cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Two Forms of LY2608204 in Healthy People

The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Must be a healthy male or a female who cannot become pregnant
* Must have body mass index (BMI) of 18.5 to 32 kg/m², inclusive
* Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
* The veins must be suitable for easy blood collection
* Must be willing to be available for the whole study and be willing to follow study procedures
* Must have given written informed consent

Exclusion Criteria:

* Were in another new drug or medical research study in the last 30 days
* Have participated in this study or any other study with LY2608204 before
* Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug
* Have drug allergy to more than 3 types of medications given by injection
* Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
* Electrocardiogram (ECG) readings are not suitable for the study
* Are infected with hepatitis B
* Are infected with human immunodeficiency disease virus (HIV)
* Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
* Are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (CRU)
* Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
* Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
* Have a history of drug or alcohol abuse
* Have donated 450 milliliter (mL) or more of blood in the last 3 months (this is about the same as the usual volume given in a blood donation)
* The study doctor thinks the subject should not participate for any other reasons
Study of MB07811 in Subjects With Hypercholesterolemia

A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.

This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening;
* Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits;
* Fasting mean serum LDL-C \<220 mg/dL from Q2 and Q3;

Exclusion Criteria:

* History of clinically significant cardiovascular disease
* Uncontrolled hypertension
* Significant sinus bradycardia defined as \<40 beats per minute (bpm);
* Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;
* Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency \> 1 per minute, any alert criteria or any other condition that requires further evaluation;
* History of clinical significant arrhythmia;
* Resting 12-lead ECG showing QTc \>450 msec or \<360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality;
* Any other cardiovascular event requiring hospitalization;
* History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed.
* Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy
* History of human immunodeficiency virus (HIV);
* Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated;
* History of myopathy, including any history of statin-induced myopathy;
* History of intolerance to statins (e.g., myalgias, elevated liver tests);
* History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis;
* Renal dysfunction;
* Alcohol and/or drug abuse within 12 months prior to screening;
Research for the Molecular Imaging of the PD-L1 Targeting Tracer

To use the molecular probe PET radionuclide (Ga-68 or F-18) WL12 peptide to detect the expression of PD-L1 in the primary and metastatic lesions in patients with solid tumor; to detect the expression heterogeneity of PD-L1 in the lesion and inter-lesions; to observe the change of PD-L1 expression in the course of treatment. To provide an approach for screening patients with high expression of PD-L1, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the Individualized antitumor treatment of targeted drugs.

In many clinical trials, Anti-PD-1/PD-L1 mAbs have achieved great success than expected in a variety of refractory and recurrent tumor patients. The latest research shows that it is not all cancer patients would respond to Anti-PD-1/PD-L1 mAbs. At present, immunohistochemistry (IHC) is still a common method to screen patients that will benefit from this therapy by detecting the expression level of PD-1 and PD-L1. However, the results of IHC were not very exact because of limitations of IHC such as the heterogeneity of expression, the influence of host cell PD-L1 expression and the changes in the course of the disease. Moreover, the tumor tissue used in IHC must obtained through the invasive method. It is difficult to dynamically monitor the expression level of PD-1 / PD-L1 during the treatment. Immuno-PET molecular imaging By radiolabeling Anti-PD-1/PD-L1 mAbs with radionuclides can be used to noninvasive assessment of biodistribution of monoclonal antibodies and provide a new strategy for patient screening.

In this study, 18F-WL12 or 68Ga-WL12 PET / CT imaging will be performed in patients with solid tumors to access the potential of 18F-WL12 or 68Ga-WL12PET / CT to screen patients who can benefit from JS001 treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Aged \>18 years old; ECoG 0 or 1;
* 2. Patients with solid tumors;
* 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4. life expectancy \>=12 weeks.

Exclusion Criteria:

* 1. Significant hepatic or renal dysfunction;
* 2. Is pregnant or ready to pregnant;
* 3. Cannot keep their states for half an hour;
* 4. Refusal to join the clinical study;
* 5. Suffering from claustrophobia or other mental diseases;
* 6. Any other situation that researchers think it is not suitable to participate in the experiment.
A New Approach to a Personalized Patient Blood Management Program (pPBM) in Total Hip Arthroplasty (THA)

The study evaluates the patient related risk and predictive factors concerning perioperative homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert max-certified orthopedic hospital in Germany.

A patient oriented preoperative decision-making algorithm (a personalised Patient Blood Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy.

The aim is to increase the patient safety by using the pPBM App and to reach a more efficient management of resources.

Retrospective audit of 470 consecutive primary THA in 2013 and 2014

Eligibility Criteria:
Inclusion Criteria:

* primary THA on patients with coxarthrosis

Exclusion Criteria:

* any kind of old or acute fractures about the basin and hip
* combined surgery, like first extracting a femur nail and than undergoing THA
* any other kind of combined or simultaneous surgery
* any kind of coagulopathy
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Elective Surgery

The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after elective surgery.

We identify all patients treated with elective surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients Undergoing Elective Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information
Modified Pedicle Subepithelial Connective Tissue Graft for Interdental Papillary Reconstruction Around Delayed Implants in the Esthetic Zone: A Case Series Trail

This case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics.

* Preparation of the implant site will be prepared by a crestal incision on the ridge bisecting the existing keratinized mucosa and vertical releasing incisions extending to the vestibule. The papillae of the adjacent teeth are not included in the flap design.
* A full thickness flap will be raised buccally exposing the underlined ridge of the implant site. A surgical drill guide will be used for the precise placement of the pilot drill. After pilot drill application, the osteotomy will be prepared with the corresponding size of parallel drill.
* The implant will be placed in the recipient site by means of an insertion device. The implant neck will be positioned flushing with the crestal bone level.
* The healing abutment extension of the implant will be placed in such a way that the head of the implant protruded about 2 to 3 mm from the bone crest.
* Reassessment of the case to assure absence of any signs of inflammation and presence of normal tissues before the surgical procedure

Eligibility Criteria:
Exclusion Criteria:

1. Pregnant females.
2. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, et al., 2009)
3. Handicapped and mentally retarded patients.
4. Patients undergoing radiotherapy.
5. Presence of systemic disease that would affect wound healing
Effectiveness of ATMX in Treating Adolescents With ADHD and SUD

Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD is a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor, and is currently used to treat adolescents with ADHD. The purpose of this trial is to evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

This study will last up to 18 weeks. Participants will receive six treatments of manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks. Participants and their parents will partake in therapy sessions. Subjects who have completed at least 2 weeks of CBT will be eligible to enter the controlled trial, at which point participants will be randomly assigned to receive either atomoxetine or placebo, which they will take once daily for 12 weeks. At the Week 12 study visit, participants will be assessed for symptoms of ADHD and SUD.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of ADHD
* Current or recent (within the three months prior to study entry) SUD, including marijuana and alcohol abuse
* ADHD CGI-S score of greater to or equal to 4

Exclusion Criteria:

* Any Unstable medical condition
* Recent history of intravenous drug use or cocaine dependence
* Currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine, amphetamine, opioids, phencyclidine, or benzodiazepine
* Mental retardation or organic brain syndrome
* Currently psychotic or history of bipolar disorder
* Currently taking any psychotropic or anti-substance abuse disorder medications
* Current DSM-IV diagnosis of major depression, depressive disorder, or anorexia
* Pregnant or breastfeeding
Growth Hormone in EB

Growth is extremely affected in epidermolysis bullosa patients

Studying the role of growth hormone and ILGF-1 in EB may pave the to new therapeutic modality that could improve the growth in those children and avoid the irreversible sequelae that affected subjects experience after adulthood

Eligibility Criteria:
Inclusion Criteria:

- Children with EB dystrophica

Exclusion Criteria:

* Adults with the same disease
Will Perceptual Learning Via Video Game Playing Improve Visual Acuity Stereopsis & Fixation Stability in Mild Amblyopes?

Contrast balanced dichoptic videogame training has been found to improve sensory functions in adults with amblyopia; best corrected distance visual acuity (BCVA) and stereopsis, but its effect on motor function, namely amblyopic eye fixation stability, is unknown. Furthermore, the effect of treatment in cases of mild amblyopia is not well understood. The aim of this study is to find out the difference on fixation stability, BCVA and stereopsis in mild amblyopes after 6 weeks' contrast balanced dichoptic video game training.

Objectives: To assess the change of fixation stability as well as visual acuity and stereopsis before and after training mild amblyopia by perceptual learning through dichoptic video game playing.

Hypothesis: It has been shown that the visual acuity, stereopsis and fixation stability are compromised in amblyopic eye. Perceptual learning via video game playing has been found effective in improving visual acuity and stereoacuity in moderate and severe amblyopic eyes, but there is no study on such treatment in mild amblyopia. In this study, we hypothesize that fixation stability, visual acuity and stereopsis will be improved after training by dichoptic video game playing in mild amblyopia.

Methods: Participants (aged 7 or above) with Best Corrected Visual Acuity (BCVA) ≤ 0.28 logMAR in the amblyopic eye and an interocular acuity difference ≥ 0.2 logMAR will be recruited. An anaglyphic, contrast balanced dichoptic video game will be provided on an i-Pod Touch (Apple Inc.) for 6 weeks of home-based training (60 mins per day). Fixation stability quantified using bivariate contour ellipse area (BCEA by micro-perimeter (MP) Nidek MP-1), BCVA and stereopsis will be assessed before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Best corrected VA in amblyopic eye ≤ 0.28 log MAR, fellow eye VA with an interocular VA difference ≥ 0.20 log MAR;
* Amblyopia could be in form of strabismic, anisometropic and mixed (both strabismic and anisometropic)
* Able to complete 3 successful measurements (each with 30 seconds fixation) of BCEA by the MP-1 systems in each eye
* Able to align the nonius cross (≤10mm horizontal error and 5mm vertical error) in the i-Pod game

Exclusion Criteria:

* Myopia of spherical equivalent power \> -6.0 diopter in either eye
* Previous intraocular surgery
* any types of ocular pathology (e.g. media opacities or retinal lesion)
* Previous or current history of neurological problem
Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection

This is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.


Eligibility Criteria:
Inclusion Criteria:

1. Male aged 21 years or older.
2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
3. Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
4. Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:

   * Patient has PSA value \>10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10.
   * Patient has PSA value \>20 and clinical stage T2 or higher, and Gleason score
5. Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
6. Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
7. Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.
8. Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.

Exclusion Criteria:

1. Participants for whom participating would significantly delay the scheduled standard of care therapy.
2. Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
3. Participants with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma

Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.

A multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; GSK) therapy. Patients have their daily physical activity recorded using triaxial accelerometry (DynaPort MoveMonitor; McRoberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Severe asthma
2. Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.

Exclusion Criteria: Comorbidities limiting physical activity
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies

Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients with advanced malignancies


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Life expectancy of at least 12 weeks
* Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
* At least 1 tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1
* Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to the first dose of study drug

Exclusion Criteria:

* History of cardiac disease: congestive heart failure \> NYHA Class II, unstable angina (anginal symptoms at rest), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism
* Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C(3)
* History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Active clinically serious infections of CTCAE \> Grade 2 (CTCAE v4.02)
* Symptomatic metastatic brain or meningeal tumors unless the subject is \> 3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. Subjects must not be on acute steroid therapy or taper off steroid therapy (chronic steroid therapy is acceptable provided that the dose is stable for 4 weeks prior to study entry and following screening CT / MRI scan). Subjects with neurological symptoms should undergo a CT / MRI scan of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable
* Seizure disorder requiring therapy (such as steroids or anti-epileptics)
* History of organ allograft
* Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE \> Grade 2 within 4 weeks prior to prior to the first dose of study drug