cyrilzakka/clinical-trials huggingface dataset:
Prehypertension Labeling

The purpose of this study is to find out whether labeling adults with prehypertension has negative effects on clinic blood pressure and quality of life 3 months after diagnosis.

Previous research has shown that a diagnosis of hypertension is associated with subsequent increases in resting blood pressure, and there is preliminary evidence of a cross-sectional association between hypertension labeling and the white coat effect. The white coat effect may be particularly problematic in prehypertensives, because a small elevation in clinic blood pressure could result in crossing the diagnostic cutoff for hypertension, potentially leading to misdiagnosis and unnecessary treatment. This study will examine effects of prehypertension labeling on clinic and ambulatory blood pressure, and will examine potential psychological mediators of these associations.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years
* average screening systolic blood pressure of 120-139 mmHg OR diastolic blood pressure of 80-89 mmHg
* average screening systolic blood pressure below 140 mmHg AND diastolic blood pressure below 90 mmHg
* able to read and write in English

Exclusion Criteria:

* past diagnosis of hypertension, prehypertension, or high blood pressure
* current or past use of antihypertensive medications
* diabetes
* renal disease
* cardiovascular disease
* current participation in another hypertension-related clinical trial
Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.

Phase III long-term safety study of Effexor XR in patients with major depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients who complete the Phase III double-blind study (Protocol Number 0600B1-816)

Exclusion Criteria:

* Patients with schizophrenia or any other psychotic disorder
* Patients with history or presence of bipolar disorder
Cohort of Inflammatory Bowel Disease Patient in Yeouido St. Mary's Hospital

Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The aim of this study is to analyze gut microbiota in IBD patients.

Inflammatory bowel disease (IBD) (Crohn's disease (CD) and ulcerative colitis (UC)) occurs worldwide with differences in epidemiology, etiology, and phenotype between regions. Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The DNA of microbiota will be investigated with samples of stool, colon tissue. The aim is to establish a cohort group for IBD (1), to make a database on cohort group characteristics such as endoscopic findings, disease severity, epidemiology, and prognosis (2), to analyze gut flora in IBD patients (3).

Eligibility Criteria:
Inclusion Criteria:

* The below 3 conditions must be met simultaneously.

  1. Patient who can voluntarily consent to this study.
  2. Patient who has inflammatory bowel disease.
  3. Patient who is aged less than 75 years.

Exclusion Criteria:

* a patient meets any of the below conditions.

  1. If a patient has an IBD other than UC and CD.
  2. If a patient is vulnerable due to his/her position as an employee of Yeouido St.Mary's hospital or a medical student of the Catholic University of Korea.
  3. If a patient is pregnant.
  4. Foreign personal who cannot speak Korean.
Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited.

The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups.

Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups


Eligibility Criteria:
Inclusion Criteria:

* Females \>18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed National Military Medical Center.
* Patients must be able to read and understand written English or have an appropriate certified medical translator available.

Exclusion Criteria:

* Known allergy to amide local anesthetics.
* Unstable cardiac arrhythmia.
* Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer).
* Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable).
* Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery.
* Significant history of opioid or alcohol abuse or addiction (requiring treatment).
* Concurrent pain management requiring the use of epidural anesthesia.
Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.

The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.


Eligibility Criteria:
Inclusion Criteria:

* Positive screen on PHQ-9

Exclusion Criteria:

* Does not own or use a mobile smart phone
Low vs Medium Pressure Pneumoperitoneum

The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.


Eligibility Criteria:
Inclusion Criteria:

* Prepped and consented for diagnostic laparoscopy for likely acute appendicitis
* 5 years or older
* 15 kg or more
* Parents/legal custodian give consent, patient shows no signs of unwillingness to participate
* Patient is hemodynamically stable

Exclusion Criteria:

* Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis
* Suspected perityphlitic abscess on preoperative ultrasound
* Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties
* Parents have inadequate knowledge of German language to understand Informed consent
* Child has inadequate knowledge of German language to allow elicitation of Pain Scores
Effect of N-acetylcystein in Myocardial Infarction

We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous coronary intervention.

Percutaneous coronary intervention(PCI) is one of the standard therapies for acute coronary syndrome. Despite major advances in PCI procedure, impaired myocardial perfusion frequently occurred after primary PCI and resulted in a larger infarct size and increased morbidity and mortality.Reperfusion injury process can be resulted in additional death of cardiomyocytes and it is suggested that oxidative stress is a contributing factor to induce reperfusion injury.During PCI,trauma occurs to the arterial endothelium, causes the activation and aggregation of platelets.

It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. The most common complication of PCI is a cell damage to cardiomyocyte that can be diagnosed by postprocedure elevation of cardiac markers. N-acetylcystein have several positive effect on platelet and vascular function and infarct size.

This study is a randomized clinical trial (RCT) evaluating the effect of N-acetylcystein on biomarkers of platelet activation and coronary reperfusion in patients undergoing percutaneous coronary intervention. Double blind randomized clinical trial on 100 patients in 2 groups (intervention \& control) is conducted. Patients with confirmed ST-elevation myocardial infarction included in this study. Patients were excluded if they had: emergency for cardiac bypass; cardiogenic shock and rescue percutaneous coronary intervention. Patients in Intervention group were administered 100 mg/kg Iv bolus N-acetylcystein and then 480mg intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention and patients in control group received standard regimens. Primary outcome was platelet activation biomarkers assessment before and 24 hours after percutaneous coronary intervention and secondary outcome was effect of N-acetylcystein on CK-MB and high sensitive Troponin T, 6 and 12 hours after percutaneous coronary intervention.Patients were assessed for coronary blood flow after percutaneous coronary intervention with the use of TIMI flow and myocardial blush grade.

Major adverse cardiac events (MACE) will be evaluated as a secondary endpoint after 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction patients who were candidate of primary PCI

Exclusion Criteria:

* Rescue PCI
* Emergency for cardiac bypass
* Cardiogenic shock
* Life expectancy less than 6 months
* Age less than 18 years old
* Uncontrolled hypertension
* Thrombocytopenia
* Malformation or aneurysm
* Sever chronic kidney disease
* Sever liver failure
* Major surgery within 3 months
* Unsatisfactory to enter the study
Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes

A triple-arm double-blinded placebo-controlled repeated-measures randomized clinical trial in Colombian elite team-sport athletes. The aim is to evaluate the effects on strength-related parameters and body composition after eight weeks of supplementation with creatine monohydrate (CrM) and creatine hydrochloride (Cr-HCl). The study will be reported following the Consolidated Standards of Reporting Trials (CONSORT) extension to Multi-Arm Parallel-Group Randomized Trials. All variables will be measured at baseline and after eight weeks.

Creatine monohydrate (CrM) is the most studied nutritional supplement and, therefore, one of the most popular ergogenic nutritional aids for athletes. Studies have shown that CrM supplementation increases intramuscular creatine concentrations which enhances exercise performance and improves body composition in different populations (from young athletes to older adults).

It is important to note that the U.S. Food and Drug Administration (FDA) have recognized CrM as a safe ingredient (Generally Recognized as Safe, GRAS - No. GRN 000931). In spite of this, other forms such as creatine chloride (Cr-HCl) have been marketed as a more bioavailable sources of creatine. Since there are not studies that rigorously compare the effects of CrM versus Cr-HCl on physical performance and body composition, the aim of this study is to evaluate the effects of a 8-week supplementation protocol with the two forms of creatine (comparing to placebo) on neuromuscular strength and body composition in Colombian elite team-sport athletes.

Eligibility Criteria:
Inclusion Criteria:

* Practicing team sports at the competitive level (handball and softball)
* Having at least one year of competitive sports training experience (including strength training at least three times a week),
* Being attended at INDEPORTES Antioquia.

Exclusion Criteria:

* Those who do not wish to participate voluntarily (do not sign informed consent),
* Those who were taking nutritional supplements (including creatine) eight weeks prior to the start of the study,
* Those who had a diagnosed pathology or health issues.
Identification of New Inborn Errors of Immunity

Analysis of DNA samples of patients with molecularly undetermined PID by whole exome/genome sequencing.

Transcriptome analysis of patients with molecularly undetermined PID.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary immunodeficiency (PID)
* Male and Female participants 0 years to adult age (any)
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* Secondary immunodeficiency
* Refusal to enter the study
SITS-IVT in Patients >80 Years Study

A non-interventional post-approval study on Safe Implementation of Treatment in Stroke - International Stroke Thrombolysis Register (SITS-ISTR) existing data of intravenous recombinant tissue plasminogen Activator (rt-PA) (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, treated according to the Summary of Product Characteristics (SmPC) in European countries.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 80 years old presenting with acute ischaemic stroke symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to SmPC are included.
* Patients over 80 years who received thrombolysis according to SmPC for acute ischaemic stroke (AIS) within 4.5 hours after stroke onset during the period (approximately 3 years) prior to July 2018 are included.

Exclusion Criteria:

* Contraindication(s) to the use of IV thrombolysis per local SmPC.
* Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of index event and for the duration of the data collection.
Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.

The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.

The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.


Eligibility Criteria:
Main Inclusion Criteria (At Screening visit):

* Informed consent signed and dated (obtained prior to initiating any procedures).
* Patient aged ≥18 years old.
* Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit

Main Exclusion Criteria (At both Screening and Randomisation visits):

* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)).
* Patient with previous or current ophthalmic condition
Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis

Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis

Clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis

Eligibility Criteria:
Inclusion Criteria:

* • Male \& female osteoporotic patient aged ≥ 50 years

  * Hypertensive \& normotensive patients
  * BMD T-score ≥ 2.5 or more SD below peak bone mass

Exclusion Criteria:

* Patients on drugs that may improve osteoporosis disease state such as:

  * Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blockers (ARBs), Thiazide diuretic, Nitrates, Spironolactone, Statins.

Patients on drugs that may worsen osteoporosis disease state such as:

• Corticosteroids, Loop diuretics, Anticonvulsants, Antidepressants, Aromatase inhibitors, Thyroid replacement therapy and Proton pump inhibitors.
A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective treatment for atrial fibrillation (1-4). However, rare but potentially life threatening complications such as thromboembolism (5), PV stenosis (5-10), left atrium-oesophageal fistula (11) and inflammatory syndromes (12) have been described. In preliminary studies an alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation (13), preserves the extra cellular matrix and creates lesions with well-delineated border zones (14). Therefore, cryoenergy seems to be the ideal form of energy to safely perform PV isolation.

We therefore hypothesise that in the setting of PV isolation for the treatment of atrial fibrillation (AF) cryoenergy is less traumatic and therefore reduces systemic inflammatory responses compared to radiofrequency energy.

78 patients presenting with symptomatic intermittent or persistent AF will be randomised to PV isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed irrigated tip) or cryoenergy (26 patients with cryoballoon). Systemic markers of cell damage and inflammatory response (t-troponin, CK, CK-MB, vWF, PAI-1, micro particles, platelet activation/overall function, CRP, IL-6, IL-8, IL-10, TNF alpha, procalcitonin) will be monitored before, during and 48h after the procedure. Further endpoints include time to PV-isolation and procedure related complications. Six month clinical follow-up will focus on freedom from AF and cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Symptomatic drug refractory (more than 2 antiarrhythmic drugs) paroxysmal or persistent AF
* Documentation of AF on 12 lead ECG and/ or Holter
* Left atrium of less than 55 mm
* Informed consent signed by the patient

Exclusion Criteria:

* Previous Ablation or operation for AF
* Contra-indication for heart catheterisation
* Cardioversion for AF during the 2 weeks before the procedure
Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients

Epidural anesthesia represents the most popular method for pain relief during labour. Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia, representing therefore the most common complication. Up to 80% of patients with a UDP may develop a post-dural puncture headache (PDPH).

When a UDP occurs, two possible strategies have been proposed in order to ensure analgesia during labour: either resiting the epidural catheter in a different intervertebral space, or inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during labour, but their relative contribution in preventing PDPH is still not known.

The primary aim of this multicenter randomized controlled trial is therefore to compare these two strategies in the occurrence of PDPH at 24 hours from the UDP.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of UDP during labour
* Written informed consent

Exclusion Criteria:

* Refusal to participate in the study
* History of PDPH
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)

The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
2. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
3. Primary diagnosis of ADHD: combined sub-type or predominantly hyperactive impulsive sub-type based on a detailed psychiatric evaluation.
4. Subject has a baseline ADHD-RS-IV score ≥ 28.
5. Intelligent Quotient (IQ) score of 80 or above on the Kaufman Brief Intelligence Test (KBIT).
6. Subject must be able to complete at least the Basic Test of the PERMP assessment.

Exclusion Criteria:

1. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
2. Subject has Conduct Disorder.
3. Subject has a documented allergy, hypersensitivity or intolerance to amphetamines.
4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
5. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
6. Subject weighs less than 50 pounds (22.7kg).
7. Subject is significantly overweight
8. Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
9. Subject has any reported history of abnormal thyroid function.
10. Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
11. Subject has a known history of structural cardiac abnormality, as well as any other condition(s) that may affect cardiac performance.
12. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments
13. Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics (bronchodilators are not exclusionary).
14. The female subject is pregnant or lactating.
15. Subject is well controlled on their current ADHD medication with acceptable tolerability.