Kornimate/medical-research-clean huggingface dataset:
comparing infectious morbidity among women with meconium-stained amniotic fluid at term, between those treated with prophylactic antibiotics zinacef vs. placebo

Conditions: Meconium-stained Amniotic Fluid; Chorioamnionitis

Summary: our randomized controlled double blind clinical trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo.

the relationship between meconium staining and chorioamnionitis, as well as neonatal sepsis, has been documented, yet the precise mechanisms remain unclear. additionally, the correlation between prolonged labor and meconium staining was described in the past. in light of these findings, our randomized controlled double blind trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo. additionally, we aimed to assess the distribution of pathogens in chorioamnionitic swab cultures relative to the antibiotic treatment

Eligibility criteria:
inclusion criteria: * singleton pregnancy at term * meconium-stained amniotic fluid exclusion criteria: * intrauterine fetal death * gbs carriers * zinacef allergy * antibiotic treatment for other indication

Keywords: meconium-stained amniotic fluid antibiotic treatment infectious morbidity chorioamnionitis zinacef
dose-range-finding, phase 2 trial of oral linaclotide acetate administered to patients with chronic constipation

Conditions: Chronic Constipation

Summary: the primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.


Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient meets colonoscopy requirements according to the american gastroenterological association * patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements * patient has successfully completed study requirements with no clinically-significant findings: physical exam, ecg, clinical laboratory tests * patient is fluent in english exclusion criteria: * patient reports loose or watery stools * patient meets criteria for ibs including protocol-defined abdominal discomfort or pain * patient may not take prohibited medications per protocol * medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

Keywords: constipation chronic constipation microbia linaclotide linaclotide acetate md-1100
interventions for weight regain after bariatric surgery

Conditions: Obese Patients With Bariatric Surgery; Obese Patients (BMI ≥ 30 kg/m²); Weight Regain Post Bariatric Surgery; Revisional Bariatric Surgery; Ketogenic Dieting; Intermittent Fasting

Summary: study objective: the aim of this study is to evaluate the effects of revisional bariatric surgery (rbs), very low-calorie ketogenic diet (vlckd), and intermittent fasting (if) on nutritional habits and clinical outcomes (anthropometric and biochemical measurements) in patients with insufficient weight loss (iwl) or weight regain (wr) after bariatric surgery, and to compare these findings with those of a control group.

study hypotheses: 1. in patients with iwl or wr after bariatric surgery, a diet following the bariatric care guidelines (bcgs) after revisional bariatric surgery (rbs) improves nutritional habits, anthropometric, and biochemical parameters. 2. in patients with iwl or wr after bariatric surgery, vlckd improves nutritional habits, anthropometric, and biochemical parameters. 3. in patients with iwl or wr after bariatric surgery, if regimen improves nutritional habits, anthropometric, and biochemical parameters. 4. in patients with iwl or wr after bariatric surgery, the diet program recommended by the asmbs as part of standard post-bariatric care improves nutritional habits, anthropometric measurements, and biochemical parameters.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 45 years who have undergone bariatric surgery (bs). * experiencing inadequate weight loss (iwl) within 18 months after surgery or weight regain (wr) following successful weight loss. * definitions used in the study: iwl is defined as \ 25% regain of the lost weight (from the lowest achieved weight). - exclusion criteria: * pregnant or lactating women. * patients with acute illnesses, infections, or comorbidities that may affect treatment efficacy or safety (e.g., cancer, type 1 diabetes, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, substance or alcohol abuse, eating disorders, severe depression or other psychiatric disorders, inflammatory bowel disease, neoplasms, arrhythmic heart diseases, heart failure, respiratory failure). * patients currently receiving corticosteroid therapy. * professional athletes.

Keywords: weight regain post bariatric surgery revisional bariatric surgery ketogenic dieting intermittent fasting nutritional status
kinesiotaping therapy for clavicular fractures fractures:

Conditions: Clavicle Fracture

Summary: this is a multicenter prospective randomized controlled study. forty patients in whom conservative treatment for clavicle midshaft fractures was indicated between january 2018 and july 2019 were included. the investigators aimed to evaluate the effectiveness of the kinesiotaping technique for the conservative treatment of clavicle midshaft fractures. the investigators hypothesized that kinesiotaping reduces the disadvantages of conservative treatment, such as early-phase pain, high nonunion rates, and a prolonged time to return to work, and yields better clinical and functional outcomes by providing good mechanical support and neutralizing the deforming muscle forces around the fractured clavicle.

the investigators divided into 2 groups and followed one group of patients with clavicle fractures only with shoulder sling, while the other group were followed with kinesiotherapy treatment and shoulder arm sling. they investigated the effect of kinesiotherapy treatment on early pain and returning time to work.

Eligibility criteria:
inclusion criteria: participants with midclavicle fracture within 24 hours exclusion criteria: participants with open fractures,

Keywords: kinesiotherapy arm sling
efficacy of repeated low-level red-light therapy in myopia control

Conditions: Myopia

Summary: low-level red-light technology provides a new and innovative myopia control approach. this strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. the efficacy of the low-level red-light technology has been proven in a chinese population. this trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. repeating this rct in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

the purpose of this study is to assess the safety and efficacy of low level red light therapy in myopia control in african, hispanic, and caucasian children. this is a prospective, multi-ethnic, parallel-controlled randomized trial that will enroll myopic children aged 8-13 years old as subjects. on top of wearing single vision spectacles, subjects in the intervention group will receive treatment twice a day from monday to friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. subjects in the control group will wear single vision spectacles. the study will evaluate axial elongation, cycloplegic spherical equivalent change, changes in other biological parameters (except axial length), and uncorrected and best corrected visual acuity of the two groups of subjects at 1 month, 3 months, 6 months, and 12 months after enrollment. the study plans to conduct an interim analysis at a three-month follow-up. the enrollment target is 90 participants: 30 hispanic children (15 control and 15 treatment) , 30 african children (15 control and 15 treatment), and 30 caucasian children (15 control and 15 treatment).

Eligibility criteria:
inclusion criteria: 1. provision of consent 2. non-chinese ethnicity 3. age: ≥8 and ≤13 years at enrollment 4. myopia: spherical equivalent refractions (sers) under cycloplegia: -1.00 to -5.00 diopters (d) 4) astigmatism of 2.50 d or less 5) anisometropia of 1.50 d or less 6) corrected monocular logmar visual acuity (va): 1.0 or better 7) consent to participate in random allocation of grouping 8) fluent in english 9) willing and able to participate in all required activities of the study6) corrected monocular logmar visual acuity (va): 1.0 or better exclusion criteria: 1. strabismus and binocular vision abnormalities in either eye 2. ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study. 3. other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment 4. noncompliance with treatment 5. children whose parents do not sign informed consent

Keywords: myopia
magnetic resonance imaging and computed tomography in patients with stage i seminoma of the testicle

Conditions: Testicular Germ Cell Tumor

Summary: rationale: imaging procedures, such as mri and ct scan, may find recurrent cancer. it is not yet known which mri or ct scan schedule is more effective in finding recurrent cancer. purpose: this randomized phase iii trial is comparing four different mri and ct scan schedules in patients with stage i seminoma of the testicle.

objectives: * to assess whether a reduced computed tomography (ct) schedule or magnetic resonance imaging (mri) could be used as safe and effective alternatives to standard ct-based surveillance in the management of patients with stage i seminoma of the testis. outline: this is a multicenter study. patients are randomized to 1 of 4 surveillance arms. * arm i: patients undergo computed tomography (ct) scan of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression. * arm ii: patients undergo ct scan of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression. * arm iii: patients undergo magnetic resonance imaging (mri) of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression. * arm iv: patients undergo mri of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression. note: \*patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis. patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of ct- or mri-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule. patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility criteria:
disease characteristics: * histologically confirmed seminoma of the testis * stage i disease, as determined by clinical examination and ct scan of the chest, abdomen, and pelvis * no evidence of any non-seminoma germ cell tumor elements * has undergone orchidectomy within the past 8 weeks * normal serum alpha-fetoprotein pre-orchidectomy and at study randomization * normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy) * not planning to undergo adjuvant therapy patient characteristics: * able to attend regular surveillance * no other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer * no contraindication to mri (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments) prior concurrent therapy: * see disease characteristics

Keywords: testicular seminoma stage i malignant testicular germ cell tumor
low intensity training combined with kaatsu on muscle vasodilatation and arterial stiffness in the elderly population

Conditions: Frail Elderly Syndrome

Summary: the purpose of the present study is to evaluate the acute and chronic effect of low intensity strength training with or without moderate blood flow restriction on muscle vasodilation and arterial stiffness in elders with low gait speed. in addition, the responses of prothrombotic factors in blood coagulation, the impact on heart rate and arterial pressure will be assessed.

the investigators propose a study of 26 sedentary elders with low speed gait, supervised by the hospital israelita albert einstein - vila mariana ambulatory. this will be an open clinical trial, prospective, single center, randomized and controlled study. it will be divided into two parts: acute and chronic phases. after signing an informed consent, the participants will be separated in two groups: group 1. resistance exercise with low intensity combined with partial blood flow restriction group 2. conventional resistance exercise with low intensity all of participants will be submitted to interventions tests before and after the period of training which are: 1. laboratory tests: blood tests 2. plethysmography 3. handgrip 4. quality of life questionaire 5. fmd tests 6. vasodilation capacity

Eligibility criteria:
inclusion criteria: * elderly people aged 60 to 85 years, with walking speed \<0.8m / s (guralnik, 1994). exclusion criteria: * elderly patients with uncontrolled diabetes mellitus or peripheral neuropathy; * symptomatic peripheral obstructive arterial disease or brachial ankle index \<0.9; * uncontrolled arterial hypertension (bp\> 160 / 100mmhg); * uncontrolled dyslipidemia (total colostrum\> 220mg / dl); * infectious with less than 1 month; * osteoarticular or neurological problems that prevent training; * history of anemia, cerebrovascular disease, myocardial infarction in the last 6 months; * pior deep venous thrombosis; * use of oral anticoagulant; * smoking \<6 months; * use of antiplatelet agents and anticoagulants; * cognitive dysfunctions: mini-mental \<24. (brucki, 2003).

Keywords: kaatsu cardiovascular system elderly
prevalence of helicobacter pylori infection and gastric cancer in the west indies

Conditions: Stomach Neoplasms; Gastric Neoplasms; Helicobacter Pylori

Summary: estimating the prevalence of helicobacter pylori infection in newly diagnosed stomach cancers in the west-indies will help to understand the epidemiology of this cancer, which is over-incident in the west indies compared to france. in addition, the constitution of a biobank (tumor tissues, healthy tissues and serum) will allow to set up in a second time etiological studies to identify other risk factors in particular in connection with the exposure to environmental pollutants to adapt the prevention measures.

in the antilles-guyana, gastric cancer affects approximately 80 men and women each year in guadeloupe and martinique, and 20 in french guiana. it is more frequent than in france and represents 4.5% of cancers in men in martinique, 5.3% in guadeloupe and 5.7% in french guyana. it is the 3rd most common cancer site in men in guadeloupe and martinique, and the 4th in french guiana. in women, it is the 3rd most frequent cancer in martinique and the 4th in guadeloupe, whereas it is less frequent in french guiana. studies are needed to estimate this prevalence in the general population and in cancer patients. the prevalence of helicobacter pylori infection is not well known in the general population in the caribbean and when gastric cancer is diagnosed, the bacterium is rarely tested. dietary habits in our regions are characterized by a high consumption of salt (salted), meat and smoked fish. these dietary habits, common to some southeast asian countries, could partly explain the high incidence of stomach cancer observed. but environmental risk factors could also be involved. patients referred to gastroenterology with a suspected endoscopic diagnosis of gastric cancer will be offered to participate in the study after the fibroscopy has been performed and their consent will be obtained for the use of diagnostic specimen remains for research purposes.

Eligibility criteria:
inclusion criteria: 1. patient over 18 years of age, residing for at least 6 months in martinique, with a primary diagnosis of gastric cancer 2. patient having read the information note and having signed the consent to participate in the study 3. patient with social security coverage exclusion criteria: 1. refusal to participate 2. patient who could not answer the questionnaires 3. patient not affiliated to a social security system 4. patient not fluent in french 5. patient under legal protection (legal protection, guardianship, curators, etc.)

Keywords: helicobacter pylori gastric cancer prevalence french west-indies
a study to evaluate the effects of sage-718 in participants with parkinson's disease cognitive impairment

Conditions: Parkinson Disease; Cognitive Dysfunction

Summary: the primary purpose of this study is to evaluate the effect of sage-718 on cognitive performance in participants with parkinson's disease mild cognitive impairment (pd-mci).


Eligibility criteria:
inclusion criteria: 1. meet the following criteria for pd-mci: have a confirmed diagnosis of idiopathic parkinson's disease (pd) according to 2015 movement disorder society (mds) clinical diagnostic criteria and meet mds task force criteria for mci in pd (excluding requirement for united kingdom pd brain bank diagnostic criteria). 2. meet the following criteria for montreal cognitive assessment (moca): for participants meeting level 1 pd-mci criteria, have a moca score of 20 to 25 (inclusive) at screening; for participants meeting level 2 pd-mci criteria (within the past year), have a moca score of 18 to 25 (inclusive) at screening. 3. meet criteria for modified hoehn \& yahr stage i to iii (mild to moderate motor severity) at screening. 4. have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator. 5. must be able to complete the color trails test 1 (including the ability to follow rater redirection and correct errors), and, based on participant's performance and investigator's opinion, participant is expected to be capable of engaging in prolonged cognitive testing for the duration of the study. exclusion criteria: 1. have a diagnosis of dementia of any etiology, including but not limited to: dementia with lewy bodies, alzheimer's dementia, and vascular dementia. 2. have any parkinsonism other than pd, including secondary parkinsonism or atypical parkinsonism. 3. in the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with pd that will interfere with completing study procedures. 4. have an ongoing central nervous system condition other than pd that in the opinion of the investigator could influence the outcome of the study. 5. have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator. 6. have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury. 7. have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).
a long-term safety study in brazilian patients with a diagnosis of spinal muscular atrophy treated with zolgensma

Conditions: Spinal Muscular Atrophies

Summary: a long-term safety study in brazilian patients with a confirmed diagnosis of spinal muscular atrophy (sma) treated with onasemnogene abeparvovec (zolgensma®)

this study is a non-interventional post authorization safety study (pass) to evaluate long-term, real-world safety data of brazilian pediatric patients diagnosed with sma and treated with onasemnogene abeparvovec (zolgensma®) for up to 15 years after the treatment. this study will support the benefit-risk assessment of onasemnogene abeparvovec in the approved indications and may also allow for detection of new safety signals and provide further guidance on the management of safety risks associated with onasemnogene abeparvovec to patients/caregivers, health care providers (hcps) and treating physicians, as required by brazilian health authority anvisa as a conditional measure for granting zolgensma®'s authorization.

Eligibility criteria:
inclusion criteria: * subject's parent or legal guardian has provided signed eicf. * subject with sma, genetically confirmed: with a bi-allelic mutation in the smn1 gene, and a clinical diagnosis of sma type 1 or up to 3 copies of the smn2 gene. * subject treated\* with onasemnogene abeparvovec (zolgensma®) prior to enrolling in this study. subjects treated with nusinersen or risdiplam prior to onasemnogene abeparvovec (zolgensma®) can be enrolled if currently not receiving it. \*subjects can be enrolled in this study on the day treated with onasemnogene abeparvovec (zolgensma®) or if prior medical history is available to complete all assessments retrospectively, in accordance with local ethical requirements. * subject and parent/guardian are willing and able to comply with the phone contacts through the course of the study exclusion criteria: * patients currently enrolled in any interventional clinical trial\*\* other than the phase iv ofelia trial will be excluded from the study. * subjects who were enrolled in a clinical trial (independently of the disease indication and interventional treatment) but are not currently enrolled, can be included in this study. during the follow-up, subjects who enroll any clinical trial with pharmacological intervention will discontinue from this study.

Keywords: spinal muscular atrophies; onasemnogene abeparvovec; brazil; nis
a study of peldesine (bcx-34) in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to determine the highest amount of peldesine that is safe. this study will also see if this amount of peldesine is effective in lowering hiv levels in the blood.

patients are given either bcx-35 or placebo for 14 or 28 days. plasma viral load will be determined at the mtd.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment. * plasma viral load by roche amplicor hiv monitor assay greater than or equal to 2,000 rna copies/ml and less than or equal to 50,000 rna copies/ml on at least 2 occasions prior to protocol treatment. * normal or non-diagnostic electrocardiogram. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * severe opportunistic infection or any other medical condition which in the opinion of the investigators is a contraindication to enrolling in this trial. * severe lactose intolerance. concurrent medication: excluded: concomitant therapy with other medications having primary renal excretion (other than 3tc, ddc, and d4t). prior medication: excluded: * ongoing dideoxyinosine or other antiretroviral therapy except zdv, 3tc, ddc, d4t, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study. * participation in a study of any systemic experimental drug within the last 2 months. required: - ongoing (at least 4 weeks) stable dosage of zidovudine (zdv) and lamivudine (3tc), zdv and stavudine (d4t), zdv and zalcitabine (ddc), d4t and 3tc, zdv alone, or ddc alone, or in combination with saquinavir, ritonavir, indinavir, or nelfinavir.

Keywords: placebos administration, oral anti-hiv agents viral load peldesine