Kornimate/medical-research-clean huggingface dataset:
immunogenicity of zoster vaccine in allogeneic hematopoietic stem cell transplant recipients

Conditions: Shingles

Summary: this is a phase ii study that will examine the immunogenicity of the shingrix vaccine in patients following an allogeneic stem cell transplant.

cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. this results in an increased risk of zoster with its associated morbidity and mortality. patients typically receive prophylactic antivirals for 1 year after allosct which reduces the incidence of zoster during this period. unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. the recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoster in patients who have received an autologous transplant. furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. as a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * ≥ 12 months and ≤ 36 months post-allosct * donor sources: matched related, matched unrelated, cord blood * any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-hodgkin's lymphoma, hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders. * any conditioning regimen * any planned immunosuppressive prophylactic regimen * patients with chronic graft-versus-host disease on stable immunosuppression * ability to understand and the willingness to sign a written informed consent. * negative pregnancy test in female patients of childbearing potential exclusion criteria: * patients who had zoster after an allogeneic transplant and prior to enrollment * patients who are currently pregnant * history of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, shingrix, or other agents used in study. * patients who have had a relapse of their primary hematological disease * previous allogeneic stem cell transplantation * acute disease at the time of vaccination * thrombocytopenia that in the judgment of the investigator would make intramuscular injection unsafe.
tenofovir df + efavirenz (tdf+efv) versus tenofovir df + efavirenz + lamivudine (tdf+efv+3tc) maintenance regimen in virologically controlled patients: cool trial

Conditions: HIV Infections

Summary: primary objective: evaluation of the efficacy of tdf+3tc+efv versus tdf+efv qd to maintain plasma hiv-1 rna blq (\< 50 copies/ml) (c/ml) at 48 weeks (w48) main secondary objectives: comparison of the two arms for genotypic resistance profile in case of virological failure cd4 changes from baseline evolution of the lipid profile and morphological changes in fat distribution, and safety efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters


Eligibility criteria:
inclusion criteria: * stable haart ≥ 3 months * hiv-1 rna \< 50 c/ml ≥ 6 months * no haart failure history exclusion criteria: * weight \> 45 kg * no cd4+ cell count criteria * no significant laboratory or clinical abnormalities * creatinine clearance \> 60 ml/min

Keywords: hiv virological control lipid profile and morphological fat distribution treatment experienced
postural recruitment maneuver in patients with acute respiratory distress syndrome due to covid-19 infection

Conditions: Sars-CoV2; ARDS

Summary: the purpose of this study is to evaluate if a postural recruitment maneuver (prm) improves the aeration and distribution of lung ventilation in patients with acute respiratory distress syndrome (ards) caused by covid-19 infection; without the need to reach high airway pressures as in the standard lung recruitment maneuver and / or place the patient in prone position. this strategy could be particularly useful in the context of a major health emergency in centers with limited resources.

the prm is based on the known effect of gravity on transpulmonary pressure (pl). two principles explain its mechanism of action: 1) the first indicates that atelectasis and poorly ventilated areas of the lung can improve their aeration by putting the lung in the highest position. opposite lateral decubitus causes that upper lung to have a higher pl and allow a recruiting effect at moderate airway pressures. 2) the second principle is based on laplace's law and postulates that once the upper lung is recruited, it remains without lung collapse if a sufficient level of positive end-expiratory pressure (peep) is applied. based on these two precepts, prm consists of sequentially moving the patient from the supine to the left lateral decubitus to recover the aeration of the right lung. after that, the patient is placed in the right lateral position to recruit the left lung; keeping the right lung without collapse by continuous use of peep. finally, the patient returns to the supine position looking for an improvement in the distribution of ventilation and global pulmonary aeration, with a subsequent improvement in gas exchange and pulmonary mechanics.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * patients with moderate-to-severe ards as per the berlin definition * infection due to covid-19 * body mass index (bmi) ≤ 35 kg /m\^2. exclusion criteria: * contraindication for eit monitoring 1. unstable spine or pelvic fractures 2. pacemaker, automatic implantable cardioverter defibrillator 3. skin lesions between the 4th and 5th ribs where the eit belt is worn * pregnancy * major hemodynamic instability:: 1. mean arterial pressure lower than 60 mm hg despite adequate fluid resuscitation and use of vasopressors. 2. fc\> 120 or \<60 per minute 3. presence of uncontrolled arrhythmias. * more than 1 week of mechanical ventilation * failure of more than 2 extrapulmonary organs.
multicenter study of 9-aminocamptothecin (9-ac) in patients with refractory leukemia

Conditions: Leukemia, Myelocytic, Acute; Acute Lymphocytic Leukemia

Summary: the purpose of this study is to evaluate the side effects of 9-aminocamptothecin (9-ac) and to determine the best dose which should be used to treat leukemia.

* the treatment patients will receive involves a continuous infusion of 9-ac intravenously for a 72 hour period. since we are unsure of the safest and most effective dose, successive groups of 4-7 patients will receive larger doses of this drug until the largest dose given safely is established. * prior to the start of therapy a bone marrow aspirate and biopsy will be taken for diagnostic and research purposes. a bone marrow exam will be repeated at 48 hours in order to determine the effects of 9-ac on leukemic cells in the bone marrow. a bone marrow scan will also be performed 14 days after the start of therapy to assess response. * frequent blood testing will be done throughout treatment, including blood samples to determine the levels of the 9-ac in the blood. * treatment could be stopped prematurely if any of the following occur: 1) drug causes severe side effects, 2) the drug does not control the leukemia, or 3) the doctors or the patient feel that it is no longer in the patients best interest to receive this therapy. * approximately 7 days after the conclusion of the 9-ac infusion, it is likely that the patient's blood counts will be low and will require support with antibiotics, red cell transfusions and platelet transfusions.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * aml or all in first or subsequent relapse, secondary aml, or cml in blastic phase * central venous access * ecog performance status of less than or equal to 2 * bilirubin \< 1.3 * sgot \< 2 x uln * alkaline phosphatase \< 2 x uln * creatinine \< 1.5 exclusion criteria: * undergone bone marrow transplantation * uncontrolled infection * other active malignancy * hiv positivity * serious medical or psychiatric illness * pregnancy

Keywords: leukemia 9-aminocamptothecin aml all refractory leukemia relapsed leukemia
dose ranging study of dronedarone for the control of ventricular rate in japanese patients with permanent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: primary objective: - to assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent atrial fibrillation (af). secondary objective: * to assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population. * to document sr33589 and sr35021 trough plasma levels at steady state.

the study period per patient is approximatively 1 month broken down as follows: * screening period up to 7 days, * treatment period of 14 days, * follow-up period of 10 days.

Eligibility criteria:
inclusion criteria: * patients of aged 20 years or more. * permanent atrial fibrillation \[af\] (defined as duration of af \> 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening. exclusion criteria: * unstable angina pectoris. * history of torsades de pointes. * prolonged qt corrected interval (≥ 500 ms). * third degree atrioventricular block (avb) on the screening ecg while in af or, documentation on previous ecgs while in sinus rhythm of pr-interval \> 0.28 sec or high degree avb (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted. * congestive heart failure (chf) of new york heart association classification (nyha) class iv or recent (within 1 month prior to randomization) unstable nyha class iii. * treatment with other class i or iii anti-arrhythmic drugs. * patients treated with amiodarone during the 4 weeks preceding randomization. * clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease. * hypokalemia and hypomagnesemia must be corrected before randomization. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
community-based management of chronic obstructive pulmonary disease in nepal

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (ncds) in nepal. the presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of copd makes it a serious public health concern. however, no attempt has been made in nepal to estimate its burden and address the disease at the community level. this community-based cluster randomized controlled study aims to fulfil that gap through mobilization of female community health workers (fchvs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. baseline and follow-up surveys will be conducted to compare the intervention and control groups. this study has the potential to generate evidence in helping address ncds in nepal and also other similar resource-limited countries.


Eligibility criteria:
inclusion criteria: * capable of performing spirometry * aged greater than and equal to 40 years * full time residents in the study area and will be in the study area for at least one year exclusion criteria: * younger than 40 years of age * self-reported pregnancy * having active pulmonary tuberculosis or being on medications for pulmonary tuberculosis * thoracic, abdominal or eye surgery in the last six months * history of mental illness * mi in past 8 weeks prior to study * hospital admission in the past six months for cardiac illness * those who decline to provide consent to the study will be excluded.
a survey about trade-offs when choosing menopause treatments

Conditions: Moderate to Severe Vasomotor Symptoms

Summary: this study is an online survey of women in menopause with moderate to severe hot flashes. menopause, a normal part of life, is the time after a woman's last period. hot flashes often occur during menopause. they can disrupt a woman's daily life. this study is about collecting information only. there will be no treatment in this study. this study will provide information on the trade-offs women are willing to make when deciding which treatment or treatments work best for them. women from australia, canada, denmark, france, germany, italy, spain, sweden and the united kingdom (uk) will take part in this study. women will be recruited through a third-party recruitment company. most women will be asked to complete an online survey. before the survey is sent to the women in the study, it will be tested by a small group of women. this group will be asked to take part in a telephone interview while taking the survey. they will be asked to say their thoughts aloud while completing the survey. researchers will record this and also take notes. the aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women. the survey will have 3 sections: firstly, the women will answer questions about their experience with menopause and their symptoms. next, they will be shown pros and cons for specific treatments for their menopause symptoms. the women will be asked to choose which treatment they would prefer, based on this information. finally, they will answer questions on how their menopause symptoms have impacted their lives.


Eligibility criteria:
inclusion criteria: * resident of australia, canada, denmark, france, germany, italy, spain, sweden, or the united kingdom * experience at least 14 moderate or severe vms episodes associated with menopause per week (or 2 to 3 episodes per day) * self-reported completion of natural menopause (post-menopausal) * willing and able to provide consent to take part in the study; speak native language of country of participation * telephone interview only: willing and able to participate in a telephone interview, and be audio recorded exclusion criteria: * experienced treatment related menopause either as a result of medical or surgical intervention * difficulty understanding or communicating in the language(s) of australia, canada, denmark, france, italy, spain, sweden, or the united kingdom * online survey only: participation in the telephone interview

Keywords: menopause vasomotor symptoms
mcg post myocardial infarction study

Conditions: Myocardial Infarction

Summary: the study is being performed to evaluate a new portable medical device, the creavo vitalscan magnetocardiograph (vitalscan) on patients who have had a confirmed myocardial infarction (heart attack) within the previous 12 weeks.

magnetocardiography (mcg) is a non-contact, passive, imaging technique that detects the magnetic fields generated by the electrical activity of the heart. the mcg technology has been evaluated in several clinical studies, demonstrating its potential usefulness in the detection of patients with stable angina and acute coronary syndrome (acs), including non-st segment elevation myocardial infarction (nstemi). previous studies have been completed using earlier versions of the vitalscan device. results showed that the device could differentiate between patients with confirmed ischaemic heart disease (ihd) and nstemi, those with non-ihd experiencing chest pain and healthy (non-ischaemic) control subjects. the aim of this pilot study is to assess the difference between abnormal mcg images from patients with a confirmed and recent myocardial infarction (mi)and normal images from previously obtained healthy volunteer controls scanned with the current device, so that comparisons can be made to the data acquired from the previous studies.

Eligibility criteria:
inclusion criteria: * patients with confirmed myocardial infarction within 12 weeks of the initial event * patients admitted to the coronary care unit (ccu) at warwick hospital on the point of discharge or patients already discharged from the ccu attending the cardiac rehabilitation classes * 18+ year old male or female * patient is willing and able to give written informed consent exclusion criteria: * atrial fibrillation * thoracic metal implants (cardiac stents allowed) * pacemaker or internal defibrillator * pregnancy (if after 20-week period)\* or lactation * patient unable to lie down (i.e. supine position up to a maximum 25 degree tilt) or stay still on the examination bed * patient unable to understand the informed consent process and/or has a poor understanding of english (e.g. english-speaking relative/translator not available) * there should not be any effect on pregnancy due to the non-invasive nature of the device. pregnancy after the 20-week period excluded from the study due to the size and position of the foetus and unknown possibility of picking up the foetal heartbeat, rendering the scan non-usable for study requirements
seline: second-line iressa phase iv study in nsclc patients

Conditions: Non Small Cell Lung Carcinoma

Summary: the purpose of this study is to evaluate orr (objective response rate) of gefitinib as a second-line therapy for nsclc patients based on recist (response evaluation criteria in solid tumors group) and check up orr difference by egfr mutation, gender, smoking history, and type of tumor.


Eligibility criteria:
inclusion criteria: * pathological diagnosis of local advanced/metastatic non small cell lung carcinoma * previously failed the first-line chemotherapy * patient who can provide sample for egfr mutation test exclusion criteria: * central nervous system metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation * any evidence of clinically active interstitial lung disease

Keywords: carcinoma non small cell lung egfr mutation gefitinib
testing the synergism of phytonutrients, curcumin and ursolic acid, to target molecular pathways in the prostate

Conditions: Prostate Cancer

Summary: a proof of concept clinical trial to assess the synergism of curcumin (curc) and ursolic acid (ua). before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect

once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (soc) appointment or via telephone. patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. following informed consent, subjects will be assigned to one of the following cohorts: cohort 1: • ursolic acid (150 mg) bid (twice a day) cohort 2: • curcumin (600 mg) bid cohort 3: • ursolic acid (150 mg) and curcumin (600 mg) bid the study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. subjects will be enrolled on a rolling basis with the first ten subjects assigned to cohort 1, the next ten subjects assigned to cohort 2, and the last 10 subjects assigned to cohort 3.

Eligibility criteria:
inclusion criteria: * have proven diagnosis of prostate cancer with gleason group 3 or lower and planning to undergo radical prostatectomy * be able to give informed consent * be age 18 or older * able to stop supplements exclusion criteria: * unable to give informed consent * age \< 18 * high-risk prostate cancer or suspected metastasis * unable to swallow pills * unable to stop supplements

Keywords: radical prostatectomy
comparison of the efficacy of boric acid mouthwashes in different concentrations

Conditions: Impacted Third Molar Tooth

Summary: surgical removal of impacted third molars is one of the most frequent procedures carried out in the oral and maxillofacial surgery clinics. there are a varying range of postoperative complications including pain, edema and swelling. antibiotics, analgesics and mouthwashes are usually prescribed for the treatment of these complications. patients undergoing impacted third molar surgery are frequently prescribed chlorhexidine mouthwashes with/without benzydamine hydrochloride. however, there has been a search for alternatives with anti-inflammatory, antibacterial and analgesic properties as part of the oral care routine following surgical removal of impacted third molars. thus, this multicenter study was aimed to evaluate the effects of chlorhexidine mouthwashes with different boric acid concentrations (%0.1, %0.5, %1, %1.5, %2 and %2.5), and boric acid mouthwash on the postoperative complications and compared with chlorhexidine mouthwash after the removal of impacted wisdom teeth.


Eligibility criteria:
inclusion criteria: * absence of any systemic disease * having impacted mandibular third molar teeth in a similar position * absence of allergy to any of the drugs used in the study, * absence of pregnancy/lactating state, * no history of any medication use during at least 2 week before the operation. exclusion criteria: * not regularly coming to the controls, * not using their medicines regularly * using any additional medication that may affect the outcome of the study

Keywords: postoperative complications impacted tooth mouthwash boric acid chlorhexidine
safety, tolerability and efficacy of havai, for correction of inter-metatarsal angle

Conditions: Hallux Valgus

Summary: a non-inferiority study to demonstrate efficacy of the havai minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (ssoc)


Eligibility criteria:
inclusion criteria: 1. adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit. 2. subject weighing \<100 kg and body mass index (bmi) \<32 kg/m2. 3. subjects with confirmed diagnosis of hv deformity based on radiography assessment of ima 12°-15°. 4. able and willing to comply with the requirements of the protocol. 5. able to understand and sign written informed consent to participate in the study. exclusion criteria: 1. patients who need or may need to have 2nd mt osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd mtpj) 2. history of: a. severe diabetes mellitus (defined as existence of: i. more than 10 years duration ii. hba1c 8.0 \ 1.3\], retinopathy, ihd)) b. claudication, known peripheral vascular disease or no palpable pulses (dp or tp). c. known rheumatoid or inflammatory disease. d. x-ray evidence of moderate osteoarthritis of mtpj-1 or tmtj-1. e. neurological conditions associated with spasticity or lower limb paralysis. f. prior operation on mt1 or mt2. g. fracture (past or present) of mt1 or mt2. 3. aseptic necrosis or any deformity of mt2 head. 4. aseptic necrosis of the mt1 head 5. pregnant women or women with childbearing potential who are not obliged to take any contraception measures 6. subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) 7. asa grade above 2