Kornimate/medical-research-clean huggingface dataset:
effectiveness of modafinil for treating fatigue in adults with hiv/aids

Conditions: HIV Infections; Fatigue

Summary: this study will determine whether modafinil (provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with hiv/aids.

fatigue is a common problem for many people with hiv/aids, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (arv) medication. fatigue in hiv is associated with disability and diminished quality of life. it may be caused by arvs or by the virus itself. this study will determine if modafinil can reduce fatigue in hiv/aids patients. this study will last 12 weeks. participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. participants who do not respond to modafinil will have the opportunity to receive other drug treatments. all participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. at each visit, participants will complete various tasks to determine cognitive function and self-report scales will be used to determine symptoms of depression and fatigue.

Eligibility criteria:
inclusion criteria: 1. ages 18-75 2. hiv+ 3. clinically significant fatigue (score of 4.5+ on fatigue severity scale, plus impairment on 1+ categories of role function scale) 4. fatigue duration for 3+ months 5. english-speaking 6. able to give informed consent 7. fecund women uses barrier method of contraception exclusion criteria: 1. primary care doctor does not approve of study participation 2. unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic infection \[o.i.\] in past month) 3. untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range) 4. untreated hypothyroidism (thyroid stimulating hormone \[tsh\] over 5 iui/ml) 5. untreated and uncontrolled hypertension 6. clinically significant anemia (hematocrit \<30%) 7. started testosterone or nandrolone in past 6 weeks 8. started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months 9. untreated or under-treated major depressive disorder 10. started antidepressant medication within past 6 weeks 11. substance abuse/dependence (past 4 months) 12. regular and frequent cannabis use (\> twice/week regularly) 13. currently clinically significant suicidal ideation or hamilton depression rating scale (ham-d) \>24 14. history or current psychosis or bipolar disorder 15. pregnant or breastfeeding 16. significant untreated insomnia (score \>3 on ham-d insomnia items) 17. currently taking psychostimulant medication or past nonresponse to modafinil 18. has no alternative viable antiretroviral regimen after the current one 19. left ventricular hypertrophy; mitral valve prolapse

Keywords: hiv aids modafinil depression
cd19/cd22 bispecific car-t cell therapy for relapsed/refractory b-cell lymphoma or acute lymphoblastic leukemia

Conditions: B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma; Diffuse Large B Cell Lymphoma

Summary: car-t cell therapy targeting cd19 has been shown to be effective in heavily-pretreated b-cell all or nhl, but relapses post-car-t are common, and cd19 antigen loss is one of the reasons. thus, we supposed that cd19/cd22 bispecific car-t cell therapy would be more effective and less relapses would occur in b-all or nhl. in this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of cd19/cd22 bispecific car-t cell therapy in relapsed/refractory b-all or large b cell lymphoma.


Eligibility criteria:
inclusion criteria: * 14 years to 85 years, expected survival \> 3 months; * cd19/cd22 positive b-cell lymphoma or b-all; * relapsed or refractory to standard first-line treatment; * ecog-ps score=0-2; * having at least one measurable lesions; * cardiac function: 1-2 levels; * liver: tbil≤3uln，ast ≤2.5uln，alt ≤2.5uln; * kidney: cr≤1.25uln; * bone marrow: wbc ≥ 3.0×10e9/l, hb ≥80 g/l, plt ≥ 50×10e9/l; * no serious allergic constitution; * no other serious diseases that conflicts with the clinical program; * no other cancer history; * no serious mental disorder; * informed consent is signed by a subject or his lineal relation. exclusion criteria: * pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); * uncontrolled active infection, hiv infection, syphilis serology reaction positive; * active hepatitis b or hepatitis c infection; * recent or current use of glucocorticoid or other immunosuppressor; * with severe cardiac, liver, renal insufficiency, diabetes and other diseases; * participate in other clinical research in the past three months; * previously treatment with any gene therapy products; * researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
patient-centered precision medicine lab result communication for older adults

Conditions: Kidney Disease, Chronic

Summary: for adults \>65 years and their providers, the investigators will test the usability and design of a tool to replace standard uniform reporting of lab results to patients and their providers with a new personalized ehr lab result communication tool that: 1) extracts patient-level data from the ehr; 2) calculates individual risk; and 3) for patients with very low risk, communicates the individualized risk information. the investigators will employ a range of user experience research methods to understand how patient and provider users interact with the new lab result communication tool and to assess their comprehension of the lab results.


Eligibility criteria:
inclusion criteria: patient inclusion criteria: older adults (aged \>65 years) with a ucla primary care provider who are: * enrolled in the patient portal; * english-speaking (as the language of the tool is currently only in english, and it would be impractical to have validated translations created for all of the potential variations and derivatives of the tool mock-ups); and * without dementia or other neurocognitive disease. provider inclusion criteria: -ucla health providers who care for large numbers of older adults in outpatient settings. exclusion criteria: patient exclusion criteria: * have lab results outside of the defined inclusion ranges; * do not have a ucla pcp; * are under the age of 65; * are not english speaking (as the tool prototypes are only in english until final verbiage is determined); * are not enrolled in the ucla mychart patient portal; or * are diagnosed with dementia provider exclusion criteria: -do not care for large numbers of older adults in outpatient settings

Keywords: lab result lab result communication tool
a multiple ascending dose study of gs 5885 in previously untreated subjects with genotype 1 chronic hepatitis c

Conditions: HCV Infection

Summary: the primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of gs-5885 in subjects with chronic genotype 1 hepatitis c virus (hcv) infection. each participant in the study will be sequestered in the clinic for the initial 5 days of the study.


Eligibility criteria:
inclusion criteria: * chronically infected with hcv genotype 1 * hcv treatment-naïve * not co-infected with hiv or hbv * hcv rna viral load of at least 100,000 iu/ml * bmi 19 to 35 kg/m2 * subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male. exclusion criteria: * history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma * serological evidence of co-infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or another hcv genotype * subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse

Keywords: hepatitis c hcv rna multiple ascending dose ns5a gs-5885 chronic genotype 1 hcv infection
preferences about personal protective equipment

Conditions: Dental Anxiety; Behavior, Child; Preference, Patient

Summary: personal protective equipment (ppe) gained importance during the coronavirus disease 2019 (covid-19) pandemic, which is a global hot topic for all healthcare staff.

to assess children and parents preferences about dentists' appearance concerning their ppe and to determine the relationship between the preferences of the children and their parents. a total of 250 children aged with 6-12 years and their parents were enrolled in the study. standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. dental anxiety of children and their parents were determined with mcdasf and mdas, respectively. decayed-missing-filled teeth (dmft) index was employed to the children.

Eligibility criteria:
inclusion criteria: * aged 6-12 years and their parents, * intellectually sufficient to complete the questionnaire, * with voluntariness to take part in the study exclusion criteria: * had mental or physical disorders, cooperation problems or dental pain

Keywords: personal protective equipment dental anxiety parents preferences health care professionals
exploring the risk factors for colorectal cancer in our general population using asian pacific screening score: a survey from pakistan

Conditions: Colorectal Cancer; Colorectal Neoplasms

Summary: in pakistan, due to the lack of a national based cancer registry exact number of crc cases is unknown. however, minimal data that is present in literature shows an increase in crc cases with a concerning increase in incidence in younger age groups11. this makes it pertinent to understand current pattern of crc and its risk factors from a local perspective. this will direct future strategies in an attempt to reduce the incidence and mortality associated with crc in our general population.


Eligibility criteria:
inclusion criteria: * individuals visiting siut as attendants to the patients visiting outpatient department or admitted in hospital. exclusion criteria: * attendants / whose patients visit gi, colon and oncology opd outpatient department or admitted in gi wards.

Keywords: colorectal carcinoma pakistan
effects of scapular therapeutic exercise on essential biomechanical and neurophysiological parameters in shoulder pain conditions with scapular impairments

Conditions: Shoulder Pain

Summary: shoulder pain is a prevalent and recurrent condition. after a period of shoulder pain, some adaptations could be found, as in scapular muscles and kinematics and/or in nervous system. it seems important to assess several biomechanical and neurophysiological outcomes to better characterize shoulder pain conditions and to program an intervention plane. therapeutic exercise is one of the treatments used for shoulder pain, however there are still doubts and controversial findings regarding exercise focusing the scapular musculature. thus, the present study aims to assess the effects of an intervention protocol based on scapular therapeutic exercise.

the study only started after approval of the protocol

Eligibility criteria:
inclusion criteria: * 18 to 65 years old * chronic (more than 3 months), continuously or intermittently, non-specific or associated with a diagnostic (except if mentioned in the exclusion criteria) shoulder pain of, at least, moderate intensity * presenting scapular alterations as scapular dyskinesis (identified at rest or during motion) exclusion criteria: * history of shoulder fracture, dislocation, tears, infection or neoplasm * shoulder surgery * cervical and/or thoracic pathologies or pain associated with active movements of these regions * neurological disease * body mass index out of the range 18,5-30 kg/m2 and muscular skinfold higher than 20mm * inability to perform the exercises * current practice of competitive/high-level exercise/sport focusing the upper limb

Keywords: shoulder pain scapular muscles scapular kinematics therapeutic exercise
the prevalence of local immunoglobulin e (ige) elevation and its effect on intranasal capsaicin therapy in the non-allergic rhinitis population

Conditions: Non-allergic Rhinitis

Summary: the purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local ige elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local ige elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal ige levels after capsaicin treatment.


Eligibility criteria:
inclusion criteria: * chronic rhinitis exclusion criteria: * active smoker * anatomic source of nasal symptoms * chronic rhinosinusitis or other nasal infection * history of sinonasal malignancy * pregnancy or lactation * use of medication affecting nasal function (topical steroids, topical anticholinergics, oral antihistamines) in the previous 4 weeks * use or abuse of nasal decongestants. * positive skin prick test for allergic rhinitis

Keywords: rhinorrhea congestion sneezing itching
efficacy and safety of bevacizumab versus pulvis talci in malignant pleural effusion

Conditions: Malignant Pleural Effusion

Summary: patients with malignant pleural effusion can be diagnosis advanced cancer. currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. the most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. the investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. the purpose of this study was to determine the efficacy and safety of intrapleural bevacizumab versus pulvis talci as treatment for malignant pleural effusions (mpe) in patients.

background： patients with malignant pleural effusion can be diagnosis advanced cancer. currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. the most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. the investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. the purpose of this study was to determine the efficacy and safety of intrapleural bevacizumab versus pulvis talci as treatment for malignant pleural effusions (mpe) in patients. methods: a unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. consecutive 183 patients were randomly assigned to two groups, a group is bevacizumab200mg by intrapleural administration; b group is injected pulvis talci with closed thoracic drainage.

Eligibility criteria:
inclusion criteria: 1. diagnose malignant pleural effusions by: * diagnose malignant pleural neoplasms by histopathology * recurrent pleural effusion, histologically or cytologically confirmed diagnosis of cancer 2. written informed consent exclusion criteria: 1. \<18years of age 2. expected survival \<3 months 3. chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once 4. planned chemotherapy 5. pregnancy or breast-feeding (women of child-bearing potential) 6. not signed informed consent or non-compliance with treatment protocols
first in man study with slv342

Conditions: Pharmacokinetics

Summary: first in man study with single and multiple rising doses with slv342


Eligibility criteria:
inclusion criteria * healthy exclusion criteria * not healthy

Keywords: first in man slv342 atherosclerosis
protectivity and safety following recombinant hepatitis b vaccine

Conditions: Immunogenicity

Summary: protectivity and safety following recombinant hepatitis b vaccine with different source of hepatitis b bulk compared to hepatitis b (bio farma) vaccine in indonesian population

protectivity and safety following recombinant hepatitis b vaccine with different source of hepatitis b bulk compared to hepatitis b (bio farma) vaccine in indonesian population. experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.

Eligibility criteria:
inclusion criteria: 1. healthy individu as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator. 2. subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form. 3. subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. subjects with known history of hepatitis b contained vaccination in the last 10 years 3. evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oc) within the 48 hours preceding enrollment. 4. known history of allergy to any component of the vaccines (based on anamnesis) 5. hbsag positive 6. known history of immunodeficiency disorder (hiv infection, leukemia, lymphoma, or malignancy). 7. history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 8. subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant. 9. pregnancy \& lactation (adult) 10. subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
a family depression prevention program

Conditions: Depression

Summary: the primary aim is to prevent depression in youth and parents in a single, integrated family intervention. hypothesis 1a: children in the family depression prevention (fdp) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the written information (wi) condition. hypothesis 1b: in parents, the amount of time in a depressive episode will be significantly lower for those in the fdp program as compared to those in the wi condition.

depression is a major public health problem affecting over 15 million u.s. adults annually and is especially prevalent in those of parenting age. offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. the current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. the rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (cbt) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. this 5- year, two-site randomized controlled trial will test a family depression prevention (fdp) program for children (ages 9-15) and their parents with depressive disorders (past or current). this "dual prevention" approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. participating families (n=300) will be randomized to either fdp (10 weekly + 3 monthly sessions) or a written information comparison (wi) condition. all parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.

Eligibility criteria:
inclusion criteria: * parent with a current or history of a depressive disorder within child's life * children ages 9- to 15-years-old exclusion criteria: * bipolar i (parent or child) * schizophrenia (parent or child) * current alcohol or drug abuse (parent or child) * conduct disorder; developmental disability (child) * current diagnosis of a depressive disorder (child)

Keywords: depression mood disorder