Kornimate/medical-research-clean huggingface dataset:
dostarlimab in chemoresistant gestational trophoblastic neoplasia

Conditions: Gestational Trophoblastic Neoplasia

Summary: the purpose of this study is to see if dostarlimab is an effective treatment for gestational trophoblastic neoplasia (gtn).


Eligibility criteria:
inclusion criteria: 1. patients with persistent unresectable gestational trophoblastic neoplasia (gtn) disease 2. female patients \>18 years old. 3. pretreatment archival tissue (if available) must be submitted for correlative studies. if pre-treatment tissue is not available, this does not exclude the patient. 4. patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, ctcae grade ≤1 except for alopecia, sensory neuropathy, or fatigue). exclusion criteria: 1. prior therapy with anti-programed death (pd)1/programed death ligand-1 (pd-l1) or anti-ctla4 antibody 2. participant must not be simultaneously enrolled in any interventional clinical trial. 3. participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects. 4. participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
the effects of an integrated mindfulness-based tai chi chuan program on sleep disturbance among community-dwelling elderly people

Conditions: Elderly; Sleep; Mindfulness; Tai Chi Chuan

Summary: the trial aims to evaluate the effects of an integrated form of mindfulness-based tai chi chuan (mbtcc) program and the underlying mechanisms of the beneficial effects on sleep disturbance over 12-month follow-up in community-dwelling elderly people.


Eligibility criteria:
inclusion criteria: * aged 60 years or above; * classified as experiencing sleep disturbances (indication of poor sleep quality through a score \>5 in the pittsburgh sleep quality index); * primary education level or above and able to communicate in cantonese; * able to give informed consent; and * no previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga). exclusion criteria: • comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.
discharge education of integrated traditional and western medicine reduces re-hospitalization in patients with chronic heart failure

Conditions: Heart Failure

Summary: although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. the investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.

although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education of integrated traditional and western medicine is not known. the investigators hypothesized that a patient discharge education of integrated traditional and western medicine program would improve clinical outcomes in patients with chronic heart failure.

Eligibility criteria:
inclusion criteria: * candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction\<0.40). exclusion criteria: * ckd4 and ckd5

Keywords: patient education chinese medicine
evaluation of the single injection of bmac vs ha in the treatment of the ankle osteoarthritis

Conditions: Ankle Osteoarthritis

Summary: the aim of the study is to compare the efficacy of the infiltrative therapy of bmac vs ha up to 24 months in the treatment of the ankle osteoarthritis. the efficacy will be assessed through clinical, objective and subjective evaluations. after 12 months patients in the control group can decide to cross-over in the treatment group.

all the patients who meet the inclusion criteria and giving written informed consent will be randomized. we planned to enrol 120 patients. following the randomization, every patient will be treated with a single injection of bone marrow aspirate concentrate (bmac) or two injections of hyaluronic acid (ha) in the affected ankle. after the treatment patients will be followed up to 24 months whit clinical and radiological assessment. after 12 months patients in the control group can decide to cross-over in the treatment group with bmac. these patients will be followed up further 12 months.

Eligibility criteria:
inclusion criteria: 1. patients with degenerative ankle cartilage disease; 2. unilateral involvement on the ankle; 3. signs and symptoms of degenerative pathology of the ankle cartilage; 4. radiographic or mri signs of degenerative pathology of the ankle cartilage (oa van dijk grade 1-3); 5. no clinically significant electrocardiographic changes (recently performed ecg). 6. ability and consent of patients to actively participate in clinical follow-up; exclusion criteria: 1. patients unable to give consent; 2. patients who have undergone intra-articular infiltration of another substance in the preceding 6 months; 3. patients who have undergone ankle surgery in the preceding 12 months; 4. patients with malignant neoplasms; 5. patients with rheumatic diseases; 6. patients with uncompensated diabetes; 9. patients with uncompensated thyroid metabolic disorders; 10. patients who abuse alcoholic beverages, drugs or medications; 11. body mass index \> 35;

Keywords: bone marrow aspirate concentrate hyaluronic acid bmac ha ankle ankle injection ankle oa
a study to evaluate the safety and efficacy of ajm300 in participants with active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the study will investigate the efficacy and safety of an oral dose of ajm300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.


Eligibility criteria:
major inclusion criteria: 1. participants diagnosed with ulcerative colitis. 2. participants with moderate ulcerative colitis who satisfy all of the following criteria at day of enrollment. 1. mayo clinic scores of 6-10 . 2. endoscopic subscore greater than or equal to (\>=) 2. 3. rectal bleeding subscore \>=1. 3. participants with inadequate response or intolerant to oral 5-asa 4. participants who are capable of providing written informed consent major exclusion criteria: 1. participants with extensive detachment of mucosa or deep ulcer. 2. participants with oral corticosteroid dependency. 3. participants with a complication of marked reduction of immune function. 4. participants who were clinically suspected to have a complication of infectious enteritis. 5. participants with a history or complication of serious infection within 1 year prior to the day of enrollment. 6. participants with central nervous system (cns) neurological symptoms. 7. participants with the following criteria: * serious heart disease * renal impairment * hepatic impairment 8. participants with a history of serious drug induced allergy with unknown cause. 9. participants with malignant tumor or those whose treatments were completed in less than 5 years. 10. participants with apparent psychological signs. 11. pregnant women, nursing women, women with suspected pregnancy, women who wish to become pregnant during the period from informed consent through to the end of observation/examination at week 8, and women who do not consent to the use of appropriate birth control methods. 12. participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc. 13. participants who are participants of another clinical study including follow-up observation at the time of informed consent. 14. participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol. 15. participants who received investigational drugs in the study of ajm300. 16. participants determined to be ineligible for participation in this study by the investigator or sub-investigator.

Keywords: ulcerative colitis inflammatory bowel disease, ulcerative colitis type colitis ajm300
clinical trials of autologous cultured adipose-derived stem cells (antg-asc) on complex fistula

Conditions: Complex Perianal Fistula

Summary: mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. they have an immunosuppressive activity. complex perianal fistula is difficult to cure and easy to relapse. autologous adipose stem cells have shown efficacy and safety on crohn's fistula in phase 1 study. based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.


Eligibility criteria:
inclusion criteria: * a patient who has complex perianal fistula * a patient who is negative in pregnancy test * a patient who has submitted a written consent exclusion criteria: * a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs. * a patient who has a history of variant creutzfeldt jacobs disease or related diseases * a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue * a patient who has an autoimmune disease * a patient who has infectious diseases such as hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) * a patient who has sepsis or active tuberculosis * a patient who is pregnant or breast feeding * a patient who has inflammatory bowel disease * over 2cm in diameter of fistula

Keywords: crohn's disease fistula complex
a phase ii study of 2 doses of zd6474 (vandetanib) in combination with folfox vs folfox alone for the treatment of colorectal cancer

Conditions: Colorectal; Cancer

Summary: the purpose of this study is to determine whether treatment with zactima (vandetanib) in combination with folfox is more effective than folfox alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.


Eligibility criteria:
inclusion criteria: * progression on or following treatment for metastatic colorectal cancer * have failed therapy with an irinotecan and fluoropyrimidine containing regimen * have world health organisation (who) performance status 0-2 and life expectancy \>12 weeks exclusion criteria: * previous treatment with small molecule tyrosine kinase inhibitors of vegfr or egfr prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab) * previous adjuvant therapy with irinotecan within 12 months of randomisation * more than one prior course of chemotherapy for treatment of metastatic colorectal cancer

Keywords: colorectal cancer zactima
a dose-ranging, multicenter polysomnography trial of pd 0200390 in elderly subjects with primary insomnia

Conditions: Insomnia

Summary: this is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (pd 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (psg) lab.


Eligibility criteria:
inclusion criteria: * 3 month history of primary insomnia * difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening) exclusion criteria: * any history of psychiatric diagnosis * history or presence of any breathing related sleep disorder * history or presence of any medical or neurological condition that could interfere with sleep * use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

Keywords: insomnia, primary insomnia, chronic insomnia, dims (disorders of initiating and maintaining sleep), disorders of initiating and maintaining sleep
fundus autofluorescence imaging in age-related macular degeneration using confocal scanning laser ophthalmoscopy

Conditions: Age-related Macular Degeneration

Summary: the purpose of this study is to define phenotypic variations in atrophic age-related macular degeneration (amd) and to identify predictive factors for disease progression based on fundus autofluorescence imaging.

age-related macular degeneration (amd) is the leading cause of legal blindness in the industrialized world beyond 50 years of age. ageing changes of the retinal pigment epithelium (rpe) play a key role in the pathogenesis of the disease. in postmitotic rpe cells autofluorescent lipofuscin granules accumulate with age in the lysosomal compartment mainly as a byproduct of constant phagocytosis of membranous disks shed from photoreceptor outer segments. with the advent of confocal scanning laser ophthalmoscopy fundus autofluorescence mediated by rpe-lipofuscin accumulation can be visualized in vivo: we plan to identify fundus autofluorescence changes as predictive factors for the development of late stage manifestations and their variation over time. furthermore, we plan to determine the effect of increased focal accumulations of autofluorescent material on retinal sensitivity using fundus perimetry. examination of human donor eyes with amd will allow for correlation of fundus autofluorescence alterations in vivo and in vitro. these investigations will be performed not only to better understand the role of lipofuscin accumulation in amd but also to manipulate these mechanisms for both experimental and therapeutic ends.

Eligibility criteria:
inclusion criteria: * must be considered reliable, willing and able to give informed consent. * age \>50 years (male or female) * must have age-related macular degeneration in at least one eye * clear media to allow imaging exclusion criteria: * any history of retinal surgery, including laser treatment, photodynamic therapy, radiation or intravitreal injections * history of retinal vascular occlusions * any concurrent intraocular condition that, in the opinion of the investigator, could exclude the patient from the medical or ethical point of view

Keywords: age-related macular degeneration geographic atrophy drusen
a study of t3011 administered via intratumoral injection in patients with advanced solid tumors

Conditions: Advanced Solid Tumor; Sarcoma; HNSCC; Breast Cancer; Esophagus Cancer; NSCLC; Non-melanoma Skin Cancer

Summary: a phase i/iia study of the safety and tolerability of t3011 administered via intratumoral injection in patients with advanced solid tumors

this is a phase i/iia, open-label, first-in-human study of t3011 given via intratumoral (it) injection in participants with advanced or metastatic solid tumors. part i and part ii of the study is a dose escalation which will use a 3+3 design to evaluate escalating doses of t3011. part i is a single dose escalation. part ii is multiple dose escalation. total enrollment will depend on the toxicities and/or activity observed, with approximately 8-48 evaluable participants enrolled. once the rp2d is established ,part iii will enroll approximately 40-60 participants with sarcoma , approximately 10-25 participants with malignant head and neck tumor,approximately 10-25 participants with breast cancer,approximately 10-25 participants with esophagus cancer,approximately 10-25 participants with lung cancer and approximately 10-25 participants with non-melanoma skin cancer.

Eligibility criteria:
inclusion criteria: * 1. age 18\~70 years part i ; age 18 years or older (part ii and iii ). 2. histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy. 3. measurable disease per recist version 1.1. 4. must have at least 1 tumor lesion that is accessible for it injection of t3011 in the opinion of the investigator. 5. eastern cooperative oncology group (ecog) performance status 0-1. 6. life expectancy \> 12 weeks. 7. women of child-bearing potential (wcbp) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of t3011. 8. wcbp must have a negative serum pregnancy test within 7 days prior to w1d1. 9. capable of understanding and complying with protocol requirements. exclusion criteria: * 1. last dose of previous anticancer therapy \< 4 weeks. 2. prior treatment with another oncolytic virus or gene therapy. 3. previous intolerance to anti-pd-(l)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease. 4. history of seizure disorders within 12 months of screening. 5.history of allergic reactions attributed to compounds of similar biological composition to hsv-1, il-12, or anti-pd-1 monoclonal antibody. 6. requires continued concurrent therapy with any drug active against hsv. 7. pregnant or lactating.

Keywords: oncolytic virus herpes virus
hdct and stem cell transplantation for mantle cell and relapsed low grade non-hodgkin's lymphoma

Conditions: Low Grade Lymphoma

Summary: low grade lymphoma patients receive r-ice reinduction therapy followed by allogeneic stem cell transplanation.

low grade lymphoma patients receive r-ice reinduction therapy followed by allogeneic stem cell transplanation if they have an hla matched sibling, or an autologous transplant if they do not.

Eligibility criteria:
inclusion criteria: * indolent histology lymphomas after relapse 1 or 2 lvef \> 50% creatinine \ 3.5x10\^9/l platelets \>100x10\^9/l other medical condition as controlled exclusion criteria: * pregnant lactating hiv positive cns involvement by lymphoma other malignancy

Keywords: autologous and allogeneic stem cell transplantation low grade lymphoma mantle cell
efficacy of long-term ribavirin in non-responders with chronic hepatitis c and advanced fibrosis

Conditions: Chronic Hepatitis C

Summary: the rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis c infected by genotype 1 with advanced fibrosis (\>f2) is rather low. monotherapy with ribavirin reduces alt levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. portal pressure, as measured by hvpg, lowers in patients with chronic hepatitis c and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. we hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis c patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. the primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis c as assessed by a reduction in hvpg.


Eligibility criteria:
inclusion criteria: * hcv rna in serum * ast/alt greater than the upper limit of normal range * hvpg \>5 mm hg * non-response or contraindication to a standard course of antiviral therapy exclusion criteria: * active alcoholism * hiv infection * serum creatinine \>1.2 mg/dl, hemoglobin \<11 g/dl, hemolysis, symptomatic ischemic heart disease or cerebrovascular disease * decompensated chronic liver disease * pregnancy * hypersensitivity to the drugs of the study * severe concomitant disease
pulse steroid injection in refractory rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis

Summary: remission or low disease activity in active rheumatoid arthritis

assessment of rheumatoid arthritis activity by disease activity score das28, das28 erythrocyte sedimentation rate (esr), american college of rheumatology (acr) 20, acr 50, acr 70 will be done at baseline and every month for 3 consecutive months for both groups.

Eligibility criteria:
inclusion criteria: * refractory rheumatoid arthritis patients exclusion criteria: * other connective tissue diseases * endocrine diseases such as dm and thyroid disorders
comparison of nebulized budesonide and intranasal budesonide spray in children with adenotonsillar hypertrophy

Conditions: Snoring; Mouth Breathing

Summary: budesonide is one of the most common drugs uesd in children with adenotonsillar hypertrophy. this study aim to evaluate the efficacy of a short course of budesonide inhalation suspension via transnasal nebulization in children with adenotonsillar hypertrophy. the second aim is to compare budesonide inhalation suspension with budesonide aqueous nasal spray in adenotonsillar hypertrophy treatment.


Eligibility criteria:
inclusion criteria: * children are ≥3 years and ≤10 years, have habitual mouth breathing or snoring, and without current or previous use of any corticosteroids or leukotriene receptor inhibitors within 4 weeks preceding the initial study. exclusion criteria: * children with craniofacial, neuromuscular, syndromic, or defined genetic abnormalities; acute upper respiratory tract infection; whose symptoms are not caused by adenotonsillar hypertrophy; and who have had adenotonsillectomy in the past.

Keywords: adenotonsillar hypertrophy nebulization intranasal budesonide spray
a clinical comparison of two soft toric contact lenses

Conditions: Astigmatism

Summary: the aim of this study is to compare the short-term clinical performance of two toric contact lenses.

the aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: 1. they are of legal age and capacity to volunteer. 2. they understand their rights as a research subject and are willing and able to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they currently wear soft contact lenses, or have done so within the past two years. 5. they have ocular astigmatism in both eyes of between 0.75dc and 2.00dc. 6. they have a spherical component: plano to -7.00ds (based on ocular refraction). 7. they are expected to be able to be fitted with the study lenses within the power range available. exclusion criteria: 1. they have an ocular disorder, which would normally contra-indicate contact lens wear. 2. they have a systemic disorder, which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they are aphakic. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they are pregnant or breastfeeding. 8. they have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 9. they have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.