Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of tenofovir disoproxil fumarate (tenofovir df) plus other anti-hiv drugs in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if giving tenofovir df plus a combination of other anti-hiv drugs is safe and effective.

patients are randomized 2:1 to add tenofovir df once daily or placebo to their existing antiretroviral regimen in a blinded manner. patients are stratified according to hiv-1 rna level, cd4 cell count, and number of antiretroviral drugs taken prior to study entry. patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. after week 24, changes in background antiretroviral therapy are permitted. at 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir df once daily for the remainder of the 48-week study. while on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. additionally, changes in plasma hiv rna levels and cd4 cell counts are monitored to assess antiviral efficacy. at the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir df is commercially available or gilead sciences terminates the study.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have been on stable anti-hiv therapy for at least 8 weeks with no more than 4 anti-hiv drugs at the time of study entry. * have a viral load (level of hiv in the blood) between 400 and 10,000 copies/ml. * have good kidney function. * are 18 to 65 years old. * agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after. exclusion criteria patients will not be eligible for this study if they: * have a new aids-related illness diagnosed within 30 days of study entry. * have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than kaposi's sarcoma or certain skin cancers). * have received a vaccine within 30 days of study entry. * are unable to take medications by mouth. * have ever taken tenofovir or adefovir dipivoxil. * have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for kaposi's sarcoma, or certain experimental drugs. * abuse alcohol or drugs. * are pregnant or breast-feeding.

Keywords: hiv-1 drug therapy, combination drug administration schedule rna, viral anti-hiv agents viral load
dynamic humeral centering exercises in subacromial pain syndrome

Conditions: Shoulder Pain; Shoulder Impingement Syndrome

Summary: subacromial pain syndrome is one of the most common musculoskeletal health conditions, causing decreased of range of motion, loss of muscle strength and disability in the shoulder region. it has been proposed that dynamic humeral centering exercises could contribute to overcome these disorders, through the modification of the dimensions of the subacromial space, however, there is no consensus on its effectiveness nor direct variables that account for its efficacy. therefore, the aim of this research is to determine the effects of a dynamic humeral centering exercise program on the functionality and disability of patients with subacromial pain syndrome.the effects of the dynamic humeral head exercises program, as well as the objective description of factors and variables associated with subacromial pain syndrome, will also allow rehabilitation science professionals to aim their interventions according to the knowledge of direct variables, which will allow objective follow-up of interventions on subacromial pain syndrome diagnosed patients.


Eligibility criteria:
inclusion criteria: * older than 18 years old and less than 60 years old. * pain in the lateral and upper arm region for more than two weeks of evolution. * at least three positive tests in the following: neer's impingement sign, hawkins-kennedy impingement sign, pattes' maneuver, jobe's test or painful arch. exclusion criteria: * having any of the following diagnoses: frozen shoulder, shoulder girdle joint instability, cancer, glenohumeral arthrosis, symptomatic acromioclavicular arthritis, glenohumeral arthritis, rheumatoid arthritis, or fibromyalgia. * cervical or thoracic pain. * fracture or surgery in the shoulder region or in the last 6 months.
use of telehealth technology by mental health care professionals in times of covid-19 pandemic

Conditions: Online Therapy

Summary: a brief online survey to be completed by clinical therapists.

a brief online survey to be completed by clinical therapists. this brief 28 question online survey asks mental health care providers questions about their use of technology.

Eligibility criteria:
inclusion criteria: • must be 18 years old, and must be a licensed mental healthcare provider actively treating patients within the past year. exclusion criteria: • less than 18 years old, or if you are not a licensed mental healthcare provider actively treating patients within the past year.
a nerve block therapy for bulbar palsy pharyngeal dysphagia

Conditions: Bulbar Palsy

Summary: this was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. besides, the observation group additionally underwent the stellate ganglion block (sgb). at admission and after 20-day treatment,yale pharyngeal residue severity rating scale, video fluoroscopic swallowing study (vfss), functional oral intake scale, and rosenbek penetration-aspiration scale (pas) were used to assess swallowing function.

dysphagia is a frequent and potentially serious complication of stroke. however, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. this study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. this was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. besides, the observation group additionally underwent the stellate ganglion block (sgb). at admission and after 20-day treatment,yale pharyngeal residue severity rating scale, video fluoroscopic swallowing study (vfss), functional oral intake scale, and rosenbek penetration-aspiration scale (pas) were used to assess swallowing function.

Eligibility criteria:
inclusion criteria: * diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy. * upper esophageal sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by videofluoroscopic swallow study. * age \>18 years. * first-time stroke. * steady vital signs, * transferred or admitted to the department of rehabilitation medicine within 15d after onset. exclusion criteria: * allergy to lidocaine injection or vitamin b12 injection; * severe cognitive impairment; * coagulation disorders; * severe dysfunction of organs including heart, lungs, kidney, liver, etc.; * complicated with other neurological diseases; * dysphagia caused by other diseases or reasons.
dose-finding study of vadadustat in japanese subjects with anemia secondary to dialysis-dependent chronic kidney disease (dd-ckd)

Conditions: Anemia; Dialysis Dependent Chronic Kidney Disease

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (pk), and pharmacodynamic (pd) of orally administered vadadustat in japanese participants with anemia secondary to dialysis-dependent chronic kidney disease (dd-ckd).


Eligibility criteria:
inclusion criteria: * male and female japanese participants ≥20 years of age * receiving chronic maintenance hemodialysis for end-stage kidney disease * hemoglobin (hb) \<10.0 grams per deciliter (g/dl) exclusion criteria: * anemia due to a cause other than chronic kidney disease (ckd) or presence of active bleeding or recent blood loss * sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * red blood cell transfusion within 4 weeks prior to or during screening * anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Keywords: anemia kidney dialysis dependent chronic kidney disease ckd dd renal vadadustat akb-6548 hypoxia-inducible factor akebia (akb) hypoxia-inducible factor (hif) hif prolyl-hydroxylase inhibitor (phi) phi japan japanese
otago exercise program combined with action observation training in stroke patients

Conditions: Stroke

Summary: stroke is one of the main causes of adult disability worldwide and global health problem. due to ongoing neurological sequelae post stroke patients have a two-fold higher risk of falling than other people with same age or gender. as the stroke patients, balance is impaired and can lead to complications such as fall. promising interventions that could be beneficial to improve the aspects of gait and balance include otago exercises and action observation training. the objective of this study is to determine the effects of otago exercise combined with action observation (ao) training on the balance, gait and functional activities in post stroke patients. a double-blinded randomized control trial will be conducted at rehabilitation centers, outpatient clinics, and hospitals for ten months. the sample size will consist of 60 participants. participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. participants will be randomly assigned into two groups: 30 to action observation (ao) training plus otago exercise group (n= 30) and 30 to otago exercise group (n= 30). the ao plus otago and otago groups will be performed 35 to 40 minutes of strength training and balance exercises from the otago exercise program 3 times a week for 12 weeks. data will be collected through various assessment tools including berg balance scale (for balance), dynamic gait index (for gait) and functional independence measure (for functional activities). the effects of the interventions will be measured at pre-treatment and post-intervention. paired t-test will be adopted to find the statistical difference within the groups and independent t-test will be applied to find the statistical difference between the groups. data analysis will be performed by using spss 26 software.


Eligibility criteria:
inclusion criteria: participants fulfilling given criteria will be included in this study * both male and female participants will be included * the age limit for the participants will be 40-65 years * sub-acute and chronic ischemic stroke up to 2 years. * participants with bbs score between 35-40. * participants having montreal cognitive assessment (moca) score greater than 24 (out of 30). * participants can walk with or without assistance. exclusion criteria: participants having given criteria will be excluded from this study * participants with other neurological diseases. * participants who will not be able to understand the informed consent form. * participants already involved in an exercise program for fall prevention. * participants have no visual field defect, no abnormality in the vestibular organs, no orthopedic disease, and an unrestricted range of motion.

Keywords: action observation training, otago exercises, stroke, gait, balance
enoxamed study in the treatment of acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: because of their anti-xa and ease of administration activity, the low molecular weight heparin represent an attractive alternative to the unfractionated heparin. several clinical trials have demonstrated that low molecular weight heparin was more effective than unfractionated heparin without increasing bleeding complications. enoxaparin has been the most studied. its use is recommended. demonstrate that enoxamed® is comparable to that of lovenox® in the anti-xa activity action.

single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-xa activity between h0 and h4.the study was done on two groups ; enoxamed® group : in this case the patient receives an injection of enoxaparin ( enoxamed® ; unimed laboratories) intravenously. curative dose (100 iu/10 kg). control group ( lovenox ® ) in this case the patient receives lovenox intravenous injection curative dose of 100 kg iu/10 .

Eligibility criteria:
inclusion criteria: * age over 18 year old * with an acute coronary syndrome confirmed exclusion criteria: * age less than 18 years * persistent st- segment elevation * contre indication of enoxaparin and heparin in general. * patient participating in another study, * pregnant or nursing women * patients taking an anticoagulant in the last three months, * patients with coagulopathy

Keywords: enoxaparin enoxamed lovenox anti xa acute coronary syndrome
lifestyle related disease management with wearable device and mobile application

Conditions: Obesity; Life Style Induced Illness

Summary: in order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback coaching.


Eligibility criteria:
inclusion criteria: * study participants must agree to support by him/herself at enroll time * patient without severe cardiopulmonary disease, cancer, or other acute diseases * patient must be over bmi \> 23 kg/m2 exclusion criteria: * patient who did not agree with this study * patient with severe cardiopulmonary disease, cancer, or other acute diseases * patient who are pregnant
imrt tomotherapy for esophagus cancer

Conditions: Esophagus Cancer

Summary: concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. unfortunately, the 5-year survival of 20% for this population is quite low. methods to intensify radiation therapy delivery without increasing local toxicities are needed. intensity modulated radiation therapy (imrt) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. the proposed study will prospectively test whether imrt is tolerable for delivering imrt doses of 60 gy for patients with esophagus cancer.


Eligibility criteria:
inclusion criteria: * age \>= 18 * karnofsky performance status of \>= 60 * tnm stages t1-4, n0-3, m0 * pathologic confirmation of esophagus cancer * evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy * evaluation by surgeon determines that patient is unresectable exclusion criteria: * age \< 18 * karnofsky performance status \< 60 * radiographic or pathologic evidence of distant metastatic disease (classified as m1b in ajcc staging manual) * prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy. * pregnant or lactating, if female.

Keywords: imrt
bicarbonate administration and cognitive function in midlife and older adults with ckd

Conditions: Metabolic Acidosis; Chronic Kidney Disease; Cognitive Dysfunction

Summary: this is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with ckd stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.


Eligibility criteria:
inclusion criteria: * age 50-75 years old * serum bicarbonate 16-22 meq/l on 2 separate measurements (at least 1 day apart) * ckd stage 3b or 4 at time of screening (egfr 15-44 ml/min/1.73m2) * blood pressure \<130/80 mm hg prior to randomization * use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker * stable anti-hypertensive regimen for at least one month prior to randomization * montreal cognitive assessment score \> 24 * no history of stroke * no history of dementia * no history of neurologic disease * able to provide consent exclusion criteria:• significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * uncontrolled hypertension * serum potassium \< 3.3 or ≥ 5.5 meq/l at screening * new york heart association class 3 or 4 heart failure symptoms, known ef ≤30%, or hospital admission for heart failure within the past 3 months * factors judged to limit adherence to interventions * anticipated initiation of dialysis or kidney transplantation within 12 months * current participation in another research study * pregnancy or planning to become pregnant or currently breastfeeding * chronic use of supplemental oxygen
a phase i study to assess psma+ and psma- tumour lesions

Conditions: Advanced and/or Metastatic Solid Tumours

Summary: cb307 is a trispecific humabody® targeting cd137; psma; and human serum albumin (hsa) undergoing phase 1 assessment in patients with psma+ solid tumours. this sub study will assess the biodistribution of radiolabelled cb307 in patients with advanced and/or metastatic solid tumours that are psma+.

phase 1, open-label, single centre, non-randomised study during which, enrolled patients will undergo a number of pet scans following administration of 89zr-cb307, in order to assess the uptake of the radiolabelled drug. a post-treatment tumour biopsy for the assessment of psma expression will also be taken, if medically feasible, after the last pet scan. the sub-study consists of 2 parts: an optimisation phase (part a) and an expansion phase (part b). in part a, both 89zr-cb307 and cb307 will be administered to patients. the timing of the scans, post-dose tumour biopsy and cb307 dose will be optimised as determined by the optimisation review committee (orc). in part b (expansion phase), 89zr-cb307 pet scanning will be performed based on the optimal dosing and timing determined in part a. the sub-study will continue for 7 days after the tracer injection. patients will then be enrolled into the main study and will receive cycle 1 day 1 (c1d1) cb307 treatment according to the main study protocol.

Eligibility criteria:
inclusion criteria: * capable of understanding the written informed consent. * aged at least 18 years. * not amenable to standard of care. * ecog ps of 0 or 1. * documented histologically confirmed diagnosis of psma+ advanced or metastatic solid tumours. * has radiologically measurable disease per recist v1.1 or elevated serum psa for castration resistant prostate cancer patients with only bone metastases. * adequate organ function. * willing to have a biopsy sample taken immediately after the last pet scan before initiation of the main study. exclusion criteria: * subjects with autoimmune disease or regular immunosuppressants. * has discontinued from anti-ctla 4, anti-pd1 or anti-pd-l1 antibody because of intolerable toxicity. * has brain metastasis including leptomeningeal metastasis or primary brain tumour. * has current or history of cns disease. * has known active infection. * biopsy cannot be safely obtained after the last pet scan, and not provided their consent.

Keywords: phase 1 study solid tumours castration-resistant prostate cancer (crpc) prostate specific membrane antigen (psma) crescendo biologics cd137 cb307 humabody® radiolabelled cb307 89-zirconium biodistribution hsa
how does skin tone affect quantitative photoacoustic imaging

Conditions: Vitiligo; Skin Abnormalities

Summary: photoacoustic imaging (pai) is an emerging method which combines light and ultrasound to assess the blood content and oxygenation of the body. light is absorbed by the blood, leading to the generation of ultrasound, from which the levels of oxygen can be derived. this high sensitivity to blood has seen it applied in multiple clinical trials for the assessment of a number of conditions including breast cancer assessment. however, the accuracy of the measurements and image quality is known to decrease as you look deeper into the body because light intensity decreases. melanin in the skin is known to absorb light very strongly and so there is considerable concern that this may bias measurements made in people with darker skin tones compared to those with lighter skin tones. in this pilot study, we intend to recruit volunteers with a wide range of skin tones and vitiligo. we will scan a number of blood vessels and muscles using pai and evaluate the photoacoustic measurements of blood content and oxygenation to identify, and ultimately correct for, biases in advance of further clinical studies.


Eligibility criteria:
inclusion criteria: 1. voluntary adult non-vulnerable participants between the age of 20 to 70. 2. can understand the information sheet and give informed consent in english. 3. normal or overweight bmi (18.5 to 29.9) exclusion criteria: 1. no participants who cannot give informed consent. 2. no tattoos or scarring of the regions to be imaged. 3. no pulmonary sleep disorder, or active respiratory disorders that may affect the blood oxygenation levels.
dehydration of stenfilcon a contact lenses versus delefilcon a contact lenses

Conditions: Myopia

Summary: the study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

the study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. the primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months. 5. is able to wear lenses for at least 12 hours a day. exclusion criteria: 1. is participating in any concurrent clinical study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. has undergone refractive error surgery; * \*for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.