Kornimate/medical-research-clean huggingface dataset:
post-approval follow-up study of the ic-8 apthera intraocular lens (iol)

Conditions: Cataract; Presbyopia

Summary: the purpose of this study is to evaluate the long-term safety of the ic-8 apthera intraocular lens (iol).

a prospective, multi-center, open-label, single-group, post-approval follow-up study of ic-8 apthera intraocular lens (iol) subjects previously implanted with the ic-8 apthera iol in the investigational device exemption (ide) clinical study (g180075). all subjects will undergo one scheduled study visit, which is the 3-year post ic-8 apthera iol implantation visit. there is one study group: subjects enrolled in the us ide study (g180075) and implanted with the ic-8 apthera iol.

Eligibility criteria:
inclusion criteria: * enrolled in investigational device exemption (ide) g180075 study and implanted with the ic-8 apthera intraocular lens (iol) * able to comprehend and have signed a statement of informed consent * availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s) exclusion criteria: * there are no exclusion criteria for this study
integrated testing strategy for simultaneous detection of esr-1 and gbrca mutations via liquid biopsy in hr+/her2- metastatic breast cancer (mbc) patients,

Conditions: Breast Cancer, Metastatic

Summary: development and validation of an integrated testing strategy for simultaneous detection of esr-1 and gbrca mutations via liquid biopsy in hr+/her2- metastatic breast cancer (mbc) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm

breast cancer is the most prevalent type of tumor and the primary cause of cancer-related deaths among women globally (1). approximately two-thirds of these tumors express hormone receptors (hr) and lack her2 overexpression and/or amplification (2). throughout treatment, resistance frequently develops, with underlying mechanisms that remain largely undefined (3).

Eligibility criteria:
inclusion criteria: * participants must have a confirmed diagnosis of estrogen receptor-positive (er+) and/or progesterone receptor-positive (pgr+) breast cancer through histological and/or cytological examination by the local laboratory participants must exhibit her2-negative breast cancer 1. or 2+). if ihc is 2+, a negative in situ hybridization (fluorescent in situ hybridization (fish), chromogenic in situ hybridization (cish), or silver-enhanced in situ hybridization (sish)) test is required by local laboratory testing. * participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (cdk)4/6 inhibitors. however, the primary tumor should be treated according to the standard of care. * written informed consent must be signed and dated by the patient and the investigator prior to inclusion. exclusion criteria: * unable to provide written informed consent

Keywords: hr+/her2- brca
immunological functionnal test validation to predict melanoma metastatic patient response to checkpoint inhibitors

Conditions: Melanoma (Skin)

Summary: checkpoint inhibitor such as anti-ctla-4 and anti-pd-1 are known to block inhibitory signals and increase the immune antimutoral response. nivolumab and ipilimumab association is considered as a more efficient immunotherapy to treat advanced melanoma. this combined immunotherapy is also responsible of severe immunes toxicyties. identification of predictives biomarqueurs remains a challenge to predict the balance between tolerability and efficency. previous data showed that advanced melanoma patient had lower level of th1 cytokines that predict a less efficient immune system than healthy donors. the second point was that high level of th1 and th17 cytokines were correlate to a better tumor response. the last point was that patients with severe immune toxicity showed an increase of il-6 and il17a production. the investigators would like to identify the predictive values of th1, th2 and th17 at the begining and during the combined immunotherapy and correlate these cytokines levels secretions to a potential efficient tumor response or to the emergence of induced immunes toxicities. this study is an original approach using functionnal test to predict the balance between efficienty and tolerability.


Eligibility criteria:
inclusion * persone of major age, * advanced melanoma confirmed, * recist 1.1 disease, * first line treatment exclusion criteria: * occular and mucosal melanoma, * previous checkpoint inhibitor treatment, * active brain metastasis, * concomitant immunosuppressive treatment
investigation of the effects of balance discs with different surfaces used in balance education in children with cerebral palsy on proprioceptive sense and balance.

Conditions: Cerebral Palsy

Summary: this is a non-invasive prospective study investigating the effects of balance discs with different surfaces used in balance education in children with cerebral palsy on proprioceptive sense and balance.

many methods are used for balance training. one of them is balance discs. balance discs consist of smooth and rough surfaces. balance training is given to children with cerebral palsy on these two surfaces. thanks to its balance disc structure, it plays an active role in the development of balance, but there is a need for evidence about whether rough or smooth surfaces and training have superiority over each other. knowing the difference between the two surfaces will help the staff about which surface to use in the treatment and will be beneficial for the children. the aim of this study is to determine whether there is a difference between a rough and smooth surface in terms of improving proprioceptive sense and balance.

Eligibility criteria:
inclusion criteria: * diagnosed with cerebral palsy * diagnosed with motor developmental delay * 0-12 years old * levels 1 and 2 according to gmfcs * having bilateral and unilaterally affected spastic type cp * cooperate with assessments exclusion criteria: * botulinum toxin administration in the last 6 months * having had any surgical operation in the last 6 months * having dyskinetic, ataxic and hypotonic type cp * unable to cooperate with assessments
endogenous modulation of pain and stretch tolerance

Conditions: Pain Threshold

Summary: this study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (eih) and a conditioning painful stimulus (cpm) on passive joint range of motion, passive resistive torque and pain sensitivity. the study is a randomized, repeated-measures cross-over study.

the increase in range of motion following stretching is related to changes in the tolerance to stretch. the mechanistic relationships behind these changes in subject sensation are however unknown but could be related to endogenous modulation of pain.

Eligibility criteria:
inclusion criteria: * eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system. exclusion criteria: * substance abuse, history of neurological or mental disabilities, lack of ability to comply with instructions, delayed onset of muscle soreness.

Keywords: stretch tolerance stretching exercises exercise induced hypoalgesia
strengthening families living with hiv in kenya

Conditions: ART; Hiv; Trust; Depression, Anxiety; PTSD; Adherence, Medication

Summary: this study seeks to use a group-based microfinance/internal lending model to develop social capital among people with hiv in kenya. this will create a context to deliver validated curriculum targeting intimate partner violence, positive parenting, agriculture, small business entrepreneurship, group-interpersonal therapy, and other determinants of well-being and art adherence among people with hiv. the primary outcomes are viral suppression, art adherence, and common mental disorders.

it is anticipated that involvement in an internal savings and lending program will create social capital among people with hiv and their guardians (in case of adolescents w hiv). this social capital accrual will be leveraged to support and disseminate social skills (i.e. positive parenting, conflict resolution), economic skills (i.e. entrepreneurship, farming), and health skills (i.e. art adherence, retention in care to produce viral suppression). the overall outcome is improved social, health, and economic well-being.

Eligibility criteria:
inclusion criteria: criteria for inclusion of subjects include: * testing positive for hiv, confirmed by the ministry of health clinics * being at or older than 13 years of age * initiating care at a qualified ministry of health clinic in the catchment area, or intending to initiate care at such a clinic (see below for definition) * any gender, age (13+ years), and comorbid disease states * provide informed consent if adult, emancipated minor or mature minor * provide assent if minor with guardian, who must provide informed consent qualified clinical locations include * those with accessible and usable public land to convene weekly meetings, * no current program targeting families with hiv known to the ministry of health exclusion criteria: * refusal to participate * current participation in a similar program * residing in a location with a similar program targeting patients with hiv * not covered by inclusion criteria.
methadone vs. transdermal fentanyl for opioid withdrawal syndrome

Conditions: Delirium in the Intensive Care Unit

Summary: many patients in the general intensive care unit experience pain, as a result of an injury or underlying disease, surgery or an invasive procedure. pain management is an integral part of the treatment of critical patients, and this is first and foremost to alleviate their suffering. along with this, there is another therapeutic benefit in the form of relief from symptoms accompanying pain such as an increase in oxygen consumption, immune changes, hyper metabolism etc. currently, the pain treatment is based on a multi-modal analgesia approach in which drugs from several drug groups and different mechanisms are given, in order to relieve the pain by suppressing several nerve and inflammatory pathways. however, the treatment is still based on opioids, despite multiple adverse effects, including tolerance and withdrawal syndrome. opioids affect several receptors, mainly the µ receptor, in an agonistic, antagonistic or agonistic-antagonistic manner. the main opioids used for pain relief in the intensive care unit are morphine, fentanyl and remifentanil. after prolonged treatment with opioids, a sudden cessation of their use will result in a withdrawal syndrome which will manifest itself in delirium, restlessness, hypertension, anxiety, sweating, vomiting etc. (2-3). in order to avoid the withdrawal syndrome, the dose must be tapered down gradually, often using alternative long-term opioids, such as methadone and buprenorphine (-4). in the general intensive care unit at our institution, patients were treated with fentanyl patches in decreasing doses in order to lead the patient safely through the withdrawal syndrome, while trying to reduce the negative physiological effects as much as possible. in november 2021, we started using oral methadone instead of fentanyl patches, as a long acting opioid, as used in many icu's worldwide, in order to avoid withdrawal syndrome in patients who received continuous infusion of short-acting opioids, such as remifentanil, for long periods of time while being intubated and ventilated. in the past year since the methadone treatment was started, 50 patients were treated in the unit with methadone with the indication of relieving the withdrawal symptoms from opioids. we intent to investigate whether there is a difference in the incidence of delirium in patients who were treated with methadone vs patients who were treated with fentanyl patches in order to alleviate withdrawal symptoms.


Eligibility criteria:
inclusion criteria:all patients aged 18-99 who were treated with methadone in the intensive care unit from november 2021 to november 2022, as well as all patients aged 18-99 who were admitted to the intensive care unit from november 2020 to november 2021 and were treated with a fentanyl patch as a control group. - exclusion criteria:none -
pegaptanib sodium compared to sham injection in patients with recent vision loss due to macular edema secondary to central retinal vein occlusion (crvo)

Conditions: Retinal Vein Occlusion

Summary: eyetech pharmaceuticals inc. and pfizer, inc. are studying an investigational drug, macugentm, for the possible treatment of crvo. an investigational drug is one that has not been approved by the u.s. food and drug administration (fda). this investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye. the purpose of this study is to compare the safety and efficacy of a macugen™ injection to a "pretend" injection. in addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or pk). this study will involve approximately 90 people. people who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are macugen™ and one of which is a "pretend" injection.

this study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.

Eligibility criteria:
inclusion criteria: * crvo must have occurred within the past 6 months and be associated with macular edema determined by oct. * vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye. exclusion criteria: * presence of signs of old branch retinal vein occlusion (brvo) or crvo in the study eye or any other retinal vascular disease including diabetic retinopathy. * vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage. * prior pan retinal photocoagulation (prp) or sector scatter photocoagulation.

Keywords: crvo central retinal vein occlusion rvo retinal vein occlusion
anterior cruciate ligament-reconstruction: quadriceps tendon or hamstrings tendon? a prospective trial

Conditions: Ligament; Laxity, Knee; Rupture of Anterior Cruciate Ligament

Summary: the purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. using either autograft hamstrings tendon or a autograft quadriceps tendon.


Eligibility criteria:
inclusion criteria: * anterior cruciate ligament rupture exclusion criteria: * current malignant disease * rheumatoid arthritis * other knee ligament instability * obesity bmi \>30 * morbus bechterew
prevention of incisional hernia with mesh-suture at umbilical trocar site.

Conditions: Incisional Hernia of Anterior Abdominal Wall; Dehiscence Wound; Wound Infection

Summary: incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. however, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. the incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. in that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias. indurate trial aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.


Eligibility criteria:
inclusion criteria: * adults (at least 18 year-old patients) * umbilical trocar incision \> 10 mm * any of the following risk factors: bmi \> 27, absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease. exclusion criteria: * umbilical trocar incision \< 10 mm * umbilical hernia \> 10 mm * hernia surgery or incisional hernia at the trocar site * conversion to laparotomy * pregnancy * ascites or cirrhosis * clasification of the american anestesiology classification iv o v. * inadequate follow-up * patients included in any other trial * patients with life expectancy \< 12 months * patients with any kind of sensibility to duramesh
evaluation of treatment satisfaction in children with an allergy and who received an antihistamine

Conditions: Allergies

Summary: this is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an h1-antihistamine. the period of last taken medication will be observed to evaluate the global satisfaction of the parents and physician for this last treatment.


Eligibility criteria:
inclusion criteria: * children from 2-12 included * history of allergy * used an antihistamine within market authorization exclusion criteria: * child not yet treated for the presented allergy

Keywords: pediatric allergies antihistamines non-interventional
carbidopa/levodopa combined with behavioral therapy for the treatment of cocaine dependence

Conditions: Cocaine Dependence

Summary: cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. to date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. one such example is contingency management (cm) interventions in which nondrug rewards are used to compete with cocaine. recent evidence suggests that certain medications improve response to cm interventions, particularly agents that target dopamine reward systems in the brain. a promising dopamine-enhancing medication is levodopa. the study team has observed the strongest effects of levodopa when the medication is administered in the context of cm therapy, perhaps through mechanisms that enhance reward saliency. the proposed study is designed to further evaluate this promising treatment approach. cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. cm will be behavioral therapy platform for both treatment groups. the study will test the primary hypothesis that cm+levodopa will be more effective than cm+placebo in reducing cocaine use. this study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.


Eligibility criteria:
inclusion criteria: * between 18 and 60 years of age * meet diagnostic and statistical manual of mental disorders, 4th. edition (dsm-iv) criteria for current cocaine dependence. * be in acceptable health on the basis of interview, medical history and physical exam. exclusion criteria: * current dsm-iv diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine. * have a dsm-iv axis i psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe. * have significant current suicidal or homicidal ideation. * have medical conditions contraindicating levodopa/carbidopa pharmacotherapy. conditions include severe pulmonary disease (bronchial asthma, emphysema), cardiovascular disease (severe or history of myocardial infarction with residual arrhythmias), narrow angle glaucoma, melanoma, history of peptic ulcer, renal function impairment. * taking medications known to have significant drug interactions with levodopa/carbidopa (e.g., monoamine oxidase (mao) inhibitors, anticonvulsants, haloperidol, phenothiazines, selegiline, anesthetics). * currently or recently (last 3 months) treated for substance use or another psychiatric condition. * having conditions of probation or parole requiring reports of drug use to officers of the court. * impending incarceration. * pregnant or nursing for female patients. * inability to read, write, or speak english.

Keywords: cocaine, levodopa, contingency management
study of management of pasireotide-induced hyperglycemia in adult patients with cushing's disease or acromegaly

Conditions: Cushing's Disease; Acromegaly

Summary: the study was designed to investigate the optimal management of hyperglycemia developed during pasireotide treatment in participants with cushing's disease or acromegaly, which was not manageable with metformin. this was a phase iv, multi-center, randomized, open-label study. eligible patients started pasireotide subcutaneously (s.c.) for cushing's disease and pasireotide lar (long-acting release) for acromegaly. participants being treated with pasireotide s.c or lar at screening were eligible as long as they met protocol criteria during the screening period. if previously normo-glycemic participants experienced an increase in their fasting blood glucose and met the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. if they continued to have elevated blood glucose above target on metformin within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks. participants who continued to receive clinical benefit after completing the core phase could enter an optional extension phase if pasireotide was not commercially available in their country or a local access program was not available to provide drug. patients continued in the extension phase until the last participant randomized in the core phase completed 16 weeks of treatment post-randomization.


Eligibility criteria:
inclusion criteria: * patients greater than or equal to 18 years old * confirmed diagnosis of cushing's disease or acromegaly exclusion criteria: * patients who require surgical intervention * patients receiving dpp-4 inhibitors or glp-1 receptor agonists within 4 weeks prior to study entry * hba1c \> 10 % at screening * known hypersensitivity to somatostatin analogues other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cushing's disease acromegaly pasireotide hyperglycemia
reinforcement of rectal anastomosis-rora

Conditions: Rectal Cancer

Summary: the anastomotic leaks are multivariable in its origin. the incidence varies among different centers between 4% and as high as 25%. the impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system. prolonged hospital stay (los), invasive treatment and intensive care are the consequences. the future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. the goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.

the rationale is to explore if the procedure of reinforcement with hemopatch and bringing more mechanical strength over an extended area around the anastomosis thus lowers the incidence of clinical anastomotic leaks. the characteristics of hemopatch, with its structural properties such as flexibility and tissue adhesion are suitable for this purpose.

Eligibility criteria:
inclusion criteria: * rectal surgery with anastomosis below 10 cm from anal verge exclusion criteria: * none