Kornimate/medical-research-clean huggingface dataset:
fosfomycin i.v. for treatment of severely infected patients

Conditions: Bacterial Infections; Bone Diseases, Infectious; Osteomyelitis; Central Nervous System Bacterial Infections; Meningitis, Bacterial; Encephalitis; Brain Abscess; Urinary Tract Infections; Respiratory Tract Infections; Pneumonia, Bacterial; Skin Diseases, Bacterial; Soft Tissue Infections; Intraabdominal Infections; Sepsis; Bacteremia; Endocarditis, Bacterial

Summary: the purpose of this european, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant smpc.


Eligibility criteria:
inclusion criteria: * male or female patients aged ≥ 18 years * treatment with fosfomycin according to the (national) summary of product characteristics (smpc) of fosfomycin i.v. * patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant smpc * written informed consent of the participant (or person in charge in case of patients incapable of giving consent) exclusion criteria: * previous documentation of the patient in the present study * patients participating in an interventional clinical trial * patients with known hypersensitivity to fosfomycin or any of the excipients * terminally ill patients * patients with "do not resuscitate order" * palliative treatment approach * failure of \> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney * manifest human immunodeficiency virus (hiv) disease (acquired immunodeficiency syndrome, aids) * fosfomycin treatment as 4th line treatment or at later stage * patients with involvement of fungi or mycobacteria in the targeted infection

Keywords: observational study non-interventional study registries prospective monitored multicentric international fosfomycin infectofos fomicyt bacterial infections gram-negative bacterial infections gram-positive bacterial infections bone diseases, infectious osteomyelitis central nervous system bacterial infections meningitis, bacterial encephalitis brain abscess urinary tract infections respiratory tract infections pneumonia, bacterial skin diseases, bacterial soft tissue infections intraabdominal infections sepsis bacteremia endocarditis, bacterial treatment outcome clinical efficacy microbiological efficacy safety
a comparative clinical investigation of two hearing instrument digital signal processing

Conditions: Hearing Loss

Summary: the purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently ce marked devices. speech in narrowband noise and acceptable levels of noise should be improved with the new system, and speech understanding overall should not be negatively affected. there should be no artefacts or unwanted noises caused by the new system.

this is a controlled, double-blinded, comparative clinical evaluation conducted monocentric at the premised of bernafon ag in bern, switzerland. for this study, bernafon ag will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (dsp). system testing of the dsp shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. the current study will compare the new dsp to the one that is used in the bernafon hearing aids that are ce- marked and currently available on the market. the goal is to determine whether the new dsp is better in real-life situations than the current system. primary endpoint: the primary objective is to assess the new dsp system with various hearing losses and levels of amplification. speech testing will be used to analyse the speech perception of participants. secondary endpoint: the secondary objective is to verify the overall performance of the new device. acceptable noise levels will be measured as well as further speech testing. questionnaires will be used to measure subjective responses to the performance. other endpoints: the subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires. safety endpoint: the study aims to identify any new risk factors and to ensure the safety of the device with the newly implemented dsp system before releasing it to the market.

Eligibility criteria:
inclusion criteria: * hearing loss (sensorineural, conductive, mixed-must have doctor approval for mixed and conductive hearing loss) * severity of hearing loss ranging from mild to profound * german speaking * current hearing aid users * ability and willingness to sign the consent form exclusion criteria: * contraindications for amplification * new hearing aid users * inability to follow the procedures * inability to attend weekly study appointments * strongly reduced dexterity * central hearing disorders * bernafon employees * family members of bernafon employees
reducing the incidence of postoperative residual curarization

Conditions: Neuromuscular Blockade

Summary: the nmb (neuromuscular blockade) is the most frequent complication in anesthesiology associated with an increase in adverse respiratory events in the postoperative period. its appearance depends on multiple factors. the introduction of a comprehensive educational strategy aimed at promoting the proper management of nmb in the intraoperative period and a package of measures that must be performed (intraoperative neuromuscular monitoring and reversal of the effect of neuromuscular blockers) may contribute to a decrease in the incidence of nmb, increase safety in the surgical patient and decrease associated costs.

multicenter, epidemiological, prospective, randomized, sequential study. the introduction of an educational program and a package of clinical measures (specific monitoring and pharmacological reversion) in the incidence of nmb will be evaluated by evaluating variations in this incidence of nmb, the rate of compliance with the preventive measures and the perception of the safety in the perioperative, through pre and postoperative survey.

Eligibility criteria:
inclusion criteria: * patients older than 18 years. * classification of the american society of anesthesiologists (asa i-iii). * patients with absence of cognitive deficit. * informed informed consent prior to surgery exclusion criteria: * negative of the patient to participate in the study * patients under the age of 18 or incapable of giving their consent * asa iv-v * pregnancy or breastfeeding * associated neuromuscular disorders * diabetes mellitus with diagnosed neuropathy

Keywords: nmb (neuromuscular blockade) anesthesia curarization tofr (train of four) pacu (postanesthesia care unit) monitorization
effects of dietary protein on undesirable postprandial events in overweight subjects

Conditions: Overweight

Summary: dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. this study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.


Eligibility criteria:
inclusion criteria: * bmi between 25 and 30 * waist circumference \> 94 cm exclusion criteria: * allergy to milk protein * abusive drug consumption * smoking * hypertension, diabetes * high level of physical activity
temozolomide as maintenance therapy in small cell lung cancer

Conditions: Carcinoma, Small Cell

Summary: temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with chemotherapy. this phase ii trial was designed to evaluate the role of temozolomide following 4 or 6 cycles of first-line treatment in patients with newly diagnosed sclc.

subjects will receive standard of care treatment for sclc with added treatment of maintenance temozolomide. efficacy and safety of temozolomide and one year survival and time to progression of patients will be recorded.

Eligibility criteria:
inclusion criteria: * cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease * patients must have measurable disease, this can include brain metastases * eastern cooperative oncology group (ecog) performance status of 0-1 * adequate bone marrow function, as defined by: absolute neutrophil count (anc) \>1,500/µl; platelets \>100,000/µl; hemoglobin \>=9.0 g/dl * normal organ function, defined as follows: aspartate aminotransferase (ast) and alanine aminotransferase (alt) \<=2.5 × the upper limit of normal (uln), or ast and alt \<=5 × the uln if liver function abnormalities are due to underlying malignancy; total serum bilirubin \<=1.5 × the uln; serum creatinine \<=1.5 × the uln * women of childbearing potential and men with partners of childbearing potential must agree to use a form of birth control that is acceptable to their physician to prevent pregnancy during treatment * patients must be informed of the investigational nature of this study and sign an informed consent form exclusion criteria: * patients who are pregnant or breastfeeding * patients receiving other investigational agents * patients with leptomeningeal involvement * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements * acquired immune deficiency syndrome (aids) based upon current cdc definition or hiv-positive patients on combination antiretroviral therapy. however, hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. excluding patients on haart is necessary due to the potential for pharmacokinetic interactions with temozolomide.

Keywords: small cell lung cancer temozolomide maintenance chemotherapy
alkaline citrate treatment to lower the risk of nephrocalcinosis in preterm infants

Conditions: Nephrocalcinosis

Summary: preterm infants are at risk to develop nephrocalcinosis. incidence numbers vary according to birth weight and gestation age. very low birth weight infants have the highest risk index, with \~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. we, the researchers at the university of cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.


Eligibility criteria:
inclusion criteria: * preterm infants \< 32 weeks gestation age and \< 1500 g birth weight exclusion criteria: * cardial, renal or gastrointestinal malformations * chronic renal failure * therapy with vitamin b6 * high dose treatment with furosemide or dexamethasone * addison's disease * severe metabolic alkalosis * worse clinical condition of preterm infant, which makes oral feeding impossible * participation in other studies

Keywords: nephrocalcinosis premature infants hypocitraturia alcaline citrate therapy nephrocalcinosis in premature infants
effects of functional versus core stability exercises on pain and sleep quality in patients with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: to compare the effects of functional and core stability exercises on pain and sleep quality in patients with primary dysmenorrhea and to check the results of exercises may be effective in pain during menstrual and before cramping in menses.


Eligibility criteria:
inclusion criteria: * having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study. * pain must be periodic (at least following 3 menstrual cycles). * lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs. * no history of blood disorders including thalassemia and folate or iron-deficiency anemia exclusion criteria: * pelvic inflammatory disease * ovarian cysts * chronic abdominal pain * fibroids, obstructive endometrial polyps, * irritable bowel syndrome * major abdominal or pelvic surgery * intrauterine devices.

Keywords: core stability,exercises,primary dysmenorrhea,sleep quality
car safety seat and gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease and Position

Summary: what's known? prone position is no longer a treatment option for gerd because of the association with sids. originally, positioning in an infant seat was recommended for infants with gerd. however, orenstein proved this position has a detrimental effect on ger, compared to prone positioning. what's new? positioning in an infant seat caused no increase in ger, compared with the supine 15 degrees anti-trendelenburg position. except for the number of long reflux episodes, which was significantly higher in the car safety seat. larger trials are needed for decisive conclusions.

objective - over the past few decades, an increase in gastroesophageal reflux disease (gerd) has been seen in infants. this increase may be due to a continuous growth in the use of car safety seats. the objective of this study was to evaluate this hypothesis by comparing positioning in a car safety seat with the supine 15 degrees anti-trendelenburg position. patients and methods - from october 2008 till august 2010 a crossover, randomized, controlled trial was performed on 31 infants, aged two weeks to six months old, who were suspected to have gerd. twenty hour continuous esophageal ph monitoring was used to compare both positions. results - the results of this trial demonstrated no differences between positioning in a car safety seat and in supine 15 degrees anti-trendelenburg position for the reflux index, the duration of the longest reflux episode and number of reflux episodes (pri = ns; plre = ns respectively pnre = ns). only the difference between the number of reflux episodes lasting longer than five minutes was significant (pnre5 = 0,05). conclusions - the results of this study suggest that an increase in gerd is not caused by a growing use of car safety seats in infants. as the sample size was limited, larger trials are needed.

Eligibility criteria:
inclusion criteria: * inclusion criteria were: healthy term-born infants between two weeks and six months old suspected to have gerd, in general good health. the infants did not need to meet the criteria for gerd to be eligible. exclusion criteria: * exclusion criteria were infants with psychomotor retardation, acute illness or contra-indication for ph monitoring.

Keywords: antireflux procedure gastroesophageal reflux infant sleep position ph monitoring
incmga00012 in combination with other therapies in patients with advanced solid tumors

Conditions: Unresectable or Metastatic Solid Tumors

Summary: the purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended phase 2 dose (rp2d) of incmga00012 in combination with other agents that may improve the therapeutic efficacy of anti-pd-1 monotherapy.


Eligibility criteria:
inclusion criteria: * histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy * measurable or nonmeasurable tumor lesions per recist v 1.1. * willing to provide fresh or archival tumor tissue for correlative studies. * eastern cooperative oncology group performance status 0 to 1. * willingness to avoid pregnancy or fathering children based on protocol-defined criteria. exclusion criteria: * receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy. * toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support). * laboratory values outside the protocol-defined range at screening. * active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids. * known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids). * evidence of interstitial lung disease or active, noninfectious pneumonitis.

Keywords: solid tumors locally advanced unresectable tumor metastatic solid tumors
a study evaluating the effect of frozen-section directed excision surgery on vulvar dysplasia

Conditions: Vulvar Neoplasm; Dysplasia Vulvar

Summary: the purpose of this study is to compare "frozen-section directed excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "wide local excision" to treat high-grade vulvar dysplasia.

this is a randomized, single-blinded study. the target population is adults ≥ 18 years of age with histological or cytological confirmation of vin 2, vin 3, vin 2/3 or high-grade dysplasia nos with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures. one group of subjects will be assigned to the frozen-section directed excision surgery arm and will undergo this procedure. the other group of subjects will be assigned to the wide local excision (standard of care) arm and will undergo this procedure. the randomization will be 1:1, meaning for every subject who gets assigned to the frozen-section directed excision surgery arm, one will also be assigned to the wide local excision arm. there is a 50% chance of getting randomized to either the frozen-section directed excision procedure or wide local excision. information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. the study team will also look at recurrence rates (return of the cancer) in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure.

Eligibility criteria:
inclusion criteria: 1. written informed consent and hipaa authorization for release of personal health information. 2. age ≥ 18 years at the time of consent 3. histological or cytological confirmation of vin 2, vin 3, vin 2/3 or high-grade dysplasia nos with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures 4. surgery is expected to occur within 90 days from randomization 5. ability to read and understand the english and/or spanish language 6. as determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study 7. no known pregnancy exclusion criteria: 1. excision is not possible due to anatomy (proximity to urethra/clitoris) 2. known immunodeficiency syndrome 3. immunosuppressant medications taken within the last 30 days (hiv, organ transplant recipient, chronic steroid use/immunosuppressant) 4. history of pelvic region radiation therapy 5. active anticancer treatment
high doses of total end range time offer better results than low doses treating proximal interphalangeal joint stiffness

Conditions: Proximal Interphalangeal Finger Joint Contractures

Summary: elastic tension digital neoprene orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. this treatment improved the results in extension and also reducing the time to obtain it.

question: in fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time? design: randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat participants: fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture intervention: the treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. researchers applied two different daily total end range time doses. group a patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group b patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. the exercise program was the same for both groups. outcome measures: the researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. the first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. this measurement at the first session was included as a modified weeks test while at the second, third and forth session was recorded as a contraction test. patient report of orthosis wear time and

Eligibility criteria:
patient inclusion criteria: * patients with flexion contractures of the proximal interphalangeal joint after trauma or post-surgical complications. * patients with long standing flexion contractures * patients with contractures greater than 45º. exclusion criteria: * patients with acute tendon injuries or fractures * patients with inflammatory conditions, * patients with proximal interphalangeal joint replacements, * patients with dupuytren conservative treatments * patients lacking active proximal interphalangeal joint extension
effect of milk and cheese on fecal fat excretion and blood lipid

Conditions: Obesity

Summary: the aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. to do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.


Eligibility criteria:
inclusion criteria: * healthy males * bmi 20-28 mg/m2 exclusion criteria: * smoking * medicine use * dietary supplements * lactose intolerance, milk allergy * dislike of dairy products * excessive physical activity (\> 10h/wk) * known chronic illnesses

Keywords: obesity prevention appetite regulation hyperlipidemia