cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Exhaled Carbon Monoxide Measurements Using the iCOquit Smokerlyzer and Vitalograph Breath CO Monitor vs Carboxyhemoglobin From Venous Samples While Validating a Mobile Research Application

The main objective of this study is to determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples, as well as assessing its agreement with the Vitalograph BreathCO monitor. Validating the precision and accuracy of the iCOquit Smokerlyzer could establish an additional, less expensive, reliable method for determining smoking status in tobacco research. Additionally, the portability of the device would allow for remote biochemical verification of smoking status, thus enlarging the number of participants that can be included in intervention studies.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed the ICF and is able to read and understand the information provided in the ICF.
2. Is 21 to 65 years of age (inclusive) at screening.
3. No intention of quitting smoking in the next 30 days.
4. Willing and able to comply with the requirements of the study.
5. Owns a smartphone running iOS or Android with text message and data capabilities compatible with the eResearch app.

Exclusion Criteria:

1. Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigators or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, concomitant medications and medical history).
2. PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts you would be better off dead, or of hurting yourself in some way") at screening.
3. Body mass index (BMI) greater than 40.0 kg/m2
4. Use of any of these products in the past 30 days:

   1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates),
   2. Experimental (investigational) drugs that are unknown to participant,
   3. Chronic opioid use.
5. Pregnant or nursing (by self-report) or positive urine pregnancy test.
6. Participant enrollment numbers met.

   -
Advancing Suicide Intervention Strategies for Teens During High Risk Periods

To inform the effective management of adolescent suicide risk by evaluating promising treatments and developing the evidence-base for interventions that are well suited for widespread adoption, sustained quality, and impact.

The current study aims to evaluate Safety Planning Intervention with follow-up (SPI+), Collaborative Assessment and Management of Suicidality (CAMS) and usual care. Adolescents, parents, and clinicians will participate in the project to advance to following Research Aims: 1) Assess the comparative effectiveness of CAMS and SPI+ compared to usual care, 2) Evaluate the mechanism of change accounting for the therapeutic effects of the interventions 3) Identify moderators of treatment effects. Participants and their parents will receive study assessments at baseline, 2-week, 1-month, 2-month, 6-month, and 12-month timepoints. Study assessments will ask about participant demographics (sample characterization), suicide attempts, suicidal ideation, non-suicidal self-injury, service utilization, self-assessed risk, treatment integrity, sleep, family cohesion, and social experiences. Youth participants and their legal guardian both consent to participate in the research procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Youth, aged 11-17
3. Endorse suicidal ideation and/or behavior
4. Admitted to acute care (emergency, inpatient medical or inpatient psychiatric) due to suicidality

Exclusion Criteria:

1. Presence of psychosis, intellectual disability, autism spectrum disorder, eating disorder with unstable vitals
2. Limited English proficiency that would interfere with the ability to complete study assessments
Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis

An observational, prospective, cohort study aiming to assess the potential predictive role of cardiopulmonary exercise testing in the prognosis of paroxysmal atrial fibrillation, in combination with echocardiographic indices and plasma biomarker values.

The "ParoxysmaL Atrial fibrillation prognosis based on Cardiopulmonary Exercise test data and novel echocardiographic and plasma BiOchemical indices" (PLACEBO) trial comprises an observational, prospective, single-center cohort study including patients with paroxysmal atrial fibrillation. All patients undergo clinical examination, detailed echocardiographic study, cardiopulmonary exercise testing (CPET) and 24-hour ambulatory echocardiographic monitoring (24-hour Holter monitoring), as well as measurement of a series of plasma biochemical indices. The study will examine the potential prognostic role of CPET variables (such as peak VO2) in the future recurrences of paroxysmal atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with paroxysmal atrial fibrillation (in sinus rhythm during baseline evaluation)
2. Age \> 18 years
3. Capability of providing written consent
4. Patients able to undergo cardiopulmonary exercise testing
5. Patients able to comply with the follow-up schedule of the study

Exclusion Criteria:

1. Patients with structural cardiomyopathy
2. Patients with congenital heart disease
3. Patients with permanent atrial fibrillation
4. Patients who have undergone atrial fibrillation ablation
5. Patients with implanted cardiac devices for primary or secondary prevention
6. Patients with recent (within the last month) acute coronary syndrome
7. Patients with heart failure with reduced ejection fraction (HFrEF) or end-stage renal disease
8. Patients with autoimmune diseases or active malignancies
9. Patients with uncontrolled thyroid disease
10. Patients unable to undergo cardiopulmonary exercise testing due to disability or motility issues
11. Patients who present with contraindications for cardiopulmonary exercise testing
12. Patients unable to provide written consent
13. Patients with poor echocardiographic images
14. Patients unable to undergo spirometry
15. Patients unable to comply with the follow-up schedule of the study
16. Patients with uncontrolled hypertension
17. Patients who have undergone recent (within the last 2 months) surgery
18. Pregnancy
Anesthesia Quality Improvement and Patients With Planned ICU Admission

Intensive care unit (ICU) is an important part of perioperative management for high-risk patients but is associated with higher medical costs. Improper ICU admission may produce overtreatment without beneficial effects. In clinical practice, delayed recovery after general anesthesia is a common indication for ICU admission after surgery. The concept of Enhanced Recovery After Surgery recommends early extubation. The investigators suppose that, for patients with planned ICU admission after elective surgery, implementing anesthesia quality improvement including extubation in the operating room will reduce the rate of ICU admission after surgery without increasing complications.

Intensive care unit (ICU) is an important part of perioperative management for high-risk patients but is associated with higher medical costs. Improper ICU admission may produce overtreatment without beneficial effects. Studies found that immediate ICU admission after surgery did not reduce the perioperative mortality. Some authors suggested that the indication of ICU admission should be the occurrence of postoperative complications, which will reasonably reduce the use of medical resources.

In clinical practice, delayed recovery after general anesthesia is a common indication for ICU admission after surgery. Old age, high ASA grade, respiratory complications, long duration surgery, large-volume fluid infusion, and use of vasopressors were main factors associated with delayed recovery. The concept of Enhanced Recovery After Surgery recommends early extubation after surgery. Studies showed that, for patients after organ transplantation, immediate extubation in the operating room can shorten hospital stay and reduce medical costs, without increasing mortality.

The investigators suppose that, for patients with planned ICU admission after elective surgery, implementing anesthesia quality improvement including extubation in the operating room will reduce the rate of ICU admission after surgery without increasing postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Scheduled to undergo elective surgery.
* Planned ICU admission after surgery.

Exclusion Criteria:

* Refused to participate in the study.
* ICU admission before surgery.
* Unexpected ICU admission.
* Other conditions that are considered unsuitable for study participation.
Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study

To examine pancreatic islet function and incretin function during intravenous and oral stimulation \>2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participation in previous study (NCT01559779)

Exclusion Criteria:

* Pregnancy/lactation
* Major chronic disease develop since previous examination with possible impact on outcomes
Comparison of Time and Cost Efficiency in Arthroscopic Shoulder Surgery Under Regional Anesthesia vs General Anesthesia

Arthroscopic Shoulder surgery can be done not only under general anesthesia but also regional technics. In this study we aimed to compare the cost and time effectiveness of regional anesthesia and general anesthesia.

In our routine practice, ultrasound guided brachial plexus blocks or general anesthesia can be used during shoulder surgery. This retrospective study is designed to investigate the data of the patients who underwent arthroscopic shoulder between 01.09.2021-01.09.2022 at Samsun University Education and Research Hospital. As well as patients' demographic data, presence of additional diseases, operation indications, duration of surgery, intraoperative medical agents that are used, duration of hospital stay will be collected from patients files.Fees for materials used for general anesthesia and regional anesthesia will be determined. A fixed cost will be determined for the use of the operating room, including the salaries of the healthcare workers. After final calculation of both of the group costs statistical analysis will be made.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) 1-2-3
* Arthroscopic Shoulder Surgery

Exclusion Criteria:

* Emergency surgery
* ASA -4
Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with familial exudative vitreoretinopathy
* Needing diode laser photocoagulation
* Consent to the study

Exclusion Criteria:

* History of corneal diseases
* History of hypersensitivity to bromfenac sodium
* History of hypersensitivity to non-steroidal anti-inflammatory drugs
* Progressive ocular infection
* Liver diseases
* Hypersensitivity to sulfur dioxide
* Receiving anti-coagulation drugs
* History of coagulopathies
S9313A Protein Expression Analysis of Breast Cancer Tissue Microarrays From Clinical Trial SWOG-9313

RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.

OBJECTIVES:

* Assess in-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 by automated quantitative analysis (AQUA™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
* Assess the main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial SWOG-9313.

OUTLINE: This is a multicenter study. Patients are stratified according to receptor status and menopausal status.

Tumor tissue samples are analyzed by quantitative protein expression analysis (AQUA™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and HER-2. AQUA™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on SWOG-9313 as a function of molecular classification.

Results of the AQUA™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (FISH) results obtained on SWOG-9313.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary invasive adenocarcinoma of the breast

  * Stage I-IIIA disease (T1-3, N0-1, M0)
* Enrolled on clinical trial SWOG-9313
* Tumor tissue available for testing

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Prospective Review of Procalcitonin After Cardiac Surgery

This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above and beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary bypass.

Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe bacterial infections and sepsis. PCT supports early diagnosis and clinical decision making.This is a prospective single center study designed to assess the normal change in PCT levels following major surgery and the utilization of PCT regarding the diagnosis of infection and the response to treatment, following major cardiac surgery

Inclusion Criteria:

Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases

Exclusion Criteria:

Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever \> 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation

Eligibility Criteria:
Inclusion Criteria:

Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases

Exclusion Criteria:

Exclusion Criteria:

Check any box that applies:

Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever \> 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease

An exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery

This Study demonstrate an exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery

Eligibility Criteria:
Inclusion Criteria:

* Patients with an ankle-brachial index (ABI) of 0.90 or less in the target lower extremity at rest.
* Patients with stenotic lesions (target lesions) requiring treatment of SFA or PPA.
* Patients with Rutherford classification 2, 3, or 4.
* The reference vessel diameter of the target lesion is between 4 mm or more and 5 mm by operator's visual estimate.
* The total length of target lesion measure ≦50㎜ by operator's visual estimate.
* Target lesion lumen stenosis is \>70% diameter stenosis by operator's visual estimate.

Exclusion Criteria:

* Patients with a history of surgical or endovascular treatment (including any percutaneous transluminal balloon angioplasty, stenting, atherectomy, or bypass) of the target lesion or vessel prior to enrollment in this study.

However, a history of balloon dilatoplasty with POBA is acceptable if it was performed earlier than 12 months prior to enrollment.

* Patients with a history of major amputation of the target lower extremity.
* Patients with another stenotic lesion in the target or contralateral lower extremity other than the target lesion that is judged to require surgery or endovascular treatment at the time of consent or within 12 months after the procedure.

However, if the patient has another stenotic lesion in the iliac artery other than the target lesion, treatment of the iliac artery lesion (POBA and stenting) is allowed at the time of the study procedure.

* Patients with acute coronary syndrome or stroke/cerebrovascular event within 3 months prior to obtaining consent.
* Patients with coagulopathy.
* Patients with renal insufficiencyor on dialysis.
* Patient who administered orally cilostazol within 7 days prior to the study procedure.
The Relationship Between Ergonomic Knowledge of Healthcare Professionals and Musculoskeletal Disorders

This study aims to investigate the relationship between the ergonomic awareness levels of Healthcare Workers and musculoskeletal disorders.

The present study is planned to be online. Personal information such as age, gender, and occupation will be collected from participants. Ergonomics information will be questioned. The Nordic musculoskeletal disorders questionnaire will be applied for the musculoskeletal disorders of the participants. Occupational burnout caused by musculoskeletal disorders will be investigated with the Maslach Burnout Scale. The degree to which musculoskeletal disorders affect sleep quality will be investigated with the Pittsburgh Sleep Quality Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Being between 25 and 45 years old.
* Being a health worker
* Having at least 2 years of work experience

Exclusion Criteria:

* Participant having a musculoskeletal disorder before the study
* Having had surgery within 6 months
* Being pregnant
* Having a traumatic accident or injury that would affect the study
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
* BMI ≥ 25 kg/m\^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m\^2 at least one obesity-related comorbidity
* Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%
* Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
* Visceral fat area ≥ 100 cm\^2
* Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study

Exclusion Criteria:

* Pregnancy or lactating women
* Use of pharmacologically active weight-loss medications
* Bariatric surgery
* Ketoacidosis, lactic acidosis, hyperosmolar coma
* Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
* Gastro-intestinal (GI) disorders associated with chronic diarrhea
* Congestive heart failure, New York Heart Association (NYHA) class III or IV
Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia

It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparas
* Request epidural analgesia
* Chinese

Exclusion Criteria:

* Allergic to opioid or local anesthetics
* Fail to perform epidural puncture and catheterization
* Organ dysfunction
* Contraindications for epidural anesthesia
Efficacy Testing of Les Mills Pilates

Objectives: Determine the effect of an 8-week intervention of the new group fitness program Les Mills Pilates on balance, core stability, abdominal, back, and hip muscle endurance, flexibility, and mood. Research questions: Does doing Les Mills Pilates twice per week for 8 weeks result in: 1) increased balance, 2) increased core stability, 3) increased abdominal, back, and hip muscle endurance, 4) increased flexibility, and 5) improved mood? Intended outcomes: this study will determine the efficacy of a new group fitness program developed by Les Mills International. Results will be used to help refine the program, as well as in marketing of the program.


Eligibility Criteria:
Inclusion Criteria:

* Not participating in regular core training (no more than 10 minutes per session, twice per week)
* Active (150 minutes per week of moderate to vigorous physical activity)

Exclusion Criteria:

* any neurological, cardiovascular, or musculoskeletal conditions that would put them at risk while participating, or be made worse by exercise
* Participants with current lower back pain
* Pregnant participants
Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.


Eligibility Criteria:
Inclusion Criteria:

* Must have participated and discontinued in the previous PAH placebo controlled study due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
* Must have completed Week 16 of the previous PAH study and had either no clinical worsening or became clinically worse at the Week 16 visit on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
* Females who have a negative urine pregnancy test and are willing to use 2 types of birth control
* Be 12 years or older (country specific regulations apply) with parental approval

Exclusion Criteria:

* Participated in the placebo controlled study and had clinical worsening on 40 mg tadalafil
* Have left-sided heart disease
* Have a musculoskeletal disorder that limits being able to get around
* Nitrate use
* Certain current systemic treatments