Kornimate/medical-research-clean huggingface dataset:
düsseldorf bread study

Conditions: Body Weight

Summary: the hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread.

carbohydrate reduction is an important element for weight loss or can also be used to keep weight constant. since the majority of the carbohydrates consumed daily in industrialized countries come from bread and rolls, the present study will examine the effect of two different types of bread on the weight development of overweight bread consumers. the two types of bread differ in their carbohydrate content and the hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread. the comparison of the two types of bread is carried out triple blinded. during two visits (before and after the bread consumption phase), the health status is determined with physical parameters and laboratory parameters from a blood test. the primary endpoint is body weight. overall, this study will for the first time allow extensive statements to be made on the health value of the three-month consumption of two different types of bread.

Eligibility criteria:
inclusion criteria: - body mass index of at least 27 kg/m2 exclusion criteria: * serious illness with hospitalization in the last 3 months * changes in body weight (estimated weekly average) by more than 2 kg in the past 4 weeks * non-smoking status for less than 3 months * change of smoking habits planned during the study * acute diseases such as respiratory or gastrointestinal infections * chronic diseases, e.g. tumor diseases, chronic obstructive pulmonary disease (copd), asthma, dementia, intestinal diseases, diabetes * regular use of medication (except contraceptives) such as lipid lowering, blood pressure lowering, weight-regulating medication, aspirin * no contraception in women of childbearing age or breastfeeding a child * high sporting activity (≥ 1 hour per day) * planned absence of\> 7 days during the intervention phase
therapeutic effect of desogestrel on ventilatory control in patients with congenital central hypoventilation syndrome

Conditions: Congenital Central Hypoventilation Syndrome

Summary: background: congenital central hypoventilation syndrome (cchs) is a rare disorder of automatic control of breathing. this disease can manifest as early as birth. patients with this disease have a fundamental lack of central drive breathing. they do not mount any responses to hypoxia or hypercapnia during sleep or wakefulness. this places them at risk of injury or death whenever they are not consciously breathing. they require lifelong assisted ventilation while sleeping, and some while awake. progesterone is a known respiratory stimulant in normal individuals, and it has been shown in one study of 2 patients that this drug may improve co2 responsiveness in patients with cchs. however, this observation requires confirmation. hypothesis: exogenous progesterone (in oral contraception pills) will improve co2 responsivity by hyperoxic hypercapnic ventilatory response testing, hypoxic responsivity using 5-breath nitrogen breathing, hyperoxic ventilatory response while breathing 100% oxygen, and improve spontaneous ventilation during sleep in cchs females \>15-years of age. the progesterone will also depress ventilatory response using a hyperoxia test. study methodology: baseline measures of co2 and oxygen responsivity, and spontaneous ventilation during sleep, will be performed at baseline and after 3-weeks of taking a progesterone containing oral contraceptive agent. co2 responsivity will be measured using a hyperoxic hypercapnic ventilatory response test. hypoxic responsivity will be measured using a 5-breath 100% nitrogen breathing test. hyperoxic responsivity will be measured by having subjects breathe 100% oxygen for 2-minutes. subjects will perform an overnight polysomnogram to assess adequacy of gas exchange during spontaneous breathing while asleep. a progesterone containing oral contraception pill will then be given for 3-weeks, and the above measures repeated. serum progesterone will be measured at baseline and at the time of study.


Eligibility criteria:
inclusion criteria: * diagnosed congenital central hypoventilation syndrome (cchs) * female * greater than or equal to 16 years of age exclusion criteria: * less than 16 years of age * male * pregnant * poor adherence to medications * inability to perform pulmonary maneuvers for tests * contraindications to oral contraceptives * pulmonary hypertension
cyclosporine inhalation solution (cis) in lung transplant recipients

Conditions: Lung Transplant

Summary: currently there are no approved therapies for lung transplant recipients in the united states (us). treatment with cis following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to food and drug administration (fda) approval. this treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to cis in advance of fda approval.


Eligibility criteria:
inclusion criteria: * single-or double-lung transplant recipients who have a high risk for developing chronic rejection * single or double-lung transplant recipients who have developed chronic rejection * single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy exclusion criteria: * known hypersensitivity to cyclosporine or propylene glycol (pg) * females who are pregnant or are considering becoming pregnant * females who are breast feeding a child.

Keywords: lung transplant transplant rejection cyclosporine bronchiolitis obliterans aerosol
measurement of energy metabolism in infants

Conditions: Infant Development; Infant Overnutrition

Summary: the purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

this study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. the overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. this cross-sectional study will answer the following questions: 1. what is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart? 2. what is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study? 3. how do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

Eligibility criteria:
inclusion criteria: * healthy, full-term infant * aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit * exclusively fed breast milk and/or infant formula * willing to accept doubly-labeled water exclusion criteria: * unable to complete 3 clinic visits within about 14 days at pennington biomedical research center * born preterm (\< 37 weeks gestation) * congenital abnormality or disability * gastric reflux * acute illness within 7 days of the study (fever, diarrhea) * use of medications to treat a chronic condition (does not include use of vitamin supplements or prn medication for flatulence or reflux such as pepcid)
neoadjuvant radiotherapy for breast cancer

Conditions: Neoadjuvant Radiotherapy; Breast Cancer

Summary: the goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer. the main questions it aims to answer are: * the clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens. * evaluate the acute and late toxicity of preoperative radiotherapy participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group.


Eligibility criteria:
inclusion criteria: * female; * age range from 18 to 70 years old; * the pathological diagnosis is invasive cancer, and immunohistochemical examination has been performed to confirm the status of er, pr, her2, ki67, etc; * clarify the brca gene mutation status; * patients who have a baseline stage of t1-3n0-3m0 and meet one of the following conditions and require neoadjuvant therapy: ① mass\>5cm; ② axillary lymph node metastasis; ③ her-2 positive; ④ three yin type; ⑤ those who have a desire to preserve breast, but have a large ratio of tumor size to breast volume, making it difficult to preserve breast; * baseline estimation requires adjuvant radiotherapy, which meets one of the following conditions: ① performing breast conserving surgery; ② t3 or n positive patients after mastectomy and axillary dissection; ③ after mastectomy, sentinel lymph nodes were positive and axillary dissection was not performed; * kps score ≥ 80; * the tumor must be visible in ct scan; * patients must undergo magnetic resonance imaging to help determine the contour of the tumor and exclude other lesions. if other lesions are found, biopsy must be performed on these lesions and the result is negative before continuing treatment; * no history of serious internal medicine diseases or other serious comorbidities, such as a history of mental illness, allergies, etc; * sign an informed consent form. exclusion criteria: * clinical or pathological stage t4 or m1 breast cancer; * received preoperative neoadjuvant therapy; * pathological confirmation shows that there is no invasive cancer component in dcis; * double breast cancer or previous contralateral breast cancer; * imaging examination suggests suspicious malignant lesions in the ipsilateral or contralateral breast, which have not been pathologically confirmed to be benign; * kps score ≤ 70; * there is active infection currently; * concomitant with severe heart, liver, kidney, hematopoietic and neurological diseases, psychiatric patients, or estimated survival time\<6 months; * history of malignant tumors in other areas, excluding curable non melanoma skin cancer and cervical cancer in situ; * history of radiation therapy at the site of previous radiation therapy; * pregnancy and lactation period; * those with poor compliance or life-threatening conditions who cannot complete treatment.

Keywords: neoadjuvant radiotherapy breast cancer
intervention to reduce infectious complications of peritoneal dialysis

Conditions: Peritoneal Infection

Summary: peritonitis is a common and serious complication of peritoneal dialysis (pd) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion.

peritoneal infections (pi) have been a very relevant representative of peritoneal dialysis (pd) for decades. pi is a very serious complication of pd and is a source of concern because of its high incidence. each episode carries clinical consequences for the patient, increases in treatment costs, hospital admissions, technical failures and risk of death, especially in the 30 days following an episode. the risk of peritonitis depends on non-modifiable factors (such as age, sex, diabetes) and modifiable factors (such as anti-infective prophylaxis, catheter care, and training). it is important to accurately analyze the effect of modifiable factors, as they are the most relevant in reducing the rate of peritonitis. patient education is very important and can affect the success of the technique and clinical results. therapeutic education has been considered a key factor in pd outcomes. the pd nurse is responsible for training the patient and/or caregiver to be self-sufficient and autonomous in care, reinforce and highlight the importance of adherence to treatment, and promote safe actions to prevent technique-related infections when this one is made at home. this is a pragmatic, retrospective-prospective (ambispective) study of educational intervention for patients with stage v advanced chronic kidney disease and those with cardiorenal syndrome starting a peritoneal dialysis program. a retrospective control group with patients starting pd before january 2020 will be included and compared with an intervention group that will systematically include all patients starting dp since the start of the study and they will be implemented a new educational intervention based on a systematic review that has been carried out with the most recent evidence.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age * medically stable * who can perform dialysis themselves or with the help of a caregiver willing to participate in the study and sign the informed consent will be included exclusion criteria: * patients with psychiatric, psychological disorders and social (language barrier included) * who do not have a formal/informal caregiver * those who due to medical needs cannot continue with the standard schedule, pregnant women, participants who suffered peritonitis before receiving the educational intervention

Keywords: educational intervention peritoneal dialysis peritonitis
analgesic benefits of perineural versus intravenous dexamethasone in patients receiving sciatic nerve block

Conditions: Fracture of Ankle

Summary: patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. the investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.

patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. more importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. we hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.

Eligibility criteria:
inclusion criteria: * asa 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia. * surgery confined to the foot and ankle. * patients aged 18-70 years. exclusion criteria: * asa classification of 4 or higher. * pre-existing neuropathy * coagulopathy * infection at the site * diabetes * non-english speaking or reading patients * systemic use of corticosteroids within 6 months of surgery * chronic opioid use * pregnancy * large (\>3cm) skin incision around the medial aspect of the foot * any other contra-indication to regional anesthesia

Keywords: nerve block anesthesia recovery period
an observational study of ozurdex® in diabetic macular edema (dme)

Conditions: Macular Edema

Summary: this is a study of ozurdex® use in clinical practice in patients with diabetic macular edema (dme).


Eligibility criteria:
inclusion criteria: * diagnosis of dme in at least one eye treated ozurdex® per clinical practice exclusion criteria: * none
assessing the role of exercise intensity in slowing disease progression in early parkinson's disease

Conditions: Parkinson's Disease

Summary: participants will complete a self-selected intensity of exercising over a 6 month period, with detailed clinical assessments at commencement and completion to determine the rate of progression of parkinsonism and gait abnormalities

participants will complete a self-selected intensity of exercising over a 6 month period - including jogging, swimming and circuit training, with detailed clinical assessments at commencement and completion (including updrs, gaitrite lab study) to determine the rate of progression of parkinsonism and gait abnormalities

Eligibility criteria:
inclusion criteria: * early parkinson's disease, * able to provide informed consent, * able to complete exercise diaries for 6 months, * no medications or on levo-dopa exclusion criteria: * not on dopamine agonists,
novel decision aid for carpal tunnel patients

Conditions: Carpal Tunnel Syndrome

Summary: a questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for carpal tunnel syndrome to help participants decide between two surgical options- wide-awake-local-anesthesia-no-tourniquet (walant) and traditional open hand surgery. these patients will be asked to complete a pre-questionnaire knowledge test and a post-questionnaire knowledge test. the primary objective is to validate this questionnaire to be used by other orthopedic surgeons. this study will also reveal patient preference between these two surgical treatments for carpal tunnel syndrome.


Eligibility criteria:
inclusion criteria: * 18 years of older, * cts patients who are ctr candidates, * comprehend and understand english, * passed the orientation-memory-concentration test done before the decision aid exclusion criteria: * younger than 18 years of age, * non-cts patients, * not ctr candidates, * do not comprehend or read english, * failed the orientation-memory-concentration test done before the decision aid

Keywords: walant wide-awake-local-anesthesia-no-tourniquet
the right ventricular responses to mild hypercarbia after mitral valve repair surgery

Conditions: Heart; Decompensation, Right Ventricle; Echocardiography; Hypercapnia

Summary: the aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.

the aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. investigators hypothesize that induced mild hypercarbia (paco2 7.5 kpa) cause elevated mean pulmonary arterial pressure and pulmonary vascular resistance, and this reflect to the right ventricle, both volume and function. and this right ventricle effect could be noticed by echocardiography.

Eligibility criteria:
inclusion criteria: * scheduled mitral valve prolapse repair surgery * able to give informed consent exclusion criteria: * preoperative right ventricular dysfunction or pulmonary hypertension * significant tricuspid regurgitation * congenital heart defect * ventricular dyssynchrony or wide qrs-complex on ecg (\> 130 ms) * prior myocardial infarction (within tree months) or pericardial constriction * preoperative left ventricular (lv) dysfunction, i.e. lv ejection fraction under 40 % * if the scheduled repair by plastic procedure has been converted to mitral valve replacement
phenomics and genomics of clinically relevant chronic postsurgical pain

Conditions: Chronic Pain; Surgery

Summary: the investigators will approach elective cardiac and thoracic surgery patients in the preoperative consultation clinic. consenting individuals will be administered, before surgery validated pain, psychological and sleep questionnaires. these questionnaires will be repeated at 3, 6 and 12 months postoperatively (po) to follow up the progression of early po pain and the transition to chronicity. participants will define clinically relevant pain by calculating a chronic pain index (cpi). in addition, the investigators will follow the development of acute postsurgical and chronic pain from before surgery up to a year after, extract dna from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.

most patients who undergo surgery heal within weeks to months and return to their baseline functional status or to an improved level of functioning. however, some patients have pain after surgery which continues. the purpose of this study is to see if there is a relationship between patient's genetic makeup (diseases that are passed on in families) and pain experience following cardiac and thoracic surgeries. this study will look for links between psychological factors, environmental factors and genetic factors in an attempt to uncover the risk for developing chronic post-surgical pain. this study hopes to determine differences between traditional pain surveys and a basic science approach called "phenomics" to measure chronic pain response after cardiac and thoracic surgery. phenomics or phenomes is the study of physical characteristics, outside influences and biochemical changes (traits or chemical characteristics) and their response to either the environment or genetic changes. validated pain questionnaires will be administered before surgery, and will repeated at 3, 6, and 12 months postoperatively to follow up the progression of early postoperative pain and the transition to chronicity. in general, the psychological and pain questionnaires are designed to measure the following: anxiety, thoughts, feelings and reactions toward pain and stressful experiences. in addition, the study will follow the development of acute postoperative and chronic pain from before surgery up to a year after. the investigators will extract dna from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain. the blood sample will be drawn at the time of the surgery.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. non- emergency cardiac surgery with midline sternotomy or thoracic surgery via vats or lateral thoracotomy 3. written informed consent to participate in the study exclusion criteria: 1. patient unable to understand the study protocol 2. history of a psychotic psychiatric disorder 3. unable to speak english
optive brand for day and night dry eye management

Conditions: Dry Eye

Summary: this is an open label study of optive eyedrops and gel combination for day and night dry eye management


Eligibility criteria:
inclusion criteria: * osdi score of ≥ 23 * ocular comfort at waking \<65 on 100-point scale * conjunctival staining grade ≥ 2 (scale 0 to 4) in at least one eye * use of eyedrops for the relief of dry eye symptoms for at least one month * best corrected visual acuity in each eye of at least 20/25 * have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study * be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule exclusion criteria: * use of benzalkonium chloride (bak) preserved eyedrops in the last month * use of optive brand eyedrops in the last month * monocular participants (only one eye with functional vision). * contact lens wear during the study * history of herpetic keratitis, ocular surgery or irregular cornea; * known pregnancy or lactation during the study period * participation in any clinical trial within 30 days of the enrollment visit