Kornimate/medical-research-clean huggingface dataset:
vhag in treating r/r t-all/lbl

Conditions: Acute T Lymphpblastic Leukemia/Lymphoma

Summary: acute t cell lymphoblastic leukemia/lymphoma (t-all/lbl) is an aggressive type of leukemia that results from the malignant evolution of t-lineage progenitor cells at different differentiation stages. after induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative mrd. this is also an important factor for the recurrence of all patients. in addition, most relapsed t-all/lbl patients relapse during first-line treatment. once the disease relapses, it is difficult to cure for most young and adult patients, and the overall survival rate of patients is less than 10%.

this is a prospective, single-arm, phase ii and open-label study. a total of 50 r/r t-all/lbl participants will be enrolled. the primary endpoint is complete remission with or without peripheral blood cell recovery. the induction therapy is a combination of venetoclax(ven), homoharringtonine(hht) , cytarabine and g-csf. the purpose of this study is to explore efficacy of the vhag in the treatment of r/r t-all/lbl patients.

Eligibility criteria:
inclusion criteria: * 1. before enrollment, a diagnosis of newly diagnosed t-cell acute leukemia/lymphoma.the diagnostic criteria refer to the 2022 who classification; 2. age ≥ 14 years,\<75 years; 3. clincally diagnosed as relapsed or refractory t-all/lbl; 4. eastern cooperative oncology group (ecog) performance status score of 0-2; 5. expected survival time ≥ 2 months; 6. no organ dysfunction that would restrict the use of this protocol during the screening period; 7. understand the study and sign the informed consent form. exclusion criteria: * 1. patients with known central nervous system (cns) involvement of t-all/lbl; 2. diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, copd, bronchiectasis, etc.) 3. cardiac ultrasound lvef \ 1.5 uln (upper limit of normal); alt or ast \> 2.5 uln; serum creatinine \> 1.5 uln; 6. known hiv infection; 7. conditions affecting the use of the study drug as assessed by the investigator; 8. inability to understand or comply with the study protocol.

Keywords: acute lymphoblastic leukemia chemotherapy relapse refractory
treatment strategies for unruptured intracranial aneurysms in the chinese population china treatment trial for unruptured intracranial aneurysm (chtuia)

Conditions: Unruptured Intracranial Aneurysm

Summary: the goal of this prospective observational cohort study is to learn about treatment strategies for unruptured intracranial aneurysms in the chinese population. the main questions it aims to answer are: * to establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy. * to establish clinical management path for patients with unruptured intracranial aneurysm. according to the treatment of all patients with unruptured intracranial aneurysm, they were divided into the following groups: 1. conservative treatment group; 2. intracranial aneurysm clipping group; 3. coil embolization or stent-assisted coil embolization group; 4. flow diversion group.


Eligibility criteria:
inclusion criteria: a. age \> 18 years. b. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery. c. patients' consent were obtained. exclusion criteria: 1. ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ; 2. traumatic, infectious and atrial myxoma-associated intracranial aneurysms ; 3. combined with cerebrovascular malformations; 4. combined with brain tumors or malignant tumors in other parts ; 5. combined with systemic connective tissue disease and systemic rheumatic disease ; 6. due to other diseases, or poor general condition, the expected survival time is not more than 12 months ; 7. during pregnancy and perinatal period.
safety, tolerability, pharmacokinetics and pharmacodynamics of liraglutide in healthy japanese volunteers

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to assess the safety and tolerability of nnc 90-1170 (liraglutide) in healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18 and 27 kg/m\^2, inclusive exclusion criteria: * clinically relevant abnormalities of physical examination, laboratory values, vital signs or ecg findings at the screening, as judged by the investigator or sub-investigator * presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the investigator * blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmhg systolic or 40-90 mmhg diastolic * heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min * alcohol intake within 48 hours prior to the screening * hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive * clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the investigator * history of significant allergy or hypersensitivity * known or suspected allergy to trial product or related products * history of drug or alcohol abuse * smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
efficacy of collagen sponge on palatal wound healing

Conditions: Gingival Recession; Inadequately Attached Gingiva

Summary: the aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.

the aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting. the included patients will be randomized into two groups. the patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. the postoperative pain will be assessed by vas scale at day 1, 3 and 7 after surgery. epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. at 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects 3. full-mouth plaque score and full-mouth bleeding score lower than 20% exclusion criteria: 1. smoking 2. pregnancy or lactation 3. untreated periodontal disease 4. severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.) 5. presence of coagulation disorders (history of haemophilia, von wille-brand disease, or anticoagulant therapy) 6. taking medications affecting periodontal health or healing 7. previous surgery for a palate graft harvested from the experimental sites
comparison of effectiveness of pre-cooling with ethyl chloride versus honey

Conditions: Irreversible Pulpitis

Summary: comparing pre-cooling with ethyl chloride versus honey in alleviating intra-oral injection pain in adult patients


Eligibility criteria:
inclusion criteria: * no medical history * patients suffering from symptomatic irreversible pulpitis requiring buccal infiltration exclusion criteria: * patients having any medical conditions considered to affect patient safety or the quality of the study * if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used
a proposed tetra-modal treatment protocol for muscle invasive urothelial carcinoma of the urinary bladder

Conditions: Bladder Cancer

Summary: in egypt, bladder cancer has been the most common cancer during the past 50 years. in 2002, egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year. about 25% of new diagnoses are muscle-invasive bladder cancer (mibc), which carry a worse prognosis compared to non-muscle invasive disease. neoadjuvant chemotherapy (nac) followed by radical cystectomy (rc) with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of mibc by multiple international guidelines. however, this is associated with a significant impact on quality of life. the effect of our proposed tetra-modal treatment protocol for muscle invasive urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival, cancer specific survival, and overall survival? koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor, induction chemoradiation (crt), and consolidative partial cystectomy (pc) with pelvic lymph node dissection, allowing the confirmation of crt response pathologically. in the preliminary analysis of the initial cases enrolled in their protocol, none of the patients who completed the protocol with consolidative pc experienced mibc recurrence, suggesting that consolidative pc may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after crt. our proposed tetra-modal treatment protocol for mibc is supposed to eliminate the surgical difficulties of performing pc in a radiated field and hence decrease the post operative complications of pc.


Eligibility criteria:
inclusion criteria: 1. tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder that is ≤ 50 % of total bladder surface. 2. tumor at least 2 cm away from bladder neck or trigone. 3. clinically, no residual disease or minimal amounts of non-invasive disease in the original mibc site after nac at restaging turbt (if done). 4. pathologically confirmed urothelial carcinoma. exclusion criteria: 1. prescence of cis. 2. presence of distant metastasis. 3. patients unfit for cisplatin-based chemotherapy.

Keywords: tetramodal bladder preservation urothelial carcinoma partial cystectomy
lifestyle intervention program for women with gestational diabetes or gestational impaired glucose tolerance

Conditions: Gestational Diabetes

Summary: the purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. eligible women will be randomly assigned to life-style intervention or usual medical care.


Eligibility criteria:
inclusion criteria: * women receiving prenatal care at kaiser permanente santa clara, santa teresa, hayward, and oakland * pregnancy complicated by high glucose levels starting november 2011 exclusion criteria: * recognized dm prior to pregnancy * uncontrolled hypertension during pregnancy * severe active thyroid disease during pregnancy * severe diseases of the cardio-pulmonary system * diagnosis of a severe psychiatric disorder * diagnosis of cancer * conditions that lead to diet changes * addiction to alcohol or illegal drugs * current corticosteroid medicine use

Keywords: gestational diabetes weight loss physical activity pregnancy postpartum intervention
comparison study of eap and disease-specific chemotherapy regimens in hematopoietic stem cell mobilization for lymphoma

Conditions: Non-Hodgkin's Lymphoma; Hematopoietic Stem Cell Mobilization

Summary: this study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (peg-rhg-csf) combination therapy (eap regimen) in mobilizing hematopoietic stem cells in patients with non-hodgkin's lymphoma (nhl). a total of 99 nhl patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the eap regimen versus disease-specific chemotherapy mobilization regimen. the primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (cd34+ cells ≥5×10\^6/kg).

based on strict inclusion and exclusion criteria, a total of 99 non-hodgkin's lymphoma patients from 16 hospitals will be selected. eligible subjects will be randomly assigned in a 2:1 ratio to either the experimental group or the control group. the experimental group will receive the eap regimen, which combines etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (peg-rhg-csf), while the control group will receive disease-specific chemotherapy mobilization regimens, such as the chop and hyper-cvad. subsequently, the number of cd34+ cells will be monitored. the study will evaluate the proportion of patients achieving the ideal collection value after a single collection (cd34+ cells ≥5×106/kg); the proportion of patients achieving the target collection value cumulatively; the total amount of cd34+ cells collected and the average number of collections; hematological and non-hematological adverse reactions; and the proportion of patients receiving plerixafor.

Eligibility criteria:
inclusion criteria: * diagnosed with non-hodgkin's lymphoma before enrollment. * indication for autologous stem cell transplantation (asct). * eastern cooperative oncology group (ecog) performance status of 0\~1. * achieved partial or better response after multiple courses of chemotherapy. * life expectancy ≥ 3 months. * subjects must be able to understand the protocol and sign the informed consent. exclusion criteria: * cardiac function class ii or higher or cardiac ejection fraction \< 40%. * serum direct bilirubin (dbil) more than twice of the upper limit of normal (uln). * alanine aminotransferase (alt) and aspartate aminotransferase (ast) more than three times the upper limit of normal (uln). * serum creatinine clearance rate ≤ 50%. * patients with active infection. * history of prior hematopoietic stem cell mobilization.

Keywords: non-hodgkin's lymphoma disease-specific chemotherapy hematopoietic stem cell mobilization etoposide, cytarabine combined with peg-rhg-csf
influence of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of various doses of afatinib

Conditions: Liver Diseases; Healthy

Summary: up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.


Eligibility criteria:
inclusion criteria: healthy subjects: 1. healthy males and females according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests. the healthy subjects must meet the matching criteria based on the matching approach (cf. section 3.3). 2. age =18 and =75 years 3. body mass index =18.5 and =34 kg/m2 4. creatinine clearance \>70 ml/min according to cockroft \& gault (for healthy volunteers, cf. section 10.2) 5. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation. hepatically impaired subjects as determined by a hepatologist/ gastroenterologist: 6. male and female liver impaired subjects determined by results of screening classified as child-pugh a; child-pugh score of 5-6 points or as child-pugh b; child-pugh score of 7-9 points, cf. section 10.2. child-pugh criteria must be stable for at least 3 months prior to screening and during the trial. 7. age =18 and =75 years 8. body mass index =18.5 and =34 kg/m2 9. creatinine clearance \>40 ml/min according to cockroft \& gault (for liver impaired subjects, cf. section 10.2) 10. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation. for all females: 11. postmenopausal female subjects (postmenopausal defined as at least 1 year of spontaneous amenorrhea \[in questionable cases or spontaneous amenorrhea below 1 year a blood sample with simultaneous follicle stimulating hormone (fsh) above 40 iu/l and estradiol below 30 ng/l is confirmatory\]) or adequate contraception\* for female subjects of childbearing potential during the study and until 2 months after study completion, e.g. any of the following: implants, injectables, combined oral contraceptives, iud (intrauterine device), sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile have to use an additional barrier method (e.g. condom). exclusion criteria: any relevant deviation from healthy conditions (excluded conditions caused by liver impairment)
transdiagnostic sleep and circadian intervention + bright light in adolescents with elevated depression

Conditions: Sleep Disturbance; Sleep; Depression; Suicide

Summary: suicide is the second leading cause of death in youth, and recent statistics indicate disproportionate risk for suicidal behavior among black youth. despite this, few interventions effectively prevent youth suicidal thoughts and behaviors (stb). sleep difficulties may be a particularly promising target for youth stb prevention efforts. to date, no intervention targeting sleep difficulties have been examined among youth at-risk for stbs nor tailored to black youth; this research is critical for maximizing intervention acceptability and impact. the transdiagnostic sleep and circadian intervention (trans-c) is an evidence-based, modularized intervention that targets a range of sleep and circadian difficulties, making it especially well-suited for treating adolescent sleep. delivery of this intervention will be through telehealth with a sleep therapist. youth will wear an actigraphy watch that monitors sleep and will complete daily sleep diaries via smartphone or email; sleep feedback reports of sleep diary and actigraphy data are available on demand after completing a diary entry. the adolescents will also wear bright light glasses in the morning and blue light blocking glasses in the evening. adolescents will also attend weekly or biweekly sessions with a sleep therapist. the sleep therapist will review sleep feedback generated from actigraph and sleep diary data with adolescents during sessions. in the sleep feedback alone intervention, adolescents will wear an actigraphy watch and complete daily diaries; they are able to view their sleep feedback on demand through user-friendly graphs of naturalistic objective and subjective sleep data.

the study proposes to adapt trans-c for at-risk adolescents using health equity-informed implementation science methods. in this randomized trial we will enroll 75 youth aged 12-18 at risk for stb and clinically significant sleep difficulties identified in primary care. the randomization that this study uses is a 2:1 allocation to compare trans-c+sleep feedback vs. sleep feedback alone.

Eligibility criteria:
inclusion criteria: * adolescents (12-18) * current moderate to severe depression as measured by the phq-9m with a total score of greater than or equal to 11 * current clinically significant sleep disturbance measured by the phq-9-m sleep item greater than or equal to 2. * english language fluency and literacy sufficient to engage in study protocol. exclusion criteria: * evidence of obstructive sleep apnea, * evidence of restless legs syndrome * evidence of psychosis * evidence of bipolar disorder * evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening.

Keywords: sleep disturbances objective sleep subjective sleep difficulties minority youth
gene therapy for severe crigler najjar syndrome

Conditions: Crigler-Najjar Syndrome

Summary: this is a phase 1/2, multinational, open-label, study to evaluate the safety and efficacy of an intravenous infusion of gnt0003 in patients with crigler-najjar aged ≥10 years and requiring phototherapy. patients will received a single administration of gnt0003 and will be followed for safety and efficacy of approximately 60 months (5 years): * a follow-up of approximately 12 months (48 weeks) * a long term follow-up of approximately 48 months (4 years), in order to be in line with the latest emea guideline on follow-up of patients administered with gene therapy medicinal products, released on 22 oct.2009 by the committee for medicinal products for human use.


Eligibility criteria:
inclusion criteria: * patients with severe crigler-najjar syndrome resulting from a molecular confirmation of mutations in the ugt1a1 gene and requiring phototherapy * male or female at least 9 years at the date of signature of informed consent * patient able to give informed assent and/or consent in writing exclusion criteria: * patients who underwent liver transplantation * patients with chronic hepatitis b or c * patients infected with human immunodeficiency virus (hiv) * patients with significant underlying liver disease * patients with significant encephalopathy * participation in any other investigational trial during this trial * patients unable or unwilling to comply with the protocol requirements

Keywords: crigler-najjar adeno associated virus