Kornimate/medical-research-clean huggingface dataset:
a phase ii trial of perifosine following tyrosine kinase inhibitor (tki) - failure in patients with renal cancer

Conditions: Renal Cell Carcinoma

Summary: this is a single-arm phase ii trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.

this is a single-arm phase ii trial assessing the antitumor activity as measured by progression free survival of perifosine in patients with metastatic rcc who have progressed on sorafenib or sunitinib. a total of 48 patients will be enrolled in the trial. all subjects will have histologically confirmed metastatic rcc with predominantly clear cell features (≤ 50% other histologic features). patients who have been taken off sorafenib or sunitinib may only have been off therapy for less than three months prior to study enrollment. patients who remain on sorafenib or sunitinib may continue on drug at their current dose until two weeks prior to the initiation of perifosine therapy. the study consists of three periods: pre-treatment/screening, treatment, and follow-up. day 1 will be defined as the first day of perifosine therapy. patients will remain in the treatment phase until progression or toxicity. patients will be seen by an md every 3 weeks with 6 weeks defining one cycle of therapy. tumor evaluations will occur every 6 weeks.

Eligibility criteria:
inclusion criteria: * patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). there must be histologic confirmation by the treating center of either the primary or a metastatic lesion * patients must have experienced disease progression by recist criteria while on sorafenib or sunitinib * patients must be off of sorafenib or sunitinib for \>= 2 weeks prior to initiation of perifosine and \<= 3 months prior to enrollment * patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy * patients must have measurable disease that is not curable by standard radiation therapy or surgery * age \>= 18 years * ecog performance status 0 or 1 * - patients must have the ability to understand and willingness to sign a written informed consent document exclusion criteria: * history or clinical evidence of cns disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke * other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage iv disease * patients may have had prior sorafenib or sunitinib and cannot have been treated with both tkis * patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed * patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib * prior thalidomide or ifnα are allowed for adjuvant therapy or stage iv disease * patients may not have had prior mtor inhibitors (cci-779, rad001)

Keywords: renal cell carcinoma tyrosine kinase inhibitor failure
transarterial chemoembolization vs cyberknife for recurrent hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: primary objective: to compare the efficacy of tace vs. cyberknife sbrt in the treatment of locally recurrent hcc after initial tace. secondary objectives: 1. to determine the progression-free survival of tace vs. cyberknife sbrt 2. to determine the overall survival of tace vs. cyberknife sbrt for locally recurrent hcc 3. to determine the toxicities associated with tace or cyberknife sbrt for the treatment of recurrent hcc.


Eligibility criteria:
inclusion criteria: * confirmed hepatocellular carcinoma by one of the following: * histopathology * one radiographic technique that confirms a lesion \>=2 cm with arterial enhancement with washout on delayed phase * hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure * radiographic evidence of persistent, progressive or recurrent disease in an area previously treated with tace. this evaluation should be determined after 6 weeks of initial tace * multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the attending radiation oncologist and interventional radiologist amenable to treatment by the respective modality * eligible patients must undergo an iv contrast ct scan of the liver within 6 weeks of enrollment onto the study; a contrast enhanced liver mri may be substituted for the iv contrast ct of the liver. * a recent serum afp must also be obtained within 4 weeks of enrollment. * unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 7.5cm as long as the dose constraints to normal tissue can be met * eastern clinical oncology group performance status 0, 1 or 2 * patients with liver disease classified as child pugh class a/b; if child's class b, score must be 8 or less * albumin \>= 2.5 g/dl * total bilirubin \<= 3 mg/dl * inr \<= 1.5 * creatinine \<= 2.0 mg/dl * age \>= 18 years old * life expectancy\>= 6 months * ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document. exclusion criteria: * prior radiation for the recurrent liver tumors * prior radiotherapy to the upper abdomen * prior rfa to index lesion * liver transplant * tumors \>= 7.5 cm in greatest axial dimension * portal vein thrombus * large varices within 2 cm of index lesion (seen on cross section imaging) * contraindication to receiving radiotherapy * active gastrointestinal bleed within 2 weeks of study enrollment * ascites refractory to medical therapy * women who are pregnant * administration of any systemic chemotherapy within the last 1 month * presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases * participation in another concurrent systemic treatment protocol * prior history of malignancy other than hcc
effects of pulses on loudness

Conditions: Hearing Loss, Cochlear

Summary: the aim of this study is to investigate the effect of varying additional factors on loudness summation in neuro zti cochlear implant users.

primary objective: - to assess the effect of the number and spatial distribution of active electrodes on the stimulation charge required to achieve the loudness associated with c and t levels (experiment 2). secondary objectives: * to assess how loudness is affected by changes in electrical charge of individual pulses made by adjusting the pulse amplitude versus adjusting pulse duration (experiment 1). * to assess how loudness elicited by a train of pulses is affected by the duration of that pulse train (experiment 3). experiment 1: the test will investigate the effect of loudness on changes in electrical charge of individual pulses, made by separately adjusting pulse amplitude or pulse width. the electrical charge required to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable") either when increasing the amplitude or the duration of the pulses. experiment 2: the test will investigate the effect of the number of stimulating electrodes and their distribution within the cochlea on the stimulation levels required to achieve t-levels and c-levels and to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable"). experiment 3: the test will investigate the effect on loudness of trains of pulses elicited by modifications to the duration of those trains, when operating around t and c levels. stimulation durations ranging from 10 to 600 ms will be tested. pulse trains will be presented to either one or several electrodes to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable").

Eligibility criteria:
inclusion criteria: * neuro one or neuro 2 user * unilateral or bilateral recipient * 12 months ci experience to allow for acclimatization to the ci sound processing and pathological changes that could alter the electrode - tissue interface and therefore t- \& c-levels. * having at least 7 step sizes on three electrodes in their current clinical map (for experimentation 1). * able and willing to provide reliable threshold and comfort level judgements exclusion criteria: * medical conditions that contraindicate the study tests (e.g. tinnitus, dizziness) * unrealistic expectations from the candidate regarding the possible benefits, risks, and limitations that are inherent to the device * unwillingness or inability of the candidate to comply with all investigational requirements * vulnerable population

Keywords: cochlear implant
comparison of two treatments on nonspecific neck pain

Conditions: Neck Pain

Summary: the purpose of this study was to evaluate the impact of ischemic compression (ic) and instrument assisted soft tissue mobilization (iastm) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain.

chronic nonspecific neck pain affects approximately 67% of the global population at least once in their lifetime. this type of neck pain, which is not linked to any specific cause or disease but often associated with the musculoskeletal system, can result from muscle strain or spasms in the neck. it causes functional limitations and decreases quality of life for those affected. individuals frequently turn to healthcare services and pain-relieving medications in their efforts to manage this discomfort. chronic nonspecific neck pain is recognized as a significant public health challenge due to its considerable socioeconomic impact. several studies have indicated that myofascial trigger points in the neck region are associated with nonspecific neck pain and that myofascial trigger point therapy can reduce pain. therefore, the role of myofascial trigger point therapy in the treatment of nonspecific neck pain has been emphasized in studies.

Eligibility criteria:
inclusion criteria: 1. having nonspecific neck pain and at least 3 myofascial trigger points in the back and neck muscles, 2. pain duration exceeding 3 months, 3. working with a computer for at least 20 hours per week for at least 1 year, 4. pain intensity rated as at least 3 on the visual analog scale (vas), 5. age between 18 and 50 years exclusion criteria: 1. use of anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medications at the start of the study or within 1 week prior to the study, 2. history of cervical spine surgery or trauma, 3. neck pain, including inflammatory rheumatic diseases, 4. malignancy or structural deformity, 5. coagulation disorders, 6. presence of cervical radiculopathy or myelopathy, 7. individuals who have undergone any physical therapy and rehabilitation interventions to the neck and back regions in the last three months

Keywords: neck pain trigger point exercise physical therapy manual therapy
effects of knee-extensor exercise training in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: copd patients have a reduced exercise tolerance due to a ventilatory limitation. several studies have shown altered skeletal muscle function. the investigator will study the physiological response to knee-extensor exercise in copd patients.

reduced exercise tolerance is one of the hallmarks of copd. the principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. however the weak correlation between exercise capacity and fev1 implies that other factors than reduced pulmonary function contribute to this impairment as well. several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction. numerous exercise studies in copd patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation. in this study we investigate training effects in patients with moderate to severe copd with special focus on skeletal muscle. copd patients will perform high intensity aerobic interval knee-extensor exercise training 3 days/week for six weeks . at baseline and follow-up, muscle oxygen consumption and mitochondrial respiration will be measured.

Eligibility criteria:
inclusion criteria: * copd diagnosis with fev1\<70% exp, fev1%fvc \<70 % * age\> 50 years exclusion criteria: * heart failure * symptomatic coronary artery disease * cancer * alcohol and drug abuse * severe mental illness * lower respiratory illness * participation in exercise- or lung rehabilitation program last 3 months * pregnancy * oral steroid use

Keywords: exercise knee extensor
a study of maribavir in adults with post-transplant cytomegalovirus (cmv) infection

Conditions: Cytomegalovirus (CMV)

Summary: the main aim of this study is to check how effective the treatment with maribavir has been to remove the cmv viruses from the blood of an adult person with cmv infection after a transplant. other aims are to learn more about how maribavir is used in normal clinical routine, study the profiles of adults treated with maribavir, and what other treatments have been given, and describe healthcare resources used for cmv management. only data already available in the medical records of the participants will be reviewed and collected during this study.

this study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. the index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. the pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.

Eligibility criteria:
inclusion criteria: * aged greater than or equal to (\>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation. * received an hsct/sot. * diagnosed with cmv infection/disease any time after the hsct/sot date. * initiated maribavir at least 4 months before the chart abstraction date (or at time of central ethics committee \[cec\]/local ethics committee \[lec\] submission as per local regulation). * participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation). exclusion criteria: * participants who do not provide informed consent, where consent is required per country regulations. * participants who participated to clinical trials investigating maribavir.

Keywords: drug therapy
follicle stimulating hormone (fsh) and luteinizing hormone (lh) response to low dose clomiphene citrate in normally menstruating fertile women

Conditions: Infertility

Summary: the goal of the study is to quantitatively evaluate pituitary hormone response, follicle stimulating hormone (fsh) and luteinizing hormone (lh), to low doses of clomiphene citrate in normally fertile women.

empirical use low-dose clomiphene citrate has been advocated by some practitioners to enhance fecundity in women with unexplained infertility. no clinical trials have examined the efficacy of such treatment in the patient population, although certain studies have shown that active ovulation induction can be effective in women with unexplained infertility, and that cycle fecundity is improved for normally cycling women with active ovulation management in a program of artificial insemination. since clomiphene citrate can have paradoxical effects on fertility through its anti-estrogenic mode of action, the benefit or lack of benefit from treatment with clomiphene citrate in this patient group needs to be evaluated. we aim to establish a dose response of fsh and lh to various low doses of clomiphene citrate in normally cycling women of known fertility, that is women with an intact hypothalamic-pituitary-ovarian-axis. the significance of this information is that it may help to elucidate the mechanism by which low-dose clomiphene citrate may improve fecundity in patients with unexplained infertility as it is currently being used empirically.

Eligibility criteria:
inclusion criteria: * normal cycling healthy women with known fertility * regular menses every 24 - 35 days * 18 to 35 years of age * be within 20% of ideal body weight * normal tsh, prolactin and mid luteal phase progesterone exclusion criteria: * women with infertility issues * irregular menstrual cycles

Keywords: pituitary hormone response clomiphene citrate follicle stimulating hormone luteinizing hormone
effects of treatment with enf (electro neuro feedback) in the reduction of post-surgical hematoma in patients undergoing hip replacement: evaluation with ultrasound method

Conditions: Post-surgical Hematoma, Hip Replacement , Surgery

Summary: the study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. these patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. this evaluation will then be repeated after 5 treatment sessions with enf (electro neuro feedback). the patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment enf (electro neuro feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to feedback (feedback). t


Eligibility criteria:
inclusion criteria: * gender: male and female * age: 35-85 years include * entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery * absence in history of neurological or psychiatric disorders. * signature of the informed consent and consent to collaborate in all the procedures of the study exclusion criteria: * presence of severe neurological / psychiatric pathologies * to sign the informed consense * of serious cardiological pathologies that can compromise patient safety * of pace maker or spinal cord stimulators or other subcutaneous electronic instruments * of active tumors in the treatment area
to prevent type i-ii myoma after tcrm recurrence by gonadotropin-releasing hormone (gnrh )analogues or mifepristone

Conditions: Submucous Leiomyoma of Uterus

Summary: transcervical resection of myoma(tcrm) has a good therapeutic effect while the probability of complete resection of type i and ii fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.at present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after tcrm.the present prospective,multicentre,randomised controlled clinical trial will enrol women after tcrm and treat them with mifepristone(10mg)or gnrha(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with tcrm，thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.


Eligibility criteria:
inclusion criteria: 1. age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years; 2. type i and ii submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm; 3. type i or ii submucosal fibroids confirmed by tcrm and no degeneration confirmed pathologically; 4. a mri test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery; 5. patients would not had used drugs such as mifepristone and gnrha 3 months before surgery; 6. participate in this trial and sign the informed consent form voluntarily . exclusion criteria: 1. combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc; 2. have fertility requirements within 3 years after surgery; 3. estrogen-dependent diseases such as adenomyosis and endometriosis; 4. drugs such as mifepristone or gnrha have been used before surgery; 5. mifepristone or gnrha drug treatment is contraindicated or cannot tolerate tcrm surgery.

Keywords: submucous leiomyoma transcervical resection of myoma gnrh analogues
duloxetine versus placebo for osteoarthritis knee pain

Conditions: Osteoarthritis Knee Pain

Summary: the primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Eligibility criteria:
inclusion criteria: * male or female outpatients with osteoarthritis knee pain. exclusion criteria: * cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. * acute liver injury (such as hepatitis) or severe cirrhosis. * previous exposure to duloxetine. * body mass index (bmi) over 40. * major depressive disorder. * daily use of narcotics.
wound infusion vs spinal morphine for post-caesarean analgesia

Conditions: Post Caesarean Analgesia

Summary: the aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective caesarean delivery.

double blind, 3 groups * control group: rachi 0,1 ml saline, infusion 300ml saline * group rachi-morphine: 0,1ml =100µg morphine/300ml saline * group kt: 0,1 ml saline/300 ml naropin 0.2%

Eligibility criteria:
inclusion criteria: * patients aged 18 years and more, asa 1 or asa 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a pfannenstiel incision and having signed the informed consent form. exclusion criteria: * refusal of the patient or contra-indication to locoregional anesthesia * allergy to the products used * asa 3 * asa 4 * sleep apnea syndrome and/or obesity (bmi \> 35) * size inferior to 155cm * existence of a language barrier

Keywords: analgesia caesarean wound infiltration intrathecal morphine.