Kornimate/medical-research-clean huggingface dataset:
the design and evaluation of an active intervention for the prevention of non-contact acl injury

Conditions: Athletic Injuries; Sprains and Strains; Wounds and Injuries; Knee Injuries

Summary: the overall goal of this project is to reduce the risk for anterior cruciate ligament injuries by designing a targeted intervention that will alter the known kinematic and kinetic risk factors associated with acl injuries.

this study will address the following specific aims: 1) to optimize a wearable, targeted, active training feedback device to reduce the risk of acl injury among healthy subjects by inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with acl injuries. 2) to evaluate the efficacy of the active device and determine if the device reduces the risk of acl injury among healthy subjects by effectively inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with acl injuries.

Eligibility criteria:
inclusion criteria:the ages would range from 18 to 65. both male and female subjects will be enrolled, and ethnic backgrounds would be mixed. exclusion criteria:(i) chronic lower body pain (ii) recent surgery of the lower or upper body (limitation of range of motion) (iii) previous history of ligament, meniscal, or chondral injury requiring surgery to the lower limb (iv) inability to complete jumping tasks
effect of cognitive behavioural therapy (cbt) for children with autistic spectrum disorders

Conditions: Autism Spectrum Disorder; Anxiety

Summary: cognitive behavioural therapy is an effective intervention program for children with high-functioning autistic spectrum disorder to remediate anxiety issues.


Eligibility criteria:
inclusion criteria: * assessed to have autistic spectrum disorder, asperger syndrome, pervasive developmental disorder, not otherwise specified by the dsm-iv criteria, based on clinical interview, asperger syndrome diagnostic scale (asds) or autism diagnostic observation schedule (ados) * child have a verbal comprehension index of 80 and perceptual reasoning index of 90 and above * no change of medication dosage 1 month prior to the commencement of program for the child and through out the duration of the study * written parental consent and assent from children above 12 years old exclusion criteria: * children with verbal comprehension index of 80 and perceptual reasoning index of 90 and below. * children who are undergoing other cognitive behavioural treatment program concurrently * those without parental consent will not be able to participate

Keywords: high-functioning autistic spectrum disorder anxiety cognitive behavioural therapy social recreational parent stress
phase 2, nab paclitaxel/gemcitabine alone and in combination with acp-196 in subjects with metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: to evaluate the safety and efficacy of acp-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria

a phase 2, multicenter, open-label, randomized clinical trial. the study was to evaluate the efficacy and safety of acp-196 plus nab-paclitaxel/gemcitabine compared with nab-paclitaxel/gemcitabine in subjects who have previously untreated metastatic pancreatic cancer.

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * ecog performance status of 0 or 1. * histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. * no previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. prior treatment with 5-fu or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. exclusion criteria: * prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years. * known central nervous system (cns) metastases and/or carcinomatous meningitis. * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. * biliary obstruction or presence of a percutaneous biliary drain. note: subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met. * breastfeeding or pregnant

Keywords: acalabrutinib
sodium alendronate in non surgical periodontal therapy

Conditions: Periodontitis; Bone Resorption

Summary: in the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. this study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. a placebo gel was used as control.


Eligibility criteria:
inclusion criteria: * chronic periodontitis * two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss \> 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact * systemically healthy volunteers exclusion criteria: * need for antibiotic or systemic/local antibiotic use in the previous 3 months * periodontal treatment in the previous 6 months * pregnancy or lactation * immunological disorders or imune suppressive treatments * diabetes * smoking * orthodontic appliances or removable prosthesis * osteoporosis * known or suspected allergy to biphosphonates * systemic use of biphosphonates
htx-011 administration study in planned caesarean section procedure

Conditions: Analgesia

Summary: this is a phase 2, open-label study to evaluate the pk and safety of htx-011 in women undergoing a planned c-section.


Eligibility criteria:
inclusion criteria: * is expected, at the time of screening visit, to deliver a single neonate. * is scheduled to undergo a planned c-section surgery with a low transverse skin incision (eg, pfannenstiel). * has american society of anesthesiologists (asa) physical status of i, ii, or iii. * agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after htx-011 administration. * agrees to refrain from the use of breast milk from this pregnancy in any manner. exclusion criteria: * has planned to breastfeed her neonate at any time during the 28-day period after htx-011 administration. * has had a prior full-term pregnancy with unsuccessful breast milk expression. * has a planned concurrent surgical procedure. * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * has been administered bupivacaine within 5 days prior to the scheduled surgery. * has been administered any local anesthetic within 72 hours prior to the scheduled surgery. * has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control. * has taken any nsaids within least 10 days prior to the scheduled surgery. * has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta. * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * has uncontrolled anxiety, psychiatric, or neurological disorder. * had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. * previously participated in an htx-011 study. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. * weight is \<50 kg at the time of screening visit. * in the investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.

Keywords: postoperative pain caesarean section c-section
the empa-fit study

Conditions: Diabetes; Diabetes Mellitus, Type II

Summary: this multicenter, open-label, prospective study randomized 46 drug-naïve adults with t2d (hba1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.


Eligibility criteria:
inclusion criteria: * participants were eligible if they had t2d with an hba1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening. exclusion criteria: * individuals with a body mass index (bmi) \<18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. participants with ckd (egfr \<60 ml/min/1.73 m²) or end-stage renal disease (egfr \<15 ml/min/1.73 m² or on dialysis) were also excluded. additional exclusion criteria included uncontrolled hypertension (bp ≥160/100 mmhg), new york heart association (nyha) class iii or iv heart failure, chronic oral corticosteroid use (\>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides \>1,000 mg/dl or ldl cholesterol \>250 mg/dl).

Keywords: metformin, empagliflozin, glucose variability
multi-component workplace energy balance intervention

Conditions: Abdominal Obesity

Summary: the purpose of the workactive-p study is to assess the outcome of an innovative multi-component intervention focused on increasing energy expenditure and re-balancing the disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing workers' abdominal obesity.

the energy expenditure intervention includes replacing workplace sedentary time with access to a dedicated pedal desk and increasing steps/day with wearable monitors. both components are incorporated into an electronically-delivered behavior monitoring and support infrastructure, thus enabling continuous management. the investigators will utilize pedaldesks manufactured and owned by pennington biomedical research center to conduct this study at blue cross blue shield of louisiana offices in baton rouge, la. 40 individuals will be recruited and randomized to either a control arm or combined walk more pedal desk (wmpd) intervention. primary (mri-determined visceral adipose tissue) and secondary (changes in body weight, total adipose tissue, subcutaneous adipose tissue, blood pressure, blood lipids, fasting glucose and insulin, hba1-c, free-living accelerometer-determined walking, time spent in sedentary behavior, exercise, and dietary intake) outcomes will be assessed at baseline and month 3.

Eligibility criteria:
inclusion criteria: * bmi: \> or equal to 25.0 kg/m2 and \< or equal to 40 kg/m2 * waist circumference: \>102 cm (men) or \> 88 cm (women) * any one of the other four defining risk factors defining metabolic syndrome (triglycerides \> or equal to 150 mg/dl , hdl cholesterol \ or equal to 130 mm hg systolic / 85 mm hg diastolic, fasting glucose \> or equal to 110 mg/dl) exclusion criteria: * systolic blood pressure \> 179 mmhg and/or diastolic blood pressure \> 99 mmhg * self-reported type 1 or type 2 diabetes, or use of diabetes-related medications * significant cvd or disorders * other significant medical conditions including but not limited to implants that may interfere with mri, chronic respiratory, gastrointestinal, neuromuscular, or psychiatric conditions, malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled, endocrine (including diabetes), any other medical conditions or disease (including arthritis) that is life threatening or that can interfere with or be aggravated by exercise. * poor compliance to activity monitors

Keywords: pedal desk workplace intervention physical activity energy expenditure
determinants of fat malabsorption after roux-en-y gastric bypass

Conditions: Severe Obesity

Summary: the purpose of this study is to determine whether or not the length of the biliopancreatic limb of the roux-en-y anastamosis plays a critical role in the development of malabsorption after gastric bypass for treatment of severe obesity.

successful surgical treatment of severe obesity by rygb is believed to require a procedure that (a) restricts the consumption of combustible food energy, and (b) reduces the intestinal absorption of food energy that is consumed. however, with rygb operations that are currently employed, many patients do not develop the malabsorption they presumably require to produce good long term control of their body weight. it is important to find a way to do rygb surgery in a way that consistently produces a moderate degree of fat malabsorption. patients who are scheduled to receive a rygb for treatment of severe obesity will be randomly assigned to receive 2 variations of the standard operation. the stomach and duodenal bypass, and the creation of a small gastric pouch will be exactly the same for all patients. there will be differences in the two jejunal limbs which create the roux-en-y anastomosis. in procedure a, the roux limb length will be 150 cm, and the biliopancreatic limb will contain 40 cm of jejunum. in procedure b, the roux limb length will be 110 cm and the biliopancreatic limb will contain 80 cm of jejunum. the total length of jejunum in both limbs is 190 cm in both procedures. thus, the only difference between procedures a and b is that b procedure has a larger percentage of jejunum in the biliopancreatic limb (80/190=42%) than procedure a (40/190 = 21%). a total of 20 patients will be studied, 10 with each procedure. before and after rygb, the patients will be studied in a clinical research laboratory. dietary intake and intestinal absorption of fat, protein, carbohydrate and combustible energy will be measured by metabolic balance techniques for 72 hours. we hypothesize that fat malabsorption after bypass will be greater and more consistent in patients who receive the longer biliopancreatic limb than in the patients who receive the longer roux limb.

Eligibility criteria:
inclusion criteria: * patients with severe obesity (bmi equal to or greater than 50) who have been scheduled to receive roux-en-y gastric bypass. exclusion criteria: * previous abdominal surgery, chronic diarrhea, and severe constipation.

Keywords: malabsorption after rygb fat malabsorption and maldigestion obesity surgery bariatric surgery
effect of transcutaneous electrical nerve stimulation and cupping therapy in the treatment of tennis elbow: a randomized controlled trial

Conditions: Tennis Elbow

Summary: one hundred and twenty patients (67 females and 53 males) with unilateral te were included in the study from january 2020 to december 2020 and diagnosed by an orthopedist. their ages ranged between 20 and 50 years old.

they were divided randomly into three groups by lottery method. group a (n=30) received conventional therapy, group b (n=30) received tens in addition to conventional therapy, group c received cupping therapy with conventional therapy and group d (n=30) received tens and cupping therapy plus conventional therapy. all patients read and signed a consent form before participation in this trial. this study was approved by the ethical committee of the faculty of physical therapy, october 6 university, egypt. patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months were included in the study while patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin were excluded from this study.

Eligibility criteria:
inclusion criteria: - patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months exclusion criteria: * patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin
outcome of acquired haemophilia with steroid combined with cyclophosphamide versus steroid combined with rituximab (creha study)

Conditions: Acquired Haemophilia

Summary: creha project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. the study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for fviii inhibitor eradication in acquired haemophilia.

creha project is a multicenter, randomized, controlled efficacity and safety study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. the study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for fviii inhibitor eradication in acquired haemophilia

Eligibility criteria:
inclusion criteria: * men or women * women post-menpausal or with ongoing contraception * 18 years old or more * diagnosis of acquired hemophilia * patient must be insured * patient has provided written informed consent prior to enrolment * patient compliant exclusion criteria: * constitutional hemophilia * chemotherapy * ongoing treatment with prednisone \> 20mg further more 1 month * ongoing treatment with prednisone \>0.7 mg/d further more 10 days * thrombocytopenia * leukopenia * chronic disease

Keywords: acquired haemophilia comparative and randomized study cyclophosphamide rituximab
comparison of the safety and immune response of three different lots of an influenza vaccine made by a new manufacturing process with a vaccine made by the traditional manufacturing process for season 2004/2005

Conditions: Influenza

Summary: the objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, vero cell-derived) at day 21 and day 180 after vaccination.


Eligibility criteria:
inclusion criteria: male and female subjects will be eligible for participation in this study if they: * are \>= 18 and \<= 60 years old on the day of screening (for stratum a only); * are \> 60 years old on the day of screening (for stratum b only); * are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study); * will reliably keep a daily record of symptoms; * understand the nature of the study, agree to its provisions, and give written informed consent; * if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study. exclusion criteria: subjects will be excluded from participation in this study if they: * have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season; * suffer from any kind of immunodeficiency; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence the normal immunologic functions; * have a history of inflammatory or degenerative neurological disease (e.g. guillain barré, multiple sclerosis); * have received a blood transfusion or immunoglobulins within 30 days of study entry; * have donated blood or plasma within 30 days of study entry; * have a history of any vaccine-related contraindicating event (e.g. anaphylaxis or other known contraindications); * have a rash or dermatological condition which may interfere with injection site reaction rating; * have a known or suspected problem with drug or alcohol abuse; * are unable to lead an independent life either physically or mentally; * were administered an investigational drug within six weeks prior to study entry; * are concurrently participating in a clinical study including the administration of an investigational product; * if female, are pregnant or lactating.
optical coherence tomography angiography and pseudophakic cystoid edema

Conditions: Pseudophakic Cystoid Macular Edema

Summary: this study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography

pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery. it is still source of debate the pathogenesis of pseudophakic cystoid edema. optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. the study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.

Eligibility criteria:
inclusion criteria: * age older than 60 years * diagnosis of pseudophakic cystoid macular oedema * treatment-naïve for pseudophakic cystoid macular oedema * absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration) exclusion criteria: * age younger than 60 years * no diagnosis of pseudophakic cystoid macular oedema * previous treatment for pseudophakic cystoid macular oedema * presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)