Kornimate/medical-research-clean huggingface dataset:
cd19-targeted car t cells for relapsed and refractory (r/r) mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: this is a phase ii, open-label, single-arm, multicenter study to assess the efficacy and safety of jwcar029 in adult r/r mantle cell lymphoma subjects in china.

this is a phase ii, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (r/r) mantle cell lymphoma (mcl) in china to evaluate the safety, efficacy, pharmacokinetics(pk), pharmacodynamics(pd) of jwcar029 and immune response after jwcar029 treatment. r/r mcl patients will be enrolled in dose level of 1.0 x 10\^8 car+ t cells. all subjects will be followed for 5 years following jwcar029 infusion.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old; * sign on the informed consent; * subject must have histologically confirmed mantle cell lymphoma; * relapsed/refractory patients; * subjects have accessible pet-positive lesion and have measurable ct-positive lesion according to lugano classification; * eastern cooperative oncology group (ecog) performance status of 0 or 1; * expected survival is greater than 12 weeks; * adequate organ function; * adequate vascular access for leukapheresis procedure; * subjects who have previously received cd19 targeted therapy must confirm that lymphoma lesions still express cd19; * women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of jwcar029; * males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of jwcar029. exclusion criteria: * central nervous system (cns) only involvement by malignancy or primary cns lymphoma; * history of another primary malignancy that has not been in remission for at least 2 years; * subjects has hbv, hcv, hiv or syphilis infection at the time of screening; * deep venous thrombosis (dvt)/pulmonary embolism (pe), or dvt/pe requires anti-coagulation within 3 months prior to signing the icf; * subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * presence of acute or chronic graft-versus-host disease (gvhd); * history of any serious cardiovascular disease or presence of clinically relevant cns pathology; * pregnant or nursing women; * subjects using of any chemotherapy, corticosteriod, experiment agents, gvhd therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * received allo-hematopoietic stem cell transplantation therapy previously. * uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * received car t-cell or other genetically-modified t-cell therapy previously.

Keywords: jwcar029 b-cell malignancies non-hodgkin lymphoma car t cells chimeric antigen receptor relapsed/refractory mantle cell lymphoma
magnetic seizure therapy (mst) for treatment resistant major depression

Conditions: Major Depression

Summary: the investigators intend to test in a single center, clinical pilot efficacy study the primary hypothesis that magnetic seizure therapy (mst) as add-on therapy to a controlled pharmacotherapy is efficacious in the treatment of refractory major depression assessed with the hamilton depression rating scale (hamd).


Eligibility criteria:
inclusion criteria: * patient is diagnosed with a major depressive episode (mde) according to dsm-iv diagnosis criteria derived from the scid. * patient has not had an acceptable clinical response due to failure (resistance) with at least two treatments from different treatment categories during the current mde. * patient has a score ≥ 20 on the 24-item hamilton rating scale of depression. * patient is able to give his informed consent to participate in this study and he is able to fulfill the requirements of the study. * patient is a male or nonpregnant female adequately protected from conception. females of childbearing potential must use an acceptable method of birth control. * convulsive therapy clinically indicated exclusion criteria: * patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnesia, or other cognitive disorders per dsm-iv. * patient has had or has currently a diagnosis of non-affective psychotic disorder per dsm-iv. * patient has had alcohol or substance dependence within the previous 12 months or abuse within the previous six months other than nicotine dependence or abuse. * patient has a history or diagnosis of clinically relevant cardiac disease. * patient has a history or diagnosis of clinically relevant injury or disease of the central nervous system. * patient has magnetic material in the head. * patient has implanted medical devices such as cardiac pacemaker, vagus nerve stimulator, medical pumps etc.
donepezil double blind trial for ect memory disfunction

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: this is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ect. patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ect. several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. the same measurements will be taken throughout the trial and one month after ending the ect.


Eligibility criteria:
inclusion criteria: * schizophrenia, schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by dsm-iv criteria and evaluated by the structured clinical interview for dsm-iv (scid) exclusion criteria: * history of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence. * pregnant women * patients who recieved ect within 6 month * patients whith contraindication to donepezil treatment. * patients with lithium treatment

Keywords: donepezil, ect, memory disfunction
feasibility study of dynasplint to prevent trismus in head and neck cancer

Conditions: Trismus; Head and Neck Cancer

Summary: the purpose of this study is to see if use of a device called the jaw dynasplint® system can be used during and immediately after cancer treatment. the dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. the device is currently approved for treatment of trismus once it has developed. this study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.

data suggest that early intervention with mechanical stretching devices for head and neck cancer patients undergoing curative therapy maximizes their effectiveness in the treatment of trismus. that being said, treatment for trismus typically begins after head and neck cancer patients are found to have moderate to severe reduction in jaw range of motion. typically, clinicians will begin therapy when the iid is 3.0 cm or less. a subset of head and neck cancer patients will develop severe or rapidly progressive trismus that will fail to respond to treatment. in this cohort, trismus may lead to permanent, severe morbidity. it may be hypothesized that preventative strategies that encourage routine stretching during and immediately after the completion of cancer therapy may prevent or minimize trismus. no studies have examined the prophylactic use of the jaw dynasplint® system during cancer treatment. furthermore, it is not known whether patients can tolerate wearing a mechanical stretching device during treatment. the investigators would like to test the hypothesis that: 1) preventive use of a mechanical stretching device during cancer treatment and early recovery is feasible, and 2) preventive use of a mechanical stretching device will result in a marked decrease in the incidence and severity of trismus in patients undergoing primary or adjuvant radiation therapy for head and neck cancer.

Eligibility criteria:
inclusion criteria: 1. patients with histologically proven head and neck cancer 2. planned primary or adjuvant radiation treatment with 50cgy or greater delivered to a total volume of at least 2cc to the muscles of mastication, unilaterally or bilaterally, over the entire course of radiation treatment 3. patients receiving induction or concurrent chemotherapy 4. baseline interincisoral distance \> 35 mm 5. willing and able to provide informed consent 6. sufficient manual dexterity to utilize the device 7. all participants must be at least 21 years of age exclusion criteria: 1. patients with collagen vascular disorders that may predispose to radiation fibrosis 2. patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation
effects of emulsification and lipid droplet size on postprandial metabolic responses

Conditions: Metabolic Diseases

Summary: the aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses.

this study will be conducted using a randomized, crossover design with three dietary phases: 1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large lipid droplet size) and 3) non-emulsified oil and water. all treatments will be consumed together with bread. all participants will be randomly allocated to the three test meals. fifteen to twenty participants aged between 21 and 50 years will be recruited from the general public in singapore. during the testing sessions, participants' glycemic, insulinemic, lipidemic responses and gastric emptying to the test meals will be measured. gastric antral distention ultrasound measurement is an indirect measure of gastric emptying rate. participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. each testing session will take approximately four hours in duration and the testing sessions will take place at least five days apart.

Eligibility criteria:
inclusion criteria: * healthy chinese male subjects aged between 21 and 50 years * body mass index between 20.0 to 24.9 kg/m2 * normal blood pressure (\<140/90 mmhg) * fasting blood glucose \<6.0 mmol/l exclusion criteria: * people with major chronic disease such as heart disease, cancer or diabetes mellitus * people with family history of diabetes or familial cholesterolaemic * people with history of liver or renal problems * people who have intolerances or allergies to test products * individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution * people with a major medical or surgical event requiring hospitalization within the preceding three months * individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
pharmacokinetics and safety profiles after administration of da-5221_01 and co-administration of 5221_01-r1 and da-5221_01-r2 in healthy adult volunteers

Conditions: Healthy

Summary: pharmacokinetics and safety profiles after administration of da-5221_01 and co-administration of 5221_01-r1 and da-5221_01-r2 in healthy adult volunteers


Eligibility criteria:
inclusion criteria: * healthy volunteers * bmi between 18 and 30 kg/m2 * body weight: male≥50kg, female≥45kg * subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study exclusion criteria: * subjects with clinically significant medical history * subjects with history of drug abuse or addicted
study to evaluate efficacy of odanacatib (mk-0822) on bone mineral density (bmd) and bone micro-architecture and overall safety in postmenopausal women (mk-0822-031)

Conditions: Osteoporosis

Summary: this study will evaluate the safety and treatment effect of 50 mg odanacatib (mk-0822) with vitamin d versus placebo with vitamin d in postmenopausal women with low bone density. the primary efficacy hypothesis is that odanacatib will increase abmd at the lumbar spine compared to placebo at 12 months.


Eligibility criteria:
inclusion criteria: * participant has been postmenopausal for 3 years * participant has bmd t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but \> -3.5 * participant has 2 hips that are evaluable by dual-energy x-ray absorptiometry (dxa) and quantitative computed tomography (qct), e.g. contain no hardware from orthopedic procedures * participant is ambulatory exclusion criteria: * participant has had a previous hip fracture * participant has had \>1 prior clinical vertebral fracture and is a candidate for osteoporosis therapy * participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (pth) or other agents with an effect on bone * participant has had metabolic bone disorder other than osteoporosis * participant has renal stones, parkinson's disease, multiple sclerosis (ms) or active parathyroid disease.
effect of concomitant radiotherapy and trastuzumab on cardiotoxicity of patients treated for early breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether concomitant radiotherapy and trastuzumab (patients treated for early breast cancer) is really safe for the heart even years after treatment and if the investigators should use these two treatments concomitantly without additional harm.

the investigators know from the studies, that were already published, that for her2 positive early breast cancer patients in adjuvant treatment concomitant radiotherapy and trastuzumab is safe during the treatment. but there is no study with long term results of cardial function, especially combination of left ventricular ejection fraction (lvef) and nt-probnp.

Eligibility criteria:
inclusion criteria: * early breast cancer patients,treated adjuvantly with radiotherapy of the operated breast or thoracic wall and treated concomitantly with trastuzumab. * reviewed many months after treatment, without recurrence of disease. exclusion criteria: * recurrence of disease

Keywords: adjuvant treatment with radiotherapy and trastuzumab
compound adapalene and clindamycin hydrochloride gel in treatment of patients with acne

Conditions: Acne

Summary: evaluate the safety and efficacy of compound adapalene and clindamycin hydrochloride gel in treatment of chinese patients with acne.


Eligibility criteria:
inclusion criteria: 1. age from 18 to 40 years old, female or male; 2. class i-iii of acne vulgaris according to the international modified pillsbury classification; 3. patients voluntarily take part in the study and sign the icf. exclusion criteria: 1. the subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient; 2. patients with secondary acne including occupational acne and corticosteroid-induced acne; 3. the affected skin has other concomitant lesion (such as solar dermatitis, psoriasis, seborrheic dermatitis, eczema and extremely severe acne) which may impact the efficacy evaluation; 4. subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis; 5. patient has history of severe cardiac disease and hypertension; 6. patient has severe liver and kidney diseases with ast/alt more than twice upper limitation, or cr, total cholesterol and triglycerides above normal range; 7. patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders; 8. patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents; 9. pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study; 10. alcoholic patients or drug abusers; 11. patient has used other acne drugs topically within 2 weeks before the study start; 12. patient has been administered with victoria a acid, vitamins, and antibiotics within 4 weeks before the study start; 13. patient has participated in other study within 3 months before the study start; 14. the subject is not fit to take part in this study in the judgment of the investigator.

Keywords: safety efficacy
mitoferrin-1 expression in erythropoietic protoporphyria (porphyria rare disease clinical research consortium (rdcrc))

Conditions: Erythropoietic Protoporphyria (EPP)

Summary: the purpose of this study is to identify the biochemical/genetic defects in erythropoietic protoporphyria (epp). people with epp have skin sensitivity to sunlight and occasionally develop liver disease. in this study, the investigators hope to learn the nature of the biochemical/genetic defects in epp because this may help explain the severity of these clinical features.

this study examines the possibility that abnormal expression of the gene mitoferrin-1, which codes for the protein that transports iron in the mitochondria of cells, is a contributing factor to the phenotype in individuals with epp. erythropoietic protoporphyria (epp) is a human genetic/metabolic disorder in which accumulation of the compound protoporphyrin causes skin sensitivity to sunlight. some individuals with the disorder also have mild anemia, and a few have hepatobiliary disease. iron is joined to protoporphyrin to form heme in the mitochondria of cells, under control of the enzyme ferrochelatase. defects in this process cause the accumulation of protoporphyrin, leading to the biochemical and clinical features of epp. abnormalities in the ferrochelatase gene are the major cause of the defect, but do not satisfactorily explain the severity of the phenotype in all subjects. mitoferrin-1 transports iron to ferrochelatase in the mitochondria of cells for heme formation, and also transports iron for the formation of a compound that keeps ferrochelatase active and stable. thus, a deficiency of this iron transporter could reduce ferrochelatase activity and contribute to the phenotype in epp.

Eligibility criteria:
inclusion criteria: 1. enrollment in the longitudinal study of the porphyrias with a diagnosis of epp 2. an individual or parent/guardian who is able to give written informed consent or assent, as appropriate - exclusion criteria: 1. patient is not enrolled in the longitudinal study of the porphyrias 2. patient is under the age of 7 3. patient is cognitively impaired 4. patient refuses to have blood drawn for establishing lymphoblast line -

Keywords: epp bloomer porphyria
a feasibility study on continuous adaptive [18f]fdg-pet-guided radiotherapy for head and neck cancer

Conditions: Squamous Cell Carcinoma

Summary: treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. this trial investigates the feasibility of using repetitive per-treatment \[18f\]fdg-pet acquired during treatment in adaptive \[18f\]fdg-pet-voxel intensity-based intensity-modulated radiotherapy (imrt) or volumetric-modulated arc therapy (vmat) for head and neck cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx. * primary unresectable tumor and/or patients refused surgery. * stage t1-4; t3-4 n0 or tany n1-3 for cancer of the glottis. * multidisciplinary decision of curative radiotherapy or radiochemotherapy. * karnofsky performance status ≥70%. * age ≥ 18 years old. * informed consent obtained, signed and dated before specific protocol procedures. exclusion criteria: * treatment combined with brachytherapy. * prior irradiation to the head and neck region. * distant metastases. * second primary tumors that are not under control * pregnant or lactating women. * creatinine clearance (cockcroft-gault) ≤ 60 ml/min before treatment. * allergy to the ct-contrast agents. * mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. * patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Keywords: primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
a study to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab in participants with moderate to severe ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (pk) of vixarelimab compared with placebo in participants with moderate to severe uc who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

this study consists of two periods: 1. an induction period which will test the induction of clinical remission; 2. an optional active treatment extension (ate) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.

Eligibility criteria:
inclusion criteria: * diagnosis of uc for at least 3 months * moderately to severely active uc, assessed by mms * inadequate response, loss of response to, or intolerance to conventional or advanced therapies for uc exclusion criteria: * diagnosis of crohn's disease or indeterminate colitis * suspicion of ischemic, radiation, microscopic, or infectious colitis * prior colectomy * inadequate response or loss of response to previous treatment of uc with tofacitinib, upadacitinib, or other systemic janus kinase (jak) inhibitor

Keywords: inflammatory bowel disease gastrointestinal disease ulcerative colitis colitis
comparison between atorvastatin and rosuvastatin in reduction of inflammatory biomarkers in patients with acute coronary syndrome

Conditions: Mi Q Wave

Summary: this study will help us to compare atorvastatin and rosuvastatin in terms of their ability to reduce biomarkers of inflammation in patients of acute coronary syndrome


Eligibility criteria:
inclusion criteria: 1. patients with age 18 years and above, of both genders, diagnosed with acute coronary syndrome (as per operational definition) who were not taking statins previously. 2. patients who sign written informed consent to participate in the study. exclusion criteria: * 1.patients who are taking either statins and/or any other drug which lower serum lipid levels, patients with a history of statin hypersensitivity, patients in whom statins are contraindicated. 2.patients who will be surgically managed will be also excluded. 3.if coronary revascularization will be planned or anticipated at the time of screening. 4.pregnant or lactating women. 5.patients having concomitant infections which cause the rise of inflammatory markers.