ischemic preconditioning in patients undergoing off-pump coronary artery bypass grafting

Conditions: OPCABG

Summary: the purpose of the study was to verify the myocardial protective effect of ripc in patients undergoing opcabg.

66 patients scheduled for opcabg are randomly assigned to a ripc group(n=33) or a control group(n=33). in the ripc group, 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmhg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision. patients in the control group wear the same cuff on an upper limb but no pressure is applied. anesthetic and surgical techniques are standardized during the trial. serum inflammatory cytokines and cardiac injury markers will be measured before and after surgery. internal mammary artery and saphenous vein tissues will be collected during the surgery to assess hypoxia-inducible factor (hif)-1a and other signalling proteins.

Eligibility criteria:
inclusion criteria: * serious changes in several coronary arteries that need to receive opcabg * nhya ii-iii * asa ii-iii exclusion criteria: * lvef\< 35% * acute myocardial infarction * multiple organ dysfunction

Keywords: ripc, myocardial protective effect
essential fatty acids in adult adhd

Conditions: Adult Attention Deficit Hyperactivity Disorder

Summary: the aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: * dsm-iv adhd exclusion criteria: * any acute psychiatric disorder
urdu version of national institutes of health stroke scale: reliability and validity study

Conditions: Stroke

Summary: the goal of this study was to translate and culturally adapt nihss into urdu language and to evaluate its reliability and validity in pakistani stroke population. also assess its correlation with glasgow coma scale, modified rankin scale and barthel index for severity and location of post-stroke impairment.

as per preceding commendation, nihss has been translated into urdu language from its english version and adapted culturally in pakistan. among stroke population, nihss-u has been administered in 225 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consent forms. for testing inter-observer reliability and intra-observer reliability of nihss-u, gcs, mrs, and bi, questionnaires has been administered by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd administration. as for the 3rd administration, it has been carried out after seven days by the first observer (re-testing), for intra-observer assessment. spss software version 24 has been used for the purpose of data entry and analysis. internal consistency has been analyzed with cronbach alpha value. test-retest reliability has been assessed by using an intraclass correlation coefficient (icc). the nihss-u has evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria:
inclusion criteria: * patients or the ones next to them who gave informed consent. * age ranges from 34 to 97 years. * patients undertake particular stroke therapy including endovascular treatment intravenous thrombolysis. exclusion criteria: * impaired strength of muscles because of cognitive and orthopedic diseases. * patients with severe hepatic, and/or renal diseases. * patients with impaired cognition and memory problems. * patients whose consent was not given by themselves, their caretakers.

Keywords: stroke urdu version of national institute of health stroke scale reliability and validity study. glasgow coma scale modified rankin scale barthel index
multicenter study of fulminant type 1 diabetes in china

Conditions: Diabetes Mellitus, Type 1

Summary: this study took ft1d（fulminant type 1 diabetes） as the research object, collected the cases of ft1d patients, and described the clinical characteristics of this type of disease. the hla susceptibility genes of ft1d were identified by pcr and other techniques, taking age-sex-matched healthy subjects as controls and hla genes as the research entry point.

1. ft1d cases related to different etiologies were collected. the collected case data were the clinical data at the time of hospitalization for the first episode of ft1d, including the history of present illness, past history, vital signs, blood glucose at the onset, blood gas analysis, myocardial enzymes, pancreatic enzymes, glycosylated hemoglobin, c peptides, islet autoantibodies and other laboratory indicators. analysis and research are carried out according to factors such as the pathogenesis of the patients, so as to conduct a complete analysis of the pathogenesis characteristics of such patients under the condition of expanding cases, so as to improve the understanding of the disease and the level of diagnosis and treatment of the disease. 2. the study collected 240 patients in the ft1d group and 250 patients in the control group with genetic blood (previous research has been available), analyzed the hla gene, and compared the risk and frequency of hla class ii alleles, genotypes and haplotypes between the two groups. , to explore the susceptibility risk genes and protective properties of chinese ft1d patients. according to gada positive and negative, the comparison of the susceptibility of chinese ft1d class ii hla genotype, from the perspective of genetics to explore the role of antibodies in the pathogenesis of ft1d.

Eligibility criteria:
patients with fulminant 1 diabetes inclusion criteria: 1) diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemic symptoms; 2) patient presented with plasma glucose ≥16.0 mmol/l and hba1c \<8.7% at the first visit; and 3) patient had urinary c-peptide excretion \<10 µg/day,fasting serum c-peptide level \<0.10 nmol/l, or postprandial serum c-peptide \<0.17 nmol/l at onset exclusion criteria: case reports of previously diagnosed with diabetes were excluded. healthy volunteers inclusion criteria: * normal control: the inclusion criteria are as follows: (1) oral glucose tolerance test (ogtt): fasting blood glucose (fpg) \<5.6 mmol/l and postprandial 2 h blood glucose (ppg) \<7.8 mmol/l. the participants voluntarily signed the informed consent and extracted 3ml of peripheral blood for dna extraction. exclusion criteria: * the exclusion criteria were as follows: (1) with heart, brain, liver, kidney or other chronic diseases; (2) with other types of autoimmune diseases; (3) with malignant tumors; (4) with a family history of diabetes.

Keywords: type 1 diabetes: hla ; fulminant
the effect of aroma massage on constipation

Conditions: Constipation

Summary: advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. constipation is one of the common problems in the elderly. therefore, the aim of this study is to examine effects of aromatherapy massage on constipation in the elderly.

old age is a physiological period of life in which various changes take place, meaning that the elderly must be given special consideration as a group with regard to health care. advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. constipation is one of the common problems in the elderly. insufficient liquid intake, insufficient or unsuitable diet, decreased mobility, the side effects of medication, underlying diseases, and rectal sensory-motor dysfunction are among the causes of constipation in the elderly. constipation is a preventable and treatable problem, which if left untreated can cause physical and associated psychological problems such as back and waist pain, rectal pressure, loss of appetite, confusion, incontinence, nausea and vomiting, urinary dysfunction, fissure, rectal prolapse, hemorrhoids, intestinal obstruction, and syncope. constipation can be managed using pharmacological methods, such as laxatives, enemas, suppositories, along with nonpharmacological procedures, such as changes in nutritional habits, fluid intake, education, activities to develop healthy intestinal habits, exercise, massage, aroma massage, biofeedback, stress management and acupuncture.

Eligibility criteria:
inclusion criteria: * 65 years and older * communication and cooperation can be established * conscious,, agreeing to participate in the research, * decreasing bowel movements, not able to deactivate for 3 days or more * living more than two of the complaints related to defecation, who have not undergone intestinal surgery before * lesion or infection that disrupts skin integrity in the abdominal region, elderly without any problems such as heart disease and dementia exclusion criteria: * had language problems * were below 65 years of age and * refused to participate in the study.

Keywords: aroma massage constipation elderly nursing
long-term efficacy and safety evaluation of growth hormone in children in china(cgls)

Conditions: Childhood Short Stature

Summary: short stature is a relatively common pediatric condition, referring to individuals whose height is more than 2 (-2 sd) standard deviations below the average height of a similar age, gender, and ethnicity population in similar living conditions, or those below the third percentile (-1.88 sd). this study is an open-label, multicenter, prospective and retrospective, observational, cohort study aimed at assessing the long-term safety and efficacy of peg-rhgh or rhgh treatment for chinese children with short stature. the study is divided into retrospective cohorts, retrospective prospective cohorts, and prospective cohorts. it is expected to include approximately 10000 patients (including around 3000 in the retrospective cohorts and around 7000 in the retrospective prospective and prospective cohorts). the total duration is expected to be 16 years, including 2 years for study center initiation and patient recruitment and follow-up of patients in the retrospective prospective and prospective cohorts until near-adult height (nah). the primary objective is to evaluate the long-term safety of peg-rhgh or rhgh for the treatment of children with short stature (including ghd, iss, sga, ts, pws, ns, shox gene deletion, and other etiologies); the secondary objective is to assess the effectiveness of peg-rhgh or rhgh treatment for children with short stature (including ghd, iss, sga, ts, pws, ns, shox gene deletion, and other etiologies).


Eligibility criteria:
inclusion criteria: 1. children aged 2 years and older with various causes of short stature. 2. height below the 3rd percentile (-1.88 sd) compared to the height of normal, healthy children of the same age and gender. 3. belonging to one of the following indications: ghd, iss, sga, ts, pws, ns, shox gene deletion, or other causes of short stature. note: in this study, the inclusion criteria for the pws cohort do not impose restrictions on height and age at the start of treatment. exclusion criteria: 1. patients with fully closed growth plates. 2. patients with signs of potential tumor progression or those already diagnosed with tumors. 3. allergic reactions to growth hormone or its adjuvants. 4. patients who have received any growth hormone treatment other than the investigational drug in the six months prior to screening. 5. any other circumstances deemed unsuitable for study inclusion by the investigator.
stem cells in umbilical blood infusion for cp

Conditions: Cerebral Palsy

Summary: this study will investigate the safety of single dose intravenous infusion of cord blood cells which were cryopreserved after the birth of a brother or sister to a child with cerebral palsy.

cerebral palsy (cp) is the most common physical disability of childhood, affecting 2 per 1000 live births across the world. cp describes permanent non-progressive motor disorders arising from damage to the developing brain. preclinical studies of different types of stem cells in models of acute brain injury similar to cp have shown significant functional improvement. the variety of stem cells available in umbilical cord blood (ucb), an ethically uncomplicated source of stem cells, has led to a focus on ucb stem cell therapy as a quick-to-clinic option. previous studies indicate that autologous or unrelated donor ucbc infusion is safe and feasible for children with cp, and may lead to improved motor functioning, but there is no information about the safety and effects of matched sibling cord blood. therefore, this trial will study the safety of infusing matched sibling cord blood cells to children with cerebral palsy.

Eligibility criteria:
inclusion criteria: 1. diagnosis of any type of cp 2. cp of any severity 3. a record of sibling cbu in storage at a tga accredited private cord blood bank 4. ability to travel to one of the trial centres 5. ability to participate in assessments 6. informed consent by parent/guardian exclusion criteria: 1. presence of progressive neurological disease 2. known genetic disorder 3. known brain dysplasia 4. immune system disorder or immune deficiency syndrome 5. infectious disease markers showing up on virology screen 6. evidence of cord blood unit contamination, or fewer than 10\^7 cells/kg body mass 7. ventilator support 8. ill health, or if the participant's medical condition does not allow safe travel 9. previous cell therapy 10. botulinum toxin a within 3 months before or after infusion 11. surgery within 3 months before or after infusion 12. cannot obtain parent/guardian consent
study providing monotherapy (sitaxsentan) and combination therapy (sitaxsentan+sildenafil) to subjects with pulmonary arterial hypertension (pah) to assess long-term safety

Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension

Summary: as sitaxsentan is the agent most highly selective for eta (endothelin type a (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (pah) therapy is these two oral drugs administered in combination.


Eligibility criteria:
inclusion criteria: * previously enrolled in b1321001 for at least 4 weeks. * previously enrolled in b1321003, discontinued from the study. * completed the b1321003 study as planned. exclusion criteria: * treated with an investigational drug (other than sitaxsentan or sildenafil in either b1321001 or b1321003) or device that has not received regulatory approval within the 30 days prior to baseline/day 1 or during the study.

Keywords: endothelin receptor antagonist (etra) sitaxsentan