Kornimate/medical-research-clean huggingface dataset:
deciphering preserved autonomic function after multiple sclerosis

Conditions: Multiple Sclerosis; Control Subjects; Autonomic Dysreflexia

Summary: this study looks to characterize gradients of dysfunction in the autonomic nervous system in patients with clinically diagnosed multiple sclerosis. the autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with multiple sclerosis typically suffer. focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. for both individuals with multiple sclerosis and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. the investigators anticipate that those with autonomic dysfunction with multiple sclerosis will exhibit abnormalities in these precise metrics. the investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from multiple sclerosis. in accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after multiple sclerosis and give physicians better tools to manage these secondary autonomic complications.


Eligibility criteria:
inclusion criteria: * 18-50 years old * clinically confirmed diagnosis of multiple sclerosis -or- uninjured control exclusion criteria: * symptoms of cardiovascular (including, but not limited to: hypertension, stroke, chest pain, etc.), respiratory, peripheral neurological or autonomic disease (particularly diabetes mellitus requiring treatment) * women who are pregnant or lactating * having a body mass index (bmi) ≥ 35 kg/m2 * taking or being administered a medication known to potentially have adverse interactions with phenylephrine * in the judgement of the principal investigator or clinical collaborator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
the coping with and caring for infants with special needs intervention in down syndrome infants

Conditions: Down Syndrome; Family; Physical Disability

Summary: the objective is to compare the impact of standard infant physical therapy and the family-centered program, coping with and caring for infants with special needs (copca), on infants born with down syndrome. this is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in spain between january 2024 and march 2024. an evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions. the infant motor profile will be the primary outcome instrument.


Eligibility criteria:
inclusion criteria: * babies with down syndrome * families involved in pediatric physical therapy exclusion criteria: * other associated developmental disorders * to not speak spanish * do not sign informed consent
histidine therapy: a project to treat hars deficiency

Conditions: HARS Syndrome

Summary: this study evaluates the role of histidine in patients with hars syndrome. children with hars syndrome will receive oral nutritional supplementation with histidine at a dose which will be increased in the event of acute febrile illness. vision, hearing and plasma biomarkers will be monitored throughout the study period.

hars syndrome is a progressive degenerative disease affecting eyesight and hearing caused by a mutation in the hars gene which codes for an enzyme involved in protein synthesis. hars syndrome has been exclusively found in the old order amish communities in southwestern ontario and in pennsylvania. children with this disorder initially have normal vision and hearing, but with a febrile illness, can have a sudden loss of vision and hearing, as well as visual hallucinations. there is some evidence that vision loss progresses, albeit at a slower rate, even without a febrile incident. in more severe cases, fluid accumulates in the lungs (acute respiratory distress syndrome or ards) which can cause a drop in oxygen levels and sometimes death. there is currently no specific treatment for hars syndrome, apart from supportive care. anecdotal evidence of an adult with hars syndrome who was treated with the amino acid l-histidine suggests that there was an improvement in vision, however there were no baseline objective measurements of vision prior to the use of histidine. we have designed a pilot project in which histidine will be given to children with hars for 6 months. investigators hypothesize that the histidine will be well tolerated and easily administered, without side effects. investigators will monitor vision, hearing and bloodwork to determine if there is any change during the course of treatment. as well, investigators plan to administer increased doses of histidine during acute illnesses, hoping to prevent deterioration in breathing due to ards. the results of this initial pilot project may pave the way for a longer term study of the use of histidine.

Eligibility criteria:
inclusion criteria: 1. have molecularly confirmed hars syndrome (y454s homozygous). 2. capable of giving informed consent or assent, or have an acceptable surrogate capable of giving consent on the participant's behalf. 3. participant or surrogate decision maker is able to understand the study procedures and comply with them throughout the course of the study. 4. able to take solid foods (ie applesauce) or swallow capsules (in younger children, capsule may be broken and contents mixed with applesauce). 5. at least 1 year of age or greater than 8 kg in weight (since histidine is supplied as a minimal dose of 500 mg/capsule. exclusion criteria: 1. unable or unwilling to give informed consent. 2. unable to understand instructions or unable to attend clinic visits. 3. children less than 1 year of age or less than \~8kg in weight (since histidine is supplied as 500 mg capsules).
a study of semen characteristics after 9 months of daily tadalafil 20 mg

Conditions: Erectile Dysfunction

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.


Eligibility criteria:
inclusion criteria: * healthy male subjects or men with mild erectile dysfunction * at least 45 years of age * with specified semen characteristics. exclusion criteria: * certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and hiv * a history of certain endocrine or hormonal abnormalities * a history of significant testicular/genital abnormalities * any significant reproductive abnormality identified at the start of the study.

Keywords: impotence erectile dysfunction semen sperm healthy male volunteers men with mild erectile dysfunction
cdx biopsies for detection of laryngopharyngeal reflux and laryngeal lesions

Conditions: Laryngeal Disease; Laryngeal Tumor; Laryngopharyngeal Reflux

Summary: the study will take place at rambam medical center, department of otolaryngology head and neck surgery, for two years. patients suspected of lpr or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.

first- all patients visiting our clinic with laryngeal complaints suspicious for either lpr or laryngeal tumor will fill the rsi questionnaire. then fiberoptic examination will be performed by a laryngologist that will complete the rfs score. patients with suspicious lesions will be referred for tfl standard biopsy and cdx brush biopsy in order to determine whether the lesions are malignant or benign. the pathologic diagnosis of invasive carcinoma from a tfl biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. all patients with benign pathology or carcinoma in-situ (cis) on tfl biopsy will be referred for subsequent direct laryngoscopy (dl) for definitive diagnosis. at the time of the dl biopsy will include also another cdx brush smear. patients with benign-appearing lesions will be taken for lesion removal and biopsy.before removal of the lesion a cdx brush smear will be collected. all the participants suspected of lpr will have: phmetry with manometry andcdx brush biopsy.all relevant demographic and clinical data will be retrieved for analysis. cdx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and lpr and will not replace the standard regimen.

Eligibility criteria:
inclusion criteria: * age 18 or over * patients suspected to suffer from lpr * patients with laryngeal/hypopharyngeal lesions. exclusion criteria: * patient refusal * patients with anatomical variants which precludes biopsy taking. * patients with allergy to lidocain-based local anesthesia agents.

Keywords: larynx reflux lpr tumor lesion
study to evaluate switching from an e/c/f/taf fixed-dose combination (fdc) regimen or a tdf containing regimen to b/f/taf fdc in human immunodeficiency virus-1 (hiv-1) infected participants aged ≥ 65 years

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) fixed-dose combination (fdc) regimen or a tenofovir disoproxil fumarate (tdf) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) fdc.


Eligibility criteria:
key inclusion criteria: * currently receiving an antiretroviral regimen of e/c/f/taf fdc (or emtricitabine \[ftc\]/tdf + 3rd agent if currently or previously participated in study gs-us-292-1826 \[nct02616783\]) for ≥ 3 months * documented plasma hiv-1 ribonucleic acid (rna) \< 50 copies/ml during treatment with e/c/f/taf (or ftc/tdf + 3rd agent if currently or previously participated in study gs-us-292-1826 \[nct02616783\]) for the last 2 visits preceding the screening visit (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml) * adequate renal function, an estimated glomerular filtration rate (egfr) ≥ 30 ml/min according to the cockcroft-gault formula for creatinine clearance key exclusion criteria: * an opportunistic illness indicative of stage 3 hiv diagnosed within the 30 days prior to screening * decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) * current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance note: other protocol defined inclusion/ exclusion criteria may apply.
long-term symptomatic follow-up of patients with long covid syndrome

Conditions: Long COVID

Summary: the goal of this observational study is to learn about the long-term evolution of long covid. the main question it aims to answer is: does the main symptoms of the patients diagnosed with long covid aproximate to those of patients who have had covid acute infection without devoloping long covid? participants will answer mailed survey questions about their main symptons.

scales, indexes and questionnaires were mailed to 40 patients with long covid to evaluate their main symptoms. fatigue, emotional disorders, sleep disorders, cognitive impairments, dyspnea, physical activity, quality of life and pain were analyzed. the patients were reassessed after three years. the same scales, indexes and questionnaires were also sent to a control group of 40 volunteers of the same age and sex as the cases.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old and younger than 75 years old * patients who accepted to participate in the study * patients who have had covid acute infection * patients who have long covid (cases) exclusion criteria: * patients who refused to participate in the study at any time of the study * patients whose diagnosis of long covid was revoked during the study (cases)

Keywords: long covid long-term follow-up symptoms scales
ph ii adjuvant carboplatin/docetaxel in curatively resected stage i-iiia nsclc

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery. purpose: this phase ii trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage i, stage ii, or stage iii non-small cell lung cancer.

objectives: primary * evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage i, ii, or iiia non-small cell lung cancer. secondary * determine the toxicity of this regimen in these patients. * determine the survival patterns of patients treated with this regimen. * assess the patterns of recurrence in patients treated with this regimen. outline: patients receive carboplatin iv on day 1 and docetaxel iv on day 1. treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Eligibility criteria:
disease characteristics: inclusion criteria: * histologically confirmed non-small cell lung cancer * stage i-iiia disease * must have undergone a complete resection * must begin adjuvant chemotherapy within 8 weeks of surgical resection patient characteristics: * eastern cooperative oncology group (ecog) performance status 0-1 * absolute neutrophil count ≥ 1,500/mm\^3 * hemoglobin ≥ 8.0 g/dl * platelet count ≥ 100,000/mm\^3 * serum creatinine normal or creatinine clearance ≥ 40 ml/min * bilirubin normal * alkaline phosphatase (ap), aspartate aminotransferase (ast), and alanine transaminase (alt) must meet 1 of the following criteria: * ap normal and ast and alt ≤ 5 times upper limit of normal (uln) * ap ≤ 2.5 times uln and ast and alt ≤ 1.5 times uln * ap ≤ 5 times uln and ast and alt normal * negative pregnancy test * fertile patients must use effective contraception during and for at least 3 months after study therapy exclusion criteria: * patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded. * women who are currently or planning to breast feed. * those with peripheral neuropathy ≥ grade 2 prior concurrent therapy: * 2-8 weeks since prior surgery and recovered

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer
effect of weight on hip excursion during gait

Conditions: Gait, Spastic

Summary: background: children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children. objective: to investigate the effect of using weight around the ankle on hip excursion in children with diplegia.

fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (a, b). both groups had received the same prescribed exercise program with classical gait training for group a and gait training while using weight around ankle for group b. treatment was conducted for one hour three sessions per week for successive 3 months. two-dimensional (2d) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.

Eligibility criteria:
inclusion criteria: * able to follow simple basic commands, * identified with gait abnormalities described as level ii on gross motor function classification system (gmfcs). * diagnosed as spastic diplegia. exclusion criteria: * severe visual or auditory problems, * lower limb surgical orthopaedic surgery or * botox injection in the six months preceding the start of the study, * and uncontrolled seizures.

Keywords: ankle; diplegia gait hip excursion weight
the prophylactic use of topical cyclosporine a 0.05% to prevent graft versus host disease related dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to determine whether restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.

the purpose of this research study is to determine if early treatment using restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (bmt) recipients.

Eligibility criteria:
inclusion criteria: * male or female * at least 18 years of age * approved candidate for allogeneic hsct * ability to understand and provide informed consent to participate in this study * willingness to follow study instructions and likely to complete all required visits exclusion criteria: * history of ocular or eyelid surgery * history of glaucoma or ocular hypertension * history of herpetic eye disease * patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator * any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results * recent (3-month) history of wearing contact lens * anticipated contact lens wear during any portion of the study * recent (3-month) history of current use of topical steroids or antiglaucoma agents * any punctal occlusion within 2 months of the screening visit * significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the nei/industry workshop on clinical trials in dry eyes (lemp, 1995) (see appendix 1and 2)) * history of connective tissue disease or diabetes * any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study

Keywords: dry eye graft versus host disease gvhd
a study of csl112 in healthy adults and in adults with moderate renal impairment

Conditions: Acute Myocardial Infarction

Summary: this is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose study to investigate the pharmacokinetics (pk), safety, and tolerability of csl112 in adult subjects with moderate renal impairment and in healthy adult subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * men or women aged 18 to 85 years (inclusive) of age, with body weight 50 kg or more. * subjects with renal impairment (ri) must have stable chronic moderate ri (estimated glomerular filtration rate \[egfr\] ≥ 30 and \< 60 ml/min/1.73 m2) * healthy subjects must have normal renal function (egfr ≥ 90 ml/min/1.73 m2) exclusion criteria: * evidence of a clinically significant medical condition, disorder or disease * evidence of hepatobiliary disease * any clinically relevant abnormal laboratory test result * known history of allergies, hypersensitivity or deficiencies to csl112 or any of its components * other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study, including: history of cancer, low platelet count, bleeding disorder or coagulopathy, significantly altered electrocardiogram waveform, unstable glycemia control in subjects with diabetes, acute renal failure, recent donation or loss of blood * evidence or history of alcohol or substance abuse
age levels in er+ metastatic breast cancer patients receiving endocrine therapy

Conditions: Breast Cancer

Summary: the purpose of this study is to look at the effects that the study drug (opc) has on age levels in patients with er+ metastatic breast cancer.

ages are a type of metabolite, or substance, found in the food. the age content in food is determined by the types of food you eat and also how you prepare your food. the researchers helping conduct this study have found a potential link between age levels and cancer. the purpose of this study is to see if certain drug (opc) has an effect on the age levels in your blood and to see if those age levels have an effect on your cancer.

Eligibility criteria:
inclusion criteria: * must have er+ breast cancer * metastatic disease; protocol does allow for bone-only disease * must be receiving endocrine therapy * must have completed at last 2 months of current endocrine therapy prior to registration * must have adequate hematologic, renal and hepatic function * prior/concurrent radiation therapy is allowed * prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment * may have diabetes, but must not be taking metformin * must be able to swallow and retain oral medication * performance status of 0-2 * treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications * must be informed of the investigational nature of this study and must have the ability to sign informed consent. exclusion criteria: * known allergy to grapes or grape seed * more than two prior endocrine therapy regimens for the treatment of metastatic er+ breast cancer. * concurrent use of restricted agents outlined in section 4.5. * history of alcohol abuse within 2 years of registration.
a clinical study of anx005 and ivig in subjects with guillain barré syndrome (gbs)

Conditions: Guillain-Barré Syndrome

Summary: this study is a multi center, open-label, study of anx005 in combination with ivig in subjects diagnosed with gbs.

the study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of anx005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with ivig. dosing of ivig will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and anx005 will be administered concurrently, beginning on day 1 or 2 of the treatment period. subjects will be followed for 6 months after treatment for observation and evaluation.

Eligibility criteria:
inclusion criteria: * diagnosis of gbs according to the national institute of neurological disorders and stroke diagnostic criteria for guillain barré syndrome * onset of gbs-related weakness ≤14 days prior to infusion * gbs-ds score of 3, 4, or 5 exclusion criteria: * clinically significant findings that may interfere with the conduct of the study or the interpretation of the data * be at risk of suicide or self-harm * received previous treatment with plasma exchange for gbs * any diagnosis of a variant of gbs * have a history of anaphylaxis or severe systemic response to immunoglobulin * documented, clinically significant, pre-existing polyneuropathy from another cause * clinically significant intercurrent illness, medical condition, or medical history * history of chronic use of steroid or immunosuppressant medication * active alcohol, drug, or substance abuse * females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study