Kornimate/medical-research-clean huggingface dataset:
anti-pd-1 antibody plus regorafenib in refractory microsatellite stable metastatic colorectal cancer

Conditions: Metastatic Colorectal Adenocarcinoma

Summary: managements for refractory proficient mismatch repair (pmmr) or microsatellite stable (mss) metastatic colorectal cancer (mcrc) were still challenging and controversial. our study sought to investigate the efficacy and safety of anti-pd-1 antibodies plus regorafenib in refractory pmmr/mss mcrc between july 2019 and june 2021 at the hunan cancer hospital.

we retrospectively analyzed the efficacy and safety of 103 pmmr/mss mcrc patients treated with at least one dose of anti-pd-1 antibodies plus regorafenib (80 mg once daily for 21 days on/7 days off 28 days as a cycle) between july 2019 and june 2021 at the hunan cancer hospital. all patients had previously received at least second-line treatment. the patients were evaluated by computed tomography every 2 or 3 treatment cycles until progression or being lost to follow-up. the primary end point was overall survival (os).

Eligibility criteria:
inclusion criteria: * inclusion criteria: * 1.has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded). 2. have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for ras wild-type). 3.has measurable or non-measurable disease as defined by recist version 1.1 4.is able to swallow oral tablets. 5.estimated life expectancy ≥12 weeks. 6.eastern cooperative oncology group performance status (ecog ps) 0 or 1 7. has adequate organ function. exclusion criteria: * 1.pregnancy, lactating female or possibility of becoming pregnant during the study. 2.has not recovered from clinically relevant non-hematologic ctcae grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation). 3.has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control cns disease. 4.has severe or uncontrolled active acute or chronic infection. 5.known carriers of hiv antibodies. 6.confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.

Keywords: colorectal cancer;regorafenib;anti-pd-1 antibodies
68ga-p16-093 pet/ct imaging in the salivary gland

Conditions: Primary Sjögren Syndrome

Summary: prostate specific membrane antigen (psma) is a type ii transmembrane protein and acts as a glutamate carboxypeptidase enzyme. it is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. this pilot study was designed to evaluate the diagnostic performance of 68ga-p16-093 in primary sjogren's syndrome patients.

primary sjogren's syndrome (pss) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.prostate-specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. however, psma is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary sjogren's syndrome patients.therefore, psma may be an ideal target for evaluating salivary gland injury.

Eligibility criteria:
inclusion criteria: * pathological diagnosis confirmed by operation or biopsy. * obtain written informed consent and accepted follow-up. exclusion criteria: * pregnant, lactating women or having parenting plans during the study * head and neck radiotherapy history ; * active hepatitis c infection (pcr positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, igg4 related diseases. * other situaition researchers considered it was not appropriate to participate in trials.
sphinkeepertm procedure for treating severe faecal incontinence

Conditions: Faecal Incontinence

Summary: patients, aged 18 - 90 years, undergoing sphinkeeper operation at the department of general surgery at the medical university of vienna are enrolled into our study. primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

the sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. therefore, we aimed to assess the functional outcome following sphinkeeper™ surgery in patients with refractory fi. patients with fi, who met the inclusion criteria were enrolled to our study and received sphinkeeper™ implantation. functional outcome and quality of life was evaluated by standard questionnaires before and after surgery. in the routine check-up patients received endoanal ultrasound and anorectal manometry.

Eligibility criteria:
inclusion criteria: * age 18 - 90 years, undergoing sphinkeeper operation at the department of general surgery, medical university of vienna * ability and willingness to understand and comply with study interventions and restrictions. * voluntarily signed informed consent after full explanation of the study to the participant. exclusion criteria: * any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives * inability to communicate well with the investigator due to language problems or reduced mental development * inability or unwillingness to give written informed consent
a phase 2 study to assess dose-response relationship of hcp1803 in patients with essential hypertension

Conditions: Hypertension

Summary: a multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of hcp1803 in patients with essential hypertension


Eligibility criteria:
inclusion criteria: * patient with essential hypertension who meet 140 mmhg ≤ mean sitsbp \< 180 mmhg and mean sitdbp \< 110 mmhg at visit 1, visit 2 exclusion criteria: * patient with differences between arms greater than 20 mmhg for mean sitsbp or 10 mmhg for mean sitdbp at visit 1 * patient with difference of ≥ 15 mmhg in mean sitsbp between visit 1 and visit 2 * patient with mean sitsbp ≥ 180 mmhg or mean sitdbp ≥ 110 mmhg at visit 1, visit 2 * patient with secondary hypertension
functional connectivity after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Rupture; Electroencephalography; Injuries

Summary: background: despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. the mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. the loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. however, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited. research purpose: to investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction? population: * patients after anterior cruciate ligament reconstruction * healthy controls protocol: first, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. in addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (eeg) measurement. during this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right). the above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. when the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. the control group will only have to carry out the above protocol once. finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.


Eligibility criteria:
patient group inclusion criteria: * older than 18 years of age. * primary anterior cruciate ligament rupture and reconstruction exclusion criteria: * major knee surgery in the past. * diagnosed with any knee pathology at this moment. * have any muscle or nerve related conditions that affect the functioning of the lower limbs. control group inclusion criteria: - older than 18 years of age. exclusion criteria: * major knee surgery in the past. * diagnosed with any knee pathology at this moment. * have any muscle or nerve related conditions that affect the functioning of the lower limbs.
oral testosterone for the treatment of hypogonadism

Conditions: Hypogonadism

Summary: low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. the medical name for low testosterone is hypogonadism. hypogonadism can be caused by many factors. symptoms include: decrease in libido, lack of energy and mood swings. the goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms. the purpose of this study is to evaluate the ability of tsx-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. this will be determined by blood sampling at specified times during the study. the study is also intended to evaluate the tolerability of tsx-002, which will be taken orally twice per day for 15 days. in addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. related outcome measures will be reported for parts 1, 2, and 4. a portion of the study (part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of tsx-002. related outcome measures to be reported for part 3.


Eligibility criteria:
inclusion criteria: * prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone \< 300 ng/dl (based on the average of 2 morning samples taken at least 1 week apart) * men over the age of 18 years with a body mass index (bmi) \< 39.0 kg/m2 and weighing ≥ 55 kg * hemoglobin levels at screening and baseline \> 12.5 g/dl * testosterone treatment not contraindicated * no evidence of suspected reversible hypogonadism * willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only) * understands the requirements of the study and voluntarily consents to participate in the study exclusion criteria: -

Keywords: hypogonadism gonadal disorders endocrine system diseases testosterone testosterone enanthate testosterone undecanoate testosterone 17 beta-cypionate methyltestosterone androgens hormones hormones, hormone substitutes, and hormone antagonists physiological effects of drugs pharmacologic actions therapeutic uses anabolic agents
efficacy of the standard treatment and fusion ontogenetic surgery for gynecologic cancers

Conditions: Cervical Cancer; Uterine Cancer

Summary: the purpose of this study is to compare standard treatment and fusion ontogenetic surgery (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and survival.

fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible. fujii method has advantage of preserving pelvic autonomic nerve with radical resection of tissue under parametrium. and ontogenetic surgery has advantage of reducing need of radiation therapy by radical resection of tissue above parametrium. this study is prospective study for fusion ontogenetic surgery that has the advantage of both fujji method and ontogenetic surgery.

Eligibility criteria:
inclusion criteria: * female, age ≥ 20 years * patients with primary, recurrent, or refractory cervical cancer (figo stage ib1-iva), primary, recurrent, or refractory uterine cancer (figo stage ia, grade 3, ib-iva), or gynecologic cancer patients showing pelvic sidewall recurrence. * ecog performance status 0 or 1 * extensive surgery might be expected to cure the disease, or expected to relieve severe pelvic pain. * patients who signed an approved informed consent * patients who do not have a treatment option other than surgery. exclusion criteria: * female, age \< 20 years * ecog performance status ≥2 * bilateral pelvic sidewall invasion * patients who had undergone radical hysterectomy, trachelectomy, or hysterectomy in case of the primary disease. * patients who refused to sign an informed consent

Keywords: ontogenetic surgery tmmr pmmr leer
computer-based tutorial for the informed consent process for cataract surgery in turkish or serbian speaking patients

Conditions: Cataract

Summary: investigate if a computer-based tutorial enhances the quality and efficiency of the informed consent process for cataract surgery in turkish or serbian speaking patients.

informing the patient and obtaining informed consent is one of the major duties physicians have to perform before beginning a medical treatment. however, patients often experience the informed consent taking as not satisfying. in the past, several approaches were used to try to improve the informed consent taking, such as printed information sheets and multimedia tools. a novel concept introduced several years ago is to use a multimedia tool including a so-called traffic light system. the patient sees and hears information concerning cataract surgery on a touch screen and after each short chapter a traffic light is shown on the touch screen. at this point the patient has to decide, whether everything is clear and he wants to continue (green light), if he has further questions for the ophthalmologist (yellow light), or if he wants to repeat the chapter (red light). the patient's feedback for each chapter is then printed and guides the ophthalmologist during the face to face interview. this approach is called "catinfo tool". the german version of the catinfo tool has been developed and evaluated in a previous study. in short, the catinfo tool was developed as a multidisciplinary project including patients, graphic designers and ophthalmologists. the first version of the tool was evaluated in patient focus-groups. afterwards, an evaluation study including 60 patients was performed. main outcome was the following: patients who used the catinfo tool were significantly better informed than patients only having a face to face interview with an ophthalmologist and the feedback concerning the catinfo tool was good. meanwhile the german version of the catinfo tool is part of our daily routine and thousands of patients profited from the catinfo tool consent always additional to the face to face interview with an ophthalmologist. however, some patients are not able to use the catinfo tool. one reason is that they are not literate in german. aim of this study is to translate and evaluate a serbian and turkish version of the catinfo tool to allow better access.

Eligibility criteria:
inclusion criteria: * cataract * age 21 and older * first eye to be operated * no previous ophthalmic surgery * written informed consent to participation in the study exclusion criteria: * not literate in serbian (serbian group) / turkish (turkish group) or german (both groups) * visual acuity of less than 6/60 in the worse eye * severe hearing loss * inability to use touch screen device (e.g. severe tremor, etc.) * pregnancy - for women in the reproductive age a pregnancy test is required

Keywords: cataract surgery informed consent process
stromal gene expression during pulmonary sarcoidosis

Conditions: Sarcoidosis

Summary: to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. by so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.

to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.

Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis exclusion criteria: * inability to provide consent

Keywords: sarcoidosis stromal gene expression pulmonary sarcoidosis bronchoscopy
fibromyalgia syndrome in france: the role of assessment and management of sleep disorders

Conditions: Fibromyalgia

Summary: the fibobs study is a multi-centered, observational, prospective study carried out within specialized chronic pain structures (cps) in france. it will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with fibromyalgia syndrome (fms) consulting within a cps. the interaction between these sleep disorders and other symptoms of fms will also be analyzed using self-administered questionnaires. based on the hypothesis that sleep disorders associated with fms are only imperfectly assessed and/or treated in cps, the fibobs study will also interview pain physician in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of fms. in addition, this study will provide a better understanding of the symptoms of fms, their impact and how patients feel.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * read, write and understand the french language * patient with a diagnosis of fibromyalgia syndrome according to acr 2010 criteria: painful symptoms present at the same intensity for at least 3 months, wpi ≥ 7 and sss ≥ 5 or 3 ≤ wpi ≤ 6 and sss ≥ 9, any other cause responsible for chronic osteoarticular pain must be excluded.primary or secondary fibromyalgia is eligible, at the discretion of the investigator. * patient seen in consultation for the first time or for a follow-up visit if the patient has already been followed up in the specialized chronic pain structure for less than a year. * have access to an internet connection (for the realization of the "patient questionnaire") * patient affiliated to a social security system * written and signed informed consent exclusion criteria: * patient undergoing anti-cancer treatment or having completed treatment less than 2 years ago * patient under guardianship, deprived of liberty, safeguard of justice * pregnant or breastfeeding women * patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator) * refusal to participate in research
the effect of the nutraceutical "hemofix" on the coagulation system

Conditions: Von Willebrand Disease; Menorrhagia

Summary: hemofix is a herbal formula based on traditional jewish and far eastern medicine created to assist in wound healing and bleeding arrest. it contains herbs such as red clover, liquorice, raspberry, ginger and more. the present study will evaluate the formula on the coagulation system.


Eligibility criteria:
inclusion criteria: * healthy volunteers and volunteers with a mild bleeding disorder exclusion criteria: * people with thrombophilic and cardiovascular complications, * people who are treated with anti-coagulants, * women taking birth control pills * people with a history hypercoagulability

Keywords: mild bleeding disorder
cardiovascular biomarkers and lung edema in severe burns patients

Conditions: Burns

Summary: burn injury leads to hypovolemic then distributive shock. fluid resuscitation remains the cornerstone of initial treatment of burn shock. however, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema. the peptide nt-pro-bnp, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma cd146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia . our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.


Eligibility criteria:
inclusion criteria: * intubated mechanically-ventilated patients within the first 24 hours of admission * and/or patients with total body surface area (tbsa) burn-injured \>20 % * and/or patients with at least 10% full-thickness burns * and/or receiving vasopressors within the first 24 hours of admission * and monitored by a picco system (picco-2 pulsion medical systems ag, munich, germany) exclusion criteria: * admission delay to icu \> 24 hours post burn * age less than 18 years * pregnancy * chronic renal impairment with a baseline egfr \< 15 ml/min * patients with chemical or electrical burns * coexisting non-burn trauma * patients moribund on admission or dead within 72 h from admission * patients with do-not-resuscitate orders

Keywords: vascular filling fluid overload biomarkers lung edema
study of vynt-0126 in the treatment of rett syndrome in adult patients

Conditions: Rett Syndrome

Summary: this is an exploratory, phase 2, multicenter, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, and efficacy of oral treatment with vynt-0126 in female subjects 18-45 years of age with rett syndrome.


Eligibility criteria:
inclusion criteria: * females age 18-45 (inclusive) * diagnosis of classic/typical rett syndrome with a documented mutation of the mecp2 gene * severity rating of between 10 and 36 (rett syndrome natural history/clinical severity scale) * concomitant medications (including approved medications for treatment of rett syndrome) must be stable for \>4 weeks prior to enrollment * able to receive liquid study drug orally or via gastrostomy tube (g-tube) exclusion criteria: * actively undergoing neurological regression; * abnormal qt interval, prolongation or significant cardiovascular history * excluded concomitant medications * current clinically significant (as determined by the investigator). cardiovascular, endocrine, hepatic, renal, or respiratory disease * gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication * history of, or current cerebrovascular disease or brain trauma * history of, or current, malignancy * clinically significant abnormalities in safety laboratory tests, vital signs, or ecg, as measured at screening or baseline * any condition which in the investigator's opinion would affect the ability of the subject to participate in the study * allergy to vynt-0126 or any ingredients of the liquid formulation