cyrilzakka/clinical-trials huggingface dataset:
Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting

Treatment of patients suffering from atrial fibrillation pose problems when percutaneous coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. The management of the antithrombotic treatment before invasive cardiac procedures is also incompletely defined. In this study we aim to determine in patients with atrial fibrillation undergoing PCI-S:

1. the contemporary antithrombotic management;
2. the relative safety and efficacy of the various post-PCI antithrombotic regimens;
3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and bioactive stents (BAS);
4. the safety of various periprocedural antithrombotic strategies including glycoprotein IIb/IIIa inhibitors and bivalirudin;
5. safety and efficacy of radial vs femoral approach.

AFCAS study is an observational, multi-center, prospective registry including patients with atrial fibrillation undergoing PCI-S. Follow-up time is 12 months.

Primary end points are major hemorrhagic and thrombotic/thromboembolic complications including cardiac death and secondary endpoints are Major adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death), stent thrombosis and major/non major hemorrhagic complications. Clinical follow-up will be completed for all patients via telephone, or clinic visits scheduled at 1, 3, 6, and 12 months after PCI-S. The 1 and 6 months visits are optional. The patients will be asked about their clinical outcomes, hospitalizations and medications. Any additional information needed, such as specific mortality, will be obtained by contacting one of the patient's physicians or other health care professional or from death certificates. CRFs will be completed and faxed without delays after discharge, and after each follow up visit. Recruitment will take approximately 12 months. Follow-up will be 12 months for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation who undergo PCI.

Exclusion Criteria:

* Because of the observational design, no exclusion criteria are provided.
Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension.

II. Assess the quality of life in these patients with this treatment regimen.

PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients receive oral midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for weeks 6-8.

Quality of life is assessed at weeks 3, 6, and 8.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy-- No concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers At least 30 days since other prior investigational agents --Patient Characteristics-- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No congestive heart failure No myocardial infarction within the last 6 months No uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Patient requires IOP lowering medication in each eye

Exclusion Criteria:

* Ocular hyperemia or other ocular surface findings in either eye
* Active ocular disease
* Current or anticipated use of any topical ocular medication (including artificial tears) during the study
* Intraocular surgery within past six months or unilateral cataract surgery.
* Functionally significant visual field loss
* Anticipated wearing of contact lenses during study
* Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit
A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD

The goal of this clinical trial is to learn if the addition of frequency filtered music (Safe and Sound Protocol) to daily cognitive processing therapy improves effectiveness for reducing PTSD symptoms. The main questions it aims to answer are:

* Does the addition of frequency filtered music reduce PTSD symptoms for patients receiving cognitive processing therapy for PTSD?
* Does the addition of frequency filtered music to cognitive processing therapy improve stress physiology (arousal)?
* Does improvement in physiological stress regulation help explain improvements in hyperarousal and PTSD symptoms? Researchers will compare the effects of a frequency filtered classical music playlist to an identical playlist without added filtering. Participants will be randomized to a music playlist.

Participants will:

* Receive 10 daily sessions of cognitive processing therapy
* Listen to 15 minutes of music before their therapy sessions (2.5 hours music listening total).
* Complete clinical interviews and questionnaires before, during, and up to 6 months after therapy.
* Have their physiological arousal monitored during listening and therapy sessions
* Wear a Fitbit device and complete smartphone surveys for 4 weeks


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Meets diagnostic criteria for a) PTSD or b) subthreshold PTSD with hyperarousal (i.e., meets diagnostic threshold for 3 of 4 symptoms, one of which is hyperarousal)
* Ability to move between sitting to standing without assistance
* Ability to attend two weeks of daily in-person therapy sessions at either the Ohio State University or at the Wright-Patterson Air Force Base (WPAFB) Medical Center

Exclusion Criteria:

* Heart condition (such as cardiac arrhythmia) or pacemaker
* An allergy that would prevent wearing adhesive for durations of 2 hours or less
* Insufficient English fluency to fully engage in psychotherapy
* Use of hearing aids
* Current or prior tinnitus (persistent ringing or other noises in ears not caused by an external sound)
* Severe traumatic brain injury
* An ongoing stressor or condition deemed by the investigators to place the participant at risk for injury or a poor outcome (e.g., undergoing disability evaluation, undergoing a medical board evaluation to be medically discharged from the military, pending negative administrative or legal actions).
* Inability to complete the informed consent process due to the acute effects of a medical or psychiatric condition (e.g., intoxication, mania, psychosis)
Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

The purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.

Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Glucagon-like peptide (GLP-1) analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in Type 2 diabetes and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide on glycemic control in AIDM.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes according to ADA criteria \<3 years.
* Age≥ 18 years.
* Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
* Fasting or postprandial plasma C-peptide more than 100 pmol/L
* Written informed consent from the patient or family representative

Exclusion Criteria:

* History or family history of medullary thyroid carcinoma or MEN 2 syndrome;
* History of chronic or acute pancreatitis;
* Allergic to liraglutide or any components in Victoza®;
* Hepatic abnormalities (transaminase \> 2 times normal);
* Renal impairments (serum creatinine \>133 umol/L);
* Cardiovascular diseases (hypertension, coronary heart disease, etc.);
* Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30;
* Any history of malignancy;
* Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years after recruitment;
* Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory tract infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion;
* Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
Capsula Closure vs. Non-Capsula Closure: Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)

The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.

Exclusion Criteria:

* Previous hip surgery in either hip
* Malignant disease
* Recent hip or pelvic fractures
* Arthritic disease
* Hip joint dysplasia
* Legg-Calvé-Perthes
* Slipped Capital Femoris Epiphysis
* Recent (within 6 weeks) medical treatment with corticosteroids
* Language problems of any kind
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent provided prior to participation in the extension study.
* successful completion of the study CLIC477D2302
* willingness and ability to comply with all study requirements

Exclusion Criteria:

* premature discontinuation from the study CLIC477D2302
* failure to comply with the study CLIC477D2302 protocol
Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing

The purpose of this study is to evaluate hair trace elements and toxic metals and plasma total antioxidant activity in children with recurrent wheezing and to evaluate whether these toxic metals and trace elements have any impact on serum cytokine levels.

Context:

In many studies it was demonstrated that children are much more susceptible than adults for environmental toxic metal exposure. Hair analysis is a promising tool for routine clinical screening and diagnosis of heavy metal exposure and essential trace element states in the human body. Additionally it was demonstrated that oxidants and antioxidants play a central role in the pathogenesis of many pulmonary diseases including asthma. Furthermore, toxic metals, trace elements and oxidative stress have many pivotal role on immune system.

Objective:

To evaluate and compare hair toxic metals, hair essential trace elements levels and plasma total antioxidant activity between children with recurrent wheezing and age and sex matched healthy children.

Intervention: Hair samples will be collected for the analysis of the toxic metals, trace elements. Blood samples will be collected for the analysis of the cytokine levels and plasma antioxidant activity.

Study Measures:

Differences in hair toxic metals, hair trace elements, plasma cytokine levels and plasma total antioxidant activity will be compared between children with recurrent wheezing and age-sex matched healthy children

Eligibility Criteria:
Inclusion Criteria:

* Children with recurrent wheezing ages between 6 months to 6 years old.
* Age and sex matched healthy children for control group.
* Parental/guardian permission (informed consent)

Exclusion Criteria:

* Systemic corticosteroid use in the last 30 days
* Chronic lung diseases including cystic fibrosis
* Immunodeficiency
* Known renal or hepatic dysfunction
* Respiratory truck infections in the last 30 days
* Anatomic abnormalities of the respiratory tract
* Suspected foreign body aspiration or croup
* Immunosuppressive or immunostimulant treatment
Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer

The goal of this clinical trial is to investigate the utility and effectiveness of a decision aid in cisplatin-intolerant patients with locally advanced cervical cancer.

The main questions it aims to answer are:

1. What is the effectiveness of the decision aid in reducing decisional conflict?
2. What is the utility of the decision aid in preparing for decision-making?

Participants will be asked to accomplish the Decisional Conflict Scale before and after using the decision aid.

Researchers will compare patients given routine care and the decision aid with patients given routine care to see if the decision aid reduces decisional conflict.

In locally advanced cervical cancer (LACC), adding chemotherapy (ChT) to radiotherapy (RT) improves survival at the cost of increased toxicity. Among patients with cisplatin contraindications, compliance to RT may be compromised. Shared decision-making (SDM) allows for more patient engagement in the decision-making process and decision implementation planning. In cancer-related decision-making, patient decision aids (PtDA) facilitate the SDM process and have increased patient knowledge and satisfaction and decreased decisional conflict and attitudinal barriers improved patient satisfaction and treatment compliance.

The CECIL study is a two-phase study to develop, validate and test the effectiveness of a PtDA for cisplatin-intolerant LACC patients faced with the decision of adding ChT to RT. Phase 1 is a mixed-methods study to develop a PtDA prototype and determine its content validity and user acceptability. Phase 2 is a block-randomized clinical trial to determine its effectiveness in reducing decisional conflict and its utility in preparing for decision-making. Adult women with biopsy-proven untreated LACC with cisplatin contraindications will be included in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Squamous, adeno- or adenosquamous histology
* International Federation of Gynaecology and Obstetrics (FIGO) Stage I-B3, II-A2, II-B to IV-A
* Contraindication to ChT, including but not limited to hydronephrosis, renal or cardiac dysfunction, frailty, or refusal
* Grade 6 level English literacy
* Informed consent

Exclusion Criteria:

* Other histologies
* Metastatic disease
* Other active cancers
* Prior cancer EXCEPT for a cancer treated curatively, in remission for ≥5 years, with low recurrence risk; adequately treated lentigo maligna or non-melanoma skin cancer without evidence of disease; or adequately treated carcinoma-in-situ without evidence of disease
* Prior pelvic radiotherapy, brachytherapy, or chemotherapy
* Pregnancy
* Cognitive impairment or psychological disturbance limiting study compliance
Autonomic Nervous System Function Following Bariatric Surgery

In the proposed study, the investigators will explore three specific aims. First, the investigators will examine cross-sectionally the association of obesity on sympathetic, parasympathetic, and sympathetic/ parasympathetic nerve fiber balance. In addition, the investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be measured before and after a mixed meal tolerance test.

In the second specific aim, the investigators will prospectively follow-up these individuals (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and osteocalcin will be examined 6 months following surgery with participants serving as their own control, pre- and post-surgical intervention.

Thirdly, the investigators will address whether the effect of weight loss on the ANS and osteocalcin differ between those who had a history of diabetes at baseline versus those with no history of diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18 - 60 years old.
2. Individuals with a BMI \> 35 kg/m2.
3. Patients that have enrolled in a program to undergo weight loss by Roux-en-Y gastric bypass and having passed the pre-operative clearance program.
4. Individuals with diabetes who are currently being treated with diet, exercise, and/or oral medications will be included.

Exclusion Criteria:

1. Patients that have had previous gastric surgery, including but not limited to pancreobiliary diversion, vertical banded gastroplasty, and jejunoileostomy.
2. Individuals with known coronary artery disease (e.g., post-MI), atrial fibrillation,frequent atrial arrhythmias, frequent ventricular arrhythmias, a pacemaker, or myocardial ischemia.
3. Individuals taking the following medications that may affect the autonomic nervous system: anti- tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol,perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin,methotrexate, barbiturates, neuroleptic drugs, antiparkinsonism drugs, fluoxetine, and nitrated drugs.
Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis

The purpose of this study is to determine whether micronized dehydrated human amniotic membrane (dHACM) suspension is more effective in reducing inflammation than conservative measures alone when used to treat acute/early lateral epicondylitis.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Medicare patients may be selected.
* Both male and female patients will be selected.
* A negative x-ray of the elbow
* Diagnosis of lateral epicondylitis by history and exam with symptoms for no longer than one year.
* Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
* Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
* Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

* Prior surgery at the site
* Site exhibits clinical signs and symptoms of infection.
* History of chronic soft tissue inflammation of more than 6 months.
* A positive X-ray for fracture or significant anatomic abnormality including fracture, advanced arthritis, excessive calcification, etc.
* No history of corticosteroid injection within the past 30 days.
* Joint instability
* No rheumatologic conditions involving the elbow.
* No evidence of significant neurological entrapment or neurological disease of the forearm
* Concurrent cervical radiculopathy
* The presence of comorbidities that can be confused with or can exacerbate the condition including:

  * Previous elbow trauma
  * Previous elbow surgery
* Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. (i.e. a one month "washout period" for these drugs.)
* Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
* History of radiation at the site.
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
* Patients who are unable to understand the aims and objectives of the trial.
* Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
* Pregnant or breast feeding. No pregnancy within the past 6 months.
The Effect of Occupational Therapy Intervention in Hemodialysis Patients

The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as chronic renal failure.
* between 18-65 years
* undergoing HD treatment for at least 1 year

Exclusion Criteria:

* Beck Depression Scale score of 17 or higher
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.

Eligibility Criteria:
Inclusion Criteria:

* Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
* Chronic HCV infection.
* Participant had to be either HCV treatment-naïve or treatment-experienced.
* Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any drug.
* Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed during screening indicating co-infection with more than one HCV genotype.