cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3084077 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug 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. The study is expected to last approximately 8 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Have normal blood pressure
* Must be a healthy male or female who cannot become pregnant
* Have a body mass index (BMI) of 18.5 to 40.0 kg/m\^2, inclusive, at screening

Exclusion Criteria:

* Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like peptide-1 (GLP1), GLP1-analogues or other related compounds
* Have previous exposure to FGF21 analogues or GLP1 analogues
* Have received live vaccine(s) within 1 month of screening, or intend to during the study
* Have previously completed or withdrawn from this study
* Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that in the opinion of the doctor, could make it unsafe to participate, or interfere with understanding the results of the study
* Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Have problems with the immune system, due to a disease or treatment
* Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2
* Have a history of pancreatitis
A Phase 1 TH-302 Mass Balance Trial

This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 \[14C\]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male subject with pathologically or cytologically confirmed solid tumor which is locally advanced or metastatic, and either refractory to the standard therapy or for which no effective standard therapy is available
* Subject has measurable and evaluable disease as RECIST version 1.1
* Age greater than or equal to (\>=) 18 years and less than or equal to (=\<) 70 years
* Body mass index (BMI) \>= 19 and =\< 33 kilogram per square meter (kg/m\^2), body weight greater than (\>) 50 kilogram (kg)
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* Life expectancy of at least 3 months
* At least 4 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is longer, after targeted or biologic therapy
* Acceptable renal function, liver function and hematologic status as defined in the protocol
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* New York Heart Association (NYHA) Class 3 or 4 congestive heart disease, myocardial infarction within 6 months, unstable arrhythmia, symptomatic ischemic heart disease or symptomatic peripheral arterial vascular disease
* Severe chronic obstructive or other pulmonary disease with hypoxemia as defined in the protocol
* Major surgery, other than diagnostic surgery, =\< 28 days prior to Day 1. Subject must have completely recovered from surgery
* Primary brain tumors or clinical evidence of active brain metastasis as defined in the protocol
* Treatment with strong inhibitors and/or inducers of drug metabolic enzymes or drug transporter as defined in the protocol
* Participation in a drug trial within 30 days prior to start of trial medication. Participation in a trial involving administration of 14C-labeled compound(s) within last 6 months prior to start of study drug
* Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
* Legal incapacity or limited legal capacity
* Other protocol-defined exclusion criteria could apply
Improving Transportation Assets and the Effects on Wellness Metrics

1. Implementation of an Advanced Connected Transportation Network (ACTiN), a novel, collaborative multinetwork transportation model for small cities and rural areas.
2. Evaluation of effectiveness in improving transportation assets for clients of a community-based nonprofit specializing in addressing social determinants of health (Lighthouse Community Health Services in Lynchburg, VA).
3. Simultaneous evaluation of wellness metrics based on the standards of the CMS Annual Wellness Visit and metrics associated with common chronic diseases.

1. Implementation of a community transportation solution The project will be managed by Unified Potential, Inc., a 501c3 tax-exempt organization for transportation.

   * The solution requires implementation of four separate transportation "networks"
   * Public / Contracted / For-Hire Transportation
   * Workforce Transportation Network
   * Community Rideshare Network
   * Volunteer Transportation Network
2. Assessment of Personal Transportation Assets

   * Subjects asked to complete a survey upon intake, at six months, and at one year
   * Digital survey:
   * Can be completed by individual using provided smartphone app or at onsite desktop kiosk
   * Can be facilitated by a caregiver or other provider not involved in data analysis
3. Assessment of health and wellness metrics and chronic disease metrics if applicable

   * Dataset based on metrics assessed in the Center for Medicare and Medicaid Services (CMS) Annual Wellness Visit
   * All metrics quantified via either binary (yes/no) or through use of a validated scale (see below)
   * Data collected electronically at onsite or in-home provider visits at intake, six months, and one year

Eligibility Criteria:
Inclusion Criteria:

* Adult resident of the City of Lynchburg, Virginia
* Under-resourced at trial entry as defined by meeting eligibility for welfare, food stamps/SNAP, Medicaid, Housing Choice Voucher program, or income at or below 200% of the Federal Poverty Threshold.

Exclusion Criteria:

* None
Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

The purpose of this study is to find out if quercetin can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers between the ages of 18-75 years old

Exclusion Criteria:

* subjects taking vasoactive medications
* hypertension or vascular disease
* asthma
* smokers
* pregnant women
* cancer
* diabetes mellitus
* history of seizures
* history of stroke or head trauma
* subjects taking digoxin, cyclosporine,felodipine, estradiol, or quinolone antibiotics
* poor transcranial Doppler insonation windows
Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)

The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed pulmonary tuberculosis patients
* Informed consent including pharmacogenomic analysis

Exclusion Criteria:

* Abnormal liver and kidney function test before treatment
* Long-term use of steroids and/or immunodepressants
* Inadequate clinical conditions
Diagnostic Modalities for VAP Detection

asses diagnostic performance of different methods for detection of ventilator associated pneumonia.

Ventilator associated pneumonia (VAP) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources.

The diagnosis of VAP is subjected to considerable interobserver variability. The Centers for Disease Control and Prevention (CDC) definition of VAP uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of VAP is limited.

The clinical pulmonary infection score (CPIS) was developed to objectively diagnose VAP and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial .

Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. It has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (VAP). However, no scientific evidence is yet available on whether LUS reliably improves the diagnosis of VAP.

Quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for VAP diagnosis with a cut off value of 104 colony-forming unit/ml. However, microbiological cultures cannot guide the early clinical management of patients with a suspected VAP, as they need at least 24 hours for preliminary results. So, starting antibiotics remains a challenge. Moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all ICUs. Therefore, it can be replaced by tracheal aspirate microbiological samples.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.

who had:

* Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
* Or new or extension of a radiological image with at least two of the following clinical criteria:

  * Body temperature ≥ 38.5 ° C or \<36 ° C.
  * Leukocytes\> 10 \* 103 / ml or \<4 \* 103/ ml or \> 10% immature cells (in the absence of other known causes).
  * Purulent tracheal secretions.
  * Hypoxemia with PaO2 \<60 mmHg or a PaO2 / FiO2 \<300.

Exclusion Criteria:

* Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
* Patients who are contraindicated for bronchoscopy
Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles

Endometrial sampling is performed using the standard technique in the outpatient department. Similarly, superovulation with gonadotrophins will be performed according to our standard practice.Endometrial sampling will be done in the follicular phase not later than day 10 of the cycle. Endometrial sampling will be performed using Pipelle sampling catheter. The Pipelle is inserted gently through the cervical canal into the uterine cavity and advanced slowly till just resistance felt by the operator. Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.

Eligibility Criteria:
Inclusion Criteria:

1. All women undergoing superovulation with gonadotrophins and intrauterine insemination.
2. All women with cervical factor, mild male factor and/or unexplained infertility.
3. At least one patent Fallopian tube.

Exclusion Criteria:

1. Bilateral tubal disease
2. Severe male factor infertility
3. Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions)
4. Women with positive cervical culture and/or acute vaginal infection
Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis

Objectives:

The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies.

Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration.

Study population:

* Retarded release phosphatidylcholine in chronic-active ulcerative colitis.
* Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.
* Dose finding study for retarded release phosphatidylcholine

Outcome parameters:

Definition of remission:

1. SCCAI \<2,5
2. Likert scale: grade 1 or 2
3. subjective impression of remission: yes/no
4. no blood in stool

Definition of relapse:

1. subjective impression: yes/no
2. SCCAI ≥ 5
3. blood in stool

Definition of low clinical activity: SCCAI \< 5

Primary endpoint:

sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.

Secondary endpoints

1. maintenance of continuous remission
2. improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score
3. relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients from previous studies with retarded release phosphatidylcholine

Exclusion Criteria:

* patients with less then 6 weeks follow-up after end of initial study
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.

In resectable gastric cancer participants who received curative surgery, to early and more accurately detect peritoneal carcinomatosis or occult metastasis is important. Also, investigators will look at CTC numbers in different timings after operation, to investigate the possibility of early detection for peritoneal carcinomatosis or occult metastasis. Also, this study will correlate the relationship of CTC and participants' survival.

Circulating tumor cells (CTCs) are an emerging "liquid biopsy" that provide prognostic value for various types of solid cancer on early recurrence and survival. The evaluation of CTCs might be a useful strategy to predict tumor progression and prognosis in Gastric adenocarcinoma (GC). Previous study has shown that the frequency of CTC detection was higher in advanced GC than early GC, in poorly differentiated GC than well/moderately differentiated GC, and in GC with lymphatic metastasis than that without lymphatic metastasis. However, the impact of CTCs in the detection of PM in GC is still under debate. Peritoneal metastasis (PM) is highly related to recurrence and metastasis in GC; therefore, it was significantly related to disease free and overall survival of participants.

Consequently, several important questions and goals will be answered by this study:

To elucidate the clinical relationship between CTCs and PM in GCs before the operation; therefore, it could be an indicator of prophylactic during operation, which may possibly prolong the disease free and overall survival.

To establish a good model to follow-up a specific surface marker on CTCs, which could be possibly utilized as a more sensitive marker, comparing with CEA or image study, to more accurately detect the early recurrence or metastasis in GC.

To verify that dynamically monitoring CTCs status and changes during long-term follow-up and anti-cancer treatment are feasible and clinically meaningful to survival or treatment responses.

Eligibility Criteria:
Inclusion Criteria:

* Enrolling 150 cases
* Stage I or more advanced gastric cancer, pathology proved
* Diagnosed at age ≥ 20 years
* Enrolled before surgery at the General Surgery Department, both inpatient and outpatient services.

Exclusion Criteria:

* Patient's refusal
* Poor compliance, unable to cooperate for blood sampling for CTC isolation as time schedule or clinical treatment or follow-up
* Difficult blood sampling
* No more needs for CTCs evaluation, decided by clinicians.
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC

This is a phase II clinical trial of SHR-1210 （an anti-PD-1 Inhibitor） simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.

It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will voluntarily participate in this study and sign informed consent.
* NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.
* No clear driven genes (including but not limited to EGFR, ALK).
* Previously received more than 1 chemotherapy regimen and progressed/recurred.
* At least one lesion is suitable for hypofraction radiotherapy.
* There is at least one measurable lesion.
* 18 to 75 years old
* ECOG 0-1
* The function of vital organs meets the following requirements. ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min。
* The estimated survival period is more than 3 months.
* Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

Exclusion Criteria:

* The subjects had any history of autoimmune disease or active autoimmune disease.
* Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
* Subjects with severe allergic reactions to other monoclonal antibodies.
* The subjects had a central nervous system metastases of clinical symptoms.
* Central squamous cell lung carcinoma.
* Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
* Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
* Failing to properly control the clinical symptoms or disease of the heart.
* Subjects had active infections.
* Subjects may receive other systemic antitumor therapy during the study period.
* Other clinical trials of drugs were used in the first four weeks of the first medication.
Outcome of Immediate Zirconia Implants

The aim is to study bone and soft tissue response to zirconia immediate implants.Volumetric changes will be measured before tooth extraction and after final crow placement.

Bone remodeling around immediate implants is a reality in clinical and literature arena. much is known about titanium implants but little in zirconia implants

In patients that require a tooth extraction anywhere in the oral cavity except 3rd molars are candidates fo the study. Once clinical conditions are establish and medical clearance is ok, the decision for an immediate implant is taken.

Patient will undergo for an intraoral Scanner (IOS, Trios 3Shape) to get an STL file of the previous situation.

On the day of surgery an atraumatically tooth extraction is performed (without rasing a flap) and a Zirconia implant is inserted on the alveolar socket.

The jumping gap (distance from crystal bone to implant body will be filled with a zenograft type of biomaterial) no sutures or membrane will be used.

A provisional crown or an individualized healing abutment will be placed. After 3 month healing an IOS will be made for crown fabrication and a second STL file generated.

After 15 days final crown will be placed, and 3 month after a 3rd IOS made to get the 3rd and final STL file.

An STL software will then make the correlation between the volume behavior in those 3 stages.

The control group, patients go for tooth extraction but no immediate implant and undergo with a classic protocol for implant placement. In this case the STL files are taken pre-operatory, before implant placement 3 month after tooth extraction, 2 month after implant placement (at final impression level), and 3 month after crown placement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a non-restorable tooth schedule for extraction
2. Anywhere on the mouth except 3rd molar teeth
3. Tooth site with no active infection
4. No loss of the buccal, palatal or inter proximal bone
5. If chronical apical pathology, the six should be less that 4 mm diameter
6. ASA 1 or ASA 2 Patient
7. Sings the Informed consent -

Exclusion Criteria:

1. Site has an active infection
2. Periapical lesion Beyond 5 mm
3. Bone resorption of buccal, palatal or inter proximal plate beyond 2 mm
4. Patient doesn't want an immediate implant
5. Patient doesn't want a Zirconia Implant
6. ASA 3 or ASA 4 Patient
7. Refuse to Sign informed consent -
Effective Treatment for Prescription Opioid Abuse

There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.

There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.

Eligibility Criteria:
Inclusion Criteria:

* For inclusion in the proposed studies, subjects must be \> 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.

Exclusion Criteria:

* Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
* Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.