Kornimate/medical-research-clean huggingface dataset:
a study of opc-262 in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical study is to evaluate the safety and efficacy of opc-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes patients with hba1c above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination 2. patients who are capable of giving informed consent 3. patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) exclusion criteria: 1. patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus 2. patients with a medical history of diabetic coma 3. patients with poorly-controlled hypertension 4. patients with heart failure 5. patients with a complication of active hepatitis or hepatic cirrhosis 6. patients undergoing treatment of glomerular diseases other than diabetic nephropathy 7. patients with a history or complication of malignant tumor
gel-one treatment in knee osteoarthritis

Conditions: Osteoarthritis Knee

Summary: the purpose of this study is to determine whether gel-one demonstrates a superior effectiveness in osteoarthritis (oa) knee pain compared with phosphate buffered saline (pbs) injections.


Eligibility criteria:
inclusion criteria: * have a knee pain * grade 1 to 3 on the kellgren-lawrence grading scale exclusion criteria: * bmi greater than 35 kg/m2 * received an intra-articular hyaluronic acid injection for the treatment of oa of the knee within 6 months prior to screening * had a joint replacement of the target knee

Keywords: knee osteoarthritis intra-articular injection
a study of vi-0521 on ambulatory blood pressure (abpm) in overweight or obese subjects

Conditions: Blood Pressure

Summary: the study is being conducted to evaluate the effect of vi-0521 (qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).


Eligibility criteria:
inclusion criteria: * overweight/obese adult males/females 18-75 years of age with a bmi ≥ 27 kg/m2; * at least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, type 2 diabetes mellitus \[t2dm\] or prediabetes, or obstructive sleep apnea). * must be ambulatory, willing, and able to wear abpm monitor apparatus for 24 hours at beginning and end of study. exclusion criteria: * screening blood pressure of \> 140/90 mmhg; * type 1 diabetes; t2dm treated with sfus, glp-1 receptor agonists, sglt inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization; * clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease; * history of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act; * history of glaucoma; * night shift workers; * obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and * smoking cessation within 3 months prior to screening; * use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or cpap therapy that has not been stable for at least 3 months prior to randomization; * covid-19 vaccination or treatment for severe covid-19 infection within a month prior to randomization.

Keywords: obesity overweight qsymia abpm
molecular genetics of schizophrenia

Conditions: Schizophrenia

Summary: this study will create a dna collection with blood samples from families with at least two siblings who have schizophrenia symptoms. this collection will help scientists identify genes that predispose people to schizophrenia.

each site will recruit individuals in a large geographic area, and use efficient ascertainment strategies and assessment procedures in order to maximize the number collected. subjects thought to have schizophrenia will be assessed by personal and family interviews and a review of medical records. diagnoses will be made by consensus best-estimate procedures. blood specimens will be obtained from all individuals with schizophrenia or schizoaffective disorder plus their available parents and also the control individuals. a clinical self-assessment will be administered to each control subject. the assessment will include validated self-assessments of lifetime major depression, anxiety disorders, and substance use, and self-reported history of bipolar or psychotic symptoms. permanent cell lines will be created and dna extracted at the nimh-sponsored center for genetic studies. at the end of the four-year project period, biological materials and blinded pedigree and clinical data will be made available to the scientific community for genetic studies of schizophrenia and related disorders. the control sample will, however, be released in a staggered fashion, twice during each fiscal year, to start during the 2nd year of recruitment. the informed consent for controls includes consent for specimens to be used in research on the genetics of any medical disorder. in years 3 and 4, we will undertake association analyses. power analyses suggest that this study will have excellent power to detect loci associated with genes with relatively small etiologic effects. data derived from this study will potentially have applications for the treatment and prevention of schizophrenia.

Eligibility criteria:
inclusion criteria: * individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder exclusion criteria: * unable to give informed consent to all aspects of the study * psychotic disorder judged to be secondary to substance use, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation

Keywords: schizophrenia genetics
a study of mrna vaccines ak154 monotherapy or in combination with ak104/ak112,and sequential mfolfirinox in surgically resected pdac

Conditions: Pancreas Cancer; Pancreas Cancer, Duct Cell Adenocarcinoma

Summary: to explore safety and efficacy of neoantigen personalized mrna vaccines ak154 monotherapy or in combination with ak104/ak112 and sequential mfolfirinox regime in resected pdac

this is a prospective, open-label, single-center, exploratory clinical study. to explore the safety, tolerability, efficacy, immunogenicity, and pk/pd profile of neoantigen personalized mrna vaccine ak154 monotherapy or combined with ak104 or ak112, sequential mfolfirinox chemotherapy regimen as postoperative adjuvant therapy in surgically resected pancreatic adenocarcino

Eligibility criteria:
inclusion criteria: * voluntarily signed the informed consent form and complied with protocols requirements * patients with radiographically resectable primary pancreatic tumors * histopathology or cytology confirmed resected pdac with macroscopic complete resection (r0 and r1) * pancreatic cancer surgical staging per ajcc 8th edition staging: t 1-3, n0-2, m0 * ecog 0 or 1 * life expectancy ≥ 6 months * surgical complications have recovered, * adequate organ function * patients with fertility are willing to use an adequate method of contraception. exclusion criteria: * the presence of other pathologic types * participating in another clinical study * have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc * plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment * severe infection occurs within 4 weeks prior to the first dose * requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration. * acute pancreatitis or subclinical pancreatitis * active autoimmune disease * allergic to immunotherapies and related drugs * history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * splenectomy history * active tuberculosis * known or highly suspected history of interstitial pneumonia. * clinically significant liver disease * uncontrolled or severe cardiovascular disease. * severe bleeding tendency or history of coagulopathy * active malignancy within the last 3 years * active syphilis infection * any other situations that are not suitable for inclusion in this study judged by investigator.

Keywords: adjuvant pancreas cancer mrna
comparative study of rituximab versus combination of rituximab and intravenous cyclophosphamide in severe pemphigus

Conditions: Pemphigus

Summary: the purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of pemphigus based on clinical, histopathological and immunological features the following: * refractory disease defined as continuing extension of old lesions, development of new lesion, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/day of prednisolone or its equivalent with or without the concurrent use of cyclophosphamide 2mg/kg/day for 12 weeks or azathioprine 2.5 mg/kg/day for 12 weeks. patients who fail to respond to 6 dcp/dp are also considered as refractory disease. exclusion criteria: * infections- hepatitis b, hepatitis c, hiv, active tuberculosis or sepsis. * abnormal liver function tests and renal function tests * known cardiac arrhythmia or conduction abnormality * systolic ejection fraction \<40% * pregnancy and breast feeding * severely decreased bone marrow functions. * known history of bladder cancer or hemorrhagic cystitis * known allergy to cyclophosphamide * patients of reproductive age group who haven't completed their family * known hypersensitivity to murine proteins. * patients who do not consent for the study.

Keywords: pemphigus rituximab rituximab and iv cyclophosphamide combination b cell re-population characteristics following rituximab
modulation of reproductive microbiota by ligilactobacillus salivarius cect5713

Conditions: Infertility Unexplained

Summary: the objective of the project is to elucidate if the oral administration of ligilactobacillus salivarius cect5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. on the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. this is a randomized, double-blind, parallel-group controlled nutritional intervention study. the intervention (ligilactobacillus salivarius cect5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first ivf cycle (estimated 1-2 months). in case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.


Eligibility criteria:
inclusion criteria: * legal age * intention to achieve a pregnancy, but without achieving it; * be willing to undergo in vitro fertilization treatment; * be on the waiting list for the ivf cycle with an expected waiting time \> 5 months. exclusion criteria: * sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...). * genitourinary malformations; * concurrence of other severe diseases (e.g.: cancer, aids, als, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...). * treatment/intervention other than the planned ivf after the start date of the intervention. * antibiotic treatment at the start date of the intervention. * intention to consume another probiotic supplement in the following 3 months. * participation in another clinical trial. * allergic/intolerant to the excipient. * inability to understand the informed consent form and/or to follow the basic instructions of the trial.

Keywords: infertility
effects of high and low tidal volumes on arterial oxygenation and pulmonary shunt during one-lung ventilation

Conditions: Postoperative Lung Injury

Summary: the ideal tidal volume (tv) during one-lung ventilation (olv) remains controversial. high tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. the investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and intrapulmonary shunt during olv. one hundred patients scheduled for thoracic surgery were enrolled. during olv, patients were randomly assigned to 30 minutes of ventilation with high tv (10 ml/kg with zero end-expiratory pressure (zeep)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm h2o positive end-expiratory pressure (peep)) at a rate of 20 breaths/minute. during the subsequent 30 minutes, each patient received the alternative management. minute volume was thus kept constant during each experimental condition. arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. results are presented as means ± sds; p \< 0.05 was considered statistically significant.


Eligibility criteria:
inclusion criteria: * asa i-iii patients scheduled for lung resection surgery. exclusion criteria: * severe cardiovascular disease * severe alteration of the preoperative pulmonary function, with fev1 70-120% predicted and fev1/fvc ≥ 70% predicted considered to be normal.

Keywords: olv one lung ventilation
zambia chlorhexidine application trial

Conditions: Sepsis

Summary: this will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in zambia when compared to the current standard of care, dry cord care.

the primary goals of the zambia chlorhexidine application trial (zamcat) are to assess whether daily 4% chlorhexidine cord cleansing is more effective than dry cord care for the prevention of neonatal deaths and omphalitis (umbilical cord infection) in southern province, zambia. secondary goals are to 1) compare where pregnant women plan to deliver and where they actually deliver, and 2) to describe the health services network available to pregnant and postpartum women in case of serious illness among the women and their newborn infants. clusters consisting of individual health centers and their respective catchment areas will be assigned to one of two arms. in the intervention clusters, mothers will apply 4% chlorhexidine to their infants daily until 3 days after the cord completely separates. mothers in the control clusters will use dry cord care as per normal routine standard of care and in accordance with zambia ministry of health policy. in order to achieve the 4th millennium development goal of reducing child mortality by two-thirds, simple, inexpensive, and scalable interventions are required. if the use of a 4% chlorhexidine umbilical cord wash effectively reduces neonatal mortality, this will be a low-cost intervention that can be easily translated from a research project into a program for countrywide implementation in zambia. these results will also add to the limited evidence base about the effectiveness of interventions for reduction of neonatal mortality in sub-saharan africa.

Eligibility criteria:
inclusion criteria: * pregnant women in the 2nd or 3rd trimester * age 15 years and above * pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum * willingness to provide cord care as per the protocol of their cluster * willingness to provide informed consent exclusion criteria: * pregnant women who are not willing to provide cord care as per the protocol of their cluster * pregnant women who are not willing to provide informed consent * pregnant women in the 1st trimester * pregnant women under age 15 years

Keywords: neonate omphalitis neonatal mortality maternal health umbilical cord infection
effectiveness of the z-track technique as a pain-reducing strategy for neonates during intramuscular injection: a randomized controlled trial

Conditions: Intramuscular Injection; Neonates; Neonatal Pain

Summary: a quantitative study, true experimental, posttest-only design has been used for the current study. one intervention (the z-track technique) and one control group involved in the study. the primary outcome measure is the neonatal/infant pain scale to be used immediately after intramuscular injections to measure the pain level among neonates.


Eligibility criteria:
inclusion criteria: * neonates delivered through cesarean section * apgar score of 8 or more * weight between 2500 - 3500 grams * neonates receiving im injections * males / females * term neonates between 37th and 42nd week of gestation exclusion criteria: * congenital anomalies * neonates who received intramuscular injection such as the hepatitis b vaccine * low birth weight * preterms * neural tube defects * neonates who are of normal vaginal delivery

Keywords: pain non-pharmacological pain managment
benefit of surgical hardware removal following clavicle fracture

Conditions: Clavicle Fracture

Summary: little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.

elective implant removal accounts for up to 30% of all orthopaedic surgeries. while there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures. patients and methods prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (vas) and active range of motion (rom) pre- and 6 weeks postoperative. functional scoring included the spadi, dash score, the constant score and the munich shoulder questionnaire (msq).

Eligibility criteria:
inclusion criteria: * age \>18 years * radiologically consolidated clavicle fracture * following orif using a superior anatomically preformed locking plate * asking for elective implant removal * written informed consent. exclusion criteria: * pregnancy * under-aged * delinquent patients.
comparison of tele-rehabilitation versus in-clinic rehabilitation for upper limb motor function stroke patients

Conditions: Stroke

Summary: to determine the effects of tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in chronic ischemic stroke patients.


Eligibility criteria:
inclusion criteria: * • patients from both genders. * patients with chronic ischemic stroke i.e. 6 months or more. * patients with 45 years old and above. * on modified ashworth scale, patient with limb spasticity equal to 2 or less than 2. * on mini mental state examination (mmse), patients with good cognitive function minimum 24 or more. exclusion criteria: * • patients with any recurrent stroke history. * cognitive deficit patients (on folstein mini mental state examination score of less than 24) * patient having other neurological diseases.
effectiveness of pharmacopuncture for chronic neck pain

Conditions: Chronic Neck Pain

Summary: in this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy.

this study is prgmatic rct of pharmacopuncture therapy for chronic neck pain compared to physical therapy.

Eligibility criteria:
inclusion criteria: * neck pain more than 6 months * vas of neck pain more than 5 * age between 17 and 70 years old * participants who wrote informed consent exclusion criteria: * migration of cancer reaching to spine, fracture of spine * progressive neurologic deficits or severe neurologic deficits * cancer, fibromyalgia, ra, or goat * stroke, mi, kidney disease, dimentia, diabetic neuropathy, or epilepsy * participants taking steroid, immunosuppressant, or psychotropic medication * hemorrhagic disease, severe diabetes or taking anticoagulant drug * participants who took nsaids or pharmacopuncture within 1 week * pregnant or lactating women * participants who had undergone cervical surgery within 3 months * participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial * participants who can not write informed consent * participants who is difficult to participate in the trial according to investigator's decision
factor ix as adjunctive therapy to emicizumab (emix)

Conditions: Hemophilia A

Summary: this trial will enroll patients with severe hemophilia a. experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. this is a pilot preclinical study.

the study aims to determine the hemostatic effect of different factor ix (fix) concentrates when added to the plasma of patients on emicizumab prophylaxis and compare it to the hemostatic effect obtained with the addition of bypassing agents (activated prothrombin complex apcc, and recombinant viia rviia, recombinant porcine fviii). the investigators will study the hemostatic effect using thrombin generation assay (cat) in the presence of different concentrations of fix concentrates. the investigators will compare the hemostatic effect of added fix to the effect of added bypassing agents (activated prothrombin complex apcc, and recombinant viia rviia, recombinant porcine fviii) plasma will be collected from patients with hemophilia a and inhibitors treated with emicizumab, a group of plasma samples will be spiked with different concentrations of factor ix. thrombin generation profiles will be obtained using cat. another group of plasma samples will be spiked with different concentrations of by passing agents (activated prothrombin complex apcc, and recombinant viia rviia, recombinant porcine fviii). thrombin generation profiles will be obtained using cat.

Eligibility criteria:
inclusion criteria: * signed informed consent/assent form * male patients, age 12 years and older at time of signing informed consent form * ability to comply with the study protocol, in the investigator's judgment * diagnosis of severe hemophilia a and are receiving emicizumab prophylaxis, on a weekly maintenance regimen exclusion criteria: * not able to sign consent * not willing to provide extra blood for the experiments. * patients carrying the diagnoses of other coagulopathies in addition to hemophilia a * patients that have received any hemostatic agent within 5 half-lives of the blood draw. this applies to any agent that might have been used for any reason prior to the blood draw and might affect the global hemostasis.

Keywords: hemophilia a with inhibitors in vitro emicizumab