Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of giomer based injectable resin composite versus resin modified glass ionomer in class v carious cavities over 18-months.

Conditions: Class V Dental Caries

Summary: class v carious lesions will be restored using either resin modified glass ionomer or giomer based injectable resin composite.the restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified united states public health service criteria.

in this study, class v carious lesions will be restored using two different restorative materials either resin modified glass ionomer or giomer based injectable resin composite. patients will be assessed for medical and dental histories first. then an examination of the patients will be done using visual inspection by using a dental mirror and probe. eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. their signature on written informed consents will be obtained. eligible participants will be randomly divided into two groups according to the type of restoration they will be received.the first group (a) (intervention): giomer based injectable resin composite (beautifil flow plus x f03, shofu, usa): the material will be applied according to manufacturer instructions. the second group (b) (comparator): resin modified glass ionomer (fuji ii lc, gc): the material will be applied according to manufacturer instructions.the restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified united states public health service criteria (usphs) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . the restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. the restorations will be scored as follows: alfa represents the ideal clinical situation, bravo will be clinically acceptable, and charlie represents a clinically unacceptable situation.

Eligibility criteria:
participant inclusion criteria * age 18-60 years. * co-operative patients approving to participate in the study. * male or female patients. * patients with good general health * moderate or high caries risk patient teeth inclusion criteria * cervical class v carious lesions. * pulp asymptomatic vital carious teeth. participant exclusion criteria * systemic disease or severe medical complications. * participants with a history of allergy to any component of restorations will be used in the study. * lack of compliance * evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits teeth exclusion criteria * presence of apical or periapical pathosis. * tooth mobility * non-vital teeth. * teeth with advanced periodontal diseases. * teeth which need indirect restoration.

Keywords: giomer injectable resin composite resin modified glass ionomer
a study evaluating the efficacy and safety of cp-690,550 in patients with moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study is designed to evaluate the efficacy and safety of tofacitinib (cp-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-tnf-alpha therapy.


Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * males and females with a documented diagnosis of uc at least 4 months prior to entry into the study. * subjects with moderately to severely active uc based on mayo score criteria. * subjects must have failed or be intolerant of at least one of the following treatments for uc: * corticosteroids (oral or intravenous). * azathioprine or 6 mercaptopurine (6 mp). * anti tnf-alpha therapy. exclusion criteria: * presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of crohn's disease. * subjects with disease limited to distal 15 cm. * subjects without previous treatment for uc (ie, treatment naïve). * subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Keywords: tofacitinib cp-690 550 moderate to severe ulcerative colitis phase 3 clinical trial mayo score
obinutuzumab in combination with lenalidomide in relapsed or refractory follicular lymphoma in real world study

Conditions: Follicular Lymphoma

Summary: this study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with r/r fl in a real-world setting in a chinese population.

available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with r/r fl, but the efficacy and safety in chinese patients remain to be verified. this study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with r/r fl in a real-world setting in a chinese population. the main questions it aims to answer are: * to assess the orr in the r/r fl patient population treated with the combination of obinutuzumab and lenalidomide * to assess crr, pfs, efs, dor, os, and safety in patients with r/r fl treated with the combination of obinutuzumab and lenalidomide participants in this study will not and should not result in any intervention to the patient's treatment and visits. all treatments and visits for patients will be at the physician's discretion according to clinical practice

Eligibility criteria:
patients must meet the following criteria for study entry:: * signed informed consent form * age ≥ 18 years at enrollment * at least one prior line of systemic (stage iii-iv) follicular lymphoma therapy * relapsed or refractory to front-line anti-lymphoma therapy; refractory is defined as: tumor shrinkage of less than 50% or disease progression after 4 cycles of standard regimen chemotherapy; response to standard regimen chemotherapy, relapse within 24 months; 2 or more relapses, meeting one of the above criteria as refractory lymphoma. * conditional treatment with obinutuzumab in combination with lenalidomide exclusion criteria: * patients currently participating or planning to participate in any interventional clinical trial * any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study

Keywords: follicular lymphoma obinutuzumab lenalidomide real-world
home respiratory rehabilitation in advanced lung cancer chemotherapy per os

Conditions: Lung Cancer

Summary: the feasibility and impact of respiratory rehabilitation (rr) in patients with advanced or metastatic (egf-r wt or mutated) non-small cell lung cancer treated with oral targeted therapy including inhibitors of egf-r tyrosine kinases (tki) and alk inhibitors. these patients will benefit, at the beginning of the chemotherapy whatever the treatment line, of a respiratory rehabilitation. the respiratory rehabilitation takes place at the patient's home with the had's cooperation 3 hours per week, divided into 2 or 3 sessions. there is associated educational, nutritional and psychological support for a total duration of 8 weeks.


Eligibility criteria:
inclusion criteria: * patient with advanced or metastatic lung cancer * in the course of treatment by oral chemotherapy of oral targeted therapy (tyrosine kinase inhibitor) in 1st, 2nd, 3rd line or more at the time of their inclusion * diagnosis of cp retained after multidisciplinary discussion of patient records exclusion criteria: * any residual toxicity of a previous antineoplastic treatment, grade\> 2. * cardio-respiratory contraindications to exercise re-training: * angina unstable * recent infarct * tight aortic stenosis * unsteady heart failure * pericarditis, endocarditis, myocarditis * evolutionary thromboembolic disease * ventricular aneurysm * intra ventricular thrombus * uncontrolled rhythm disorders * instability of the respiratory state defined by uncompensated respiratory acidosis * carcinological contraindications: * bone metastases at risk of fracture and / or algae despite optimal analgesic treatment, symptomatic central nervous system metastases * presence of anemia (hb \<8g / dl or \<10g / dl if patient with previous cardiac history), thrombocytopenia (\<100,000 platelets / mm3) * chimio toxicity (neurological, cardiac) according to the investigator's assessment * neuromuscular contraindications: * neuromuscular and / or osteo-articular disease making it impossible to re-train * severe cognitive impairment * patient under tutorship or curatorship
single incision laparoscopic cholecystectomy compared with conventional laparoscopic cholecystectomy, a randomized controlled clinical study

Conditions: Cholecystectomy, Laparoscopic

Summary: laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. conventional laparoscopic cholecystectomy (clc) was defined as three or four port surgery carried out with either french or american position. it reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. single-incision laparoscopic cholecystectomy (silc) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. silc uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. silc can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. but the real clinical benefits for patients still remain a matter of debate. in the last 5 years, many studies on silc have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.based on the above controversy, we conduct a rct comparing clinical and peri-operative outcomes, such as quality of life (qol), of silc and clc with the intent to assess the actual indications of the single-incision approach.


Eligibility criteria:
inclusion criteria: * benign gallbladder disease exclusion criteria: * combined with liver cirrhosis (child grade b and above) * upper abdominal surgical history; * gallbladder gangrene perforation; * changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.) * patients and their families do not agree with the treatment lost follow-up

Keywords: single-incision laparoscopic cholecystectomy conventional laparoscopic cholecystectomy
the beneficial effect of tj-134 for patients with symptomatic pneumatosis cystoides intestinalis

Conditions: Pneumatosis Cystoides Intestinalis

Summary: the traditional japanese medicine, keishi-ka-shakuyaku-daio-to is administered to patients with symptomatic pneumatosis cystoides intestinalis (pci) as compared with lactomin for 8 weeks.

1. based on endoscopic finding, patients with symptomatic pci are recruited. 2. after enrollment, abdominal symptoms are evaluated and abdominal ct is performed. 3. patients were randomized in a 1:1 ratio in blocks of 4 to undergo either the traditional japanese medicine or lactomin (control). randomization was carried out by computer-generated random sequences. 4. the traditional japanese medicine, keishi-ka-shakuyaku-daio-to（tj-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) or lactomin (3g/day) is administered to enrolled patients for 8 weeks. 5. after the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal ct is performed again.

Eligibility criteria:
inclusion criteria: * typical findings of pci on colonoscopy; line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa exclusion criteria: * patients can not take keishi-ka-shakuyaku-daio-to（tj-134）

Keywords: pneumatosis cystoides intestinalis
optical coherence tomography in patients with acute myocardial infarction and nonobstructive coronary artery disease

Conditions: Myocardial Infarction

Summary: the purpose of this study is to evaluate the prevalence and morphological features of coronary plaques by means of oct in patients with acute myocardial infarction but without any significant coronary stenosis at coronary angiography. in addition, cardiac magnetic resonance imaging (cmr) will be performed to assess the prevalence, location, and pattern of myocardial injury as well as other concomitant findings. as a secondary analysis, the association between the distribution and characteristics of coronary plaques detected on oct and myocardial injury shown by cmr will be evaluated. in addition, a post-hoc survey regarding the potential modification of the interventional treatment approach based on oct analysis will be conducted.

the mechanism of myocardial infarction in patients with nonobstructive coronary artery disease remains unknown. the soft-mi study has been designed as a single-center, prospective observational trial to investigate the prevalence of vulnerable and disrupted plaques in patients with acute mi but without any significant coronary stenosis (defined as stenosis of \>50%) at coronary angiography. all patients will undergo coronary oct immediately after coronary angiography. in addition, cmr will be performed within 1 week of coronary angiography to evaluate associated myocardial abnormalities as well as extracardiac findings. the study will provide insight into the mechanism of mi without obstructive coronary artery disease at coronary angiography, and may be useful in order to establish an appropriate therapeutic strategy for the secondary prevention of ischemic events.

Eligibility criteria:
inclusion criteria: * evidence of myocardial infarction: elevation of troponin to above the laboratory upper limit of normal (uln) or new st segment elevation of ≥1mm on 2 contiguous ecg leads or new left bundle branch block * symptoms of ischaemia (chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms with concomitant st-segment depression, t wave inversion or transient st-segment elevation) * delivery of an informed consent and compliance with study protocol * age ≥ 18 years exclusion criteria: * prior diagnosis of obstructive cad (including history of percutaneous coronary intervention or coronary artery bypass grafting) * stenosis \>50% of any coronary vessel on invasive angiography * contraindication to oct in the opinion of the treating physician * use of vasospastic agents * alternate causes of myocardial injury/ischaemia (severe anaemia, hypertensive crisis, acute heart failure, cardiac trauma, pulmonary embolism, etc.) * severe renal failure (egfr\<30) * pregnancy

Keywords: coronary artery disease coronary thrombosis coronary stenosis tomography, optical coherence magnetic resonance imaging
ayurvedic management of chronic kidney disease

Conditions: Diabetic Nephropathy; Hypertensive Nephropathy

Summary: the purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment in the patients of various types of chronic kidney disease.

ayurvedic treatment includes some complex classical herbal formulations and niruha basti (procto-colonic administration of ayurvedic medicines mainly contained decoction of punarnavadi compound, rocksalt, sesame oil and mixture of some herbal poweders) will be given to the patients of chronic kedney disease who are not on dialysis. patients of ckd of various etiology will be grouped accordingly and will get the same treatment.

Eligibility criteria:
inclusion criteria: * patients having a confirm diagnosis of chronic kidney disease with gfr level \ 3 months) indicates substantial reduction in kidney function. confirmation of diagnosis with ultrasound of kub, indicating reduction of kidney size and / or cortico-medullary difference. exclusion criteria: * female patients having pregnancy, breast feeding or post-delivery period. * patients who are on dialysis treatment from more than 6 months period. patients who are already operated for renal transplantation and then having nephropathy. * patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, other kidney, liver or metabolic disorders etc.

Keywords: nephropathy chronic renal failure chronic kidney disease chronic renal disease ayurveda herbal treatment
domestic violence intervention to reduce psychological distress and violence among women experiencing ipv in nepal

Conditions: Intimate Partner Violence; Domestic Violence; Intervention; Mental Health; Secondary Prevention; Problem Management Plus; Cluster Randomized Trial

Summary: the aim of this study is to implement and evaluate the feasibility, acceptability, and effectiveness of a validated integrated multi-component intervention targeting secondary prevention of violence and addressing the mental health needs of women experiencing intimate partner violence.

this study's aim is to assess the feasibility and effectiveness of an integrated multicomponent intervention among women experiencing violence in madhesh province of nepal. 1. to assess the feasibility of devi in health care centers in nepal by exploring the views of key stakeholders, health care providers, and local women in the community. 2. to train non-specialist mental health care providers on the delivery of devi among women exposed to ipv. 3. to explore participants' and health care providers' experiences with devi intervention and the opportunities and challenges encountered during implementation. 4. to measure the effectiveness of the devi intervention in addressing psychological distress, reducing the occurrence of ipv, and developing safety strategies among women experiencing ipv. 5. to measure the impact of the devi training on knowledge, attitudes, skills, and stigma towards ipv and its consequences, particularly on psychological trauma among health care providers.

Eligibility criteria:
inclusion criteria: * women between the age of 18-49 years * having experienced abuse (physical, sexual, or psychological) in a heterosexual relationship from her husband or her family members in the last 12 months * non-pregnant or pregnant in the first trimester * score of 3 and above in the psychological distress scale (measured by general health questionnaire (ghq-12)) * living with her husband or in-laws for at least six months. exclusion criteria: * have a severe cognitive impairment * seeking treatment for life-threatening emergency care * have suicidal thoughts
the effect of fragmin in the treatment of neuroischaemic foot ulcers in diabetic patients (a6301086)

Conditions: Diabetic Foot Ulcer

Summary: the primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (paod) and peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * subjects must have completed the 6 month study duration in the a6301083 study. * subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction \>0%) at visit 8 (eot visit) from baseline in the a6301083 study. * all ulcers must have an ulcer staging of 1c, 2c, 1d or 2d according to the university of texas wound classification system exclusion criteria: * subjects who have the following: * intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the eot visit in the a6301083 study). * a study ulcer area at visit 8 (eot visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ≥0%) in the a6301083 study. * subjects with an ulcer grading of 0 or 3 or staging of a or b according to the university of texas wound classification system. * subjects with a known bleeding disorder or evidence of active bleeding. * subjects who are on dialysis. * subjects who where found to be major protocol violators in a6301083 study. * subjects who did not complete the 6 month study period of the a6301083 study

Keywords: diabetic foot ulcers neuroischaemic
amnioinfusion initiative

Conditions: Oligohydramnios

Summary: the aim of this study is to compare perinatal survival in patients presenting with early spontaneous pprom and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.

early spontaneous preterm premature rupture of membranes (pprom) is associated with high perinatal mortality. due to pulmonary hypoplasia and preterm delivery, mortality exceeds 60% when pprom occurs prior to 24 weeks. when oligohydramnios persists, it may raise to 90%. morbidity in survivors is also significant. in uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%. we propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous pprom and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. inclusion criteria: single pregnancy, early spontaneous pprom \< 24.3 weeks, oligohydramnios (deepest vertical pocket \< 2 cm) for at least 4 days and no longer than 15 days at enrolment. the study is open and will be run through a dedicated password protected web site, and with a minimal number of outcome measures. primary outcome: survival till discharge from the nicu. secondary outcomes: latency time from pprom to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.

Eligibility criteria:
inclusion criteria: 1. patients above 18 years, who are able to consent, with 2. singleton pregnancy 3. with a normal structural examination as much as possible; 4. at least 2 us examination after pprom for gestational age confirmation and diagnosis of persistent oligohydramnios 5. follow up ultrasound examinations weekly in the treatment group 6. acceptance of randomisation and to comply with the protocol exclusion criteria: 1. maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful; 2. preterm labour defined as contractions \>6/hour associated with cervical changes, cervix shortened (\<15 mm at randomization), 3. cervical cerclage in place 4. chorioamnionitis, defined as 2 or more of the following: maternal temperature\>38 degrees, foul-smelling vaginal discharge, uterine tenderness, fetal tachycardia\>170 bpm, white blood cell count \>18,000 5. fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes 6. previous invasive procedure in this index pregnancy 7. fetal condition mandating immediate delivery 8. severe bleeding 9. maternal hiv and hcv infection 10. multiple gestation

Keywords: pprom oligohydramnios amnioinfusion prematurity early premature rupture of membranes in pregnancy