cyrilzakka/clinical-trials huggingface dataset:
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.


Eligibility Criteria:
Inclusion Criteria:

* Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy.
* Subject is a male or female aged 6-17 years inclusive at the time of consent
* Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation
* Subject must have a baseline ADHD-RS-IV total score 28.

Exclusion Criteria:

* Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response
* In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms.
* Subject has previously been exposed to STRATTERA or to amphetamine therapy
* Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy
* Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments.
* Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency

The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF).

Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low body levels of iron might increase shortness of breath and fatigue.

The purpose of this prospective, double blind parallel group randomized study is to compare the effects of ferric carboxymaltose vs. placebo on skeletal muscle mitochondrial oxidative capacity, submaximal exercise tolerance, and health-related quality of life in non-anemic Heart Failure (HF) patients with functional iron deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic NYHA Class II-III heart failure \>3 months
* Guideline-recommended heart failure treatment for \> 3 months
* Hemoglobin \>13 g/dl for men and \>12 g/dl for women
* Functional iron deficiency (defined as serum ferritin level \<100 ng/ml or between 100 and 299 ng/ml with transferrin saturation \<20%)
* Left ventricular ejection fraction \<40%, or left ventricular ejection fraction ≥40% with left atrial enlargement (left atrial volume index \>28 ml/m2) and/or left ventricular hypertrophy (left ventricular mass index \>95 g/m2 (women) or \>115 g/m2 (men) determined by echocardiogram within last 24 months.
* Able and willing to provide written informed consent

Exclusion Criteria:

* Presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
* Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy
* Weight \<50 kg or \>120 kg
* Coronary or cerebral atherothrombotic events in the past 6 months
* Hospitalization of emergency room visit for heart failure within past 3 months
* ICD shock in last 3 months
* Known peripheral artery disease or ankle-brachial index \<0.9 at screening visit
* Exercise primarily limited by angina, lung disease or neuromuscular disease
* Systolic blood pressure \<100 or \>160 mmHg
* Heart rate \<50 or \>110 min-1
* Estimated glomerular filtration rate \<30 ml/min
* Liver function tests \>3 times upper limit of normal
* Serum phosphate below normal limit
* Pregnant or breast-feeding women
* Women of child-bearing potential unwilling to use recommended contraception methods during the study
* Treatment with oral iron supplements (except multivitamins) in past year
* Treatment with intravenous iron in past year
* Treatment with erythropoiesis stimulating agents in the past year
* Known intolerance of intravenous iron
* History of anaphylaxis
* Participation in another clinical trial within last 30 days.
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

OBJECTIVES:

I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.

II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.

III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.

IV. Evaluate any antilymphoma effects of this drug in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment
* At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR at least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present
* Measurable or evaluable disease
* Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only)
* Not eligible for curative conventional therapy

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0-2
* Life expectancy: At least 3 months
* Platelet count at least 75,000/mm3
* Bilirubin less than 2.5 mg/dL
* SGOT less than 3 times upper limit of normal
* Creatinine less than 2.0 mg/dL
* No New York Heart Association class III or IV heart disease
* No clinically significant pulmonary disease
* No active serious infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior interferon
* Concurrent transfusions allowed
* At least 4 weeks since prior cytotoxic chemotherapy
* No concurrent antineoplastic agents
* At least 4 weeks since prior corticosteroids
* No concurrent glucocorticoids
* At least 4 weeks since prior radiotherapy
Assessment of an Orthopedic Surgery Rotation on Musculoskeletal Competency in Emergency Medicine Residency Training

Patient commonly present with orthopedic injuries in the emergency department. Musculoskeletal education has not historically been emphasized in American medical schools, and the effectiveness of an orthopedic surgery rotation has not been well studied in emergency medicine (EM) training. Competency in musculoskeletal education has been tested previously with a validated instrument, the basic competency exam (BCE), to assess baseline knowledge in primary care and emergency physicians.

Residents from 2 different EM residency training programs will be given the BCE to determine baseline musculoskeletal knowledge prior to their orthopedic surgery rotations. A post-test BCE will be given to the residents from both EM training programs upon completion of their orthopedic surgery rotation and compared.


Eligibility Criteria:
Inclusion Criteria:

* Emergency Medicine Residents at either San Antonio Military Medical Center or University Hospital

Exclusion Criteria:

* Not emergency medicine residents at the inclusion sites.
the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial

The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

1. females aged 15-65 years,
2. American Society of Anesthesiologists (ASA) physical status classification I-III
3. no previous laparotomy(major abdominal surgery).
4. need a laparascopic surgery

Exclusion Criteria:

1. required hospitalization after the laparoscopic surgery,
2. the procedure required conversion to laparotomy
3. if a 48-hour follow-up was not feasible
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA


Eligibility Criteria:
Inclusion Criteria:

1. Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria:

1. Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
2. Participant who has previously received PC945.
3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
4. Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis
Study of Massage Therapy Within a Brain Tumor Setting

The purpose of this study is

* to assess the feasibility and acceptability of massage therapyto examine the effects of massage therapy
* to explore whether psychological outcomes are associated with changes in patient reported QoL.

As a part of this study, we will provide massage therapy to brain tumor patients. Our contribution here is expected to determine whether massage therapy is safe and helps to improve patient QoL. This contribution is significant because it is expected to provide pilot data on effect sizes so that we may design an adequately powered study to develop massage therapy programs and interventions for patients with brain tumors. In addition to benefiting brain tumor patients, the information from this study may be applied to improving the QoL of other cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmed, newly diagnosed, post surgical WHO grade III/IV malignant glioma (i.e., glioblastoma, anaplastic astrocytoma) being followed at the Preston Robert Tisch Brain Tumor Center (PRT-BTC) at Duke University Medical Center (DUMC) will be considered potential participants for this study.
* Additional eligibility criteria will be:

  1. \> 18 years old
  2. Karnofsky Performance Score of \> 70 at onset of study
  3. estimated life expectancy of \> 3 months
  4. approval from attending oncologist
  5. the ability to speak, read and write English
  6. live within a 60 mile radius of the DCL
  7. be identified as "stressed" by Perceived Stress Scale (PSS) score, \> 12.1 and 13.7 for men and women respectively, and 8) signed informed consent prior to initiation of study-related procedures.

Exclusion Criteria:

* N/A
A Prospective Clinical Study Evaluating the Newton™ TKA Protocol

Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol

The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).

Eligibility Criteria:
Inclusion Criteria:

* Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant

Exclusion Criteria:

* Patients may be excluded due to some medical conditions
Effects of a Mindfulness Programme on Competitive Athletes With Physical Disabilities

Pain affects the athlete's sporting career directly or indirectly. Directly, the injury affects other areas of the body causing a physical decompensation in the athlete and this affects the correct execution of the sporting technique, or how technical gestures can cause pain. Indirectly, through the psychological consequences of pain that generate a series of negative consequences and feelings. Some studies suggest that psychological skills are an important tool for pain management. For that reason, a mindfulness intervention programme would be a useful tool for manage pain in this population.

The study hypothesised that the Mindfulness Sports Performance Enhancement (MSPE) programme adapted for this population, was more effective than mindfulness-based relaxation training as a treatment for chronic pain and associated emotional disturbances in Para athletes with physical disabilities, and that it contributes more to modifying psychological variables that have been shown to be related to or have modulatory value in the experience of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Have a physical disability
* A minimum of 5 points on a Likert-type scale from 1 (no pain) to 10 (worst pain imaginable) at the time of recruitment
* Be at least 15 years of age
* Have been a competitive athlete (regional, national, world and/or Paralympic Games level) in any sport discipline.
* Have an official regional or Spanish Federation of Sports for People with Physical disabilities licence
* Be willing to participate in a mindfulness programme for pain management
* Sign an informed consent form.

Exclusion Criteria:

* Not having at least one of the criteria mentioned as inclusion.
The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.

The aim of this study is to evaluate the therapeutic effect of escitalopram (cipralex) in the treatment of negative symptoms in schizophrenic patients receiving either typical or the newer atypical antipsychotics (olanzapine and risperidone) in a double-blind placebo-controlled study. As there is no drug treatment that is considered as first-line treatment in the treatment of negative symptoms, we thought that the comparison with placebo is plausible. However, it is important to note that the patients will receive the commonly used treatment for their disorder (i.e. antipsychotic medication).

Eligibility Criteria:
Inclusion Criteria:

* Chronic schizophrenia patients,
* Age \<60,
* Medicated,
* Inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
* Patients will be clinically stable and free of any additional axis I diagnosis or significant medical illnesses before enrollment into the study.
* A Positive and Negative Syndrome Scale (PANSS) score of 50 or above will be required for entry to the study.

Exclusion Criteria:

* Comorbidity with mania or major depression,
* Pregnancy,
* Lactation,
* Impaired renal or hepatic function,
* History of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (SSRI) group.
* Additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and CGI scores of "condition much worsened".
* Patients will be excluded during the study if they will remove their informed consent.
Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

Eligibility Criteria:
Inclusion criteria:

* Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
* 2nd or later relapse after chemotherapy (with no prior transplantation),
* Relapse after HSCT, or
* Refractory disease
* Had treatment for relapsed or refractory disease between 2005-2012
* Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

Exclusion criteria:

* No CNS involvement at relapse
* No previous treatment with blinatumomab
Changes in Mitochondrial Uncoupling Protein 2 (UCP2) Messenger RNA(mRNA) in Type 2 Diabetes (T2DM) Patients

Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose levels, high free fatty acids and high oxidative stress.

The investigators intend to learn about the changes in UCP2 along the process of reaching glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Un balanced diabetic patients.

Exclusion Criteria:

* No current infection.
A Comparison of Epidural Techniques for Labour Analgesia

A trial comparing outcomes for different epidural techniques in labour analgesia

Epidurals are the most common form of pain relief in labour. There are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (CSE). CSE has been shown to work faster and provide better pain relief than epidural alone. The investigators aim to show that CSE also requires less medication over the course of labour as this may mean it has fewer side effects. The amount of medication needed during labour between the two different techniques given in a standardized way will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, singleton presentation at term

Exclusion Criteria:

* Significant comorbidities likely to alter outcome of labour
Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. The trial will last approximately 4 months for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the United States
* Females and males ages 25-75 (inclusive)
* Able to speak and read English
* No unexplained weight loss, fevers, anemia, or blood in stool
* Willing and able to follow the trial instructions, as described in the recruitment letter
* Signed and dated informed consent prior to any trial-specific procedures.
* PHQ9 score of 5-24 (inclusive)

Exclusion criteria

* Unwilling to change their current diet
* Prior use of Viome products or services
* Antibiotic use in the previous 4 weeks
* Pregnancy (current or planned in the next 4 months)
* \< 90 days postpartum
* Breast feeding
* Active infection
* Unable or unwilling to use Viome's App on an iPhone or Android smartphone
* Significant diet or lifestyle change in the previous 1 month
* IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
* Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
* Cancer therapy within the previous 1 year
* Major surgery in the last 6 months or planned in the next 4 months
* Allergies to any supplement ingredients listed in the screening survey
* Currently on a specific diet: FODMAP, KETO, PALEO
* Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
* Gastrointestinal disease including:

  * GI surgery except:

    * Appendectomy and benign polypectomy
* Esophagitis
* Celiac disease
* GI malignancy or obstruction
* Peptic Ulcer Disease
* Duodenal or gastric ulcer disease
Sleep Disordered Breathing and Lung Transplantation

The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.

All patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled.

We collect:

* Medical history
* Blood pressure
* Anthropometrics
* Pulmonary function
* Arterial blood gas
* Questionnaire (QOL, ESS)
* Sleep diary
* Polysomnography

Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage respiratory failure who are referred for lung transplantation
* Informed consent from patient

Exclusion Criteria:

* Patients who are declined for lung transplantation
* Patients \< 18 years old