Kornimate/medical-research-clean huggingface dataset:
guided bone regeneration in atrophic anterior maxillary ridges

Conditions: Bone Resorption Disorder

Summary: this study is aiming to evaluate clinically, radiographically ,and histologically gbr using collagen membrane in combination with a mixture of abbm and autogenous particulated bone compared to collagen membrane with abbm in atrophied anterior maxilla.

guided bone regeneration (gbr) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 to protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. expanded polytetrafluoroethylene (e-ptfe) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. however, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. resorbable membranes in combination with particulated anorganic bovine bone (abb) can be used for the augmentation of horizontally deficient ridges. particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

Eligibility criteria:
inclusion criteria: * patients with atrophied anterior maxillary ridge area. * age: 18 years and older. * both sexes. * no intraoral soft and hard tissue pathology. * no systemic condition that contraindicate bone augmentation exclusion criteria: * • heavy smokers more than 20 cigarettes per day.(32) * patients with systemic disease that may affect normal healing. * psychiatric problems. * disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia. * pregnant or nursing women. * patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis. * patient with previous history of radiotherapy.

Keywords: gbr, autogenous bone, xenograft
relaxation, depressive symptoms, quality of life in people living with hiv: a pilot study

Conditions: HIV; Depressive Symptoms

Summary: progressive muscle relaxation (pmr) and autogenic training (at) are effective relaxation techniques to reduce depressive symptoms. however, no studies on their effectiveness have been conducted among people living with hiv and depressive symptoms. the primary aim of this pilot study was to assess the feasibility and acceptability of pmr and at interventions among people living with hiv who have depressive symptoms. a secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life.

this study was a three-arm pilot randomized control trial with mixed methods. participants were randomized to pmr, at, or control group (cg), with four assessments (baseline, one-, three-, and six-month). the pmr and at interventions consisted of six one-hour sessions of individual training over 12 weeks and home practice. recruitment, attrition, and completion rates were calculated. depressive symptoms and quality of life were assessed at all times. participants' perceptions of the interventions were collected in semi-structured interviews.

Eligibility criteria:
inclusion criteria: * age \> 18 years * hiv diagnosis of at least two years * depressive symptoms between 5 and 14 in the phq-9 scale * untreated with antidepressants or psychotherapy * able to speak and understand french exclusion criteria: * started antiretroviral treatment within the last 6 months * start or already receiving interferon

Keywords: hiv depressive symptoms quality of life relaxation viral load cd4+ t cell count
effect of abdominal myofascial release on pain and functional outcomes of neck in females with cesarean section

Conditions: Cesarean Section

Summary: to investigate the effect of abdominal myofascial release on pain, rom and functional abilities of neck in females with cs scar.

irty females with neck pain will participate in this study. subjects will receive treatment session of thirty minutes in length in order to minimize tissue irritation and avoid increased tension of the scar area, which would counter the goal of the session. treatment sessions will be provided biweekly for two weeks apart in order to allow physiological and biomechanical healing time between treatment sessions. mfr techniques will be employed to release the caesarean scar and myofascia of the dfl of each subject. the depth of the scar in this study takes us through all the layers from the skin to the uterus, following the surgical incision procedure. mfr was the primary treatment applied to the accessible structure of the patients' dfl, through myers's mfr techniques of dfl. mfr in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure.

Eligibility criteria:
inclusion criteria: 1. female patients suffering from chronic neck pain since more than 3 months. 2. they underwent cs since at least 2 year before entry into study. 3. not suffering from neck pain before cs 4. their age will range from 20 to 35 years. 5. they will be primiparous 6. body mass index (bmi) will range from 20-30 kg/m2. exclusion criteria: 1. pregnancy. 2. bmi over 30 kg/m2. 3. less than six months after cs. 4. history of pathologies resulting in weakening of connective tissue (diabetes, neoplasms, rheumatic illnesses). 5. any abdominal surgeries other than caesarean sections. 6. any head or neck trauma. 7. skin irritation/inﬂammation at the site of scar. 8. any spinal deformity as kyphosis or scoliosis.

Keywords: cesarean section myofascial release
effect of different scoring systems on mortality rates and length of hospitalization in cardiac surgery patients

Conditions: Heart Diseases

Summary: precise risk estimation of mortality in cardiac surgery patients is often difficult. main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and intensive care and also on actualized mortality.


Eligibility criteria:
inclusion criteria: * asa anesthesia risk group 2-5 patients between 18-70 years of age and with planned cardiac surgery exclusion criteria: * terminal malignant diagnosis, multiple organ failure, confirmed brain dead, mechanical ventilation dependent or planned transplantation patients

Keywords: mortality length hospitalization cardiac surgery patients
vexus score and aki in critically ill adult patients-a prospective observational study.

Conditions: Acute Kidney Injury; VExUS

Summary: introduction renal perfusion is dependent on the renal perfusion pressure across the renal capillaries. venous congestion due to excess fluid therapy can drastically reduce the renal perfusion pressure in spite of a normal mean arterial pressure. increasing cumulative fluid balance during the icu stay has been found to be associated with negative outcomes including acute kidney injury (aki) and hospital mortality. venous excess ultrasound (vexus) to assess the doppler studies of renal, hepatic and portal veins along with the inferior venacava has been shown to reliably predict the incidence of aki in certain icu patient population more specifically in cardiorenal syndrome. the aim of this study was to correlate the incidence of aki and vexus scores in a mixed icu population and hence determine the contribution of venous congestion on the causation of aki in a general icu. methods: the patients included who have aki at admission or developed aki during their icu stay were included. the definition of aki used for this study was as defined by kidney disease: improving global outcomes (kdigo). point of care vexus scans were done on each patient at inclusion (day 0), then each day for a total of 4 days (day 1, 2 and 3), till initiation of renal replacement therapy, death or discharge form the icu. correlation between vexus grades and creatinine clearances was explored as the primary objective.


Eligibility criteria:
inclusion criteria: * age ≥18 years * admitted to the adult icus of tuth (icu a and icu b) * admitting diagnosis of aki or who developed aki during their icu stay exclusion criteria: * pregnancy * diagnosed case of chronic kidney disease * diagnosed case of cirrhosis/ portal hypertension * arrhythmias which would interfere with the acquisition and interpretation of the doppler waveforms * inferior venacava thrombus * poor window for assessment

Keywords: vexus acute kidney injury cumulative fluid balance point of care ultrasound
safety, tolerability & potential anti-cancer activity of increasing doses of azd5363 in different treatment schedules

Conditions: Advanced Solid Malignancy; Safety and Tolerability; Pharmacokinetics; Pharmacodynamics; Tumour Response; Advanced or Metastatic Breast Cancer; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; PIK3CA; AKT1; PTEN; ER Positive; HER2 Positive

Summary: this study is designed to investigate the safety and tolerability of a new drug, azd5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. this study will also investigate how the body handles azd5363 (ie, how quickly the body absorbs and removes the drug). this study will also investigate anti-tumour activity of azd5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either akt1 / pik3ca or pten mutation.

a phase i, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of azd5363 under adaptable dosing schedules in patients with advanced solid malignancies.

Eligibility criteria:
inclusion criteria: * aged at least 18 years. * parts a,b: the presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist. * er+/her2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a pik3ca gene mutation (part c), akt1 gene mutation (part d) or a dysregulatory aberration on the pik/akt pathway (part d), advanced or metastatic er+ positive breast cancer that has an akt1 gene mutation (part e) or advanced or metastatic er+ positive breast cancer that has a pten gene mutation (part f). * the presence of at least one lesion that can be accurately assessed at baseline by ct, mri or plain x-ray and is suitable for repeated assessment. estimated life expectancy of more than 12 weeks. * estimated life expectancy of more than 12 weeks. exclusion criteria: * clinically significant abnormalities of glucose metabolism. * spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids). * evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv. * evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures. * a bad reaction to azd5363 or any drugs similar to it in structure or class.

Keywords: advanced solid malignancy,pik3ca mutated,akt1 mutated, pten mutation, pten alteration, metastatic,er+,breast,ovarian,endometrial,azd5363,akt inhibitor,
treating donors with intravenous immunoglobulin to reduce donor-derived infections

Conditions: Viremia; Bacteremia; Acute Rejection of Renal Transplant

Summary: the goal of this clinical trial is to learn about the benefit of ivig in donor-derived infections and the potential immunomodulatory effect on transplanted organs. the main questions it aims to answer are: 1. how effective ivig is in preventing donor-derived infections 2. does ivig has potential immunomodulatory effect on transplanted organs

donor-derived infections are defined as any infection present in the donor that is transmitted to one or more recipient. donor-derived infections can be categorized into two groups: "expected" and "unexpected" infections. expected transmissions occur when the donor is known to have an infection, as demonstrated by positive serology or nucleic acid test (nat) result for cytomegalovirus (cmv), epstein-barr virus (ebv) or hepatitis b and c, or positive cultures in the donor at the time of donation. unexpected transmissions may occur despite current screening strategies and are not expected in the donor at the time of organ placement. intravenous immunoglobulins (ivig) are produced by pooling together of serum immunoglobulins from multiple donors, and are known to have powerful immunomodulatory and anti-inflammatory functions in vitro and in vivo. the goal of this study is to figure out the benefit of ivig in donor-derived infections and the potential immunomodulatory effect on transplanted organs.

Eligibility criteria:
inclusion criteria: * any person approved as a transplant donor with recipient who has never undergone a previous transplantation * transplant donor must be 6 years old or older * they must have provided signed informed consent * the donors must be willing to contribute samples of blood exclusion criteria: * any potential transplant donor who is receiving or have received anti-herpes medication in the past week * any potential transplant donor to a recipient who has received a previous solid organ transplant * any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications * any potential transplant donor who is on corticosteroids

Keywords: ivig infection
babies born early antibody response to men b vaccination: bear men b

Conditions: Prematurity; Vaccination; Meningococcal Disease

Summary: in the uk, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. this policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), haemophilus influenzae type b, pneumococcal disease and now meningococcal b disease. the 4cmenb vaccination (bexsero®) was added to the uk schedule in september 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. the investigators want to compare two different schedules of 4cmenb and see if one gives better protection to babies born prematurely. it is possible that an extra 4cmenb dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. this is what the investigators are trying to find out through this study.

this will be an open label, phase iv study. after appropriate consent, 132 premature infants born at \<35 weeks gestation (i.e. up to 34 weeks and 6 days), 50% \<30 weeks gestation (i.e. up to 29 weeks and 6 days) will be randomised to 1 of 2 4cmen b schedules either at 2,4 and 12 months or 2,3,4 and 12 months. babies will remain in the study for around 12 months, from recruitment to 13 months of age. all visits can be performed at the participant's home or in clinic, depending on the preference of the parents and study team. blood samples will be obtained at 5 months of age (post primary sample), 12 months (persistence sample) and 13 months (post booster sample). reactogenicity and safety will be assessed by caregiver completion of a 7-day diary after each vaccine dose. inpatients will be monitored for cardiorespiratory events for 72 hours after vaccination by healthcare staff and this information will be collected on the crf. this will include details of oxygen saturations, heart rate, respiratory rate and details of any episodes of desaturation, bradycardia or apnoea. particular emphasis will be placed on rates, timing and intensity of fever and other adverse reactions in the first 24 hours after vaccination, because this remains a cause of great concern amongst neonatologists.

Eligibility criteria:
inclusion criteria: * premature infant born at \<35 weeks gestation * no contraindications to vaccination according to the 'green book' * willing and able to comply with study procedures * written informed consent exclusion criteria: * contraindication to vaccination according to the green book * life-limiting congenital abnormality or condition * prior diagnosis of an immunodeficiency syndrome * considered unlikely to complete expected follow up until the end of the study

Keywords: prematurity vaccination
pilot study of the haymakers for hope fitness program

Conditions: Cancer; Exercise Test; Fatigue; Mood; Quality of Life; Biomarkers

Summary: this research study is assessing the effect of an exercise program on cancer survivors. the exercise program is haymakers for hope 16-week exercise program

this is a pilot study, it is the first time investigators are examining the effect of this exercise program on cancer survivors physical and emotional functioning. the exercise programs is based on the conditioning program used by boxers.- haymakers for hope 16-week exercise program * the research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * participants will attend the 16-week program of boxing conditioning. it is expected that about 10 people will take part in this research study. * this 16 week will include supervised exercises designed to improve strength, flexibility, balance and cardiopulmonary fitness. * there will be 4 sessions of 1 hour each week for each of the 10 participants. * the program will be conducted at gymnasiums contracted with the h4h program and outcomes assessments at massachusetts general hospital and the gymnasiums..

Eligibility criteria:
inclusion criteria: * cancer diagnosis excluding non-melanoma skin cancer * age ≥ 18 years * ecog performance status ≤1 * medical clearance by treating clinician * no known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, serious or non-healing wound, peripheral neuropathy greater than or equal to grade 3, or myocardial infarction within 1- year. * able to complete forms and understand instruction in english * willing and able to attend the h4h program for 16 weeks * willing and able to complete the baseline and follow-up visits at mgh * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * participants who have had surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to surgery more than 4 weeks earlier. * blastic or lytic bone lesions * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * chest pain brought on by physical activity * pregnant women or women intending to become pregnant during the study period * presence of dementia or major psychiatric illness that would preclude participation in a group program

Keywords: cancer exercise test cardiopulmonary exercise test fatigue mood quality of life biomarkers analysis, survival
lanreotide levels in acromegaly

Conditions: Acromegaly

Summary: recently lanreotide (a somatostatin analog) has come into the us marketplace as a commercially available medication approved by the fda for the treatment of acromegaly. blood levels in patients getting this drug are unknown and it may be critical to know the levels in patients whose symptoms are poorly controlled. this is a clinical study of a medical device where the following condition is met: this is research on a medical device for which an investigational device exemption application (21 cfr part 812) is not required. the study is exempt from ide requirements under 21 cfr 812.2(c)(3): the participants will be 10 csmc patients who are taking lanreotide for clinical purposes. after receiving an information sheet and providing verbal consent, the participants will go to their routine blood draw. at this time, they will have an additional 10 cc plasma drawn, which will be sent to intersciences institute in inglewood california to have the lanreotide plasma levels measured. the key points of this study are: patients will have blood drawn at the same time as they are having blood drawn for routine care to avoid unnecessary sticks. no patient identifiers will be sent to the lab or to any investigators- all plasma tubes will be coded by isi as a kit and these kits will be given to the physicians. in turn the physician will give the kit to the patients who wish to have their levels measured and the patient will take the kit with them to their routine blood draw. following the drawing and processing of the blood we will request that the lab just drop the coded plasma tube (and the patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. the only information that the investigators will receive is the patient's height, weight and monthly lanreotide dose and the plasma lanreotide level. no more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide measurement. whenever possible plasma (which would otherwise be discarded) will be used rather than freshly drawn blood. all plasma will be assayed at isi. the patient will not be charged for the lanreotide assay, an investigational assay. the assay is currently investigational and does not have a "maker" at this time.


Eligibility criteria:
inclusion criteria: * 18 years or older * receiving lanreotide depot for treatment of acromegaly exclusion criteria: * unwilling to provide consent

Keywords: acromegaly lanreotide
monotherapy study in patients with type 2 diabetes mellitus (0431-021)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * patient is not pregnant or breastfeeding * male or female patient unlikely to conceive * patient not on an antihyperglycemic drug exclusion criteria: * patient has history of type 1 diabetes mellitus * patient has history of ketoacidosis * patient requires insulin within 8 weeks prior to start of study * patient on weight loss program and is not in maintenance phase * patient taking weight loss medication within 8 weeks prior to start of study * patient on or likely to require = 14 days or repeated courses of corticosteroids * patient taking immunosuppressive/immunomodulating medication * patient taking digoxin or other cardiac medication * patient has undergone surgical general anesthesia within 30 days prior to start of study * patient taking investigational drug within 8 weeks prior to start of study * patient is diagnosed with liver disease * patient has chronic myopathy, progressive neurological/neuromuscular disorder * patient has with severe cardiac conditions within the last 6 months * patient is human immunodeficiency virus (hiv) positive * patient has hematological disorder * patient has history of malignancy * patient has history of alcohol or drug abuse within the past 3 years