cyrilzakka/clinical-trials huggingface dataset:
Why Join a Walking Program?

The purpose of this interview study is to learn why adults would join a walking program. This study involves interviews with persons who are 65 years of age or older. The interview takes approximately 25 minutes. A total of 132 people will be enrolled. This study will examine the utility or value of various potential features of an incentive-based walking program. These data will enable us to monitor and improve upon enrollment of incentive-based walking programs.


Eligibility Criteria:
Inclusion Criteria:

* age 65 or older
* self rated health at least good on a scale of poor, fair, good, very good, excellent
* self reports no physical reason not to exercise or health condition that would interfere with being active
* self reports able to walk at least 2 blocks without assistance or stopping not participating in a daily walking exercise program
Young Adults and Low Nicotine Cigarettes

The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.

Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide \[CO\]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will be 100 male and female young adult smokers who:

  * Are aged 18-25
  * Report smoking ≥ 100 lifetime cigarettes
  * Report smoking at least 1 non-menthol, filtered cigarette per day

Exclusion Criteria:

* We will exclude those who:

  * Plan to quit smoking in the next month
  * Smoke menthol cigarettes \> 80% of the time
  * Report consuming ≥ 25 alcohol-containing drinks per week
  * Report a history or current psychiatric diagnosis or severe medical condition,
  * Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
  * Are pregnant and/or lactating

Additional, general reasons for exclusion include:

* Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
* Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
* Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies.

The study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of ICIs on cells of the immune system, outside the tumor microenvironment.

Diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti PD-(L)1; either for bronchial cancer, melanoma or any other type of cancer. Patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (BAL) performed during bronchial fibroscopy as part of their routine care. These analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ICI toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject (≥ 18 years old)
* Patient having consented to the research

Group 1:

* Patient with cancer who was treated with immunotherapy
* Appearance of CT lung abnormalities during immunotherapy, not related to cancer
* With high suspicion of infiltrative lung disease:
* Pneumopathy (CTCAE version 5 classification).
* Patients requiring bronchial fibroscopy with BAL

Groups 2:

* Patient with lung cancer with peripheral tumor
* Requires surgical pulmonary lobectomy in the operating room

Exclusion Criteria:

* Patient treated or having been treated in the last 2 months with corticosteroid therapy
* Patient treated with immunosuppressant and/or cyclophosphamide, and/or Anti-TNF α in the last 12 months
* Absence of consent
* Patient under curatorship, guardianship or safeguard of justice
* Pregnant woman
* Group 1:
* Patient with respiratory failure

Groups 2:

* Patient with lung cancer with proximal or endobronchial tumor
* Patients requiring bilobectomy or pneumonectomy
* Patient who has been treated with immunotherapy
Heparin Resistance: Predictors and Outcomes

The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.


Eligibility Criteria:
Inclusion Criteria:

* enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008

Exclusion Criteria:

* presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.
A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants

This study will investigate the effect of multiple doses of cotadutide on the cardiac activity (QTc interval) of healthy participants.

This study will be a randomized, double-blind, placebo-controlled 3-arm parallel study with a nested crossover design for positive control with moxifloxacin administration in healthy male and female participants.

Participants will be randomized to receive treatment with either cotadutide during the 13-week treatment period (Arm 1) or cotadutide-placebo (Arm 2).

The cotadutide-placebo treatment arm will be further divided into 2 subgroups (Arms 2A and 2B), in a nested crossover design for only the placebo-treated participants.

Participants will be randomized in a 2:1:1 ratio to Arm 1, Arm 2A, and Arm 2B.

Approximately 80 participants will be randomized to have 64 evaluable participants in the study.

Each participant will be involved in the study for approximately 22 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants of age 18 to 55 years.
* Females must have a negative pregnancy test.
* Have a Body Mass Index (BMI) of ≥ 18 and ≤ 29.9 kg/m\^2.

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition (including gastrointestinal surgery) known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* History of acute or chronic pancreatitis.
* Family history of sudden cardiac death before the age of 50 of a first-degree relative.
* History of additional risk factors for Torsade de Pointes (eg, heart failure, clinically important bradycardia and electrolyte disturbances eg, hypokalemia, hypocalcemia, hypomagnesemia or family history of long QT syndrome).
* History of neoplastic disease
* Any clinically significant abnormalities in clinical chemistry, hematology, urinalysis results or vital signs.
* Any clinically significant abnormalities in rhythm, conduction, or morphology of the 12-lead resting electrocardiogram (ECG).
* Any positive result on screening for serum hepatitis B surface antigen OR anti-HBc antibody, indicative of active hepatitis B (ie, participants with positive anti-HBc antibody result are acceptable if anti HBc IgM antibodies are negative), hepatitis C antibody, and Human immunodeficiency virus (HIV) antibody.
* Current smokers or those who have smoked or used nicotine products (including e-cigarettes).
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* Use of drugs with enzyme-inducing properties such as St John's Wort.
* Participant has a positive test result for SARS-CoV-2 RT-PCR during screening period or at baseline.
* Participant has clinical signs and symptoms consistent with COVID-19 or a history of severe COVID-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).
Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.

The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency


Eligibility Criteria:
Inclusion Criteria:

* All adult patients are candidates for a long-term CAP or central catheter placement.
* Benefiting from sedation or general anesthesia.

Exclusion Criteria:

* Patient aged \<18 years.
* Pregnant woman.
* Lack of anesthesiologist with knowledge of ultrasound.
* Site of femoral puncture
Yeego! Healthy Eating & Gardening School-Based Randomized Controlled Trial

In this study, one year changes in healthy eating and gardening behaviors associated with the intervention were estimated using a group randomized controlled trial design, with the comparison arm receiving a delayed intervention in the following school year.

The small randomized controlled trial of an intensive curriculum and school garden intervention was implemented in elementary schools in two communities (Shiprock and Tsaile). The study began in year 1 with a period of engagement and recruitment of schools in each community; with the goal of recruiting three schools in each community to complete the run-in phase. The run-in period included time for greater engagement with the school community, an assessment of the potential garden site and an assessment of evaluation readiness. Depending on whether three schools in the community qualify for the study at the end of run-in, or only two schools per community, it was planned to randomize three or two schools to intervention or delayed intervention status in each community. Six schools were randomized, two intervention schools and 4 comparison (delayed intervention) schools. Baseline data collection was conducted at the beginning of the school year 2019-2020 in Year 2 with 3rd and 4th grade children. Students in the intervention schools received the curriculum and school garden during that academic school year (Study Year 2). At the end of the school year, 8-month follow-up assessment was conducted. The main evaluation period is between baseline and 8-month follow-up, and the statistical analysis methods estimate the differential change in outcome measures (healthy eating and gardening).

Not part of the clinical trial, the study continued in the next school year (2020-2021). At the beginning of Study Year 3, the comparison schools were scheduled to receive the delayed intervention. During Study Year 3, it was planned to conduct quarterly community gardening workshops for adult family members in all schools. Due to the COVID-19 pandemic, a series of 10 video workshops were produced and made available via YouTube. Attendance/Views were tracked. A final assessment survey was conducted at the end of that school year (in 2021) in all 6 schools to allow additional descriptive analyses.

Eligibility Criteria:
Inclusion Criteria:

* Elementary schools in Tsaile and Shiprock will have been in existence for at least three years, school size (have between 40 to 100 students in grades 3 and 4 combined), have more than two-thirds Navajo students and satisfy a garden site checklist that can overcome garden barriers (e.g. have access to water)
* Assessment is restricted to Male/female students in grades 3 and 4 attending school in either Tsaile or Shiprock

Exclusion criteria:

* Students in grades other than 3rd or 4th are not eligible for assessment
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Eligibility Criteria:
Inclusion Criteria:

* 19-70 years,
* American Society of Anesthesiology physical status 1 and 2
* Scheduled for elective urologic surgery under spinal anesthesia.

Exclusion Criteria:

* Patients with cardiac and psychological problems.
* Patients who take sedatives or narcotics.
* Patient who have allergy to study drugs.
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar

This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults, 18-70 years of age inclusive
* Normal hepatic function or mild to moderate impaired liver function (Child-Pugh class A or B)
* Body mass index (BMI) 18 to 40 kg/m2 inclusive
* Females must be either surgically sterile, postmenopausal, or willing to use two reliable methods of contraception for the duration of the study and started 3 months before study start

Exclusion Criteria:

* For subjects with hepatic impairment: evidence of progressive liver disease within the last 4 weeks, or biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease
* For healthy volunteers: positive test for hepatitis B or C, alcohol intake of more than 14 units per week, or history of clinically significant alcohol or drug abuse
* Acute infection or current malignancy requiring treatment
* History of clinically significant allergic disease or drug hypersensitivity
* Positive test for HIV-1 or HIV-2 at screening
* Participation in a clinical study with an investigational drug or new chemical entity within 2 months prior to screening
* Females who are pregnant or lactating
First-line Combination Treatment Based on Anlotinib

The aim of this study is to explore safety and therapeutic efficacy of anlotinib combined with erlotinib/chemotherapy/IBI308 as first-line treatment in advanced NSCLC patients. The primary endpoints of the study are safety and objective response rate (ORR);the secondary endpoints are disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).


Eligibility Criteria:
Inclusion Criteria:

1. Patients have voluntarily to join the study and give written informed consent for the study
2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
3. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
4. Mutation status including EGFR, ALK ROS are explicit;
5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
6. Patients did not receive systemic anti-cancer therapy previously, including traditional Chinese medicine.
7. Able to comply with study and follow-up procedures
8. Age ≥ 18 years and ≤ 75, ECOG PS: 0\~1, estimated survival duration more than 3 months;enough organ function;

8)Major organ function

1. For regular test results（no blood transfusion within 14 days）：

   1. Hemoglobin（HB）≥90g/L；
   2. Absolute neutrophils count（ANC）≥1.5×109/L；
   3. Blood platelets（PLT）≥80×109/L
2. Biochemical tests results defined as follows：

   1. Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
   2. Alanine aminotransferase（ALT）and aspartate aminotransgerase AST≤2.5ULN，liver metastases，if any，ALT和AST≤5ULN；
   3. Creatinine（Cr）≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min；
3. Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value(50%).

Exclusion Criteria:

1. Small cell lung cancer(including patients with mixed small cell lung cancer and non-small cell lung cancer) or central squamous cell carcinoma with cavity
2. Mutation status are unknown
3. Previously (within 5 years) or presently suffering from other malignancies,
4. Symptomatic or uncontrolled brain metastases
5. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication
6. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
7. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
8. Pregnancy or lactation
9. Previously treated including treated with traditional Chinese medicine
10. Patients who are allergic to any of the agent or any ingredient -
Application of CAD-CAM Technology in Orbital Bone Reconstruction

Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone.... etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.

This study will be a prospective cohort study. It will include patients treated with the custom-made implants for orbital blow out fractures, ZMC fractures or tumors. The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial, Head and Neck Unit, General Surgery Department, Faculty Of Medicine, Sohag University, Egypt. The patients will be randomly divided into two groups, group (A) reconstructed with patient specific implant and group (B) reconstructed with preformed plate preoperatively bended on stereolithographic model. The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. All patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (CT) then virtual surgical planning and custom-made patient implant will be manufactured. Post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.

Eligibility Criteria:
Inclusion Criteria:

* fracture of the orbital floor and/or medial wall and/or lateral wall.
* complex fracture of the zygomatic bone (those affecting orbital volume).
* Old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry.
* Periorbital neoplasm affecting orbital volume and need surgical resection

Exclusion Criteria:

* injury to the globe that restricts surgical reconstruction.
* neurological diseases with influence on eye motility or sight.
* Patients with special needs.
* Medically compromised patients who are not fit for surgery.
* Patients refused participation in this study.