Kornimate/medical-research-clean huggingface dataset:
a study to evaluate ap-101 in familial and sporadic amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: single ascending doses of ap-101 will be administered by intravenous (iv) infusion


Eligibility criteria:
inclusion criteria: * all participants must adhere to contraception restrictions * female patients of non-childbearing potential due to: 1. menopause: spontaneous amenorrhea for at least 12 months not induced by a medical conditions such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) 2. surgical sterilization * have possible, probable, probable laboratory supported or definite and definite familial laboratory-supported als in accordance with the el-escorial criteria * have familial or sporadic als. * with onset of als symptoms, specifically onset of muscle weakness within past 48 months * have slow vital capacity (svc) of (greater than or equal to) ≥60% * if on riluzole, must be on a stable dose * if on edaravone, must have completed 2 cycles and are expected to remain on the same dose throughout the study * able to provide informed consent. if the patient is not able to provide written consent due to aggravation of disease condition, written informed consent may be provided by a legally authorized representative * have venous access sufficient to allow for blood sampling * have clinical laboratory test results within normal reference range for the population or study site, or results with acceptable deviations that are judged to be not clinically significant exclusion criteria: * are currently enrolled in, or discontinued from, within the last 30 days, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study * have previously completed or withdrawn from this study * have a history or presence of medical illness including, but not limited to, any cognitive, cardiovascular, hepatic, hematological, renal, endocrine, or psychiatric, or any clinically significant laboratory abnormality that indicates a medical problem that would preclude study participation * show evidence of human immunodeficiency virus (hiv) infection and/or positive human hiv antibodies * show evidence of hepatitis c and/or positive hepatitis c antibody * show evidence of hepatitis b and/or positive hepatitis b surface antigen * are women who are lactating. * have undergone a tracheostomy unless it was removed at least 6 months prior * are on feeding tube, unless the insertion of a feeding tube is considered prophylactic * are on nasal intermittent positive pressure ventilation (nippv) \>4 hours per day or at the discretion of the medical monitor * have undergone stem cell therapy

Keywords: familial amyotrophic lateral sclerosis sporadic amyotrophic lateral sclerosis
sym004 in scchn patients failing anti-egfr based therapy

Conditions: Carcinoma, Squamous Cell of Head and Neck

Summary: the trial is designed as a multi-center, open label phase 2 trial that investigates the efficacy and safety of sym004 in subjects with squamous cell cancer of the head and neck (scchn). subjects included must have responded to previous anti-epidermal growth factor receptor (anti-egfr) monoclonal antibody-based therapy and subsequently become resistant to that therapy. it is believed that sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced scchn. symphogen was the sponsor for planning/conducting and reporting results for this trial.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis initially or at relapse of scchn of the oral cavity, oropharynx, hypopharynx or larynx * recurrent and/or metastatic scchn not amenable to curative treatment with surgery and/or (chemo)radiation * previous treatment with an anti-egfr monoclonal antibody (mab) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing: * documented clinical benefit or response for at least 8 weeks (pr, cr or sd) on the anti-egfr mab-based therapy and * documented disease progression (verified by computed tomography \[ct\] scan or magnetic resonance imaging \[mri\] according to recist (1.1) during or within 12 weeks following the last administration of anti-egfr mab * accessible tumor for biopsy and subject acceptance of repeat tumor biopsies * other protocol-defined inclusion criteria could apply exclusion criteria: * more than 2 lines of prior chemotherapy in the palliative setting * expected survival \<12 weeks * subjects with known brain metastases * chemotherapy or radiation therapy within 21 days prior to visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions * anti-egfr mabs within 14 days prior to visit 2 * major surgery within 4 weeks prior to visit 2 and subjects must have recovered from effects of major surgery * other protocol-defined exclusion criteria could apply
tacrolimus treatment of patients with idiopathic focal segmental glomerulosclerosis

Conditions: Focal Glomerulosclerosis

Summary: the purpose of this study is to assess the efficacy of tacrolimus treatment of patients with idiopathic focal segmental glomerulosclerosis.

primary fsgs is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. steroids, which are currently used to treat the disease, are effective in part of patients. over the past decade, a number of studies have reported therapeutic efficacy for treatment with cyclosporine-a (csa) in patients with fsgs. recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of t-helper cells, for example, tacrolimus, may be effective in the treatment of primary fsgs. the experience with tacrolimus (fk506) in the treatment of patients with fsgs has been limited to uncontrolled trials in adult patients.

Eligibility criteria:
inclusion criteria: * age 14-50 years at onset of signs or symptoms of fsgs * biopsy proven fsgs * estimated glomerular filtration rate (gfr) ≥ 40 ml/min/1.73 m2 * urine protein \> 3.5 g/24h * biopsy confirmed primary fsgs (including all subtypes) * willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures exclusion criteria: * secondary fsgs * prior therapy with sirolimus, csa, mmf, or azathioprin, cytoxan, chlorambucil levamisole, methotrexate, or nitrogen mustard in the last 90 days * active/serious infection * malignancy * previously diagnosed diabetes mellitus type 1 or 2 * clinical evidence of cirrhosis or chronic active liver disease * history of significant gastrointestinal disorder * allergy to study medications, and inability to consent/assent

Keywords: idiopathic focal segmental glomerulosclerosis treatment steroids
functional exercise for sarcopenia

Conditions: Sarcopenia

Summary: sarcopenia is one of the major causes of functional decline and negative health outcomes among older adults. prominent evidence suggests exercise interventions can reverse sarcopenia. however, past studies mainly focus on structured exercise programs, automatically excluding many older adults who are not motivated and lack the time/resources to conduct the structural exercise. therefore, we propose to examine the effect of the sarcopenia translation functional exercise program (the step program) on community-dwelling older adults. the step is a functional exercise program designed to address low motivation and other time/resources barriers for rapid translation in community settings. the 12-week step program teaches older adults to apply functional exercise activities incorporating resistant training principles in their daily routines. with a dual focus apriori in assessing clinical effectiveness and potential implementation strategies for future community implementations, we will conduct a single-blind randomized control trial among 60 community-dwelling older adults at risk or with sarcopenia. the study's purposes are threefold: (1) to assess the effect of the functional exercise intervention compared to usual care on primary outcomes of sarcopenia (muscle strength, muscle mass, and physical function); (2) to assess the long-term effects of the functional exercise intervention on primary outcomes of sarcopenia; (3) explore potential implementation strategies for rapid community implementation including development of a communityappropriate protocol for tracking long-term effects such as metabolomic biomarkers. this study aims to develop an effective functional exercise program as an alternative to structured exercise programs. additionally, the goal is to accelerate the translation of the functional exercise program for older adults at risk or with sarcopenia in real-world settings.


Eligibility criteria:
inclusion criteria: 1. age 65 or older 2. reside in northern taiwan 3. at risk of /with sarcopenia determined by awgs diagnostic guidelines exclusion criteria: 1. meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly 2. needs 24-hour resistance for the activity of daily living activities 3. has severe knee or back pain 4. severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients) 5. unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions 6. impaired cognition (mini-mental state examination \[mmse\] score \< 24, or \<17 for participants with lower education level) 7. has a metal clip, implant, or pacemaker

Keywords: habit community older adult functional exercise
evaluation of liver stiffness by ultrasound elastography for predicting early hcc recurrence after treatment

Conditions: Hepatocellular Carcinoma

Summary: we aim to evaluate liver stiffness as a marker of severity and duration of the underlying liver disease to predict for early hcc recurrence after treatment.

hepatocellular carcinoma (hcc) is one of the most common cancers worldwide and contributes to enormous cancer-related deaths annually . hepatocellular carcinoma is a frequent complication of liver disease. early recurrence is mainly tumour or treatment-related . liver fibrosis stagging is essential to evaluate the expected prognosis against the concomitant therapies. liver biopsy remain the gold standard for diagnosing liver fibrosis, however, it is limited due to the associated costs, invasiveness, and intra and inter observer variability. patient discomfort, refusal and risk of complications. ultrasound elastography is a non-invasive imaging method liver fibrosis staging . ultrasound elastography is an imaging technology sensitive to tissue stiffness that was developed in the 1990s. it has been further developed and refined in recent years to enable quantitative assessment of tissue stiffness. elastography methods take advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes . elastography is an application, which produces the force coupled with a measurement system for the deformities caused by the force. there are several types of forces: 1. static compression induced externally by manual compression or internally by organ motion (heart, vessel, and breathing) 2. dynamic compression induced with a continuous vibration at a given frequency 3. impulse compression (transient vibration) induced externally by a transient mechanical impulse ( fibroscan) or internally by an ultrasound impulse (arfi, swe), both compression types producing shear waves. while contrast-enhanced imaging is the first-line approach in the diagnosis of hcc, recent report show that the non-invasively measured stiffness of hepatic nodule could help to distinguish between malignant and benign liver lesions. the treatment of hcc depends on the stage of liver disease and in many cases, curative resection is not possible. therefore local ablative therapies, such as transarterial chemoembolization (tace) and radiofrequency ablation (rfa), are considered viable therapeutic options . however, hcc might behave very differently and could show more or less of a response to local ablative treatment

Eligibility criteria:
inclusion criteria: * all patients with liver cirrhosis and hcc. exclusion criteria: * metastatic hepatic focal lesions.
clinical trial to evaluate the safety and effects of ethnicity and food on pharmacokinetics of yh25448

Conditions: Non-Small Cell Lung Cancer

Summary: clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of yh25448, which yuhan corporation plans to develop as a therapeutic agent for non-small cell lung cancer.

this clinical trial will be conducted in healthy korean and caucasian volunteers at seoul national university hospital (snuh) clinical trial center. it is expected to take approximately 39 days from the first dosing of investigational product until the final follow-up visit. it will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the investigational product.

Eligibility criteria:
inclusion criteria: 1. informed of the investigational nature of this study and voluntarily agree to participate in this study. 2. subjects with bmi range of ≥18.5 kg/m2 and \< 30.0 kg/m2 and weighing ≥ 50 kg 3. subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis 4. healthy korean and caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent exclusion criteria: 1. clinically significant chronic infection (e.g. aids) or clinically significant medical or psychiatric illness 2. hypotension (sbp ≤ 90 mmhg or dbp ≤ 50 mmhg) or hypertension (sbp ≥ 150 mmhg or dbp ≥ 100 mmhg) 3. a marked baseline prolongation of qtc greater than 450 msec by bazett's formula 4. within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications

Keywords: yh25448 non-small cell lung cancer
the effectiveness of prophylactic antibiotics for urethral bulking

Conditions: Stress Urinary Incontinence; Postoperative Urinary Tract Infection; Urethral Bulking

Summary: the goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (sui). one commonly reported post-procedural complication is urinary tract infection (uti). uti rates are variable where studies have reported rates from as low as 0% to as high as 40%. along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. the american urologic association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. the objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural utis.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo a urethral bulking procedure * age 18 ≥ over exclusion criteria: * history of recurrent urinary tract infections * known history of urinary retention * allergies or contraindications to multiple antibiotics * inability to tolerate oral antibiotics * concomitant surgical procedures at the time of urethral bulking * pregnant or breastfeeding
cyberbullying, empathy, and storytelling in adolescents

Conditions: Cyberbullying

Summary: the type of this study is a randomized controlled experimental study. the aim of this study is to determine the effect of storytelling method on cyberbullying and empathy level in adolescents. the population of the study consisted of 5th and 6th grade middle school students. the sample of the study will consist of students involved in cyberbullying. the sample will be selected through randomization and stratified selection will be made according to gender. the students in the intervention group will receive 4 sessions of storytelling intervention. the active control group will receive 4 sessions of cyberbullying training. questions that the research aims to answer: is there a difference between the intervention group and the control group in terms of cyberbullying level? is there a difference between the intervention groups and the control group in terms of empathy level? participants: the intervention group will participate in 4 sessions of storytelling intervention. the control group will participate in 4 sessions of cyberbullying training.


Eligibility criteria:
inclusion criteria: * family approval * volunteering to participate in the study. * being a 5th and 6th grade student * engaging in cyberbullying behavior exclusion criteria: * having a diagnosis of any mental illness * having at least one of vision, speech and hearing disabilities * foreign nationality * being a 7th and 8th grade student * not engaging in cyberbullying behavior
comparison of straumann boneceramic vs. allograft bone in extraction sockets

Conditions: Tooth Loss

Summary: the primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with straumann boneceramic (sbc) versus freeze dried bone allograft (fdba).

subjects will undergo a single tooth extraction and then will be randomized to receive sbc or fdba. following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. the subject will be followed for one year following dental implant placement for implant success and survival.

Eligibility criteria:
inclusion criteria: * subjects must have voluntarily signed the informed consent form * subjects must be between the ages of 18 and 80 * subjects must need a single tooth extraction in ada sites 3-6 and 11-14 without septal bone in the maxilla and in ada sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant * subjects must be committed to the study and the required follow-up visits * subjects must be in good general health as assessed by the investigator exclusion criteria: * presence of conditions requiring chronic routine prophylactic use of antibiotics * pregnancy * medical conditions requiring prolonged use of steroids * history of leukocyte dysfunction and deficiencies * history of bleeding disorders * history of neoplastic disease requiring the use of chemotherapy * history of radiation therapy to the head and neck * subjects with a history of renal failure * subjects with severe or uncontrolled metabolic bone disorders * uncontrolled endocrine disorders * subjects who knowingly have hiv or hepatitis * physical handicaps that would interfere with the ability to perform adequate oral hygiene * subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study * alcoholism or drug abuse * subjects who are heavy smokers (\>10 cigarettes per day or cigar equivalents) or chew tobacco * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability * local inflammation including untreated periodontitis * mucosal diseases such as erosive lichen planus * history of local radiation therapy * presence of oral lesions (such as ulcerations or malignancy) * bone defects that exclude implant restoration * subjects who have a full mouth plaque level \>30% at the baseline visit * severe bruxing or clenching habits * persistent intra-oral infection * subjects presenting with an acute abscess in the tooth to be extracted or in the adjacent teeth to the extraction site (sites with presence of asymptomatic chronic lesions are eligible) * subjects with inadequate oral hygiene or unmotivated for adequate home care * at the time of tooth extraction, if any bony wall is severely damaged or completely lost (i.e., anything other than a four wall extraction socket)
effects of home-based exercise program in children after acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this prospective randomized controlled study aimed to investigate the effects of a home-based exercise program on physical functions, inflammatory markers, and brain-derived neurotrophic factor (bdnf) in children followed after acute lymphoblastic leukemia (all) treatments. ankle dorsiflexion range of motion (rom), dorsiflexion and knee extensor muscle strength, hand grip strength, aerobic endurance, and functional mobility were assessed using a goniometer, digital dynamometer; hand dynamometer, 6 minute walk test (6 mwt), timed up and go test respectively. interleukin-1 beta, tumor necrosis factor-alpha, interleukin-6 (il-6), and bdnf values were examined using elisa kits. 20 patients will be included in the study. the patients randomly divided into 2 groups: exercise (n:10) and control (n:10). the exercise group performed a home-based exercise program consisting of aerobics 3 days a week and strengthening and stretching exercises 2 days a week, with videos and infographics, for 8 weeks. the control group was advised to increase physical activity.


Eligibility criteria:
inclusion criteria: * being between the ages of 6-18, * having clinical diagnose of acute lymphoblastic leukemia, * being completed medical treatment exclusion criteria: * having a history of neurological, developmental, or genetic disorders, * communicating problems * medical conditions such as advanced cardiac damage, decreased bone quality, acute infection, and cancer recurrence. children who could not accomplish the exercises and evaluations, who did not want to continue the study, who could not be contacted for more than 2 weeks, and who disrupted the exercise program for more than 2 weeks were excluded from the study.

Keywords: leukemia acute lymphoblastic interleukins inflammation exercise