Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of s-adenosyl-l-methionine in treatment of alcoholic hepatitis with cholestasis

Conditions: Hepatitis, Alcoholic

Summary: to determine the efficacy and safety s-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.

randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.

Eligibility criteria:
inclusion criteria: * body mass index range 19-30kg/m2 * alcohol drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day; * stb from 2 to 10x uln; * alp\>1.5x uln or ggt\>3x uln exclusion criteria: any one of below, * active virus hepatitis, or anti-hiv(+) * exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( ama/ana\>1:100), wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis * other non-hepatic diseases caused jaundice * primary hepatic carcinoma
peri-implant mucosal changes over time following implant provisional removal in the esthetic zone

Conditions: Tooth Loss; Implant Site Reaction

Summary: the study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. the main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?" the area of the implant crown will be scanned with an intra-oral scanner over a period of 15 minutes.

when an implant crown is removed, the gum in the area, usually supported by the crown, might go through temporary changes once that support is gone. while the change itself may be temporary, some ways to make a final crown that would be esthetically pleasing might require making a copy of the temporary crown or a mold of the gum around the crown. this study will involve the removal of an implant crown at a site where a failing tooth was removed, and a dental implant and a crown was placed into the extraction socket. once the subject enrolls in the study, the area of the implant crown will be scanned right after the removal of the implant crown, and 1, 2, 3, 5, 7, 10, and 15 minutes after the removal of the crown. in order to record the exact location of the implant, a tag will be placed onto the implant and the tag will be scanned as well. the subject's crown will be also scanned so that all the data can be overlaid on top of each other to assess the actual change that occurs. after, the crown will be re-inserted in the patient's mouth so that the gum can rebound back to its original shape. if the patient is able to return in the near future for a new crown, the patient will be asked to make one final scan of the mouth to see if there is any changes in the gums between that of the old and the new crown. this will show if the shape of the crown under the gums might have an effect on how the gums might look. the study will look into whether an immediate change might happen, and how much change actually takes place over the 15 minutes, in whichever direction it might happen.

Eligibility criteria:
inclusion criteria: * patient must have a maxillary anterior immediate implant and provisionalization treatment completed. * the adjacent tooth next to the implant should be a natural tooth * the temporary crown must have been in place for a minimum of 4 months * the patient needs to be of general good health, with no significant medical history or social habits that might directly affect the hard and soft tissue * patient must have generally good oral hygiene without any history of gum disease or gum recession of other teeth around the region of interest exclusion criteria: * patient with an implant crown that has no teeth next to the implant crown * patients who have an active gum disease

Keywords: immediate implant placement provisional impression
pnf strengthening and de-lorme and watkins exercises on upper extremity function and strength in stroke patients

Conditions: Upper Extremity Paresis

Summary: the aim of this study is to evaluate the effects of proprioceptive neuromuscular facilitation strengthening exercises and de-lorme and watkins exercises program in stroke patients with upper limb weakness in chronic stroke patients. the randomized central trial will recruit patients according to consecutive sampling into two intervention groups. one group will receive proprioceptive neuromuscular facilitation strengthening exercises and other group will receive de-lorme and watkins exercises program.

a study in which the participants (n=26) were recruited in the study suffering from stroke and meeting the inclusion criteria. two groups formed such that patients in group a will be treated with conventional therapy and pnf and group b will be treated with pnf and nmes in along with conventional therapy. the protocol will cover 6 weeks of treatment. regular assessment at 0,3rd and 6th week will be carried out. in the rehabilitation period, we will evaluate upper extremity function, activities of daily living(adls), mental status examination at regular interval during the rehabilitation.in previous studies there is less literature regarding the combine effects of proprioceptive neuromuscular facilitation techniques and de-lorme and watkins exercise program on upper limb function and strength in chronic stroke patients with upper limb weakness. therefore there is dire need to explore which training technique is most effective in improving upper limb function and strength in chronic stroke patients therefore this study aims in comparative effects of proprioceptive neuromuscular facilitation strengthening exercises and de-lorme and watkins exercise program on upper limb function and strength in chronic stroke patients.

Eligibility criteria:
inclusion criteria: * chronic stroke patients. * medically stable patients having a single stroke. * history of stroke 6 to 24 months. * a score greater than 24-30 in mini-mental test. * patients having consciousness with gc;10 exclusion criteria: * recurrent stroke * patients with gullian berrie syndrome, multiple sclerosis lesion osteoarthritis of shoulder. * manual muscle testing below grade ii.

Keywords: proprioceptive neuromuscular facilitation
to compare the pharmacokinetics and pharmacodynamics of hr20014, ins068 and ins062 after single subcutaneous injection in healthy subjects

Conditions: Diabetes

Summary: this is a single-center, randomized, open, six-sequence, three-period crossover phase i clinical trial in healthy subjects to compare the pk/pd and safety profiles of single dose of hr20014, ins068, and ins062. in this study, 12 subjects were randomly assigned to 6 administration sequences in a ratio of 1:1:1:1:1:1, and hr20014, ins068 or ins062 injection were given subcutaneously three times before and after each sequence.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent; 2. male or female aged 18-45 at screening (both inclusive); 3. subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator; 4. male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (bmi) in 18.0\~26.0 kg/m2 (both inclusive); 5. during the screening phase oral glucose tolerance test (ogtt), intravenous fasting plasma glucose ≥3.9 mmol/l and \< 6.1 mmol/l; glucose 2 hours after negative charge static pulse blood sugar \<7.8mmol/l； and normal or abnormal insulin levels have no clinical significance. exclusion criteria: 1. a history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug; 2. have a history of hypertension; 3. severe systemic infectious diseases within 1 month before screening; 4. patients with a history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis; 5. patients with serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past, or existing diseases of the above systems, were judged by the researchers to be unfit to participate in this study; 6. use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening; 7. presence of any abnormal and clinically significant laboratory tests. 8. ecg (12-lead electrocardiogram) showed abnormal and clinically significant. 9. those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (the elder shall prevail), who participated in clinical trials are defined as random, prior to screening. 10. blood donation within 1 month before screening; or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 ml in the 3 months prior to screening. 11. women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (wocbp) are reluctant to use appropriate contraception during the trial. 12. the investigators determined that other conditions were inappropriate for participation in this clinical trial.
ace inhibitors or arbs discontinuation in context of covid-19 pandemic

Conditions: History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection

Summary: since december 2019, a novel coronavirus called sars-cov-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as covid-19. individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death. because of the potential interaction between ras blockers and sars-cov-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with covid-19. it is crucial to determine whether ras blockers should be discontinued or not in patients with covid-19.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * chronically treated with ras blockers (ace inhibitors or arbs on the last prescription prior to admission with a treatment duration ≥ 1 month). * diagnosis of covid-19 confirmed by the presence of sars-cov-2 on any biological sample with any detection method. * patients hospitalized in a non-intensive care unit. * pregnancy test at inclusion visit for women of childbearing potential. * women of childbearing potential must agree to use adequate contraception according to recommendations related to contraception and pregnancy testing in clinical trials, by clinical trial facilitation group (ctfg). exclusion criteria: * shock requiring vasoactive agents. * acute respiratory distress syndrome requiring invasive mechanical ventilation. * circulatory assistance. * history of malignant hypertension according to the definition of the 2018 esc/esh guidelines on hypertension. * uncontrolled blood pressure despite the use of five antihypertensive drugs. * history of nephrotic syndrome. * history of hospitalization for hemorrhagic stroke in the past 3 months. * ras blockers therapy previously stopped \> 48h. * no affiliation to the french health care system "sécurité sociale". * inability to obtain informed consent.

Keywords: sars-cov-2 cardiovascular disease ras blockers
effects of spironolactone on matrix metalloproteinases (mmps) in heart failure

Conditions: Chronic Stable Heart Failure

Summary: the purpose of this study is to evaluate the effects of spironolactone on circulating mmp levels and insulin resistance in patients with chronic heart failure.

myocardial fibrosis is observed in failing hearts. mmps are considered markers of fibrosis. recently, circulating mmps can be measured and are elevated in patients with chronic heart failure (chf). it has been reported that spironolactone improves myocardial fibrosis in chf animal models. therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating mmp levels in patients with chronic heart failure.

Eligibility criteria:
inclusion criteria: * chronic stable heart failure

Keywords: heart failure fibrosis mmp spironolactone furosemide
effectiveness of the step up wellness program for people with depression

Conditions: Depression

Summary: this randomized pilot study will evaluate the feasibility and acceptability of a phone-based wellness program for improving mood, physical activity, and smoking abstinence rates among people with depression who also are physically inactive and smoke cigarettes.

this pilot study will evaluate the feasibility, acceptability, and potential effectiveness of the step up wellness program among people with depression who also are physically inactive and smoke cigarettes. participation in this study will last 6 months. all participants will complete a baseline survey and then be assigned randomly to receive the step up wellness program or usual care for 3 months. participants in the step up program will receive weekly phone calls from a study health coach. during these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking. participants will also be given materials to review and homework assignments between calls. participants in the usual care group will receive standard care which includes referrals for treatment of depression and nicotine dependence, as well as self-help information on physical activity. all participants will be surveyed at 4 and 6 months post-enrollment. participants will also provide qualitative feedback on the program.

Eligibility criteria:
inclusion criteria: * member of group health insurance plan * aged 18 to 75 * experiencing at least moderate depressive symptoms * low physical activity defined as failure to meet centers for disease control (cdc) guidelines for weekly activity or low to moderate physical activity as assessed by international physical activity questionnaire (ipaq) * current smoker * has a phone * able to read and speak in english * no mobility or physical impairments that would prevent engaging in moderate physical activity * without a hearing impairment that would prevent participation with the phone-based counseling or assessments exclusion criteria: * self-report of bipolar disorder or schizophrenia * currently receiving specialty mental health care or smoking cessation treatment * if on an antidepressant, has been taking it less than 30 days

Keywords: depression smoking physical activity
exploring the value of 18f-alf-fapi pet/ct in assessing the activity of thyroid eye disease

Conditions: Thyroid Eye Disease

Summary: fapi pet has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. this prospective study aims to explore the value of 18f-alf-fapi pet/ct in assessing the activity of thyroid eye disease (ted) and investigate whether fapi pet/ct may be superior to 99mtc-dtpa spect/ct for the diagnosis, therapy response assessment, and follow-up of ted.

subjects with ted underwent 18f-alf-fapi pet/ct and 99mtc-dtpa spect/ct for activity assessment within a 10-day period. on 18f-alf-fapi pet/ct, uptake in the extraocular muscles was quantified using suv metrics and target-to-background ratio. on 99mtc-dtpa spect/ct, uptake in the extraocular muscles was semi-quantified using the uptake ratio. activity of ted was determined through comprehensive clinical data. the correlation between suv metrics and activity status was calculated to explore the value of 18f-alf-fapi pet/ct in assessing ted activity. the diagnostic accuracy of 18f-alf-fapi pet/ct and 99mtc-dtpa spect/ct in assessing ted activity was compared. additionally, the correlation of changes in suv metrics and therapy response will be calculated to explore the value of 18f-alf-fapi pet/ct in therapy response assessment of ted.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. patients diagnosed with ted; 3. complete understanding and voluntary participation in this study, with the signing of an informed consent form. exclusion criteria: 1. severe liver or kidney dysfunction; 2. inability to maintain a supine position for 5 minutes to cooperate with the examination; 3. suffering from claustrophobia or other psychiatric disorders; 4. patients planning pregnancy or in the prenatal or lactation period; 5. other conditions deemed unsuitable for participation in the trial by the investigator.
jab-21822 in combination with cetuximab in patients with advanced crc and other solid tumors with kras g12c mutation

Conditions: Advanced Colorectal Cancer; Small Intestinal Cancer; Appendiceal Cancer

Summary: this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of jab-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with kras p.g12c mutation.

the primary objective of this study is to evaluate the safety and tolerability of jab-21822 in combination with cetuximab to determine the mtd and rp2d during dose escalation phase; then to evaluate preliminary antitumor activity when jab-21822 is administered in combination with cetuximab during dose expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with kras p.g12c mutation.

Eligibility criteria:
inclusion criteria: * participants must be able to provide an archived tumor sample * histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with kras p.g12c mutation * must have received at least 1 prior standard therapy * must have at least 1 measurable lesion per recist v1.1 * must have adequate organ function * must be able to swallow and retain orally administered medication exclusion criteria: * has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days * active infection requiring systemic treatment within 14 days * active hiv, hbv or hcv * any severe and/or uncontrolled medical conditions * lvef\<50% assessed by echo * qt interval \>470 msec
a study with an open-label extension phase to evaluate the efficacy and safety of perampanel (e2007) administered as an adjunctive therapy in subjects with refractory partial-onset seizures

Conditions: Partial-onset Seizures

Summary: the purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures


Eligibility criteria:
inclusion criteria 1. male or female and greater than or equal to 12 years of age; 2. have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures 3. participants with computed tomography (ct) or magnetic resonance imaging (mri) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (cns) disorders, example, neurodegenerative disorders, brain tumors. for participants without existing ct or mri results, ct or mri was performed at or after visit 1 but results evaluation was performed by visit 2 4. participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (aed) for 2 years before enrollment 5. during the 6-week prerandomization phase participants must have had greater than or equal to 5 partial seizures per 6-week 6. are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved aeds. only 1 inducer aed (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 aeds is allowed exclusion criteria 1. presence of nonmotor simple partial seizures only; 2. presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies; 3. presence or previous history of lennox-gastaut syndrome; 4. a history of status epilepticus within 1 year prior to screening 5. seizure clusters where individual seizures cannot be counted 6. a history of psychogenic seizures within 5 years prior to screening

Keywords: partial-onset seizures partial seizures seizure epilepsy
understanding treatment adherence among individuals with bipolar disorder

Conditions: Bipolar Disorder

Summary: this study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.

bipolar disorder (bpd), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. an individual with bpd may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. the manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. bpd is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. many bpd medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. research has shown that the way individuals experience illness has an effect on their response to medication. the purpose of this study is to gain insight into how individuals with bpd perceive and respond to medication treatment. factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence. this 6-month study will consist of 3 interviews. each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. the questionnaires will assess participants' attitudes toward bpd treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of bipolar disorder type i for at least two years prior to study entry * has experienced an index depressive episode * received treatment with medication to stabilize mood for at least 6 months prior to study entry * able to participate in psychiatric interviews * lives in the northeast ohio area and is a patient at either northeast ohio health services or the mood disorders clinic at university hospitals of cleveland exclusion criteria: * unable/unwilling to participate in psychiatric interviews

Keywords: depression, bipolar manic-depressive psychosis