cyrilzakka/clinical-trials huggingface dataset:
Enhanced Smoking Cessation for University Students

This trial studies how well a new smoking cessation and prevention intervention works in enhancing smoking cessation for university students. The new intervention may be easier to use for students to quit smoke.

PRIMARY OBJECTIVES:

I. To establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression.

II. Demonstrate the feasibility of a smoking prevention website.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes.

ARM II: Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2.

After completion of study, participants are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* CESSATION ARM: Student at University of Houston Central Campus or Texas A\&M University
* CESSATION ARM: Smoke 1 or more cigarettes a day
* CESSATION ARM: Speak and read English
* CESSATION ARM: Signed informed consent and an acknowledgement of participation requirements
* CESSATION ARM: Be enrolled in at least one class at respective campus at baseline
* CESSATION ARM: Provide current contact information
* CESSATION ARM: Have access to the Internet
* PREVENTION ARM: Student at University of Houston Central Campus or Texas A\&M University
* PREVENTION ARM: Speak and read English
* PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements
* PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline
* PREVENTION ARM: Provide current contact information
* PREVENTION ARM: Have access to the Internet
* PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale)
* CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study
* PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

Exclusion Criteria:

* CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 \[Patient Health Questionnaire-9\])
* CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT \[Alcohol Use Disorders Identification Test\] measure)
* PREVENTION ARM: Current tobacco use
* PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year
* CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year
* PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 \[Patient Health Questionnaire-9\])
* PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)
* CESSATION ARM: Pregnancy
Impact of Gluten Contamination in Celiac Patients Clinically Responsive and Unresponsive to the Gluten-free Diet

The primary aim of the study is to detect the presence of gluten immunogenic peptides (GIP) in urine samples from celiac patients on a gluten-free diet clinically responsive and non-responsive to dietary treatment and from suspected celiac patients already on a gluten-free diet.

Once a year, celiac patients perform a clinical (gastroenterological visit) and blood chemistry (blood tests) check. At the Center for the Prevention and Diagnosis of Celiac Disease, about 1400 check-ups of celiac patients are carried out per year. During this annual control visit, consecutive patients afferent to the center and suffering from celiac disease who have been treated for more than 6 months, clinically "responsive" and "non-responsive" to the gluten free diet (GFD), will be invited to participate in the proposed study. Those who participate will be given the symptom questionnaires (VAS), the food questionnaire in order to evaluate the relevance of the symptoms reported and the type of diet followed by the patient and the adherence test to the gluten-free diet (CDAT). Urine samples will be collected to test the presence of GIP (gluten immunogenic peptides) and for patients whose samples test positive, will be asked for a stool sample to detect GIP.

Subjects with suspected celiac disease but already on a gluten-free diet will undergo a challenge, or the reintroduction of gluten in incremental steps of three weeks (routinely performed as per the instructions of the Italian Health Care System).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 65 years old
* Gender: Males and Females
* Patients: suffering from Celiac Disease and suspected, but already on a gluten-free diet

Exclusion Criteria:

* Celiac patients less than 6 months after diagnosis
* Celiac patients reporting intentional gluten ingestion
Personalized Drinking Feedback Interventions

The objective of this research is to better understand how to reduce hazardous drinking among OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered preventative program.

Excessive drinking among OEF/OIF veterans represents an important public health problem for both the veterans themselves and those with whom they interact. The objective of this research is to better understand how to reduce hazardous drinking among this group by assessing the effectiveness of a low-cost, computer-delivered preventative program. It is hypothesized that an intervention that provides personalized feedback about drinking behaviors will be more effective than an education-only control condition at reducing alcohol use and negative alcohol-related consequences.

Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF Veteran

Exclusion Criteria:

* None
Thoracotomy Effects on Pulmonary Function Test and Chest Expansion

The purpose of the present study was to investigate the effect that corrective surgery for scoliosis would have on pulmonary function as well as the circumference of the chest. As a result, the current investigation was carried out on thirty individuals who had idiopathic scoliosis and had been admitted to the hospital. Before the surgery, after it had been completed (on the fifth day), and again three months later, the pulmonary function was tested.

The purpose of this study was to see how corrective scoliosis surgery affected pulmonary function and chest circumference. As a result, the current investigation was carried out on 30 individuals brought to the hospital with idiopathic scoliosis. The pulmonary function was assessed before surgery, on the fifth day following surgery, and three months thereafter.

Eligibility Criteria:
Inclusion Criteria:

• Adolescent idiopathic scoliosis

Exclusion Criteria:

* smoking.
* Associated comorbidity that affects PFT.
* Any contraindication interfering with performing spirometry.
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.

The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.

It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the "LIBERATE Extension Study". This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological evidence of emphysema
* Nonsmoking for 4 months prior to screening interview
* BMI less than 35 kg/m2
* Stable on current medication regimen
* Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
* Residual Volume less than 175% predicted (determined by body plethysmography)
* Little or no collateral ventilation (CV-) as determined using the Chartis System

Exclusion Criteria:

* Had two or more hospitalizations over the last year for a COPD exacerbation
* Had two or more hospitalizations over the last year for pneumonia
* Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
* Had a heart attack or congestive heart failure within the last 6 months
* Have heart arrhythmia
* Is alpha-1 antitrypsin deficient
Prevalence Of Internal Pudendal Artery Disease In Patients With Erectile Dysfunction Undergoing Diagnostic Coronary Angiography

Subjects in this study have recently had or are scheduled for a coronary angiography as part of their normal, routine medical care. This procedure uses x-ray imaging to see the inside of the heart's blood vessels.

This research study will evaluate the possible relationship between erectile dysfunction and vascular disease (diseases of the veins). In order to look at this possible relationship, subjects will complete a questionnaire which will ask questions regarding their sexual activity. Additionally, we will gather information from their medical records and take extra images during the coronary angiography procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age \>40 years

Exclusion Criteria:

1. Creatinine Clearance \< 60mL/min/1.73m2
2. Age\>85
3. History of penile prosthesis
4. History or pelvic radiation or trauma
Effect of Deferasirox on Endocrine Complications in Subjects With Transfusion Dependent Thalassemia

The CENTAurus trial is a prospective clinical study designed to address systematically some of the relevant endocrine complications in an iron overloaded thalassemic population, primary objective being the assessment of the effect of deferasirox therapy on glucose metabolism/homeostasis. Other endocrine parameters complementary or supportive to the primary objective will be assessed and analyzed during this study. A number of lab parameters related to other axes of the endocrine system will be collected and analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Beta thalassemia major and severe intermedia patients transfusion dependent and with transfusional iron overload 2. Patients with diagnosis of impaired fasting glucose or impaired glucose tolerance 4.Patients naïve to deferasirox or patients who already receive deferasirox at sub-optimal doses 5.Cardiac MRI T2\* \>10 msec; 7.normal cardiac function (LVEF \> 56%);

Exclusion Criteria:

1. Non transfusional hemosiderosis;
2. Patients with diabetes mellitus (genetic or secondary) or history of diabetes mellitus in 1st degree relatives;

4.Patients who received organ transplant; 5.Patients with galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption; 6.Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox; 7.History of hypersensitivity to the study drug or any of its excipients; 8. Renal impairment 10. Liver impairment; 11.Patients with active chronic hepatitis B infection, active hepatitis C infection;

Other protocol-defined inclusion/exclusion criteria may apply" at the end
A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study

This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.

A Phase 1, double-blind, randomized, placebo-controlled, single and multiple-dose escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB-718 following subcutaneous administration in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
2. Males or females, of any race, between 18 and 55 years of age, inclusive.
3. Male subjects will weigh at least 50 kg, and female subjects will weigh at least 45 kg. Body mass index between 20.0 and 30.0 kg/m2 (Part A) or 25.0 to 50.0 kg/m2 (Part B), inclusive.
4. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and Check-in/predose as assessed by the Investigator (or designee).

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular or other heart disease, gastrointestinal, urinary/prostatic, neurological, respiratory, endocrine, or psychiatric disorder, or glaucoma, as determined by the Investigator (or designee).
2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
3. Liver disease or liver injury, as indicated by abnormal liver function tests (e.g. serum bilirubin, direct bilirubin, ALT, AST, γ-GT, or ALK exceeding the ULN) at Screening or Baseline which may be repeated for confirmation per the Investigators discretion at Screening and Check-in.
4. History of multiple endocrine neoplasia type 2 or an abnormal thyroid function test (thyroid stimulating hormone, triiodothyronine, thyroxine) at Screening or Baseline.
5. Fasting plasma glucose greater than ≥126 mg/dL at Baseline.
6. Hemoglobin A1c value \>6.5%
7. History of chronic or acute pancreatitis, or amylase or lipase exceeding 2 × ULN at Screening or Baseline. -
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse events, and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).

Total knee replacement is a surgical procedure performed to replace the weight-bearing surfaces of the knee joint. The goal of total knee replacement is to improve a patient's mobility by improving the function of the the knee joint.

The PEAK PlasmaBlade® uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing total knee replacement.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 21 and 80 years old
2. Physically healthy, stable weight
3. Requiring unilateral total knee arthroplasty (TKA)
4. Subject exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion
5. Subject has severe knee pain and disability due to degenerative joint disease
6. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
7. Subject must be willing and able to comply with all follow-up evaluations
8. Subject must be willing to undergo TKA using the Signature Knee System

Exclusion Criteria:

1. Age younger than 21 or greater than 80 years old
2. Previous history of infection in the affected joint
3. Peripheral vascular disease
4. Revision procedures
5. BMI \> 35
6. Valgus or varus deformity \> 15 degrees
7. Flexion contracture \> 15 degrees
8. History of diabetes
9. Anticoagulation therapy which cannot be discontinued
10. Cognitive impairment or mental illness
11. Severe cardiopulmonary deficiencies
12. Known coagulopathy
13. Immunocompromised
14. Kidney disease (any type)
15. Unable to follow instructions or complete follow-up
16. Currently taking any medication known to affect healing
17. Currently enrolled in another investigational device or drug trial
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.

This clinical trial is designed as an open-label, dose-escalating, single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with acute peripheral arterial occlusion. Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours. Different dose regimens will be evaluated in an ascending-dose fashion; an infusion will be administered for up to 4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
* Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
* Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
* Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).

Exclusion Criteria:

* Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
* Occlusion not penetrable by the infusion guide wire.
* Known or suspected allergy to contrast agents or heparin sodium.
* Active bleeding or known hemorrhagic diathesis.
* Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus

This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus


Eligibility Criteria:
Inclusion Criteria:

* o Older than 16 years

  * In a patient with SLE, patients who fulfill the criteria of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
  * In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification (WHO classification, and the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification.

Exclusion Criteria:

* Patients with other autoimmune rheumatological diseases, lymphoproliferative disorders, malignancies, liver diseases, end-stage kidney disease, diabetic nephropathy, active infections, recent history of blood transfusion and patients with deficiencies in vitamin B12, folate, and iron are excluded from the study.
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation

This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.
2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
3. Subjects with a history of documented symptomatic atrial fibrillation.

Exclusion Criteria:

1. Subjects who are not candidates for cardiac ablation procedures.
2. Pregnant or nursing.
3. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes

Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.

The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .

Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.

The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm \& 0.2mm)

Eligibility Criteria:
Inclusion Criteria:

* partially edentulous patients seeking for dental implant
* Bucco-lingual width more than 6 mm
* Medically free patients

Exclusion Criteria:

* patients with thin ridges that may need augmentation
* patients with systematic diseases that may affect bone quality
* completely edentulous patients
* patients with limited mouth opening
Intravenous Iron Pre-treatment in Prognathic Surgery

The objective of the present study is to determine the impact of preoperative IV-iron (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood transfusion amount in patients undergoing elective prognathic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prognathism in undergoing elective prognathic surgery
* Patients provided a written informed consent.
* Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
* Patients with preoperative Hematocrit \> 39% (male) and \> 36% 9female)serum hemoglobin \>13 g/dL (male) and \>12 g/dL (female)

Exclusion Criteria:

* Patients with history of anaphylaxis, iron overload, active infection.
* Patients with endocrine disease
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.