cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3549492 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in healthy participants. The blood tests will be performed to check how much LY3549492 gets into the bloodstream and how the body handles LY3549492. This study includes two parts and will last up to approximately 76 days for each participant, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and females (excluding women of childbearing potential at the time of signing the informed consent)
* Glycated hemoglobin (HbA1c) value of \<6.5% at screening
* Body mass index (BMI) within the range 20 to 40 kilograms per square meter (kg/m²), inclusive
* Capable of giving signed informed consent form (ICF)

Exclusion Criteria:

* Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome.
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, Gastro-intestine (GI) (including cholecystectomy with no sequelae, GI disease that significantly impact gastric emptying or motility, such as severe gastroparesis or pyloric stenosis even if treated), endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
* Have undergone any form of bariatric surgery.
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (\>2.5 fold the upper limit of normal (ULN)).
* Have a personal or family history of medullary thyroid carcinoma or have Multiple Endocrine Neoplasia Syndrome Type 2.
* Have a serum calcitonin level of ≥20 nanogram/liter (ng/L) at screening, if estimated glomerular filtration rate is ≥60 milliliter/minute/1.73 square meter (mL/min/1.73 m2).
* Have an active or history of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the uterine cervix that have been resected with no evidence or recurrence or metastatic disease for at least 3 years.
* Have known liver disease, obvious clinical signs, or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 2 times \[ULN\]).
* Have total bilirubin level (TBL) \>1.5 × ULN (except for participants diagnosed with Gilbert's syndrome).
* Have serum triglyceride \>500 milligram/deciliter (mg/dL) at screening.
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis

The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients \> 18 years with old suspected or confirmed infection
2. At least two of the following four criteria (SIRS):

   1. Temperature \> 38 or \< 36o C
   2. Heart rate \> 90 bpm
   3. Respiratory rate \> 20 bpm or PaCO2\< 32 mmHg
   4. White blood cell count \>12,000 or \<4,000 per mm3; or \>10% bandemia
3. Lactate ≥2.0 and ≤4.0 mMol/L
4. Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria

Exclusion Criteria:

1. Age \< 18 years
2. On vasopressor therapy
3. Systolic blood pressure \< 90 mmHg
4. Received more than 3-liter crystalloid fluid prior to randomization
5. Patient presenting with pulmonary edema
6. Patient presenting with acute coronary syndrome
7. Patient presenting with new onset cardiac arrhythmia
8. Patient presenting with trauma, including burns
9. Patient requires immediate surgery
10. Patient presenting with stroke
11. Patient with end stage renal disease on renal replacement therapy
12. Patient with known pregnancy
13. Patient being treated with immunosuppressive therapy for organ transplant
PRecision Oncology CUhk pRogrammE (PRO-CURE)

The main aim of this project is to establish an innovative model of a comprehensive precision oncology platform to help individualizing drug therapy for patients with advanced cancers at The Chinese University of Hong Kong. The other objectives include to optimize the genomic matching and access of patients with unique cancer subtypes to the relevant clinical trials of novel therapies, and to construct a personalized drug screening platform for individuals using novel cancer models established from patient-derived cancer cells and tissues. Other objectives include to investigate the utility and feasibility of genomic sequencing using circulating tumor DNA(ctDNA), and to establish a biobank of tumor tissues derived from patients with unique cancer subtypes.


Eligibility Criteria:
Inclusion Criteria:

* Must be aged between 18 to 75 years
* Must have ECOG performance status of 0 to 1
* Must have histologically/cytologically confirmed cancers of certain subtype
* Medically fit patients who would need systemic therapy as part of their oncological treatment in any one or more of the following oncological setting(s): palliative, neoadjuvant, adjuvant, concurrent with radiotherapy. This includes patients who have limited systemic therapeutic options for their cancers and are candidates for clinical trials.
* Able to give written informed consent
* Willing to have blood samples taken.
* Availability of an archived paraffin-embedded tumor block

Exclusion Criteria:

* Patients who refuse or are medically unfit for systemic therapy for their cancer
* Patients with more than one invasive cancers diagnosed over the last FIVE years.
* Patients without measurable tumor lesions on radiological imaging
* Patients who are unable to give written informed consent.
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).


Eligibility Criteria:
Inclusion Criteria:

Postmenopausal female subjects

* at least 50 years of age
* with at least two points of cardiovascular risk
* with a clinical diagnosis of HSDD.

Exclusion Criteria:

Subjects must not

* require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
* have used androgen therapy within 2 months of randomization,
* have a history of estrogen-dependent neoplasia or any gynecologic cancer,
* have a history of cancer of any kind in the past 10 years prior to randomization,
* have a history of malignant melanoma or a history of invasive cancer at any time,
* have a screening mammogram with any finding that requires follow up within 6 months of randomization,
* have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
* have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.
Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
* Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
* Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
* Signed informed consent

Exclusion Criteria:

* Previous irradiation to the same breast
* Metastatic disease
* Concurrent chemotherapy
* Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
The Effect of Therapeutic Touch and Reiki Application on Anxiety and Stress Levels in Female Academicians

Stress and anxiety form an integral part of organizational life in universities. Studies reveal that the stress experienced by academicians has increased dramatically in recent years. Stress affects employee performance. In order to reduce the stress level of female academicians, methods such as non-pharmacological treatment, massage that can be applied to support scientific medicine, acupressure, hot and cold application, therapeutic touch should be used. The non-pharmacological methods that investigators will look at in our research are therapeutic touch and reiki. The improvement of the balance in the body and the reduction of negative effects such as pain, stress and anxiety with non-pharmacological touch methods are explained by Gate Control and Endorphin theories. The universe of the research will be female academicians working at Osmaniye Korkut Ata University. participants will be determined by the block randomization method. Data; It will be collected using the Introductory Information Form, Depression, Anxiety and Stress Level Assessment Form. TT and Reiki application will have positive contributions as it is a non-pharmacological method, easy to apply and low cost. When the studies were examined, no other study was found in the same application as our study.

Therefore, in this study, it was aimed to evaluate the effect of therapeutic touch and reiki practice on anxiety and stress levels in female academicians.


Eligibility Criteria:
Inclusion Criteria:

* Academicians who do not have any communication problems
* Do not have psychological problems

Exclusion Criteria:

* Those who do not want to participate in the research
A Clinical Trial of a Self-Management Education Program for People With Chronic Stable Angina

The purpose of this clinical trial was to determine the effectiveness of a supportive and educational self-management program for improving health-related quality of life (HRQOL), angina symptoms, and self-efficacy and resourcefulness to self-manage for chronic angina patients. 130 participants were enrolled in the trial for 3 months. The program, entitled the Chronic Angina Self-Management Program, (CASMP) was found effective for improving HRQOL, angina symptoms, and self-efficacy to manage symptoms, compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

Medical diagnosis of coronary artery disease CCS Class I-III Angina for at least 6 months Speak, read, understand English -

Exclusion Criteria:

MI/Bypass last 6 months CCS Class IV angina A major cognitive disorder -
Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm

Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick
* Planned to undergo general anesthesia for cardiac catheterization standard of care
* Parent/Guardian able to provide informed consent

Exclusion Criteria:

* Not planned for standard of care general anesthesia for cardiac catheterization
Comparison of Two Methods for Treatment of Colles´s Fracture

The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Fracture Older type 2.
* Fracture Older type 3.

Exclusion Criteria:

* Fractures older than 3 weeks.
* Pregnancy.
* Seq. after previous fracture.
* Distal fragments volar cortex \< 10 mm.
* Open fracture larger than Gustillo 1.
* Disability due to other illness.
* Congenital abnormity or injury/disease in the affected extremity.
* Not capable of mentally/physically to cooperate.
* Not able to go to followup on the operating hospital.
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
* Adequate coagulation, liver, and renal function.
* Candidate for DCE-MRI evaluations.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria:

* Evidence of significant bleeding problems.
* History of certain gastrointestinal problems including fistula and abscess.
* Chronic, uncontrolled hypertension.
* Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer

Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted \[In-111\]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events.

Up to four PSMA-Targeted \[In-111\]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the \[In-111\]-labeled Trillium Compound may be co-administered with PTI-122.


Eligibility Criteria:
Inclusion Criteria:

* Adult males with metastatic prostate cancer
* ECOG performance score 0-2
* Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated
* PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either:

  1. One soft tissue lesion measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ SUVmean normal liver, OR
  2. Two bone lesions measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ 2 x SUVmax normal liver
* Able to understand and adhere to study requirements, and voluntarily give informed consent

Exclusion Criteria:

* No other malignancy undergoing treatment
* No PSMA-targeted therapy ongoing
* Inability or unwillingness to undergo SPECT/CT imaging
* Serum creatinine \> 1.5 mg/dL or creatinine clearance ≤50 mL/min by Cockcroft-Gault estimation
* Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s)
* Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator
Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

The impact of the postoperative inflammatory response on the central nervous system after cardiac surgery is uncertain.

The goal of this study was to evaluate the role of complement activation on cellular brain injury and neurological functioning in patients undergoing coronary artery surgery. In addition, the effect of complement activation on the cerebral vasomotricity was assessed.

Because receptors to activated complement are present on astrocytes, the heparin-coated cardiopulmonary bypass that reduces complement activation should minimize these postoperative neurological adverse events. Heparin-coating might also influence blood flow velocity in cerebral arteries postoperatively if complement activation mediates cardiopulmonary bypass induced cerebral vasomotor dysfunction.

Closed cardiopulmonary bypass and controlled suctions of pericardial shed blood were standardized in all patients.

Bedside transcranial Doppler examination served to evaluate the development of cerebral vasomotor dysfunction in a subgroup of patients.

Eligibility Criteria:
Inclusion Criteria:

* men undergoing coronary artery bypass surgery using cardiopulmonary bypass

Exclusion Criteria:

* clinical conditions expected to potentially influence the magnitude of the systemic inflammatory response after surgery such as open heart surgery, women because they show higher complement activation after surgery, redo cases, organ dysfunction as defined by the Euroscore such as chronic airway disease or renal dysfunction with creatinine level above 200 µmol/L, patients with left ventricular ejection fraction below 35%, diabetes mellitus under insulin therapy prior to the operation, presence of active inflammatory disease or patients taking anti-inflammatory drugs (except acetylsalicylic acid).
* significant carotid artery stenoses (\>70%) at the preoperative echo-doppler examination, evidence of preexisting neurologic or psychiatric disease, existence of preoperative neuropsychological impairment as defined by preoperative Mini-Mental State Examination (MMSE) below 27, and alcohol addiction.
Effect of Nuvigil on Fatigue

The purpose of this study is to determine if armodafinil improves quality of life and is an effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.

Fatigue is one of the most prevalent symptoms occurring in peri- and postmenopausal women. It is strongly associated with reduced quality of life in this population. Studies have shown a strong association between fatigue and menopausal symptoms such as hot flashes, vaginal symptoms, and sexual dysfunction. Because sleep disturbance commonly co-occurs in women with hot flashes as a result of nocturnal hot flashes disrupting sleep, sleep disturbance may explain the association between hot flashes and fatigue in this population. However evidence suggests that fatigue can occur in the absence of sleep disruption, indicating that sleep problems do not exclusively explain the etiology of fatigue in this population.

Armodafinil is a wakefulness-promoting agent that acts as a central nervous system stimulant. It is chemically and pharmacologically unrelated to other CNS stimulants, such as methylphenidate and amphetamine. Armodafinil is FDA approved to increase wakefulness in patients with excessive sleepiness due to narcolepsy, obstructive sleep apnea, and shift work sleep disorder. It has not be studied in menopause-associated fatigue.

In the proposed study, the investigators plan to investigate the effect of armodafinil on quality of life and fatigue in a population of peri- and postmenopausal women with fatigue and reduced quality of life who do not have primary sleep disorders, significant levels of insomnia, or depression.

Eligibility Criteria:
Inclusion Criteria:

Women

* Ages 40-65
* Peri- and postmenopausal
* Suffering from fatigue
* Experiencing hot flashes(Not required for perimenopausal women)

Exclusion Criteria:

* Current episode of major depression
* Moderate-to-severe insomnia
* Night shift workers
* Previous diagnosis of manic depressive disorder, psychotic disorder, or psychotic symptoms
* Suicidal ideation
* Alcohol/drug abuse
* Concern about potential misuse of study medication
* Use of prescribed medications to treat insomnia or other sleep disturbance symptoms
* Pregnant or breastfeeding
* Use of systemic menopausal hormonal therapy or birth control
* Use of centrally active medications, such as antidepressants, anxiolytics, and hypnotics agents
* Use of clopidogrel
* Use of atomoxetine
* Cardiovascular contraindications of use of armodafinil
Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy

GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon's discretion, regardless of impaction level.

Exclusion Criteria:

* Pregnant and lactating females
* Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery
* Current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Eligibility Criteria:
Inclusion Criteria:

1. from 18-65 years old
2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)\>6 months, and now HBsAg or HBV DNA(+)
3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP\>1.5ULN and GGT\>3ULN or STB\>2ULN

Exclusion Criteria:

1. liver mass, liver carcinoma
2. liver failure
3. non-hepatic diseases caused jaundice
4. obstructive jaundice