Kornimate/medical-research-clean huggingface dataset:
attention deficit hyperactivity disorder (adhd) in adolescents with substance use disorders (sud)

Conditions: ADHD; Substance Abuse

Summary: the purpose of this study is to determine the efficacy of osmotic-release methylphenidate (oros-mph) versus placebo for the treatment of adhd in adolescents with sud.

research shows a high prevalence of attention deficit hyperactivity disorder (adhd) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. although research indicates that the majority are not treated for adhd while in substance treatment, we do not know whether concurrent pharmacotherapy for adhd will improve treatment outcomes. this clinical trials network (ctn) study will evaluate the efficacy of osmotic-release methylphenidate (oros-mph), relative to placebo, in treating adhd and decreasing substance use in adolescents (13-18 years old) with adhd and a substance use disorder. approximately 300 participants will be recruited at 11 sites and randomly assigned to either oros-mph or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.

Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual for mental disorders, 4th edition (dsm-iv) diagnostic criteria for adhd * meet dsm-iv diagnostic criteria for at least one non-nicotine substance use disorder * has a dsm-iv adhd symptom checklist score ≥ 22 derived from the adolescent-completed checklist exclusion criteria: * serious medical illness * history of tic disorder * pregnant or breastfeeding * meet dsm-iv criteria for current or life-time psychotic disorder * meet dsm-iv criteria for current or life-time bipolar disorder * requires/or prescribed other concurrent psychotropic medication * taking any medications that may produce interactions with oros-mph * opiate dependence * methamphetamine abuse or dependence * suicidal risk * enrolled in an inpatient, residential, day treatment, or outpatient substance abuse program within 28 days prior to signing consent
dietary intervention study for hypertension (dish)

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: the primary objective of this multicenter cooperative clinical trial was to determine if dietary modification would enable drug controlled hypertensive patients to remain at 'goal blood pressures' after antihypertensive medication was withdrawn. the proposal made use of the hdfp hypertensive population who had five years of treatment for their hypertension. additionally, the group of investigators proposed to determine if dietary treatment would permit patients not previously adequately controlled under the hdfp program to achieve normalization of blood pressure with a combination of dietary modification and drug treatment. the study also proposed to search for predictors (i.e., levels of hormonal agents such as plasma renin activity) of responsiveness to dietary manipulation among the hypertensive population as well as to identify psychological attributes that might be of importance in managing these patients.

background: the background against which the proposal was made had been developed from the combined information of the veterans administration cooperative study and the hypertension detection and follow-up study. data from both these studies clearly established the importance of reducing sodium content by means of diuretic administration as a mainstay of the treatment of elevated blood pressure. the risks of the lifetime of treatment were undefined, but the cost of indefinite treatment of high blood pressure was sufficiently high to stimulate careful examination of alternative modes of management of such patients. the demonstrations by parijs and others that moderate reduction in sodium intake led to improved management of hypertension and data suggesting that increased potassium intake may enhance this blood pressure lowering effect associated with sodium restriction was cited by the investigators as a basis for the trial. any additional data regarding modest sodium restriction and potassium ingestion would have impact on utilizing such therapy in preventing hypertension and as adjunctive therapy. design narrative: the study was intended to take advantage of the availability of patients at the three centers at the completion of the hypertension detection and follow-up program study. these patients were enrolled as 'stepped-care' participants and had been treated with antihypertensive drugs for at least five years. the main objective of the study was to determine the contribution of dietary modification to maintenance of normal blood pressure after withdrawal of medication. two types of diet change were followed: 1) reduction of sodium intake coupled with increased potassium intake; and 2) reduction of weight in the subgroups of patients that were obese.

Eligibility criteria:
men and women with hypertension. diastolic blood pressure equal to or above 95 mm hg and 90 mm hg, respectively for home and clinic readings.
transition in transgender

Conditions: Gender Dysphoria

Summary: the aim of this longitudinal, observational study is to investigate the effects of gender-affirming hormone treatment in ftm (female to male) and mtf (male to female) transgender (tg) people with regard to changes in brain structure and function as well as psychological and behavioral consequences. methodological problems and missing studies in this area were mentioned several times with an emphasis on the need for longitudinal research.

transgender (tg) is still a polarizing issue today. the lack of acceptance in society and often even in one's own family, the feeling of a lack of identity and connection with one's own body and the experienced discrimination all lead to a considerable degree of suffering in tg and elevated levels of psychiatric symptoms as well as a reduced quality of life. many tg people seek hormonal treatment. physical and psychological consequences of this treatment still need to be revealed. to this aim, the investigators recruit tg people (mtf and ftm) who intend to seek gender-affirming hormonal treatment. before treatment, various measures will be taken, including a semi-structured interview to assess psychiatric symptoms, self-ratings, behavioral experiments (to assess male/female face recognition and male/female voice perception), while functional mri scans are taken to assess respective neural correlates. in addition, resting-state scans as well as anatomic images will be taken. six months after having started gender-affirming hormone treatment, participants will be reinvited to undergo the same study protocol. in between testing sessions, patients will perform several online surveys regarding their psychological well-being.

Eligibility criteria:
inclusion criteria: 1. a diagnosed gender dysphoria (dsm 5) or gender incongruence (icd-11) 2. the pursuit of hormone therapy 3. native german speakers 4. age: 18-55 5. written informed consent following oral and written information 6. persons who are legally competent and mentally able to follow the instructions of the staff exclusion criteria: 1. drug abuse/addiction 2. first-degree relatives with psychotic disorders 3. pregnant or breastfeeding 4. traumatic brain injuries 5. neurological diseases 6. known internal, e.g. metabolic, endocrine or cardiac disorders 7. magnetic metal implants 8. hearing disorders, voice disorders and pronounced hoarseness 9. shift workers or irregular day-night rhythm 10. persons placed in an institution by order of the authorities or courts 11. persons who are in a dependent or employment relationship with the auditor 12. simultaneous participation in a clinical trial 13. hormone treatment already started

Keywords: transgender female to male male to female hormone treatment gender reassignment
a novel treatment for metastatic melanoma

Conditions: Metastatic Melanoma

Summary: a novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.

a novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser.

Eligibility criteria:
inclusion criteria: 1. age 18 and older 2. subjects must have stage iii or iv melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site. 3. subjects must have measurable disease. see section 10.2 for the evaluation of measurable disease (recist). 4. eastern cooperative oncology group (ecog) performance status 0-2 5. required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment): platelet count \> 40,000 per mm3 absolute neutrophil count (anc) \> 1,500 per mm3 exclusion criteria: 1. life expectancy, in the opinion of the investigator of less than 4 months 2. known allergy to any drugs used in treatment 3. immunosuppression, including hiv positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment 4. chemotherapy/immunotherapy within 4 weeks of initiation 5. local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation 6. radiation therapy at the treatment site within 4 weeks of initiation 7. uncontrolled brain metastases 8. history of cutaneous photosensitization or photodermatoses 9. non-treated, active cancers other than melanoma and non-melanoma skin cancers. 10. active infectious disease requiring antibiotic therapy 11. unstable medical illness 12. past or present major psychiatric illness 13. pregnant or lactating women 14. end stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance \<50cc/min 15. acute hepatitis (any cause)

Keywords: metastatic melanoma
a phase ib/ii study of ak112 in combination with ak117 in advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: phase ib/ii open label, multicenter study to evaluate the efficacy and safety of ak112 (anti-pd-1 and vegf bispecific antibody) combined with ak117#anticd47 antibody# in advanced malignant tumors


Eligibility criteria:
inclusion criteria: 1. 18 to 75 years old. 2. have a life expectancy of at least 3 months. 3. have an eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. phase ib: histologically or cytologically confirmed selected advanced solid tumor. 5. phase ii: cohort 1 and 2 : a. has histologically confirmed recurrent or metastatic hnscc who had failed only first-line platinum-containing therapy. b. has histologically confirmed recurrent or metastatic hnscc with pd-l1 positive (cps≥1) without prior systemic antitumor therapy. cohort 3: has histologically confirmed recurrent or metastatic hnscc without prior systemic antitumor therapy. 6. have at least one measurable lesion based on response evaluation criteria in solid tumors (recist) 1.1 assessed by investigator. 7. has adequate organ function. exclusion criteria: 1. undergone major surgery within 30 days prior to the first dose of study treatment. 2. active central nervous system (cns) metastases. 3. history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. active hepatitis b or hepatitis c. 5. received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. history of severe bleeding tendency or coagulation disorder.
evaluation of an oligonucleotide array for rapid identification of dermatophytes in clinical specimens

Conditions: Tinea Unguium; Onychomycosis

Summary: the nail specimens from patients with suspect onychomycosis were analyzed. samples were collected as part of standard patient care from the department of dermatology, national cheng kung university hospital (nckuh, a tertiary referral hospital), tainan, taiwan. comparing the array results with the regular methods by sensitivity, specificity, npv and ppv.

the nail specimens from patients with suspect onychomycosis were analyzed. collection: samples were collected as part of standard patient care from the department of dermatology, national cheng kung university hospital (nckuh, a tertiary referral hospital), tainan, taiwan. nail samples were collected as subungual scrapings, clippings, or curettings. samples were immediately transported in sterile eppendorf tubes at room temperature to the laboratory of department of dermatology, nckuh, for koh stain and routine fungal cultures. sample prepare: each sample was cut into small pieces with a surgical blade and homogenization by 2-ml glass homogenizer. the suspension treated by lyticase at 37°c for 30 min and extracted dna with blood \& tissue genomic dna kit.pcr program and array hybirdization same with previous study. analysis: if the results between array and culture method, discrepant analysis with re-sequencing, koh mount and the patient's outcome of after antifungal treatment. the performance evaluation of the array and culture methods with sensitivity, specificity, positive (ppv) and negative predictive value (npv) were calculated after discrepant analysis. significant difference was estimated by fisher's exact test.

Eligibility criteria:
inclusion criteria: * atypically results by culture and microscopy * suspect tinea infection exclusion criteria: * lost follow * not tinea unguium
chinese registry study on treatment of cholecysto-choledocholithiasis

Conditions: Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis

Summary: patients with gallstone and confirmed common bile duct stones are registered in this study. the three managements for common bile duct stones are endoscopic sphincterotomy (est), laparoscopic common bile duct exploration (lcbde) and laparoscopic transcystic common bile duct exploration (ltcbde). patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. all patients were followed up for 3 years by telephone interview ang outpatient visits. abdominal us and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. if there were unusual findings, magnetic resonance cholangiopancreatography(mrcp) was carried out.


Eligibility criteria:
inclusion criteria: * patients with age between 18 - 80 years. * patients diagnosed with gallstones. * patients diagnosed with common bile duct stone by one of the three exam (mri、mrcp and ct). * patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration. * patients accepted one of the three managements (est+lc, lcbde and ltcbde). exclusion criteria: * combined with mirizzi syndrome and intrahepatic bile duct stones * previous est/endoscopic retrograde cholangiopancreatography (ercp) or percutaneous transhepatic biliary drainage (ptbd) * history of upper abdominal surgery. * serious heart,brain,lung, metabolic diseases history. * pregnant women * unwillingness or inability to consent for the study.

Keywords: laparoscopic transcystic common bile duct exploration laparoscopic common bile duct exploration endoscopic sphincterotomy, cost-effective analysis
detailed evaluation of microchimerism

Conditions: Chimerism; Blood Transfusion; Wounds and Injuries; Hematopoiesis

Summary: individuals who experience traumatic injury often require blood transfusion. in some individuals who receive blood after an injury, white blood cells from a person who donated blood may remain in the body for years, a condition known as microchimerism. this study is designed to examine a group of people who are known to have long-term microchimerism and, through analysis of their blood, determine whether there is evidence that the microchimerism involves blood stem cells that can become any type of blood cell (red blood cells, white blood cells, or platelets) and that might be a permanent part of the body.

transfusion-associated microchimerism, the persistence of donor white blood cells months or years after transfusion in the recipient, has been observed in approximately 10-15% of transfused trauma patients. previous studies suggest that the microchimeric cells include multiple immunophenotypes of leukocytes (cd4+, cd8+, cd15+, and cd19+) and that they can persist for decades, features suggestive of hematopoietic engraftment. in this study, ten subjects known to have long-term microchimerism will undergo either leukapheresis (a blood filtering procedure) or collection of a 500 ml whole blood sample (the amount of a standard blood donation). these samples will then be analyzed to determine whether the microchimeric (donor) cells include hematopoietic stem cells (cd34+) and precursor cells in the red blood cell, white blood cell, and platelet lineages.

Eligibility criteria:
inclusion criteria: * demonstrated long-term microchimerism following transfusion for traumatic injury exclusion criteria: * prior bone marrow or solid organ transplantation * pregnancy * blood transfusion within the past 12 months

Keywords: transfusion-associated microchimerism injuries leukocytes
study of embeda (kadian nt, alo-01) in subjects with chronic moderate to severe nonmalignant pain

Conditions: Pain

Summary: open-label, safety study to evaluate the long-term safety of kadian nt (alo-01) administered for up to 12 months.


Eligibility criteria:
inclusion criteria: * subject 18-70 years of age * subject agrees to refrain from taking any opioid medications other than study medication during study period. * history of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline exclusion criteria: * subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated. * subject is pregnant or breast-feeding. * subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin). * subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the baseline visit. * subject has a body mass index (bmi)\>45kg/m2.

Keywords: chronic pain joint pain back pain diabetic peripheral neuropathy post herpetic neuralgia alo-01 embeda chronic non-malignant pain
a phase i/ii study with bm7pe immunotoxin in colorectal cancer patients

Conditions: Colorectal Cancer Metastatic

Summary: this phase 1/2 study will evaluate the safety, tolerance and dose of bm7pe treating patients with colorectal cancer who have progressed to standard cell therapy or cannot tolerate such therapy. the study starts as a phase 1 study with the aim of assessing the final dose for this group of patients. based on the results, the study will continue into a phase 2. the phase 2 study aim to examine overall survival ≥ 9.3 months.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma of colon or rectum * ambulatory with an ecog performance status 0-1 * at least 18 years of age * progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy * laboratory values as the following: anc, platelets, hb, creatinine, bilirubin, asat, alat, albumin levels, inr * signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ich gcp, and national/local regulations exclusion criteria: * history of prior metastatic disease the last 3 years * history of cns or bone metastases * significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia * chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment * alcohol or drug abuse * any reason why, in the opinion of the investigator, the patient should not participate * has a known history of human immunodeficiency virus (hiv) * has known active hepatitis b (e.g., hbsag reactive) or hepatitis c (e.g., hcv rna \[qualitative\] is detected) * is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Keywords: intolerance last line standard chemotherapy
a dose-response study of dietary resveratrol on lipid metabolism disorder

Conditions: Dyslipidemias

Summary: in order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized intervention trials were conducted to compare the effects of resveratrol on the improvement of lipid and uric acid metabolism in different dose groups. to explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

in order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized controlled trials were conducted to enrolled 160 patients with dyslipidemia. the subjects were divided into 0 mg / d, 100 mg / d, 300 mg / d, 600 mg/ d four dose groups, intervention for 8 weeks, comparing different doses of resveratrol on lipid and uric acid metabolism. to explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

Eligibility criteria:
inclusion criteria: * dyslipidemia * the age between 35 and 70 years old exclusion criteria: * intake of any medicine that affect lipid metabolism currently or in the preceding 6 months * dietary supplementation with phytochemicals including resveratrol in the preceding 3 months * history of acute or chronic infectious disease, autoimmune disease, cancer, traumatic injury, or surgery in the preceding 1 month * history of severe chronic disease including as and cvd, liver or renal dysfunction, and lactation or pregnancy * pregnant woman and breast feeding women
nlrp3 inflammasome activation among patients during acute gout flares

Conditions: Gout Arthritis

Summary: gout is a chronic joint disease associated with deposition of monosodium urate crystals, as a consequence of hyperuricemia. gout is an intermittent flaring condition and acute gout flares are driven by nlrp3 inflammasome and il1-beta production. however pathogenesis of acute gout flares remains poorly known in vivo in human. the aim of this study is to evaluate nlrp3 inflammasome activation in vivo in patients cells during acute gout flares.

blood and synovial fluid will be obtained from remainder of patients' samples during an acute gout flares. white blood cells will be isolated and nlrp3 inflammasome activation will be assessed. then, nlrp3 inflammasome inhibitors will be tested on cells with nlrp3 inflammasome activity.

Eligibility criteria:
inclusion criteria: * hospitalization for acute gout flare confirmed by joint fluid analysis or nijmegen score \> 8 * aged \> 18 exclusion criteria: * gout treatment already started * inflammatory arthritis other than gout arthritis * pregnant or breast feeding women * patient protected by law