Kornimate/medical-research-clean huggingface dataset:
protocol for the treatment of cryptosporidiosis in aids patients with diclazuril (r64,433)

Conditions: Cryptosporidiosis; HIV Infections

Summary: to evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as treatment of cryptosporidial related diarrhea in aids patients. treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * patients who require anti-diarrheal medication must have received only one anti-diarrheal medication, loperamide, for at least 7 days prior to study entry. dose of loperamide cannot be increased during study. * aerosolized pentamidine. * ganciclovir for cytomegalovirus (cmv) retinitis only but patient must be stable at least 4 weeks prior to study entry. * zidovudine (azt). * nystatin for oropharyngeal infections if not taken within 2 hours of diclazuril. patients must have: * diagnosis of aids that is confirmed hiv positive by western blot or aids defined diagnosis, or cdc defined aids. stool specimens positive for cryptosporidium oocysts. * given written informed consent after the purpose and nature of the study, as well the possible drug-related adverse effects, have been explained. * ability to return for all subsequent applicable visits on days 8, 15, 21, and, if necessary, 28. prior medication: allowed: * aerosolized pentamidine. * loperamide. * ganciclovir for cytomegalovirus (cmv) retinitis. exclusion criteria co-existing condition: patients with the following are excluded: * diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with aids for more than 4 weeks. * other treatable enteric pathogens including clostridia must be treated and eradicated prior to study entry. * inability to swallow capsules. * uncontrolled vomiting. concurrent medication: excluded: * trimethoprim/sulfamethoxazole (bactrim). * ganciclovir for any other reason except cytomegalovirus (cmv) retinitis. * other antibiotics. * other anti-protozoal drugs. * anti-fungal drugs other than nystatin. * amphotericin b. * other investigational drugs. patients with the following are excluded: * diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with aids for more than 4 weeks. * inability to swallow capsules. * uncontrolled vomiting. * life expectancy of \< 28 days. * can not be depended upon to follow the instructions of the investigator. * participation in an investigational study within 15 days of study entry. prior medication: excluded within 15 days of study entry: * another investigational drug or device (except aerosolized pentamidine). prior treatment: excluded within 15 days of study entry: * participation in an investigational study.

Keywords: aids-related opportunistic infections cryptosporidiosis diarrhea diclazuril coccidiostats acquired immunodeficiency syndrome
use of the atkins diet for adults with intractable epilepsy

Conditions: Epilepsy

Summary: this is a prospective study to determine whether the atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. the investigators plan to establish the seizure baseline and type, initiate the atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.

patients are seen in the johns hopkins general clinical research center (gcrc) and started on a modified atkins diet (15g/day of carbohydrates). medications remain unchanged and labs are drawn. followup is at 1 month, 3 months, and 6 months into the study. after 1 month, carbohydrates and medications can be altered. ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar. this study is ongoing with approximately 20 patients of 30 enrolled as of february 2006.

Eligibility criteria:
inclusion criteria: * ages 18 and over * weekly seizures or 4 times per month * use of at least 2 anticonvulsant drugs exclusion criteria: * prior use of the atkins diet for \> 1 week * prior use of the ketogenic diet within the past year * kidney, heart disease, renal disease * hypercholesterolemia * pseudoseizures * pregnancy * body mass index (bmi) below 18.5 * status epilepticus within the past 6 months * 2 week seizure-free period within the past 6 months

Keywords: intractable ketogenic ketosis atkins
adaptive plasticity following rehabilitation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. for example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. however, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined. moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks. therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.


Eligibility criteria:
inclusion criteria: * multiple sclerosis diagnosis according to mcdonald criteria * right handedness as assessed by the edinburgh handedness inventory * absence of relapses in the last three months * mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the medical research council scale (grade 3-4) exclusion criteria: * steroid-use or a worsening of the expanded disability status scale (edss) score in the last three months * psychiatric disorders * severe cognitive impairment * magnetic resonance imaging contraindications

Keywords: upper limb motor rehabilitation voluntary movements functional magnetic resonance imaging
efficacy and safety of sublingual tablets of grass pollen allergen extract

Conditions: Seasonal Allergic Rhinitis

Summary: the objective of this study is to assess the effect of grass pollen extract slit tablets on the rhinoconjunctivitis total symptom score (rtss) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from seasonal allergic rhinoconjunctivitis (sar) due to grass pollen.

the purpose of this study is to determine whether slit tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of slit tablets on allergic rhinitis symptoms.

Eligibility criteria:
inclusion criteria: * male or female outpatients 18-50 years old * grass pollen rhinoconjunctivitis of at least 2 years. * positive specific skin prick test and a specific ige dosage level of at least 0.70 ku/l at screening. * written consent * a positive response to the baseline challenge test (rtss reaches 7 at one time-point at least during baseline challenge) exclusion criteria: * allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study * asthma requiring treatment other than short-acting beta-2 inhaled agonists. * desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.

Keywords: sublingual immunotherapy rhinitis conjunctivitis allergen challenge allergen exposition chamber grass pollen tablet allergic rhinoconjunctivitis
robot-assisted vs. video-assisted lobectomy for nsclc (ravar)

Conditions: Non Small Cell Lung Cancer

Summary: video-assisted thoracic surgery (vats) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (nsclc) for many years. however, vats has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (rats) was first applied for lung resection. in recent years, rats has developed rapidly, but there are still many unsolved scientific problems in the field of rats. thus, a multicenter prospective randomized controlled trial was conducted with stage i-ii nsclc patients as the study subject and 5-year dfs as the primary endpoint to compare the short-term and long-term outcomes of rats and vats in the treatment of early-stage nsclc.


Eligibility criteria:
inclusion criteria: 1. age from 18 to 80 years old; 2. patients with blood pressure\ = 40 % and diffusing capacity of the lung for carbon monoxide (dlco) \>= 40 %; (3) total bilirubin \ = 60ml/min; 3. the first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types; 4. clinical stage t1-2n0-1 (ci-ii): maximum diameter of tumor \<= 5cm and short diameter of mediastinal lymph node \<= 1cm in thin layer ct; 5. performance status of eastern cooperative oncology group (ecog) 0-1; 6. all relevant examinations were completed within 28 days before the operation; 7. patients who understand this study and have signed an approved informed consent. exclusion criteria: 1. patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery. 2. patients with the previous history of other malignancies; 3. patients with secondary primary cancer when enrolled; 4. patients diagnosed as pure ground glass opacity (ggo) before surgery; 5. patients diagnosed as mixed ggo whose solid part \<= 50% and maximum diameter of tumor \<= 2cm; 6. patients with small cell lung cancer; 7. patients with prior unilateral open thoracic surgical procedures; 8. woman who is pregnant or breastfeeding; 9. patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema; 10. patients with an active bacterial or fungal infection that is difficult to control; 11. patients with serious psychosis; 12. patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.

Keywords: non-small cell lung cancer robotic-assisted lobectomy video-assisted lobectomy
physical activity before obesity surgery

Conditions: Obesity; Physical Activity

Summary: there are limited knowledge about the impact of increased pre-operative physical training on postoperative physical activity levels as well as on recovery and complication rates after bariatric surgery. the primary aim of this study is to investigate whether an intervention including individual coaching to improve level of physical activity before and after gastric bypass surgery leads to a changed of level physical activity post-operatively at eight weeks, one and two years. secondary aims of the study are to investigate whether increased physical activity has effects on complication rates, re-admissions and re-operations, post-operative weight-loss, gastrointestinal pain, recovery measured as hospital stay, sick-leave and qol, resumption of normal physical activity. methods 300 patients will be recruited and randomized to an intervention group or control group. the patients in the intervention group will receive individual coaching by a physical therapist to: * increase physical activity 30 minutes/day (at least 150 min/week) * decrease time spent sitting/lying the patients in the control group will receive standard care. before surgery, 6 weeks, and one year after surgery patient will fill in a questionnaire including level of physical activity, sick leave, quality of life and gastrointestinal pain. in addition blood test will be taken and complication rates recorded.


Eligibility criteria:
inclusion criterion: - patients at including hospitals scheduled for gastric bypass surgery exclusion criteria: * inability to understand given information. * inability to perform the intervention

Keywords: obesity physical activity
acute exposure to simulated hypoxia on exercise capacity

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary hypertension (pah, cteph) to assess the acute response to simulated altitude (fio2:15.1, equivalent to 2500m above sea level) in constant loaded exercise capacity.

low altitude baseline measurements will be performed in zurich (460m asl) including echocardiography, right heart catheterization, six-minute walk test (6mwt), pulmonary function test, clinical assessment and blood gas analysis. randomly assigned to the order of testing, the participants will be tested under simulated altitude (fio2: 15.1% with the "amc altitrainer") and shamed altitude with the same device. towards the end of the exposure after approximately 1h, the participants will perform a constant loaded exercise test on an ergometer with a calculated resistance of their 60% max. workload. the patients will be encouraged to perform this test up to their physical exhaustion.

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mean pulmonary artery presssure (mpap) ≥ 25 mmhg along with a pulmonary artery wedge pressure (pawp) ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting partial oxygen pressure (pao2) ≤7.3 kilopascal (kpa) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, high altitude pulmonary edema (hape), etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: exercise capacity simulated altitude
the effect of virtual reality glasses application on labor pain and comfort in multiparous pregnants

Conditions: Labor Pain

Summary: one of the non-pharmacological methods used to reduce labor pain in multiparous pregnant women is the application of virtual reality glasses. this study aims to measure labor pain and determine the effect of virtual reality glasses application on comfort.

one of the non-pharmacological methods in the management, control and reduction of labor pain is the application of virtual reality glasses. non-pharmacological methods applied by midwives in obstetrics clinics are preferred because they do not have any side effects to the mother and fetus, their cost is very low and they are easy to apply. this study was planned to determine the effect of virtual reality glasses application on labor pain and comfort in multiparous pregnant women. the research was planned at istanbul sultanbeyli state hospital between 15 september 2023 and 31 june 2024. the universe of the research will be the pregnant women who were hospitalized to give birth in this hospital, and the sample will be multiparous pregnant women (60 experimental group, 60 control group) who are in the active phase of labor and comply with the sampling criteria, and a total of 120 pregnant women. block randomization will be used in sample selection. those who volunteered to participate in the study will have to sign the informed consent form, and the pregnant woman descriptive information form, visual analog scale-vas, comfort scale-ql and birth satisfaction scale will be filled in by the researchers by face-to-face interview technique. data collection will take approximately 15-20 minutes.as a result of the study, to reveal the effectiveness of virtual reality glasses application, which is one of the non-pharmacological methods, in reducing labor pain and increasing the birth comfort and satisfaction of mothers, and to contribute to the literature in this field by adding a new one to the limited studies in this field. this study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses application on labor pain and comfort in multiparous pregnant women.

Eligibility criteria:
inclusion criteria: * those between the ages of 18-35 * at least primary school graduate * able to speak and understand turkish * 37-42 weeks of pregnancy (term) * having a singleton pregnancy * fetal presentation is head * vaginal birth planned * multiparity (2 or more births) * does not have any risks related to pregnancy and birth * there is no problem in the fetus * in the active phase of labor * pregnant women who volunteer to participate in the study and approve the consent document will be included. exclusion criteria: * those under the age of 18 (adolescents) * primiparity (first to give birth) * those who are planned to have a caesarean section * analgesics administered at birth * those who did not want to participate in the study or participated in the study voluntarily but later those who give up

Keywords: birth labor pain virtual reality glasses
effect of a candy flavoring before local anesthesia on anxiety and pain perception in children

Conditions: Local Anesthesia

Summary: this is a randomized clinical trial that aimed to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception when compared to a negative control group. applying the flavor before injecting local anesthesia helped in distracting the child and reduced the associated pain.

background: distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. no studies so far have used a sugar-free solution as a distraction method. aim: to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design. methods: a total of 84 children, aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study. each child received two injections. the children were randomly allocated into two groups, group 1 received the first injection after applying a flavor, and group 2 received the first injection after applying sterile water. the children received the first injection either on the right or left side, and switched sides on the next visit, resulting in (n=168) total injections. the observed pain perception was assessed using the sem scale. wong-baker faces pain rating scale will be used to assess the pain reported by the child. pulse rate, bmi, and sweet taste preference were also recorded by an independent observer to ensure blinding. results: using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia.

Eligibility criteria:
inclusion criteria: * healthy (asa grade 1 status) children * first dental experience for the child including local anesthesia. * children with caries lesions that require restorative treatment. * children who require the same treatment on upper primary first or second molars bilaterally. exclusion criteria: * children with poor behavior (unable to cooperate for dental treatment). * previous unpleasant dental experience (dental phobia). * history of abscess, redness, fistula in the injection site (need for extraction). * presence of a systemic disease, mental, cognitive and intellectual disabilities.
the initiating factors of myopia among primary and secondary school students in tianjin

Conditions: Myopia; Refractive Error

Summary: there was a prospective cohort observational study. forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. all patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. a multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.


Eligibility criteria:
inclusion criteria: * students in grades 1-3 * can cooperate with the examination of students exclusion criteria: * obvious strabismus and amblyopia * eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases * history of ocular surgery
hyperbaric oxygen therapy in children with inflammatory bowel diseases

Conditions: Inflammatory Bowel Diseases; Children, Only

Summary: the study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease or ulcerative colitis according to the criteria from porto - based on the clinical condition as well as imaging and endoscopic examinations with histopathological assessment; * failure to achieve the remission despite the use of standard treatment in accordance with international guidelines; * written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age. exclusion criteria: * intolerance of enclosed spaces; * contraindications for hyperbaric therapy: otolaryngological (otitis media, sinusitis); cardiac (clinically significant defects or arrhythmias); pneumological (clinically significant defects) * exacerbation of inflammatory bowel disease during the therapy; * contraindications for hyperbaric therapy in a patient's caregiver in a situation, where the patient requires his/hers presence inside the hyperbaric chamber during the session.