cyrilzakka/clinical-trials huggingface dataset:
Role of the Stress in the Development of the Metabolic Syndrome

The purpose of this study is determine the incidence of metabolic syndrome (MetS) in people of high risk, of 40 or more years and attended in the Primary Care. Evaluating the association between anxiety, depression, quality of life and the vital stressful events, and the development of the metabolic syndrome in general population.

Our hypothesis is that population of the cohort with bigger degree of stress will develop earlier the metabolic syndrome.

If our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing in a future interventions on these factors of risk to prevent or to decrease the incidence of this syndrome in the Primary Care.


Eligibility Criteria:
Inclusion Criteria:

* Both genders, elderly than 40 years
* Subjects with 1 or 2 criteria of NCEP-ATPIII set for Metabolic Syndrome

  * Abdominal waist \> 102 cm ( men ) or \>88 cm ( women )
  * Blood Pressure ( \>130/85 mmHg ) ( or else pharmacologic treatment of hypertension )
  * Hypertriglyceridaemia ( \>150 mg/dl ) ( or else pharmacologic treatment )
  * HDL-cholesterol \<40 mg/dl ( men ) or \<50 mg/dl ( women ) ( or else treatment )
  * Fasting glucose \> 110 mg/dl.

Exclusion Criteria:

* Metabolic Syndrome (NCEP-ATPIII defined)(3 criteria of above mentioned)
* Severe or terminal disease
* Severe mental disease that difficulties the follow-up
Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

This is a prospective, multi-centre, cross sectional observational study to determine the prevalence of ocular surface disease (OSD) in glaucoma patients, nationwide. The study also analyses sub group of OSD prevalence, stratified according to the treatment types (i.e. preserved, preservative-free, and combination of preservative-free and preserved eyedrops), and illustrates the patient perspective on OSD.

For this prospective, multi-centre, cross sectional observational study, patients who attend routine eye examination at the medical institutions and who have been diagnosed with primary open-angle glaucoma, primary angle-closure glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or ocular hypertension will be studied. The medical institutions are selected across different regions of Malaysia to assess the nationwide prevalence of OSD in glaucoma patients. The routine assessments include Corneal Evaluation, Tear Break-Up Time (TBUT), Hyperemia and Schirmer's test whereby the data from these assessments will be collected and analyzed. The study will also includes Symptom Evaluation and Questionnaire feedback.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age of 21 years or older and those who can provide informed consent.
* 2) On anti-glaucoma medications for \>6 months
* 3) IOP ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
* 4) If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
* 5) A best-corrected visual acuity score of 6/36 on the Snellen Chart, or better in each eye.

Exclusion Criteria:

* 1) Those with secondary ocular hypertension or glaucoma
* 2) Those with severe visual field disorder (mean deviation of 20 dB or worse)
* 3) Those with a history of ocular surgeries (intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
* 4) Those with a history of glaucoma surgery
* 5) Those with a history of corneal refractive surgery
* 6) Those with severe dry eye associated with systemic disorders, or in need of drugs to treat dry eye
* 7) Those with ocular allergy, ocular infection or ocular inflammation
* 8) Those using eye drops for other ocular comorbidities
* 9) Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment)
* 10) Female patients who are pregnant, nursing or lactating
* 11) Those who use contact lenses
* 12) Any corneal abnormality or other corneal comorbidity condition preventing reliable applanation tonometry
* 13) Those on oral antihistamine, antipsychotic or anti-depressant drugs.
Dosing of Ketorolac in the Emergency Department

The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

Eligibility Criteria:
Inclusion Criteria:

\> 18 y/o

Exclusion Criteria:

pregnant allergic other contraindication
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 and ≤75 years old on the day of signing the ICF
* At least 1 measurable lesion per RECIST v1.1
* Expected survival ≥3 months
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
* Adequate organ function
* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms

Exclusion Criteria:

* Active or pre-existing autoimmune diseases that may relapse
* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage
* Allergies to any component of ALK201 or other monoclonal antibodies
* Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
* Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening
* Vaccinated with live vaccines within 4 weeks prior to the first dose

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia

To explore and compare antihyperalgesic effects of Dexmedetomidine,Nalmefene,and a combination of both received before anesthesia induction.

To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.

There are a dramatically increasing number of evidences that administration of the potent, ultra-short-acting opioid remifentanil seems to cause opioid-induced hyperalgesia (OIH) more frequently and predictably compared with the others, likely due to its rapid onset and offset. Therefore, prophylaxis of remifentanil induced hyperalgesia is indispensable to postoperative comfort and satisfaction.

There is no denying the fact that OIH is related to central glutaminergic system and N-methyl-d-aspartate(NMDA)receptor-activation induced central sensitization. Dexmedetomidine is an 2-adrenergic agonist that has been shown to synergize with opioids. Dexmedetomidine inhibits NMDAR excitability by reducing the phosphorylation of N-methyl-D-aspartate receptor 2B subunit phosphorylation of spinal dorsal horn induced by remifentanil, thereby achieving the goal of reducing OIH. Nalmefene is a pure opioid receptor antagonist that antagonizes the Mu receptor, alleviating the central sensitization of NMDA, thereby reducing OIH. At the same time reported in the literature, opioid receptor has a bimode：On the one hand can be mediated by Gs protein-mediated pain, respiratory depression, nausea and vomiting, etc ; on the other hand can be coupled with Gi / Go protein mediated analgesic effect. Low-dose nalmefene (\<1.0ug / kg) and other opioid receptor antagonists can antagonize the role of Gs protein-coupled opioid receptors, blocking the pathway of opioid excitatory effects, thereby reducing the incidence of adverse reactions.The following study is carried out to evaluate whether dexmedetomidine combined with nalmefene can be safely and effectively applied to prevent postoperative hyperalgesia induced by remifentanil in patients undergoing Laparoscopic gynecological surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are scheduled to undergo Gynecological surgery under a short general anesthesia of 1-3 hours.
2. American Society of Anesthesiologists physical status is I-II.
3. Written informed consent was obtained from all the subjects.

Exclusion Criteria:

1. Subject has a diagnosis of Coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency.
2. Subject has a diagnosis of Severe high blood pressure , diabetes, obesity (BMI\>30).
3. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 h before surgery.
4. .Subject has Pregnancy, psychiatric disease.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Inability to understand the Study Information Sheet and provide a written consent to take part in the study.
Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.


Eligibility Criteria:
Inclusion Criteria (Study A07\[NCT00857415\]):

* Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
* Can tolerate a 10 minute PET scan; and
* Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Exclusion Criteria (Study A07\[NCT00857415\]):

* Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
* Have any major, focal structural loss of brain matter;
* Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
* Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
* Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
* Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
* Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
* Are females of childbearing potential who are pregnant or not using adequate contraception.
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens.

For every five patients randomized, two will receive treatment number 1 (irofulven + prednisone), two patients will receive treatment number 2 (irofulven + capecitabine (Xeloda®) + prednisone), and one patient will receive treatment number 3 (mitoxantrone + prednisone). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, patients must meet the following criteria:

1. Cancer of the prostate confirmed by a biopsy sample.
2. 18 years of age or older.
3. Disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (CT) scan, bone scan or clinical examination.
4. At least one prior hormonal treatment with documented disease progression during hormone therapy.
5. One previous line of chemotherapy that included Taxotere® (as monotherapy or in combination). This could be in addition to estramustine single agent therapy.
6. Disease progression during prior Taxotere-based therapy or within 3 months of discontinuing.
7. Recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery.
8. Recovered from any toxic effects associated with other investigational drugs, if applicable.
9. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.

Exclusion Criteria:

Patients cannot participate in the study if any of the following apply:

1. Unable to use prednisone.
2. Prior treatment with irofulven, capecitabine (Xeloda), continuous/protracted infusion 5-FU (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone.
3. Ongoing treatment with a corticosteroid at a prednisone-equivalent dose \> 10 mg/day.
4. More than 1 prior treatment with either 153Sm or 89Sr, or radioisotope treatment within 8 weeks prior to entering this study.
5. Initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. Pre-existing treatment with bisphosphonate agents is to be continued during this study.
6. Treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail and answer any questions. Patients can then decide if they wish to participate.
Drug Interaction Study Between Raltegravir And UK-453,061

The purpose of this study is to estimate the effect of steady state raltegravir on the steady state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state pharmacokinetics of raltegravir.


Eligibility Criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive; Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Development of a Minimally Invasive Seizure Gauge

The researchers are trying to assess changes in physiological signals before and during seizures.

Subjects that are undergoing video EEG monitoring in their home for their epilepsy at Seer Medical will be consented to participate in this study for a minimum of two days and/or the duration of their monitoring period for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys.

When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.

Eligibility Criteria:
Inclusion Criteria:

* Patients with epilepsy undergoing scalp EEG for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures
* Patients of age 18 or above

Exclusion Criteria:

* Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).


Eligibility Criteria:
Key Inclusion Criteria:

* If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be \< 50 copies/mL.
* At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
* Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows:

  * A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
  * A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
  * A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
* No documented or suspected resistance to bictegravir (BIC).
* Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Key Exclusion Criteria:

* Prior use of, or exposure to, lenacapavir (LEN)
* Active tuberculosis infection
* Chronic hepatitis B virus (HBV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy

The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.

This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-\[5-amino-4-oxopentanoate\]) and placebo, for the treatment of AK with PDT.

Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent.
* Men and women between 18 and 85 years of age.
* 4-8 AK lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth were not considered for treatment during the planned study.
* Target AK lesions were to be discrete and quantifiable; adjacent AK lesions were to show a minimum distance of 1.0 cm from one another.
* Confirmation of AK by biopsy taken at screening.
* Free of significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment region that could have caused difficulty with examination or final evaluation.
* Willingness to stop the use of moisturizers and any other topical treatments within the treatment region.
* Good general health condition.
* Healthy subjects and subjects with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) were permitted to be included in the study if the medication taken for the treatment of the disease did not match an exclusion criterion or was not specified as prohibited concomitant medication.
* No extensive sunbathing or solarium use during the trial.
* Negative pregnancy test at screening.

Main exclusion criteria:

* Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations
* Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult
* Presence of photodermatoses
* Presence of other tumors in the treatment areas within the last 4 weeks
* Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening
* Current treatment with immunosuppression therapy
* Hypersensitivity to porphyrins
* Presence of porphyria
* Presence of inherited or acquired coagulation defect
* Any topical treatment within the treatment area within 12 weeks before PDT1 (first PDT Treatment)
* Topical treatment with ALA or MAL outside the treatment area during participation in the study
* None of the specified systemic treatments within the designated period before PDT1
Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

HealthLoop is a mobile-device application (cell phone App) that allows physicians to monitor for signs and symptoms of potential adverse events, and communicate with patients during the postoperative recovery process. The platform enables doctors to identify patients at risk of decline in the follow up period. Patients are engaged through mobile and web-based surveys, reminders, and information personalized to the patient's specific condition or treatment plan. Alerts are sent to physicians about patients who are at risk of treatment failures, complications, or hospital readmissions. Physicians are informed if patients are trending toward an adverse outcome based on the patient's responses.

Patients who choose to participate in this Research Study will be randomly assigned (like a flip of a coin) to one of two groups. Group A will receive standard, routine medical care. Group B will be asked to use the HealthLoop application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients will not be able to choose which group they will be in.

Eligibility Criteria:
Inclusion Criteria:

* Primary total hip arthroplasty or total knee arthroplasty patient
* Personal or surrogate consent to participate
* Patient has internet access or mobile access with a valid email address at the time of enrollment

Exclusion Criteria:

* Staged arthroplasty procedure within 6 months of the index procedure
* Abandoned email address of record
* Less than 14 days until date of surgery