Kornimate/medical-research-clean huggingface dataset:
evaluation of ssd8432 and ritonavir in adult subjects with covid-19 clinical study

Conditions: COVID-19

Summary: this is a randomized, double-blind, placebo-controlled, phase ii clinical study to evaluate ssd8432 in combination with ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with covid-19.

this is a randomized, double-blind, placebo-controlled, phase ii clinical study to evaluate ssd8432 in combination with ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with covid-19. this study planned to enroll 72 subjects, randomly divided into low-dose group, high-dose group and placebo group according to 1:1:1.

Eligibility criteria:
inclusion criteria: 1. ≥18 and ≤80 years old, male or female. 2. asymptomatic infection,mild or common type of covid-19. 3. initial positive test of sars-cov-2 within 5 days of randomization. 4. initial onset of covid-19 signs/symptoms within 3 days of randomization. exclusion criteria: 1. transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ecmo is required or anticipated to be urgently required. 2. prior to current disease episode, any confirmed sars-cov-2 infection. 3. known medical history of active liver disease (other than nonalcoholic hepatic steatosis). 4. receiving dialysis or have known moderate to severe renal impairment. 5. known human immunodeficiency virus (hiv) infection. 6. suspected or confirmed concurrent active systemic infection other than covid-19 that may interfere with the evaluation of response to the study intervention. 7. oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization.. 8. treatment with antivirals against sars-cov-2 within 14 days. 9. current or expected use of any medications or substances that are highly dependent on cyp3a4 for clearance. 10. concomitant use of any medications or substances that are strong inducers of cyp3a4 are prohibited within 28 days. 11. has received or is expected to receive covid-19 monoclonal antibody, convalescent covid-19 plasma or other prohibited concomitant medication. 12. females who are pregnant or breastfeeding.
impact of jump start nutrition program on weight loss and associated measures

Conditions: Weight Loss

Summary: the purpose of the proposed study is to evaluate the impact of the jump start program to facilitate weight loss in a sample of overweight and obese men and women. the study will not only evaluate weight loss and changes in body-shape but will also assess the type of weight lost (fat vs. lean mass) and other health measures affected by obesity including lipids, glucose, insulin, resting heart rate and blood pressure, and perceived wellness. this study will contribute to the general weight loss literature by providing evidence for or against the use of a meal replacement centered one-week weight loss program to yield weight loss and other health-specific benefits. the hypothesis is that the jump start program will result in an average 3-5 pound weight loss, as well as improvements in bloodborne markers of health, from day 1 to day 8.


Eligibility criteria:
inclusion criteria: * bmi of 28-39.9 kg/m2 * can fast \>10 hours * maintain existing exercise regiment during study exclusion criteria: * weight greater than 500 lbs * type i or ii diabetic * liver disease * tobacco user * adversity to fiber or protein supplement * taking weight loss dietary supplements or adhering to any weight loss plan in the month prior to and during participation in the study * taking a multi-vitamin or pro-biotic, or if they were not recommended by a doctor, willing to stop for 4 weeks prior to the study. * consumption of alcohol or caffeine within 24 hours of each testing visit * strenuous exercise during the 24 hours period before each testing visit * self-reported active infection or illness of any kind * pregnant or lactating

Keywords: jump start usana
proximal gastrectomy anterior anastomosis with pyloroplasty versus esophagogastric anastomosis for gastric cancer

Conditions: Proximal Gastric Adenocarcinoma; Gastric Cancer; Gastroesophageal Reflux Disease

Summary: this research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the stomach, t1-t4 stages. 2. eastern cooperative oncology group performance status of 0 or 1. 3. adequate organ function. exclusion criteria: 1. patients had distant metastasis. 2. oesophageal invasion of more than 3 cm. 3. borrmann type 4 or large (more than 8 cm) type 3 carcinoma. 4. previous chemotherapy or radiation therapy for any other malignancies.
histopathologic evaluation of high grade brain tumors by high order diffusion tensor imaging

Conditions: High Grade Brain Tumor

Summary: this study will examine the use of a variation of standard magnetic resonance imaging (mri) called diffusion tensor mri (dt-mri), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. the infiltrated tissue is then isotropic (or less anisotropic). dt-mri can assess anisotropy after datasets post treatment. primary outcome is to find if a correlation exists between ga (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.

patients with high grade brain tumor undergo a usual brain tumor mri protocol as well as a 20 or 60 directions dt-mri sequence upon patient collaboration. images are acquired using a 3 tesla mri scanner (ge mr750 discovery). the usual brain tumor mri protocol contains the following sequences: 3dt1, axial t2, flair, t2 eg, diffusion (b0-b1000), 3dt1ce. they will then undergo stereotactic tumor biopsies with leksell frame mounted. biopsy targets will be surgically planned. the coordinates of this first biopsy will be recorded for later coregistration with dt-mri datasets. histopathologic analysis of the biopsies will be done using usual procedure. various immunologic markers such as map2, ki67 will be used on the first biopsy sample in order to estimate the percentage of infiltration (ratio of tumor cells number over total cells number). analysis of dt-mri datasets will be done using home-made software for high order tensor resolution and ga estimation at the exact coordinates of the biopsy sites. finally a statistical analysis (pearson or spearman) will be done to correlate ga and the infiltration percentage.

Eligibility criteria:
inclusion criteria: - patients with high grade brain tumor * age greater than 18 yo and under 85 yo * signed informed consent from patient exclusion criteria: * -any person with pacemaker, metal implant, claustrophobia, or any other contraindication for mr examination * severe renal failure * brain tumor biopsy contraindication

Keywords: high grade brain tumor glioma glioblastoma multiform brain cancer diffusion-weighted magnetic resonance imaging high order diffusion tensor imaging guided biopsy histopathologic evaluation infiltration percentage
bio-car-t bs study

Conditions: Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B-cell Lymphoma (PMBCL); Acute Lymphoblastic Leukemia (ALL)

Summary: the aim of this study is the evaluation of post-infusion car-t (chimeric antigen receptor t cell) expansion and persistence in patients with dlbcl, pmbcl and all undergoing car-t therapy; and the feasibility and efficacy of the treatment in the real life practice.

this study is characterized by several biological sub-studies, reported as below: * post-infusion car-t expansion and persistence analysis by both flow cytometry and digital pcr (dpcr): the aim of this point are the evaluation and enumeration of car t cells (cd4+ and/or cd8+) during patients follow-up and set up of specific panels for longitudinal evaluation and monitoring of car-t subsets. * circulating extracellular vesicles quantification and analysis on peripheral blood and cns (central nervous system) liquor: the aim are the identification of alterations in small evs (extracellular vesicles) ( number and cargos composition (proteins or mirna) after car-t cell infusion and identification of small evs markers which may distinguish patients "good responders" from patients "not responders" and/or which may predict particular post-infusion complications. * evaluation of neurological markers for icans (immune effector cell-associated neurotoxicity syndrome): the purpose of this substudy are the assessment of previously identified plasma and csf (cerebrospinal fluid)biomarkers for inflammation, neuronal damage and glial activation in patients who develop icans and the characterize temporal neuronal and glial involvement by assessing plasma and csf inflammatory, neuronal and glial biomarkers in icans and their role on outcome.

Eligibility criteria:
inclusion criteria: * patients with b-cell-all (≤ 25 years) or patients with dlbcl (18-70 years) or patients with pmbcl (18-70 years) who were relapsed/refractory after two lines of treatments; * adequate performance status (0 or 1); * adequate organ function; * no active or uncontrolled infections; * no thrombo-embolisms within the last 6 months; * absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months); * life expectancy of at least 3 months. exclusion criteria: * patients with b-cell-all \> 25 years * patients with dlbcl \ 70 years * patients with pmbcl \ 70 years * performance status \> 1; * active or uncontrolled infections; * thrombo-embolisms within the last 6 months; * presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months); * life expectancy \< 3 months.
a randomised trial comparing trastuzumab deruxtecan to cdk4/6 inhibitors in non-luminal a, er-positive/her2-low metastatic breast cancer

Conditions: Metastatic Breast Cancer; ER-positive Breast Cancer; Luminal B; Her2 Enriched; Basal Like

Summary: the objective of this trial, dbcg r25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (pfs) in first-line for patients with non-luminal a, er-positive/her2-negative metastatic breast cancer

study design and setting we will conduct an international, multicentre, open-label, randomised controlled trial. all oncological departments who treat patients with metastatic breast cancer can participate. the eu clinical trial regulation will be applied. interventions trial participants will be randomised to trastuzumab deruxtecan or standard treatment. trastuzumab deruxtecan patients randomised to trastuzumab deruxtecan will be treated as: trastuzumab deruxtecan until progression or intolerable toxicity, trastuzumab deruxtecan: 5.4 mg/kg intravenous on day 1 of a 21 days cycle. standard patients randomised to standard will be treated as: cdk4/6 inhibitor with an endocrine therapy until progression or intolerable toxicity cdk4/6 inhibitor: physician's choice of ribociclib (600mg daily for 21 days in a 28 days cycle) or abemaciclib (150mg twice daily). endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks) other treatment prophylactic antiemetics are allowed, including corticosteroids. prophylactic antibiotics are allowed if deemed necessary for the patient. g-csf is allowed when needed. all other symptomatic treatment to perform best of care is allowed as long as name, administration and length is documented in the chart. bone targeted agents are allowed. no other antineoplastic treatment is allowed. radiological evaluation patients will initially be scanned every 9-12 weeks as per investigator's or co-investigator's discretion with minimum a ct of the thorax and abdomen or a fdg-pet/ct. patients with response can have this interval extended. upon progression treatment/control is to be done according to department preferences, but subsequent treatment and day of death must be registered.

Eligibility criteria:
inclusion criteria: * women aged 18 or above. * radiologically/pathologically verified metastatic breast cancer. * er-positive (1% or more) and her2-low (her2 1+ or her2 2+/ish-neg)10,11. * pam50 luminal b, her2-enriched or basal-like. * performance status 0-1. * evaluable disease exclusion criteria: * patients who are incapable of understanding the written material received * patients with inaccessible tumour tissue * other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)
computer-assisted hair restoration study using artas system

Conditions: Androgenic Alopecia

Summary: prospective, multi-center, up to 4 investigational centers evaluating the performance of the artas system in hair restoration procedures.


Eligibility criteria:
inclusion criteria: * subject is male with clinical diagnosis of androgenetic alopecia with norwood-hamilton grade of iii-vi * subject is 20 to 70 years old * subject agrees to cut hair short (\< 1 mm) on the scalp in the designated study areas for harvesting and implantation * subject is able to understand and provide written consent * subject consents to post-operative follow-up per protocol exclusion criteria: * subject has prior history of scalp reduction surgery(s) in the past six months * subject has bleeding diathesis * subject has active use of anti-coagulation medication * subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
landing biomechanics following fatigue in athletes with and without a history of patellar tendinopathy

Conditions: Patellar Tendinitis; Fatigue

Summary: in this case-control study, two- and three-dimensional landing biomechanics, by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), will be compared between 30 male volleyball/basketball players with a history of patellar tendinopathy and 30 healthy controls.


Eligibility criteria:
inclusion criteria: * volleyball or basketball players * male * history of patellar tendinopathy exclusion criteria: * history of surgery of the lower extremities * history of fractures of the lower extremities

Keywords: biomechanics landing
seretide plus tiotropium versus individual components

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study was designed to evaluate the effects on lung function of a combination of seretide 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and seretide 50/500mcg twice daily alone) in subjects with copd. the study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.

a randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of seretide™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and seretide 50/500mcg alone) in the treatment of subjects with copd

Eligibility criteria:
inclusion criteria: * has an established clinical history of copd as defined as per the gold definition. * post-bronchodilator fev1 of \>30% to 75% of predicted normal at visit 1, a post-bronchodilator fev1 / fvc ratio = 70%. * current or ex-smoker with a smoking history of \> 10 pack-years. exclusion criteria: * has unstable copd (chronic obstructive pulmonary disease). * has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) requires regular (daily) or long term oxygen therapy (ltot). (ltot is defined as \> 12 hours oxygen use per day).

Keywords: cross-over tiotropium triple copd seretide 50/500 dyspnoea impulse oscillometry plethysmography
combined cumulative irritation potential and repeat insult patch test of leo 90100

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to determine the skin irritation potential and sensitisation potential of leo 90100 and the vehicle after repeated applications on the skin of healthy subjects.


Eligibility criteria:
inclusion criteria: * 1. following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out. * 2. healthy male or female subjects, 18 to 65 years of age inclusive at screening. exclusion criteria: * 1. female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding * 2. subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type v and vi on the fitzpatrick scale)
the influences of anterior capsule polishing on anterior capsular changes and intraocular lenses stability of super high myopic eyes

Conditions: Myopia, High, With Cataract and Anterior Capsule Polished

Summary: a prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. the refractive state and size of anterior opening were measured at postoperative 1 day as the baseline. then they followed up at 1 month, 3 months and 6 months after surgery to record refractive state, higher-order aberrations, size of anterior opening, tilt and decentration of iol (intraocular lenses)and pad(postoperative aqueous depth). the paired t test was used to compare the differences between the two groups, and the same test the postoperative follow-up comparing with the baseline.


Eligibility criteria:
inclusion criteria:cataract patients with super high myopia (axial length \>27mm) and difference of binocular was less than 1mm exclusion criteria:larger corneal astigmatism need toric intraocular lens; patients with any systemic or ocular diseases that may influence the anterior capsule opening morphologic, such as keratonosus, glaucoma, uveitis, pseudoexfoliation syndrome, retinitis pigmentosa and diabetes and myotonic dystrophy, etc.; patients with ophthalmic surgery and trauma history.
verapamil and catamenial epilepsy

Conditions: Catamenial Epilepsy

Summary: one in 3 epilepsy patients have refractory seizures. this drug resistance is likely related to the over expression of multidrug resistance proteins (mdr). progesterone is a known inhibitor of mdrs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting mdrs and thus may help patients with refractory seizures. if the study shows improved seizure control, the results will help establish the role of mdrs in refractory epilepsy.


Eligibility criteria:
inclusion criteria: * females * at least 2 seizures per month * more than 50% of the seizures occur 7 days before or 7 days after the onset of menses * patient of the toronto western hospital epilepsy clinic exclusion criteria: * cardiovascular history

Keywords: epilepsy seizures menstrual cycle
outcome evaluation of solutions for wellness and team solutions program in patients with severe mental illness

Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Summary: obesity is increasing at an alarming rate in patients with schizophrenia, possibly in association with the increased use of atypical antipsychotics. in order to address the weight and metabolic syndrome issues, manhattan psychiatric center (mpc) has implemented the solutions for wellness and team solutions program. this program is designed to create a supportive, educational and monitoring environment to stabilize both the psychiatric and medical conditions and to prepare patients for independent management of their psychiatric and physical health condition in the community.

the present program is divided into five detailed segments with three progressive levels, that provide a manualized lesson-by-lesson curriculum for implementation on the treatment mall. * medication education * symptom recognition and management * living healthy * interpersonal skills * discharge preparation the program comprised of detailed instructor and patient manuals, specific curriculums and pre- and post-tests to determine acquisition of the learned materials. all modules are imbedded in weekly small group sessions. * each of the 5 modules are discussed in groups in weekly morning or afternoon session, monday through friday. * each module is divided into three 12-week periods for a total of 36 sessions. * upon completing 12 weeks at level 1, each patient moves to level 2 and then level 3 for 12 weeks each. * each group has two trained instructors. * number of patients per group: ≤ 15. * sessions are interspersed within the patient's regular treatment mall classes

Eligibility criteria:
inclusion criteria: 1. are at lease 18 years of age; ≤ 65 years. 2. are male or female 3. are currently hospitalized at manhattan psychiatric center and attend daily treatment mall programs. 4. are fluent in the language of the investigator, and study staff (including testing administrators, group leaders and supervisors) 5. have a documented current psychiatric diagnosis as obtained from patient's medical charts and recorded by a qualified psychiatrist. 6. recently admitted patients will be included if their clinical state permits it. exclusion criteria: 1. are \> 65 years of age; 2. are currently enrolled in the intensive psychiatric services (ips) program at manhattan psychiatric center;