Kornimate/medical-research-clean huggingface dataset:
immunotherapy for recurrent cervical cancer refractory to platinum-based chemotherapy: multi-center trial

Conditions: Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Immune Checkpoint Inhibitors; Anti-PD-1 Antibody; Albumin-bound Paclitaxel

Summary: this is a updated trial of nct04188860 as a multi-center study. for recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. however, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. the marketing of anti-pd-1 antibody has provided an opportunity of curative management. this single arm, open, phase ii trial would recruit 122 eligible patients. a combination of anti-pd-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients. the primary end is overall response rate (orr). the second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. a molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.


Eligibility criteria:
inclusion criteria: * female of 18-75 years old * eastern cooperative oncology group score 0-1 * pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage ia1 (with lymph-vascular space invasion) to ivb, which had accepted radical treatment for the purpose of cure * having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen * at least one measurable lesion defined by response evaluation criteria in solid tumors (recist) guideline 1.1 * anticipative survival period of 3 months or more * lab testing within reference ranges * with appropriate contraception * provided consents of participating the trial exclusion criteria: * with brain metastasis * with addiction to psychiatric medications or with mental disorders * with following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of \> 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to pd-1 antibody, or pd-l1 antibody, or pd-l2 antibody, or cytotoxic t lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency * with adverse effects more than common terminology criteria for adverse events grade 1 (except for alopecia), which caused by previous anti-tumor treatment * with infective disease which need systematic treatment within 14 days * with severe open trauma, fracture or major surgery with past 4 weeks * with potential allergy or intolerance to study regimens * not eligible for the study judged by researchers
intelligent analysis and clinical validation of cerebral small vessel disease on magnetic resonance imaging：a multi-center study

Conditions: Cerebral Small Vessel Disease

Summary: cerebral small vessel disease (csvd) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. early identification of csvd is critical for early intervention and improve clinical outcomes. magnetic resonance imaging (mri) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. the study is to investigate the comprehensive evaluation by using ai in early diagnosis and management of csvd.

cerebral small vessel disease (csvd) is an important cause of stroke, cognitive impairment, and other diseases, and its early quantitative evaluation can significantly improve patient prognosis. magnetic resonance imaging (mri) is an important method to evaluate the occurrence, development, and severity of csvd. however, the diagnostic process lacks quantitative evaluation criteria and is limited by experience, which may easily lead to missed diagnoses and misdiagnoses. based on the current technical challenges, subject development and upgrade of knowledge, to avoid the occurrence of adverse medical accidents, simplify the diagnostic process, artificial intelligence（ai） has become the alternative method of choice, by constructing training deep learning model,which can assist doctors in clinical decision-making to improve diagnosis effectiveness of cscd detection and diagnosis.

Eligibility criteria:
inclusion criteria: * ① men and women age 40 years or older; * at least one vascular risk factor has been identified, including hypertension, diabetes, hyperlipidemia, coronary heart disease, and chronic kidney disease； * the patient performed two brain mri examinations simultaneously at a time interval of more than 6 months (≥6). exclusion criteria: * ① the patient had no vascular risk factors； * no clinical follow-up images; * there are significant motion artifacts in the image, which cannot meet the

Keywords: cerebral small vessel disease artificial intelligence deep learning magnetic resonance imaging
efficacy and safety of lbsa0103 versus hyruan plus injection in patients with knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to compare efficacy and safety of intra-articular lbsa0103 once versus intra-articular hyaluronic acid injections (hyruan plus injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * over 40 years of age * kellgren \& lawrence grade i-iii * if there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm vas * be willing to discontinue all nonsteroidal anti-inflammatory drugs(nsaids), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study exclusion criteria: * body mass index \> 32 * have rheumarthritis * patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-vas * have sudek's atrophy, paget's disease, spinal disc herniation * kellgren \& lawrence grade iv

Keywords: osteoartritis knee lbsa0103 hyruan plus inj.
biodistribution and safety of the pet probes [18f]fprgd2 and [18f]fpprgd2

Conditions: Breast Cancer; Non-Small-Cell Lung Cancer; Glioblastoma; Other Cancers

Summary: the purpose of the study was to conduct a pilot test of new tracers (\[18f\]fprgd2 and \[18f\]fpprgd2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). healthy volunteers provided the normal biodistribution data. the same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.

the tracer \[18f\]fprgd2 was not evaluated in this study. the protocol title was never amended to reflect this.

Eligibility criteria:
inclusion criteria: healthy volunteers: 1. must be 18 years of age or older. 2. must have no known medical problems and have had a full medical exam within 6 months of the study. 3. must understand and voluntarily have signed an informed consent after its contents have been fully explained. 4. women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization). 5. men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose. cancer subjects: 1. greater than 18 years-old at the time of radiotracer administration 2. provides written informed consent 3. diagnosed with advanced non-small cell lung cancer (nsclc), breast cancer, pancreatic cancer and glioblastoma multiforme (gbm); patients will undergo bevacizumab or cyberknife therapy 4. able to remain still for duration of each imaging procedure (about one hour) exclusion criteria 1. less than 18 years-old at the time of radiotracer administration 2. pregnant or nursing

Keywords: healthy volunteers
effects of ginger on nonalcoholic fatty liver disease in t2dm

Conditions: Fatty Liver; Diabetes Mellitus, Type 2

Summary: the investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (nafld) in patients with type 2 diabetes mellitus (t2dm).

ginger (zingiber officinale roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. it contains several hundred valuable compounds and new constituents are still being found. ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner. in a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (nafld) in patients with type 2 diabetes mellitus (t2dm).

Eligibility criteria:
inclusion criteria: * controlled type 2 diabetes mellitus (hba1c\<7%) * age: 20-65 years * body mass index: 18-35 kg/m2 * serum alt level: \>60 u/lit. in males, \>38 u/lit. in females * grade \>=2 fatty liver in liver sonography exclusion criteria: * pregnancy * acute or chronic liver failure * acute or chronic renal failure * autoimmune or viral hepatitis * wilson's disease * alcoholism * malignancy * hypothyroidism or hyperthyroidism * drug used in last three months: ocp, vitamin e, ursodeoxycholic acid, glucocorticoids.

Keywords: ginger medicine, traditional herbal medicine
dexmedetomidine compared to ondansetron for postanaesthetic shivering in patients undergoing a cesarean section

Conditions: Postanesthetic Excitement; Cesarean Section

Summary: evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.

randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with asa (american society of anesthesiologist) ii or iii, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the bsas (bedside shivering assessment scale) scale, at the hospital central from san luis potosi, mexico. the main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; the evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.

Eligibility criteria:
inclusion criteria: * asa ii or iii, undergoing scheduled or emergency cesarean section with regional anesthesia (hyperbaric bupivacaine 0.5% with morphine at 1 mcg kg-1) and who presented tremor grade \>1 based on the bsas scale exclusion criteria: * hemodynamic instability, heart disease or sinus bradycardia, allergy to any of the medications applied, psychiatric diseases or hypothermia \<35.2 ºc measured by tympanic temperature.

Keywords: shivering, dexmedetomidine, ondansetron, regional anesthesia
transmural healing and disease-modifying effect of guselkumab in crohn's disease patients

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called magnetic resonance index of activity (maria) based on a scan at week 48.


Eligibility criteria:
inclusion criteria: * has luminal crohn's disease (cd) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * has clinically active cd, defined as a baseline cd activity index (cdai) score greater than or equal to (\>=)220 but \ =4, based on the unweighted cdai component of the number of liquid or very soft stools or b. mean daily ap score \>=2, based on the unweighted cdai component of abdominal pain (ap) * active transmural activity in at least one segment (segmental magnetic resonance index of activity \[maria\] \>= 11) * a. has demonstrated inadequate response/intolerance to conventional therapy; b. has previously demonstrated lack of initial response (that is, primary non-responders), responded initially but then lost response with continued therapy (that is, secondary non-responders), or was intolerant to a maximum of 1 class of advanced therapies at a dose approved for the treatment of crohn's disease (that is, janus kinase \[jak\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents) exclusion criteria: * has complications of crohn's disease, such as symptomatic strictures or stenoses (unless less than \[\<\]3 centimeter (cm) dilatation and not symptomatic or displaying associated fistula/fistulae and/or or abscess), fibrotic stenosis, internal fistulas, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the cdai to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab * currently has or is suspected to have an abscess. recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. participants with active perianal fistulas may be included if there are no associated stenoses, no anticipated surgery and no abscesses currently identified * has had any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline * has a draining (that is, functioning) stoma or ostomy * has a stool culture or other examination positive for an enteric pathogen, including clostridioides difficile (formerly known as clostridium difficile) toxin, in the previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
compression garments on hypermobility type of ehlers-danlos syndrome (cgheds)

Conditions: Hypermobility Type Ehlers-Danlos Syndrome

Summary: this study evaluates the effects of wearing a compression garment on the postural balance of patients with hypermobility type of ehlers-danlos syndrome, in randomised controlled study.


Eligibility criteria:
inclusion criteria: * age ≥16 years * heds with the 2017 diagnostic criteria . * a normal neurological examination with no sensory disorders, no cerebellar syndrome or vestibular syndrome. * an optimal balanced analgesic treatment before inclusion * patients who have not modified their physical treatment (physiotherapy) since 6 months. exclusion criteria: * surgery of the lower limb (hip, knee or ankle) * patient having already wear compression garments in the year preceding. * neurological history of sensory , vestibular or cerebellar disorders.

Keywords: compression garment
trial of nonpharmacologic interventions in elderly (tone)

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: to test the efficacy of weight loss and sodium restriction, alone and combined, in maintaining the normotensive state following withdrawal of antihypertensive medications in an elderly cohort. conducted in collaboration with the national institute on aging.

background: an estimated 30 to 40 percent of elderly persons are treated with blood pressure medications. the efficacy of blood pressure drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven, but such therapy can adversely affect quality of life and biochemical profile. in 1992 when the study started, there was a compelling rationale to identify what proportion of medicated, well-controlled elderly hypertensives could be maintained long-term or greater than 30 months in the normotensive state following withdrawal of blood pressure medications. there was also a need to determine whether nonpharmacologic therapy could significantly increase the proportion with a successful outcome. design narrative: randomized. a total of 585 overweight subjects were assigned in a 2 x 2 factorial design to weight loss, sodium reduction, combined weight loss and sodium reduction, or usual life-style control. the remaining 390 subjects of normal weight were assigned in a 2-armed design to a sodium reduction or an attention control group. the control groups were engaged in a series of non-blood pressure related health encounters designed to control for non-specific effects of groups contacts. withdrawal of antihypertensive medication was attempted following three months of intervention. the primary endpoint was a blood pressure of 150/90 mm hg or greater, resumption of antihypertensive drug therapy, or the occurrence of a blood pressure-related clinical complication during two to three years of follow-up. recruitment ended in june, 1994. follow-up ended in december, 1995. nhlbi support for the trial ended in march, 1997. the nia supported the coordinating center and two clinical centers through february 1998. the study completion date listed in this record was obtained from the "completed date" entered from the old format in the protocol registration and results system (prs).

Eligibility criteria:
men and women with a systolic blood pressure of less than 145 mm hg and diastolic blood pressure of less than 85 mm hg on single-drug therapy.
retinal venous pressure and et-1 in patients with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (rvp) and endothelin (et-1)levels.

diabetic retinopathy and maculopathy are the main causes of visual loss. hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. these in turn lead to hypoxia in the tissue and promote the release of vegf (vascular endothelial growth factor) , which in turn increases the vascular pathology. simultaneously, there is an increased expression of endothelin (et-1). endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling. in ocular blood flow perfusion pressure plays an important role. while in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. an increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. a measurement of the retinal venous pressure and the hormone et-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type i or ii * no diabetic retinopathy exclusion criteria: * known diabetic retinopathy * acute or chronic inflammation of the eyes * narrow angle glaucoma * minority

Keywords: diabetes mellitus retinal venous pressure endothelin-1
extended therapeutic effect of 35kda hyaluronan fragment injection in patients with chronic pain caused by myofascial pain syndrome

Conditions: Chronic Wound; Myofascial Pain Syndrome

Summary: to verify the efficacy and safety of ha35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study. this study aims to evaluate the 15-day treatment of ha35 on patients with myofascial pain syndrome and to observe the effects for up to 3 months.


Eligibility criteria:
inclusion criteria: * male and female, aged 18-65 years old ; * suffering from muscle strain, sprain, fall, wind and other diagnosed as myofascitis in patients with chronic back pain; * the pain reported by the subject should reach level 3 or higher on the digital rating scale of 0-10 ( 0 means no pain, 10 represents the strongest pain imaginable ); * the mental state is good, and the pain level can be evaluated independently; * be able to cooperate with the treatment independently and sign a written consent. exclusion criteria: * previous severe trauma with permanent musculoskeletal dysfunction; * symptomatic lumbar disc herniation with neurological deficits; * specific spinal diseases, including rheumatoid arthritis, ankylosing spondylitis, and osteoporosis; * diagnosed with mental illness; * agree not to sign the written consent; * pregnant, lactating or fertile women; * currently participating ( or participating in the past 30 days ) in research-based treatment or equipment trials.
post-approval clinical trial comparing the long term safety and effectiveness coflex vs. fusion to treat lumbar spinal stenosis

Conditions: Spinal Stenosis

Summary: post-approval clinical study comparing the long term safety and effectiveness of coflex vs. fusion to treat lumbar spinal stenosis

the primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. the coflex® interlaminar technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from l1-l5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. the coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

Eligibility criteria:
cngb1 and allied disorders

Conditions: Retinitis Pigmentosa Associated With CNGB1 Mutations

Summary: mutations in the rod-expressed gene, cyclic nucleotide-gated channel beta subunit (cngb1) and associated inborn errors in metabolism are causes of retinal disease that causes progressive loss of vision. retinitis pigmentosa (rp) is a major cause of untreatable blindness associated with cngb1 (cngb1-rp). rp involves the death of photoreceptor cells that can be caused by mutations in a number of different genes. treatment by gene therapy could prevent blindness in cases of inherited retinal dystrophies including rp. in the future rp due to mutations in cngb1 may be treatable by gene therapy since this form of photoreceptor degeneration involves a slow loss of rod photoreceptor cells. this provides a wide window of opportunity for the identification of patients and initiation of treatment. our efforts are directed toward developing gene therapy as a treatment. to this end, our objective is to better understand the disease process of cngb1-rp and other allied inherited disorders so that we can develop clinical tests to measure the outcomes of treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of cngb1-associated rp by study physician, who are trained retinal specialists in the university clinic * must be able to commit to 4 follow-up study visits (3 years)

Keywords: retinitis pigmentosa cngb1 natural progression