Kornimate/medical-research-clean huggingface dataset:
comparison of efficacy and safety of thalidomide vs hydroxyurea in thalassemia patients: a single-centre pilot study.

Conditions: Beta-Thalassemia

Summary: the goal of this study is to compare the effectiveness and safety of two hemoglobin f inducer. this is single centered interventional pilot study is to compare the efficacy and safety parameters in beta thalassemia patients. as this is a pilot study, the investigator took a small number of patients. the sample size was calculated by the world health organization sample size calculator. after screening 39 patients and 24 patients were eligible for enrollment in this study. the main objective was to evaluate safety of both drugs in genetic disorder like thalassemia. for safety evaluation, hematological parameters were evaluated that includes total bilirubin , indirect bilirubin, serum glutamate pyruvate transaminase, serum glutamic-oxaloacetic transaminase, urea, creatinine and lactate dehydrogenase were monitored . moreover to evaluate the efficacy of drug, hematological parameters that includes hemoglobin, red blood cells , nucleated red blood cells , reticulocytes count, red blood cells indices ( mean corpuscular hemoglobin, mean corpuscular volume and mean corpuscular hemoglobin concentration) , white blood cells and platelets were done. another important parameters to evaluate the efficacy of hemoglobin f inducer is transfusion frequency. test were done at baseline and after completion of study means after 06 months.


Eligibility criteria:
inclusion criteria: * know case of beta thalassemia age between 10-30 years exclusion criteria: * patients on any other haemoglobin f inducer or erythropoietin. * patients with co-morbidities like cardiopulmonary and neurological disease * pregnant, lactating women. * patient did not willing to take contraceptive measures. * participants with history of thrombosis.

Keywords: thalidomide, hydroxyurea hemoglobin f inducers beta thalassemia
neuromodulation for post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: the investigators propose to use a clinical trial to test trigeminal nerve stimulation (tns) to examine the efficacy of tns as a new treatment for post traumatic stress disorder (ptsd) in veterans. recruitment will take place at the ptsd outpatient clinic at the veterans affair greater los angeles (va gla). study participants will be asked to complete, at most, 9 assessments/questionnaires regarding their ptsd symptoms and quality of life, use the tns device every night for 8 hours, log their use of the device, and attend weekly visits to monitor safety and complete assessments. each subject will be asked to attend 8 visits over the course of 8 weeks. subjects who receives the sham-controlled treatment will have an additional follow-up phone visit 4 weeks after the week 8 endpoint to examine symptom improvements. enrollment and subject-related procedures are projected to take approximately 36 months. preparations for clinical trial, clinical trial/study procedures and data analysis will occupy a 6 month period, a 36 month period, and a 6 month period, respectively. the duration of this project is approximately 4 years.


Eligibility criteria:
inclusion criteria: 1. 21-65 years old and be a patient in the post traumatic stress disorder(ptsd) clinic at the veterans affair greater los angeles 2. have experienced trauma while serving in a war zone in iraq or afghanistan 3. meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) criteria for current war zone-related ptsd with a duration of at least 3 months 4. have completed a course of prolonged exposure(pe) therapy in the resident psychotherapy program in the ptsd clinic within six months of enrollment and with significant residual ptsd symptoms as evidenced by a clinician-administered ptsd scale score \>50 5. consent to be randomized to active or sham trigeminal nerve stimulation treatment 6. if receiving medication for depression, anxiety, sleep, or mood stabilization, must have been on stable dose for at least six weeks prior to randomization. exclusion criteria: 1. current substance abuse not in remission for at least 3 months 2. a history of bipolar, schizophrenia, other psychotic disorder, or dementia 3. current suicidal or homicidal ideation requiring hospitalization, or suicide attempt within six months 4. report of severe traumatic brain injury (tbi) with coma duration (30 minutes or more) during the screening interview and/or duration of post - traumatic amnesia (1hour or greater) on the post-traumatic amnesia questionnaire (ptaq) 5. evidence of receiving antidepressant, antianxiety, antipsychotic, or mood-stabilizer medication where the dose has not been stable for a minimum of six weeks prior to entering the randomization 6. evidence of receiving psychosocial or medication treatment through a clinic or facility other than the va gla ptsd clinic. 7. infection or loss of integrity of skin over the forehead, where the electrode pads will be placed.

Keywords: trigeminal nerve stimulation post-traumatic stress disorder
fsme immun new follow-up to study 205 in children aged 6 to 16 years

Conditions: Encephalitis, Tick-borne

Summary: the purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a tbe vaccine in all volunteers who completed two vaccinations in one of the three treatment groups of baxter study 205 (safety and immunogenicity of two vaccinations with fsme immun new in healthy volunteers aged 6 to 16 years).


Eligibility criteria:
inclusion criteria: all volunteers who participated in baxter study 205 and received two vaccinations will be invited to participate. male and female children will be eligible for participation in this study if: * they received two vaccinations with one of the three different dosages of fsme immun new during the course of baxter study 205 * they and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent exclusion criteria: there are no specific exclusion criteria for this study entry. however volunteers will be assessed for eligibility to receive a third vaccination. volunteers will be excluded from vaccination and consecutive visits in this study if they: * are not clinically healthy, (i. e. the physician would have reservations vaccinating with fsme immun new outside the scope of a clinical trial) * have already been administered a third tbe vaccination elsewhere after the two vaccinations in baxter study 205 * have had an allergic reaction to one of the components of the vaccine since the last vaccination in baxter study 205 * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions * have received banked human blood or immunoglobulins within one month of study entry * are known to be hiv positive (a special hiv test is not required for the purpose of the study) since the last visit of baxter study 205 * have had a vaccination against yellow fever and / or japanese b-encephalitis since the last visit in baxter study 205 * had received an investigational new drug within 6 weeks prior to study start * if female and capable of bearing children - have a positive pregnancy test at the first medical examination
prevalence of sleep-disordered breathing in children

Conditions: Lung Diseases; Sleep Apnea Syndromes

Summary: to investigate the prevalence and clinical significance of sleep-disordered breathing (sdb) in children.

background: sdb in children appears to be a common condition, affecting approximately 1 to 3 percent of children. many aspects of childhood sdb remain understudied and poorly understood, including its precise prevalence, the optimal means of identifying children who should undergo polysomnography, and the potentially major impact of this condition on health, cognitive development, and behavior. design narrative: the population-based, cross-sectional study of 6- to 16-year-old schoolchildren in dauphin county, pennsylvania is a two-part study. in the first part of the study, parents of every child enrolled in local elementary schools will complete a questionnaire that will assess general sleep, behavior, and learning problems. in the second part of the study, 1,000 children will be randomly selected based on their risk for sdb, as determined by the questionnaire. they will be evaluated in a sleep laboratory to determine the presence of sdb. a thorough pediatric ear, nose, throat, and pulmonary evaluation will be conducted; school records and behavior will also be assessed. the parents of the children will be interviewed, and information will be collected on the family history of risk factors associated with childhood sdb. this strategy will be beneficial in establishing the prevalence and clinical significance of sdb in children.

Eligibility criteria:
inclusion criteria: * phase i: sampled all children by questionnaire completed by parent or guardian in three school districts in dauphin county, pennsylvania * phase ii: recruited a representative sample of 700 to complete a more detailed analysis in the laboratory

Keywords: sleep-disordered breathing
study of pentaxim™ vaccine versus tetraxim™ vaccine given with acthib™ vaccine in south korean infants.

Conditions: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus Influenzae Type B

Summary: this study is designed to assess the immunogenicity and safety of pentaxim™ combined vaccine versus tetraxim™ vaccine to support registration of pentaxim™ in south korea. primary objective: to demonstrate the non-inferiority in terms of seroprotection rates (diphtheria, tetanus, polio types 1, 2 and 3, polyribosyl ribitol phosphate \[prp\]) and vaccine response rates to acellular pertussis antigens of sanofi pasteur's pentaxim™ vaccine versus sanofi pasteur's tetraxim™ and act (haemophilus influenzae type b) hib™ vaccines, one month after the three-dose primary vaccination.

all participants will receive three primary doses of their assigned study the vaccine, on days 0, 60, and 120. they will be assessed for immunogenicity on day 0 before vaccination and day 150 post-vaccination. safety will be assessed for all participants throughout the study, up to day 157.

Eligibility criteria:
inclusion criteria: * aged 2 months (56 to 70 days) inclusive on the day of inclusion * born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the trial inclusion * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood derived products received in the past or current or planned administration during the trial (including immunoglobulins). * any vaccination in the 3 weeks preceding the first trial vaccination. * history of diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically). * clinical or known serological evidence of systemic illness including hepatitis b, hepatitis c and/or human immunodeficiency virus (hiv) infection * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or haemophilus influenzae type b infection with the trial vaccine or another vaccine. * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current major neurological diseases or seizures. * febrile illness (axillary temperature ≥ 38ºc) or acute illness on the day of inclusion. * known family history of congenital or genetic immuno-deficiency.

Keywords: diphtheria tetanus pertussis haemophilus influenzae type b poliomyelitis pentaxim™ tetraxim™
conventional vs tailored limb lengths in laparoscopic roux-en y gastric bypass surgery

Conditions: Obesity; Metabolic Disease; Bariatric Surgery Candidate; Metabolic Surgery; RYGB

Summary: the study aims to investigate whether tailoring limb lengths based on the 1/3rd and 2/3rd concept improves clinical outcomes in laparoscopic roux-en-y gastric bypass (lrygb) surgery compared to conventional limb lengths. in this study, two groups were described, first group involves patients who will undergo lap rygb with conventional limb lengths of 75cms and 125cms, while the second group is given tailored limb lengths according to the total small bowel length. in the follow up period, total percentage weight loss, improvement in bmi along with the remission of co-morbidities were also assessed.


Eligibility criteria:
inclusion criteria: 1. age: 18-65 years 2. body mass index (bmi): bmi ≥ 40 kg/m² or bmi ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea). 3. asa - less than or equal to 3 4. informed consent: ability and willingness to provide written informed consent and comply with procedures. 5. previous weight loss attempts: documentation of previous attempts at weight loss through diet, exercise, or medical management. exclusion criteria: 1. previous bariatric surgery: prior bariatric or major gastrointestinal surgery that might affect the outcome of rygb. 2. severe cardiopulmonary conditions: significant cardiac or pulmonary conditions that pose a high surgical risk (e.g., severe congestive heart failure, severe chronic obstructive pulmonary disease). 3. uncontrolled psychiatric disorders: severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders. 4. pregnancy: current pregnancy or plans to become pregnant within 12 months post-surgery. 5. malignancy: active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer). 6. severe liver disease: cirrhosis or significant liver dysfunction (e.g., child-pugh b or c). 7. inability to comply: patients who are unable or unwilling to comply with the postoperative follow-up schedule and dietary requirements. 8. chronic use of medications: chronic use of medications known to affect weight or metabolism significantly, such as corticosteroids or antipsychotics. 9. other medical conditions: any other medical condition or surgical finding that, in the opinion of the investigators, would make the patient unsuitable for the study.

Keywords: obesity rygb bariatric surgery metabolic surgery metabolic syndrome
improve outcomes for older allogeneic transplant recipients

Conditions: Allogeneic Transplantation

Summary: this is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic hct. the primary objective is to determine feasibility. up to 60-72 evaluable subjects will be enrolled. evaluable subjects are defined as those participating in the exercise intervention.


Eligibility criteria:
inclusion criteria: cohort a (prehab) 1. age 60 years or older. 2. planned allogeneic hct in the next 1-6 months. 3. hematological malignancy as the indication for hct. 4. pre-frail or frail by fried frailty phenotype. cohort b (rehab) 1. age 60 years or older. 2. planned allogeneic hct or hct within the last 30 days. 3. hematological malignancy as the indication for hct. exclusion criteria: cohorts a and b 1. comorbid disability or illness that prevents safe exercise.
efficacy and safety study of symbicort® turbuhaler® versus oxis® turbuhaler® in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary purpose of the study is to investigate if symbicort is more effective than oxis in increasing forced expiratory volume in one second (fev1), measured at the clinics, in patients with copd.


Eligibility criteria:
inclusion criteria: * a current clinical diagnosis of chronic obstructive pulmonary disease * documented chronic obstructive pulmonary disease symptoms for more than 2 years * a smoking history of at least 10 pack years exclusion criteria: * history and/or current clinical diagnosis of asthma * history and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Keywords: symbicort oxis chronic obstructive pulmonary disease copd efficacy
a study of jnj-87189401 plus jnj-78278343 for advanced prostate cancer

Conditions: Advanced Prostate Cancer

Summary: the purpose of the study is to determine the recommended regimen for phase 2 (rp2rs) of combination of jnj-87189401 with jnj-78278343 (part 1: dose escalation) and further evaluate the safety at rp2rs (part 2: dose expansion) in participants with advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * metastatic castration-resistant prostate cancer (mcrpc) as defined by prostate cancer working group 3 (pcwg3): histologically confirmed adenocarcinoma of the prostate. adenocarcinoma with small cell or neuroendocrine (ne) features is permitted. however, small cell carcinoma, carcinoid tumor, mixed ne carcinoma, or large cell ne carcinoma is disallowed * measurable or evaluable disease per pcwg3 criteria; all participants must have a serum psa value greater than or equal to (\>=2) nanograms per milliliter (ng/ml) at time of screening * prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (gnrh) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase * have an eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus) * any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (new york heart association \[nyha\] class ii to iv), e. transient ischemic attack, and f. cerebrovascular accident
functional respiratory imaging and orkambi in cf

Conditions: Cystic Fibrosis

Summary: open-label study to investigate the effects of orkambi in cf patients homozygous for the f508del mutation by functional respiratory imaging. primary endpoints in this study are the changes in specific airway volumes (sivaw) and specific airway resistance (siraw). a total of 20 orkambi-naive patients with cystic fibrosis, homozygous for the f508del mutation will be included in this open label study and will be followed through 3 months of treatment. the treatment will be started after all assessments are performed at visit 1. after the start of the treatment some baseline measurements will be repeated throughout the 3-month treatment period. the patient will be asked to visit the hospital monthly. all study visits should be scheduled around the same time.


Eligibility criteria:
inclusion criteria: * documented diagnosis of cf (homozygous for the f508del mutation must be present, this should be documented in the medical history). * age ≥ 12 years * fev1 \> 50% * signed informed consent. if patient is a minor, parents/guardians must give written informed consent * patient must be on a stable regimen of cf medication for 4 weeks prior to visit exclusion criteria: * fev1 \< 50% * anticipated requirement for hospitalization within the next three weeks * history of pneumothorax within the past 6 months prior to visit 1 * history of haemoptysis requiring embolization within the past 12 months prior to visit 1 * unable or unwilling to complete study visits or provide follow-up data as required per the study protocol * has taken intravenous (iv) antibiotics within the past 4 weeks prior to visit 1 * has ongoing exacerbation or allergic bronchopulmonary aspergillosis (abpa) * pregnant or lactating female * posttransplant patients * patients with severe hepatic impairment
a study comparing gsk2118436 to dacarbazine (dtic) in previously untreated subjects with braf mutation positive advanced (stage iii) or metastatic (stage iv) melanoma

Conditions: Cancer

Summary: brf113683 is a phase iii, randomized, open-label study comparing the efficacy, safety, and tolerability of gsk2118436 to dacarbazine (dtic), in subjects with braf mutant advanced (stage iii) or metastatic (stage iv) melanoma. subjects will be randomized to receive 150 mg of gsk2118436 twice daily or 1000 mg/m2 dtic every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. subjects who progress on dtic will be allowed to crossover to an optional extension arm of the study to receive gsk2118436.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * has advanced (unresectable stage iii) or metastatic (stage iv) melanoma that is braf mutation positive (v600e) * is treatment naive for advanced (unresectable) or metastatic melanoma, with the exception of interleukin 2 (il-2) which is allowed. * has measurable disease according to recist 1.1 criteria. * women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment. * women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication. * men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication. * must have adequate organ function. * must have eastern cooperative oncology group (ecog) performance status of 0-1. exclusion criteria: * currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery). * evidence of active central nervous system (cns) disease. * previous treatment for metastatic melanoma, including treatment with braf or mek inhibitor. * a history of other malignancy. subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * history of human immunodeficiency virus (hiv) infection. * certain cardiac abnormalities

Keywords: metastatic melanoma melanoma braf mutant advanced melanoma