Kornimate/medical-research-clean huggingface dataset:
effects of chondron (autologous chondrocytes) with ankle cartilage defect

Conditions: Articular Cartilage Defects of Ankle Joint

Summary: an open clinical trial transplanting chondron (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.

this clinical trial was designed to observe effects of chondron (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. in this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) gel-type chondron (fibrin mixed autologous chondrocytes) was transplanted at the defects. evaluation variables were aofas, 100 mm vas, hannover score, self-assessment of improvement by the patient, mri and arthroscopy.

Eligibility criteria:
inclusion criteria: 1. adult men and women over 15 and less than 65 years of age 2. applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint 3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance. 4. patients which surrounding cartilage are normal 5. patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form exclusion criteria: 1. patients hypersensitive to bovine protein 2. patients hypersensitive to gentamicin antibiotics 3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis 4. patients with arthritis related to autoimmune disease 5. pregnant, breast-feeding patients or those who have a possibility of pregnancy 6. patients with accompanying diseases other than articular cartilage defects, including tumors 7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years 8. patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that chondron administration is possible is appended by a doctor are excluded) 9. patients who are administering antibiotics and antimicrobial agents due to infection 10. patients who receive steroid hormone therapy 11. patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager

Keywords: articular cartilage defects aci ankle joint chondron
a safety and efficacy study of farletuzumab in participants with adenocarcinoma of the lung

Conditions: Adenocarcinoma of the Lung

Summary: the primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (pfs) as determined by response evaluation criteria in solid tumors (recist) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (fra)-expressing stage iv adenocarcinoma of the lung.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the lung classified as stage iv * confirmed folate receptor-alpha (fra) expression by immunohistochemistry (ihc) * measurable disease with at least one unidimensionally measurable lesion according to recist criteria version 1.1 by computed tomography (ct) or magnetic resonance imaging (mri) scans (ct or mri scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo) * must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung exclusion criteria: * participants who have had previous chemotherapy for adenocarcinoma of the lung * prior surgery with curative intent for adenocarcinoma of the lung * prior radiotherapy for adenocarcinoma of the lung. (prior treatment with local radiotherapy for symptom control \[i.e., palliative radiation with non-curative intent\] is permitted)
real-life assessment of brexpiprazole (rexulti) in schizophrenia and in depressive disorders

Conditions: Psychosis; Depression

Summary: not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders, antipsychotics, especially the second-generation antipsychotics (sgas) have also been recommended as augmenting agents for treating depression. dopaminergic agents, including both dopamine d2/d3 antagonists and dopamine partial d2 agonists, have been effective for treating psychosis and schizophrenia. amongst all sgas, those with partial d2 agonistic property are generally acknowledged to have better side-effect profiles with lower incidence of extrapyramidal side-effects, prolactin increase, weight gain, qtc prolongation, and metabolic syndrome, as well as more efficacious in alleviating depressive symptoms. up-to-date, three sgas, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial d2 agonism. resd-hk study is part of the resd asian study aiming to carefully evaluate a cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as treatment for schizophrenia and/or depression in a real-life clinical setting.

this is a 6-month, non-interventional, prospective naturalist study that adult patients (18-65 years old) receiving brexpiprazole for treatment of psychosis and/or as adjunctive treatment for major depressive disorder are eligible to participate. minimal exclusion criteria are employed to fit the usual real-life setting.

Eligibility criteria:
inclusion criteria: * age: 18- 65 years old at the time of enrollment * able to read and communicate in english and/or chinese * able to give informed consent * has been diagnosed according to diagnostic and statistical manual of mental disorders, 5th edition (dsm-5), or international statistical classification of diseases and related health problems 10th revision (icd-10) to have either psychotic disorders (f10-f19.5, f20-23, f25, f32-f33) * is receiving brexpiprazole as treatment for less than 4 weeks at the time of recruitment exclusion criteria: * age \<18 years old * unable to read english or chinese * unable to give informed consent * had been diagnosed to have intellectual disabilities (dsm-5) or mental retardation (icd-10 f70-73)
partial liver radiotherapy for unresectable liver metastases

Conditions: Metastatic Colorectal Liver Cancer

Summary: this study is designed to treat tumors in the liver that cannot be removed surgically and chemotherapy cannot control these tumors, using radiation therapy and a more precise delivery than has been used before.

the purpose of this study is to evaluate safety and feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer. this study would also evaluate local control rate within irradiated area and to assess failure patterns and survival of patients treated with conformal liver radiation.

Eligibility criteria:
inclusion criteria: * liver metastases unequivocally seen on contrast enhanced ct and/or mri from colon or rectal cancer, previously confirmed pathologically as adenocarcinoma * either 1) the tumor must be unresectable, 2) the patient must be medically inoperable, or 3) extra-hepatic metastases are present (making hepatic surgery an inappropriate treatment option) * good performance status (0-1) * age \> 18 years. adult patients of all ages, both sexes and all races will be included in this study. female patients within reproductive years may not be, nor become, pregnant during participation in this study * life expectancy \> 3 months exclusion criteria: * patients with active hepatitis or clinically significant liver failure * patients receiving anticoagulation treatment with warfarin or heparin * prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver * clinically apparent ascites * central nervous system metastases

Keywords: colorectal liver cancer metastatic radiation therapy
multicenter randomized controlled trial to compare the outcome of conservative triple target treatment with emg-biofeedback in chronic obstipation

Conditions: Chronic Obstipation

Summary: previous studies revealed only a low evidence for the various biofeedback methods and pelvic floor exercises for treatment of chronic obstipation. the number of randomized controlled trials is low with in part significant systemic deficiencies. however, the results from the previous study with 3t treatment in patients with obstructed defecation syndrome (ods) are so promising that a further randomized controlled trial appears useful to demonstrate a higher degree of evidence. the purpose of this study is to determine whether triple target treatment (3t) or emg-biofeedback alone are effective in the treatment of chronic obstipation and if the duration of treatment (3, 6 or 9 months) influence the efficacy.

methods in this parallel-group randomized multicenter study with blinded observer we enroll 140 patients with chronic obstipation. the study is divided into two trials. after three months the first trial is completed and can be extended directly into the second trial (completed after 12 months) after an interim analysis. primary endpoints are changes from baseline to three and twelve months in the altomare ods score.

Eligibility criteria:
inclusion criteria: * all patients with chronic obstipation (rom criteria ii) exclusion criteria: * chronic inflammatory bowel disease, systemic peripheral neuropathy (ms, diabetes), disorders of enteric nervous system (hirschsprung disease, chagas, ind, myopathy desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual deficits.

Keywords: exercise therapy biofeedback (psychology) adult chronic obstipation/*therapy emg - biofeedback emg - triggered stimulation augmented biofeedback
characterization of cardiac electrophysiological effects of autonomic neuromodulation

Conditions: Ventricular Tachycardia

Summary: prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.


Eligibility criteria:
inclusion criteria: * planned catheter based vt ablation * age at least 18 years exclusion criteria: * pregnancy * contraindication to sgb or vt ablation * hypersensitivity of local anesthetic of amide type * hemodynamic instability during the procedure prior to the study protocol
evaluation of repeat administration of purified poloxamer 188

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to evaluate the safety of repeat administration of mst-188 during vaso-occlusive crisis of sickle cell disease. additionally, this study will evaluate the development of acute chest syndrome during voc and re-hospitalization for recurrence of voc.


Eligibility criteria:
inclusion criteria: * completed participation in study mst-188-01 (epic study) * subject age 4 through 65 years * subject is experiencing acute pain typical of voc and requires treatment with parenteral opioid analgesia * subject requires hospitalization exclusion criteria: * subject has acute chest syndrome * subject's laboratory results indicate inadequate organ function * subject is pregnant or nursing an infant * subject had a painful crisis requiring hospitalization within the preceding 14 days * subject has been transfused within the past 14 days * subject has complications related to scd

Keywords: sickle cell vaso-occlusive crisis
mindfulness based cognitive therapy (mbct) for primary care patients

Conditions: Depression, Anxiety

Summary: this study is done to evaluate the effects of mindfulness based cognitive therapy (mbct) for primary care patients that have mild to moderate symptoms of depression and anxiety. half of the study participants will receive treatment as usual (tau), and the other half will receive tau plus mbct. the investigators will be comparing changes in symptoms of depression and anxiety between the groups, and hypothesize that the tau plus mbct group will have significantly lower symptoms of depression and anxiety compared to tau group post-intervention

patients that show mild to moderate symptoms of depression and anxiety are common in the primary care setting. these patients are often treated with antidepressant or anxiolytic medication instead of cognitive therapy, which is the first choice of treatment according to clinical guidelines in iceland. although these patients are often referred to cognitive therapy, there are long waiting lists for group therapy and personal therapy is expensive. mbct has been shown to have good effects on people with recurrent depression and on patients suffering from anxiety. therefore, the investigators main objective is to assess whether mbct is effective in the primary care setting for patients with mild symptoms of anxiety and depression and compare its effect to tau.

Eligibility criteria:
inclusion criteria: * phq-9 and gad-7 score 5-14 points * age18 - 67 * no current/recent psychotherapy of any kind other than his/hers physicians therapy( can be taking antidepressants but not in cbt) * no regular meditation or yoga practice * not mentally retarded * speaks and understands icelandic * no current substance dependence * not diagnosed with schizophrenic symptoms or bipolar disease that that currently requires treatment * not participating in another mental health study exclusion criteria: 1. age: \ 67 years old. 2. severe psychiatric symptoms requiring psychiatric care 3. risk of suicide 4. inability to participate in group sessions because of severe substance misuse; 5. inability to speak and understand icelandic 6. pregnancy; 7. current psychotherapy of any kind; 8. participation in any other psychiatric intervention study; 9. thyroid disease (if newly diagnosed by the doctor). 10. score under 5 on both gad7 and phq-9 and score over 14 on either gad7 or phq-9. 11. one or more of the following icd-10 psychiatric diagnoses: f00-f09 organic, including symptomatic, mental disorders f10-f19 mental and behavioural disorders due to psychoactive substance use f20-f29 schizophrenia, schizotypal and delusional disorders f70-f79 mental retardation -

Keywords: mild to moderate depression mild to moderate anxiety mindfulness based cognitive therapy primary care phq-9 gad-7 antidepressants anxiolytica subjective wellbeing
the effects of short-term preoperative treatment with hormonal therapy on gene profiles in breast cancer

Conditions: Breast Cancer

Summary: the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.

breast cancer is among the most common malignancies in women in the united states. over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. this was mainly due to the introduction of chemotherapy and hormonal therapy. hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. however, while this is well documented in the clinical outcomes. little is known in regards what happens on the genetic level. as such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer. the hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower ki67 expression, and changes in estrogen receptor (er) and progesterone receptor (pr) expression. the data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.

Eligibility criteria:
inclusion criteria * treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3. * co-enrollment in the flex registry * estrogen receptor positive (er+) progesterone receptor positive (pr+) confirmed hormone receptor status measured by immunohistochemistry (ihc) * patients should understand patients' condition and be able to give informed consent to participate exclusion criteria * history of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer. * allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs. * any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer. * patients without invasive disease (stage 0) * patients with metastatic breast cancer(stageiv) * patients that are human epidermal growth factor 2+(her2+) by ihc/fluorescence in situ hybridization (fish).

Keywords: breast cancer genomic assay hormone therapy
treatment off gingival recession defects using a xenogenic acellular dermal matrix compared to connective tissue graft.

Conditions: Gingival Recession

Summary: limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. we want to show if mucoderm used in tunnel technique to recover miller class i and ii recessions defects could be an alternative to connective tissue graft.

connective tissue graft harvested from the palate does not always have sufficient size to cover multiple recession defects. moreover, connective tissue graft shows significant postoperative morbidity to treat generalized multiple gingival recessions. the goal of this study is to show if mucoderm could be considered has a substitute of connective tissue graft in the coverage of gingival recession defects.

Eligibility criteria:
inclusion criteria: * patients \> 45 years, postmenopausal women (ie with amenorrhea for more than a year). * subject with bilateral miller class i or ii recessions defects * non smoking patients * patients having read and understood the information note on the study and signed the informed consent form. * patients affiliated to the social security system. exclusion criteria: * patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever. * patient with metabolic bone disease (paget's disease, osteomalacia, osteogenesis imperfecta) * patient with an asa score ≥ 3. * patient with absolute contra-indication to dental surgery * patient with severe hematologic disease * patient with i or type ii diabetes * patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study. * patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants. * patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy. * patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months. * patient monitoring considered difficult by the investigator. * patient with poor oral hygiene incompatible with oral surgery. * patients with periodontal disease unstabilized * patient with oral dermatitis or adverse occlusion. * patient with an acute or chronic infection of the surgical site (osteomyelitis). * patient with a known allergy to collagen * patient with autoimmune disease * patient with a linguistic or mental incapacity to understand information * patient younger than 45 years old * patient trust under curatorship or judicial protection * patients aged over 45 premenopausal. * patient participating in another clinical study.
pharmacokinetic study of palifermin in subjects receiving radiation therapy and chemotherapy followed by blood stem cell support

Conditions: Leukemia; Lymphoma; Myeloma

Summary: open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. the amount of palifermin in the blood following administration will be evaluated. the safety of palifermin administration and its effect on reducing mucositis will also be evaluated.

mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of erythema and ulcerative lesions in the mouth. mucositis can be serious, resulting in pain requiring interventions such as analgesic medications and the use of parenteral feedings. currently, no standard therapy is available to prevent or treat mucositis.

Eligibility criteria:
* patients diagnosed with non-hodgkin's lymphoma, hodgkin's disease, leukemia and myeloma. - eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support.

Keywords: mucositis chemotherapy radiation therapy
effect of perineural dexamethasone on the duration of popliteal nerve block for anesthesia after ankle surgery

Conditions: Postoperative Pain; Nerve Block

Summary: effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

this study is proposed to explore the effect of perineural dexamethasone on the duration of popliteal nerve block for analgesia after ankle surgery. after ankle or foot arthrodesis patients need a good analgesia. nevertheless early mobilisation and discharge are important for the healing process after surgery. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. perineural dexamethasone added to local anesthetic prolongs the duration of analgesia of the perineural nerve block. the perineural use of dexamethasone is still off-label. there is a ongoing discussion of which has better benefits, intravenous or perineural dexamethasone. there are multiple research where the intravenous and perineural dexamethasone use has compared, but there is still a limited amount of research of low dose perineural dexamethasone versus intravenous dexamethasone. in this study investigators compare different doses of perineural dexamethasone added to ropivacaine 2 mg/ml 20ml. after arthrodesis under spinal anaesthesia the patients receive popliteal block ropivacaine 2 mg/ml 20 ml and dexamethasone of different doses. groups 1 to 4 has dexamethasone doses 0, 2mg, 3mg or 4 mg. after the popliteal nerve block investigators follow postoperative pain, opiate consumption, mobilisation and long term quality of life. investigators goal is to find a dexamethasone dose which is as low as possible but at the same time covers the need for a good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: adult people under ankle/foot arthrodesis as a curative therapy of ankle arthrosis or situation after ankle injury or malposition exclusion criteria: age under 18 years complicated diabetes mellitus lack of finnish language skill and/or co-operation chronic pain steroid medication in regular use
phamacokinetics and safety profiles of da-1229_01 5/1000mg in healthy subjects at fed state

Conditions: Healthy

Summary: this phase i clinical study is to evaluate the safety/tolerability and pharmacokinetics of da-1229_01(5/1000 mg x1 tablets) at fed state.


Eligibility criteria:
inclusive criteria: * healthy volunteers * bmi between 18 and 30 kg/m2 * body weight : male≥50kg, female≥45kg exclusion criteria: * allergy or drug hypersensitivity * clinically significant medical history