Kornimate/medical-research-clean huggingface dataset:
tmc114-c202: a study of safety, efficacy, and tolerability of tmc114 and low dose ritonavir in hiv-1 infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (pi) called tmc114 given with low dose ritonavir.

a phase ii randomized, controlled, partially blinded, trial to investigate dose response of tmc114/rtv in hiv-1 infected patients who have previously received all three licensed classes of hiv antiviral drugs (known as nucleoside reverse transcriptase inhibitors (nrti), nonnucleoside reverse transcriptase inhibitors (nnrti) and protease inhibitors (pi)), and who are on a stable pi-containing regimen not including an nnrti may be eligible to participate. four doses of tmc-114/ritonavir will be studied. 300 patients in the united states and puerto rico will participate. the duration of the study is 96 weeks. randomize to one of 4 treatment groups (tmc114/rtv: 400/100 mg qd; 800/100mg qd; 400/100mg bid; 600/100 bid) or control arm for 24 to 48 wks. optimal dose (tmc114/rtv 600/100mg bid) open label portion of the study. the trial was extended to include 144wks of treatment.

Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older * documented hiv-1 infection * stable pi regimen for at least 8 weeks prior to screening * plasma viral load at screening above 1000 hiv-1 rna copies/ml * prior use of more than 1 nrti for at least 3 months * prior use of one or more nnrtis as part of a failing regimen * at least 1 primary pi mutation as defined by the ias guidelines * treatment with at least 1 pi for a total of at least 3 months * patient has given informed consent exclusion criteria: * presence of any currently active aids defining illness except stable cutaneous kaposi's sarcoma and wasting syndrome due to hiv infection * current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures * nnrti as part of therapy at screening * patients on a treatment interruption at screening * patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening * hepatitis a, b, or c.

Keywords: hiv tmc114 ritonavir tolerability safety and efficacy tmc114-c211
pk study of t-817 in subjects with hepatic impairment

Conditions: Healthy; Hepatic Impairment

Summary: the primary objective is to determine the single-dose pharmacokinetics (pk) of t-817 and t-817m5 (metabolite of t-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects. the secondary objective is to determine the safety and tolerability of single-dose t -817ma (maleate salt of t-817) in subjects with mild, moderate or severe hepatic impairment.


Eligibility criteria:
inclusion criteria: for subjects with mild, moderate or severe hepatic impairment 1. adult male or female, 18 - 75 years of age 2. must weigh at least 50 kg and have a body mass index (bmi) ≥ 18.5 and ≤ 40.0 kg/m2 3. have mild, moderate or severe defined by child-pugh classification hepatic impairment for matched healthy control subjects healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status exclusion criteria: 1. subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2. history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the pi. 3. history or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients. 4. female subjects who are pregnant or lactating.

Keywords: hepatic impairment
safety and efficacy study of raav.sflt-1 in patients with exudative age-related macular degeneration

Conditions: Macular Degeneration; Age-related Maculopathies; Age-related Maculopathy; Maculopathies,Age-related; Maculopathy,Age-related; Retinal Degeneration; Retinal Neovascularization; Eye Diseases

Summary: the study will involve approximately 40 subjects aged 55 or above who have exudative age-related macular degeneration (wet amd). patients will be randomized to receive one of two doses of raav.sflt-1 or assigned to the control group.

a new treatment for exudative age-related macular degeneration (wet amd) is being investigated. the purpose of this phase i/ii clinical research study is to examine the baseline safety and efficacy of an experimental study drug to treat a complication of the disease which leads to vision loss. the name of the study drug is raav.sflt-1. this experimental study uses a non-pathogenic virus to express a therapeutic protein within the eye. the therapeutic diminishes the growth of abnormal blood vessels under the retina. the duration of effect is thought to be long-term (years) following a single administration. the clinical research study will look at the baseline safety and efficacy of a single injection of raav.sflt-1 injected directly into the eye. approximately forty (40) subjects will participate in australia. the primary endpoint of the study is at one month, with extended follow up for 3 years.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 55 years; * subfoveal cnv secondary to amd and with best corrected visual acuity of 3/60 - 6/9 with 6/60 or better in the other eye; * fluorescein angiogram of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion, or cnv currently under active management with anti-vegf therapy; * must be a candidate for anti-vegf intravitreal injections; * no previous retinal treatment of photodynamic therapy or laser; * able to provide informed consent; * able to comply with protocol requirements, including follow-up visits. exclusion criteria: * liver enzymes \> 2 x upper limit of normal; * any prior treatment for amd in the study / control eye, excluding anti-vegf injections; * extensive sub-foveal scarring, extensive geographic atrophy, or thick subretinal blood in the study eye as determined by the investigator; * significant retinal disease other than sub-foveal cnv amd;

Keywords: age-related macular degeneration aav amd wet amd neovascular amd gene therapy ocular ocular gene therapy eye diseases macular degeneration retinal degeneration retinal neovascularization wet macular degeneration retinal diseases
palliative expeditiously adaptive quad shot radiation therapy (peaq-rt)

Conditions: Head and Neck Cancer

Summary: the investigators propose evaluating the feasibility of using the novel cone beam computed tomography (cbct)-guided ethos system to deliver expedited, adaptive quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy experiencing current head and neck lesions. quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the us for palliation of head and neck cancers, and safety in the setting of re-irradiation. the use of the ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. the ethos system would be used to consolidate ct simulation, replanning, and treatment for quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between quad shot cycles. the goal of this pilot study will be to evaluate the feasibility of the ethos system to eliminate the need for a ct simulation for cycles 2 and 3 of quad shot radiation.


Eligibility criteria:
inclusion criteria: * history of a head and neck malignancy or history of any malignancy experiencing current head and neck lesions suitable for radiation. past history of radiotherapy is allowed for inclusion and brain metastases are allowed for inclusion. * deemed medically fit for quad shot radiation by treating physician * at least 18 years of age. * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: -pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test within 14 days of study entry. if pregnancy test is not clinically indicated as determined by treating physician or protocol pi, documentation of this exception is sufficient in lieu of pregnancy test.
chemotherapy with cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia.

objectives: i. evaluate the safety, maximum tolerated dose, adverse effects, and toxicities of cordycepin, given 1 hour following a fixed dose of the adenosine deaminase inhibitor pentostatin, in patients with refractory tdt positive leukemia. ii. determine the single and multiple dose pharmacokinetics of cordycepin given 1 hour following a fixed dose of pentostatin. iii. characterize selected whole blood and blast cell metabolic parameters serially in relation to cordycepin/pentostatin administration. iv. measure and quantify any clinical responses in refractory tdt positive leukemia patients following cordycepin/pentostatin administration. outline: this is a dose escalation study. each treatment course is 28 days in length. on days 1-3 pentostatin is administered over 5 minutes by iv bolus and followed 1 hour later by a 1 hour infusion of cordycepin iv. an escalating dose of pentostatin is given with a fixed dose of cordycepin until the desired level of adenosine deaminase inhibition is observed. after this is determined, a dose escalation schedule for cordycepin is initiated to determine the maximum tolerated dose (mtd) when given in combination with pentostatin. the mtd is determined by the number of patients who exhibit dose limiting toxicity and the severity of the toxicity. projected accrual: approximately 30 patients will be accrued.

Eligibility criteria:
disease characteristics: tdt positive acute lymphocytic leukemia or blastic chronic myelogenous leukemia failed at least one standard treatment patient characteristics: age: 18 and over performance status: karnofsky greater than 70% life expectancy: at least 3 months hematopoietic: not specified hepatic: bilirubin no greater than 2.0 mg/dl transaminases no greater than 2.5 times normal renal: creatinine no greater than 1.5 mg/dl creatinine clearance greater than 60 ml/min cardiovascular: ejection fraction greater than 40% other: not pregnant or nursing no serious concurrent illness prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 3 weeks since chemotherapy no concurrent chemotherapy endocrine therapy: not specified radiotherapy: at least 3 weeks since radiation therapy surgery: not specified

Keywords: recurrent adult acute lymphoblastic leukemia blastic phase chronic myelogenous leukemia tdt positive adult acute lymphoblastic leukemia
assessment of sense of identity in patients diagnosed with borderline personality disorder. a pilot study

Conditions: Borderline Personality Disorder

Summary: one of the key features and long considered a fundamental element of borderline personality disorder is the disruption of identity. autobiographical memory is closely linked to the development and maintenance of a coherent, stable sense of self. it enables the individual to understand who he or she is. the investigators hypothesize that individuals diagnosed with borderline personality disorder have a less coherent, stable sense of the self than healthy controls. the aim of the study is therefore to compare the sense of identity between a group of patients diagnosed with borderline personality disorder and a group of healthy individuals (without borderline personality disorder ). this can be measured by evaluating the content of the self-defining memory using the self-defining memory scale.


Eligibility criteria:
inclusion criteria: * subject must have given written consent * subject affiliated or beneficiary of a health insurance plan. * adult subjects between 25 and 55 years of age * oral and written mastery of the french language inclusion criteria for the borderline group: * subject diagnosed as having borderline personality disorder according to the dsm iv classification exclusion criteria for the borderline group: * patients without diagnosis of borderline personality disorder according to the dsm iv classification after taking the scid ii (structured clinical interview for dsm-iii-r axis ii disorders) test exclusion criteria for the control group: * subjects considered borderline after taking the scid ii (structured clinical interview for dsm-iii-r axis ii disorders) test * subjects with a score above 8 on the hads questionnaire corresponding to questionable symptomatology for anxiety and depressive symptoms. general exclusion criteria: * subjects under court protection, guardianship or curatorship * subjects for whom it is impossible to give informed information * subjects participating in a category 1 or 2 riph in the 3 months prior to the study * subject refusing to give written consent * presence of known neurological disease * pregnant or breastfeeding women

Keywords: personality disorder, borderline psychology self-identity
investigation of clinical outcome of acl reconstruction utilizing two tibial fixation techniques, concentric tapered interference screws and interference screw and sheath

Conditions: Primary ACL Tears

Summary: tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in acl reconstruction. the objective is to study two groups of patients undergoing double loop hamstring autograft acl reconstruction and compare between the two tibial fixation devices: the tapered deltascrew and the intrafix screw and sheath .


Eligibility criteria:
inclusion criteria: * males and females between ages 21 and 40 years. * primary acl tears. * signed informed consent. * availability during follow up period. exclusion criteria: * additional meniscal injury requiring suture. * articular cartilage injury requiring surgical management. * concomitant ligament injuries to the same knee requiring surgery. * bilateral acl injury. * revision acl surgery. * concurrent fractures of the lower limbs caused by the same accident. * post operative wound infection. • post operative nerve injury * cardiovascular compromise. * professional sports people. * soldiers on active military service. * patients actively seeking compensation for injury. * patients on other research protocols. * patients receiving medications which alter bone metabolism: corticosteriods, calcitonin, flourides, biphosphonates, vitamin d and its derivatives, cytotoxic drugs. * non compliance. • pregnancy
spinal cord stimulation for parkinsonism

Conditions: Parkinsonism

Summary: spinal cord stimulation (scs) is a newly emerged neuromodulation technique in recent years. it is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for pds with scs. we intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in parkinsonism (pds) patients before and after scs treatment, and shed new light on the treatment for pds.


Eligibility criteria:
inclusion criteria: 1. diagnosed with parkinsonism according to mds clinical diagnostic criteria for parkinson's disease 2. aged between 50 and 80 years 3. able and willing to follow instruction of the researcher 4. no other conditions that the researchers consider inappropriate for inclusion exclusion criteria: 1. severe depression (hamd-17 above 17 as moderate to severe) or anxiety 2. pregnancy 3. history of alcoholism 4. non-neurological disease-related symptoms that prevent patients from participation in the study
after surgery acute renal failure incidence in total knee arthroplasty with and without tourniquet

Conditions: Arthroplasty, Replacement, Knee; Acute Kidney Injury; Tourniquets; Knee Osteoarthritis

Summary: this study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

this study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Eligibility criteria:
inclusion criteria: * patients knee arthrosis * required a surgical treatment with total knee arthroplasty exclusion criteria: * not accept to be in the study * not signed consent form * not having blood sample for creatinin meassure
comparative clinical evaluation of daily disposable lenses in symptomatic daily disposable lens wearers

Conditions: Myopia

Summary: the purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.


Eligibility criteria:
inclusion criteria: * currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months. * habitually wear lenses for at least 8 hours per day and 4 days per week. * report 2 or more qualifying symptoms with current contact lenses. * able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks immediately prior to enrollment. * currently enrolled in any clinical trial. * any use of ocular medications, exclusive of contact lens rewetting drops. * history of corneal or refractive surgery. * cylinder correction greater than 1.00 d * current monovision contact lens wearers. * other protocol-defined inclusion/exclusion criteria may apply.
the effect of lmwh on icsi in patients with unexplained infertility and negative immunological markers

Conditions: Unexplained Infertility

Summary: the purpose of this study is to assess the efficacy of lmwh treatment in women with unexplained infertility and negative immunological markers undergoing icsi.

inclusion criteria: 1. patients undergoing 1st trial icsi 2. unexplained infertility 3. negative immunological markers including acl abs, lac, ana, ata, anitdsdna exclusion criteria: 1. previous ivf/icsi 2. any cause of infertility 3. suspected and/or unexpected poor response during ovulation induction 4. positive immunological markers 5. age \> 40 years. all participants will undergo ivf/icsi cycle using the long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and bmi. all patients will have 2-3 embryos transferred at d5 according to their age. the primary outcome will be lbr. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.

Eligibility criteria:
inclusion criteria: * age less than 38 years * at least 12 months of infertility * women with unexplained infertility exclusion criteria: * age more than or equals 38 years * serum amh level less than or equals 1 ng/ml * patients of anticoagulant therapy * immune-compromised patients * patients with contraindications to low molecular weight heparin * positive immunological markers * patients with other than unexplained infertility * male factor infertility * refusal of participation * patients with unexpected poor or over response during induction of ovulation
simultaneous measurement of electroencephalography (eeg) and functional magnetic resonance imaging (fmri) in patients with alcoholism

Conditions: Alcoholism

Summary: investigation of inpatients with alcoholism after detoxification with simultaneous electroencephalography (eeg) and functional magnetic resonance imaging (fmri).


Eligibility criteria:
inclusion criteria: * age of 18 or more * inpatient with alcoholism after detoxification. exclusion criteria: * neurological disease

Keywords: patients with alcoholism according to icd-10 after detoxification