Kornimate/medical-research-clean huggingface dataset:
oral contraceptive efficacy and body weight

Conditions: Contraception; Body Weight

Summary: the purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. the purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.

the blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. after validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. all women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. during each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. during the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. women will also need to report in a written diary that they have taken their birth control pill for the day.

Eligibility criteria:
inclusion criteria: * age 18 to 35 * single baseline hematocrit ≥ 36% * single progesterone level of 3 ng/ml or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with ocs. exclusion criteria: * any absolute contraindications to ethinyl estradiol and levonorgestrel * smoking * actively seeking or involved in a weight loss program (must be weight stable) * pregnancy, breastfeeding, or seeking pregnancy * diagnosis of polycystic ovarian syndrome * recent (8 week) use of oc (patch or ring included), intrauterine, or implantable hormonal contraception * depoprovera use within six months * current use of drugs that interfere with metabolism of sex steroids.

Keywords: contraceptive efficacy body weight
a prospective, multi-center trial for reinforced staple during distal pancreatectomy

Conditions: Pancreatic Neoplasms

Summary: the aim of this study is to evaluate if the endo gia reinforced reload with tri-staple technology reduce incidence of pancreatic fistula (isgpf grade b and c) after distal pancreatectomy by a prospective, multi-center trial.

reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. there is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.this study will be conducted to scientifically investigate the impact of endo gia reinforced reload with tri-staple technology in distal pancreatectomy. the aim of this study is to evaluate if the endo gia reinforced reload with tri-staple technology reduce incidence of pancreatic fistula (isgpf grade b and c) after distal pancreatectomy by a prospective, multi-center trial.

Eligibility criteria:
inclusion criteria: 1. disease of pancreatic body and tail 2. ps (ecog performance status scale)0-1 3. age: 20 years or older 4. distant metastases are not diagnosed preoperatively. eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis 5. patients who can provide written informed consent exclusion criteria: 1. patients with severe ischemic cardiac disease 2. patients with severe liver cirrhosis or active hepatitis 3. patients with respiratory illness that requires oxygen administration 4. patients with chronic renal failure requiring dialysis 5. patients requiring other organ resection 6. patients who are unfit for the study as determined by the attending physician
the effect in wedge resection and ivb/v resection of the liver for gallbladder cancer

Conditions: Gallbladder Cancer

Summary: the extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. this study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. patients with t2 or t3 gallbladder cancer on preoperative ct exam or patients who were pathologically diagnosed as t2 or t3 gallbladder cancer after initial simple cholecystectomy were enrolled. all patients are randomly assigned to wedge resection or bisegmentectomy group. number of patients in each group is 44. primary endpoint is recurrence-free-survival rates and overall survival rates.

the extent of hepatic resection for gallbladder cancer has a wide range. a partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. this study enrolls patients with t2 or t3 gallbladder cancer on preoperative ct exam or patients who were pathologically diagnosed as t2 or t3 gallbladder cancer after initial simple cholecystectomy. eighty eight patients are randomized to wedge resection group or bisegmentectomy group. except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same. primary endpoint is recurrence-free-survival rates and overall survival rates.

Eligibility criteria:
inclusion criteria: * patients with t2 or t3 gallbladder cancer on preoperative ct exam * patients who are pathologically diagnosed as t2 or t3 gallbladder cancer after initial simple cholecystectomy exclusion criteria: * peritoneal seeding or distant metastasis * impossible to resect the cancer radically * pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc. * r1 or r2 resection were pathologically diagnosed.

Keywords: gallbladder cancer bisegmentectomy
evaluate whether combination therapy with methotrexate and raptiva in psoriasis patients is safe and increases efficacy

Conditions: Psoriasis

Summary: to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (raptiva) increases efficacy. the secondary objectives of this study are 1) to evaluate the efficacy of raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of raptiva and methotrexate.

the primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (raptiva) increases efficacy. the secondary objectives of this study are 1) to evaluate the efficacy of raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of raptiva and methotrexate. the design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with raptiva and adding methotrexate to those patients who do not improve significantly

Eligibility criteria:
inclusion criteria: * moderate to severe plaque-type psoriasis * a candidate for systemic therapy or phototherapy * not using prescription systemic therapies for psoriasis prior to starting the study * not using efalizumab within 3 months prior to starting the study we are seeking adults who: * have moderate to severe plaque-type psoriasis * are generally healthy * are not hypersensitive to raptiva® (efalizumab) or any of its components. * are not pregnant or lactating women you will: * be interviewed and examined * have blood drawn * be injecting the study medication exclusion criteria: * hypersensitivity to raptiva or any of its components * pregnant or lactating women * history of liver disease or abnormal liver enzymes * history of chronic infection or malignancy * history of significant hematologic abnormalities
metabolic monitoring during therapeutic hypothermia (cooling) for hypoxic ischaemic encephalopathy

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: this study aims to determine if cgm can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

in the uk approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (hie). hie not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. the clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. we have used continuous glucose monitoring (cgm) to help target glucose control in extremely preterm infants who require intensive care. cgm however has not been used in babies who are being cooled. this study aims to determine if cgm can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Eligibility criteria:
inclusion criteria: * hypoxic ischaemic encephalopathy informed parental consent exclusion criteria: * known significant congenital malformation
regenerative potential of cultured gingival fibroblast- mesenchymal stem cells in treatment of periodontitis

Conditions: Periodontal Intrabony Defect

Summary: clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and gmscs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters

in the present study, twenty posterior two or three osseous intrabony periodontal defects were involved . they were grouped in to two groups. group i included ten intrabony posterior defect received beta tri calcium phosphate (β tcp) bone substitute. group ii included ten posterior intrabony periodontal defect and they received a mixture of gingival fibroblast(gf) and gingival mesenchymal stem cells(gmscs) carried on a vehicle of β tcp covered by a resorbable collagen membrane. cbct was used preoperatively and after 6 months for hard tissue evaluation. pdgf and bmp were measured in gcf at days 1,3,7,14.

Eligibility criteria:
inclusion criteria: * presence of interproximal osseous defects estimated from radiographic evaluation (cone beam ct) and transgingival bone sounding ≥3mm of two or three osseous walls. * probing depth ≥5mm after initial therapy. * attachment loss ≥4mm. * full mouth plaque score and bleeding on probing score ≤ 20% after phase i therapy. * non vital teeth only involved. * no furcation involvement of the teeth presenting the intraosseous defects. * thick gingival biotype more than 1 mm with enough width of attached gingiva. * accepts healthy volunteers exclusion criteria: * patients with systemic disease or compromised immune illness using cornell medical index * smoker's patients. * pregnant and lactating females. * uncooperative patients (low compliance, bad oral hygiene). * decision impaired individuals (prisoners, handicapped and mentally retarded patients).
the serotonin transporter in attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aim of the present proposal is to prove that adult attention deficit hyperactivity disorder (adhd) patients show lower serotonin transporter (5-htt) binding using positron emission tomography (pet) and the selective radioligand \[11c\]dasb. specifically, the 5-htt binding will be quantified in 20 adult medication-free adhd patients (50% females) and in 20 age- and sexmatched healthy controls. investigating untreated adult adhd patients without any psychiatric comorbidities will provide the opportunity to estimate the change of serotonin transporter binding in adult adhd patients compared to a group of healthy controls. several lines of evidence support the hypothesis that serotonergic neurotransmission may, in addition to dopamine, play an important role in the aetiology of adhd. so far, no pet study investigating serotonergic neurotransmission in adult adhd patients has been conducted, although alterations in the serotonin system may be substantially involved in the susceptibility and subtype characterization of adhd.


Eligibility criteria:
inclusion criteria: * patients must be male or female outpatients who are at least 18 years of age and no more than 65 years of age when informed consent is obtained. * patients must meet dsm-iv-tr criteria for current adhd as well as for historical diagnosis of adhd during childhood as assessed by the conner´s adult adhd diagnostic interview for dsm-iv (caadid, conners 1999). * patients must have a score of \>2 on at least 6 items of either the inattentive or hyperactive score subscales at screening on the rated caars-inv:sv (conners 1999). in addition, their caars-inv:sv 18-item total adhd symptom score (the sum of the inattention and hyperactivity/impulsivity subscales) must be \>20. * patients must have a cgi-adhd-s score of \>4 (moderate symptoms) at screening. * patients must be physically healthy. * patients must be able to understand and willing to sign the written informed consent document. exclusion criteria: * patients suffering from severe somatic diseases will be excluded from the study. * any treatment with stimulants, selective norepinephrine reuptake inhibitors or any other psychotropic treatments, such as ssris, etc. within six months prior to screening. * patients suffering from any current comorbid psychiatric disorder (axis i or axis ii diagnosis according to dsm-iv-tr) will be excluded. * patients who are currently using alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet dsm-iv-tr criteria for alcohol or other substance dependence. * any implant or stainless steel graft. * positive urine pregnancy test. * participation in studies with pet or spect within the last 10 years.
mindfulness-based cognitive therapy (mbct) for people with parkinson's disease

Conditions: Parkinson Disease; Anxiety; Depression

Summary: this study aims to explore the feasibility and effectiveness of mindfulness-based cognitive therapy (mbct) in reducing anxiety and/or depressive symptoms in people with parkinson's disease.

an adapted mbct intervention will be offered to people with parkinson's disease and mild-to-moderate depression and/or anxiety. two 8-week long mbct groups will be held between september 2019 and march 2020, based on the adapted protocol. modifications will include shortening the traditional 120-minute to 90-minute format and performing mindful yoga from a chair, instead of a floor mat. participants will be recruited from the community, according to the eligibility criteria detailed below. the participants' pre- and post-mbct anxiety and/or depressive symptom severity and mindfulness levels (as measured with standardized, validated scales) will be compared, using a paired t-test.

Eligibility criteria:
inclusion criteria: 1. diagnosis of parkinson's disease or parkinsonism (established by a neurologist) 2. living in the san francisco bay area 3. being able and willing to attend 8 weekly 90-minute group sessions 4. mild-to-moderate anxiety: gad-7 score ≤ 16 5. mild-to-moderate depression: phq-9 score ≤ 18 exclusion criteria: 1. severe anxiety: gad-7 score \> 16 2. moderately severe-to-severe depression: phq-9 score \> 18 3. cognitive impairment: montreal cognitive assessment (moca) score \< 24 4. heavy alcohol or drug use 5. severe psychosis 6. active suicidal or homicidal ideation 7. severe motor fluctuations (less than 2 hours "on" time per day)

Keywords: parkinson's disease mindfulness-based intervention mindfulness-based cognitive therapy (mbct)
modified pectoral nerve block vs thoracic erector spinae plane block for analgesia for aesthetic breast surgeries

Conditions: Postoperative Pain

Summary: the aim of this study is to evaluate the effectiveness of ultrasound guided modified pectoral nerve block (pecs ii) versus thoracic erector spinae plane block (espb) for postoperative analgesia in cases of aesthetic breast surgeries.

preoperative settings: all the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about numeric rating scale (nrs) and its interpretation. intravenous access will be inserted, premedication with midazolam 3 mg will be done. on arrival to operating room, routine monitoring including electrocardiography (ecg), non-invasive arterial blood pressure(nibp) and pulse oximetry will be used. the mean arterial blood pressure (map)and heart rate (hr) will be recorded before induction of general anaesthesia (baseline). intraoperative \& postoperative settings : a prophylactic antibiotic will be given after skin sensetivity test then general intravenous anaesthesia induction will be done. patient inductions by propofol (2 mg/kg), atracurium 0.5 mg/kg and fentanyl 1 µg/kg. endotracheal intubation will be settled then patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal co2 between 30-35 mmhg guided by capnogram. anaesthesia will be maintained with isoflurane 1,5 to 2 vol%. patient will be given 50% oxygen/air mixture, and incremental doses of fentanyl (0.5µg/kg) will be given every 1 hour. the depth of anaesthesia will be adjusted to keep changes of hemodynamics; (map) and (hr); within the range of ±20% of the baseline. under complete aseptic conditions, the blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks. the blocks will be performed with a 20gauge, echogenic needle (pajunk, 120mm, germany). the patients will be randomly divided into two groups,then the desired block will be done. surgical procedure will be started after performing the desired block. at the end of surgery, patients will be extubated after reversal of muscle relaxant by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg. patients will be transported to post anaesthesia care unit (pacu). hr, systolic, diastolic and mean pressures will be observed.

Eligibility criteria:
inclusion criteria: * females aged ≥21 years' old. * bmi ≤35. * patients with asa i \& ii. * scheduled for one of the aesthetic breast surgeries. exclusion criteria: * patients refusal. * contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection. * patients with unstable cardiovascular disease. * emergency surgery. * patients with chronic pain. * history of allergy to the medications used in the study.
mindfulness-based stress reduction for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (mbsr) for adults with any type of multiple sclerosis. the secondary objectives are to: 1) explore the ability of mbsr to improve perceived stress and quality of life compared to an education control group; and 2) explore the durability of the effects of mbsr over one year.


Eligibility criteria:
inclusion criteria: * men and women 18 years of age or older * definite relapsing remitting, secondary progressive, or primary progressive ms by revised mcdonald criteria; * expanded disability severity scale ≤ 8 at baseline; * stable on ms disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit; * mild to moderate stress defined by a score of ≥ 10 on the perceived stress scale at screening; * ability to read and write in english; * willingness to provide informed consent and comply with study activities, including weekly mbsr sessions and daily practice or weekly education control classes. exclusion criteria: * mbsr or cognitive behavioral therapy training within the last 5 years; * current regular meditation or yoga practice (weekly or more often); * ms exacerbation within 30 days of baseline visit; * mini-mental status examination (mmse) score of ≤ 26 at screening visit; * active suicidal ideation (beck depression inventory) at screening visit; * reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety; * other current life-threatening or severely disabling physical disorders; * positive pregnancy urine test at baseline and women planning pregnancy during the study period (contraception not required); * cancer, other than basal or squamous skin cancers; or * inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Keywords: mindfulness meditation stress, psychological quality of life randomized controlled trial
the effectiveness of video-capsule endoscopy in gastrointestinal bleeding of obscure origin

Conditions: Gastrointestinal Bleeding

Summary: the study objective is to compare the cost-effectiveness of vce to push enteroscopy in patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.

background: the introduction of the wireless capsule endoscopy (wce) may dramatically alter the management of patients with small bowel disease such as chronic gastrointestinal bleeding of obscure origin (cgb). yet, to date, this non invasive technique has undergone widespread diffusion in the absence of properly designed prospective comparative cost-effectiveness evaluations. objectives: to examine the clinical impact and cost-effectiveness of a novel approach employing wce compared to that of push enteroscopy (pe). hypothesis: wce is more cost-effective than pe in patients with cgb. study design: we propose a randomized clinical trial comparing wce to pe. study population: patients with cgb having undergone initial normal assessment with gastroscopy, colonoscopy and radiological examination of the small bowel. outcomes: primary objective: to compare the detection rates of "clinically significant" small bowel lesions using wce versus pe in cgb patients randomized to either modality. secondary objectives: to determine the "cure rate" for each technique after 6 months, the cost-effectiveness of wce versus pe, the type of small bowel lesions most likely to impact on clinical care, inter-rater variability in reading wce examinations, the feasibility of wce interpretation by a dedicated technician, the safety of each imaging modality, and to compare patient satisfaction and quality of life between the two groups.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * normal gastroscopy, colonoscopy and small bowel follow through in the last 3 months exclusion criteria: * demonstrable source of blood outside the gi tract * significant cardiopulmonary disease * suspicion of strictures or fistulae of the gi tract * pregnancy * numerous small intestinal diverticula * zenker's diverticulum * extensive crohn's enteritis

Keywords: gastrointestinal bleeding of obscure origin