Kornimate/medical-research-clean huggingface dataset:
results of distal clavicle graft in shoulder dislocation clavicle auto graft in patient with recurrent anterior shoulder dislocation

Conditions: Shoulder Injuries

Summary: to evaluate the clinical and radiological outcome of distal clavicle auto graft in patient with recurrent shoulder dislocation

the glenohumeral joint is the most commonly dislocated joint of the human body,the stability of gh joint relies on a complex network of static and dynamic structures,the anterior labrum plays a key role in antero posterior stability as it deepens the glenoid cavity up to 50% there option for glenoid reconstruction including: distal clavicle auto graft (dca), proven is a good option to coracoid transfers

Eligibility criteria:
inclusion criteria: * recurrent traumatic anterior shoulder dislocation (≥ 3 times). exclusion criteria: .on-track hill-sachs lesion. .multi directional instability. * voluntary dislocation.
self-sampling for non-participants in an organised cervical cancer screening programme

Conditions: Cervical Cancer

Summary: the trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (hpv) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.

the choice trial is a parallel randomised controlled, open label trial. participants will be equally randomised into three arms: 1) directly mailed a second reminder including a hpv self-sampling kit; 2) mailed a second reminder offering a hpv self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) mailed a second reminder for a conventional practitioner-collected sample (control group).

Eligibility criteria:
inclusion criteria: * women resident in the central denmark region who have not participate in cervical cancer screening after an invitation and one reminder exclusion criteria: * women younger than 30 years are not included due to the lower specificity of hpv dna tests in younger women

Keywords: hpv self-sampling, cervical cancer screening
a phase 1 study in subjects with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.

this is a first in human phase 1 multicenter open label study to evaluate the safety and tolerability of amg 224 in subjects with relapsed or refractory multiple myeloma. the study will be conducted in 2 parts. part 1 is the dose-exploration and part 2 is the dose-expansion. study medication will be administered once every 3 weeks by intravenous (iv) infusion.

Eligibility criteria:
inclusion criteria: - pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma. prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalidomide). * willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines). * measurable disease per the international myeloma working group (imwg) response criteria * hematological function, as follows, without transfusion support: * absolute neutrophil count ≥ 1.0 x 10\^9/l, * platelet count ≥ 75 x 10\^9/l (in patients with \< 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 x 10\^9/l (in patients with ≥ 50% of bone marrow nucleated cells were plasma cells) without transfusion or growth factor support * hemoglobin \> 8 g/dl (\> 80 g/l) * adequate renal and hepatic function * left ventricular ejection fraction (lvef) \> 50% exclusion criteria: * currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study * autologous stem cell transplant less than 90 days prior to study day 1 * multiple myeloma with igm subtype * poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, plasma cell leukemia, waldenstrom's macroglobulinemia or amyloidosis * glucocorticoid therapy (prednisone \> 30 mg/day or equivalent) within 7 days prior to study day * myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (new york heart association \> class ii) * a baseline ecg qtcf \> 470 msec * anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1

Keywords: multiple myeloma relapsed multiple myeloma refractory multiple myeloma
hypofractionated radiotherapy for thymic epithelial tumors

Conditions: Thymoma and Thymic Carcinoma; Thymoma; Thymic Cancer; Thymic Epithelial Tumor

Summary: the goal of this clinical trial is to learn if hypofractionated radiotherapy works to shorten the treatment time without increasing the side effects in patients of thymic epithelial tumors. the main questions it aims to answer are: * does hypofractionated radiotherapy provide better results? * can hypofractionated radiotherapy reduce toxic and side effects compared with conventional radiotherapy? researchers will compare the efficacy and safety of hypofractionated radiotherapy after thymic tumor surgery. participants will: * receive hypofractionated radiotherapy or conventional radiotherapy * visit the hospital regularly once every 12 weeks for checkups and tests

according to the world health organization histological classification system, thymic epithelial tumors (tet) are divided into thymoma and thymic carcinoma. surgery is the main treatment for thymic tumors, and radiotherapy (rt), as an important auxiliary method of surgery, also plays an irreplaceable role in all stages of thymoma. hypofractionated radiotherapy is a common mode of radiotherapy for thoracic tumors. unlike conventional radiotherapy, hypofractionated radiotherapy has a higher single dose and a shorter course of treatment. because it improves the treatment efficiency, it can reduce the treatment time of patients and medical institutions and the cost of patients. in the postoperative radiotherapy stage, conventional radiotherapy and hypofractionated radiotherapy were used. the course of hypofractionated radiotherapy was shorter than that of conventional radiotherapy. patients chose to accept hypofractionated radiotherapy as the hypofractionated group, but not the conventional group.

Eligibility criteria:
inclusion criteria: 1. patients must provide written informed consent. 2. 18 years old ≤ age \<75 years old. 3. thymoma confirmed by pathology: type a, type ab, type b1, type b2, type b3. thymic carcinoma. patients with previous thymectomy were required to have complete surgical related data. 4. masaoka⁃koga ⁃ stage ⅰ-ⅲ 5. ecog performance status 0-2. 6. expected survival time \> 1 year. 7. participants of childbearing age must agree to use effective contraception during the trial; in women of childbearing age, a serum or urine pregnancy test must be negative. 8. patients who are not lactating. 9. sufficient bone marrow reserve and good function of important organs. exclusion criteria: 1. patients with prior thoracic radiotherapy; 2. diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure; 3. uncontrolled infectious disease or other serious medical or mental illness that may interfere with care 4. patients with other malignant tumors that are not under stable control; 5. known history of mental illness, substance abuse, alcohol or drug abuse. 6. other conditions deemed unsuitable for enrollment by the attending physician.

Keywords: thymoma hypofractionated radiotherapy thymic carcinoma
non-surgical management of attenuated and deleterious (classical) familial adenomatous polyposis: a long-term surveillance program

Conditions: Attenuated Familial Adenomatous Polyposis; Deleterious Familial Adenomatous Polyposis

Summary: the primary objective of this chart review study is to evaluate the outcomes of subjects with attenuated familial adenomatous polyposis (afap) and deleterious familial adenomatous polyposis (fap) who have not undergone surgical resection of the colon. a secondary objective of this study is to compare 1) the colonoscopic and pathology histories including history of ampullary adenoma in the duodenum over family generations, 2) the use of chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic surgical resection of the colon with those that have elected to continue routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary adenoma and level of dysplasia, etc) which may influence management decisions.

the utmdacc family history database will be queried for the presence of cases meeting the above criteria (attenuated familial adenomatous polyposis (fap), classical afp \[i.e. identifiable apc mutation\], and/or a compatible family history or personal adenoma burden of \> 50 adenomas). the data related to the patients with attenuated fap and classical afp who underwent endoscopic surveillance or surgery will be collected through chart review and all data is retrospective as of february 15, 2016. the university of texas md anderson cancer center (utmdacc) medical record number for these cases will be used to identify the patient in clinicstation: 1) records of endoscopy procedures, 2) operative reports, and 3) associated clinic notes will be reviewed for: a) whether the above evaluation criteria have been met, b) age, c) gender, d) age at initial colonoscopy, e) total number of colonoscopies, f) number of adenomas identified, g) cancer diagnoses, h) chemopreventive medications, i) type of surgery, j) number of hospitalizations, k) length of hospital stay, l) identification of an underlying apc mutation, and ll) family history information. the ut mdacc family history database will also be reviewed for updated family history information including ampullary adenomas and outcomes of genetic testing for identified cases.

Eligibility criteria:
inclusion criteria: 1. participants with either a genetic diagnosis of afap/fap (i.e. an identifiable apc gene mutation), and/or a compatible family history and pathology including history of ampullary adenoma in the duodenum over family generations, or personal adenoma burden of \> 50 adenomas are to be included. exclusion criteria: 1. participants who do not have with attenuated familial adenomatous polyposis (afap) and deleterious familial adenomatous polyposis (fap).

Keywords: attenuated familial adenomatous polyposis afap deleterious familial adenomatous polyposis fap chart review
effect of three weight-adjusted vasopressors for elective cesarean delivery

Conditions: Cesarean Section Complications

Summary: this study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.

at present, the ed90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. we compare the effects of three drugs on the fetus and mothers at the concentration of ed90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .

Eligibility criteria:
inclusion criteria: 1. singleton pregnancy at term scheduled to be delivered via elective cesarean delivery; 2. height 150-180 cm; 3. american society of anesthesiologists (asa) physical status ii-iii; 4. body mass index (bmi) \<35 kg/m2. exclusion criteria: 1. transverse presentation, fetal macrosomia; 2. uterine abnormalities (eg, large fibroids, bicornuate uterus); 3. polyhydramnios; 4. ruptured membranes, oligohydramnios; 5. intrauterine growth restriction; 6. gestational or nongestational hypertension, diabetes, or eclampsia; 7. hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure; 8. contraindications for combined spinal-epidural anesthesia; 9. participants who declined to sign informed consent forms.
study of int 747 in combination with urso in patients with primay biliary cirrhosis (pbc)

Conditions: Liver Cirrhosis, Biliary

Summary: the primary hypothesis is that int-747 will cause a reduction in alkaline phosphatase levels in primary biliary cirrhosis patients, over a 12 week treatment period, as compared to placebo.

none provided

Eligibility criteria:
inclusion criteria: * male or female age 18 to 70 years. * stable dose of ursodeoxycholic acid (urso, udca) for at least 6 months prior to screening. * female patients must be postmenopausal, surgically sterile, or prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of dosing. * male patients must be prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing. * proven or likely pbc, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors: 1. history of increased ap levels for at least 6 months prior to day 0 2. positive ama titer (\>1:40 titer on immunofluorescence or m2 positive by elisa) or pbc-specific antinuclear antibodies (antinuclear dot and nuclear rim positive) 3. liver biopsy consistent with pbc. * screening ap value between 1.5 and 10 × uln. exclusion criteria: * administration of the following drugs at any time during the 3 months prior to screening for the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids. * screening conjugated (direct) bilirubin \>2 × uln. * screening alt or ast \>5 × uln. * screening serum creatinine \>1.5 mg/dl (133 mol/l). * history or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites). * history or presence of other concomitant liver diseases including hepatitis due to hepatitis b or c virus (hcv, hbv) infection, primary sclerosing cholangitis (psc), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (nash). * pregnancy.

Keywords: pbc, primary biliary cirrhosis, liver,
clinical study, multicenter, randomized with 2 arms of pantoprazole + domperidone and pantoprazole isolated at the gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: this superiority phase iii study to compare the combination of pantoprazole and domperidone with pantoprazole isolated to the treatment of gastroesophageal reflux disease. the hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.


Eligibility criteria:
inclusion criteria: 1. subscription of ic; 2. age ≥ 18 years and \<70 years 3. diagnosis initial clinical or previous symptomatic gerd; 4. symptom score ≥ 4; 5. ability to conduct examinations of endoscopy; 6. ability to perform washout of drug classes ppis, h2 antagonists, and prokinetics for at least 14 days. exclusion criteria: 1. presence of esophagitis requiring intervention, esophageal varices, barrett's esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy pangastritis detected at the time of study enrollment; 2. eradication treatment of h. pylori completed less than 15 days of v0; 3. presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no evidence of gastrointestinal bleeding); 4. gastric or esophageal surgery prior (except for simple ulcer closure); 5. females in pregnancy, lactation, or who wish to become pregnant if they refuse to use adequate contraception during the study period. 6. concomitant serious diseases such as kidney failure, heart and liver; 7. suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancer diagnosed in the last 5 years; 8. history of gastric cancer in relatives of 1st degree; 9. use of illicit drugs or alcohol abuse according to the investigator; 10. values changed (outside the normal range for the local laboratory) in leukocytes, platelets or hemoglobin; 11. significant changes in serum sodium, potassium, calcium or creatinine; 12. intolerance or allergy to any component of the drugs evaluated in the study; 13. use of anti-inflammatory drugs (nsaids), antiemetics, macrolides and systemic steroids for a period of not less than 2 weeks prior to the study or who have expected necessity of prolonged use during the study treatment; 14. current use of bisphosphonates, as well as those who need calcium channel blockers or other drugs that affect esophageal motility or lower esophageal sphincter tone. 15. use of other scheduled medications metabolized by cytochrome cyp3a4 during the study; 16. participation recent (past 12 months) or participation in a clinical trial expected during this study in other clinical trials involving drugs of any kind.
down syndrome, physical activity and sleep apnea

Conditions: Down Syndrome

Summary: to realize a sleep phenotyping in a population with down syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome.

sleep disorders are widely observed in the down's syndrome population, due to a number of risk factors, and can become established in early childhood. diagnosis of sleep disorders in down's syndrome is difficult and often delayed, which can contribute to poor health in children with down's syndrome. phenotyping sleep characteristics in this down syndrome population will enable early identification of the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic.

Eligibility criteria:
inclusion criteria: * total autosomal trisomy caused by the presence of a third copy (partial or total) of chromosome 21 exclusion criteria: * people with abnormal electrocardiographic tracings, * existence of heart failure or cardiovascular disease, as determined by any abnormalities in cardiovascular adaptations to exercise. * existence of a declared or uncontrolled progressive disease. * pregnant or breast-feeding women.

Keywords: down syndrome sleep disorders apnea physical activity neurocognition autonomic nervous system
effectiveness of cga on qol in older patients with cancer receiving systemic therapy

Conditions: Geriatrics; Comprehensive Geriatric Assessment

Summary: the g-oncocoach study aims to evaluate the effectiveness of the comprehensive geriatric assessment (cga) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is cga coordinated by an oncology team.

the g-oncocoach study aims to evaluate the effectiveness of the comprehensive geriatric assessment (cga) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is cga coordinated by an oncology team. the medical research council (mrc) framework, developed to test complex interventions, is used to design this study. a multicenter randomized controlled trial will be conducted in two academic hospitals (uz brussel - uz leuven) with a follow-up at 3, 6 and 12 months after the start of systemic therapy. patients will be recruited in both academic hospitals in the period between the cancer diagnosis and the start of the systemic therapy.

Eligibility criteria:
inclusion criteria: * patients aged 70 years and older * diagnosis of cancer (solid tumors) * starting systemic therapy (chemotherapy, immunotherapy, targeted therapy or hormonal therapy) * curative intent (neo-adjuvant / adjuvant / concomitant / other) * palliative intent (first line / second line) * patients must be able to comply with the study procedures * physician-estimated life expectancy must be more than 6 months exclusion criteria: * patients with antihormonal monotherapy * previous participation in geriatric intervention studies * patients included in clinical trials with non-registered anticancer drugs

Keywords: cancer older persons comprehensive geriatric assessment geriatric interventions patient compliance
validation of the sickle cell disease pain burden interview

Conditions: Sickle Cell Disease; Pain

Summary: the purpose of this study is to validate a brief survey tool, the scd pain burden interview (scpbi), which can be used in the clinical and/or research settings to assess the impact of pain on children with sickle cell disease.


Eligibility criteria:
inclusion criteria: * documented sickle cell disease * 7 years old or greater * primary caregiver present at the first visit for children \< 18 years of age exclusion criteria: * primary language spoken other than english * patient is in acute pain episode at time of initial visit
a study in healthy men to test whether zongertinib influences the amount of 4 other medicines (dabigatran, rosuvastatin, metformin, and furosemide) in the blood

Conditions: Healthy

Summary: for part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. for part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).


Eligibility criteria:
inclusion criteria : * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 55 years (inclusive) * body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ich-gcp) and local legislation prior to admission to the trial exclusion criteria : * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmhg), diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator further exclusion criteria apply.