cyrilzakka/clinical-trials huggingface dataset:
The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia

Excessive inflammation, production of free radicals and vascular injury are considered the main contributors to the development of organ dysfunction in patients with severe infections and sepsis. The endogenously produced unconjugated bilirubin is one of the most powerful anti-oxidants of the human body and the administration of bilirubin in animal experiments has been shown to protect from inflammation-induced death. However, bilirubin for human administration is not yet available. Therefore, we wish to exploit one of the side effects of atazanavir, a registered drug currently used as a protease inhibitor in HIV infected patients. Atazanavir inhibits the enzyme UPD glucuronosyl transferase enzyme (UGT1A1) and therefore increases endogenously produced bilirubin levels moderately. To study the effect of hyperbilirubinemia during inflammation we will apply the human endotoxemia model. The human endotoxemia model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting. We hypothesize that atazanavir-induced hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human endotoxemia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Use of any medication or anti-oxidant vitamin supplements.
* History of allergic reaction to atazanavir.
* Smoking.
* Previous spontaneous vagal collapse.
* History, signs or symptoms of cardiovascular disease.
* (Family) history of myocardial infarction or stroke under the age of 65 years.
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
* Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90).
* Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50).
* Renal impairment (defined as plasma creatinin \>120 μmol/l).
* Liver enzyme abnormalities or positive hepatitis serology.
* Subjects with a total bilirubin level above 15 μmol/L and a normal direct bilirubin level suggesting Gilbert Syndrome.
* Positive HIV serology or any other obvious disease associated with immune deficiency.
* Febrile illness in the week before the LPS challenge.
* Participation in a drug trial or donation of blood 3 months prior to the LPS challenge.
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists

This clinical utility study is based on a review of real but de-identified and randomized patient cases and aims to evaluate radiation oncologist's treatment recommendations before and after reviewing the results provided by the Decipher test. The primary intent is to help guide development and design of future clinical utility studies for Decipher.

Patient cases were selected using existing data generated from patient specimens collected in a separate IRB approved protocol, in which pathological specimens were tested to generate a test result for comparison to outcomes. Those test results are presented in this study, but not the individual patient outcomes. Physicians participating in this current study did not provide care for any of the subjects in the previous study. Cases are presented to physicians in a randomized order and in a form that prevents the patients from being identified, directly or indirectly.

High risk patient cases were selected to reflect a range of clinicopathological variables and were further stratified based on the Decipher predicted probability of developing metastasis 5 years after RP and 3 years after BCR (as shown in the table below). High (low) Decipher (GC) risk was defined as a 5- or 3-year predicted probability of metastasis greater (less) than 6% for the adjuvant setting and greater (less) than 18% for the salvage setting.

Eligibility Criteria:
Case Inclusion Criteria:

Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:

Pathological Gleason score ≥ 8 or Gleason score 7 with primary pattern 4; Pathological stage T3a (= Extracapsular extension) or T3b (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery Detectable PSA, defined as failure of PSA to fall to undetectable, or PSA detectable and rising on 2 or more subsequent determinations

Case Exclusion Criteria:

Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment prior to radical prostatectomy (radiation, hormone, chemotherapy)
The Neuroimage Study of the Neuromuscular Disorders.

The neuromuscular disorders could be briefly divided to neuropathy, myopathy, motor neuron disease, and neuromuscular junction disorder. In the past, the evaluation of the neuromuscular disorders depended on several ways (ex. electrodiagnostic studies and biopsy) to evaluate the pathophysiology and the pathological change. However, due to the issue of resolution, few image studies were available to evaluate the structure for clinical practice. With the growing techniques, there are two ways to see the nerve and muscle in vivo, the magnetic resonance imaging (MRI) and the ultrasonography. The availability of the machine, the high cost, inability to change the position for dynamic views of the nerves, and the relative invasion considering the large energy penetrating the patient might limit the clinical use of MRI. The nerve ultrasonography is a safe and easily available technique. The development of high-frequency transducers has led to an improvement in the resolution of ultrasonography and enables the exploration of peripheral nerve and muscle structural changes. In additional to evaluate the morphological changes, ultrasonography has been used extensively for the vessel status assessment through duplex ultrasound. In present study, we will apply variable approaches, including to muscle, nerve, and skin biopsy, electrophysiological study, quantitative sensory testing, autonomic functional tests, pain evoked potentials, MRI, and ultrasonography to integrally investigate the different aspects of neuromuscular disorders. The results of the study will provide integrated insights of (1) the neurophysiology of nerve and vessels and (2) pathogenesis of different neuromuscular disorders.

This is a prospective observational study which will be performed in both the inpatient and outpatient setting of National Taiwan University Hospital. Patients age at least 20 years, and have been diagnosed as neuromuscular disorders by the neurologist. Patients who are unable to read the questionnaire, fail to accept all the examinations, and refuse to provide inform consent are excluded from this study. The normal group (age at least 20 years) who had no neurological symptoms or signs were also recruited. The neurological examination performed by the board neurologist must be normal in the normal group.

Different interventions were performed periodically to see the serial change. The interval between the interventions is within 1 month and there is no new symptoms or any events.

Eligibility Criteria:
Inclusion Criteria (Neuromuscular group):

* been diagnosed as neuromuscular disorders by the neurologist
* at least 20-year-old

Inclusion Criteria (Normal group):

* no past history of neurological disorders.
* The neurological examination performed by the board neurologist must be normal
* at least 20-year-old

Exclusion Criteria (Neuromuscular and normal group):

* Patients who are unable to read the questionnaire, fail to accept all the examinations, and refuse to provide inform consent
A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. Participants will be randomized to receive either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1 of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. After progression, participants in the bevacizumab arm may continue to receive bevacizumab in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of the disease (Stage IIIb, IV or recurrent disease)
* Mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Evidence of tumor invading major blood vessels on imaging
* Central nervous system (CNS) metastases, even if previously treated
* History of hemoptysis in the 3 months prior to enrollment
* History or evidence of inherited bleeding diathesis or coagulopathy
* Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy
* Clinically significant cardiovascular or vascular disease
* Malignancies other than non-small cell lung cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent
Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of Depression

The purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. Behavioral activation therapy targets changes in behavior as a method for improving a depressed individual's thoughts, feelings, and overall quality of life. This study is designed to test whether a computerized brain exercise called cognitive control training can enhance the effects of a 5-session behavioral activation therapy program. CCT has been shown to reduce depressive symptoms in two other studies, but it has not yet been combined with behavioral activation therapy. The investigators hypothesize that individuals assigned to the behavioral activation plus cognitive control training condition will demonstrate reduced depressive symptoms from pre to post treatment compared with those assigned to the behavioral activation plus computerized control condition. The investigators hypothesize that these gains will be maintained at one-month follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ages 18-65
2. Primary psychiatric diagnosis of major depressive disorder
3. Ability to read and speak English sufficiently to complete study procedures
4. If taking antidepressant or anxiolytic medication, participants must be taking a stabilized dose for a minimum period of at least 8 weeks prior to entry into the study
5. Willingness and ability to comply with the requirements of the study protocol

Exclusion Criteria:

1. Lifetime history of bipolar disorder or psychotic disorder
2. Neurological disorder such as Parkinson's disease or traumatic brain injury
3. Alcohol or substance dependence within the past 6 months
4. Substantial suicide risk
5. Concurrent psychotherapy initiated within 2 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the depression other than general supportive therapy
6. Current use of antipsychotics, stimulants, or modafinil
GLP-1 Response in Women With PCOS and Prediabetes

Women with PCOS are more prone to obesity which exacerbates insulin resistance, the abdominal fat disposition and metabolic risk of these patients. With development of obesity these women have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in turn to type 2 diabetes.

Glucagon-like peptide 1 (GLP-1) is involved in body weight maintenance. Beside energy balance it is also involved in glucose homeostasis. Functional deficit in GLP-1 facilitates obesity. We investigated the link between the concentration of incretin hormones and glucose homeostasis, metabolic complications and the distribution of body composition in obese women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary sindrome (NICHD criteria)
* BMI of 30 kg/m2 or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins within 90 days prior to study entery
Oral Processing and Appetite in Older Adults

The goal of this observational study is to learn about changes in oral processing and appetite in older adults aged 65+ years old. The main question it aims to answer is if oral processing affects gastric emptying in older adults (≥65 years old).

* To investigate if food intake and satiety differ between faster and slower eaters, within older adults (≥65 years old).
* To assess if chewing rate, salivary flow rate, oral processing and gastric emptying differ between older adults (≥65 years old) with smaller versus bigger appetites.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old or over (no upper age limit);each group will contain an equal number of male and female participants;
* living sufficiently local to attend the two visits needed;
* able to understand and communicate in English language.

Exclusion Criteria:

* Diagnosed dysphagia;
* (recent) oral surgery that significantly affects eating and/or swallowing;
* diagnosis of type 1 or type 2 diabetes;
* participant undergoing current treatment for cancer;
* participants with zero natural teeth;
* severe loss of appetite and not able to finish a meal (based on CNAQ) and/or people on special or therapeutic diets that restrict the consumption of a full meal and/or the meals provided;
* not able to provide informed consent as defined by the T-CogS test (participants with T-CogS \< 22 will be excluded);
* participants having a pacemaker;
* not able to accept the two meal dishes provided and/or relevant food/ingredient included in the meals allergies or intolerances or aversions;
* not able to feed themselves.
Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

The purpose of this research study is to explore whether genetic testing can offer a personalized and timely approach to assist physicians in making more informed medication decisions for stroke or high-risk transient ischemic attack (TIA) patients during their hospital stay.

This is a pilot clinical trial for feasibility

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-89 years of age
* admitted to University of Alabama at Birmingham (UAB) main hospital with symptoms or signs of minor ischemic stroke, or high risk TIA
* eligible to receive dual antiplatelet load (presented to the hospital within 66 hours of last known well)

Exclusion Criteria:

* diagnosis of atrial fibrillation, valvular heart disease, index stroke due to known hypercoagulability (subset of other determined etiology) or large vessel disease (culprit vessel stenosis of ≥50%)
* prescribed anticoagulation prior to stroke
* treated with intravenous thrombolysis
* treated with mechanical thrombectomy
* missing NIH Stroke Scale score
Home Fortification of Complementary Foods in Bihar India

This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar. The study also seeks to assess the field level worker experience with counseling and dissemination of home fortification products.

This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar.The key objectives of this study are to examine acceptability and utilization by target population, assess impact on infant and young child feeding (IYCF) practices, evaluate impact on child growth, evaluate impact on hemoglobin concentration, and assess front line worker experience and motivation to disseminate enhanced counseling and home fortification products.

Eligibility Criteria:
Inclusion Criteria:

* Randomly selected children living within Health-Sub Centers (HSC) in West Champaran Bihar

Exclusion Criteria:

* Children less than six months of age
* Children greater than eighteen months of age
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

This study was designed to compare the efficacy and safety of tislelizumab (BGB-A317) combined with gemcitabine plus cisplatin versus placebo combined with gemcitabine plus cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal cancer.


Eligibility Criteria:
Key Inclusion Criteria:

1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
2. Aged between 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
3. Histologically or cytologically confirmed, recurrent or metastatic NPC
4. Participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded \[FFPE\] blocks or approximately 10 \[≥ 6\] freshly cut unstained FFPE slides) with an associated pathological report. The archival tumor tissues must be collected within 2 years before screening. In the absence of sufficient archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is mandatory
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
6. Must have ≥ 1 measurable lesions as defined per RECIST v1.1
7. Must be treatment-naive for recurrent or metastatic NPC.

Key Exclusion Criteria:

1. Participants with locally recurrence suitable for curative surgery or radiotherapy
2. Received any approved systemic anticancer therapy, including hormonal therapy, within 28 days prior to initiation of study treatment. The following exception is allowed:

   * Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \> 7 days prior to baseline imaging.
3. Has received any immunotherapy (including but not limited to interferons, interleukin 2, tumor necrosis factor interleukin, and thymoxin) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) of randomization
4. Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
6. Active autoimmune diseases or history of autoimmune diseases that may relapse
7. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Spinal Morphine for Postoperative Analgesia in Urology

The study was performed in urology patients elicited for open prostatectomy or open nephrectomy. Comparison of analgesic effect between group (M) with spinal morphine before general anaesthesia and group without this intervention was measured.

Patients elicited for open prostatectomy or open nephrectomy were randomly divided in 2 groups. Group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces. Control group (C) were given no intervention. Placebo intrathecal injection in C was not used because of ethical reason. Standard general anaesthesia was used in both groups. After surgery all patients were transferred to urology ICU and were given standard analgesic regimen according to level of pain measured by numeric rating scale (NRS) 0 - 10: NRS \> 3 metamizol 1 g IV every 6 h., max. 4 g/24 h., NRS \> 3 paracetamol 1g IV every 6 h., max. 4 g/24 h., NRS \> 3 lasting 30 min. after administration of previous ones diclofenac 75 mg IM á 12 h., max. 150 mg/24 h., NRS \> 4 morphine 10 mg SC á 6 h. Personnel of ICU was blinded to the analgesic method used.

Noticed parameters: pain intensity (NRS), time to NRS ≥ 4, time to the first morphine request, side effects (respiratory rate \<8, SpO2\<90 %, nausea, vomiting, naloxone administration for SpO2\<88 %, itching).

Standard statistical analysis was used, p value \< 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria

* elicited open prostatectomy or open nephrectomy

Exclusion Criteria

* drug or alcohol dependence
* psychiatric drug use
* ASA classification IV or V
* general contraindication to neuroaxial injection
The Effect Of Music Listened By Patients With Moderate Dental Anxiety During The Restoration Of Occlusal Caries

It is aimed to evaluate the effect of music listened by patients with moderate dental anxiety during the restoration of posterior occlusal dental caries on vital signs of the participants.

The study will be applied on 70 patients; 35 patients will be in the control group (the group not listening to music during treatment), 35 patients will be in the experimental group (the group listening to music during treatment).

Modified Dental Anxiety Scale consisting of 5 questions will be applied to the participants who come to the clinic and have occlusal dental caries in the posterior region. The participants whose scores are between 10-18 according to this scale will be included in the study. One occlusal tooth decay will be treated. Before starting treatment, saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be made. The participants will be asked to spit in sterile plastic containers for saliva cortisol measurement. During dental treatment, the participants will listen to music in experimental group. In control group the participant will not listen to music. Heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated in the middle of the treatment (without going through the restoration phase when the cavity is opened). Saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated when the treatment is completed. The questionnaire containing the modified dental anxiety scale will be re-administered to the participants.

Eligibility Criteria:
Inclusion Criteria:

Must be healthy volunteers, Clinical diagnosis of at least one occlusal dental caries, Must have moderate dental anxiety

-

Exclusion Criteria:Unhealthy volunteers, Teeth with dental cavities in the adjacent teeth where the rubber dam would not be placed, and dental caries closer than 1 mm to the pulp tissue were not included in the study