Kornimate/medical-research-clean huggingface dataset:
effect of omt on asthma symptoms in southwest virginia

Conditions: Asthma

Summary: there is a high prevalence of asthma in southwest virginia and there are multiple osteopathic manipulative techniques (omt) which are thought to improve lung function. however, there are inadequate studies regarding the effectiveness of using osteopathic manipulative treatment (omt) as an office treatment or a home treatment to address obstructive lung disease. in addition, there is little information on the level of acceptance, use, and cost effectiveness of using omt in rural southwest virginia. the purpose of this study is to determine the viability of omt treatment with asthma, the level of acceptance in selected clinics in southwest virginia, and the effectiveness of home omt education in order to implement a program to improve asthma control. the study hypotheses are: 1. osteopathic manipulation delivered to the asthmatic patient will significantly improve spirometry values, thoracic excursion, and subjective asthma symptoms. (.05 alpha) 2.patients who are taught and use a home treatment regime for asthma will significantly improve spirometry values, thoracic excursion, and subjective asthma symptoms after two weeks, compare with those who do not have home treatment. 3.physicians educated on the use of omt for asthma will increase their perceived future use of omt as an adjunct to treat this disorder.

in this study, participants will be recruited from several family practice, pulmonologist, and asthma specialist offices in southwest virginia. these participants will undergo two visits. at the first visit, a lung assessment comprised of three components will be performed, then a 10 minute omt session, then the lung assessment will be repeated. the lung assessment includes a patient symptom survey, a thoracic excursion measurement, and spirometry. the participants will then be divided into one of two groups. group 1 will have no further instruction while group 2 will be taught some simple home omt techniques and asked to do them at home. both groups will return two weeks later for a follow up lung assessment. results when then be studied to determine the effect of omt on lung function in asthmatics as well as the effect of incorporating home omt. in addition, physicians will be involved in learning about omt and these techniques and they will be assessed for a change in attitude, awareness, and willingness to incorporate omt when applicable.

Eligibility criteria:
inclusion criteria: * age 5-55 * mild intermittent, mild persistent, or moderate persistent asthma exclusion criteria: * severe persistent asthma * congestive heart failure * active pulmonary infection * oral steroid burst in past month * hospitalization for pulmonary causes in past three months * omt treatment directed towards thoracic and ribs in past three months
α prospective observational study for the evaluation of disease control and quality of life in patients with benign prostatic hyperplasia under fixed dose combιnation treatment with dutasteride and tamsulosin . prosperity group of studies (i&ii)

Conditions: Benign Prostatic Hyperplasia

Summary: investigation of the efficacy and safety of the stable combination of dutasteride and tamsulosin (dinaplex®) in the greek population as well as the evaluation of the quality of life of patients with benign prostatic hyperplasia (bph) in treatment with a stable combination of dutasteride and tamsulosin (dinaplex®)

combination therapy with the 5-α reductase inhibitor, dutasteride, and the α-blocker, tamsulosin, in men with moderate to severe benign prostatic hyperplasia and prostate enlargement, was studied in the combination of avodart ™ and tamsulosin (combat) which was a four-year, global, multicenter, randomized, double-blind, parallel design (3 arms) study. the aim of the study was to investigate the benefits of combination therapy (dutasteride-tamsulosin) compared to monotherapy in terms of improvement of symptoms and long-term results (aur and surgery), in men with moderate to severe bph. the primary endpoint in the two years since the start of the study was the change in the ipss score, while the primary endpoint, after four years of treatment, was the time until the long-term results manifested (i.e. aur or cf surgery) as well as the percentage of participants who were led to them. patients were at least 50 years old with a prostate tumor ≥30 cm3 and a psa level ≥ 1.5 ng / ml. 4838 men (39) participated in this study.

Eligibility criteria:
inclusion criteria: * adult male patient with moderate to severe bph symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment. * adult male patient with bph who has fully understood the study procedures and has signed a consent form after information. exclusion criteria: * patient who does not meet the criteria for taking the study drug (s), according to the summary of product characteristics of each drug in the study.

Keywords: benign prostate hyperplasia ipss (international prostate symptom score) luts (lower urinary tract symptoms)
impact of maxillomandibular deformities on individuals' nutritional status

Conditions: Maxillofacial Abnormalities

Summary: this cross-sectional study explores the influence of various types of maxillomandibular deformities on the nutritional status of individuals. maxillomandibular deformities, which involve the misalignment of the upper and lower jaws, can significantly affect oral functionality, potentially leading to nutritional deficiencies due to compromised food intake. by analyzing the dietary habits and nutritional health of a diverse group of individuals with these deformities, the study seeks to establish the correlation between the severity of the deformity and the individual's nutritional status. findings from this research can provide a deeper understanding of the additional health risks that maxillomandibular deformities pose and help in the development of nutritional guidelines specifically tailored for individuals suffering from these conditions.


Eligibility criteria:
inclusion criteria: * adults aged between 18 and 45 years old * individuals who are not currently undergoing orthodontic treatment and have a complete set of teeth, excluding wisdom teeth. * citizens of the republic of turkey * able to read and write in turkish language * able to understand and follow the questionnaire instructions * willing to participate in the study exclusion criteria: * individuals above 45 years old * unwilling to sign the informed consent for participation in the study * unwilling to answer all the questionnaire items * individuals with a chronic disease that requires a specific diet * individuals with any eating disorders * pregnant and/or nursing individuals * individuals with cognitive impairment to a degree that would prevent giving clear and accurate responses will be excluded from the study.

Keywords: orthognathic surgery nutritional status angles classification
study to evaluate the efficacy and safety of cc-90001 in participants with non-alcoholic steatohepatitis (nash) and liver fibrosis

Conditions: Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of cc-90001 compared with placebo, in non-alcoholic steatohepatitis (nash) participants with stage 2, stage 3 liver fibrosis. this study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. it will also assess dose response and overall safety.


Eligibility criteria:
inclusion criteria: * key inclusion criteria diagnosis of non-alcoholic steatohepatitis (nash) with presence of stage 2, stage 3 fibrosis based of the non-alcoholic steatohepatitis (nash) clinical research network (crn) histologic scoring system and a nonalcoholic fatty liver disease (nafld) activity score (nas) of 4 or higher exclusion criteria: - key exclusion criteria 1. history or evidence of decompensated liver disease, 2. hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (nash). 3. participant has urine ethyl glucuronide (etg) \> 500 ng/ml at screening. 4. history or positive screen for human immunodeficiency virus (hiv) infection or congenital or human immunodeficiency virus (hiv)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency \[cvid\]). 5. history of hepatitis b and/or hepatitis c. 6. history of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ). 7. pregnancy or lactation.

Keywords: non-alcoholic steatohepatitis nash non-alcoholic fatty liver liver fibrosis cc-90001
dorsal root ganglion stimulation for hand and upper limb pain

Conditions: Dorsal Root Ganglion Stimulation; Pain in Limb, Hand, Foot, Fingers and Toes; Causalgia of Upper Limb

Summary: there are no studies as yet specifically investigating the application of drg stimulation in the treatment of chronic pain affecting the upper limbs. the investigators propose to investigate the effect of dorsal root stimulation in patients with chronic hand or upper limb pain.

dorsal root ganglion (drg) stimulation is a form of spinal cord stimulation (scs), which has been available and used for the treatment of chronic pain in europe since late 2011. clinical practice and pre/post market studies have shown that stimulation of the drg can significantly reduce chronic intractable pain of various aetiologies. however, there are no studies as yet specifically investigating the application of drg stimulation in the treatment of chronic pain affecting the upper limbs. furthermore, there are very few studies of scs generally, in an upper limb pain population, despite this being a group often referred for and treated with scs in tertiary, interventional pain practices. due to several limitations of traditional scs systems, chiefly concerning the stability of stimulation induced paraesthesia, drg stimulation is being increasingly utilised in its place for this condition.

Eligibility criteria:
* subject is appropriate for scs implantation according to standard criteria from the dutch neuromodulation society * subject is \>18 to \<75 years old. * subject is able and willing to comply with the follow-up schedule and protocol * subject has chronic (\> 6 months) uni/bi-lateral pain, primarily in the upper limb(s) * (arm and/or hand) * minimum baseline pain rating of 60 mm on the vas in the primary region of pain * documented, successful paraesthesia mapping of transient stimulation over painful anatomy * subject is able to provide written informed consent exclusion criteria * subject has no other exclusion criteria for scs implantation according to standard criteria from the dutch neuromodulation society * subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days * subject has had radiofrequency treatment of an intended target drg within the past 3 months * subject has participated in another clinical study within 30 days * subject has been previously treated with and failed to respond to an implantable neuromodulation therapy * subject has had a complete or partial amputation of the painful upper limb(s) and is experiencing phantom and/or stump pain post amputation

Keywords: neurostimulation dorsal root ganglion hand pain upper limb pain
the efficacy of niacin on hyperphosphatemia in patients undergoing haemodialysis

Conditions: Hyperphosphatemia

Summary: hyperphosphatemia is a common complication of end-stage renal disease and particularly affects haemodialysis patients. elevated serum phosphorus contributes to the development of secondary hyperparathyroidism, mineral bone disorders,metastatic calcifications and calcific uremic arteriolopathy. there is a significant association between hyperphosphatemia and increased morbidity and mortality in end stage renal disease patients including cardiovascular morbidity and mortality ,also it's associated with hospitalization of haemodialysis patients.

hyperphosphataemia is mainly due to impaired renal phosphate excretion and primary increase in renal phosphate reabsorption,due to acute or chronic renal insufficiency. renal excretion is so efficient in normal subjects that balance can be maintained with only a minimal rise in serum phosphorus concentration even for a large phosphorus load. therefore, acute hyperphosphataemia usually resolves within few hours if renal function is intact. although, there is multiple lines of treatment of hyperphosphatemia in end stage renal disease patients undergoing hemodialysis but still inadequate. as calcium containing phosphate binders may sometimes result in adverse effects such as hypercalcemia. non-calcium containing phosphate binders, such as sevelamer and lanthanum, are expensive. aluminum-containing agents are efficient but no longer widely used because of their toxicity. several trials have shown that nicotinamide and niacin are capable of remarkably reducing serum phosphate levels in patients undergoing haemodialysis. niacin is a water-soluble vitamin, and a part of the b complex vitamin, both nicotinamide and niacin (nicotinic acid) are forms of vitamin b3 . as a broad-spectrum drug that can affect lipid levels, niacin reduces levels of total cholesterol, triglyceride, and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol levels. niacin also lowers serum phosphorus levels in patients with chronic kidney disease, dyslipidemia, and diabetes mellitus. furthermore, niacin plays a key role in cardiovascular diseases and cardiovascular-related mortality by modifying both dyslipidemia and phosphorus levels. recently, nicotinic acid and related compounds such as nicotinamide have also been shown to decrease phosphorus absorption in the gastro-intestinal tracts of animals by a different mechanism than the traditional phosphate binders. the major side effects of niacin are vasodilation and flushing, which appear to be mediated through prostaglandin production, and thus can be attenuated by premedication with aspirin.

Eligibility criteria:
inclusion criteria: 1. end stage renal disease patients aged from 18-60 years old. 2. duration of hemodialysis \>6 months. 3. serum phosphorus level \>5 mg/dl exclusion criteria: * 1)patients on sevelamer or cinacalcet. 2)hepatitis c virus +ve patients. 3)connective tissue disease. 4)active malignancy. 5) pregnancy 6) active peptic ulcer disease 7) treatment with carbamazepine.
human adipose derived mesenchymal stem cells for critical limb ischemia (cli) in diabetic patients

Conditions: Critical Limb Ischemia (CLI); Diabetes

Summary: a prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. the study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (cli) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group. in each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)


Eligibility criteria:
inclusion criteria: * diabetes, type 1 or 2 * critical limb ischemia (rutherford becker class ii,iii or iv)of at least one limb. * no options for target limb revascularization. exclusion criteria: * cancer antecedent in the last two years * current limb infection or limb gangrene

Keywords: critical limb ischemia (cli) diabetes mesenchymal stem cells regenerative therapy
comparing several strategies to manage moderate acute malnutrition among children from 6 to 24 months old

Conditions: Moderate Acute Malnutrition

Summary: the aim of this open-label randomized controlled trial conducted in four african countries (madagascar, niger, central african republic and senegal) is to compare three strategies of renutrition for moderate acute malnutrition (mam) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. cognitive development of children (senegal) will also be studied and compared.

the main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (mam) which is the major milestone before severe malnutrition. this will be based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours. the purpose of the malinea study is to compare three management strategies for moderate acute malnutrition (mam) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months. the 3 groups will be compared on several anthropometric measurements \[weight, length, mid upper arm circumference (muac)\], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention cognitive development of children (senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion. the investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children.

Eligibility criteria:
inclusion criteria: * children aged from 6 to 24 months olds. * moderate acute malnutrition defined by a -3 ≤ weight/height z-score \< -2 sd. * written informed consent of parents or legal guardian. * child able to be brought back to the centre on the two following days of inclusion. * child able to be followed up during at least three months. exclusion criteria: * severe malnutrition defined by a mid upper arm circumference \< 115 mm or weight/height z-score \< -3 sd or presence of nutritional oedema. * clinical complications or according to the physician any clinical sign requiring care outside of the recruitment centre (referral to specialised centre or hospitalisation) * diarrhea with mucus and bloody stools. * current incompatible treatment : antacids, cetirizine, digoxin, ergotamine, azidothymidine. * known hypersensitivity to macrolides or albendazole (or one of its components) * known allergy to enriched flours or prebiotics used in the study, or one of its components.

Keywords: children africa metagenomic prebiotic randomized controlled trial pragmatic trial azithromycin cognitive impairment
autologous bone marrow stem cells in pressure ulcer treatment

Conditions: Type IV Pressure Ulcers; Chronic Wounds; Spinal Cord Injury

Summary: the aim of the study is to determine the safety and feasibility of an autologous mononuclear stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the efficacy of the treatment.

taking into account the encouraging results obtained in the treatment of non-healing chronic wounds using bone marrow cells given that treatment strategies for pressure ulcers can be both costly and complex, in this study we examine the possibility of improving pressure ulcer healing using stem cell therapy.

Eligibility criteria:
inclusion criteria: * type iv ulcer pressures of more than 4 months topical treatment without response * no option for conventional surgery * age range of 18-75 years old exclusion criteria: * patients out of inclusion age range * patients with evidences of mental illness * patients with evidences of previous alcohol or drugs dependencies * pregnant women * patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma

Keywords: pressure ulcers chronic wounds spinal cord injury patients bone marrow mononuclear debridement
comparative study between oral liposomal iron,iron supported lactoferrin and iv iron dextran in ckd children

Conditions: CKD - Chronic Kidney Disease

Summary: this is a randomized, parallel study that will be conducted on pediatric patients with ckd.

the study will be conducted on 90 pediatric patients with ckd who will be divided into 3 groups: group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. group 3: 30 pediatric patients who will receive iv iron dextran 50 mg/3 times weekly for 12 weeks.

Eligibility criteria:
inclusion criteria: * a) pediatrics ≤18 year old male and female patients. b) pediatrics with ckd stages 3-5. exclusion criteria: * a) ckd patients' ≥18 year old. b) active bleeding c) malignancy d) anemia due to any disease other than ckd e) blood transfusions
hippocampus-sparing wbrt and simultaneous integrated boost for multiple brain metastases from nsclc

Conditions: Brain Metastases

Summary: this study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. the primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to ctcae v4.03, and quality of life.


Eligibility criteria:
inclusion criteria: * pathologically proven diagnosis of primary non-small cell lung cancer * 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced mri within 14 days prior to registration * kps ≥70 * age ≥55 years * informed consent prior to study entry exclusion criteria: * patients with leptomeningeal metastases * ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months * contraindication to mri such as implanted metal devices or foreign bodies * prior radiation therapy (including srs) to the brain

Keywords: hippocampus radiotherapy
melatonin vs gabapentin for post trauma surgery

Conditions: Anxiety, Preoperarative

Summary: this project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. gabapentin has analgesic as well as sedative properties. melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. it is now being explored as a preoperative medication.


Eligibility criteria:
inclusion criteria: patients will be recruited if they satisfy the following inclusion criteria: * age 18-65 years, * asa score i-ii, * scheduled either for non-emergency surgery after trauma and * presumptive duration of operation not exceeding 3 hours. exclusion criteria: the following patients will be excluded from the study: * patients for emergency surgeries * surgeries taking place after 1pm (to account for diurnal variation in cortisol levels) * patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication * patients who have come for a repeat surgery and have already been included once in the study

Keywords: melatonin gabapentin preoperative anxiety