Kornimate/medical-research-clean huggingface dataset:
use of azithromycin and rifabutin administered 3 times weekly for the treatment of m. avium complex (mac) lung disease

Conditions: Mycobacterium Avium Complex

Summary: to determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with m. avium complex(mac)

azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of mac

Eligibility criteria:
inclusion criteria: * meet american thoracic society criteria for nontuberculous lung disease: two or more afb smear positive, culture positive sputums or bronchoscopic samples and/or two or more afb smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal cxr consistent with m. avium lung disease; abnormal cxr consistent with m. avium lung disease; absence of other lung pathogens (except for the coexistence of m. abscessus). * age 18 and older * pretreatment isolate of m. avium complex available for mic determination * baseline laboratory and clinical testing for baseline cbc, chemistry (including liver enzymes), hearing test, visual acuity and color discrimination * available for long term followup exclusion criteria: * history of macrolide or rifamycins allergy * laboratory evidence of mycobacterial resistance to azithromycin * children less than 18 years of age * if a menstruating female, not pregnant and on adequate birth control * hiv+ or at risk

Keywords: mac
a study to evaluate the efficacy and safety of spn-810 as adjunctive therapy in children with impulsive aggression comorbid with attention-deficit/hyperactivity disorder (adhd)

Conditions: Impulsive Aggression Comorbid With ADHD

Summary: this will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with attention-deficit/hyperactivity disorder (adhd). the target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of adhd. a total of 120 subjects will be randomized across approximately 30 us centers to one of four treatment groups.


Eligibility criteria:
inclusion criteria: 1. healthy pediatric male or female subjects, age 6 to 12 years. 2. diagnostic and statistical manual of mental disorders - iv -text revision (dsm-iv-tr) diagnosis of adhd. 3. r-moas score \>=24 at screening and r-moas score \>=20 for randomization 4. iq greater than 71. 5. weight of \>=20kg 6. current treatment with psychostimulant (1 month prior to screening)

Keywords: impulsive aggression attention deficit hyperactivity disorder adhd
immediate postmastectomy breast reconstruction (strattice breast)

Conditions: Breast Cancer

Summary: this prospective, multicenter, open-label study will assess the clinical outcomes of the ltm product in three planned analyses. the primary objective of this study is to prospectively assess the clinical outcomes associated with the use of ltm in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

nothing to add

Eligibility criteria:
inclusion criteria: * a candidate for immediate, two-stage breast reconstruction using ltm following a skin sparing mastectomy * an asa physical status classification5 of 1 or 2 (see app i) * estimated life expectancy \> 1 year exclusion criteria: * clinically significant systemic disease * received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time * predicted excised breast mass of \>750 gms * co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection * need for tissue flap in addition to expander * history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction * enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial * any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate

Keywords: breast reconstruction
using kinect motion capture to measure shoulder motion in patients undergoing capsular distension for adhesive capsulitis

Conditions: Adhesive Capsulitis; Adhesive Capsulitis of Shoulder; Frozen Shoulder; Shoulder Frozen; Shoulder Pain; Mobility Limitation

Summary: this study will compare shoulder range of motion assessment using the kinect motion tracking system vs goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing ultrasound-guided capsular distention procedures (standard of care). the investigators hypothesize that, for shoulder adhesive capsulitis, the kinect motion analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

the study will be a single-center, investigator-initiated protocol to assess the reliability of the kinect motion analysis 2.0 motion tracking system for range of motion (rom) assessment in patients with shoulder adhesive capsulitis undergoing ultrasound guided capsular distention procedures (standard of care for adhesive capsulitis). secondarily, the study will describe the relationship between range of motion of the shoulder girdle in the four quadrants of normalized reachable workspace by the kinect 2.0, promis person-reported outcome scores for pain, pain interference and function (general mobility and upper extremity function), and vas pain scores. study participants are anticipated to remain in the study for 12 weeks: an initial visit followed by 6- and 12-week follow up visits. given the nature of scheduling appointments in medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2 weeks longer if needed to successfully complete the follow-up visit. the investigators hypothesize that, for shoulder adhesive capsulitis, the kinect motion analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

Eligibility criteria:
inclusion criteria: 1. diagnosis of limited rom due to adhesive capsulitis 2. duration of symptoms of ≥ 3 months 3. persistent functional limitation (defined as either limitations occupationally, in independent activities of daily living, or activities of daily living) 4. x-rays and mri excluding alternative diagnosis 5. age 18 years or older. exclusion criteria: 1. prior shoulder surgery on the affected side 2. complete rotator cuff tear (based on clinical history, examination, and imaging) or planned surgical intervention on the affected side 3. ipsilateral subacromial injection within the last 3 months 4. autoimmune or rheumatologic disease affecting the joints 5. lack of scheduled same-day physical therapy appointment 6. inability to complete follow-up appointments or surveys 7. inability to provide informed consent 8. symptomatic glenohumeral or acromioclavicular pathology 9. referred pain from the neck or internal organs 10. generalized myofascial pain syndrome

Keywords: adhesive capsulitis frozen shoulder shoulder pain range of motion capsular distention capsular distension
beovu in the treatment of dystrophy-related macular neovascular degeneration

Conditions: Dystrophy, Retinal

Summary: dystrophy-related macular neovascularization degeneration occur is a vision threatening condition.the investigators evaluate the efficacy of beovu intravitreal treatment.

baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. procedure included intravitreal injection of brolucizumab (beovu®, genen-tech, south francisco, ca)

Eligibility criteria:
inclusion criteria: * dystrophy-related macular neovascularization degeneration exclusion criteria: * age related macular degeneration , other causes of macular neovascularization degeneration

Keywords: macular degeneration beovu retinal dystrophy
influence of initial levothyroxine dose on neurodevelopmental and growth outcomes in congenital hypothyroidism

Conditions: Congenital Hypothyroidism

Summary: the primary objective of this study is to evaluate the risk-benefit profile of long-term treatment of two different initials treatment schemes with l-t4 on the neurodevelopmental and auxological outcomes in children with congenital hypothyroidism, diagnosed by neonatal screening in order to find the best dose of initial thyroid hormone replacement to assure the best long-term developmental outcome without any adverse effects on auxological, cardiovascular and skeletal outcomes. the secondary objective of the study is to evaluate the role of other factors that, in addition to the initial l-t4 therapy,can influence long-term neurodevelopmental and auxological outcomes as well as the cardiovascular system and bone metabolism outcomes.

seventy-two neonates detected by the neonatal screening program for congenital hypothyroidism were randomly assigned to receive one of the two initial l-t4 replacement dose: group a received an initial replacement dose of 10-12.5 mcg/kg/die and group b received an initial replacement dose of 12.6-15 mcg/kg/die. the adequacy of treatment were monitored closely by clinical evaluation and regular measurement of ft4 and tsh. cognitive development were evaluated through the griffiths mental development scales at the the age of 2 yeas. cognitive and behavioural assessment at the age of 4 years were performed using the wechsler preschool and primary scale of intelligence. growth were evaluate at the enrolment and at each visit. skeletal maturation were evaluated at diagnosis and at the age of 1 and 4 years. at the age of 4 years a quantitative ultrasound measurements and cardiovascular evaluation were performed.

Eligibility criteria:
inclusion criteria: * congenital hypothyroidism diagnosed by neonatal screening program * age less than 30 days at diagnosis * tsh value at confirmatory diagnosis above 30 mu/l * caucasian ethnicity exclusion criteria: * prematurity * major congenital malformations * neonatal diseases * chromosomopathies * known maternal thyroid diseases

Keywords: neonatal screening levothyroxine treatment neurocognitive growth
progressive collective-exercise program on the knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the investigators hypothesized that an eight-week collective group exercise program would improve pain, quality of life and functional capacity in patients with knee osteoarthritis (koa) compared with those receiving no exercise intervention.


Eligibility criteria:
inclusion criteria: * symptomatic and moderate to severe medical diagnostic of koa. * subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's koa database and eligible to participate if they had presented: lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 visual analogue scale), stable doses of non-steroidal anti-inflammatory drugs (nsaids) and no regular physical exercise or use of canes in the months prior to the study. exclusion criteria: * symptomatic heart disease; symptomatic disease of the lower limbs (other than koa); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions
using mesenchymal stem cells to fill bone void defects in patients with benign bone lesions

Conditions: Bone Neoplasms

Summary: the purpose of this study is to determine whether using mesenchymal stem cells will heal benign bone lesion defects faster than demineralized bone matrix

orthobiologics have recently become a mainstay in treating bony defects whether related to trauma, tumor, or other various reconstructive entities.1 historically, benign bone growths that were excised, would be filled with either cement, autograft bone, or allograft substances. more recently, other substances have been utilized. these substances carry any or all osteoinductive, osteoconductive, or osteogenic properties. various materials have been used to fill bony voids specifically related to benign bone growths. trinity™ by blackstone medical inc. is an allograft substance that has recently began utilization. the difference in trinity compared to various other allografts is that it utilizes mesenchymal stem cells (msc) along with an allograft carrier to incorporate and induce bone formation. previously, in order for stem cells to be included in grafting, it would require bone marrow aspiration and the morbidity that is associated with iliac crest bone grafting. trinity msc's are pre-immunodepleted and therefore, do not stimulate local t-cell proliferation but instead are activated to act as osteoblasts and stimulate bone formation. this local response, could accelerate healing, earlier weight-bearing, healing, and filing of bone voids in patients that have had excision of bony masses. in previous animal models, the use of msc's have been shown to increase bone healing in critical sized defects. trinity is currently approved for fda use in bone defects specifically within the spine or trauma. it has not been shown to have any significant adverse events over standard bone substitute products. we hypothesize benign bone lesions that undergo curettage and filling with trinity will heal faster than bone lesions filled with basic bone grafting.

Eligibility criteria:
inclusion criteria: * ages \> 11 years * benign bone lesion exclusion criteria: * previous surgery

Keywords: bone defect benign bone lesions stem cells
sildenafil versus low molecular weight heparin in fetal growth restriction treatment

Conditions: Fetal Growth Abnormality; Fetal Growth Restriction

Summary: comparing the effect of using sildenafil citrate and lmwh in treatment of cases of iugr due to placental insufficiency

one hundred pregnant women with documented intrauterine growth restriction due to placental insufficiency at 28-35 weeks of gestation will be distributed into two groups: * group s: 50 women will receive sildenafil citrate 25 mg tab 3 times daily. * group h: 50 women will receive single dose of lmwh subcutaneous daily. both groups will undergo strict fetal surveillance in the form of: umbilical artery doppler (uad) is the primary surveillance tool in the fgr fetus: middle cerebral artery (mca) doppler, ultrasound for (ac, efw, and deepest vertical pocket (dvp) for amniotic fluid) and non stress test and biophysical profile (bpp)

Eligibility criteria:
inclusion criteria: * maternal age between 20-35 years. * being at a gestational age 28-35wks. * singleton pregnancy. * fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the 10th percentile, and/or fetal abdominal circumference at or below the tenth percentile. exclusion criteria: * maternal age less than 20 years or more than 35 years. * undetermined gestational age. * multiple gestation. * chronic diseases with pregnancy e.g. chronic hypertension, diabetes type 1 or 2. * etiologies of fgr other than placental insufficiency as fetal malformations, aneuploidy or infections. * suspected fetal compromise requiring emergency delivery. * any contraindication to the use of sildenafil e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil. * any contraindication to the use of lmwh e.g. known bleeding disorder, active antenatal bleeding or at increased risk of major hemorrhage (e.g. placenta praevia), thrombocytopenia, severe renal or hepatic disease. * drug or alcohol abuse. * patient refusing to participate in the study or unable to consent.
the safety and tolerability of alprostadil liposome for injection in healthy adult volunteers

Conditions: Lower Extremity Arterial Occlusive Diseases

Summary: conducted in chinese healthy adult volunteers,the study aims to observe the safety, tolerability and pharmacokinetic of single-dose administration of different doses of alprostadil liposome for injection as well as to confirm the safety dose range.


Eligibility criteria:
inclusion criteria: * healthy volunteers are at least 18 years of age and no older than 40. * bmi are at least 19.0kg/m2,and no more than 24.0kg/m2.(the male weight is greater than or equal to 50kg.the female weight is greater than or equal to 50kg.)subjects who are overweight or underweight will not be inclusion. * subjects with normal medical history,vital signs,physical examination and clinical examination (routine blood,routine urine,blood chemistry,coagulation function and ecg,x-ray,intraocular pressure and so on). * a negative hepatitis b surface antigen,hepatitis c,hiv or syphilis test result. * subjects with the ability to communicate with investigators.besides,subjects must be willing to remain at the study center as required per protocal to complete all visit assessments. exclusion criteria: * subjects have brain dysfunction,mental development disorders or speech disorders that unable to communicate with investigators. * subjects with a history of psychiatric disease or drug dependence. * subjects with a medical history about cardiac,liver,renal,digestive system or neurological. * subjects with the family history of diabetes,the history of pancreatitis,cholelithiasis or asthma. * subjects significantly abuse alcohol or tobacco. * drink in 24 hours before post-dosing of study drug. * subjects who had taken medications within 2 weeks. * subjects who had suffer from exsanguine or donated blood over 400ml within 3 months will be excluded. * subjects who participate in other clinical trials within 3 months will be excluded. * history of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes. * subjects with a history of fainting. * subjects who had infected for unknown reason. * subjects with interstitial pneumonia. * subjects with glaucoma or intraocular pressure with hyperthyroidism. * women who are pregnant or lactating.
cognition in breast cancer patients: the impact of cancer-related stress

Conditions: Breast Cancer

Summary: the study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. the hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.

primary hypothesis: \*the adverse effects of cancer and cancer therapy on cognitive function in breast cancer patients are entirely or partly mediated by stress and the ensuing dysfunction of the hpa-axis. secondary objectives: * determining the effect of cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on the hpa-axis in breast cancer patients * determining the effect of cognitive dysfunction assessed with neuropsychological tests, cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on subjective cognitive function in breast cancer patients * prevalence of acute stress response, posttraumatic stress disorder and posttraumatic stress symptoms, and extent of cancer-specific stress in breast cancer patients treated with or without chemotherapy

Eligibility criteria:
inclusion criteria, both patient groups: * primary breast cancer, stage 0-iiic, therapy not yet started * informed consent inclusion criteria, healthy control group: * breast diagnostics with benign result (no treatment necessary) * informed consent exclusion criteria: * not fluent in german * substance abuse * history of psychosis * history of neurologic disorder * previous systemic cancer treatment * addison' disease * cushing's syndrome

Keywords: chemotherapy, adjuvant adverse effects breast neoplasms cognition disorders stress disorders, post-traumatic cortisol
long term comparison of two different techniques of uterine cesarean incision closure

Conditions: Cesarean Section; Complications; Placenta Previa; Placenta Accreta

Summary: cesarean section (c/s) is an operation most commonly performed in obstetrics and gynecology clinics. complications related with incomplete healing of kerr uterine incision after c/s (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. classically kerr incision is repaired with continuous locked suturing. purse string suturing of kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. for this reason, the investigators aimed to compare two closure techniques.

in the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) in the first group of patients classical closure method of kerr incision(double layered continuously locked suturing) will be used. in the second group of patients double layered purse string closure technique will be used. women will be followed for a subsequent pregnancy in the next average 6 years. if they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. patients will be followed especially from the aspects of placental anomalies. presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * term (\> 37 weeks) pregnancy * cervical dilatation \< 4 cm * kerr incision * age \> 18 years old exclusion criteria: * being in active phase of labor * emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) * having a history of uterine surgery (myomectomy, hysterotomy) other than cs * extension of kerr incision * multiple pregnancy * maternal diabetes mellitus * maternal connective tissue disease * uterine malformation * uterine fibroids on kerr incision line * chorioamnionitis

Keywords: cesarean section kerr incision purse string suturing in cs continuous locked suturing in cs
ten years follow-up after insertion of a mus (mid urethral sling) due to stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the investigators intend to investigate the long-term complications and the subjective well-being among women who underwent insertion of a mus due to stress urinary incontinence 2006-2010.


Eligibility criteria:
inclusion criteria: * underwent a mus in sweden 2006-2010 due to stress urinary incontinence. * were registered in the swedish national quality register of gynecological surgery. exclusion criteria: * did not undergo mus surgery in sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.