Kornimate/medical-research-clean huggingface dataset:
3 tpv/rtv doses in multiple arv experienced patients - tipranavir dose defining study

Conditions: HIV Infections

Summary: a dose defining study of the protease inhibitor tipranavir (tpv), boosted with low dose ritonavir (rtv). three dose combinations of tpv/rtv are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to trial participation. * human immunodeficiency virus 1 (hiv-1) infected males or females \> 18 years of age. * at least 3 months experience taking nucleoside reverse transcriptase inhibitors (nrtis), non-nucleoside reverse transcriptase inhibitor (nnrtis), and protease inhibitors (pis). * current pi-based antiretroviral (arv) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other pi-based regimen. * hiv-1 viral load ≥1000 copies/ml at screening. * genotypic resistance report indicating one or more primary pi resistance mutation(s), including 30n, 46i/l, 48v, 50v, 82a/f/t, 84v or 90m. * availability of 2 or more non-pi arv medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance". * acceptable screening laboratory values that indicate adequate baseline organ function. * laboratory values are considered to be acceptable if severity is no higher than grade 3 gamma glutamyl transferase (ggt), grade 2 cholesterol or triglycerides, and no higher than grade 1 for all other tests based on the "division of acquired immune deficiency syndrome" of national institute of health, usa - daids - grading scale. all laboratory values outside these limits are subject to approval by boehringer ingelheim (bi). * further inclusion criteria apply. exclusion criteria: * arv medication naïve. * only one or no available arv medications as determined by genotypic resistance testing. * female subjects who: * have a positive serum pregnancy test at screening or during the study; * are breast feeding; * are planning to become pregnant; * are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam). * any active opportunistic infection within 60 days before study entry. * active hepatitis b (hcb) or hepatitis c (hcv) disease defined as hbsag positive or hcv rna positive with aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> grade 1. * prior tipranavir use. * use of investigational medications within 30 days before study entry or during the trial.some expanded access drugs may be acceptable; must be approved by bi. tenofovir, investigational at time of preparation of this protocol, is acceptable. * use of concomitant drugs which may significantly reduce plasma levels of the study medications. * further exclusion criteria apply.
physical activity and acceptance and commitment therapy as treatment for long term pain

Conditions: Chronic Pain

Summary: only to a limited extent has been compared the effectiveness of physical exercise and psychological interventions in subjects with chronic pain. knowledge about this is necessary in order to compose optimal multimodal rehabilitation programs at different health care levels. moreover, assuming that both types of interventions have effects, these effects may necessarily not concern the same outcome variables. therefore it may be important to understand to what extent the effects overlap and the extent to which the effects are isolated to an intervention. the overall strategic purpose of the present study is to develop effective multimodal rehabilitation programs. in this study the effectiveness of following three interventions are compared. * group-based rehabilitation according to a concept based on an acceptance and commitment training -stress management intervention (act-smi) * group-based rehabilitation compromised of physical exercise (exercise). * group-based discussion concerning pain and its consequences (i.e., the control group, con) the effectiveness is investigated with respect to long-term effects on pain and its consequences, including perceived health and return to work / sick leave. the overall hypothesis is that the former intervention means better long-term results because it clearly helps the individual to process the psychological aspects of itself likely to have long lasting effects.


Eligibility criteria:
inclusion criteria: * chronic pain in the neck and/or back with or without pain in one or more quadrants of the body exclusion criteria: * inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs

Keywords: pain rehabilitation exercise psychological intervention
rt-pcr database analysis for covid-19 infections and re-infection

Conditions: Covid-19; SARS-CoV Infection

Summary: the sars-cov2 pandemic remains associated with many concerns. one of the them is the real frequency of likely re-infection and subsequently the level of protection conferred by the acquired immunity following primary-infection. we propose to analyze a large set of laboratory data produced since the early beginning of the sars-cov2 spread in the french population to identify recurrent infection events and, more generally, gain insight about infection kinetics.


Eligibility criteria:
inclusion criteria: - people with at least one positive sars-cov2 rt-pcr result with a known sampling date exclusion criteria: - patient refusing to participate in research

Keywords: sars-cov2 infection positive sars-cov2 rt-pcr sars-cov2 immune status reinfection kinetics rt-pcr immunity
impact of a. lumbricoides on pulmonary aspergillosis development

Conditions: COPD Exacerbation Acute; Ascaris Lumbricoides Infection; Chronic Pulmonary Aspergillosis

Summary: the prevalence of ascariasis in copd patients with and without concomitant pulmonary aspergillosis and in controls will be determined. to assess the influence of ascaridosis on the development of pulmonary aspergillosis in copd patients cytokine status of patients will be studied.


Eligibility criteria:
inclusion criteria: * copd patients * copd patients with aspergillosis * copd patients with ascariasis * copd patients with mix-infection * healthy individuals (controls) exclusion criteria: * copd patients with other autoimmune diseases * copd patients with oncological diseases * copd patients with other co-infections

Keywords: copd aspergillosis ascariasis cytokines helminths
effect of anti-interleukin 5 (il5) therapy on sputum cells and cytokines

Conditions: Asthma

Summary: 22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.


Eligibility criteria:
inclusion criteria: * fev1 \< 80% in the last 12 months * use of high dose inhaled corticosteroids (ics) in combination with other additional medication or continuous use of oral corticosteroids (ocs) * at least 2 exacerbations in the last 12 months * at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion * anti-il5 treatment prescribed by the physician exclusion criteria: * not completing all visits
ziprasidone pharmacokinetics using a reduced food effect formulation compared to pharmacokinetics from commercial capsules

Conditions: Healthy

Summary: commercial ziprasidone capsules show a large increase in bioavailability with food. the formulation tested in this study aims to reduce or eliminate that increase.


Eligibility criteria:
inclusion criteria: * healthy subjects * signed informed consent document exclusion criteria: * any significant physical or psychological disease * concomitant administration of other pharmaceuticals

Keywords: schizophrenia, pharmacokinetics, bioavailability, food effect
nucleus basalis deep brain stimulation for thinking & memory problems in parkinson's.

Conditions: Dementia in Parkinson's Disease

Summary: we will perform a pilot study to evaluate the effectiveness of human nbm dbs at improving cognitive deficits in pd patients referred and eligible for conventional dbs treatment for coexisting motor impairments. six patients with pd with both motor fluctuations and cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral electrodes implanted to ensure that superficial contacts lie in the conventional motor gpi target, while the deepest electrical contacts lie in the nbm- (see figure 1). we will place electrodes using our conventional image guided, stereotactic frame-based procedure currently used in patients at nhnn. patients will be randomised into 2 groups in a crossover trial design to have 3 month periods of nbm stimulation switched on or switched off separated by a 1 month washout period, following which the patient will cross over to have the opposite condition for a further 3 months- see timeline. at the end of the crossover period, all patients will be invited for continued follow up with stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals. patients will be given the option of receiving additional conventional stimulation to the motor gpi, through the higher contacts of each electrode, at the end of the crossover period.


Eligibility criteria:
inclusion criteria: * all patients will meet queen square brain bank criteria for the diagnosis of pd and will have motor fluctuations (off periods and/or l-dopa induced dyskinesias) in response to medications that are known to improve with gpi dbs, and will be appropriate candidates for gpi dbs aside from the coexistence of cognitive impairment. patients will be aged between 35 and 80 years. patients will be able to give informed consent. patients will meet criteria for pd dementia. patients will have a mmse score between 26 and lower cutoff of 21 to restrict the sample to those with mild dementia and cognitive impairment. this will be equivalent to an age and education adjusted scaled score of greater than 5 and lower than 9 (mildly impaired range) on the mattis dementia rating scale-2. patients will have only minimal atrophy on pre-operative brain mri scans. patients will be living at home and will have a carer living with them e.g. their spouse able to comply with trial protocol and willing to attend clinic necessary visits exclusion criteria: * diagnosis or suspicion of other cause for parkinsonism or dementia. known abnormality on ct or mri brain imaging considered likely to compromise compliance with trial protocol. prior intra-cerebral surgical intervention for parkinson's disease including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplant.
risk factors and disorders linked to uterine adenomyosis on mri in reproductive-age women

Conditions: Adenomyosis; Endometriosis; Leiomyoma (Uterine Fibroids); Ovarian Cysts

Summary: the goal of this observational case-control study is to identify risk factors and associated conditions related to adenomyosis in women of reproductive age. the main questions it aims to answer are: is there an association between a history of uterine surgery and the occurrence of adenomyosis? does a higher prevalence of endometriosis or increased number of pregnancies correlate with adenomyosis? researchers will compare women with mri-confirmed adenomyosis to a control group of women who underwent pelvic mri for other reasons but were not diagnosed with adenomyosis to see if there are significant differences in risk factors such as endometriosis, number of pregnancies, and history of uterine surgery. participants will: undergo pelvic mri with and without intravenous contrast provide information on factors such as age, smoking, number of pregnancies, history of uterine surgery, and coexisting conditions like leiomyoma and ovarian cysts this study aims to inform better management strategies for reducing the incidence of adenomyosis by targeting modifiable risk factors.


Eligibility criteria:
inclusion criteria: * women of reproductive age (18-50 years). * patients who underwent pelvic mri for clinical indications. * mri-confirmed diagnosis of adenomyosis (for the case group). * patients without adenomyosis confirmed by mri (for the control group). * willingness to participate and provide informed consent. exclusion criteria: * women outside the reproductive age range (under 18 or over 50 years). * pregnancy or lactation at the time of mri. * previous hysterectomy or other major uterine surgeries. * presence of malignancies or other serious conditions that could interfere with the study. * inability to undergo mri due to contraindications (e.g., metal implants, pacemakers). * incomplete or missing mri data. * non-consent to participate in the study.

Keywords: adenomyosis magnetic resonance imaging risk factors
a comparison of study drug with placebo and haloperidol in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy of the drug sm-13496 compared to a placebo and to haloperidol in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * the patient has a primary diagnosis of schizophrenia * the patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening * the patient has had a duration of illness of at least one year. * the patient has a bprs score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the panss * the patient is able to remain off antipsychotic medication for a 4 day washout period exclusion criteria: * the patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening. * the patient is considered treatment resistant-substance abuse-prolactin level of \> 200 ng/ml at baseline * pregnancy

Keywords: schizophrenia latuda lurasidone
the effect of ibuprofen on intrauterine contraceptive device associated uterine bleeding

Conditions: Contraception

Summary: the copper intrauterine device is the most common method of reversible contraception worldwide. abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device. excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.there are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. another one is thromboxane which has two types; a2 which is active and rapidly converted into b2, which is inactive. thromboxane causes vasoconstriction and blood clotting. non-steroidal anti-inflammatory drugs (nsaids) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. since its discovery; several drugs in nsaids class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen. the most recent systematic review found nsaids is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. the cochrane review also found that nsaids are the most effective treatment to reduce the bleeding with copper intrauterine device use.


Eligibility criteria:
inclusion criteria: 1. women have menorrhagia secondary to iud. 2. planning for birth spacing for at least 1 year. 3. patient aged between 20-45 years old. 4. no history of any medical treatment. 5. living in a nearby area to make follow-up reasonably possible. exclusion criteria: 1. evidence of defective coagulation. 2. history or evidence of malignancy. 3. hyperplasia in the endometrial biopsy. 4. incidental adnexal abnormality on ultrasound. 5. untreated abnormal cervical cytology 6. contraindications to ibuprofen
a comparison of two surgical techniques using the unity knee™ total knee system

Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis; Post-Traumatic Osteoarthritis of Knee; Varus Deformity, Not Elsewhere Classified, Knee; Valgus Deformity, Not Elsewhere Classified, Knee; Flexion Deformity, Knee; Fracture of Distal End of Femur; Fracture of Upper End of Tibia

Summary: a comparison of two unity knee™ tissue-balancing techniques by analysing the results from x-rays and patient questionnaires.


Eligibility criteria:
inclusion criteria: * subjects suitable for the unity knee™ total knee system according to the product "instructions for use" * over 18 years old * male and female subjects who are skeletally mature * subjects who have a smartphone (ios or android) with internet connection via mobile internet data or wi-fi connection * subjects able to understand what is expected of them and be able to comply with the study protocol requirements exclusion criteria: * any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee * any subject with fixed flexion contracture greater than 20 degrees * any subject with varus/valgus deformity greater than 15 degrees * any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months * any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months * any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems * any subject with a known sensitivity to device material * any subject who is pregnant * any subject currently a prisoner * any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes * any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims * any subject unable to read and understand english
balance and proprioception training program in patients with chronic ankle sprains

Conditions: Ankle Sprains

Summary: to examine the effects of an individualized balance and proprioception training program on pain, function, and the risk of recurrent ankle sprains.


Eligibility criteria:
inclusion criteria: * adults aged 18-55 years * history of at least two ankle sprains within the last 12 months * presence of ankle instability symptoms, such as recurrent giving way or chronic pain exclusion criteria: * acute ankle injury within the last six weeks * lower extremity fracture within the last six months * other musculoskeletal or neurological disorders affecting the lower extremity * inability to comply with study requirements
rhtpo combining dexamethasone versus high-dose dexamethasone for initial treatment of itp

Conditions: Purpura; Idiopathic Thrombocytopenic Purpura

Summary: the project was undertaking by qilu hospital of shandong university and other 13 well-known hospitals in china. in order to report the efficacy and safety of recombinant human thrombopoietin combining with dexamethasone for the treatment of adults with primary immune thrombocytopenia (itp), compared to high-dose dexamethasone therapy.

the investigators are undertaking a parallel group, multicentre, randomised controlled trial of 200 primary itp adult patients from 14 medical centers in china. one part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300units/kg for7-14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). platelet count was evaluated before and after treatment, in order to report the conversion ratio of primary itp to chronic itp.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group（ecog）performance status ≤ 2. 5. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(ivig)in the 3 weeks prior to the start of the study. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. 4. severe medical condition (lung, hepatic or renal disorder) other than itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 7. patients who are deemed unsuitable for the study by the investigator.

Keywords: recombinant human thrombopoietin rhtpo dexamethasone
low power thulep for prostate size more than 80 gm

Conditions: Benign Prostatic Hyperplasia

Summary: feasibility and efficacy of lower power thulium enucleation of prostate more than 80 grams

intra operative outcome and postoperative follow up of ipss score and ieff score at 6 months.

Eligibility criteria:
inclusion criteria: * bph patients with failed medical treatment * refractory retention * hematuria * bladder stones * renal impairment due to bph exclusion criteria: * neurogenic patients * stricture urethra
open-label study of teduglutide for subjects with pn-dependent short bowel syndrome (sbs)

Conditions: Short Bowel Syndrome

Summary: this study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in cl0600-020.

some people with sbs need to infuse parenteral nutrition (pn) in order to live. although pn can save lives, it can lead to some serious side effects such as infection or liver damage. the risk for those effects increases the longer people are on pn. teduglutide is an investigative medicine being evaluated as a possible treatment for people with pn-dependent sbs. teduglutide is similar to a protein the body makes. when people have sbs, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. we want to see if teduglutide can help decrease the amount of pn needed because the body is doing a better job of taking up what it eats and drinks. we also want to find out how safe teduglutide is and record any side effects.

Eligibility criteria:
inclusion criteria: * must have completed 24 weeks of dosing of the cl0600-020 study exclusion criteria: * none

Keywords: short bowel syndrome parenteral nutrition pn hpn tpn sbs