cyrilzakka/clinical-trials huggingface dataset:
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.

Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
* Referred for medically indicated aortic valve replacement
* Sinus rhythm
* Provide written informed consent

Exclusion Criteria:

* Inclusion in other trial
* Left ventricular ejection fraction less than 0.45
* Presence of any coexisting severe valvular disorder
* Previous cardiac surgery
* Urgent or emergent surgery
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.

The purpose is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in Danish myopic children aged 6-12 years. It is a clinical randomized non-inferiority trial, where the participants are randomly assigned to either OKL or DIMS spectacles. The participants are followed during 18 months of therapy. The hypotheses:

* There is no statistically significant difference between the myopia control efficacy between OKL and DIMS spectacles.
* Larger pupil size is positively correlated to treatment efficacy for both devises.
* Increasing choroidal thickness during early treatment is positively correlated to treatment efficacy for both devises.
* There is no difference in vision related quality of life between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Myopic children aged 6 to 12 years. Myopia of the 6 to 8-year-olds: -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism. Myopia of the 9 to 12-year-olds: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism.
* Anisometropia \< 1,5 D cycloplegic spherical equivalent refractive error.
* Best corrected visual acuity: Age 6 to 8 (inclusive) years: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters). Age 9 to 12 years: 1.0 Snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 ETDRS letters)

Exclusion Criteria:

* Manifest or latent squint.
* Contraindications to the use of OKL comprising keratoconus, chronic allergic conjunctivitis and keratoconjunctivitis sicca.
* Previous eye surgery.
* Chronic eye disease demanding daily use of eye drops.
* Non-compliance to eye examinations
Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus

The purpose of this study is to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.

Type 1 diabetes results from an attack by the body's own immune system on the insulin producing cells in the pancreas. Around 80% of diagnosed patients have detectable antibodies to islet cell self-proteins including, insulin IA-2 and glutamic acid decarboxylase. The drug, BHT-3021 is being studied because an agent that stops autoimmune damage could offer patients benefit.

Study Description: A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes Mellitus that will enroll up to 72 subjects in this trial. Subjects will be randomized to BHT-3021 or BHT-placebo in a 2:1 ratio.

The duration of the study is approximately 25 to 37 months depending on treatment assignment: 4 week Screening Period; 12 month Blinded Treatment and Evaluation Period; 12 month Cross-over Treatment and Evaluation Period (BHT-placebo subjects only); 12 month Long Term Follow-Up period.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of Type 1a Diabetes Mellitus based on ADA Criteria
* ≤5 years since T1D was diagnosed
* ≥ 18 years of age
* ≤ 40 years of age at the time of diagnosis of Type 1a diabetes
* Presence of antibodies to at least one of the following antigens:

insulin, GAD-65, or IA-2

* Detectable fasting C-peptide level
* C-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/mL
* Presence of antibodies to at least one of the following antigens: insulin, GAD-65, or IA-2. If insulin antibody positive only, determination must be within 2 weeks of insulin initiation

Exclusion Criteria:

* BMI \> 30 kg/m2
* Unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
* Current use of inhalable insulin
* Previous immunotherapy for T1D
* Administration of an experimental agent for T1D at any time or use of an experimental device for T1D within 30 days prior to screening, unless approved by the medical monitor
* History of any organ transplant, including islet cell transplant
Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis

The adverse effects of rheumatologic diseases, especially Ankylosing Spondylitis (AS), on sexual functions are known. The causes of sexual dysfunction in rheumatologic diseases are due to factors such as pain, weakness, fatigue, stiffness, functional disability, anxiety, depression, hormonal deficiency, drug use, decreased libido and poor body image. Depending on these factors, sexual intercourse and frequency of sexual intercourse may decrease. Sexual dysfunction may be seen in AS due to physical and emotional problems caused by the disease.

There are many studies in the literature that determine sexual satisfaction and sexual dysfunction in individuals with AS and compare individuals with AS to healthy individuals . In the light of these studies, the investigators thought that the sexual function of partner of individuals with AS may also be affected negatively. In the literature, no previous study examines the sexual function of partner of individuals with AS. Therefore, the aim was to determine the sexual function of partner of individuals with AS and to compare with healthly adults of the same sex.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with AS for individuals with AS,
* No additional disease (comorbid and psychiatric disease, hypothyroidism, hypopituitarism, hypogonadism or hyperprolactinemia)
* Having a partner (relationship status in a monogamous sexual relationship),
* Not smoking and drinking,
* Non-AS partner have not been diagnosed with AS and their partner is AS.

Exclusion Criteria:

* Overweight or obesity (BMI \<28 kg / m2)
* Having had a pelvic injury, urological or gynecological operation in the last 3 months
* Hypogonadism; penile abnormalities such as hypospadias, congenital curvature or Peyronie's disease with preserved penis stiffness
* Prostatic disorder
* Use of drugs that may affect erectile function (steroids, antihistamines, ß-blockers or SSRIs)
Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study

Major surgery involving the knee is often associated with severe postoperative pain. Postoperative pain control remains a significant contributor to delayed recovery and length of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of major concern due to the need for early mobilization, a crucial factor in good postoperative rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of anesthetics provide an effective method for analgesia while minimizing the need for systemic opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation. Administration of fentanyl has shown to be a highly effective method to control pain after Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will result in greater post-operative strength in the operative knee.

All subjects scheduled to receive a unilateral, primary total knee replacement were evaluated for eligibility in the preoperative anesthesia center. Adults, older than 18 years of age, ASA I-III were included in the study. Subjects who were either pregnant, on anticoagulant therapy, allergic to opioids, local anesthetics, chronic pain patients, history of traumatic lower extremity injury, or had a body mass index of greater than 35 kg/m2 were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral primary total knee replacement
* ASA class I-III
* 18 years and older

Exclusion Criteria:

* Patient refusal
* Pregnancy
* Coagulopathy
* Adverse/allergic reaction to any opioids or local anesthetics
* History of long-term opioid use (greater than 60 days)
* Infection
* Traumatic lower extremity injury
Alzheimer's Plasma Extension

The APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years.

Approximately 1000 participants will be enrolled across three groups:

* Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative),
* Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and
* Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials.

Primary Objectives:

* Collect longitudinal cognitive and functional assessments and blood-based biomarker data
* Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants
* Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status

Exploratory Objectives:

• Collect baseline amyloid PET on participants without prior amyloid PET data (Group C)


Eligibility Criteria:
Inclusion Criteria:

1. Documentation of the participant's informed consent to study procedures and for the use of protected health information (HIPAA Authorization, if applicable). Informed consent processes and documentation must adhere to state laws/local requirements, including consent provided by the participant's legally authorized representative (LAR), responsible next of kin, surrogate consent with assent, etc.
2. Previously consented to participate in A3-45 screening.
3. Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
4. If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
5. As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.

Exclusion Criteria:

1. Current treatment with an FDA approved medication for Alzheimer's disease, including prior or current treatment with a prohibited medication.
2. Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five half-lives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm.

   Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval.
3. Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia).
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes


Eligibility Criteria:
General Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
* Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
Feasibility of a Positive Parenting Program for Women Experiencing Homelessness Who Have a History of Interpersonal Violence

The purpose of this study is to strengthen the skills and self-efficacy of women by addressing the social and emotional trauma that they have experienced from interpersonal violence (IPRV) and homelessness and to promote positive parenting strategies through Play and Learning Strategies (PALS), an evidence based intervention.


Eligibility Criteria:
Inclusion Criteria:

* report of at least one physically violent act from a partner within the past 24 months
* have at least one child 5 years or younger.

Exclusion Criteria:

* do not speak English
* their intimate partner is physically present at the time of enrollment
Treatment of Choledocolithiasis by Laparoscopic Exploration

There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.

this study was revision of clinical files.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service

Exclusion Criteria:

* Less than 18 year old
How Does Basic Body Awareness Therapy Effect Pain Coping Strategies in Postmenopausal Women?

Exercise interventions are deemed essential for the effective management of patients with pain. Various therapy methods have been shown in the literature for pain and coping with pain. However, there is no study investigating the effectiveness of Basic Body Awareness Therapy in pain and coping with pain. In this respect, our study will contribute to the literature. The aim of our study is to compare the effectiveness of Basic Body Awareness Therapy and Therapeutic Exercises on pain coping strategies of Postmenopausal women.

The patients will be randomly assigned into three groups: Therapeutic Exercise (TE) Group, Therapeutic Exercise+Basic Body Awareness (TE+BBAT) Group, and Control Group. Each group will be treated for 12 weeks. Individuals will be evaluated in detail at the beginning and end of the study. The follow-up assessments of the study will be done 3 months after the conclusion of the treatments. Physical and sociodemographic characteristics will be evaluated by dedicated form. The body awareness of the participants will be evaluated Body Awareness Questionnaire (BAQ) developed by Shields, Mallory \& Simon in 1989. The pain levels of the PmW will be measured with the Short Form McGill Pain Questionnaire. Pain coping strategies of PmW will be assessed with Pain Coping Inventory (PCI). The Oswestry Low Back Pain Disability Index will be used for evaluating the disability level caused by low back pain. The Neck Disability Index will be used for evaluating the disability level caused by neck pain.

Eligibility Criteria:
Inclusion Criteria: Participants should have;

* Chronic lower back or neck pain lasting at least six months
* Gone through the menopausal transition naturally within the last year
* Not received a physiotherapy approach for pain management in the last six months
* Be able to read and write in Turkish.

Exclusion Criteria:

* Presence of significant neurological disorders
* Presence of serious mental and psychological disorder
Sleep Ventilation for Patients With Advanced Hypercapnic COPD

Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.

The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.

The purpose of this protocol is to perform a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure. The study will focus on the primary end-points of time to hospital re-admission for acute exacerbation of COPD and/or an episode of acute on chronic hypercapnic respiratory failure, in addition to other clinically relevant outcomes including patient health-related quality of life, sleep quality indices, and gas exchange parameters. Approximately 300 BIDMC adult patients will be recruited and each patient monitored over a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure.
2. Male or female aged ≥ 18 years with advanced hypercapnic COPD

   1. FEV1 ≤ 50% predicted and
   2. Prolonged hypercapnia during the daytime, at rest, without O2 or ventilatory support, PaCO2 \> 52 mmHg on ABG (performed off of NIPPV), compensated with pH \> 7.30
3. Willingness to use NIPPV treatment
4. English speaking

Women and minorities will be recruited in numbers reflecting representation in the Boston Metropolitan community which is approximately 84% Caucasian, 9% African American, 5% Hispanic American, and 2% Asian American, as the knowledge gained can apply to individuals of all ethnic background and gender.

We do not wish to limit our sample to a highly selected group of patients, to allow for more generalizable results.

Exclusion Criteria:

Subjects will be excluded from participation in the study for a history of:

* Significant sleep disordered breathing (AHI 4% ≥ 15 events/hour) or high clinical suspicion (BMI ≥ 35)
* Neuromuscular disease or other causes of hypoventilation
* Abnormalities of the thorax or lungs other than COPD
* Already treated with home NIPPV
* Unable to wean from ventilator during admission
* Unable to wean from NIPPV, pH \< 7.30
* Recent tracheotomy decannulation
* History of severe depression or bipolar disorder requiring prior hospitalization or suicide attempts or ideation
* Cognitive impairment (such as advanced dementia) that would limit ability to provide consent or to use NIPPV
* Active recreational drug use
* Unstable housing that would limit ability to use NIPPV
* Severe heart failure (New York Heart Association stage IV)
* Active/unstable CAD
Patient Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS)

This is a multi-centre, multi-national, prospective, observational study of Friedreich's Ataxia (FRDA) with a control group to:

* obtain natural history data on individuals affected by FRDA
* relate clinical assessments and results from proteomic analyses
* expedite identification and recruitment of participants for clinical trials
* develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of FRDA which may also be potential outcome measures for use in future clinical trials and clinical care
* plan for future research studies

The EFACTS patient registry integrates prospectively and systematically collected clinical research data (e.g. clinical tests, demographical characteristics) with access to biological specimens (e.g. blood, urine) obtained from individuals with genetically confirmed FRDA and unrelated control research participants.

The EFACTS patient registry started out as a 4-year study and is currently running without a set end date. Eligible subjects are assessed at annual study visits on the clinical symptoms and signs of the disease. At each study visit, general clinical, motor function, cognitive, and Quality of Life assessments are administered. In addition, participants are providing bio samples for the purposes of genetic testing and for research to identify valuable biomarkers of FRDA. Biological specimens and clinical data are made available to qualified scientists within the EFACTS network whose projects are reviewed and approved by the EFACTS Steering Committee. Research projects should aim to advance scientific knowledge towards establishing clinically effective treatments that delay onset and/or slow the progression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of FRDA
* For control research participants: genetically confirmed absence of FRDA