Kornimate/medical-research-clean huggingface dataset:
viracept expanded access program

Conditions: HIV Infections

Summary: to make nelfinavir mesylate (viracept) available for treatment of hiv positive patients who are unable to take the three commercially available protease inhibitors (because of failure, intolerance, or contraindication) and who have a cd4 cell count of \<= 50. to obtain additional information on the safety profile of nelfinavir mesylate (viracept). (per amendment 1/8/97: people now qualify for the viracept program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)


Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 t cell count \<= 100 cells/mm3. * failed, been intolerant of or had a contraindication to all three commercially available protease inhibitors (saquinavir, indinavir and ritonavir). (per amendment 1/8/97: * people now qualify for the viracept program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.) exclusion criteria prior medication: excluded: prior therapy with viracept. required: * indinavir. * saquinavir. * ritonavir.

Keywords: acquired immunodeficiency syndrome hiv protease inhibitors cd4 lymphocyte count nelfinavir anti-hiv agents
a study to evaluate the safety, tolerability, and pharmacokinetics of hh-006 in healthy volunteers

Conditions: Hepatitis B

Summary: huahui health is developing a treatment for hepatitis b virus. this study is designed to evaluate the safety and tolerability of hh-006, a hepatitis virus neutralizing monoclonal antibody in healthy volunteers, and to determine its pharmacokinetic profile and immunogenicity.

this is a double-blind, placebo-controlled, phase ia study aimed to evaluate the safety and tolerability of hh-006 after single ascending doses given as subcutaneous injections.

Eligibility criteria:
inclusion criteria: * generally healthy male or female individuals aged between 18 to 65 years old * a bodyweight ≥ 45 kg and the body mass index (bmi) is between 18 to 32 kg/m2. exclusion criteria: * history of anaphylaxis or other significant allergy in the opinion of the investigator or known allergy or hypersensitivity to any of the components of the ip * history of drug, alcohol, or substance abuse * any history of liver disease or known hepatic, or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones) * any history of anaphylaxis, severe allergic reaction, neutralizing antibody generations, or hypersensitivity to albumin or any protein-based therapeutics such as natalizumab (tysabri) or any other monoclonal antibodies * any previous exposure to chimeric, humanized, or human monoclonal antibody, whether licensed or not * medical history of active infection (acute or chronic) * any safety concern or personal condition that is inappropriate for the study participation per the investigator's judgement.
histopathology of the aspirated thrombus during acute myocardial infarction

Conditions: Thrombosis; Acute Coronary Syndrome

Summary: this study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). consequently, the thrombus composition of a de novo clot could differ from the other one, extracted during the occurrence of a subacute thrombosis, regarding the number of various cells, the amount of fibrin and platelet aggregates and the relationship among these components. in addition, it seems relevant to evaluate the numbers and the distribution of the local monocytes, once these cells may interact with platelets (via cell -adhesion mechanisms e.g., by cd31 \[pecam-1\]) and by the extrinsic coagulation pathway (via tf/fvii elaborated by plaque-resident macrophages). such a distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary arteries, and may have clinical implications.


Eligibility criteria:
inclusion criteria: * patients with acute coronary syndrome who undergo angiography * evidence of coronary thrombus * undergo aspiration procedure yielding thrombus fragments exclusion criteria: -
the secret trail of moon (serious videogame) and chess on adhd: a clinal trial

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: blackground: currently research on alternative forms of cognitive training in patients diagnosed with adhd is gaining interest. especially, the use of virtual reality video games. our team has developed an innovative video game based on virtual reality, "the secret trail of moon (tstm) as a cognitive tool to train 5 main areas of deficit in patients with adhd. it is superiority study comparing tstm with therapeutic chess and control group. methods: this study is prospective, unicentric, randomized with a control group. 105 patients diagnosed with adhd and pharmacologically stable, aged between 12 and 22 years. these patients will be randomized intro three groups: tstm group (the secret trail of moon); tc group (therapeutic chess) and cg (control group). objective and subjective measures of the patient, parents and teachers will be included. patients´visit will be different for each group. the tstm group will have 15 face-to face visits: pre-inclusion visit, inclusion visit, 12 training visits and final visit. ct and gc group patients will have 3 face-to- face visits (pre-inclusion, initial visit and final visit) and 12 email or phone communications during training. discussion: this study aims to demonstrate the added efficacy of cognitive training to drug treatment. it is a study that tries to demonstrate the superiority of cognitive training with tstm compared to a traditional cognitive training (tc) and a control group. tstm is presented as a new and powerful cognitive tool thanks to four factors that make it unique: the feeling of immersion in the scenarios, the variety of mechanics, the personalization and the playful aspect.


Eligibility criteria:
inclusion criteria: * adolescents and young adults (male and female) between the ages of 12 and 22. * diagnosis of attention deficit hyperactivity disorder. * patients with stable pharmacological treatment for adhd. * signature of the informed consent by the patient and their parents. exclusion criteria: * a diagnosis of adhd comorbid with autism spectrum disorder or mental retardation. * suffering from epilepsy. * mobility plans in the next 3 months. * plans to begin other psychological treatment, including cognitive-behavioral psychotherapy in the next 3 months. * possibility of suicide risk as assessed by the clinician.

Keywords: attention deficit hyperactivity disorder serious videogames cognitive training chess
acute and chronic pain, especially neuropathic pain, after thoracotomy and continuous application of ketamine.

Conditions: Acute Pain; Chronic Pain; Neuropathic Pain

Summary: chronic pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. the continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. the investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. parallel group design, comparing one group with a continuous application (24 hours) of ketamine against a placebo group.


Eligibility criteria:
inclusion criteria: * posterolateral thoracotomy for lung parenchyma resection * informed consent * asa (american society of anesthesiologists) status i-iii exclusion criteria: * history of chronic pain * history of neuropathic pain * pregnancy or breastfeeding * participation in another trial * hypersensitivity for ketamine * medication with can influence neuropathic pain (gabapentin, clonazepam) * history of neurological or behavioral illness * history of alcohol abuse * history of chemotherapy or radiation * opioid medication

Keywords: neuropathic pain chronic pain posterolateral thoracotomy
mechanistic studies of phase iii trial with baf312 in secondary progressive multiple sclerosis

Conditions: Secondary Progressive Multiple Sclerosis

Summary: the primary goal of this study is to evaluate the effects of baf312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of baf312 or placebo treatment, in patients with secondary progressive multiple sclerosis (spms) who are enrolled in a clinical trial (nct01665144) to evaluate the effectiveness and safety of baf312.

this study is complementary to a multi-center, randomized, double-blind,parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of baf312 to placebo in patients with spms (nct01665144). investigators will explore both immunological and neuroprotective mechanisms of baf312 (siponimod), a novel agent in the setting of a spms clinical trial. this study is part of a multi-center study, with the university of michigan serving as the central site.

Eligibility criteria:
inclusion criteria: * participants enrolled in the multicenter, randomized, double-blind, parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of baf312 to placebo in patients with secondary progressive multiple sclerosis (spms) protocol no. cbaf312a2304 (sponsored by novartis). refer to clinicaltrials.gov record nct01665144. * subjects enrolled at one of the participating ams04 study sites located in the united states. * subject must be able to provide written informed consent. exclusion criteria: * subjects with severe bleeding disorders, platelet count less than (\<)50,000/microliters (μl), and/or who are currently on full anticoagulant therapy will be excluded from the optional csf collections.

Keywords: autoimmunity clinical research mechanistic studies blood draw cerebrospinal fluid (csf) by lumbar puncture (optional)
ovarian-sparing adaptive radiotherapy in young adult women

Conditions: Uterine Cancer; Rectal Cancer; Colon Cancer; Breast Cancer; Lung Cancer; Sarcoma; Cervix Cancer; Head and Neck Cancer; Anal Cancer; Liver Cancer; Gastric Cancer; Bladder Cancer

Summary: female patients with early onset (\<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. there is an unmet need for innovative techniques to protect ovarian function.


Eligibility criteria:
inclusion criteria: * biologic female * age between 18 and 50 years old (inclusive) * clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms) * at least one of two ovaries readily visualized on diagnostic ct or mr imaging as confirmed by radiologist * planning to receive radiation therapy (for any indication) * ability to understand and willingness to sign an irb-approved written informed consent document. exclusion criteria: * prior pelvic radiation * prior cancer therapies that are known to impact ovarian function * prior diagnosis of ovarian insufficiency/failure or menopause * clinically peri- or post-menopausal * for patients \> 45 years old, if there is a clinical history of vasomotor symptoms or irregular periods, then the patient must be excluded. * for patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause or irregular menstruation for ≥3 months or recent changes in their menstrual cycle \> 14 days, then the patient must be excluded. * surgically removed or transposed ovaries * pregnant and/or breastfeeding

Keywords: young onset colorectal cancer early onset pre-menopausal ovarian sparing radiation
study of arq 197 in hepatocellular carcinoma (hcc)

Conditions: Advanced Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and tolerability of arq 197 in hepatocellular carcinoma (hcc) patients treated with daily oral arq 197, to determine the recommended dose of arq 197 in advanced hcc patients.


Eligibility criteria:
inclusion criteria: * confirmed hcc patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * child-pugh classification a at the time of registration * adequate bone marrow, liver, and renal functions within 14 days prior to registration exclusion criteria: * prior therapy with a c-met inhibitor (including arq 197) * any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. if the treatment/agent was antibody, within 4 weeks * local treatment for malignancy within 4 weeks prior to registration * major surgical procedure within 4 weeks prior to registration
study on the sociopsychoemotional mechanism of dysfunction in patients with acute and chronic low back pain

Conditions: Low Back Pain

Summary: low back pain is defined as pain that extends from the 12th rib to the iliac bone, and its increasing incidence makes it one of the major causes of decreased productivity worldwide. dysfunction is one of the important complications in patients with chronic low back pain, and related studies have shown that depression, pain catastrophization and other emotions can affect the occurrence and development of dysfunction. so the investigators wanted to study which psychological emotions affect the development of dysfunction in patients with low back pain.


Eligibility criteria:
inclusion criteria: 1. age 18-75; 2. patients with low back pain; 3. have good communication skills to ensure the collection of scale information exclusion criteria: 1. suffering from severe mental or psychiatric disorders.; 2. unwilling to participate in the interview; 3. patients with pain in other areas
feasibility study of the use of the gekotm device for faecal incontinence in older people living at home or in care homes

Conditions: Fecal Incontinence

Summary: this research aims to investigate the feasibility for the treatment of onpulse(tm) for the treatment of faecal incontinence (fi) (including mixed faecal and urinary incontinence) in older people living at home or in a care home. it will determine patient acceptability, tolerability and usability of the t-2 gekotm device for fi by assessing: 1. device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions; 2. tolerability of device: skin tolerability.


Eligibility criteria:
inclusion criteria: 1. male or female 2. aged 60 and over? 3. reporting faecal incontinence of any severity 4. living in own home or a care home 5. able to understand the patient information sheet and willing to sign the written informed consent form. 6. able and willing to follow the protocol requirements. exclusion criteria: 1. patients or carers unable to speak, read or understand english 2. patients or carers unable to give informed consent because of lack of capacity 3. patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekotm device. 4. have implantable electronic devices 5. has sore, infected or inflamed areas, broken skin or skin eruptions for example phlebitis, thrombophlebitis, venous leg ulcers, varicose veins etc. in the region where the device would be fitted. 6. any cancerous lesions in the lower limb 7. is pregnant
effects of nitroglycerin versus labetalol on tissue perfusion during deliberate hypotension

Conditions: Tissue Perfusion; Deliberate Hypotension; Sinus Endoscopic Surgery

Summary: deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. the aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension

hypotensive anesthesia is associated with the risk of reduced tissue perfusion. the usual target mean arterial pressure during deliberate hypotension is 50- 65 mmhg; however, the status of peripheral perfusion under this target is not well investigated. nitroglycerin and labetalol are commonly used drugs to achieve deliberate hypotension. nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. no study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. the peripheral perfusion index (ppi) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. measurement of ppi is based on analysis of the pulse oximetry signal. ppi showed increasing popularity as a non invasive monitor of peripheral perfusion. serum lactate is another frequently used marker of global tissue perfusion.the aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during fess operations. tissue perfusion will be evaluated using ppi and serum lactate as markers of peripheral and global tissue perfusion respectively.

Eligibility criteria:
inclusion criteria: * adult male or female patients * 18-45 years * asa physical status i-ii * scheduled for fess operations exclusion criteria: * uncontrolled hypertension * cerebrovascular disorders * coagulation disorders * cardiovascular diseases * renal impairment * liver impairment * history of allergic reaction to any of the study medications

Keywords: deliberate hypotension nitroglycerin labetalol peripheral perfusion
changes in sensitivity, taste and smell in stroke patients

Conditions: Dysphagia; Stroke

Summary: this study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. younger (\ 60 years) volunteers will serve as control.

stroke is the second leading cause of death. at least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke \[2\]. it is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex. ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures \[1\]. power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration \[3\]. by combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing. additionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients

Eligibility criteria:
inclusion criteria: volunteers: * informed consent stroke patients: * informed consent * new supratentorial stroke (\<72 hours old) confirmed by ct (computed tomography) or mri (magnetic resonance imaging) exclusion criteria: * pre-existing stroke oder dysphagia * extensive white matter lesions in ct- or mri-scan * allergies to odorous substances or flavoring * contraindications for fees (flexible endoscopic evaluation of swallowing), ct or mri (stroke patients only)
engage coaching for latinos

Conditions: Social Isolation; Loneliness; Caregiver Burnout

Summary: this study asks: "what behavioral strategies are needed to help socially disconnected hispanic/latino caregivers with significant barriers to increasing connectedness?" this study uses a mixed methods approach to adapt a brief behavioral intervention-social engage psychotherapy-for use with socially disconnected hispanic/latino caregivers. this study is a single-arm clinical trial of social engage psychotherapy. we propose to enroll 10 participants for up to 8 weekly individual social engage psychotherapy sessions, over up to 3 months. subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with adrd, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 yrs; 2. hispanic/latino 3. english or spanish speaking; 4. caregiver for a community-dwelling family member with adrd, living with (or in close proximity to) family member with dementia; 5. endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item perceived stress scale (pss-10) and/or a score of 5 or greater on the modified caregiver strain index (mcsi); 6. endorse clinically significant loneliness as measured by a score of ≥ 6 on the ucla loneliness scale: short form. 7. has access to e-mail in order to complete the e-consent module in redcap which will be used in this study. exclusion criteria: 1. primary language is not english or spanish; 2. recent or current psychosis; 3. significant cognitive impairment on a cognitive screening measure at the harp screening assessment; 4. hearing problems that preclude completion of the intervention.