Kornimate/medical-research-clean huggingface dataset:
the safety and effectiveness of pentamidine in the prevention of pneumocystis carinii pneumonia (pcp) in patients with aids who have had pcp before

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate and compare the safety, tolerability, and efficacy of biweekly administration of 1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have recovered from their first episode of aids-associated pneumocystis carinii pneumonia (pcp).


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * zidovudine (azt). exclusion criteria co-existing condition: patients with the following are excluded: * requiring ongoing active therapy for an opportunistic infection (o.i.) at time of entry or those with either of the following aids-defining o.i.'s prior to entry: * toxoplasmosis. * cryptococcosis. * transfusion dependent (requiring blood transfusion more than once per month). the last transfusion cannot have been given within 7 days of study entry. * pulmonary kaposi's sarcoma (ks). * asthma requiring medication. * active therapy for tuberculosis. concurrent medication: excluded: * active therapy for tuberculosis. patients with the following are excluded: * requiring ongoing active therapy for an opportunistic infection (o.i.) at time of entry or those with either of the following aids-defining o.i.'s prior to entry: * toxoplasmosis. * cryptococcosis. * transfusion dependent (requiring blood transfusion more than once per month). the last transfusion cannot have been given within 7 days of study entry. * pulmonary kaposi's sarcoma (ks). * unwilling to sign informed consent. * cannot cooperate with study procedures. * asthma requiring medication. prior medication: excluded within 30 days of study entry: * antiretrovirals other than zidovudine (azt). * immunomodulating agents. * corticosteroids. patients must: * have aids and recovered from their first episode of cytologically or histologically proven pneumocystis carinii pneumonia (pcp). * be at least 2 weeks and no more than 24 weeks status post therapy for acute pcp. * have positive antibody to hiv by any federally licensed elisa test kit, or confirmed western blot test. * have adequate pulmonary function (vital capacity = or \> 80 percent of predicted; forced expiratory volume (fev), 1 s = or \> 65 percent of total fev; and corrected pulmonary diffusion capacity \> 60 percent of predicted). * free of acute medical problems. active substance abuse.

Keywords: aids-related opportunistic infections pneumonia, pneumocystis carinii pentamidine dose-response relationship, drug aerosols acquired immunodeficiency syndrome
assessment of compliance with monitoring conducted by a physician in person or by a nurse in remote monitoring

Conditions: Stage I Testicular Seminoma; Stage I Testicular Nonseminomatous Germ Cell Tumor; Gastrointestinal Stromal Tumors; Ovarian Germ Cell Tumor; Adenocarcinoma, Clear Cell; Borderline Ovarian Tumor; Sex Cord-Stromal Tumor; Mucinous Adenocarcinoma of Ovary; Carcinoma, Small Cell; Carcinosarcoma, Ovarian; Serous Tumor of Ovary; Glioma; Neuroendocrine Tumors; Aggressive Fibromatosis of Abdominal Wall (Disorder)

Summary: this is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). the study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

the primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms. the secondary objectives are to compare between the two arms : * long-term compliance (5-year follow-up) * use of care * oncological events and their management * supportive care needs the exploratory objectives are to : * evaluate the costs in terms of medical transportation * evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression) * evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center) * evaluate the reasons for recruitment failures

Eligibility criteria:
inclusion criteria: * positive diagnosis (anatomopathology) of tumor within 12 months * patient 18 years of age or older * patient with one of the following conditions: 1. desmoid fibromatosis of the abdominal wall operated on or under active surveillance 2. stage i testicular seminoma (whether or not treated with carboplatin auc7) 3. stage i non-seminomatous germ cell tumor (with or without adjuvant bep chemotherapy) 4. operated gist with low risk of relapse 5. rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated 6. low-grade glioma, operated 7. low-grade neuroendocrine tumor, treated by surgery alone * patient who has given consent to participate in the study exclusion criteria: * contraindication to imaging tests required for the surveillance plan * no telephone * patient under guardianship or curatorship
brain change after fun, athletic, sports-skill training (befast)

Conditions: Cerebral Palsy

Summary: the purpose of this study is to determine the associations between changes in neural activity and structure, advanced gross motor skills, gait characteristics, and physical activity participation following a gait-related intervention that is based on motor learning principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. the investigators' hypothesis is that in conjunction with a program of motor learning based training, functional neuroplastic changes in the involved motor areas will be strongly associated with changes in gait and advanced gross motor skills, moderately associated with physical activity based participation changes, and will have a fair association with structural neuroplastic change.


Eligibility criteria:
inclusion criteria: * age 7 to17 years inclusive; * gmfcs level i or ii; * able to follow testing and motor imagery instructions; * able to actively participate in a minimum of 45 minutes of physical activity; * able to independently dorsiflex both ankles; * able to commit to attendance of sessions two to three times weekly for six weeks. exclusion criteria: * orthopaedic surgery within the last 9 months (muscle) or 12 months (bone); * botulinum toxin-a (btx-a) injections to lower limb in the last 4 months; * inability to discontinue btx-a for period of 12 weeks (during trial) due to concerns about rom or pain; * severe spasticity (may be a contraindication for neuroimaging procedures); * seizure disorder (if not fully controlled by medication for the 12 months); * not prepared or unable to discontinue a regular lower limb therapy intervention during the course of the trial; * involved in another intervention study; * standard mri contraindications (e.g., metal implants such as cochlear implant, claustrophobia).
evaluation of a composite cancellous and demineralized bone plug (cr-plug) for repair of knee osteochondral defects

Conditions: Knee Injury

Summary: the objective of this study is to determine how effective a plug made out of human bone (called "cr-plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).

the main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (\<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.

Eligibility criteria:
inclusion criteria: * 18 to 55 years * skeletally mature * have a symptomatic score international cartilage repair society (icrs) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the medial femoral condyle or lateral femoral condyle. symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling * functional meniscal tissue (defined as 5 mmor greater) * a score of = or greater than 4 on the vas questionnaire exclusion criteria: * associated tibial or patellar articular cartilage defect greater than 2 icrs * osteoarthritis of either knee * mechanical axis malalignment of greater than 5 degrees * patellofemoral incongruity on merchant view * one or more multiple defects greater than 2.5 cm * osteochondritis dissecans (ocd) with depth of bone loss greater than 4 mm * ligament treatments in the affected knee within one year prior to current study * previous surgical meniscus treatment in the affected knee in the last 6 months * less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment * use of any investigational therapy within 30 days prior to the first visit * corticosteroid or viscosupplementation within the past 3 months * a score of 3 or less on the vas questionnaire * active gout or pseudogout or systemic inflammatory condition * microfracture less than one year prior to current study

Keywords: allograft knee injury cartilage injury
anesthesia methods on percutaneous kyphoplasty

Conditions: Vertebral Fracture

Summary: the aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (pkp). method: patients were split into three groups according to anesthesia methods: (1) general anesthesia (sedation), (2) central block (spinal and epidural anesthesia), (3) peripheral block \[erector spina plane block (espb), and paravertebral block (pvb)\]. patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with visual pain scales (vas).

demographic characteristics (body mass index \[bmi\], gender, age, asa use, pain values \[vas\] before surgery, analgesic use habits, anesthesia technique chosen by anesthesiologist blind to the study, perioperative hemodynamic parameters, additional opioid during surgery, parol? or anesthetic need, perioperative complications \[patients who willingly stopped the procedure during the intervention, moaning, hypotension, hypertension, bradycardia, respiratory depression, desaturation and need for mask ventilation\] were taken from the records of the individuals with the treatment of pkp between 01/22-07/22 after the approval of the sbü bursa yüksek i̇htisas eah ethics committee (2021-kaek-25 2021/12-09) and the patient's consent. in addition, the first mobilization time, additional analgesic need, total amount of analgesic used in 24 hours, discharge time, vas values at 2, 6,12, and 18 hours, complications (nausea, vomiting, pain, delirium, respiratory insufficiency, infection, deep vein thrombosis, pulmonary embolus, need for re-operation, need for intensive care or mechanic ventilator) were also recorded.

Eligibility criteria:
inclusion criteria: * 18-100 ages kyphoplasty surgery patients * written consent form received exclusion criteria: * the patient's unwillingness to participate in the study * inability to communicate with the patient * the patient does not speak turkish, * previous cvo, presence of cognitive impairment

Keywords: percutan kyphoplasty vertebroplasty
augmented reality game-based training on social communication of children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the study aims to determine the effects augmented reality game-based training on social communication of children with autism spectrum disorder.

augmented reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. the aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.

Eligibility criteria:
inclusion criteria: * participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following. exclusion criteria: * sensory issues and patients on medication.

Keywords: autism augmented reality social communication
initial evaluation of ultra fast breast magnetic resonance in breast cancer screening: comparative study with mammography and ultrasound.

Conditions: Breast Cancer

Summary: mammography remains an imperfect screening test especially in women with extremely dense breast tissue, missing biologically aggressive cancers especially in younger population and picking up indolent cancers that do not need treatment. the most sensitive test for breast cancer detection at our disposal is magnetic resonance imaging (mri). the preliminary study of dr kuhl provide strong arguments that ultra fast breast magnetic resonance is suitable for breast cancer screening with high sensitivity and specificity values. data clearly demonstrates that fast breast mri could be the standard for breast cancer screening: it is safe, does not induce cancers, and can find more cancers than mammography. however this study was performed in women with low to moderately increased risk.the value of fast breast magnetic resonance in normal screening population has to be assessed before a modification of current strategy of breast cancer screening with mammography.


Eligibility criteria:
inclusion criteria: * women referred for routine breast cancer screening exclusion criteria: * disabled women (eg, unable to stand) * pregnant women * allergy to gadolinium

Keywords: screening mri
the effects of lactobacillus plantarum on cortisol, iga and alpha-amylase levels in human saliva during stress

Conditions: Stress Reaction

Summary: in the present study the main goal has been to clarify the effect of the probiotic bacteria lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination stress. salivary iga from minor glands and in whole human saliva was measured as alternative marker of stress. the hypothesis was that the levels of cortisol would be reduced or stabilized in the test group in comparison to the placebo group where the cortisol levels were expected to increase due to the examination-induced stress. by contrast, the salivary iga levels were expected to increase in the test group in comparison to the placebo group.


Eligibility criteria:
inclusion criteria: * adults * studying at the university in lund * participation in ongoing examination period exclusion criteria: * pregnancy * intake of antibiotics * medication with cortisone during the study period
efficacy and safety of irreversible electroporation for chronic symptomatic tonsillar hypertrophy treatment

Conditions: Tonsillar Hypertrophy

Summary: the purpose of the ire system is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) while minimizing side effects and complications. procedure time will also be reduced. the ire system is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume.

the purpose of the ire system is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) while minimizing side effects and complications. procedure time will also be reduced. the ire system is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume. on basis of these finding and in view of the known safety profile (refer to chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the ire system in tonsillar reduction.

Eligibility criteria:
inclusion criteria: * age 18 - 70 years. * tonsillar hypertrophy of grade 2 or higher on the bgst. exclusion criteria: * age below 18 years. * patients with a pacemaker or similar electro stimulator. * patients for whom the anesthesia involves high risk. * epilepsy or other condition involving convulsions. * inability to give informed consent and to complete self-reported questionnaires. * patients with an inability to cooperate for treatment and follow-up. * severe heart disease. * pregnancy or breastfeeding. * significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease). * bleeding diathesis. * patients suffering from obesity as indicated by a body mass index (bmi) \> 32kg/m2. * known or suspected complications for any general or local anesthetic agents and/or any antibiotic medications.
relationship between vitamin d biomarkers and survival in blood samples from patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how well patients will respond to treatment. purpose: this research trial is studying the relationship between vitamin d biomarkers and survival in blood samples from patients with advanced pancreatic cancer.

objectives: primary objective * to measure baseline serum 25-hydroxyvitamin d (25\[oh\]d) levels in a cohort of patients with advanced pancreatic cancer enrolled in the cancer and leukemia group b (calgb) study 80303 and evaluate the association between vitamin d status and overall survival (os) or progression free survival (pfs). secondary objective * to evaluate the association between common germ-line single nucleotide polymorphisms (snps) in the vitamin d pathway genes and 25(oh)d levels in patients with advanced pancreatic cancer. * to evaluate the interaction between serum 25(oh)d levels and germ-line snps in the vitamin d pathway genes in predicting os in advanced pancreatic cancer. outline: this is a multicenter study. archived serum samples are analyzed for 25-hydroxyvitamin d levels by competitive chemiluminescence immunoassay. results are then compared with the germ-line single nucleotide polymorphisms from the genome-wide association study (gwas) and patients' clinical data.

Eligibility criteria:
1. eligible patients had unresectable adenocarcinoma of the pancreas 2. received no prior therapy for metastatic disease (prior radiation and/or chemotherapy in the adjuvant setting were allowed). 3. baseline eastern cooperative oncology group (ecog) performance status of 0 to 2 4. adequate renal, liver, and bone marrow function were required. 5. patients signed informed consent for participation in the therapeutic trial and consented to the companion study for biomarker research (calgb-151006).

Keywords: recurrent pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer
the singulair® add-on study effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with uncontrolled asthma (0476-384)

Conditions: Asthma

Summary: the purpose of this study is to evaluate the effectiveness of adding montelukast sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.


Eligibility criteria:
inclusion criteria: * patients is 18 years old note 1: regulatory requirements necessitate the following criterion. it may not be appropriate for your patients. female patients of childbearing potential should be informed not to become pregnant during the study by using the appropriate contraceptive methods (oral or long-acting contraceptive injections (depo provera), intrauterine device (iud), or barrier methods (e.g. condom or diaphragm plus spermicide) or to be abstinent (no sexual intercourse)) beginning at least 7 days before visit 1 and continuing at least 14 days after visit 4 or a discontinuation visit note 2: for alberta: investigators who will recruit in private office, no patients can be recruited in the study until approval from the college of physicians and surgeons of alberta ethics committee is obtained exclusion criteria: * patient is well controlled, adherent and satisfied with current controller therapy
clinical study of clinical efficacy and tolerability of hmg-ibsa s.c.in women undergoing coh in an art programme (ivf).

Conditions: Infertility

Summary: multicenter, prospective, randomized, investigator blind, controlled clinical trial. two parallel groups, one receiving the test drug hmg (hmg-ibsa, ibsa institut biochimique sa) and the other the reference drug hmg (menopur, ferring pharmaceuticals, inc.).

the purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hmg preparations (hmg-ibsa, ibsa vs menopur, ferring pharmaceuticals, inc.) when administered to patients undergoing controlled ovarian stimulation for ivf.

Eligibility criteria:
inclusion criteria: * women undergoing ovarian stimulation for ivf with or without icsi (intracytoplasmic sperm injection) and with the following characteristics: * voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures; * \> 18/= and \< 37 years old; * bmi between 18 and 28 kg/m2; * less than 3 previous completed ivf cycles; * basal fsh level less than 10 iu/l once within 6 months prior to the study; * within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or tvus; * normal or clinically insignificant haematology and blood chemistry values. exclusion criteria: * primary ovarian failure or women known as poor responders; * signs of pco, according to the rotterdam criteria; * at least one ovary inaccessible for oocyte retrieval; * one or more ovarian cysts \> 10 mm; * hydrosalpinx that have not been surgically removed or ligated; * stage iii or iv endometriosis; * patients affected by pathologies associated with any contraindication of being pregnant; * hypersensitivity to the study medication; * abnormal bleeding of undetermined origin; * uncontrolled thyroid or adrenal dysfunction; * neoplasias; * pap smear iii within the last 2 years; * severe impairment of the renal and/or hepatic functions; * lactation; * hyperprolactinaemia; * participation in a concurrent clinical trial or in another trial within the past four weeks; * use of concomitant medication that might interfere with study evaluations.

Keywords: infertility ivf art hmg