Kornimate/medical-research-clean huggingface dataset:
clinical trial scheme of tanreqing capsules in the treatment of covid-19

Conditions: Novel Coronavirus Pneumonia

Summary: this study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. two groups were designed, the experimental group and the placebo control group. patients in both groups received basic treatment with vitamin c effervescent tablets. tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. the treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.

the purpose of this study was to evaluate the efficacy and safety of tanreqing capsule in the treatment of mild and common covid-19. the trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial design. a total of 480 patients were divided into 2 groups: experimental group and control group 3:1. patients in both groups received basic treatment with vitamin c effervescent tablets. tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. the treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.

Eligibility criteria:
inclusion criteria: 1. according to the diagnosis and treatment plan for pneumonia infected by novel coronavirus (trial version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary； 2. aged greater than 18, with no gender limitation; 3. symptom score greater than or equal 3 points; 4. voluntarily accept the drug treatment and sign the informed consent. exclusion criteria: 1. patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from covid-19; 2. immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months; 3. pregnant and lactating women; 4. people with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study); 5. mentally ill persons or persons without self-awareness; 6. patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening; (8) in patients with serious primary diseases of heart, brain, liver and kidney, alt and ast were 1.5 times higher than the upper limit of normal value; (9) other conditions that the investigator considers inappropriate for clinical trial participation.

Keywords: mild, common
tofacitinib registry of patients with ulcerative colitis in germany

Conditions: Colitis, Ulcerative; Biologics; Tofacitiniib; Chronic Inflammatory Small Bowel Disease; Bowel Diseases, Inflammatory; Bowel Disease; CED

Summary: this registry on tofacitinib and biologics (anti-integrin/anti-tnf) in the treatment of ulcerative colitis (uc) patients in germany will extend the prospective documentation of safety issues and efficacy in induction and maintenance therapy of tofacitinib (xeljanz®) in addition to other biologics used in germany with a particular interest in predictors of long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with januskinase(jak)- inhibitors/biologics.

this is an investigator-initiated non-randomized, non-interventional observational prospective long- term research (iir) as part of the normal treatment of uc patients for the safety and efficacy of tofacitinib / biologic therapies. as of 01st july 2019, uc patients who have been provided tofacitinib / biologics for uc according the respective label by the treating physician may be prospectively included in an online database by the participating study centers by 31st march 2021. an interim analysis is planned at the end of patients ́ recruitment with respect of the induction phase (week 16) for october 2021 with a first publication of the data in a peer-reviewed journal (e.g., jcc, gut, ueg journal). up to 480 patients (including about 360 uc patients with tofacitinib and about 120 uc patients with biologics) will be included in the online documentation. a specification to the study centers regarding the group inclusion (patients treated with tofacitinib (group 1) or a biologics (group 2)) will not be made; this means, each study center can include patients in both groups. the ced service gmbh assume that approximately 20-30% of tofacitinib patients will be biologic-naïve uc patients, many of whom will represent early disease patients (\< 2 years after first diagnosis).

Eligibility criteria:
inclusion criteria: * patients with moderate to severe ulcerative colitis aged 18-80 years at enrollment * written informed consent is given exclusion criteria: * malignant disease in history (except for non-melanoma skin cancer) * any contraindication according to the smpc of the respective medication
physiologic effects of prms & testosterone in the debilitated elderly

Conditions: Muscle Weakness; Muscular Atrophy

Summary: this study's primary objective is to determine the independent and combined effects of progressive resistance muscle strength training and testosterone on the development of sustainable improvements in physical function.


Eligibility criteria:
inclusion criteria: the study will be limited to those patients who are metabolically stable and free of metastatic cancer and limiting end organ disease. their total serum testosterone must be less than 480 and psa less than 10. exclusion criteria:

Keywords: aging nutrition rehabilitation
the effect of stress ball utilisation on treatment duration, dyspnea severity and anxiety level in nebuliser therapy

Conditions: Inhalation Therapy; Complications

Summary: nebul therapy is very effective in quickly improving the symptoms of respiratory system diseases. while applying this treatment, patients are expected to complete a sufficient period of time. however, this waiting and the symptoms of the disease may cause anxiety in the patient. the aim of the study was to enable patients to spend their nebul period actively by using a stress ball. thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels. the main questions it aims to answer are: does using a stress ball contribute positively to nebulizer usage time? is the use of a stress ball effective in reducing the severity of dyspnea? is using a stress ball effective in reducing anxiety levels? for this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy. they will be expected to continue this with at least two nebuliser therapy per day. a control group will be used to determine the effectiveness of the stress ball. this group will not use a stress ball while receiving nebulizer treatment.


Eligibility criteria:
inclusion criteria: * hospitalized for at least three days * having nebulizer treatment at least twice a day * medicines that have the same effect as prescribed (bronchodilators) * patients who are required to have at least 4 ml of medication in the reservoir * patients who have previous experience of using a nebulizer at home exclusion criteria: * those who have severe exacerbation attacks * people with speech problems * people who experience severe dyspnea due to heart disease * those with high anxiety levels for any reason (death of a relative, etc.) * those with muscle or nerve problems in their hands * those who did not consent to participate in the study

Keywords: nebuliser inhalers dyspnea anxiety level
home telerehabilitation for deconditioned older adults

Conditions: Osteoarthritis

Summary: the purpose of this study is to develop a home exercise program for patients 60 years of age and over who are deconditioned following their discharge from the hospital, or recruited from gla outpatient clinics. the program will be designed to monitor and improve patients' exercise behavior through the use of home technology, such as text messaging monitors.

the aim of this study is to develop and determine the feasibility of implementing a home exercise and functional status monitoring telerehabilitation program, known as tel-rehab, for older adults 60 years of age and over who are deconditioned following their discharge from the inpatient setting, or recruited from gla outpatient clinics. deconditioning is a modifiable risk factor for preventing institutionalization of frail elderly patients who would otherwise be able to live independently. home exercise programs are an effective intervention to reduce the risk, but patient compliance with home exercise programs, and assessments of patients during home exercise programs, are barriers to achieving maximal benefits. face-to-face visits with physical medicine professionals are an effective means to perform these functions, but are problematic because of professional time impacts and patient transportation problems. a tel-rehab program will empower these patients to take responsibility for their own health by providing ongoing communication with a healthcare provider. in this way, telerehabilitation may assist older adults to remain independent in their homes as long as possible.

Eligibility criteria:
inclusion criteria: * acute decline in functional status while hospitalized as reported by the patient * physically inactive outpatients (exercise less than 30 min/day, 3 d/wk) * ability to hear and communicate via telephone * ability to read a video or text monitor * ability to manually operate the technology * have a working telephone and power source * willingness to use the tel-rehab technology exclusion criteria: * does not speak english * poor cognition as determined by the mini-cog * non-ambulatory * had a stroke, myocardial infarction, hip fracture, or total hip or knee replacement within the prior 6 months

Keywords: telehealth telerehabilitation deconditioning exercise
eras in posterior approach of cervical spine operation

Conditions: Cervical Myelopathy

Summary: enhanced recovery after surgery (eras) strategy has been used in the patient management of different diseases. this study aims to evaluate the effectiveness of eras in the perioperative period of posterior approach of cervical spine operation among patients with csm.

enhanced recovery after surgery (eras) strategy has been used in the patient management of different diseases, but up to now, few effort has been done to evaluate the effectiveness of eras in patients perioperative management of cervical spine surgery. as a interdisciplinary cooperation system, either qualitative or quantitative method alone can not completely reflect the function of eras. mixed model research (mmr) is a appropriate method to evaluate a complex system, but it has not been used in eras evaluation. this study aims to evaluate the effectiveness of eras in the perioperative period of posterior approach of cervical spine operation among patients with csm using mmr, including the retrospective quantitative part and prospective qualitative part. in the retrospective part, we will collect the data of length of stay, vas scores, mjoa scores and sf-36 scores to compare the difference between eras group and regular group. in the prospective part, we will collect the data from the focus group meetings and personal interviews of patients, to verify that eras has the ability to improve the postoperative outcomes, while maintain an equal surgical effect.

Eligibility criteria:
inclusion criteria: 1. patients should be diagnosed as csm based on the history, symptoms, physical signs and radiographic results. 2. patients did not respond to the 3-month conventional treatment. 3. patients were performed posterior approach of cervical spine operation. 4. patients should have complete pre- and post-operative data. exclusion criteria: 1. patients with severe organic diseases. 2. patients with previous history of cervical spine surgery. 3. patients with mental or psychological abnormality. 4. patients with severe osteoporosis (t value \<-2.5).

Keywords: cervical myelopathy enhanced recovery after surgery surgical outcome
preoperative nutritional intervention in head and neck cancer

Conditions: Head and Neck Cancer; Malnutrition

Summary: the purpose of this study is to determine the impact of preoperative nutritional supplements on head and neck surgery patients.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 who are seen in the department of otolaryngology-head and neck surgery clinic, have a new h\&n cancer diagnosis, and have not undergone previous treatment for h\&n cancer are eligible for this study. we will enroll only patients who will be undergoing primary surgery for their cancer treatment, and those undergoing primary radiation or primary chemoradiation for treatment will be excluded. all eligible patients will undergo nutritional screening using the pg-sga. those who screen positive for malnutrition (\>1 on the pg-sga scale) will be randomized to either our standard care (control) versus nutritional intervention group. exclusion criteria: * prior treatment for head and neck cancer. those undergoing primary radiation or chemoradiation for their head and neck cancer. vulnerable populations. patients who screen as well nourished (\>1 on the pg-sga scale) will be excluded as they do not require nutritional intervention. patients who screen as severely malnourished (\>8 on the pg-sga scale) will be excluded as these patients require intervention and should not be potentially randomized to our control arm. patients requiring nasogastric tube feeding or gastrostomy tube feeding will be excluded. patients are routinely evaluated by speech pathologist prior to surgery. those in which there is concern for aspiration will be excluded as they will not be able to participate fully in the intervention.

Keywords: cancer surgery malnutrition preoperative nutrition
silent stroke during mitraclip implantation

Conditions: Mitral Regurgitation; Silent Stroke

Summary: the mitraclip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. the number of new cerebral ischemic lesions without clinical manifestations is high. the aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the mitraclip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.

mitral regurgitation is the second most common manifestation of valvular heart disease in adults. surgical reconstruction is considered treatment of choice. for some patients the surgical risk is to high an operation is refused. for those patients the mitraclip system (abbott vascular, menlo park, ca, usa) offers a much less invasive treatment option. occurrence of a stroke or transient ischemic attack (tia) is one of the potential complications during this procedure. 1% of all patients have an acute stroke. the number of new ischemic lesions without clinical manifestations is much higher (up to 85%). the impact of these lesions on the global cognitive function is unclear. the aim of this study is to determine the frequency of cerebral embolisms related to predefined procedural intervals and postprocedural cerebral lesions using transcranial doppler ultrasound and magnetic resonance imaging. furthermore we want to study the correlation between cerebral embolisms seen as high intensity signals in transcranial duplex ultrasound and cerebral lesions seen in the cmrt. the results should build a basis for further studies that want to reduce the amount of cerebral lesions.

Eligibility criteria:
inclusion criteria: patients undergoing a mitraclip-procedure due to mitral regurgitation in the study period written consent procedure recommended by a cardio-thoracic surgery conference exclusion criteria: patients who are not able to give consent patients \<18 years participation in another interventional trial pregnant or lactating females contraindication to mri
improving complete endoscopic mucosal resection (emr) of colorectal neoplasia

Conditions: Neoplasms; Gastric Cancer

Summary: the investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. the investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

the primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in endoscopic mucosal resection (emr), a combined needle and snare unit (isnare, us endoscopy) versus an oval braided snare with spiral wire (snaremaster, olympus). the secondary aim is to explore whether emr efficacy and efficiency is depended upon the injection solution used, saline versus gonak (a solution containing hpmc, saline, and epinephrine) for emr.

Eligibility criteria:
inclusion criteria: * sessile colorectal polyp * laterally spreading lesions as defined by paris classification type ii and \> 1 cm or greater exclusion criteria: * those with ulcerated depressed lesions (paris type iii) or biopsy proven invasive carcinoma * inflammatory bowel disease patients * coagulopathy ( inr\> 1.5) that cannot be corrected

Keywords: sessile neoplasms flat neoplasms gastric cancer
long-term follow-up durability (efficacy) study of en3835 for the treatment of ac of the shoulder (frozen shoulder)

Conditions: Adhesive Capsulitis; Frozen Shoulder

Summary: this is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to en3835 compared to placebo in participants who were treated in en3835-210 or the pivotal phase 3 parent studies for the treatment of ac of the shoulder (frozen shoulder).


Eligibility criteria:
inclusion criteria: 1. have been enrolled and completed the en3835-210 or pivotal phase 3 parent studies (for study en3835-223 eligibility, completed participants are those who were assessed for safety and obtained ases scores at day 95/eos visit; does not include early terminated participants). 2. be willing not to use pain medications for the duration of the study period and for 2 weeks prior to the day 180 visit. pain medications include but are not limited to: barbiturates, benzodiazepines, methadone, buprenorphine, opioids (e.g., codeine, heroin, hydrocodone, hydromorphone, morphine, oxycodone), and cannabis. note: nsaids (ibuprofen, etc.) are allowed. 3. be willing to undergo mri of the affected shoulder as required by the protocol. 4. be able to read, understand, and independently complete patient reported outcome instruments in english. 5. be willing and able to cooperate with the requirements of the study. 6. be adequately informed and understand the nature and risks of the study and be able to provide consent. exclusion criteria: 1. is from a vulnerable population, as defined by the us code of federal regulations (cfr) title 45, part 46, section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the irb/iec. 2. plans to receive (or received prior to day 180) any invasive or minimally invasive (ie, steroid injections, shoulder manipulation, surgery, etc.) procedures to the affected shoulder during study participation. note: pt is allowed. any pt received should be captured in the respective electronic case report form (ecrf). 3. has any contraindications for mri (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos-with exemption of the area to be treated/reviewed, claustrophobia, syncope, low blood pressure, epilepsy, asthma, anemia, or sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing imaging. 4. has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
trabeculectomy versus canaloplasty to treat glaucoma

Conditions: Glaucoma

Summary: the aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. the risks in the postoperative course in canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-c. conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. precisely this question is investigated in the study.


Eligibility criteria:
inclusion criteria: * patients with open angle glaucoma and excavation of 0.4 - 0.8 * 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for canaloplasty) the ratio of female / male is not involved. * eye pressure under local therapy: 20mmhg and above (corrected with pachymetry table). * local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops. * general anesthesia possible. * the operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. if the operation does not meet this criterion, the patient is excluded from the study. exclusion criteria: * all patients are not included in the group of inclusion criteria, or: * phenprocoumon therapy. * operation is not done state-of-the-art. * after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy) * uveitis, or possible inflammation of the eye * previous eye pressure lowering operations or laser interventions * corneal refractive surgery (pseudophakia allowed)

Keywords: glaucoma