Kornimate/medical-research-clean huggingface dataset:
the adult antiretroviral treatment and resistance study (tshepo)

Conditions: AIDS; HIV Infection

Summary: the "adult antiretroviral treatment and resistance study," hereafter referred to as "the tshepo study," is the first large-scale research study of antiretroviral therapy to treat aids and hiv infection in botswana. the tshepo study is an open-label, randomized study comparing: (1) the rate of development and specific types of drug resistance mutations with various antiretroviral combination therapies to hiv-1c, the subtype of hiv found in southern africa, and (2) the short and long-term effectiveness of two operational modifications of directly observed therapy (dot) medication adherence strategies for antiretroviral therapy. specifically, treatment follow-up via the standard of care, the national standard of care as it evolves in botswana, with intensive clinic-based follow up including regular adherence education sessions, will be compared to community-based directly observed therapy (com-dot). com-dot involves the soc with added community or family-based dot. this com-dot component would involve a trained, community or family-based medication partner ("mopati") who observes the patient take his or medications daily.


Eligibility criteria:
inclusion criteria:(1) hiv infection indicated by (a) positive elisa in two separate blood samples, the second no more than eight weeks prior to randomization), (b) cd4 cell count of less than 200 cells/ml or cd4 cell count between 201-350 with plasma hiv-1 rna level of greater than 55,000 copies/ml, (c) karnofsky (performance) score greater than or equal to 50; (2) no history of previous antiretroviral therapy, except for zidovudine and/or single-dose nevirapine administered during pregnancy to prevent mother-to-child hiv transmission of hiv-1; (3) baseline hemoglobin of greater than or equal to 8.0 g/dl (4) baseline absolute neutrophil count greater than or equal to 1000 cells/mm3 (5) baseline serum creatinine level less than 200 micromol/l (6) baseline sgpt(alt) less than 205 u/l and sgot (ast) less than 170 u/l (7) baseline alkaline phosphatase level less than or equal to 330 u/l etc.
effect of nutritional formula (protison) on various cancer patients: a randomized clinical trial

Conditions: Cancer

Summary: many studies (including aspen/espen) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 fa), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-pcnf (rich in ω-3 fa, fibers, mtc, bcaa, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

many studies (including aspen/espen) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 fa), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. hence, oncologic nutritionist strongly recommends cancer patients (with cachexia) to consume a diet rich in protein and dietary fibers along with balanced essential micronutrients like vitamins and minerals (van norren et al., 2009; yeh et al., 2013). from the above statement, it cleared that nutritional support is a crucial aspect of multi-modal cancer care, by improving the overall health status by suppressing various adverse events as well as enhance treatment regimen for a speedy recovery. hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-pcnf (rich in ω-3 fa, fibers, mtc, bcaa, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

Eligibility criteria:
inclusion criteria: * only hospitalized cancer patients with risk of malnutrition and underweight (confirmed with bmi, protein, and pre-albumin level) and must be under ng tube feeding. exclusion criteria: * avoiding cancer patients under critical conditions, with cardiac, renal, and hepatic disorders. also, heavy smokers, chronic or chain smokers, and pregnant/lactating women were not included.

Keywords: cancer cachexia nutritional status tube feeding pcnf
the impact of ramelteon on sleep and delirium in patients who undergo pulmonary thromboendarterectomy (pte) surgery

Conditions: Delirium; Sleep Deprivation

Summary: sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. in these patients, the levels of melatonin can also be altered. melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. the investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). in order to improve sleep quality, the investigators will conduct a study of ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.


Eligibility criteria:
inclusion criteria: * patients with chronic thromboembolic pulmonary hypertension (cteph) who are admitted to ucsd for a planned pte surgery. * age \> 18 years exclusion criteria: * pregnancy * cirrhosis of any etiology * current use of any atypical antipsychotic including fluvoxamine (contra-indicated with ramelteon) * any contraindication to eeg/sleep recording * non-english speaking (who are unable to complete delirium questionnaires)
blood flow restriction training for treatment of chronic patellar tendinopathy

Conditions: Patellar Tendinopathy; Jumper's Knee

Summary: the purpose of this study is to investigate the clinical and functional outcome of a 12-week rehabilitation regime consisting of low-load blood flow restriction compared to heavy-slow resistance training in male patients with chronic unilateral patellar tendinopathy.

chronic tendinopathy represents a considerable problem in both elite and recreational athletes, and symptoms may affect athletic performance and reduce or even result in retirement from sports participation. the current best treatment is considered to be heavy-slow resistance training (hsrt); however, not all patients are able to cope with heavy exercise loads. therefore, low-load strength training performed under partial blood flow restriction may be a clinically relevant rehabilitation tool. this project aims to investigate a new innovative intervention to treat chronic unilateral patellar tendinopathy in male individuals using strength training with low-load muscle contractions performed under partial blood flow restriction (ll-bfr), and to compare the resulting treatment outcome to that of the current best practice (hsrt). specifically, the effect of ll-bfr will be investigated using a randomized controlled trial design with two groups; 1) a low-load blood flow restriction training program, and 2) a heavy-load slow strength training program. a total sample size of 36 participants are needed when assuming a 10 % dropout. the training protocol consist of three weekly training sessions during a 12-week rehabilitation period. the primary outcome is measured using the single-leg decline squat at 12-week. if ll-bfr proves to be an effective treatment strategy for tendinopathy, it can easily be implemented in daily clinical practice.

Eligibility criteria:
inclusion criteria: * unilateral patellar tendinopathy * chronic (symptoms \>3 months) * pain of ≥ 4 during preferred sporting activity on the numerical pain rating scale (nrs; with 0 being no pain and 10 being the worst imaginable pain) * ultrasonographical tendon swelling * ultrasonographical hypo-echoic area with doppler exclusion criteria: * bilateral tendinopathy * cardiovascular diseases * diabetes * smoking * previous surgery or trauma to the knee joint with an effect on the presenting clinical condition * participants must not have been enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three months * previous corticosteroid injection for patellar tendinopathy

Keywords: patellar tendinopathy overuse injury rehabilitation
genetic screening and assisted oocyte activation in couples with diminished/aberrant embryonic development.

Conditions: Embryo; Embryo Disorder; Genetic Disease

Summary: this is an interventional comparative study at the department of reproductive medicine at ghent university hospital. patients with previous embryo developmental problems are eligible for the study. patients will undergo an icsi-aoa treatment and will also be screened for genes important in the oocyte activation and embryonic development process. also, the calcium releasing pattern of the patients' spermatozoa will be investigated.

assisted oocyte activation (icsi-aoa) will be the treatment for these patients to overcome their previous embryo developmental problems. this protocol artificially induces calcium rises in the oocyte, which mimics the natural oocyte activation process induced by the sperm factor plczeta. if 6 or more mature oocytes are collected at oocyte retrieval, 50%icsi and 50% icsi-aoa will be applied to all oocytes. the best embryo(s) will be transferred back. rest embryo(s) will be vitrified for future cycles. patients will be followed up. furthermore, an additional sperm sample will be produced to investigate the calcium inducing pattern of the patients' spermatozoa. thereby, mouse and/or human (research-donated control oocytes) will be pre-incubated with a ca2+ sensitive dye. next, human spermatozoa will be injected into these mouse/human oocytes and the calcium pattern will be recorded under an inverted epifluorescence microscope. both partners will give a saliva sample to screen for mutations possible genes involved in oocyte activation and embryo development.

Eligibility criteria:
inclusion criteria: * patients with one or more previous icsi cycles (uz gent) and * patients with: * complete developmental arrest (no transfer), or * complete developmental delay (no morula/blastocyst on day 5), or * significantly reduced blastocyst formation (≤15%) * willing and able to give informed consent exclusion criteria: * patients which went for oocyte or sperm donation * patients with severe male infertility or low fertilization (\<33%) after icsi * cycles requiring surgical sperm recovery procedures

Keywords: aoa embryo developmental problems genetic screening calcium pattern analysis
comparison of ivf and icsi in human ivf

Conditions: Infertility

Summary: in this prospective randomized clinical trial we plan to compare two fertilization method which are widely used during in vitro fertilization (ivf) treatment. outcome of conventional ivf and intracytoplasmic sperm injection (icsi) treatment will be compared in this study.


Eligibility criteria:
inclusion criteria: infertile patients entering in vitro fertilization treatment at least 1 oocytes collected semen sample is suitable for ivf and icsi fertilization as well number of oocytes collected is lower than 5 and/or female age is equal or more than 40 years exclusion criteria: samen sample is not suitable for conventional ivf fertilization previous conventional ivf treatment resulted in \<50% fertilization rate

Keywords: in vitro fertilization intracytoplasmic sperm injection fertilization assisted reproduction
the effect of dextrose prolotherapy on isokinetic power in the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis; Dextrose Prolotherapy Injection; Physical Therapy

Summary: osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some biochemical and morphological changes in the synovial membrane and joint capsule. it is the most common joint disease that causes serious morbidity and its prevalence increases with age. it is known that there is a decrease in the muscle strength around the knee in knee osteoarthritis, which creates difficulties in daily living activities. prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces. in this study, it is aimed to investigate the effect of dextrose prolotherapy application in and around the knee on pain, range of motion and knee flexor/extensor muscle strength.


Eligibility criteria:
inclusion criteria: * women aged 50-75 years * 2-3 knee osteoarthritis by kellgren lawrence stage * knee pain and functional limitation exclusion criteria: * past knee surgery * intra articular knee injections in the last six months * symptomatic heart and lung disease * joint contracture * history of malignant disease * bleeding disorder
non-invasive evaluation of cerebrovascular reactivity in spontaneous intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: spontaneous intracerebral hemorrhage (ich) remains a significant cause of morbidity and mortality around the globe. the most common etiology of nontraumatic spontaneous ich is hypertensive arteriopathy (ha), while cerebral amyloid angiopathy (caa) is the most prevalent cause of spontaneous lobar ich in the elderly. both ha and caa belong to the family of cerebral small vessel disease (csvd). csvd involves pathological processes that affect the arteries, arterioles, capillaries, and veins on the surface and beneath the brain. the resultant changes of csvd in the brain vasculatures can be detected with neuroimaging, includes cerebral microbleeds, white matter hyperintensities, lacunes, dilated perivascular spaces, and brain atrophy. investigators of this study have probe into various imaging markers in patients with csvd. investigators found that the lacune and cerebral microbleeds location was related to distinct underlying etiology of csvd. further, investigators utilized amyloid pet study to directly quantified the cerebral amyloid burden, and demonstrated the correlation between amyloid deposition and deep/superficial microbleeds ratio. the association between cerebellum microbleeds, which is a novel marker for csvd, and the underlying pathology in patient with spontaneous ich has been investigated. investigators also summarized and published the current research of different csvd imaging markers and its implication on patient care. cerebrovascular reactivity (cvr) represents the phenomenon that cerebral vessels dilate or constrict in response to stimuli, which provides insights into the vascular reserve information. the vascular reserve parameter is complementary to steady-state vascular index, such as cerebral perfusion or other neuroimaging markers. measurement of cvr using advanced mr techniques is an emerging technique with multiple potential clinical utilities, and impaired autoregulation may contribute to the pathogenesis of csvd. recently, diminished cvr under visual stimuli has been linked to vascular amyloid deposits and related vascular dysfunction. clarifying the mechanism of csvd-related brain injury would be an important step towards identifying candidate treatment approaches. the goal of this study is to understand the features of cvr in patients with csvd-related spontaneous ich, for the purpose of establishing new biomarkers in csvd diagnosis and understanding the underlying pathophysiology.


Eligibility criteria:
inclusion criteria: * age between 20-90 years-old * patient with spontaneous intracerebral hemorrhage or healthy control * consciousness clear * willing to receive brain mri exclusion criteria: * renal failure or creatinine \> 2mg/dl * coagulopathy or hepatic insufficiency * unstable vital sign under inotropic agents * allergy to dipyridamole * pregnancy * asthma history * metal implant or cardiac pacemaker

Keywords: intracerebral hemorrhage mri human
contingency management to reduce alcohol use in a soup kitchen sample

Conditions: Alcohol Abuse; Contingency Management

Summary: alcohol use and alcohol-related disorders are highly prevalent in soup kitchen users, and this population is overrepresented by minorities and disproportionately affected by alcohol-related morbidity and mortality. contingency management is a behavioral intervention effective in reducing substance use, but few studies have evaluated the efficacy of contingency management in the context of soup kitchens or homeless programs. the investigators found that contingency management, using a twice weekly testing and reinforcement schedule, had benefits for decreasing drinking in individuals receiving services at a homeless shelter. this study will replicate and extend these earlier findings to a soup kitchen population using more sophisticated alcohol monitoring procedures to better assess the extent of drinking in this group and in response to a contingency management intervention reinforcing submission of negative breath samples. specifically, 40 hazardous drinkers recruited from a soup kitchen will be randomly assigned to one of two conditions: alcohol monitoring or the same plus reinforcement for provision of daily negative breath alcohol samples. the interventions will be in effect for 3 weeks, and all participants will also wear transdermal continuous alcohol monitors during the intervention period. objective and subjective indices of alcohol consumption will be evaluated and compared between and within the treatment conditions. this pilot project will provide information regarding the effect size of contingency management reinforcing negative breath samples in an important health disparities group, and results from this study will guide subsequent grant applications focusing on methods to decrease drinking in this underserved population.


Eligibility criteria:
inclusion criteria: * age ≥18 * frequent soup kitchen users who drink alcohol * willing to wear transdermal alcohol monitor for 3 weeks * willing to sign a property transfer form and return scramx equipment exclusion criteria: * uncontrolled, severe psychopathology and/or severe cognitive impairment * non-english speaking * in recovery for pathological gambling * has a medical condition that would interfere with transdermal alcohol readings * legal charges pending that are likely to lead to incarceration
temozolomide in treating patients with recurrent malignant glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients who have recurrent malignant glioma.

objectives: i. determine the safety and efficacy of temozolomide in patients with recurrent malignant glioma. ii. determine the radiographic response to this regimen in these patients. iii. determine the time to tumor progression of these patients on this regimen. iv. determine the quality of life of these patients. outline: patients receive oral temozolomide once daily for 42 days. courses repeat every 70 days for up to 1 year in the absence of disease progression or unacceptable toxicity. quality of life is assessed every 1-2 months. patients are followed every 3-4 months. projected accrual: a total of 20-35 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent malignant glioma, including: glioblastoma gliosarcoma high grade glioma anaplastic astrocytoma anaplastic mixed oligoastrocytoma anaplastic oligodendroglioma must have evidence of tumor recurrence or progression on gadolinium enhanced mri or ct scan following radiotherapy with or without chemotherapy patient characteristics: age: 18 and over performance status: karnofsky 60-100% life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 10 g/dl hepatic: bilirubin less than 1.5 times upper limit of normal (uln) sgot and sgpt less than 3 times uln alkaline phosphatase less than 2 times uln renal: creatinine less than 1.5 times uln bun less than 1.5 times uln other: no nonmalignant systemic disease that would cause patient to be a poor medical risk no acute infection requiring intravenous antibiotics no psychological disorder that would interfere with study compliance hiv negative no aids-related illness not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) no prior or concurrent malignancy, except: surgically cured carcinoma in situ of the cervix basal or squamous cell skin cancer prior concurrent therapy: biologic therapy: at least 4 weeks since prior immunotherapy at least 4 weeks since prior biologic therapy chemotherapy: see disease characteristics at least 4 weeks since prior chemotherapy no prior temozolomide or dacarbazine endocrine therapy: not specified radiotherapy: see disease characteristics at least 4 weeks since prior external beam radiotherapy at least 8 weeks since prior stereotactic radiosurgery surgery: at least 2 weeks since prior brain biopsy, craniotomy, or other surgery

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma adult giant cell glioblastoma adult gliosarcoma