Kornimate/medical-research-clean huggingface dataset:
kn046 combined with ningatinib in the treatment of advanced hepatocellular carcinoma

Conditions: Advanced HCC

Summary: this study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of kn046 combined with ningatinib in subjects with advanced hepatocellular carcinoma.

the study consists of dose escalation and dose expansion, the mtpi-2 (modified toxicity probability interval) will be used for dose exploration. the preset dose of kn046 is 5 mg/kg q3w and the preset dose of ningatinib is 10 mg (rapid titration), 20 mg qd, 30 mg qd, and 40 mg qd.dose expansion will be divided into two cohorts, cohort 1 will enroll subjects who have not received system therapy and cohort 2 will enroll subjects who have previously received at least first-line system therapy.

Eligibility criteria:
inclusion criteria: * has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology； * barcelona clinic liver cancer (bclc) stage b or c； * ecog performance status: 0-1； * child pugh score≤7； * enough organ function； * has at least one measurable lesion based on recist 1.1； * life expectancy ≥3 months； * patients must be able to understand and willing to sign a written informed consent document； exclusion criteria: * fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc; * past or present hepatic encephalopathy; or budd-chiari syndrome; or tumor thrombus invasion at the main portal vein (vp4), inferior vena cava or heart involvement; * subjects who have previously received immune checkpoint inhibitors (such as anti-pd-1/l1, ctla-4, etc.); or have a history of ≥ grade 3 immune-related adverse reactions; or hyperprogressive after immunotherapy previously； * subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration; * subjects who need corticosteroids or immunosuppressive agents for systemic therapy; * any previous or current active autoimmune disease or history of autoimmune disease; * history of liver transplantation; * history of interstitial lung disease or non-infectious pneumonia; * history of allergic reactions to related drugs; * lvef\< 50% or lln * clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy; * with serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable; * subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months; * untreated hepatitis infection: hbv dna\>2000iu/ml or10000 copies/ml, hcv rna\> 1000copy/ml, both hbsag and anti-hcv body are positive; * evidence of active pulmonary tuberculosis (tb); * positive test of immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids); * pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;
rad 1501: a trial of virtual cone trigeminal neuralgia radiosurgery

Conditions: Trigeminal Neuralgia

Summary: to determine the feasibility of frameless virtual cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

to determine the feasibility of frameless virtual cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. to measure pain relief after virtual cone radiosurgery utilizing the barrow neurologic institute pain intensity score (bni).

Eligibility criteria:
inclusion criteria: * patients with trigeminal neuralgia pain that is not well controlled despite medical management (bni 4 or bni 5) * patients must have an ecog status of 0, 1, or 2 * patients must be at least 18 years of age * life expectancy must be greater than 12 months * mri of brain within prior 12 months to confirm lack of other causes of facial pain * all patients must be given written informed consent exclusion criteria: * patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons * patients with atypical trigeminal neuralgia or headache pain syndromes * patients with pain associated with multiple sclerosis or base of skull tumor * patients with medical contra-indications to mr imaging (e.g. pacemaker)

Keywords: radiosurgery (rs) trigeminal neuralgia (tgn)
safety and efficacy study of iv artesunate to treat malaria

Conditions: Malaria

Summary: the purpose of this study is to determine how gmp iv artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.

this is an unblinded non-randomized phase ii pharmacokinetic study of a new gmp formulation of intravenous artesunate. artesunate has been used throughout asia and africa for many years. its overall efficacy associated with the ability to lower parasitemia is well established. to date, pharmacokinetic studies have not been done in africa using gmp (good manufacturing practices)-produced drug. the objective of this study is to show that gmp iv artesunate rapidly clears parasites in adult kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (asians and north americans).

Eligibility criteria:
inclusion criteria: * adult male \& non-pregnant females, 18-65 years * fever, defined as \>37.5ºc, during the current illness, or history (within the last 48 hours) of fever. * diagnosis of falciparum malaria, greater than or equal to 200 parasites/ul * able to communicate well with the investigator and to comply with the requirements of the entire study. * willing to be admitted for the period of drug administration and/or to follow up (return to hospital) * provision of the written informed consent to participate as shown by a signature on the informed consent form. exclusion criteria: * administration of any investigational drug in the period 0 to 16 weeks before entry to the study. * the use of any medication during the period 0 to 14 days (prescribed drugs) or 0 to 5 days (otc) before entry to the study (including herbal or dietary supplements), except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study. * existence of any surgical or medical condition that, in the judgment of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug. * history of serious adverse reaction or hypersensitivity to study drug or follow on treatment. * mixed malaria infection (malaria other than falciparum malaria mono-infection as detected by screening blood smear) * severe falciparum malaria (as defined by the who; attachment 1). * donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study, * transfusion of blood within past 30 days. * refusal to prevent pregnancy during the 14 days of the trial * pregnancy as defined clinically or by a positive urine bhcg at the time of screening, or nursing mothers. * laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. specifically, the following will serve as exclusionary lab values: * creatinine \>1.4 x uln (\>2.0 mg/dl) * glucose \<lln (65mg/dl) * ast, alt \>3x uln (120 u/l)

Keywords: uncomplicated malaria gmp artesunate
a clinical trial to evaluate the safety and efficacy of an implantable wireless brain-computer interface（bci）system neo in patients with tetraplegia

Conditions: Tetraplegia; Spinal Cord Injuries (SCI)

Summary: to evaluate the safety and efficacy of a minimally invasive wireless implantable brain-computer interface (bci) system neo in patients with tetraplegia and to provide a basis for product registration. through brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years old, no restriction on gender. 2. tetraplegia caused by cervical spinal cord injury. 3. score of ≤1 on either the ball grasp or water pouring tasks of the arat (action research arm test). 4. muscle strength of finger flexors \< grade 3 according to isncsci (international standards for neurological classification of spinal cord injury). 5. score of ≥2 for "hand to mouth" on arat; scores of ≥1 for both "hand to top of head" and "hand to behind the head." 6. neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified. 7. diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment. 8. normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial. exclusion criteria: 1. without the consent of the patient or the patient's legal guardian. 2. presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant's ability to engage in training. 3. requires ventilator support. 4. baclofen dosage \>30 mg/day. 5. received botulinum toxin injections in the upper limb, neck, or hand within 6 months prior to enrollment, or received stem cell therapy within 1 year. 6. high risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000. 7. patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system. 8. any unstable or significant medical condition that may interfere with study procedures or confound the evaluation of study endpoints, such as depression, mood disorders, or other cognitive impairments. 9. diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome. 10. autoimmune-mediated spinal cord dysfunction/injury. 11. history of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy. 12. peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies). 13. in the investigator's opinion, the study is unsafe or inappropriate for the participant, or the participant is unlikely to comply with the study follow-up schedule.

Keywords: bci, neo, tetraplegia spinal cord injury
smart-cpt for ptsd/concussion implementation

Conditions: PTSD; Concussion, Mild

Summary: the clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing smart-cpt, a treatment targeting the two primary factors leading to poor outcomes following concussion, in veterans. it will test effectiveness and broad implementation feasibility of smart-cpt compared to standard cognitive processing therapy (cpt).


Eligibility criteria:
inclusion criteria: * ptsd diagnosis; * mild tbi sustained greater than three months prior to enrollment; * cognitive complaints; * not medicated or stable on prescribed psychiatric medication for at least 6 weeks prior to study enrollment with no anticipated/pending medication changes; * english literacy. exclusion criteria: * mtbi sustained less than 3 months previously; * history of moderate, severe, or penetrating tbi; * history of other significant neurological condition unrelated to tbi; * severe psychiatric disturbance expected to interfere with successful completion of the study; * current severe alcohol or other substance use disorder; * suicidal intent or attempt within the previous month; * current homicidal ideation; * impaired decision making capacity; * prior completion of five or more sessions of cpt or cognitive rehabilitation; -concurrent participation in other intervention studies for ptsd or tbi; * life threatening or unstable medical illness; * inability to read; * dementia
the happy older latinos are active (hola) health promotion study in hiv-infected latino men

Conditions: Human Immunodeficiency Virus; Cardiometabolic Risk

Summary: the purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older latino adults living with hiv. the investigators expect that the participant will be in this study for seven months. participants will be interviewed and asked to take part in walking groups.


Eligibility criteria:
inclusion criteria: * are latino (self-identified); * are age 50+ years; * are male; * are hiv infected but are virologically suppressed (viral load \<200 copies/ml); * volunteer informed consent; * have medical clearance by a physician; * expect to stay in miami for the next 6 months; and * have documented risk of cardiometabolic disease. exclusion criteria: * diabetes diagnosis; * at baseline meet criteria for current major depressive disorder or generalized anxiety disorder; * meet criteria for current alcohol or other substance abuse disorders; * have a lifetime history of bipolar disorder or other psychotic disorder; * have a diagnosis of any neurodegenerative disorder or dementia (parkinson's disease, alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a mini mental status exam score \<24; * have contraindications to physical activity outlined in the american college of sports medicine standards; * have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the paykel questionnaire); * are unable to complete 10 m walk test; * currently residing in a nursing or group home; * have a terminal physical illness expected to result in the death within one year; * have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.
a pilot study of hand function in children with cerebral palsy undergoing intensive neurophysiological rehabilitation

Conditions: Cerebral Palsy

Summary: the aim of the study is to observe the effects of intensive neurophysiological rehabilitation system on hand function in children with spastic cerebral palsy.

intensive neurophysiological rehabilitation system is a novel multimodal rehabilitation approach that combines different treatment modalities. the treatment course lasts for 2 weeks with daily therapy up to 4 hours. main treatment programs include biomechanical correction of the spine, extremity joint mobilization, physical and occupational therapy, reflexotherapy, special massage system, rhythmical group exercises, mechanotherapy and computer games therapy and some other. preliminary observational studies indicate an improvement of gross and fine motor functions in children with cerebral palsy after the treatment course. the aim of the study is to observe the effects of intensive neurophysiological rehabilitation system on hand function in children with spastic cerebral palsy. about 50 patients with spastic forms of cerebral palsy with mild to moderate impairment of hand function (level i to iii according to manual abilities classification system) would be evaluated before and after the two-week treatment course. this study may help to generate the hypothesis of the effects of the intensive treatment course on hand function abilities and to prepare a future randomized controlled trial.

Eligibility criteria:
inclusion criteria: * spastic cerebral palsy: uni- and bilateral * age: 6-15 * level i-iii according to manual ability classification system (macs) exclusion criteria: * ataxic or dyskinetic cerebral palsy * non-cooperative behavior * moderate to severe mental deficit * severe contractures of upper extremity joints * upper extremities trauma within 6 months prior to the study * previous hand surgery * epilepsy with frequent seizures

Keywords: cerebral palsy rehabilitation hand
ecg signal collection from long qt syndrome, wide qrs complexes, heart failure, and cardiac resynchronization patients

Conditions: Long QT Syndrome; Wide QRS Complexes; Heart Failure; Cardiac Resynchronisation

Summary: the purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long qt syndrome, heart failure, cardiac resynchronization therapy or wide qrs during a routine outpatient assessment. the ecgs collected will be used as test signals by the sponsor for the development of a subcutaneous implantable defibrillator

the objective of this study is to record standard ecg signals is each of the 4 patient populations together with signals from 4 non-standard surface positions when these patients attend the outpatient department for follow-up. the non-standard electrode positions mimic the positions of the subcutaneous electrodes of the subcutaneous implantable defibrillator (s-icd) system in development by cameron health. the collection of these signals will allow bench testing of the algorithms proposed for the s-icd system. additionally, it will allow a comparison of the response of different defibrillators to these same signals to asses how each would treat a particular rhythm.

Eligibility criteria:
inclusion criteria: * patients attending the outpatient for routine follow-up for their cardiac disease or to have an implanted device follow-up exclusion criteria: * patients unable or unwilling to provide informed consent * any condition which precludes the subject's ability to comply with the study requirements, including completion of the study

Keywords: s-icd icd ecg signals resting
a study of pemetrexed in the treatment of patients with advanced metastatic cancer of the liver

Conditions: Liver Cancer

Summary: this study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy. * patient must have measurable disease * patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy * prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment. * prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms. exclusion criteria: * patients who have had prior therapy with pemetrexed. * patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. * patients who have received radiation to more than 25% of marrow
myocardial infarction triggers and onset in jordan study 2

Conditions: Triggers of Acute Myocardial Infarction; Time of Onset of Acute Myocardial Infarction; Long-term Prognosis After Acute Myocardial Infarction

Summary: a previous study (mintor 1) found that 43% of st elevation myocardial infarction (stemi) patients in jordan had a triggering events. fifteen years later, with changing demographics and in the post covid-19 time, we believe that triggered acute myocardial infarction might have changed in incidence and nature of the triggering events.

the onset of acute st elevation myocardial infarction (stemi) is a complex interplay of internal circadian factors and external physical and emotional triggers. these interactions may lead to rupture of an often nonocclusive vulnerable atherosclerotic coronary plaque with subsequent formation of an occlusive thrombus. the onset of mi has a distinct pattern, with peak incidence within the first few hours after awakening, on certain days of the week, and in the winter months. physical and emotional stresses are important triggers of acute cardiovascular events including mi. triggering events, internal changes, and external factors vary among different geographical, environmental, and ethnic regions. life-style changes, pharmacotherapy, and psychologic interventions may potentially modify the response to, and protect against the effects of triggering events. mintor 1 showed that 43% of 900+ jordanians with stemi were exposed to a physical or emotional triggers before the onset of the heart attack. it was also found that friday was the day of the week that witnessed more mis that other days of the week and that 55% of mis occurred in the early morning hours. it is largely unknown if the frequency and types of triggers, onset time of mi, day with peak of mi incidence have changed over time in jordan with changing population demographics, especially in the post covid-19 times. these patients will be followed up for 3 years for occurring of incident vascular events.

Eligibility criteria:
inclusion criteria: * age 18 years and above. * documented acute st elevation myocardial infarction. * willing to sign an informed consent. * available contact numbers for a 3-year follow up exclusion criteria: * unwilling to sign an informed consent.

Keywords: acute myocardial infarction acute st-segment elevation myocardial infarction triggers of acute myocardial infarction middle east prognosis
modulating the vaginal microbiome after implantation failure

Conditions: Implantation Failure; Infertility, Female; Vaginal Flora Imbalance

Summary: vaginal microbiome has in studies shown a link with the outcome of fertility treatment. the investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal supplements.


Eligibility criteria:
inclusion criteria: * unfavorable vaginal microbiome using artpreds test * non-smoker exclusion criteria: * use of oral antibiotics oral probiotics between diagnosis and inclusion in the study * pregnancy at inclusion * allergy towards study drugs

Keywords: infertility, female vaginal microbiome