Kornimate/medical-research-clean huggingface dataset:
monitoring skeletal muscle mass using cbct in patients with h&n cancer undergoing chemoradiotherapy

Conditions: Head and Neck Cancer; Radiotherapy; Adverse Effect

Summary: chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (hnc). however, malnutrition is present in 44-88% hnc patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (smm) and poor clinical outcomes. timely assessment of smm and early intervention of malnutrition are particularly important for hnc patients undergoing radiotherapy. however, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss. cone-beam ct (cbct), a variation of traditional ct, is widely performed to ensure the appropriate position of the patients during radiotherapy. the previous study showed that measuring skeletal muscle areas and its changes using cbct during radiotherapy is feasible. the hypothesis of this study is loss of smm is associated with severe adverse effects in hnc patients during radiotherapy compared with body weight loss.

this is a prospective observational phase ii study. patients with locally advanced hnc scheduled to receive radical radiotherapy are prospectively enrolled in this study. cbct and body weight are obtained before radiotherapy and once a week during radiotherapy. severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.

Eligibility criteria:
inclusion criteria: * histologically confirmed hnc including oral cavity, oropharyngeal, nasopharynx, hypopharyngeal, and laryngeal cancers * clinical stage ii-iva according to the american joint committee of cancer (the seventh edition) * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * previous head and neck radiotherapy * previous cervical lymph node dissection * active infections * palliative treatment

Keywords: cone-beam computerized tomography skeletal muscle mass body weight malnutrition
lanreotide autogel in the treatment of symptomatic polycystic liver disease

Conditions: Polycystic Liver Disease

Summary: an open-label, phase ii clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.


Eligibility criteria:
inclusion criteria: * liver volume ≥ 4 liter * ≥ 20 liver cysts * symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity: * abdominal distention perceived as uncomfortable * frequent abdominal pain * early satiety * nausea (with the inclusion of dyspeptic complaints) * dyspnea * diagnosed with adpkd or adpld * male and female patients of 18 years and older * written informed consent exclusion criteria: * creatinine clearance \< 20 ml/min * patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year * hormonal replacement therapy * hormonal contraception * pregnant or lactating * presenting with an uncontrolled disease (other than adpkd/adpld) * planned to undergo any surgery of the liver during study participation * planned to undergo any surgery of the kidney during study participation (adpkd patients only) * patients with known allergies to somatostatin or its analogues or any of its components * patients who received somatostatin analogues in the 6 months preceding study inclusion

Keywords: polycystic liver disease
positive suggestions via mp3 messages

Conditions: Post Intensive Care Unit Syndrome; Psychological Trauma; Anxiety; Depression; PTSD

Summary: the purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.

following screening and consenting processes, patients will be randomized to enroll in interventional or control groups. the interventional group will listen to an audio recording of psychological support based on positive suggestion for about 30 min each day via headphones. at the time of icu discharge, patients will be administered validated questionnaires to screen for symptoms of anxiety/depression (hads), ptsd (ies-r), cognitive dysfunction (moca-blind), as well as evaluation of health status (eq-5d). six months post icu discharge, patients will again be contacted and repeat the assessment with above questionnaires. scores on the questionnaires will be compared between the groups at the two times points. patient demographic data will also be obtained and assessed to contextualize study findings.

Eligibility criteria:
inclusion criteria: * acute respiratory failure and/or requiring vasopressors * admitted to the icu * expected to stay \>48 hours in the icu exclusion criteria: * history of dementia * history of mental retardation * history of suicide attempt * history of psychotic disorders such as schizophrenia * acute alcohol/substance intoxication or withdrawal * severe metabolic encephalopathy * patients on comfort care * patients not expected to survive the hospital stay * those with hearing impairment * non-english speaking.

Keywords: post traumatic stress syndrome anxiety depression pics
rate of torque development in adolescents with osgood-schlatter

Conditions: Osgood-Schlatter Disease

Summary: osgood-schlatter is a growth-related condition involving multiple different types of tissue in the tendon-bone interface at the tibial tubercle. osgood-schlatter affects one in ten adolescents causing persistent pain and reduced ability to maintain physical activities. changes in rate of torque development is associated with decreased neuromuscular functioning and pain chronicity, thereby affecting athletic performances and general physical activities. however, changes in rate of torque development has not been investigate in patients with osgood-schlatter and could help characterize the condition and guide management. the aim of the study is to investigate early and peak rate of torque development during maximal voluntary isometric knee extension and knee flexion in adolescents with osgood-schlatter, compared to a matched group of asymptomatic adolescents (controls), in a cross-sectional study. the study will include 13 adolescent participants with osgood-schlatter and a group of 13 pain free controls matched on sex, age, and sports participation on the group level. testing will include rate of torque measurements of knee extension and flexion for each limb with a fixated handheld dynamometer during a single test-session lasting approximately two hours. the examiner responsible for strength-testing will be blinded to case-status. along with anthropometric data, participants will perform the anterior knee pain provocation test to assess pain-response to sustained knee loading, a countermovement jump test to assess power and jump height, and provide patient-reported measures of condition severity, pain, disability, and quality of life. data collection will start march 2023 and is expected to finish by may 2023.


Eligibility criteria:
inclusion criteria: * patients must be 9-16 years of age * presence of pain for 12 weeks or more * pain at tibial tubercle during loading activities * palpable pain at the tibial tuberosity exclusion criteria: * previous knee or hip surgery * other main diagnose of anterior knee pain (patellofemoral pain, sinding-larsen johansson disease, jumpers knee, etc.) * hip and/or back pain interfering with activities of daily living or physical activities * suspicion of other main diagnose such as meniscal tears and or ligamental tears * unable to communicate verbally or orally in danish

Keywords: adolescents rate of torque development osgood-schlatter neuromuscular inhibition
phase iv study to evaluate the efficacy and safety of fang le shu compared to guo na fen for controlled ovarian stimulation in infertile women undergoing in vitro fertilization-embryo transfer (ivf-et).

Conditions: Female Infertility

Summary: the aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase iv study is to assess the efficacy and safety of fang le shu versus guo na fen used for controlled ovarian stimulation in infertile women undergoing in vitro fertilization-embryo transfer.


Eligibility criteria:
inclusion criteria: * is pre-menopausal female aged ≥20 to \<40 years. * has regular menstrual cycles of ≥25 to ≤35 days. * has normal baseline serum fsh, lh, e2, p4. * is able to voluntarily sign the informed consent form (icf). * has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement. exclusion criteria: * has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease. * has body mass index (bmi) of \>30 kg/m2. * has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization * has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll). * has history of severe ovarian hyperstimulation syndrome (ohss) defined as grade 4 or higher. * poor ovarian reponder according to bologna criteria * has plans to donate oocyte or recieve embryo from another women or undergo preimplantation genetic testing(pgt) * has history of three or more failures in previous ivf cycles * has history of recurrent miscarriage * has known current active pelvic inflammatory disease. * is currently breastfeeding. * has a contraindication to pregnancy that would preclude participation in the trial.
to observe the dual-target chimeric antigen receptor t cells in the treatment of b cell hematologic tumors

Conditions: 19 and 22+ B Cell Hematologic Tumors; 19 and 20+ B Cell Hematologic Tumors

Summary: to observe the long-term efficacy and safety of dual-target chimeric antigen receptor t cells in the treatment of refractory relapsed b cell hematologic tumors (at least 2 years).

this study is open single-arm prospective clinical study to relapse/refractory blood b cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double targets cart cell injection treatment, follow-up observation of the adverse reactions and the treatment effect of the drug to the data (at least 2 years), assessment of double targets car - t long-term efficacy and safety of cell injection

Eligibility criteria:
inclusion criteria: 1. refractory and relapsed b-cell tumor determined by clinical diagnosis, b cell tumors include the following three categories: b cell acute lymphocyte leucocyte; inert b cell lymphoma (cll、 fl、 mzl); aggressive b-cell lymphoma (dlbcl、 bl、 mcl); 2. cd19 positive and cd20 positive or cd22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old; 4.estimated survival time\>3 months; 5.ecog scores: 0\~2; 6.there should be at least one measurable tumor foci according to recist version 1.1; 7.the functions of vital organs must meet the following conditions: ef\>50%, and no obvious abnormality of electrocardiogram; spo2≥92%; cr≤1.5uln; altand ast≤5uln, tbil≤3uln; 8.subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.the subject or guardian understands and signs the informed consent. exclusion criteria: 1. with other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease; 2. presence of other malignant tumors; 3. there are severe infections that cannot be effectively controlled; 4. hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) positive, peripheral blood hepatitis b virus (hbv)dna higher than the detection limit should be excluded; if hepatitis c virus (hcv) antibody positive, peripheral blood hcv rna positive need to exclude; cytomegalovirus (cmv)dna positive; epstein-barr virus dna positive in peripheral blood; 5. known positive serology for human immunodeficiency virus (hiv) or syphilis; 6. a history of severe allergies to biological products (including antibiotics); 7. patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (gvhd); 8. female patients who are under pregnancy and/or lactation; 9. active autoimmune disease requiring systemic immunosuppressive therapy; 10. conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.
amphotericin b cholesteryl sulfate complex for injection(abcd) in the treatment of invasive candidiasis and invasive aspergillosis

Conditions: Invasive Candidiasis; Invasive Aspergillosis

Summary: this is an open, multicenter clinical trial of abcd for invasive candidiasis and invasive aspergillosis.

this study will evaluate the safety, efficacy and population pharmacokinetic characteristics of abcd in the treatment of invasive candidiasis and invasive aspergillosis. about 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.

Eligibility criteria:
inclusion criteria: 1. patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis; 2. agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication; 3. female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment. 4. signed informed consent form. exclusion criteria: 1. allergic to abcd or azole antifungal drugs； 2. for ic patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin b in 7 days; 3. for ia patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin b in 7 days; 4. patients with candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection; 5. patients with a history of drug abuse or drug dependence; 6. chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis; 7. patients are known to have mixed invasive candida or aspergillus infections and/or abcd is known to be ineffective; 8. patients with abnormal liver function; 9. patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis; 10. hypokalemia, which cannot be corrected before trial treatment; 11. expected survival time is less than 2 months; 12. patients with cardiac function of new york heart association（nyha）class iii/iv; 13. positive for hiv antibody; 14. pregnant or lactating women;
atra, celecoxib, and itraconazole as maintenance

Conditions: Relapsed Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and tolerability associated with the combination of atra/celecoxib/itraconazole as maintenance therapy given after an autologous stem cell transplant in relapsed multiple myeloma patients.

primary objective: to evaluate safety and tolerability associated with the combination of atra/ celecoxib/itraconazole given after a salvage transplant for relapsed myeloma in 25 patients in a cycle schedule consisting of three weeks of treatment followed by a rest period of two weeks for a total of five cycles. subjects will be evaluable only if they have received at least one dose of maintenance treatment. the salvage transplant is not part of this study. secondary objective: to explore changes in frequency and molecular signature in the multiple myeloma stem cell (mmsc) fraction based on flow-cytometric assays and gene expression profiling before and after the experimental treatment and to correlate outcome with expression levels of rarα2 at time of relapse.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsed multiple myeloma * recent salvage transplant (≤ 6 months but ≥ 45 days post-transplant prior to study enrollment) for relapse * 18-75 years of age at the time of study entry * platelet count ≥70k/mm3 un-transfused * resolution of all transplant-related toxicity to ≤ grade 2 per ctcae v.4 * left ventricular ejection fraction as measured by echo or muga should be ≥ 40% * creatinine of ≤ 2 mg/dl and a calculated gfr of \>50ml/min/1.73m2 * a total bilirubin, alt, ast, and alkaline phosphatase of ≤ 2 uln * performance status of 0-2 based on the ecog criteria. patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this * prospective study participants must be informed of the investigational nature of the study and must have signed an irb-approved informed consent form in accordance with institutional and federal guidelines exclusion criteria: * prior allogeneic transplant * greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening * uncontrolled diabetes * recent (\ 160 mm or a diastolic bp \> 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult- to-control cardiac arrhythmias * evidence of qt prolongation and/or torsades de pointes (tdp) on ekg. * any co-morbid condition that poses a greater threat to the patient's life expectancy than the recurrent myeloma * no concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening * presence of an infection that requires intravenous antibiotics * pregnant or nursing females. any patient of reproductive potential may not participate unless he/she has agreed to use an effective contraceptive method as covered during the informed consent process * known history of an hiv seropositive test

Keywords: relapsed multiple myeloma
electrophysiological and clinical effects of walking downhill in stroke patients

Conditions: Stroke

Summary: investigation of the effects of walking for 20 minutes on the acute h/m ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory. at the same time, the aim of the study is to obtain the clinical effectiveness of this walking pattern and control of the h/m ratio by checking the h/m ratio again after 5 sessions and 20 minutes of walking for the patients participating in the study.

participants will wear a seat belt connected to an overhead support and will walk on a treadmill with a dual-band instrument at a sampling frequency of 2000 hz. the seat belt will only serve as a safety mechanism in case of a fall and will not support any body weight while walking. each participant will walk for 20 minutes under one of 3 slope conditions; treadmill walking on 0° flat ground, , downhill walking with treadmill on -7.5° slope and downhill walking with treadmill on -15° slope. first, by asking the participants to walk at their comfortable speed for straight walking on the treadmill with tools, the walking speed will be determined and carried out at the specified speeds. all self-selected walking speeds will be determined in two 30-second trials. during the 20-minute walk for each condition, if the participant needs to slow down, the speed of the treadmill will be reduced to adapt to this, and the average walking speed during the 20-minute walking session will be reported. pulse and blood pressure will be monitored before, during and after the walk. all participants will be evaluated with modified asworth scale, modified tardeu scale, 2 minute walking test, modified rankin scale, timed get up and walk test, fatigue impact scale, stroke impact scale, berg balance scale, fugl meyer assessment scale before treatment. patients will be randomized into 3 groups. then, the h / m ratio will be looked at in all 3 groups. after the first walking session, the h / m ratio will be repeated. after completing the 5-session walking program, clinical and electrophysiological tests will be repeated.

Eligibility criteria:
inclusion criteria: patients diagnosed with stroke between the ages of 18 and 65 dec exclusion criteria: * other neurological disorders, * expressive or receptive aphasias, * severe heart disease, * a history of poorly controlled diabetes, * active cancer, * those who have been injected with botilinum toxin in the last 3 months, * orthopedic conditions affecting the legs, a history of hip or knee replacement, * serious simultaneous medical problems, such as peripheral nerve damage * inability to comprehend verbal instructions
effects of music therapy on sensory processing, adaptive behavior and social interaction

Conditions: Music Therapy

Summary: the purpose of our study is to examine the effects of music therapy on sensory processing, adaptive behavior, and social interaction in individuals with autism.

the study was designed as a randomized controlled trial. a simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). a simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. this decision will determine whether the individual will be assigned to the intervention or control group. the study will be conducted at hacettepe university. the study group and the control group will receive sensory integration training for 45 minutes per day, 2 days per week, for 6 weeks. the children in the control group will receive only sensory integration training, while the study group will receive music therapy training for 30 minutes per day, 2 days per week, for 6 weeks in addition to sensory integration training. sociodemographic information of the children will be collected before the research and sensory processing problems of the children will be assessed with the sensory profile and adaptive behavioral skills will be assessed with the adaptive behavior scale (ads).

Eligibility criteria:
inclusion criteria: having been diagnosed with autism spectrum disorder (asd) by a child psychiatrist being between the ages of 6-10 being able to cooperate exclusion criteria: having any neurological, orthopedic or psychiatric diagnosis in addition to autism diagnosis having undergone any surgical intervention in the last 3 months being inadequate in understanding visual and auditory commands having a visual and hearing impairment recorded in the health report

Keywords: autism sensory integration music therapy sensory processing social interaction