cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Smartphone Application for Self-help for Social Anxiety

The present study examines whether a self-help app can reduce symptoms of social anxiety disorder.

The study will test the effectiveness of a newly developed mobile app in treating patients with social anxiety. Participants will be randomly assigned to one of the following groups: app use only, therapist-guided app use, and a wait-list control group. Over a 12-week period, the study will examine whether mobile app use leads to significant reductions in symptoms associated with social anxiety, as well as improvements in secondary outcomes such as quality of life, depression, or psychological impairment.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Social Anxiety Disorder
* Written informed consent before the start of the study
* Age: 18 to 65 years
* Possession of smartphone
* Familiarity with using smartphone apps

Exclusion Criteria:

* Acute suicidality
* Active substance abuse or dependence
* Severe medical conditions (e.g., chronic cardiovascular disease)
* Severe depression
* Psychotic disorder
* Bipolar disorder
* Borderline personality disorder
* Current psychotherapeutic treatment
* Current psychopharmacological treatment
* No proficient skills in the German language
Randomized Trial for Botox Urinary Incontinence

The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.

Eligibility Criteria:
Inclusion Criteria: Subjects must have ALL of the following:

* Completed a routine evaluation of incontinence (urodynamics, bladder diaries, and pad weights) through the urogynecology clinic at SMH within 3 months of the screening visit
* Symptoms of urge incontinence associated with leakage on bladder diary
* 24-hour pad weight \>100 cc's (volume requiring multiple daily diaper changes)
* Absence of a bladder infection or other condition that could explain urinary leakage
* Absence of stress incontinence or a cough leak point pressure \> 100 cm H2O on cystometry (this correlates with mild stress incontinence)
* Failed anticholinergic therapy
* Willingness and ability to perform intermittent clean catheterization (due to the risk of prolonged urinary retention from Botox)
* The ability and willingness to return for surveillance evaluations
* A negative urine pregnancy test if at risk for pregnancy
* Competent to give signed consent and complete all of the study measures

Exclusion Criteria:

* Children (\< 21 years old), pregnant women and prisoners
* History of carcinoma of the bladder
* Absence of a measurable detrusor contraction on a pressure flow micturition study
* A foreign body in the bladder or other correctable etiology for the UUI
* Prior documented resistance to Botox
* Gross fecal incontinence (due to confounding effects on pad weights and counts)
* Known allergy to lidocaine or related compounds (used for local analgesia)
* Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis)
* Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects
* Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.
NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)

In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax.

In patients with suspected APE referred to the intensive care unit after major surgery, serum NT-proBNP, Troponin-I and D-dimers were measured according to the standard hospital protocol. Blood samples were obtained within one hour after the onset of clinical symptoms.

Definitive confirmation or exclusion of APE was performed with an angiographic CT-scan of the thorax.

Eligibility Criteria:
Inclusion Criteria:

all patients referred to the ICU with suspected APE

Exclusion Criteria:

none
An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology
* Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)
* No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease
* Participants must have biomarker test results available for randomization
* ECOG Performance Status of ≤ 1
* Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

* Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements
* Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Participants with an active, known or suspected autoimmune disease \[Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\]
* Participants with untreated CNS metastases are excluded \[Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment\]

Other protocol defined inclusion/exclusion criteria could apply
The Illness of Uncertainty, Personality and Coping Strategies in Patients With Hepatocellular Carcinoma

The aims of this study are to (1) understand the uncertainty , personality and coping strategies in patients with HCC, and identify the significant factors for coping.

A cross-sectional correlated design will be used and (2) patients will be recruited by purposive sampling from wards and outpatient departments at a medical center in Taipei.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Has HCC and knows condition
* Con's clear
* Agree join the study

Exclusion Criteria:e

* BCLC stage C or D
* Accepted C/T, R/T,target therapy or supportive care
* Patient who receive liver transplantation
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.

A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.

Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 6 months from the time of first subject enrollment to completion of the last subject follow up.

Eligibility Criteria:
Preoperative Inclusion Criteria:

* Patient is undergoing a primary full abdominoplasty procedure without concomitant liposuction; and
* Patient is willing and able to give written informed consent for registry participation

Preoperative Exclusion Criteria:

* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and
* Patient has religious or other objections to porcine, bovine, or human components

Intraoperative Inclusion Criteria

* Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
* The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indications for Use
Randomized Trial of Prehospital Tropin Levels in Acute Coronary Syndrome (ACS)

This study randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. The study group is treated normally as well, however troponin measurements are made using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the receiving physician. Door-to-reperfusion time is monitored for both groups.


Eligibility Criteria:
Inclusion Criteria:

* Over years of age
* ACS without ST-segment elevation
* Patient being transported to one of two participating hospitals

Exclusion Criteria:

* Less then 18 years of age.
* Post cardiac arrest.
* ACS with ST-segment elevation.
Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.

The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes an increase in plasma volume, total plasma protein concentration, and albumin concentration. This is an important step in understanding the effects of OLT, specifically its effects on fluid in the body. The primary role of the lymph system is the return of fluid and proteins lost from the blood vessels. Despite this, no research has been done to see what effects an OLT has on fluid and protein levels in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy volunteers
* Males
* Age 20 to 40 years

Exclusion Criteria:

* History of cardiovascular, kidney, or liver disease.
* Cannot have taken medication or drugs or have been ill at the time of the study or for two weeks prior.
Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome

The purpose of this study was to access the possible beneficial effects of oral use of pilocarpine in relieving signs and symptoms of patients with Sjogren's syndrome

After being informed about the study, its potential risks and having signed the informed consent form, this placebo-controlled, crossover study involved patients with Sjögren's syndrome to use oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, and tear ferning test. Side effects observed during the treatment period were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Sjögren's syndrome, both in primary and secondary forms, whose diagnoses were established according to the criteria defined by the - American-European Consensus for the diagnosis of Sjögren's syndrome.
* Patients with the secondary form of the syndrome, collagen disease considered controlled by a rheumatologist, before the start of the trial and stable until the end of the study.
* Systemic therapy instituted up to two months before the beginning of the protocol.
* Literate patients.
* Signature of the informed consent form

Exclusion Criteria:

* Eye or eyelid surface disease not attributed to Sjogren's syndrome.
* Temporary or permanent occlusion of tear points.
* Use of contact lenses.
* Use of systemic medication that is known to influence tear flow.
* Need to modify the systemic treatment of the underlying disease during the trial.
* Pregnancy or breastfeeding.
* Known hypersensitivity reaction to pilocarpine hydrochloride.
* Severe cardio-pulmonary disease.
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Buerger's disease.

Buerger's disease, also known as thromboangiitis obliterans, is a rare disorder that, in most cases, affects young or middle-aged male cigarette smokers. It is characterized by narrowing or blockage (occlusion) of the veins and arteries of the extremities, resulting in reduced blood flow to these areas (peripheral vascular disease). The exact cause of Buerger's disease is not known; however, most affected individuals are heavy tobacco users.

This drug is an autologous cell treatment for necrosis in the legs of patients with Beurger's diseases to improve symptoms through vascular regeneration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age :20-80, males and females
* Patients at least 6 months after Buerger's disease
* Patients with a luminal stenosis of more than 50% on angiography
* Rutherford class II-4, III-5 or III-6
* Subjects not eligible to undergo a revascularization or vascular bypass graft
* Patients who can't treat with traditional medication and need a arthroplasty.
* Patients whose lesion is 2\~6 cm2 in size
* Duration of pain over Grade 4(11-point numeric scale) : \> 4 months

Exclusion Criteria:

* Subjects who cannot survive more than 6 months with critical other complications.
* Patient with well-known active malignant tumor.
* Patients who exceed normal reference values from following test : PAP smear screening, chest X-ray, PSA, mammogram, occult blood test
* Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia
* Patients with uncontrolled iliac artery obstruction of targeted areas.
* Condition with targeted lower limb that have widespread necrosis or in need of amputation.
* End-stage renal failure patients who depend on hemodialysis
* Patients with uncontrolled diabetes mellitus (HbA1c \> 10%).
* Treatment with immunosuppressant (prednisone \> 5mg/day).
* Treatment with a anti-inflammatory drugs within 1 weeks prior to enrollment.
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Subjects who have cerebrovascular accident within 6 months prior to inclusion in the study.
* Patients with acute myocardial infarction, angina pectoris.
* Subjects who had been underwent a cardiovascular surgery such as carotid endarterectomy, arterial aneurysm, bypass surgery and coronary bypass surgery within 3 months prior to inclusion in the study.
* Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients

The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor
* Able to provide written informed consent

Exclusion Criteria:

* Life expectancy \<12 months
* Anticipated non-compliance with the follow-up scheme
* Moderate to severe Chronic Obstructive Pulmonary Disease
* Primary pulmonary hypertension
CEUS in Kidney and Pancreas Transplantation

This study is to investigate whether it is possible to use a special type of ultrasound scan (CEUS, Contrast Enhanced Ultrasound Scan) to view the shape, assess blood supply and calculate the amount of oxygen being carried to a transplanted kidney and pancreas. We currently use a nuclear scan (Transcan) to assess this in the kidney. This is cumbersome, involves nuclear medicine and takes 45- 60 minutes to complete.

We do not routinely image the blood supply to the pancreas post-surgery, despite the most common complication post pancreas transplantation being vascular in origin. In an emergency a CT angiogram is carried out. This involves transfer of a sick patient to the CT scanner and injection of contrast which is harmful to the kidneys.

CEUS involves injection of a safe contrast prior to conducting an ultrasound scan. This can be carried out at the bed-side, provides instant results and is cheap and safe enough to do on a routine basis for all kidney and pancreas transplant recipients. Although the uses of CEUS are well recognised, it is currently not routinely used in transplantation. CEUS has been compared to other modes of imaging and has been found to be comparable/ beneficial. However, it has never been compared to Transcan. We will therefore perform CEUS on our kidney transplant recipients and compare the results to Transcan. We will also assess whether CEUS is able to visualise the blood supply to the kidney and pancreas and quantify the perfusion to the pancreas.


Eligibility Criteria:
Inclusion Criteria:

* adult kidney transplant recipients
* adult pancreas transplant recipients

Exclusion Criteria:

* patients unable to consent to the study
* patients under the age of 18
* patients with an absolute or relative contra-indication to receiving SonoVue contrast
* serious intra-operative complication
Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients

The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the requirements of the study protocol
* Considered for treatment with one or more Tornier shoulder arthroplasty or fracture devices included in this study

Exclusion Criteria:

* Patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
Pharmaceutical Care Service in Diabetes

The purpose of this study is to examine the effectiveness of pharmaceutical care service in the management of poorly controlled type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria: Patients who visit Endocrinology and Metabolism department of Pusan National University Hospital, are with type 2 diabetes mellitus, and meet one of the following criteria

* Who are diagnosed with type 2 diabetes mellitus for the first time
* Who need the education for medication or disease
* Who are with poorly controlled blood glucose
* Who have poor medication adherence
* Who have been hospitalized with diabetes complication or poorly controlled blood glucose
* Whose physician recommend the pharmaceutical care to them

Exclusion Criteria: Patients who meet one of the following criteria

* Who are with gestational diabetes
* Who are not able to respond to questionnaires
* Who are with severe condition such as cerebrovascular disease, mental disorder, and acquired immune deficiency syndrome
* Who are not able to be followed-up during 9 months in Pusan National University Hospital
Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery

This pilot clinical trial studies bathing bundle regimen in reducing gynecological surgical site infection in patients undergoing surgery. A bathing bundle regimen may reduce the risk of wound infection, extended length of hospital stay, readmission into the hospital, and the overall healthcare costs in patients undergoing surgery.

PRIMARY OBJECTIVES:

I. To investigate whether gynecology surgical patients using a Bathing Bundle using chlorhexidine gluconate (CHG) 4% skin prep solution (Intervention Group A) have a lower incidence of surgical site infection (SSI) than patients treated with the current standard of care (patient's choice of antibacterial soap). Standard of care results will be based on historical information gathered on Roswell Park Cancer Institute (RPCI) gynecology (GYN) patients prior to July 1, 2010 (Historical Control Group B).

OUTLINE:

Patients undergo preoperative preparation with the "Bathing Bundle" comprising CHG 4% skin prep solution and disposable wash cloths to bathe or shower with the night before and morning of surgery.

After completion of study treatment, patients are followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* GYN surgical patients scheduled for abdominal surgery

Exclusion Criteria:

* Patients with known hypersensitivity to chlorhexidine
* GYN non-surgical patients or surgical patients that will not have an abdominal incision (i.e. vaginal procedures)
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa

To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal Mucosa.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for gastroendoscopy examination

Exclusion Criteria:

* Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium