Kornimate/medical-research-clean huggingface dataset:
body composition assessment in spinal cord injury

Conditions: Diabetes Mellitus; Body Composition; Tetraplegia; Paraplegia; Spinal Cord Injury

Summary: the purpose of this research is to evaluate different methods of measuring body composition (amount of fat, muscle, bone, and water in your body) and to determine relationships between body composition and other medical problems associated with spinal cord injury (sci).

a preliminary investigation in our laboratory has demonstrated the advantage of using 4-compartment modeling to assess body composition in sci adults. in comparing body composition analyses techniques in 20 individuals with sci, we found total error to be 8.0% with dual x-ray absorptiometry, 8.4% with hydrodensitometry, 11.5% with bioelectrical impedance analysis, and 21.8% with standard skinfold equations when compared to 4-compartment modeling, the currently accepted gold standard for body composition assessment. to date there is no gold standard for the determination of body composition in sci individuals.

Eligibility criteria:
inclusion criteria: * criteria for participation will include men and women within the age range of 18-65 years old with c5-l2 motor-complete (asia a\&b) * sci of duration greater than 12 months to ensure a homogenous sample. exclusion criteria: * persons with uncompensated hypothyroidism, and/or renal disease will be excluded from the study. * additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis * pressure ulcers \> grade ii will be excluded.

Keywords: body composition glucose tolerance insulin sensitivity metabolic syndrome
development of simulated hippotherapy system and investigation of its effectiveness in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this study is to develop a simulated hippotherapy system controlled by electromyography (emg) signals and investigate its effectiveness in children with cerebral palsy. in order to investigate its effectiveness evaluation of gross motor functions, lower extremity joint movements, spasticity of the lower extremities, functional independence, body movements, sitting and standing balance, muscle tone, stiffness and elasticity level, analysis of the walking are planned.

hippotherapy is a therapeutic method in which a real horse is used for therapeutic purposes. it is widely used in many countries in the treatment of neuromuscular diseases (multiple sclerosis, stroke, cerebral palsy, etc.). although the use of hippotherapy is widespread, many people can not reach and use this method effectively because of many reasons such as the high cost of caring, feeding, and sheltering horses or fear of people from horses. in recent years, hippotherapy simulation devices (mechanic and robotic horses) have been developed to overcome these problems. these devices aim to create the effects of hippotherapy on people by simulating a real horse's movement. the aim of this project is to develop and produce a simulated hippotherapy system, which can be controlled by electromyography (emg) signals coming from the rider, movements programmable (for different musculoskeletal problems), rehabilitation-specific, providing evaluation during therapy, integrating virtual reality system and therapy games and investigate its effectiveness in children with cerebral palsy.

Eligibility criteria:
inclusion criteria * having a diagnosis of spastic cerebral palsy, * children aged between 5 - 18 years, * gross motor functional level is i, ii or iii, * independent seating * walking at least 10 meters independently, * can understand simple verbal instructions, * those with a spasticity level less than 2 according to modified ashworth scale , * having bilateral hip abduction enough to sit on the hippotherapy device, * voluntary acceptance to participate in the study exclusion criteria * having hip dislocation, * severe contracture or deformity, * scoliosis (above 20 degrees), * acute uncontrolled acute seizures, * epilepsy, * visual and auditory problems, * injection of botulinum toxin in the last 6 months, * history of surgical operation such as muscle relaxation, tendon extension and selective dorsal rhizotomy in the last 6 months.

Keywords: cerebral palsy physiotherapy and rehabilitation hippotherapy balance
effect of biomagnetic therapy on gonarthrosis

Conditions: Knee Osteoarthritis

Summary: in order to assess the effectiveness of biomagnetic therapy (pst) in the treatment of gonarthrosis, we conducted a randomized, double blind controlled clinical trial comparing one group of patients treated with pst and a second group of patients treated with conventional physical therapy.


Eligibility criteria:
inclusion criteria: * at least 35 years old * local symptoms over a period of at least one-year * persistent symptoms despite non steroidal anti-inflammatory drugs * informed consent exclusion criteria: * operative treatment in the last six months * intra-articular injection in the last four months * rheumatic disease * homolateral coxarthrosis * malignant disorder * body mass index greater than 33% * pregnancy * inability to understand the visual analog scale
a study to determine the antiviral activity of tmc310911 when administered with ritonavir in treatment-naive human immunodeficiency virus - type 1 (hiv-1) infected patients

Conditions: Human Immunodeficiency Virus Type 1

Summary: the purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of tmc310911 co-administered with ritonavir.

this is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (hiv-1)-infected participants (participants who had not been treated with a therapeutic hiv vaccine within 1 year prior to enrollment and who had never been treated with an antiretroviral \[arv\] medication indicated for the treatment of hiv-infection or arvs for treatment of hepatitis b infection with anti-hiv activity prior to screening). in this study approximately 32 participants will be enrolled and randomly assigned to receive 4 different dose regimens co-administered with ritonavir (8 participants in each dosing regimen). the trial will consist of a screening period (maximum 6 weeks), a treatment period with tmc310911 (2 weeks), and a follow-up period (4 weeks). safety evaluation will include assessment of adverse events, clinical laboratory tests, vital sign measurements, physical examinations and electrocardiograms.

Eligibility criteria:
inclusion criteria: * documented human immunodeficiency virus type 1 (hiv-1) infection for at least 6 months prior to the screening date * participant who has not been treated with a therapeutic hiv vaccine within 1 year prior to enrolment and has never been treated with an antiretroviral (arv) medication indicated for the treatment of hiv infection or arvs for treatment of hepatitis b-infection with anti-hiv activity * participant agrees not to start antiretroviral therapy (art) before the baseline visit * able to comply with the protocol requirements and have good accessible veins * hiv-1 plasma viral load at screening visit of above 5,000 hiv-1 ribonucleic acid copies/ml * cd4+ cell count above 200 cells/mm3 at screening exclusion criteria: * hiv-2 infected participants and/or participants with any active or chronic hepato-renal disease * life expectancy of less than 6 months * documented acute (primary) hiv-1 infection * pre-existing protease inhibitor (pi) medication resistance * any currently active acquired immunodeficiency syndrome (aids) - defining illness * any active clinically significant disease or findings during screening or medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study * any confirmed grade 3 or 4 toxicity according to the division of aids (daids) grading scale at screening

Keywords: human immunodeficiency virus type 1 hiv-1 hiv-1 treatment-naive tmc310911 protease inhibitor ritonavir antiviral activity hiv infections treatment naive
newly formulated, extruded fortified-blended foods for food aid: the mffapp tanzania efficacy study

Conditions: Anemia, Iron-Deficiency; Deficiency, Vitamin A

Summary: corn-soy vitamin and mineral fortified blended foods (fbfs) are primarily used for food aid, although sorghum and cowpea may be suitable alternative fbf commodities. the objective of the micronutrient fortified food aid pilot project (mffapp) tanzania efficacy study is to determine whether newly formulated, extruded sorghum- and cowpea-based fbfs have equal, or better, nutritive value and acceptance compared to a traditional corn-soy blend. the effectiveness of each blend will be determined in an efficacy study of tanzanian children under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin a.


Eligibility criteria:
inclusion criteria: * hemoglobin \<10.3mg/dl * weight-for-height z-scores \>-3 exclusion criteria: * exclusive breastfeeding * unwillingness to travel to health facilities * enrollment of child in school during study period * anticipated relocation of the family during the study * allergy to the fortified-blended food product ingredients

Keywords: fortified-blended foods extrusion sorghum cowpea vitamin a iron protein food aid anemia, iron-deficiency deficiency, vitamin a growth velocity stunting wasting protein-energy malnutrition complementary feeding corn soy fortified foods food assistance
a study on the timing of folfox for patients with operable, node positive rectal cancer

Conditions: Operable T2-3N+M0 Rectal Cancer (Stage III)

Summary: this study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.

in recent randomized studies with preoperative combined chemotherapy and external beam radiation (ebrt/ct) with total mesorectal excision (tme surgery), the compliance to adjuvant chemotherapy ranged from 42.9% to 70%. this low compliance rate could influence the efficacy of chemotherapy. this is quite unique to patients with rectal cancer, since compliance is not a major issue in patients with colon cancer, belonging to the same age group. therefore, it is reasonable to postulate that this difference might due to the additive toxicity burden of neoadjuvant ebrt/ct and tme. in this randomized phase ii study, compliance to chemotherapy will be compared in the two groups: in the first group, patients will receive half of their chemotherapy regimen in neoadjuvant and half in adjuvant; and, in the second group, patients will be receiving all their chemotherapy in adjuvant. furthermore, brachytherapy will be used to deliver radiotherapy.

Eligibility criteria:
inclusion criteria: 1. pathology: adenocarcinoma of the rectum. 2. t2 (crm+) or t3 tumour at ≤ 10 cm from the a-v margin (as per mri criteria) 3. evidence of perirectal nodes on mri or eus (n1 or n2), any crm+ and n0 tumor, or any emvi+ tumor 4. tumors with an adequate lumen to allow the positioning of the oncosmart intracavitary mould applicator (e.g. non obstructive tumor). 5. tumour of less than 3.5 cm thickness documented at the ct simulator. 6. patient should be a suitable candidate for surgery and chemotherapy. 7. who performance status 0-2 8. age \> 18 years. 9. written informed consent. 10. adequate birth control measures in women with childbearing potential. exclusion criteria: 1. patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral). 2. evidence of distant metastases (m1). 3. previous pelvic radiation. 4. other cancers except for basal cell carcinoma of the skin or cis of the cervix. 5. presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy). 6. extension of malignant disease to the anal canal 7. patients with severe co-morbid conditions (recent mi, infections, aids, etc) 8. pregnancy
a long-term safety surveillance study in participants previously treated with 177lu-ipn01072

Conditions: Neuroendocrine Tumors

Summary: the purpose of the protocol is to evaluate the long-term safety of medicine 177lu-satoreotide tetraxetan (also known as 177lu-ipn01072 or 177lu-ops201) for patients who have previously received 177lu-satoreotide tetraxetan in the clinical study ops-c-001 / d-fr-01072-001.

the study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.

Eligibility criteria:
inclusion criteria: * participant is capable of giving signed informed consent * participant must have received at least one infusion of 177lu-ipn01072 in study ops-c-001 exclusion criteria: - there are no exclusion criteria in this safety surveillance study.
safety and efficacy of folatescan (technetium tc 99m ec20) in subjects with suspected metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: the folate receptor (fr) is overexpressed by many different cancer types, including renal cell carcinoma. besides helping in the diagnosis of cancer, a folate-targeted imaging agent could provide an effective method to identify folate receptor-positive (fr+) cancer patients that may benefit from folate-targeted therapy. up to 40 subjects, with known or strongly suspected metastatic renal cell carcinoma with at least one target lesion detected by a diagnostic imaging procedure (e.g. ultrasonography, ct, or mri), will be enrolled in this study.

the investigational new drug (folatescan or technetium tc 99m ec20) is a folate-targeted diagnostic radiopharmaceutical designed to bind to the folate receptor. the folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues. folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. in contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. therefore, these folate conjugates are specific to cancer cells. endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic imaging agent (111in-dtpa-folate) to ovarian cancer tumors. this proof-of-principle study was designed to demonstrate the ability of folate to target drugs to folate-receptor-positive (fr+) cancer tissue.

Eligibility criteria:
inclusion criteria: * subjects must meet the following eligibility requirements to be enrolled in the study. 1. subject must be 18 years of age or older. 2. subject must have known or strongly suspected metastatic renal cell carcinoma with at least one target lesion as identified by ultrasonography, mri, or ct. 3. subject must have good kidney function. 4. subject must provide written informed consent prior to enrollment. exclusion criteria: * subjects must be excluded if any of the following conditions are present: 1. subject is pregnant or breastfeeding. 2. subject is simultaneously participating in another investigational drug study, excluding the follow-up phase. 3. subject has received an investigational agent within 7 days prior to enrollment. 4. subject is unable to tolerate conditions for radionuclide imaging. 5. subject has been administered another radiopharmaceutical that would interfere with the assessment of technetium tc 99m ec20.

Keywords: metastatic renal cell carcinoma
beat covid-19 - observational trial

Conditions: COVID-19

Summary: jupiter is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of covid-19 and understand factors that help reduce disease progression in patients with covid-19. we aim to accomplish this by obtaining self-reported historical and longitudinal data from study participants.

this is an observational study that will electronically collect self-reported participant data in a database that follows hipaa security requirements for those with a clinically confirmed case of covid-19 or those who have had exposure to covid-19. the aim of this study is to gather a large, diverse dataset from a large population of participants in order to gather longitudinal observational data on what health practices participants are practicing and what, if any, benefits these practices may be providing the participants. data for this study will be gathered via self-reporting from participants who wish to participate in the fight against covid-19. this will include getting a baseline of each participant's health and then monitor their health over time while looking at how their symptoms are progressing or regressing. the jupiter study may also seek historical data from patients who have recovered from covid-19. the jupiter dataset may be shared (in accordance with applicable state, federal, and local laws) so that others may utilize the data from the dataset for further analysis to determine relevant trends in the data and in turn hopefully use these trends to determine potential treatment protocols or lifestyle recommendations to help prevent covid-19 spread and reduce hospitalization rates, as well as to understand how certain factors may aide in the covid-19 disease progression.

Eligibility criteria:
inclusion criteria: 1. adults residing in the united states aged 18 years or older proficient in understanding and reading the english language who wish to participate in the fight against covid-19 by providing self-reported health information. 2. ability to complete electronic informed consent process. 3. ability to use the internet and check email regularly. 4. consent to provide a hipaa waiver of health information to share protected health information. exclusion criteria: 1. inability to provide regular updates to their health status when contacted by the beat covid study personnel via email or sms.
the effect of soya foods on cognitive function and menopausal symptoms in postmenopausal women.

Conditions: Menopause

Summary: participants will be randomly assigned to one of three treatment groups to receive soyafoods (alpro drinks) providing a low (\<10 mg), medium (35mg) or high-dose (60 mg) of isoflavones daily for a period of 12 weeks. the group receiving \<10mg isoflavones daily will serve as a low-dose control group. women will be asked to avoid consuming any additional soya foods during the study. dietary intake will be assessed at baseline using the validated food frequency questionnaire a 4 day food diary will be completed at baseline and post-intervention. weight and height will be measured and a general health \& lifestyle questionnaire will also be completed by participants at baseline. cognitive function will be assessed at baseline and post-intervention using the well validated and widely used computerised test battery system. menopausal symptoms, quality of life, mood, stress and coping will also be assessed. plasma concentrations of the soya isoflavones genistein and daidzein will be measured to assess compliance. circulating concentrations of equol (a daidzein metabolite), will also be measured to investigate associations between equol and cognition and menopausal symptoms as a potential mechanism for the efficacy of soya.


Eligibility criteria:
inclusion criteria: * apparently healthy * within 7 years postmenpopausal with the absence of vaginal bleeding for at least 1 year * ≥ 24 in mini mental state examination * not suffering from psychiatric distress as assessed using ghq28 questionnaire exclusion criteria: * surgically induced menopause * habitual consumers of soys foods (\> 2 serves/week) * currently using hormone therapy * currently on isoflavone supplements * antibiotics use within last 3 months * use of psychoactive medication * history of cvd, cancer, diabetes, thyroid, renal or kidney disease, alcohol or drug abuse * red-green colour blindness

Keywords: soya menopause cognitive function isoflavones
effect of lucinactant on mucus clearance in cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: mucus clearance is impaired in cystic fibrosis. inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. this in turn my improve lung health. the investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.

this single-center pilot study is designed as a double-blind, randomized, cross-over clinical trial to evaluate the effects of inhaled lucinactant, an investigational peptide-containing synthetic surfactant (6 ml of 20 mg total phospholipid (tpl)/ml solution x 5 doses) in patients with mild to moderate cf lung disease. lucinactant and vehicle will be delivered via a 510k approved vibrating mesh nebulizer, the pari eflowtm. the study duration corresponds to a 2-10 day screening phase, followed by a 20 day post-randomization phase that consists of two treatment periods (3 days each) and a washout period (14 days). a total of 16 patients will be enrolled and randomly assigned to one of two treatment sequences (lucinactant followed by vehicle or vehicle followed by lucinactant). the primary outcome will be the rate of mc, as assessed via gamma scintigraphy, post-lucinactant and post vehicle. secondary outcomes will include the rate of cough clearance (cc), lung clearance index (lci), absolute change from baseline in fev1 after 5 doses of study medication, cf-specific quality of life score (via cfq-r instrument), in vitro assessments of sputum rheology, and various safety parameters.

Eligibility criteria:
inclusion criteria: * cystic fibrosis * fev1\>40% exclusion criteria: * unstable lung disease * unable or unwilling to stop hypertonic saline and dornase alfa for 3 days prior to each study period * relevant drug allergy or intolerance * recent investigational drug use (30 days)
european clinical evaluation of the bd hpv assay on the bd viper lt system

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of the study is to compare the results of the becton dickinson (bd) human papilloma virus (hpv) assay on the viper lt instrument from surepath media diluted in hpv diluent (pre-quot and/or residual), preservcyt media diluted in hpv diluent (pre-quot and/or residual) and a bd cervical brush in bd transport medium to reference histology results from biopsy.

this is a multicenter study consisting of 2-3 european clinical trial sites, and up to 2 bd viper lt systems. the bd hpv diluent tube will be run on the bd hpv assay with the viper lt instrument and compared to histology, digene hybrid capture 2 (hc2), and roche linear array hpv genotyping test results.

Eligibility criteria:
inclusion criteria: * referred to follow up due to one or more abnormal pap or an hpv infection * subjects who have provided informed consent * subjects who meet the minimum age set forth by the ethics committee (ec) and/or national screening guidelines. exclusion criteria: * known to be pregnant * with prior complete or partial hysterectomy involving removal of cervix * subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds. * subjects on who conization, loop electrosurgical excision procedure (leep), laser surgery or cryosurgery has been performed.

Keywords: hpv cervical cancer cervical neoplasms