cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Peer-Delivered Trauma-Specific Treatment

Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience, has the potential to increase access to trauma treatment in underserved communities. This could positively impact the lives of millions of people as 70% of adults in the U.S have experienced a traumatic event and the consequences of trauma are devastating and far reaching, including chronic and comorbid physical and mental health problems. The most known consequences of trauma include post-traumatic stress disorder (PTSD) and substance use disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required to conduct SS, all the evidence comes from studies using trained clinicians to implement the treatment, including social workers, psychologists, and psychiatrists. However, these research findings do not generalize to underserved communities that lack mental health professionals. Innovative approaches to treatment, such as peer-delivered services, are required to meet the demand for care in underserved areas. While the benefits of peer-delivered services have been well-documented in many areas, the value of peers in the provision of trauma-treatment is unknown. A theoretical basis supports the potential for peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome and a typical result of peer-patient relationships.

Our research question is whether there is a difference between peer-led SS (PL-SS) groups and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs?

The investigators have three specific aims:

1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing substance use and PTSD symptoms and improving coping skills, overall mental health and physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in improving outcomes.
2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in impacting outcomes in the PL-SS compared to CL-SS groups.
3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.


Eligibility Criteria:
Inclusion Criteria:

* Be a member of INSIDE OUT, a peer-run wellness center
* Be at least 18 years old
* Have a history of trauma
* Meet DSM-IV diagnostic criteria for lifetime and current full or sub-threshold PTSD
* Meet DSM-IV diagnostic criteria for current substance abuse or dependence
* Be able to provide informed consent to participate in the study.

Exclusion Criteria:

* Live outside of catchment area
* Suicidal
* Pending immediate incarceration
GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.

This study consists of 3 distinct aims:

In Aim 1, the investigators will evaluate clinical acceptance of the GaitBetter solution by subjects and therapists. To do so, the investigators will run a pilot study to gather feedback from stakeholders (not reported here).

In Aim 2, the investigators will evaluate the efficacy of using the GaitBetter solution to improve motor-cognitive function of chronic stroke survivors. To do so, the investigators will run a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke.

In Aim 3, the investigators will explore the efficacy of using the GaitBetter solution for improving rehabilitation outcomes in sub-acute stroke survivors. To do so, the investigators will run a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.

Eligibility Criteria:
Inclusion Criteria:

* Male and females of age between 18 to 85 year of age
* History of one-sided ischemic or hemorrhagic stroke

  * Chronic: more than 6 months post-stroke (Aim 1 and Aim 2)
  * Subacute: within 8 weeks post-stroke (Aim 1 and Aim 3)
* Residual functional impairment of a lower extremity as a result of the stroke
* Ability to walk at least 15 meters with or without assistive devices (FIM walk subsection, levels 6 and 7)
* Ability to walk 3 consecutive minutes (5 minutes for Aim 2) on a treadmill at a speed equal to or greater than 0.22 m/s (0.8 km/h or 0.5 mph) with or without hand support.
* Medical clearance received from treating physician to participate in the gait training program proposed in the study

Exclusion Criteria:

* Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally
* Cognitive impairment limiting the ability to understand and follow instructions (as assessed by a score \<23 on the Mini Mental State Examination)
* Previous diagnosis of neurological diseases other than stroke
* Recent history of lower extremity fractures (\<12 months ago), unhealed wounds
* Current indication for isolation precautions (e.g. MRSA, VRE, C. difficile, and others)
* Severe visual impairments (as assessed by the NIH Stroke Scale Visual Field subscale. score \>0)
* Hemispatial neglect (as assessed by the Line Bisection Test)
* Subjects diagnosed with a medical condition that would interfere with their participation in regular sustained exercise (such as a severe pulmonary and/or cardiovascular condition)
* For Aim 2: currently participating in a gait training intervention (PT or research)
* Adults with impaired decision-making capacity
* Women who are pregnant
Phase 1 Study to Assess Safety and Efficacy of ANG003

Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. The study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.

The Phase 1 study was designed to compare a 24h Baseline Substrate Absorption Challenge Test (SACT) period with no enzymes to a 24h ANG003 SACT period with enzymes. Eligible subjects will be randomly assigned with equal allocation to one of four active dose levels of lipase, protease and amylase. Approximately 48 to 60 eligible subjects are planned to be enrolled in the study with 12 to 15 subjects assigned to each dose level from up to 21 investigational sites.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 years of age or older.
2. Confirmed diagnosis of CF defined as: a) CF signs and symptoms AND b) Two CF-causing mutations on genetic testing or sweat chloride \>60 mEq/L.
3. Documented history of fecal elastase \<100 µg/g stool.
4. EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.
5. Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.

Exclusion Criteria:

1. Subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on Days 1 and 5 for a daily total of 6 hours.
2. Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \>5% of body weight within 1 month.
3. Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.
4. CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
5. Subjects who cannot discontinue omega-3 supplements \>500 mg of DHA and EPA daily.
6. Subjects unable to tolerate missing a dose of PERT.
Evaluating Disparities in Precision Oncology

This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.

This study proposes an innovative approach leveraging the molecular tumor boards across four comprehensive cancer centers, where real- world, diverse patients with metastatic cancer are seen receiving a broad scope of therapies in the context of precision medicine. The study plans to collect detailed clinical, social, and genomic data from patients to identify significant contributors of disparate survival and toxicity outcomes for patients with metastatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and HIPAA authorization
2. Patients must be ≥ 18 years old at the time of consent
3. Patients planning to undergo molecular testing as part of their routine cancer care

Exclusion Criteria:

N/A
Immunotherapy in Lymphoma

The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade B cell lymophoma patients. The main question it aims to answer is:

Does advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies?

Researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes.

Laboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 to 74 years.
* Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma
* Patients who have received immunochemotherapy as treatment for relapsed/refractory lymphoma

Exclusion Criteria:

* Patients who have progressed to acute leukemia
* Patients who developed solid tumor during treatment
* Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)
Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-75 years;
2. Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1;
3. Symptoms persisting for at least three months prior to surgery;
4. Given written Informed Consent Form;
5. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
6. Oswestry Disability Index score of at least 40/100 at baseline;

Exclusion Criteria:

1. Bilateral foraminal stenosis requiring surgical decompression on both sides;
2. Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille;
3. More than one symptomatic level requiring multi-level surgical decompression and/or fusion;
4. Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
5. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
6. Spondylolisthesis grade II or higher of any etiology;
7. Prior lumbar spinal fusion at any level;
8. Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
9. History or presence of any other major neurological disease or condition that may interfere with the study assessments;
10. Severe arterial insufficiency of the legs or other peripheral vascular disease;
11. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Spanish Registry of Esophagogastric Cancer

This study aims to development of a database through a web page for epidemiological and clinical research purposes that is accessible to members of the AGAMENON - SEOM group that guarantees a rigorous collection, exploitation and analysis of the data and information contained, increases the knowledge of esophageal and stomach cancer in order to optimize the management, treatment and evolution of patients, the possibility of comparing variables with those of other series or groups, and promotes the quality of scientific publications.

Patient data will be collected from medical records retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years) diagnosed with carcinoma of the esophagus, gastroesophageal junction and stomach, including all histologic subtypes, with or without erbB2 overexpression (and tumors in which this data is unknown).
* Follow-up of at least 3 months with clinical information during this period, exempting patients with early death from any cause.

Exclusion Criteria:

* A patient for whom, for whatever reason, the information necessary to complete the database cannot be known or obtained.
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)

This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
* Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
* Has a measurable, positron emission tomography (PET) assessable lesion
* Adequate blood, liver, bone marrow and kidney functions
* Has not received any chemotherapy for at least 4 weeks prior to entry in this study
* Agrees to take adequate measures to prevent pregnancy.

Exclusion Criteria:

* Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
* Patient has had treatment with investigational agents within the last 30 days.
* Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
* Patient has HIV, hepatitis B or hepatitis C infection.
* Patient is pregnant or lactating.
* Patient has allergy to any component of the study drug.
Effects of Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population

After lumbar pain, neck pain is the most common cause of patients needing chiropractic care; the second most common cause of spinal manipulation use (1). Manipulation and mobilization are commonly used by chiropractors, osteopaths and manipulative physiotherapists in the treatment of neck pain. Many studies show that the Activator instrument is also used for this purpose in the chiropractic profession (2) There are several published case reports that relate to neck manipulation to vertebral artery dissection and stroke. The prevailing theory is that the neck extension and / or rotation may damage the vertebral artery in the foramen transversarium, especially at the C1-C2 level (2). However, most cases of extracranial vertebral artery dissection are thought to be spontaneous (3).

In the literature, there have been no studies investigating the effects of instrument-assisted spinal manipulation on vertebrobasilar and internal carotis arteries. the aim of this study to compare the effect of manual and instrumental spinal manipulation on blood flow parameters of vertebrobasilar and internal carotis arteries on healthy persons which have mechanical neck pain and asymptomatic in vertebrobasilar insufficiency test.


Eligibility Criteria:
Inclusion Criteria:

* Being between 20-40 years of age
* Having non-specific mechanical neck pain for more than 3 months with symptoms provoked by neck postures, movements, or palpation
* Willingly participating to the study
* Signing the confirmation form.

Exclusion Criteria:

* Spinal root compression (radiculopathy)
* Neurological symptoms like weakness and numbness in extremities and face, uncontrolled movements, abnormal gait, dizziness, undefined nausea/vomiting, swallowing and speaking difficulties
* Acute inflammatory disease
* Spontaneously vertebral artery dissection in family
* Tested positive in premanipulative vertebrobasilar artery insufficiency test
* Being on anticoagulant and antiaggregant medication.
Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain

The purpose of this study is to analyse the changes in back muscle size and strength following use of Dysport®, and to establish whether there is any association between pain reduction and change in strength, in patients suffering from chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from muscular low back pain (between L-1 and S-1 level).
* Symptoms of more than six months duration.
* No benefit from previous treatments.
* Patient must present with bilaterally more than 2 active trigger points (TrPs) in the region of the low back musculature.
* CT scan or MRI examination of the lumbar spine was performed within the past year.
* Absence of significant pathology, such as bone fracture, nerve damage or severe psychiatric condition.

Exclusion Criteria:

* Constant or persistent severe pain due to nerve root compression or fibromyalgia.
* The patient has received surgery on the spine.
* Other musculoskeletal disabilities e.g. myasthenia gravis, or disorders of the neuromuscular junction.
* Any serious pathology, such as cancer, systemic inflammatory disease, vertebral fractures, neurological signs, spinal infection.
* Epidural injection of local anaesthetics and steroids within 12 weeks proceeding inclusion.
* Trigger point injection of local anaesthetics and steroid within 8 weeks proceeding inclusion.
* Pain associated with urinary tract infections, or gynaecological disorders.
* Bleeding disturbances or currently using coumarin derivatives.
Predictors of Response to Treatment for Depression

The current study will examine neurophysiological, specifically event-related potential (ERP), measures of emotional processing as predictors of response to cognitive behavior therapy for adolescent depression.

Neurophysiological measures (i.e., event-related potentials) of reward responsiveness and regulation of mood-congruent, sad stimuli will be assessed in a sample of adolescents with depression prior to group cognitive behavior therapy (CBT). CBT will follow the Adolescent Coping with Depression Course, an established 16-session group treatment protocol, and consist of behavioral activation, relaxation skills, cognitive therapy, social skills, problem solving, and relapse prevention. Changes in symptoms will be monitored through biweekly self-report and clinician ratings to examine prediction of change in symptoms across CBT. Baseline individual differences in reward responsiveness and emotion regulation will be evaluated as predictors of change in self-reported symptoms and clinician-rated improvement following CBT.

Eligibility Criteria:
Inclusion Criteria:

* Participants presenting with major depressive or persistent depressive disorder and moderate severity on the Clinical Global Impressions scale.
* Participants may have comorbid externalizing or anxiety disorders.
* Participants (and parents of minors) fluent in English.

Exclusion Criteria:

* Youth with history of treatment for substance use disorders.
* Youth with intellectual or developmental disabilities (e.g., autism spectrum disorders, pervasive developmental disorders).
* Youth with lifetime schizophrenia, psychosis, or mania.
* Youth with severe current suicidality.
* Youth taking antipsychotic medications or mood stabilizers.
* Youth with recent changes in dosage of antidepressant (adolescents with change in dosage in past 30 days who otherwise meet study criteria will be asked to begin the study once dosage has been stable for 30 days).
* Parent or child not fluent in English.
* Youth who are unable to complete study procedures because of visual or hearing impairments.
* Youth who have recently started outside therapy (past 30 days at time of intake), are engaged in treatment that is determined to be too similar to study therapy (e.g, other CBT groups), or are currently in treatment that is too intensive to allow for participation in study therapy (e.g., partial hospitalization programs)
AngioDefender Versus Brachial Artery Ultrasound Imaging

The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2

Exclusion Criteria:

1. Body mass index (BMI) \>50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>40 cm
3. Sinus arrhythmia (RR intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting tremor or inability to remain still for the duration of AD and BAUI testing
6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff
Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. Male sex;
2. Age 50-70;
3. PSA 3-20 and/or abnormal DRE;
4. Biopsy naïve.

Exclusion Criteria:

1. Prior personal history of prostate cancer;
2. Prior prostate imaging using microUS or MRI;
3. Contraindication to microUS or MRI;
4. Testosterone replacement therapy within last 12 months; or
5. Androgen deprivation therapy within last 12 months.