Kornimate/medical-research-clean huggingface dataset:
comparative study between socket shield technique versus allograft buccal sheet technique on alveolar bone resorption after immediate implant placement

Conditions: Bone Loss in Jaw

Summary: 22 patient where divided randomly into 2 groups : control group did dental implant utilizing socket shield , while study group did dental implant with allogenic bone graft there is no significant bone loss between the two groups after 4 month follow up


Eligibility criteria:
inclusion criteria: - patient has remaining root in upper anterior without lesion exclusion criteria: periapical lesion under the tooth
weight regain treatment post-bariatric surgery

Conditions: Obesity, Overweight

Summary: this study will examine behavioral and pharmacologic (naltrexone+bupropion) treatments for weight regain after bariatric surgery.


Eligibility criteria:
inclusion criteria: * be in the age range ≥18 years of age and ≤70 years of age * have a bmi ≥30 (or bmi ≥27 with a medical comorbidity) and ≤50 kg/m2 * have had laparoscopic roux-en-y gastric bypass or sleeve gastrectomy * experiencing weight regain after bariatric surgery * be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies). * read, comprehend, and write english at a sufficient level to complete study-related materials. * provide a signed and dated written informed consent prior to study participation. * be available for participation in the study for up to 3 months. exclusion criteria: * has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold). * has a history of anorexia nervosa or history of bulimia nervosa. * is currently taking a medication that is a contraindication to nb medication (e.g., maoi, opiates). * is currently using other medications for weight loss. * has a history of allergy or sensitivity to bupropion or naltrexone. * has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression) * has untreated hypertension with a seated systolic blood pressure \> 160 mmhg, diastolic blood pressure \> 100 mmhg, or heart rate \> 100 beats/minute. * has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke. * has current uncontrolled hypertension. * has current uncontrolled type i or type ii diabetes mellitus. * has untreated hypothyroidism with a tsh \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit. * has gallbladder disease. * has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder. * has a recent history of drug or alcohol dependence (since having bariatric surgery). * is currently in active treatment for eating or weight loss. * is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. * is breast-feeding or is pregnant or is not using a reliable form of birth control. * reports active suicidal or homicidal ideation.
evaluation of the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in chinese participants with high-risk neuroblastoma

Conditions: High-risk Neuroblastoma

Summary: this was an open-label, multi-center, single-arm, phase 1 study. the purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in chinese participants with high-risk neuroblastoma


Eligibility criteria:
1. signed informed consent form (icf) and ability to comply with study requirements 2. age ≥ 12 months at consent 3. diagnosis of high-risk neuroblastoma according to the international neuroblastoma staging system (inss) criteria. 4. participants who have previously received induction chemotherapy and achieved a partial or complete response followed by myeloablative therapy and stem cell transplantation. stem cell transplantation should be completed within 120 days of dinutuximab beta first administration exclusion criteria: 1. hypersensitivity to ≥ 1 component of dinutuximab beta antibody or against mouse proteins 2. actively progressive disease (not stabilized) or recurrent disease at the time of inclusion into the study 3. previous treatment with anti-gd2 antibody before enrolling in this study note: other protocol defined inclusion/exclusion criteria may apply
effects of the golo weight management program with and without release supplement on weight and metabolic parameters in subjects with obesity

Conditions: Obesity

Summary: this randomized, double-blind placebo-controlled study was intended to measure the effects of the gwmp with release supplement versus gwmp with placebo supplement in a representative group of obese subjects with or without diabetes at one outpatient medical practice.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤ 80 years 2. body mass index (bmi) ≥ 30 and ≤ 60 kg/m2 3. have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking 4. willing to comply with study procedures described herein exclusion criteria: 1. current diagnosis of type 1 diabetes 2. subjects with a history of hypoglycemia 3. a history of an eating disorder as defined by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) 4. known allergy to any of the components in the release supplement 5. a history of prior surgery for weight loss 6. currently taking injectable medications to control diabetes, including insulin and glp-1 agonists 7. currently pregnant or breastfeeding or have had a baby within the last six weeks 8. planning to become pregnant in the next three months. women of child bearing potential must be willing and able to use adequate and reliable contraception throughout the study (e.g. abstinence or barrier with additional spermicidal foam or jelly, or the use of intrauterine device or hormonal contraception). 9. uncontrolled hypertension at screening defined as systolic blood pressure greater than 180 mmhg or diastolic blood pressure greater than 110 mmhg 10. current clinical diagnosis or signs and symptoms of unstable (in the opinion of the principle investigator) heart, kidney or liver disease, cancer, or chronic neurological disease. 11. current participation in any other weight loss or weight management program 12. currently taking weight loss medications, or medications or supplements known to be associated with significant weight loss or weight gain 13. has any condition that, in the opinion of the investigator, would make participation in this study not in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments. examples include: history of diabetic ketoacidosis; active chronic liver disease or cirrhosis; chronic autoimmune disease; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, subjects predisposed to intestinal obstruction; chronic intestinal diseases associated with marked disorders of digestion or absorption -
tonefitreha: proof of concept and usability study.

Conditions: Neurological Disorder; Orthopedic Disorder

Summary: the importance of physical activity and exercise-based interventions in neuro-orthopaedic rehabilitation is undisputed. yet, patients and clinicians do not implement minimally required doses of physical activity in standard rehabilitation programs. this is partly due to intrinsic factors such as motivation, or due to physical condition that prevent any kind of exercise. in most cases, however, it is owed to limited time spent with therapists who would be able to supervise and apply the required doses to induce any potential exercise effects. methods to semi-autonomously exercise with high motivation and continuous feedback would complement existing therapies and allow adherence to minimal dose recommendations. for this study, a prototype of a new portable training solution for intensive walking exercise with built-in sensor-technology and a smartphone interface will be tested regarding its usability and its efficiency in a clinical setting.


Eligibility criteria:
inclusion criteria: * in-patients with non-specified pathological background * at trial centre for at least 2 weeks * if less than 4 weeks, willingness to visit clinic for the remaining exercise sessions. * must be able to walk independently (no or minimal gait impairment) * deemed fit for walking group exercise and other exercise (medical expert opinion). * cleared for low-intensity endurance exercise by treating physicians and therapists (medical expert opinion). * informed consent as documented by signature (appendix informed consent form). exclusion criteria: * health condition does not allow free movements of body segments (e.g. un-consolidated upper limb fracture) * contraindications to low-intensity endurance training (e.g. congestive heart failure, unstable angina, peripheral arterial occlusive disease). * fresh wounds around waist and trunk. * orthopaedic condition that limits walking ability (e.g. newly operated total hip replacement). * women who are pregnant or breast feeding, * intention to become pregnant during the course of the study * lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable double-barrier method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, combined with mechanical barriers (e.g. condoms or diaphragms) or who are not using any other method considered sufficiently reliable by the investigator in individual cases. female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (derived from medical history), * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons.
endolumenal partial myotomy for esophageal motility disorders

Conditions: Esophageal Motility Disorders

Summary: achalasia and esophageal spasm are primary esophageal motility disorders where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. surgical myotomy represents an appropriate therapeutic option. the purpose of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to overcome the need for invasive surgery.

in this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from primary esophageal motility disorders. under general anesthesia patients will have upper endoscopy. submucosal injection and mucosal incision is created for entry into the submucosal space. a submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. dissection will continue distally beyond the lower esophageal sphincter. the inner circular muscle fibers will then be divided to achieve an adequate myotomy length. the mucosal entry is then closed appropriately. results will be compared to historical data of conventional heller myotomies.

Eligibility criteria:
inclusion criteria: * candidate for elective heller myotomy * ability to undergo general anesthesia * ability to give informed consent exclusion criteria: * previous mediastinal or esophageal surgery * contraindications for egd

Keywords: endolumenal myotomy, per oral endoscopic myotomy
impact of the be well care well program on early care education teachers

Conditions: Burnout, Caregiver

Summary: the study will address the following specific aims: (1) assess the impact of the bwcw program on teacher stress and physical activity, (2) examine feasibility of collecting cortisol.


Eligibility criteria:
inclusion criteria: teachers that meet the following criteria will be included: 1. currently employed as a teacher or assistant teacher at a participating ece center; 2. ages 18 or older; 3. men or women; 4. able to speak, read, and write english. exclusion criteria: none
continuous correction

Conditions: Type 1 Diabetes

Summary: the potential of currently available diabetes technologies could be further exploited. the investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. in practice, this is carried out by running the bolus calculator every 10 minutes. the glucose sensor will provide the bolus calculator with glucose input. many times, the bolus calculator will come to the result that no insulin is needed. however, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump. the investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * t1d ≥ 3 years * csii ≥ 1 year * hba1c ≤ 8.0% (64 mmol/mol) exclusion criteria: * pregnancy or nursing * hypoglycemia unawareness * gastroparesis * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

Keywords: type 1 diabetes continuous glucose monitoring insulin pump sensor-augmented pump continuous correction of high blood glucose
perfusion index as an objective measure for postoperative pain assessment in pediatric patients.

Conditions: Postoperative Pain

Summary: it has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult. perfusion index (pi) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. pi can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. low pi values suggest peripheral vasoconstriction and high pi values suggest peripheral vasodilation. the sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation. in the current study, investigators hypothesise that the pi could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.


Eligibility criteria:
inclusion criteria: 1. asa physical status i-ii 2. age 3 to 7 years 3. children undergoing adenotonsillectomy. exclusion criteria: 1. parents' refusal. 2. children with behavioral changes 3. children with physical developmental delay 4. children on treatment with sedative or anticonvulsant.
effect of pyramidal training on epicardial fat for coronary artery disease prevention

Conditions: Coronary Artery Disease; Class I Obesity

Summary: to show the effect of pyramidal training for coronary artery disease prevention on: -epicardial fat, bmi, waist circumference (wc), lipid profile, quality of life and mediterranean diet adherence.

back ground: coronary heart disease (chd) is a type of ischemic heart disease characterized by atherosclerotic plaque accumulation in the coronary arteries.obesity leads to coronary artery disease (cad) in part through an inflammatory process that accelerates atherosclerotic plaque formation which may start as early as childhood. epicardial adipose tissue (eat) is the visceral adipose tissue (vat) of the heart .eat has unique embryologic, anatomic, and histologic features, including smaller adipocytes and higher prevalence of immune cells when compared to subcutaneous adipose tissue (sat). purpose: to show the effect of pyramidal training for coronary artery disease prevention on: -epicardial fat, bmi, waist circumference (wc), lipid profile, quality of life and mediterranean diet adherence. methods: this study is randomize control trail that will be carried out on 50 females' patients and will be selected from the outpatient clinics at pharos university. patient will be randomly assigned to two groups. experimental group: this group will include 25 patients who will receive pyramidal aerobic training by treadmill for 40 minutes per session (three sessions per week) for (12 weeks) in addition to mediterranean diet. control group: this group will include 25 patients who will receive mediterranean diet for (12 weeks). results: data analysis with independent t-test will be used to compare the baseline parameters between the intervention and control groups. repeated measures anova will be used to compare the changes in eatt, anthropometrics and lipid levels at the baseline and after 12 weeks between the two groups. keywords: pyramidal training, epicardial fat, coronary artery disease.

Eligibility criteria:
inclusion criteria: * fifty females' patients with class i obesity (bmi 30 to 34.9 kg/m2, waist circumference \> 88 cm). * their age ranges from 30-40 years old. * dyslipidemia and lipid profile as follow (total cholesterol high: 240 mg/dl, hdl less than 40 mg/dl, ldl high: 160-189 mg/dl and triglycerides high: 200-499 mg/dl). * all patients will be clinically and medically stable when attending the study. exclusion criteria: * patients with conditions will be excluded such as: * musculoskeletal problems. * chronic pulmonary disease. * missed more than two weeks of the program or want to terminate the program. * unstable angina. * acute illness. * uncontrolled cardiac arrhythmia. * decompensated heart failure. * cognitive impairment or mental disorders. * systolic blood pressure higher than 180, and/or diastolic blood pressure over 100mmhg. * dvt. * multiple food allergies/intolerances or gastrointestinal difficulties of the prescribed diet. * cancer (have special nutritional and training needs).

Keywords: pyramidal training, epicardial fat,coronary artery disease.
efficacy and safety of the combination of pozelimab and cemdisiran versus continued eculizumab or ravulizumab treatment in adult patients with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the primary objective of the study is: to evaluate the effect of pozelimab and cemdisiran combination therapy on hemolysis, as assessed by lactate dehydrogenase (ldh), after 36 weeks of treatment, in patients with pnh who switch from eculizumab or ravulizumab therapy versus patients who continue their eculizumab or ravulizumab therapy the secondary objectives of the study are to: * evaluate the effect of pozelimab and cemdisiran combination treatment versus anti-c5 standard-of-care treatment (eculizumab or ravulizumab) on the following: * transfusion requirements and transfusion parameters * measures of hemolysis: ldh control, breakthrough hemolysis, and inhibition of ch50 * hemoglobin levels * fatigue as assessed by clinical outcome assessments (coas) * health-related quality of life (hrqol) as assessed by coas * safety and tolerability * to assess the concentrations of total pozelimab and either total eculizumab or total ravulizumab in serum and total cemdisiran and total c5 protein in plasma * to assess the immunogenicity of pozelimab and cemdisiran


Eligibility criteria:
key inclusion criteria: 1. diagnosis of pnh confirmed by a history of high-sensitivity flow cytometry from prior testing 2. treated with eculizumab or ravulizumab prior to screening visit as described in the protocol note: biosimilars are not permitted, unless approved by the sponsor key exclusion criteria: 1. patients with a screening ldh \>1.5 × uln who have not taken their c5 inhibitor within the labeled dose interval at the dose prior to the screening ldh assessment 2. receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplant 3. body weight \< 40 kilograms at screening visit 4. any use of complement inhibitor therapy other than eculizumab or ravulizumab in the 26 weeks prior to the screening visit or planned use during the study with the exception of study treatments 5. not meeting meningococcal vaccination requirements for eculizumab or ravulizumab according to the current local prescribing information (where available) and at a minimum documentation of meningococcal vaccination within 5 years prior to screening visit. 6. any contraindication for receiving neisseria meningitidis vaccination. 7. positive for hepatitis b, and/ or hepatitis c as described in the protocol 8. history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer 9. participation in another interventional clinical study (except r3918-pnh-2021) or use of any experimental therapy within 30 days before screening visit or within 5 half-lives of that investigational product, whichever is greater, with the exception of eculizumab or ravulizumab. 10. patients with functional or anatomic asplenia note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: pnh
safety and efficacy of fingolimod in ms patients in china

Conditions: Multiple Sclerosis (Relapsing Remitting)

Summary: to evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in ms patients in china


Eligibility criteria:
inclusion criteria: -patients must have relapsing remitting multiple sclerosis exclusion criteria: patients with: * history of chronic immune disease * certain cancers * uncontrolled diabetes * certain eye disorders -negative for varicella * zoster virus igg antibodies * certain hepatic conditions * low white blood cell count * on certain immunosuppressive medications or heart medications * certain heart conditions or certain lung conditions * inability to undergo mri scans -diagnosis of neuromyelitis optica. * other protocol defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis (ms) relapsing remitting multiple sclerosis (rrms) fingolimod
effect of endometrial thickness on ivf outcome

Conditions: Infertility

Summary: although many studies have evaluated the relationship between endometrial thickness and ivf outcome, the results are still controversial. we notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on ivf outcome; however, for blastocyst stage embryo transfers, ivf outcome seems to have little association with endometrial thickness. thus, the aim of this prospective observational study is to explore the relationship between endometrial thickness and ivf outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers, respectively.


Eligibility criteria:
inclusion criteria: * age between 22-38 years old; * the first cycle of ivf treatment with standard long protocol; * transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo. exclusion criteria: * pgd cycles; * gamete donation cycles

Keywords: ivf endometrial thickness cleavage stage embryo blastocyst stage embryo ongoing pregnancy rate