Kornimate/medical-research-clean huggingface dataset:
study of therapeutic options for subjects discontinuing efalizumab and experiencing disease recurrence

Conditions: Psoriasis

Summary: this is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.


Eligibility criteria:
inclusion criteria: * participation in genentech study acd2601g, genentech study hupa 600 or serono study imp24011. * inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the investigator. psoriasis had to be rapidly developing, symptomatic and inflammatory in nature. * written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care. * female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either: * being post-menopausal or surgically sterile, or * using an accepted form of contraception. * confirmation that the subject was not pregnant had to be established by a negative urinary hcg test at sd1. a pregnancy test was not required if the subject was post-menopausal or surgically sterile. * outpatient status at the time of enrolment. exclusion criteria: * disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.

Keywords: psoriasis discontinuation of efalizumab managing inflammatory recurrence
a study of hrs-4642 in combination with antineoplastic agents in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: to evaluate the safety and preliminary efficacy of hrs-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with kras g12d mutations, and to determine the maximum tolerated dose (mtd) and the recommended phase ii dose (rp2d).


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. age 18-75 years old (inclusive) at the time of signing the informed consent form 3. male or female 4. ecog score of 0 or 1 5. expected survival ≥ 12 weeks 6. at least one measurable lesion according to recist v1.1 criteria exclusion criteria: 1. any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study 2. presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures 3. known hypersensitivity to any component of hrs-4642; history of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; known history of severe hypersensitivity to antineoplastic agents in combination 4. received other major surgery other than diagnosis or biopsy within 28 days before the first dose; minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures 5. subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter 6. use of a live attenuated vaccine within 28 days prior to the first dose of study medication, or anticipated need for a live attenuated vaccine during study treatment 7. have a history of immunodeficiency, including a positive hiv test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation 8. those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated 9. active hepatitis b 10. presence of clinically significant acute or chronic pancreatitis 11. poorly controlled or severe cardiovascular and cerebrovascular diseases, arterior/venous thrombotic events within 6 months prior to study entry 12. presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the start of study treatment, but screening can be performed if surgical treatment has been performed and the obstruction has been completely resolved
beneficial effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy

Conditions: Lung Neoplasm Malignant

Summary: it is important for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy, because radiation therapy also affect the lung function and general conditions of patients. the effect and safety of pulmonary rehabilitation is well-proven in various diseases. because there is no standard treatment, the investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.

roles of the radiation therapy in lung cancer are as followings; 1) to treat the lung caner stage 1 \~2 patients, who are inadequate for operation due to declined lung function, 2) to treat the locally advanced and inoperable stage 3 patients with concurrent chemotherapy, and 3) to palliatively treat the stage 4 patient. however, it is also possible that radiation therapy worsens the general weakness and lung function, although the degree of deterioration was generally less than lung resection. therefore, it is crucial for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy. the effect and safety of pulmonary rehabilitation is well-proven in various diseases. investigators presented a retrospective study about the effect of pulmonary rehabilitation in patients receiving radiation therapy, which showed less decreased lung function, less radiation related pneumonitis, and decreased mortality. investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.

Eligibility criteria:
inclusion criteria: * lung cancer patients with scheduled radiation therapy (postoperative adjuvant radiation therapy and concurrent chemoradiation therapy) during more than 4 weeks (5 times a week, 20 times a week) * lung parenchymal cancer * consent to regular outpatient-based pulmonary rehabilitation program, considering residence and other factors. exclusion criteria: * communication restrictions * failed to obtain consent form * accompanied by psychiatric problems or severe dizziness * patients have comorbidities, which are regarded as contraindications of pulmonary rehabilitation, such as severe pulmonary hypertension or hemodynamic instability

Keywords: pulmonary rehabilitation radiation therapy lung cancer
shared decision making for prostate cancer screening: a practice-based randomized controlled trial

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

background: professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. in this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. we secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates. methods: we plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. additionally, medical charts will be reviewed 9 months later to assess for actual screening.

Eligibility criteria:
inclusion criteria: * ages 40-80 years * their physician agreed to participate in the study * seen in practice for at least one year exclusion criteria: * prior history of prostate cancer * presenting for acute medical visit * non-skin cancer * lung disease requiring oxygen * renal failure requiring dialysis * intensive care visit in last 6 months * need assistance with activities of daily living

Keywords: prostate cancer screening shared decision making prostate-specific antigen decision making physician-patient relations
variation in humeral head bone marrow characteristics with rotator cuff repair healing

Conditions: Rotator Cuff Tears; Rotator Cuff Repairs

Summary: this study investigates correlations between humeral head bone marrow characteristics and tendon healing of rotator cuff repairs. the anticipated results would motivate future research aimed to investigate local enrichment or transplantation of connective tissue progenitor cells to augment rotator cuff repair and the pursuit of novel methods of bone marrow screening to preoperatively identify patients with bone marrow characteristics related to rotator cuff repair success or failure.

healing following rotator cuff repair (rcr) remains a significant clinical challenge, and repair failure rates of 20-30% continue to be reported. to date limited attention has been directed toward understanding how intrinsic mechanistic factors may contribute to variable healing rates following rcr. the objective of this proposal is to quantify the variability of the humeral head bone marrow in patients undergoing rcr and test the prognostic significance of the local concentration of connective tissue progenitors (ctps) for tendon healing. our approach will be to enroll 50 patients undergoing rcr. at the time of rcr, 8 ml of bone marrow will be aspirated from the humeral head for quantitative progenitor cell assays. a core biopsy at the tendon repair footprint will be collected for histologic analysis of bone marrow composition. tendon healing will be assessed by mri (sugaya score) at 6 months follow-up, the timeframe in which majority of re-tears occur the variation of bone marrow characteristics among patients will be described (aim 1) and their correlation with rotator cuff tendon healing will be investigated (aim 2). the proposal seeks to shift the investigational paradigm to intrinsic patient biologic factors, a fundamental and under-investigated realm of potential prognostic factors of rcr healing. demonstrating that humeral head characteristics associate with re-tear after rcr will support future work to develop tools to screen patient bone marrow for characteristics predictive of rcr success or failure and advance novel methods that promote local enrichment or transplantation of progenitor cells to augment rcr.

Eligibility criteria:
inclusion criteria: * males or females * 18-75 years * 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendon(s) that is fully reparable by double row technique as confirmed at surgery exclusion criteria: a 35 point exclusion criteria covers a variety of shoulder, musculoskeletal and general heath related conditions such as: * prior shoulder surgery (including rotator cuff repair) * symptomatic cervical spine disease * a frozen shoulder-- defined as a loss of passive range of motion (rom) of more than 20° in any plane compared to the contralateral shoulder * advanced (grade 3 or 4) glenohumeral arthritis * worker's compensation cases * isolated subscapularis tears.

Keywords: longitudinal cohort, healing, imaging
prevalence of electrolyte imbalance in chronic kidney disease:a study at tertiary care hospital in south punjab,pakistan

Conditions: Chronic Kidney Diseases

Summary: an observational cross-sectional study is done to calculate the electrolyte imbalance at different stages of chronic kidney disease at tertiary care hospital.

an observational cross-sectional study is done to calculate the electrolyte imbalance at different stages of chronic kidney disease at tertiary care hospitals of south punjab, pakistan .the outcomes of chronic kidney disease and end stage of renal failure will be calculated according to standard protocol. under the supervision of pathologists, pharmacologists, pharmacists, nephrologists, urologists and biostatistician. the standard protocol was authorized by ethical committee of each center. patient consent form was

Eligibility criteria:
inclusion criteria: * ckd patients ranging * age from 20-80 * dialysis and pre-dialysis patients * who provide written consent form exclusion criteria: * congenital one kidney patients * organ or kidney donors and transplantation * pregnant women * renal injury during trauma

Keywords: ckd
assessment of a new protocol for indirect pulp capping procedures

Conditions: Reversible Pulpitis

Summary: the aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. it was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.

indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, this study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. one group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal, the other group will be treated with a more conservative clinical procedure using carisolvtm gel with the aid of an operating microscope for caries removal. the study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. the study also compare the radiographical findings of 3d cone beam computed tomography (cbct) scans with that of normal xrays in detecting the presence of early bone changes associated with the roots of these teeth. the study carried out at king's college london/ dental institute at guy's hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the cbct scans. volunteers given written information about the process and given time to consider participation. once any questions have been answered, fully informed written consent obtained if they are interested in taking part. at least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and xray dental assessment. the procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will at 12 months. radiographic assessment including cone beam computed tomography (cbct) will be done at baseline and 12 months. it is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.

Eligibility criteria:
inclusion criteria: clinical diagnosis of reversible pulpitis with positive response to cold pulp test. exclusion criteria: clinical diagnosis of irreversible pulpitis, pregnant women, mobile teeth and teeth with tenderness to percussion.
autophagy bladder cancer

Conditions: Bladder Cancer

Summary: • bladder cancer is the most common malignancy of the urinary tract. it represents the 7th most commonly diagnosed cancer in male population worldwide and drops to the 11th when both genders are considered . according to the american cancer society's estimates of bladder cancer in 2017, the number of the new cases of bladder cancer is 79,030, and the mortality figures reached 16,870 .

* in egypt, bladder cancer is the most prevalent malignancy among egyptian males (16%) producing more than 7900 deaths annually . the majority of patients with bladder cancer about (70-80%) present with non-muscle invasive bladder cancer . * autophagy is a highly conserved catabolic process that degrades cellular organelles and proteins to maintain cellular biosynthesis during stress ; cancer cells induced autophagy to counteract with anticancer therapy by helping them to evade apoptotic pathway .autophagy is achieved by many autophagy-related genes . * previous studies found that human bladder cancer cell lines exhibit high basal level of autophagic activity that may contribute to resistance to current anticancer treatment, so targeting basal autophagy may help to develop novel therapeutic strategies . autophagy is potently induced by activating transcription factor 6(endoplasmic reticulum stress marker) , and malondialdehyde (oxidative stress marker) . * recently several studies demonstrated the role of autophagy in bladder cancer progression as evidenced by detection of microtubule associated protein and its relevance with muscle invasion beside its grade dependency . autophagy was grade dependent process . autophagy related gene 7 is a key protein involved in autophagosomes biogenesis, knockdown of autophagy related gene 7 induced apoptotic cell death in bladder cancer cell lines measured by increased caspase 3 level, based on these previous studies autophagy plays a role in bladder cancer progression so interruption of its pathway may serve a novel target for future therapies.

Eligibility criteria:
inclusion criteria: * 1)patients confirmed histopathologically to have bladder cancer. 2) both sexes. 3) patients who will accept to participate in the study. exclusion criteria: * patients with past history of bladder cancer with previous chemotherapy or any other types of cancer in the last 5 years.
a phase ii trial of adjuvant docetaxel in patients at high risk of relapse following prostatectomy

Conditions: Prostate Cancer

Summary: this clinical trial is designed to study whether docetaxel (taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. during the trial, doctors will also closely monitor patients for side effects of the chemotherapy. docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. the researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor. all of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. if the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.


Eligibility criteria:
inclusion criteria: * patients with prostate cancer who have just undergone prostatectomy, * high risk of their cancer recurring (high risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.) exclusion criteria: * prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy. * prior radiation therapy * patients receiving any concurrent therapy for cancer. this includes alternative therapies * patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids. * history of a malignancy other than prostate cancer * peripheral neuropathy \>/= grade 2 * psychological, familial, sociological or geographical conditions which do not permit treatment and/or medical follow-up required to comply with the study protocol * patients with a history of hypersensitivity reaction to products containing polysorbate 80 (tween 80).
efficacy and safety of laparoscopic lateral suspension and transvaginal sacrospinous ligament fixation in patients with pelvic organ prolapse

Conditions: Pelvic Organ Prolapse (POP)

Summary: this study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with stage iii or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. the primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. we hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. according to the pop-q classification, patients who meet any of the following conditions: a. patients with anterior wall prolapse of stage iii or higher; b. patients with apical prolapse of stage iii or higher; 3. patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse; 4. patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time; 5. patients who have received education at the primary school level or above; 6. patients who are able to visit the hospital for examinations; 7. patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment. exclusion criteria: 1. patients who have previously undergone surgery for pelvic organ prolapse (pop); 2. patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation; 3. patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.