Kornimate/medical-research-clean huggingface dataset:
radiation therapy with capecitabine in rectal cancer

Conditions: Rectal Cancer

Summary: this study will use an experimental combination of treatment with the drug capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. the drug capecitabine is an oral form of a drug called 5-fu which has been widely used to treat rectal cancer. this is a phase ii clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with capecitabine and radiation therapy. the purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. the study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur. preliminary human studies using capecitabine and radiation therapy have produced encouraging results with acceptable side effects.


Eligibility criteria:
eligibility criteria 1. histologic confirmation of adenocarcinoma of the rectum. 2. the lesion must be located in the rectum. for purposes of this study, the lesion must be within 12 cm of the anus as measured by sigmoidoscopy. 3. patients must have indication of a locally advanced lesion defined for this study as tumor through the bowel wall (\> t3) or involving regional lymph nodes (\>n1). clinical stage determination may be made by physical examination (for t4 lesions only), endoscopic ultrasound or ct scan of pelvis. 4. patients with metastatic disease are eligible provided operative intervention on primary site is anticipated. 5. patients must have adequate organ function defined as pretreatment leukocyte count \> 3,000/ul, platelet count \> 100,000/ul, serum creatinine \< 2.0 mg/dl, serum bilirubin \< 2 mg/dl. note: capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance \< 30 ml/min). in patients with calculated creatinine clearance of 30-50 ml/min capecitabine will begin at (-)1 level dose reduction (see section 6.3) 6. patients must be at least 18 years of age and have a zubrod performance status of \< 2 (see appendix 1.) 7. patients must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to the initiation of therapy. exclusion criteria: 1. patients may not have received previous pelvic irradiation for any indication, or previous chemotherapy for cancer therapy within the preceding 6 months. 2. patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent. 3. pregnant or lactating women may not participate. women/men of reproductive potential must agree to use an effective contraceptive method. 4. patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
drug-induced kidney injury model

Conditions: Acute Kidney Injury

Summary: to establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments


Eligibility criteria:
inclusion criteria: * drug-induce acute kidney injury exclusion criteria: * 1.dialysis patients; 2.no baseline creatinine; 3.obstructive aki; 4.clinical data were incomplete.

Keywords: acute kidney injury drug
psychosocial counseling in afghanistan

Conditions: Mental Health; Stress

Summary: the assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in mazar-e-sharif, afghanistan. treatment was administered by local counselors who had received specific education and training

psychosocial stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with ongoing war-like conditions. there is a lack of intervention research in these population. the purpose of this assessment was to examine whether the type of psychosocial counseling developed by our group is effective in reducing symptoms of depression and anxiety and significantly increasing the quality of life of help-seeking afghans.

Eligibility criteria:
inclusion criteria: * diagnosis of mental health problems by a local medical doctor exclusion criteria: * schizophrenia * mental retardation

Keywords: afghanistan depression anxiety social stress counseling medication psychotherapy mental health
the effect of preoperative explanatory videos in total extraperitoneal inguinal hernioplasty on information providing: a multicenter randomized controlled trial

Conditions: Inguinal Hernia

Summary: the use of electronic media in informed consent giving has become increasingly important in recent years. due to the easy access to information via electronical media, patients are primed in a heterogeneous manner concerning expectations and wishes regarding surgical interventions. inherent to its nature elective interventions are critically questioned as there is time for information gathering and reflection. in this study, the investigators set out to investigate the effect of an educational video as a supporting element in the process of informed consent giving for one the most frequently performed interventions in general surgery, namely inguinal hernia repair. in a multi-center setup, eligible patients for primary inguinal hernia repair will be randomly assigned to 1 of 3 groups. the intervention video provides basic principles of endoscopic extraperitoneal hernia repair. the second video is similar in length and design and displays general aspects of day surgery in the two study centres. the third group's link will lead to the digital version of the informed consent. primary outcomes will consist of 1) score in a multiple choice test assessing gain of knowledge regarding hernia repair, 2) difference in the state-trait anxiety inventory (stai) and 3) patient satisfaction questionnaire (icf, picker institute, germany) as assessed 1-2 days after the first consultation.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral hernia with indication for surgical therapy * signed informed consent form for trial participation exclusion criteria: * patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia * combination interventions (umbilical and inguinal hernia repair, e.g.) * cognitive, audio-visual or linguistic handicap raising concern of complete understanding of the research project

Keywords: inguinal hernia informed consent stai icf state-trait anxiety inventory individual clinician feedback
running related injury among novice runners

Conditions: Treatment Error; Overuse Injury

Summary: about 31% of the danish population participates regularly in running. the positive health benefits of running have been well documented in the literature. unfortunately, running has been connected with a high risk of injuries. running related injuries can cause a long rehabilitation and may even force the runner to quit running permanently. to ensure that running can be practiced as a safe exercise activity prevention must be considered.

training errors (i.e. excessive volume, sudden change of training routines etc.) are held to be the main reasons to running related injuries. fortunately, training errors can be avoided as training characteristics (distance, duration, pace) can be controlled by the runner. in order to avoiding training errors, especially excessive volume many novice runners follow 0-5 kilometres type training programmes. however, limited research has been conducted on the training volume of beginner programs and the risk of running related injuries. the purpose of this study is to investigate the relationship between the running volume the first 4 weeks of a running regime and the risk of running related injuries among novice runners. the relationship between running volume and running related injuries will be investigated in proportion to their body mass index (bmi).

Eligibility criteria:
inclusion criteria: * both gender between 16-65 years * no running-training within the last year * less than 20 hours of sports activity within the last year (in total) * internet access and mail address * body mass index between 18.5 - 25 or 30-35 * owns a pair of running shoes exclusion criteria: * do not want to use a gps watch * unable or unwilling to follow the running regime in 4 consecutive weeks * previous injury in lower extremity within the last 2 years * unable to read or understand danish * former heart surgery * known heart surgery * known lung disease * diabetes * current pregnancy * known tendency to shortness of breath or chest pain with activity * known tendency to leg pain when walking long distances

Keywords: running related injury overuse injury running pattern
comparison of surgery and active surveillance in the treatment of bosniak iii renal cysts

Conditions: Cystic Renal Disease; Kidney Cancer; Surgery

Summary: the incidence of renal cysts is rising due to increased abdominal imaging. renal complicated cysts have been traditionally classified according to the bosniak classification, which distinguishes cystic masses by specific features of walls and septa. the categories i and ii are benign and class iif most probably benign but needs a short radiological follow-up. categories iii and iv have been traditionally operated due to the increased risk of renal cell carcinoma. however, recently published studies show that approximately 50% of the operated bosniak iii cystic masses are benign, which means that half of the cases are overtreated by surgery. it has also been shown that surgical pathology of stable bosniak iif cysts is malignant in less than 1%, while the cysts, which are upgraded to higher bosniak classes will show malignant surgical pathology in 85%. so far, there is lack of prospective data on active surveillance in bosniak iii cystic masses. the aim of the study is to compare active surveillance and surgery in patients with bosniak iii renal cystic masses. patients will be randomized in active surveillance or immediate surgical excision of a cystic mass. in the active surveillance group, patients are followed according to the study protocol for 10 years and treated with delayed surgery if the cystic mass upgrades into bosniak iv/solid, becomes symptomatic or grows over a preclassified threshold. the primary objective is to compare surgical pathology between patients treated with immediate surgery versus delayed surgery. according to recent retrospective data, active surveillance of bosniak iii cystic masses is reasonable and oncologically safe. therefore a prospective randomized controlled trial is needed to get high level evidence to support a change in the treatment strategy. the study may significantly reduce unnecessary operations performed in patients with bosniak iii cystic masses.


Eligibility criteria:
inclusion criteria: * a sporadic single cm of bosniak 3 according to the bosniak classification v.2019 is diagnosed with ct or mri * maximal diameter of cm 10-70 mm * age ≥50 years * ecog performance status \<2 * life expectancy ≥5 years * patient is fit to undergo surgery and as. * patient understands a national language or english * signed informed consent exclusion criteria: * genetic syndromes associated with rcc * previously or simultaneously diagnosed and pathologically verified rcc * previously or simultaneously radiographically identified solid mass or cm of bosniak 3/4 with diameter ≥10mm * the target cm of bosniak 3 has progressed in sequential imaging from bosniak 1-2f * presence of radiographic findings which are suspect for nodal or distant metastatic disease * symptomatic cm * kidney insufficiency (gfr\<55 ml/min/1,73m2) * patients who have contraindications for both ct and mri imaging. . anatomically solitary kidney

Keywords: bosniak classification active surveillance renal cystic mass cystic renal cell carcinoma
acupuncture for post-tonsillectomy pain control in children

Conditions: Tonsillectomy; Post-Operative Pain; Acupuncture

Summary: a randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture. the hypothesis is that postoperative treatment of children undergoing tonsillectomy with acupuncture will reduce pain with minimal unwanted effects.

a randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture. the study will be conducted in accordance with the ethical standards of the helsinki declaration and has been approved by the human experimentation ethics committee of the ziv medical center and the ministry of health. patients will be recruited through the preoperative clinic conducted on the day before surgery. all parents and children will be given a full explanation of the study by an experienced member of the research team before randomization. the explanation will include the nature of acupuncture and the proposed treatment. parents will sign an informed consent. patients randomized to the acupuncture group will have a "trial run" at the time of consenting with a member of the research team experienced with performing acupuncture in children , in order to familiarize the child and family with the procedure.

Eligibility criteria:
inclusion criteria: • children aged 3-12 years undergoing tonsillectomy with or without adenoidectomy for tonsillar hypertrophy with suspected sleep disordered breathing and for recurrent tonsillar infections. exclusion criteria: * lack of parental consent * skin lesions near acupuncture sites * relevant psychiatric disorder * coagulopathy * drug allergies to regular analgesic treatment * intake of medications possibly affecting postoperative pain * any child who has received acupuncture treatment in the past or the parents or siblings have received such treatment.

Keywords: tonsillectomy post-operative pain acupuncture
efficacy and safety of testosterone nasal gel for treating hypogonadism in men.

Conditions: Hypogonadism

Summary: this is a phase iii study for evaluation of nasotestt efficacy compared to androgel in the treatment of male participants with hypogonadism condition (reduced levels of testosterone) that have clinical indication of hormonal replacement with testosterone.

this efficacy and safety study will evaluate the superiority of nasotestt (nasal gel) treatment compared to androgel (topic gel) after 60 days of starting use. the efficacy endpoint will be verified through the percentage of participants which presented at the end of 60 days normalized levels of total testosterone (\ 1050 ng/dl). secondary efficacy endpoints will be collected throughout the study through: evaluation of symptoms of erectile dysfunction (the international index of erectile function - iief), symptoms of prostatic disease (international prostate symptom score - ipss), measurement of abdominal perimeter and clinical global response to treatment (cgi-i questionnaire). as exploratory investigation, the satisfaction/comfort of nasotestt use will be assessed by a specific questionnaire that will be applied to participants at the end of study. safety evaluation data will include report of all adverse events, including type, frequency, intensity, seriousness, severity and action taken related to the investigational product of the study.

Eligibility criteria:
inclusion criteria: 1. male research participant, aged 18 years or older, with bmi between 18.50 and 32.00 kg/m2; 2. to present symptomatic or asymptomatic hypogonadism and serum total morning testosterone levels ≤ 300 ng / dl; 3. laboratory evaluation of prostate specific antigen (psa) levels within the normal range established by the laboratory or with non clinically significant changes (ncs) judged by the study investigator; 4. rhinoscopy and glatzel mirror test normal or with changes that do not interfere with nasal absorption of medication test; 5. present healthy skin in the region of comparator product application (skin of the shoulder). exclusion criteria: 1. diagnostic of prostatic and/or breast neoplasia; 2. psa levels 4 ng/ml or higher, or 3 ng/ml or higher with elevated risk for prostatic neoplasia development; 3. treatment with estrogens, gonadotropin releasing hormone (gnrh), growth hormone (gh) in the last 12 months; 4. treatment with testosterone or any other androgen in the last two weeks (oral, buccal and topic), four weeks (intramuscular) or twelve weeks (implant) that precede randomization in the study; 5. active rhinitis: allergic, seasonal, medicinal, vasomotor and atrophic; 6. presence of grade ii or iii septum deviation (in any region of the nasal septum) and / or presence of nasal polyps or other conditions that determine nasal obstruction; 7. hypersensibility of testosterone as well as to components present in the formulation of drugs.

Keywords: hormonal reposition, testosterone nasal, nasotestt
procure tumor and initiate melanoma tumor-reactive tumor infiltration

Conditions: Melanoma

Summary: procure tumor and initiate melanoma tumor-reactive tumor infiltration lymphocytes (til)

the purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of melanoma.

Eligibility criteria:
inclusion criteria: 1. patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose. 2. patients must be \> 15 years of age and must have metastatic melanoma. 3. patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery. 4. patients must be able to understand and sign the informed consent document. 5. patients must be able to complete the supplemental data form exclusion criteria: 1. women who are pregnant or breastfeeding 2. inability to give consent
echocardiographic characterization of cardiac amyloidosis

Conditions: Cardiac Amyloidosis

Summary: this is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at the fondazione policlinico universitario agostino gemelli irccs (rome, italy) will be enrolled. the primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype. secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.


Eligibility criteria:
inclusion criteria: * patients with cardiac amyloidosis, defined according to the recommendations provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data and with at least one follow-up visit. exclusion criteria: * missing data * decline to the study participation

Keywords: echocardiography left ventricle
effects of eldoa in patients with cervicogenic headache

Conditions: Cervicogenic Headache

Summary: the aim of our study is to determine the effect of eldoa in relieving pain, improving rom and functional disability in patients with cervicogenic headache. this study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. moreover, it would add to the society as no literature is available on the effect of eldoa technique in the management of cervicogenic headache.

cervicogenic headache (ceh) is mainly caused by neck or paravertebral soft tissue lesions. it is chronic headache that arises from the atlanto-occipital and upper cervical joints and is perceived in one or more regions of the head or face. one of the known treatment options that create decompression at spinal segment level is called eldoa it is described as a conditioning method involving a series of movements and body stretches to help correct body posture, rehabilitate people with injuries and prevent injuries

Eligibility criteria:
inclusion criteria: * age: 30-45 years * both male and female. * onset of pain \> 4 weeks. * flexion rotation test positive with estimated rotation range reduced by more than 10 degrees from the anticipated normal range (44 degrees) * tenderness of upper three cervical joints. * presence of active trigger points in upper trapezius and sub occipital extensors. exclusion criteria: * hypertension. * recent (\<6 months) whiplash injury and other cervical soft tissue injuries. * history of cervical spinal vertebrae fracture. * positive sharp purser test * acute disc protrusion • history of cancer. * previous surgical intervention of head, neck and thoracic spine

Keywords: eldoa cervicogenic headache cervical spine
gate: generalized anxiety - a treatment evaluation

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with generalized anxiety disorder.

we are currently conducting a treatment study to reduce stress and anxiety in people with generalized anxiety disorder (gad). this study will not use a medication, but instead will involve weekly stress reduction classes that use different strategies to reduce anxiety. the study involves having a formal psychiatric interview, filling out questionnaires, ecgs, saliva samples, a urine test for drugs of abuse, and study visits over 12 weeks. each study visit will take a few hours. qualified participants will be compensated for time and travel.

Eligibility criteria:
inclusion criteria: * male or female outpatients \> 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder * clinical global impression-severity scale (cgi-s) score of 4 or higher * off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, or stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose * willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol. * for women of childbearing potential, willingness to use a reliable form of birth control exclusion criteria: * patients unable to understand study procedures and participate in the informed consent process. * pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age * women who are planning to become pregnant * serious medical illness or instability for which hospitalization may be likely within the next year * significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the beck depression inventory-ii \[bdi-ii\]) * history of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment * posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months * lifetime history of psychotic disorder, bipolar disorder, or developmental disorder * significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview) * prior experience with (more than 5 yoga classes or cbt sessions within the last 3 years) and/or current practice of mindbody techniques (e.g., yoga, meditation, tai-chi, etc) or cognitive behavioral therapy (cbt) * concomitant therapy for generalized anxiety disorder (gad) (any therapy) * physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems) * cognitive impairment (moca\<21)

Keywords: generalized anxiety disorder gad yoga cbt