Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gr2001 in chinese healthy adults

Conditions: Tetanus

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of gr2001 and compare the anti-tetanus neutralizing antibody titers of gr2001 with human tetanus immunoglobulin (htig)in healthy adult subjects.

this is a multicentre, randomized, double-blind, placebo-controlled, phase i/ii study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gr2001 injection in healthy subjects. in the phase i part of the study, a total of 94 healthy subjects will be enrolled. the 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. each participant will receive a single im dose of gr2001 or placebo or htig according to the cohort in which they were enrolled. after injection (day 0), participants will remain in the study site for observation up to day 1. the phase i part will last for 105 days following the assessments of safety, pk, pd and ada. in the phase ii part of the study, a total of 108 healthy subjects will be enrolled. the 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.the phase ii part will last for 105 days following the assessments of safety, pk, pd and ada.

Eligibility criteria:
inclusion criteria: 1. healthy male or female, 18-60 years of age (both inclusive); 2. body mass index within 18.0-27.0 kg/m2 (both inclusive); 3. subjects including partners are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last study drug administration. 4. completed written informed consent process, signed the informed consent forms and agreed to complete all follow-ups. exclusion criteria: 1. history or evidence of severe drug or excipient allergy; 2. history or evidence of tetanus infection; 3. inoculation of tetanus vaccine within 10 years; 4. history or evidence of any other acute or chronic disease； 5. known or suspected history of drug abuse； 6. positive outcome for tetanus-antibody igg test; 7. nursing mothers or pregnant women.
phase ii clinical trial scheme of ganoderma lucidum spore powder for postoperative chemotherapy of osteosarcoma

Conditions: Osteosarcoma

Summary: osteosarcoma is the most common primary highly malignant bone tumor in children and young people. incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patients over 60 years of age. the 5-year survival rate of patients with osteosarcoma is less than 20%. this study aims to improve the prognosis of patients and change the outcome of patients with osteosarcoma.

this project intends to conduct a multicenter, randomized, double-blind, parallel-controlled clinical trial of ganoderma spore powder and doxorubicin combined with cisplatin chemotherapy in the treatment of osteosarcoma patients. the combination therapy of traditional chemotherapeutics has not played a good effect and has large side effects. the ganoderma lucidum spore powder group is a natural botanical drug that has a good anti-tumor auxiliary effect in regulating the tumor immune microenvironment. the investigators' previous research showed that ganoderma lucidum spore powder can inhibit the growth and metastasis of osteosarcoma in the body without obvious toxic and side effects, which indicates that this research scheme has strong feasibility.

Eligibility criteria:
inclusion criteria: - signed informed consent form clinical diagnosis of osteosarcoma must be able to swallow tablets after surgical resection exclusion criteria: - symptomatic central nervous system metastases and/or carcinomatous meningitis known hiv or active hepatitis b/c infection active infection requiring systemic treatment clinically significant cardiac arrhythmias class iii or iv congestive heart failure as defined by the new york heart association functional classification system \< 6 months prior to screening a pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception any condition for which participation would not be in the best interest of the participant patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements patients participating in another clinical investigation at the time of signature of the informed consent

Keywords: ganoderma lucidum osteosarcoma
preventing urinary tract infection post-surgery

Conditions: Urinary Tract Infection

Summary: approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (cauti) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery. cranberry products provide alternative means for preventing cauti and could result in decreased use of antimicrobials. in this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry powder capsules or placebo powder capsules. the low risk of harm associated with using cranberry to reduce uti coupled with its potential benefit makes it a desirable intervention for the prevention of cauti. the conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.

cranberry products prevent bacteria that cause uti, especially escherichia coli, from adhering to bladder cell wall thus preventing infection. adherence of type 1 pili is inhibited by the fructose and of p pili by the proanthocyanidins present in cranberry.

Eligibility criteria:
inclusion criteria: 1. presenting at the gynecology clinic for a pre-operatory visit 2. ability to give informed consent 3. willing to take cranberry capsules for up to 6 weeks 4. 18 of age or older exclusion criteria: 1. pregnancy 2. history of nephrolithiasis 3. history of allergy to cranberry 4. patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery 5. less than 18 years old

Keywords: cystitis pyelonephritis bladder infection kidney infection
contraceptive awareness and reproductive education

Conditions: Pregnancy; Sexually Transmitted Infections

Summary: the long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and sexually transmitted infections (stis) for a highly under-served at-risk youth population.

this trial will evaluate a motivational interviewing (mi) intervention designed to improve contraceptive use and decrease stis for at-risk youth for both those who do and do not want a pregnancy. those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. the investigators will utilize title x programs in rhode island to provide reproductive health services in the community. the investigators will recruit 250 at risk youth from ri juvenile probation department (jpd), ri group homes and alternative schools, job corps of rhode island, and community mental health centers and randomize them to two interventions: two sessions of personalized mi or two sessions of awareness for sexual health (ash), both delivered individually by trained counselors. mi is based on the principles of the transtheoretical model (ttm) and on mi, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ash provides didactic information about contraception, sti prevention and abstinence, and is intended to control for the effects of assessment and attention.

Eligibility criteria:
inclusion criteria: * 1) age 14-21; * 2) currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months; * 3) willing to comply with protocol, follow-up assessments, and provide at least one locator; and * 4) fluent in english. exclusion criteria: * 1) inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling); * 2) girls who are not sexually active; or * 3) currently pregnant.

Keywords: pregnancy sti prevention adolescents probation
paravertebral block vs. suprascapular block for treatment of frozen shoulder

Conditions: Pain, Shoulder

Summary: background: adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder. objectives: the primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. the primary outcome is pain measured through the visual analogue scale (vas) over a follow up period of 6 months. methods: this is a prospective randomized clinical trial that will be conducted between february 2021 and january 2022. patients will be randomly allocated into two groups. group i will receive paravertebral block guided by a nerve stimulator. group ii patients will receive suprascapular nerve block. patients will be followed up at week 1, month 1, month 3 and month 6.


Eligibility criteria:
inclusion criteria: * 18 years and older * presenting with frozen shoulder and were unresponsive to conservative therapy exclusion criteria: * complete rotator cuff tear * osteoarthritis * calcified tendinitis * history of shoulder joint injury * cervical radiculopathy * bleeding disorder * active infection * allergy to bupivacaine * diabetes mellitus
to evaluate the clinical efficacy of iguratimod in the treatment of igg4 related disease (igg4-rd) with mild symptom

Conditions: IgG4-related Disease

Summary: 30 untreated igg4 related disease (igg4-rd) patients with mild symptom are enrolled in this study, and will be treated with one dose of diprospan,then take iguratimod 25mg, bid orally. patient's peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. the clinical efficacy will be evaluated by the igg4-rd responder index, serum immunoglobulin, igg4 and ige, cytokines, and peripheral blood t cell and b cell sub-populations will be measured at baseline and follow up.

glucocorticoid is the recognized first-line medication for igg4-rd, but it has many side effects. in order to avoid long time glucocorticoids intake, patients with mild disease will be treated with iguratimod combined with one dose of diprospan. 30 untreated igg4-rd patients with mild symptom will be enrolled in this study, and be treated with one dose of diprospan,then take iguratimod 25mg, bid orally. 5 ml of patients' peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. at baseline and each follow-up, the clinical efficacy of treatment will be evaluated by igg4-rd responder index, serum immunoglobulin, igg4, immunoglobulin e (ige), serum cytokines, such as interleukin 1, 6, and tumor necrosis factor, will be measured by elisa, peripheral blood t cell sub-populations, b cell sub-populations and plasma cells will be measured by flow-cytometry.

Eligibility criteria:
inclusion criteria: * mikulicz disease, with/without nasosinusitis or lymph node swelling. * without internal organs affected, * with slow disease progression. exclusion criteria: * vital organs related:including autoimmune pancreatitis,retroperitoneal fibrosis, sclerosing cholangitis, lung related, kidney affected, igg4 related castleman's disease and hypophysitis， * combined with other connective disease, * with tumors, * pregnancy or to be pregnant, * active infection, including hepatitis b virus, hepatitis c virus, and tuberculosis. * leucocytopenia, impairment of liver and kidney function, * allergy of iguratimod, or cannot tolerate iguratimod.
hemorrhoidectomy only versus hemorrhoidectomy with lateral internal sphincterotomy

Conditions: Hemorrhoids

Summary: the aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy.

hemorrhoids arise from congestion of anal cushions and characteristically lie in the 3, 7 and 11 o clock positions (with the patient in lithotomy position) . the most common complication of open hemorrhoidectomy is postoperative pain caused by spasm of the internal sphincter . lateral internal sphincterotomy is one good technique. it reduces pain by reducing spasm of internal anal sphincter which is the main cause of pain . the addition of lateral internal sphincterotomy to haemorrhoidectomy resulted in generally lower postoperative anal pressures . the long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after lateral internal sphincterotomy . patients with recurrence of hemorrhoids, severe pain, prolonged constipation, or anyone with high sphincter tonicity in the digital rectal examination would be a candidate for manometric evaluation of anal canal pressure. these patients with high analcanal pressure confirmed with manometry might receive internal sphincterotomy plus hemorrhoid-ectomy .

Eligibility criteria:
inclusion criteria: 1. surgically fit according to asa. 2. cases with hemorrhoids grade ll\& iii \& iv. 3. age between (18-60). exclusion criteria: 1. age less than 18 years old. 2. complete rectal prolapse. 3. grade i hemorrhoids.
probiotic in autism

Conditions: Autism Spectrum Disorder

Summary: one suitable probiotic packet will be administered to one group and placebo to another group of autism children and improvement in cars will be monitored


Eligibility criteria:
inclusion criteria: 1. all children diagnosed with autistic spectrum disorders by dsm 5 criteria 2. aged: 2-18 years. 3. normal hearing (clinically or whenever required by oto-acoustic emission / automated brainstem evoked response audiometry) 4. preferably patients from delhi-ncr or ready to come for follow up - exclusion criteria: * on standard treatment and care for more than 12 weeks 2. received in last 12 weeks or currently on any complementary and/or alternate therapy including dietary therapy 3. associated chronic systemic illness 4. known allergy to any component of probiotic supplement
assessment of safety and efficacy of arthrum 2.5% for treatment of painful osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: arthrum 2.5% mono-injection as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in knee osteoarthritis. the reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the french law of 9 august 2004 relative to public health policy. however, the response to this need is not limited to treatment with health products. this prospective, open, multi-centre trial of the real-life efficacy of arthrum 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from knee osteoarthritis

parameters used to determine treatment outcomes include: western ontario mcmaster universities osteoarthritis index (womac index), evaluation of quality of life and handicap and assessment of therapeutic efficacy

Eligibility criteria:
inclusion criteria: * men or women aged over 40 * suffering from unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage i, ii or iii according to kelgreen (knee in extension) and with minimal pain on walking (womac a1) of two points on the likert scale and functional discomfort for at least three months * patient able to understand the trial procedure and give his/her consent to take part, in writing * patient geographically stable during the trial * patient affiliated to the french social security regime or benefiting from such a french regime. exclusion criteria: * inflammatory arthritis * progressive infectious condition of the knee being studied * previous treatment with viscosupplementation for at least one year * injection of corticoids into the knee studied for less than three months * known hypersensitivity to hyaluronic acid or substances with similar activity * anticoagulant treatment in progress * insulin-dependent / type i diabetes * pregnant or breast-feeding women * patient under guardianship or tutorship or under judicial protection * patient currently taking part in another clinical research study.

Keywords: hyaluronic acid knee osteoarthritis
efficacy and safety study of eligard 22.5mg with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate efficacy and safety of eligard 22.5mg in the treatment of subjects with prostate cancer.


Eligibility criteria:
inclusion criteria: * male of 20 years or above * subject with prostate cancer with tnm stage t2\~4nxmx * blood testosterone concentration ≥ 100ng/dl * bilirubin ≤ 1.5xuln, transaminase ≤ 2.5xuln * who ecog performance status ≤ 2 * signed written informed consent exclusion criteria: * hormone-refractory prostate cancer * brain metastasis * another primary malignant tumor except for prostate cancer * other conditions which in the opinion of the investigator preclude enrollment into the study

Keywords: eligard prostate cancer
improving quality of life for african american female adolescents with lupus

Conditions: Lupus

Summary: this study will evaluate a program designed to help african american adolescents with lupus (systemic lupus erythematosus or sle) cope with the disease.

sle is the most common autoimmune connective tissue disease of childhood, affecting 5,000 to 10,000 children; the prevalence is higher among african american children and approximately 80% of sufferers are female. sle is multisystemic in onset and has no known cure. children with chronic illness have at least a two-fold increased risk for adjustment problems relative to their healthy peers. this risk is heightened among adolescents, who are at greater risk for psychopathology than are younger children. the diagnosis of a chronic medical condition during adolescence presents unique stressors, particularly for adolescents with lupus, who must endure bodily changes, including dermatological problems, hair loss, and changes in appearance due to medical therapies. psychosocial processes, including methods of coping, expectations, and family functioning, are believed to mediate the influence of disease severity. this study will evaluate the effectiveness of a cognitive-based intervention to improve the quality of life of adolescents with sle. participants in this study will be randomly assigned to either the cognitive-based intervention, a lupus education program, or a control group. participants in the intervention group will have five study visits over 5 months. the first three visits are biweekly, 45-minute sessions during which the adolescent will be taught coping skills and cognitive restructuring techniques. the coping skills training will include training in relaxation, distraction, and problem-solving skills. the cognitive restructuring techniques will assist adolescents in using more accurate and adaptive cognitive responses. caregivers will join the adolescent at the end of each training session to gain familiarity with the content reviewed in each session. the remaining two study visits are booster sessions during which the intervention material will be reviewed. participants in the education program will also have five study visits. study visits will include disease-appropriate education materials. caregivers will not be included in the education program. participants will be assessed at study entry and months 6, 9, and 12. assessments will include questionnaires designed to measure disease severity, pain intensity, methods of coping, expectations of efficacy, social support, and adjustment.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle) exclusion criteria: * severe depression with suicidal thoughts * delirium, dementia, or cognitive impairment (e.g., mini mental status examination 24 or less) * severe intellectual impairment * terminal illness with a life expectancy of less than 1 year

Keywords: african american adolescent coping adjustment quality of life
psilocybin - induced neuroplasticity in the treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: the primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. the primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.

in this placebo-controlled, blinded study, individuals with depression will participate in 2 experimental sessions approximately 4 weeks apart during which they will receive two of the following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium dose psilocybin (0.3 mg/kg).

Eligibility criteria:
inclusion criteria: * diagnosed with major depressive disorder (mdd), single or recurrent episode, and currently experiencing a major depressive episode (mde) * failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode * currently engaged in treatment with a mental health clinician exclusion criteria: * axis i psychotic disorder (e.g. schizophrenia, bipolar i, depression with psychosis) * axis i psychotic disorder in first degree relative * currently taking a conventional antidepressant medication * unstable medical or neurological conditions * significant cognitive disorders * history of intolerance to drugs known to significantly alter perception e.g., psilocybin, lsd, salvinorin a, mescaline, etc. * pregnant, breastfeeding, lack of adequate birth control * urine toxicology positive to drugs of abuse on experimental test days

Keywords: psilocybin
a study of neorecormon (epoetin beta) in anemic patients with chronic hepatitis c.

Conditions: Anemia

Summary: this single arm study will assess the safety of neorecormon in the correction of anemia in patients with chronic hepatitis c who are being treated with pegylated interferon + ribavirin combination therapy. patients will receive neorecormon at a starting dose of 30,000 iu s.c. which will be adjusted as required to maintain a target hb of 11-13g/dl. the anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic hepatitis c; * quantifiable serum hcv rna; * pegylated interferon + ribavirin treatment started \<6 months before study; * hb \<10g/dl. exclusion criteria: * treatment with esa during preceding 12 weeks; * poorly controlled hypertension; * history of cancer, except for basal cell cancer and cervical cancer in situ.