Kornimate/medical-research-clean huggingface dataset:
the optimal duration of preoperative anti-tuberculosis treatment of spinal tuberculosis

Conditions: Tuberculosis, Spinal

Summary: the purpose of this study is to determine the better preoperative anti-tuberculosis treatment period of patients with spinal tuberculosis.

quality assurance plan：all the investigators will receive uniform training. standard cases follow-up,collection,management systems will be established.the process of cases follow-up,collection,management will be supervised by the third party.data entry will be in the manner of independent parallel entry.the endpoints events are judged by third party.statistical analysis are implemented by the statistics institutions of the third party.in order to control the bias,this study takes multicenter,random,control study design. sample size assessment:under the condition of multicenter,random,control design, computational formula takes the rate comparisons of two groups.the key endpoints event is soft tissue width of vertebral side measured by computed tomography. the incidence of the key endpoints event in two weeks group is 30%.the incidence of the key endpoints event in four weeks group is 15%.when alpha value is 0.5 and power value is 0.9,the sample size is 161 patients.if loses visit rate is 20%,the sample size is 194 patients. statistical analysis plan:the key events are analyzed by chi-squared test.the statistical significance factors among them are calculated by relative risk. data checks and source data verification are supervised by a third-party organization (contract research organization，cro). standard operating procedures:investigator's brochure has explained in detail about the standard operating procedures of everything.data dictionary can be found in standard operating procedures. plan for missing data: the investigators set a 20% rate of lost to follow-up.

Eligibility criteria:
inclusion criteria: * patients are diagnosed as spinal tuberculosis clinically,and they do not receive antituberculosis therapy or with 2 weeks. * the age is between 15 years old and 75 years old. * patients have good compliance,and have clear surgical indications.4.willing to join the research exclusion criteria: * patients have surgical contraindications. * patients have bad habits:taking drug,drinking.3.patients have mental disease. * patients have bad compliance. * patients have hematogenous disseminated pulmonary tuberculosis, serious central nervous system tuberculosis,and serious extrapulmonary tuberculosis. * patients with drug resistance for antituberculosis drugs,and patient have to change the treat plan,and patients have immunodeficiency diseases. * patients are not diagnosed as spinal tuberculosis clearly. * not willing to join the research

Keywords: tuberculosis spinal general operation drug therapy
study to determine the effects of nebivolol and hydrochlorothiazide in african americans with hypertension

Conditions: Hypertension

Summary: the main purpose of this study is to evaluate the effects of nebivolol and hydrochlorothiazide on blood pressure in african americans with high blood pressure.

many blood pressure medications are not effective in african american men and women. the two lower chambers of the heart contract to pump blood to the body. the lower chambers have to relax so they can refill with blood to pump out again. many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. some patients with the stiffness in the lower chambers of the heart will develop heart failure. the study is to test whether or not nebivolol (bystolic)and a diuretic hydrochlorothiazide (hctz) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.

Eligibility criteria:
inclusion criteria: * known hypertension by history * self-described african american exclusion criteria: * uncontrolled diabetes mellitus (hba1c\>10) * known cad, cerebrovascular disease, pvd or renovascular disease * liver disease * chronic renal disease * uncontrolled hypertension (\>199 systolic and/or \>115)

Keywords: hypertension african americans arterial stiffness vascular resistance
expanded access study of uc-msc in dmd patients

Conditions: Duchenne Muscular Dystrophy

Summary: the primary objective of this study is to provide uc-msc treatment to patients with dmd. secondary objectives will be to further evaluate treatment-related adverse events as well as changes in dmd-related functional testing/assessments, blood laboratories, and inflammation related biomarker levels over time.

the study will enroll ambulatory male participants between the ages of 5 and 10, who will receive four, 3-day intravenous dose cycles of uc-msc treatment, each administered every three months. participants will be closely monitored throughout the study period for treatment-related adverse events and changes in dmd-related functional assessments at specific follow-up intervals through 24 months.

Eligibility criteria:
inclusion criteria: 1. male sex by birth with a genetically confirmed diagnosis of duchenne muscular dystrophy (dmd). 2. age is greater than or equal to 5 and less than or equal to 10 years. 3. has a north star ambulatory assessment (nsaa) score greater than 13 and less than 30. 4. demonstrates the ability to perform the "time to rise" test in under 10 seconds. 5. is up-to-date on immunizations. 6. is on a stable dose of glucocorticoids for at least 12 weeks prior to study participation, except for weight-based or toxicity-related adjustments. 7. is on a stable dose of supplements for at least 12 weeks prior to study participation. 8. has the ability to comply with the requirements of the study and the ability to understand and provide written informed assent and a guardian's consent. 9. patient must be either a non-responder to or a poor candidate for treatment with another established therapy. exclusion criteria: 1. active cancer or prior diagnosis of cancer within the past year (patients with basal and squamous cell cancer of the skin will not be excluded). 2. bmi \> 45 kg/m². 3. any other condition (including concomitant treatment) that, in the judgment of the investigator or sponsor, would be a contraindication to enrollment, study product administration (e.g., known hypersensitivity to dimethyl sulfoxide (dmso), human serum albumin (hsa), or plasmalyte), or follow-up. 4. treatment with an exon skipping therapy within 3 months of study start. 5. cognitive delay or impairment that can confound motor development in the opinion of the investigator. 6. major surgery within 3 months prior to day 0 or planned surgery or procedures that could affect the conduct of the study.
a study of csl362 in patients with cd123+ acute myeloid leukemia currently in remission

Conditions: Leukemia, Myeloid, Acute

Summary: this is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of csl362.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older. * previous diagnosis of cd123+ acute myeloid leukemia (aml), de novo or secondary. * completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (cr)/cr with incomplete platelet recovery (crp); either first or second cr. * has factors conferring high risk of relapse. * no plans for additional post-remission chemotherapy. * not currently a candidate for allogeneic hematopoietic stem cell transplant (hsct). exclusion criteria: * diagnosis of acute promyelocytic leukemia (apl). * known leukemic involvement of the central nervous system. * life expectancy 4 months or less as estimated by the investigator. * concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
non-pharmacological interventions on cognitive functions in older people with mild cognitive impairment

Conditions: Mild Cognitive Impairment; TTM; Physical Activity; Cognitive Rehabilitation

Summary: this project is proposed to be a three-year project. the purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, qol and depression) among community-dwelling elderly adults with mci.

aim. develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, qol and depression) among community-dwelling elderly adults with mci. background. mild cognitive impairment (mci) is a common clinical syndrome that identifies people at high risk of developing dementia, and the prevalence range from 7.7 to 51.7%. although treatments for mci are currently unavailable, preliminary evidence has identified potential neuro-protective effects of exercise program and cognitive rehabilitation, which may lead to improved outcomes. however, the design and delivery of an appropriate program for people with mci is challenging for having physical, psychological, cognitive, and social barriers. design. a prospective randomized control trial. we developed a physical activity stage-matched intervention (smi) (1st year), cognitive rehabilitation (2nd year) and new lifestyle program

Eligibility criteria:
inclusion criteria: * had a subjective memory complaint * mmse score\ 9 years, respectively, yeh et al., 2000), but needed \>13 or objective memory impairment: aq\>5 or at least one item of iadl dependence * able to carry out activities in daily life exclusion criteria: * using walking devices * depression or dementia diagnosis
radiotherapy with or without concurrent chemotherapy for limited lymphatic metastasis of esophageal cancer - 3jecrog p-02

Conditions: Esophageal Neoplasms

Summary: this phase iii trial is designed to explore a higher radiation dose by using imrt simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.


Eligibility criteria:
inclusion criteria: * age\<70 * diagnosis of clinical stage t2-4n0-1m1（according to uicc 2002） * a untreated squamous esophageal carcinoma * karnofsky performance status(kps)≥ 70 and charlson score ≤3 * adequate organ function * no known history of drug allergy * blood routine examination : wbc≥4.0 * hepatic and renal function are normal exclusion criteria: * age≥ 70 or \< 18 * already received the treatment of chemotherapy or radiotherapy * pregnant or lactating females * known drug allergy * without agreement of informed consent form * insufficient hepatorenal function or blood routine examination * severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
a study to evaluate the effect of hepatic impairment on lazertinib (jnj-73841937)

Conditions: Hepatic Impairment; Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.


Eligibility criteria:
inclusion criteria: all participants: * must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on day -1 * willing and able to adhere to the prohibitions and restrictions specified in this protocol * if a woman, must not be of childbearing potential: postmenopausal (amenorrhea for at least 12 months and a serum follicle stimulating hormone within postmenopausal range); or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation procedure) healthy participants with normal hepatic function: * blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmhg) systolic for participants less than or equal to (\ ) 60 years old, inclusive, and no higher than 90 mmhg diastolic. if blood pressure is out of range, up to 2 repeated assessments are permitted per visit * pharmacogenomics: healthy participants must have matching glutathione s-transferase mu 1 (gstm1) genotype (null or non-null gstm1 genotype) to individual hepatic impairment group participants participants with hepatic impairment: * a 12-lead electrocardiogram (ecg) consistent with adequate cardiac conduction and function as per judgement by the investigator, including: a) sinus rhythm; b) heart rate between 50 and 100 beats per minute (extremes included); c) qtc interval \<= 480 milliseconds (ms) (corrected cf. fridericia; qtcf) * concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed. participants must be on a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study exclusion criteria: all participants: * participant has known allergies, hypersensitivity, or intolerance to lazertinib or its excipients * any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, crohn's disease etc.), with the exception of hepatic impairment * active gall bladder or biliary tract disease (example, acute cholecystitis, symptomatic cholelithiasis) * participant tests positive for human immunodeficiency virus (hiv)-1 or hiv-2 at screening * participant has a lack of adequate venous access
study of the concordance of the measurements between the evaluation of the area of a wound by the technique of transparent (gold standard) compared to the evaluation of the area by the algorithm of a decision support system (wound-size)

Conditions: Wound Healing

Summary: the goal of this clinical trial is to compare the evaluation of a wound area and wound tissue content made by different methods on patient population with need for directed wound healing. the main question test of the concordance of the measurements between the evaluation of the area of a wound by the technique of transparent (gold standard) compared to the evaluation of the area by the algorithm of a decision support system (woundsize) patient wounds will be examined: * by eye by the principal investigator * using a ruler by the principal investigator * by woundcare algorithms (aka woundtrack) using smartphone photography by the principal investigator * tracing the outline of the wound using a transparent sheet by the principal investigator * by eye by a second investigator * using a ruler by a second investigator * by woundcare (aka woundtrack) algorithms using smartphone photography by a second investigator. * tracing the outline of the wound using a transparent sheet by the second investigator


Eligibility criteria:
inclusion criteria: * patient suffering from a wound requiring controlled healing ranging from 4 to 150 cm² * age greater than or equal to 18 years old * person affiliated to a social security scheme or beneficiary of such a scheme * person having received complete information on the organization of the research and having signed informed consent. * wound that can be taken in one photo in its entirety. exclusion criteria: * person with a medical condition which, in the judgment of the investigator, is not compatible with participation in the study * wound on a part of the body that would make the person participating in the photos of the wound identifiable (tattoo, piercing, birthmark, etc.). * several wounds are in the photo. * pregnant, parturient or breastfeeding women * person deprived of liberty by a judicial or administrative decision * adult subject to a measure of legal protection (guardianship, curatorship, safeguard of justice) or unable to express their consent, persons subject to psychiatric care.

Keywords: wound healing surface tissue content
clinical and radiological outcomes: two-level cervical prodisc-c vivo versus hybrid construct.

Conditions: Cervical Disc Disease

Summary: the objective of this study is to investigate the clinical and radiological results of two-level cervical prodisc-c vivo versus hybrid construct.

this is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level prodisc-c vivo artificial cervical disc replacement and hybrid construct, i.e., combining acdf (anterior cervical discectomy fusion) and prodisc-c vivo to treat degenerative disc disease (ddd). 542 ddd patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). one group will be treated with two level prodisc-c vivo disc replacement. the other group will be treated with hybrid construct. clinical outcomes and radiological analysis will be done at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Eligibility criteria:
inclusion criteria: * a diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from c-3 to c-7. * the symptom is unresponsive to nonoperative treatment for at least 6 weeks. * the patient demonstrates progressive symptoms calling for immediate surgery. exclusion criteria: * any prior cervical spine surgery.

Keywords: prodisc-c vivo hybrid cervical degenerative disc disease
growth hormone treatment in adult patients with chronic kidney disease

Conditions: Chronic Kidney Disease; End-Stage Renal Disease

Summary: this trial is conducted in asia, europe, and middle east. adult patients with chronic kidney disease are treated with growth hormone to assess effect on nutritional status.


Eligibility criteria:
inclusion criteria: * esrd patients exclusion criteria: * diabetes mellitus * severe and malignant diseases * patients in intensive care units
pirfenidone, an antifibrotic and antiinflammatory drug

Conditions: Fibrosis; Hepatitis C Chronic

Summary: the aim of this study was to assess whether two-year treatment with pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis c.


Eligibility criteria:
inclusion criteria: * patients with established advanced liver disease caused by hepatitis c virus (hcv) chronic infection defined by a positive test for anti-hcv antibodies and detectable serum hcv rna (amplicor hcv 2.0 polymerase chain reaction (pcr) assay). * sign an informed consent form to allow the collection of liver biopsies before and after treatment. * no antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy. * no alcohol intake for at least 6 months before nor during pirfenidone (pfd) treatment. exclusion criteria: * patients with clinical contraindications to hepatic biopsy

Keywords: fibrosis, necroinflammation, hepatitis c chronic
safety trial of naproxen sodium/ diphenhydramine

Conditions: Pain

Summary: the purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (dph) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.


Eligibility criteria:
inclusion criteria: * healthy, ambulatory, male and female volunteers ages 12 and older * history of experiencing occasional sleeplessness accompanied by aches and pains at least two times, but not continually for more than 14 days per month, in at least 2 of the past 3 months * female subjects of childbearing potential must be using a medically acceptable form of birth control, e.g., oral or patch contraceptives, intrauterine device, depo-provera®, for at least 1 month prior to screening (3 months on oral contraceptives), or double-barrier and have a negative pregnancy test at screening. female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy * be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol * provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects \<18 years of age must sign a written assent and have parental or guardian consent). exclusion criteria: * history of hypersensitivity to naproxen sodium, acetaminophen, or any nsaids (nonsteroidal antiinflammatory drugs), diphenhydramine or any other antihistamines, and similar pharmacological agents or components of the product * evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies with the last 5 years * a history of a chronic or severe sleep problem which does not respond to otc (over-the-counter) medication and/or requires a prescription hypnotic or sedative * currently experiencing chronic pain or on chronic nsaid therapy (defined as taking a daily \[5 to 7 days per week\] regimen of prescription or otc nsaids) * current or past history of gastrointestinal ulcers or bleeding or other bleeding disorders * use of any otc or prescription medications with which the administration of naproxen, acetaminophen, or any nsaids, diphenhydramine or any other antihistamines or sedatives, is contraindicated * chronic use of other products containing diphenhydramine, including topical products * use of steroids or blood thinning (anticoagulant) drugs (aspirin 81 mg is permitted if the dose has been taken for at least one month prior to screening)

Keywords: maximum use safety trial
long term safety of naldemedine

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.


Eligibility criteria:
inclusion criteria 1. subjects aged 18 to 80 years inclusive at the time of informed consent 2. subjects must have non-malignant chronic pain treated and must have opioid induced constipation (oic) 3. subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate 4. subjects may or may not be on a routine laxative regimen at the time of screening exclusion criteria 1. evidence of significant structural abnormalities of the gastrointestinal (gi) tract 2. evidence of active medical diseases affecting bowel transit 3. history of pelvic disorders that may be a cause of constipation 4. surgery (except for minor procedures) within 60 days of screening 5. history of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical gi obstruction) 6. subjects who have never taken laxatives for the treatment of oic 7. current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists

Keywords: opioid induced constipation