Kornimate/medical-research-clean huggingface dataset:
a study of adrx-0405 in subjects with select advanced solid tumors

Conditions: Solid Tumors

Summary: the primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of adrx-0405 in patients with select advanced solid tumors.

this is a 2-part study. the phase 1a will consist of a dose escalation of adrx-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors \[including metastatic castration resistant prostate cancer (mcrpc), gastric cancer (gc), and non-small cell lung cancer (nsclc)\], and to identify the recommended dose to be used in the phase 1b. the phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of adrx-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mcrpc).

Eligibility criteria:
inclusion criteria: * phase 1a dose escalation: subjects with histologically confirmed select advanced solid tumors, including metastatic castration resistant prostate cancer (mcrpc), gastric cancer (gc), and non-small cell lung cancer (nsclc). * phase 1b dose expansion: subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone \< 50 ng/dl \[\< 2.0 nm\]) and that is intolerant/resistant to standard of care (soc) therapies. * measurable disease according to recist version 1.1 or evaluable disease per pcwg3 for subjects with prostate cancer * eastern cooperative oncology group (ecog) performance status of 0-1 in 1a; 0-2 in 1b * adequate hematologic, liver, and renal function exclusion criteria: * active and uncontrolled central nervous system metastases * significant cardiovascular disease * history of another malignancy other than the one for which the subject is being treated on this study within 3 years * receipt of any anticancer or investigational therapy within: 5 elimination half-lives or 14 days (whichever is less); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer * history of (non-infectious) ild/pneumonitis that required steroids within 2 years of study enrollment, has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out by imaging at screening. * receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted
prohepcidin, inflammation and iron homeostasis in hemodialysis patients with chronic hepatitis c

Conditions: Renal Failure Chronic Requiring Hemodialysis; Hepatitis C

Summary: the aim of this study is to address questions regarding the link among hepcidin, hematological iron markers, inflammation and hepatitis c in hd patients. in attempt to address this issue, we planned to measure serum levels of hepcidin prohormone (pro-hepcidin), inflammatory and iron parameters.

hepatitis c virus (hcv) infection is the most common cause of chronic liver disease in the world and also common among chronic hemodialysis (hd) patients. patients with chronic hcv often have increased liver iron, a condition associated with reduced sustained response to antiviral therapy, more rapid progression to cirrhosis, and development of hepatocellular carcinoma; however, little is known about the mechanism of iron accumulation in the liver. recently identified hepcidin, a 25-amino acid peptide hormone exclusively synthesized in the liver, is thought to be a key regulator for iron homeostasis and is induced by infection and inflammation. hepcidin expression is modulated by iron stores, so that it decreases in iron deficiency to facilitate iron absorption while it increases in iron repletion to prevent pathological overload. interleukin (il)-6 has been proposed as a major inducer of hepcidin, via direct transcriptional activation of hepatic hepcidin expression by binding to its receptor complex containing gp130 to activate janus kinase (jak) and activator of transcription 3 (stat 3).

Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients exclusion criteria: * patients positive for hepatitis b virus surface antigen (hbsag) * patients previously diagnosed nonrenal cause of anemia other than iron deficiency * patients with an evidence of active or occult bleeding * patients received blood transfusion within the past 4 months * patients with a history of malignancy, end-stage liver disease, or chronic hypoxia * patients with a history of recent hospitalization or infection requiring antibiotics within the past 4 weeks.

Keywords: hemodialysis hepatitis c inflammation iron stores prohepcidin
momentum 3 pivotal cohort extended follow-up pas

Conditions: Advanced Refractory Left Ventricular Heart Failure

Summary: the study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the hm3 lvas compared to the hmii lvas in those patients that are ongoing at the 2-year follow-up in the momentum 3 ide trial. a total of 1028 subjects were enrolled in the momentum 3 ide trial. approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this pas. this study will be conducted at sites that participated in the momentum 3 ide trial which will include up to 69 centers in the united states.

subjects on lvad support after the momentum 3 ide trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. they will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first. subjects who have been transplanted, their device exchanged to another pump other than a hm ii or hm3, or explanted after the momentum 3 ide trial 2-year follow-up but prior to providing consent for this pas can also be enrolled. data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected. once enrolled, if subjects receive a device exchange to any device other than hm ii or hm3, at any time during the study, they will be withdrawn from the study and will not be followed. in the event that a subject expired prior to providing consent, irb approval will be obtained to collect the date and cause of death.

Eligibility criteria:
inclusion criteria: * subject or legal representative has signed informed consent form (icf) * subject was enrolled in the momentum 3 ide trial and was ongoing at the 2-year follow-up visit exclusion criteria: * subject or legal representative does not consent to extended data collection after the momentum 3 ide trial 2-year follow-up visit special circumstance: * sites with patients who expired after the momentum 3 ide trial 2-year follow-up visit but prior to signing the icf for this pas will obtain irb approval to collect only the date and cause of death
a study to treat subjects with telaprevir, ribavirin, and peginterferon who are coinfected with hiv and hepatitis c virus (hcv)

Conditions: Hepatitis C

Summary: the purpose of this study is to treat human immunodeficiency virus (hiv) and hepatitis c virus (hcv) co-infected subjects with telaprevir, pegylated interferon alfa-2a (peg-ifn-alfa-2a), and ribavirin (rbv) to achieve undetectable hepatitis c virus ribonucleic acid (hcv rna) 12 weeks after the last planned dose of study drug.


Eligibility criteria:
inclusion criteria: * participants must have chronic, genotype 1a or 1b, hepatitis c with hcv rna greater than (\>) 1000 international units per milliliter (iu/ml) * population a: hcv pegylated interferon (peg-ifn)/rbv treatment naive (received no prior hcv therapy)or peg-ifn/rbv prior treatment with relapse * population b: peg-ifn/rbv prior null or partial responder * participants must not have achieved undetectable hcv rna 24 weeks after the last planned dose of study drug (svr24) after at least 1 prior course of peg ifn/rbv therapy of standard duration * participant must have positive hiv antibody at screening * participant must have a diagnosis of hiv-1 infection \>6 months before screening * participants should be taking 1 of the following permissible highly active antiretroviral therapy (haart) regimens for hiv continuously for 12 weeks prior to screening: * atripla® or equivalent components (efavirenz, tenofovir, emtricitabine) * efavirenz plus epzicom® (abacavir, lamivudine) or equivalent components * boosted atazanavir (atazanavir with ritonavir) plus truvada® (tenofovir, emtricitabine) or equivalent components * boosted atazanavir plus epzicom®, or equivalent components * raltegravir plus truvada®, or equivalent components * raltegravir plus epzicom®, or equivalent components * cluster of differentiation 4 (cd4) counts and human immunodeficiency virus type 1 (hiv-1) ribonucleic acid (rna) meeting acceptable criteria at screening as specified in the protocol * laboratory values within acceptable ranges at screening as specified in the protocol exclusion criteria: * subjects anticipating a need to switch haart regimens within 14 weeks after day 1 or any switches occurring 12 weeks prior to day 1 * use of azidothymidine (azt), didanosine (ddi) or stavudine (d4t) nucleosides * contraindications to any planned haart component as per the respective drug labeling information * contraindications to peg-ifn or rbv * evidence of hepatic decompensation * clinical suspicion of acute hepatitis * any other cause of liver disease in addition to hepatitis c * history of organ transplantation (except cornea and skin) * autoimmune-mediated disease * participated in any investigational drug study within 90 days before day 1 * previous treatment with an hcv protease inhibitor
palmer's point versus the umbilicus as routine primary entry site in gynecologic laparoscopy

Conditions: Gynecologic Disease

Summary: we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with palmar's point

all these cases will undergo: 1. history taking patients are randomly arranged in 2 groups group (a):- palmer's point is the primary entry site. the stomach will be emptied of secretions and air following endotracheal intubation. (this is most easily performed using a nasogastric tube.) the left upper quadrant will be inspected for scars and the upper abdomen palpated for hepatomegaly or splenomegaly. a 10-mm incision will be made over palmer's point. veress needle first will be used for insufflation and tests of safety will be considered. a 10-mm port will be held vertically and the layers observed via a 10-mm laparoscope. a gentle rotating action in a vertical direction was used to allow the bladeless tip to separate the tissues. the layers of the abdominal wall seen at palmer's point are as follows: * skin, * subcutaneous fat, * external oblique aponeurosis, * internal oblique aponeurosis, * transversalis muscle fibres, * (sometimes) extraperitoneal fat, * peritoneum. once the peritoneum will be breached, the introducer will be carefully removed from the port. the laparoscope will be then reintroduced. an extra 360° check was then performed to exclude a through-and-through bowel injury. the umbilicus was then inspected and any adhesions cleared using one or more 5-mm ports inserted under direct vision. at the end of the operation, the skin was closed using a single subcuticular suture group (b):- the umbilicus is the primary entry site. first of all, the umbilicus is well cleaned with a piece of gauze with betadine or alcohol then small incision is done (10mm) in the umbilicus, veress needle is then inserted and tests of safety of intraperotineal insufflation are considered. 10 mm port is then introduced with gentle rotating action in a vertical direction to allow the bladeless tip to separate the tissues. the layers of the abdominal wall seen at palmer's point are as follows: * skin * linea alba * peritoneum. once the peritoneum is breached, the trocar will be carefully removed from the port. the laparoscope will then reintroduced. an extra 360° check was then performed to exclude a through-and-through bowel injury. at the end of the operation, the skin will be closed using a single subcuticular suture

Eligibility criteria:
inclusion criteria: * patients listed for diagnostic or operative laparoscopy. exclusion criteria: * • splenomegaly * hepatomegaly * previous left upper quadrant surgery. * midline laparotomy * umbilical surgery * presence of umbilical hernia
therapy protocol acute lymphoblastic leukemia stem cell transplantation international

Conditions: Acute Lymphoblastic Leukemia

Summary: to evaluate whether hsct from matched family or unrelated donors (md) is equivalent to the hsct from matched sibling donors (msd). to evaluate the efficacy of hsct from mismatched family or unrelated donors (mmd) as compared to hsct from msd/md. to determine whether therapy has been carried out according to the main hsct protocol recommendations. the standardisation of the treatment options during hsct from different donor types aims at the achievement of an optimal comparison of survival after hsct with survival after chemotherapy only. to prospectively evaluate and compare the incidence of acute and chronic gvhd after hsct from msd, from md and from mmd.


Eligibility criteria:
inclusion criteria: all patients with all (except for patients with b-all) who fulfil the following criteria: * age at time of initial diagnosis or relapse diagnosis, respectively ≤18 years * indication for allogeneic hsct * complete remission (cr) is achieved before sct * written consent of the parents (legal guardian) and, if indicated, the minor patient via "informed consent form" * no pregnancy * no secondary malignancy * no previous hsct * hsct is performed in a study participating centre. exclusion criteria: * not signed inform consent of the parents (legal guardian) * pregnancy * secondary malignancy * previous hsct

Keywords: hsct all gvhd
safety, tolerability, pharmacokinetics and pharmacodynamics of explorative formulation of insulin degludec

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.


Eligibility criteria:
inclusion criteria: * healthy subjects: * subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator * body mass index (bmi) between 18.0-27.0 kg/m\^2 (both inclusive) * subjects with type 1 and type 2 diabetes: * subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator * diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months * body mass index (bmi) between 18.0-27.0 kg/m\^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m\^2 (both inclusive) for subjects with type 2 diabetes * glycogylated haemoglobin (hba1c) maximum 8.5 % based on central laboratory results * subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening exclusion criteria: * participation in any other trials involving investigational products within 3 months preceding the start of dosing * history of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator * hepatitis or carrier of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or a positive result to the test for human immunodeficiency (hiv) antibodies * any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator * subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
a 48 week observational study of the frequency of symptomatic herpes virus i and ii in hiv infected subjects

Conditions: HIV Disease; Herpes Simplex 1; Herpes Simplex 2

Summary: this study is an observational, cohort, prospective study looking at the frequency of herpes simplex virus (hsv) 1 and or 2 outbreaks in hiv positive patients who's hiv virus is controlled on highly active anti-retroviral therapy. we will be enrolling fifty (50) patients.

we will be confirming that the patients are hiv positive and has antibodies to either hsv 1 or hsv 2 as part of the screening process. if so, we will then obtain patient baseline hiv-pcr, cd4, medial history including medications on day one. whether the patient is on any or no herpes controlling medication. if the patient has what they feel is a flare up of hsv, they will come into clinic where the lesion will be culture and the patient's hiv-pcr and cd4 will also be obtained. otherwise, the patient will receive phone follow ups every three months to see if there has been and change in their health or medications. the main endpoint is to see if there is a correlation between outbreaks in hiv patients and their cd4 cells and/or hiv and/or herpes medication.

Eligibility criteria:
inclusion criteria: 1. subject must be 18 years or older at the time of screening 2. males, females, transgender male and transgender females 3. hiv positive 4. positive antibody to hsv- 1/and or hsv-2 5. if female of child baring potential, documented negative pregnancy test at the time of screening. exclusion criteria: 1. active opportunistic infection 2. current chemotherapy 3. unable to give informed consent

Keywords: hiv, herpes simplex 1, herpes simplex 2
cervical cancer screening in madagascar using smartphone photos and mobile telemedicine

Conditions: Cervical Precancer

Summary: the purpose of this study is to determine whether smartphone photos may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of via (d-via), on-site and off-site, compared with conventional via, for human papillomavirus (hpv) positive women.

background: cervical cancer is the leading cause of cancer death in females in madagascar. in this country, a large-scale screening of precancerous lesions with cytology is hardly possible, because of the lack of specialists and infrastructures. visual inspection of the cervix with application of 5% acetic acid (via) is an inexpensive alternative but very subjective since it depends on the examiner's experience. mobile telemedicine is a very promising tool in order to assist non-expert health-care workers in rural area for cervical cancer screening. objective: to assess if smartphone may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of via (d-via) compared with conventional via, for women testing positive for human papillomavirus (hpv). material and method: on-site health care workers will be trained in via. prescreened hpv-positive women will be referred to via evaluation, during which digital images with a smartphone (d-via) will be taken for later evaluation by a via specialist in geneva linked by telemedicine. women with positive via results will be treated with cold coagulation if eligible. histological results will be considered as gold standard. the results will be analyzed with cohen's kappa coefficient, mcnemar's test and bonferroni's adjustment for multiple comparisons to assess the performance of d-via. expected results: based on the results of this project, the investigators will develop an educational training and quality assurance program for health providers for via and so contribute to a scaling-up of cervical cancer control. an appropriate triage by via will reduce not only an excessive referral rate but also an excessive treatment delay, giving the possibility of a "screen (hpv), see (via/d-via), and treat" program in a single or two visits.

Eligibility criteria:
inclusion criteria: * 30-49 years * hpv-positive * attending the cervical cancer screening program conducted by the saint-damien health-care centre * understands study procedures and accepts voluntarily to participate by signing the informed consent form (icf) exclusion criteria: * previous hysterectomy * conditions that can interfere with visualization of the cervix * pregnancy \> 20 weeks * not able to comply with protocol study.

Keywords: cervical cancer hpv via screening smartphone telemedicine
trifocal diffractive intraocular lens after cataract extraction with phacoemulsification

Conditions: Refractive Errors

Summary: multifocal iols that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.multifocal iols improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal iols. however, halos and reduced contrast sensitivity have been associated with multifocal iols and are common reasons for patient's dissatisfaction.trifocal technology has been developed to create intermediate focus to overcome these difficulties. continuous reports of the visual outcomes of the finevision trifocal iols are encouraging.

monofocal iols, which provide effective distance vision, currently account for the majority of iols implantations. patients who have undergone cataract surgery with implantation of monofocal iol may require spectacles to perform near-distance (e.g., reading) or intermediate-distance (e.g., using a computer) tasks depending on their visual demandsmultifocal iols that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.multifocal iols improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal iols. however, halos and reduced contrast sensitivity have been associated with multifocal iols and are common reasons for patient's dissatisfaction.trifocal technology has been developed to create intermediate focus to overcome these difficulties. continuous reports of the visual outcomes of the finevision trifocal iols are encouraging.

Eligibility criteria:
inclusion criteria: * patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation. exclusion criteria: * any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and marfan's syndrome).