cyrilzakka/clinical-trials huggingface dataset:
Improving Outcomes in Autism: Community Implementation of Stepped Transition in Education Program

The goal of this study is to conduct the first community-based implementation of the STEPS program and test feasibility and preliminary impact. After first working with stakeholders to refine and optimize the program we will launch a Hybrid Type 1 open trial, targeting 25 transition-age youth (TAY) with ASD.

This community-engaged, applied research study will test the effectiveness of STEPS (Stepped Transition in Education Program for Students with ASD), a program designed to help transition-age youth (TAY) with ASD prepare for independence. Adults with ASD have worse outcomes, with respect to employment, education, and quality of life, than neurotypical peers. Research-informed transition planning that addresses core impairments in skills needed for autonomous and independent living, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. In a prior trial, the investigators found STEPS to be feasible, acceptable, and efficacious. The proposed study is the first test of STEPS as implemented by community-based providers. Through a series of implementation working group meetings with identified community partner agency and stakeholders (families, TAY with ASD) in the region, the study team will refine STEPS with the goal of optimizing program sustainability within community settings. Following this, a Hybrid Type 1 open trial will be launched, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. With a sample of TAY with ASD (n=25) immediate and longer-term clinical outcomes of adult functional outcomes and vocational engagement will be assessed. This research will produce findings with the potential to shift clinical practice related to transition to adulthood for people with ASD.

Eligibility Criteria:
Inclusion Criteria:

* ages 16-25 confirmed diagnosis of ASD caregiver willing to participate stable medication

Exclusion Criteria:

* evidence of intellectual disability evidence of suicidal intent
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant finding on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enyzme altering drugs.
* History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.
Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar

The Lubo cervical collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner. The purpose of the device is to manage cervical spine control and airway protection in the trauma patient.

Cervical spine stabilization is usually achieved by a semi-rigid collar. While these collars achieve the goal of supporting the cervical spine, they limit the possibilities for jaw thrust or other airway manipulations. Definitive airway protection usually must be achieved by orotracheal intubation. Thee Lubo collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner that is simple to operate. The objective of the study is to test the safety of the collar volunteers. The study is composed of two stages:1.healthy volunteers that will not undergo any intervention except testing the LCC.2. second group of patients scheduled to undergo an operation under general anesthesia with endotracheal intubation or laryngeal mask airway.

Eligibility Criteria:
Inclusion criteria

1. Males or females.
2. Age 18-60.
3. Normal airway anatomy, with expected easy ventilation and intubation.
4. Anesthetic risk- class 1or 2 by the American Society of Anesthesiologists (ASA) criteria.
5. Patients scheduled for an elective operation at the lower part of the body in supine position not supposed to last more then 2 hours.
6. Anesthetic plan- general anesthesia

Exclusion criteria

1. Known problems of the cervical spine.
2. Known problems of the temporomandibular joint.
3. Suspected difficult intubation or difficult mask ventilation.
4. High risk of gastric content aspiration.
5. Morbid obesity (BMI \>32).
6. Pregnancy
7. Psycho- social problems
8. Any cerebrovascular or cardiovascular disease
9. Known hypersensitivity reactions to fabrics or plastics
10. Any rash, eruption, wounds or sores at the upper torso, the neck and the head.
11. No participation in other clinical trail at the time of the trail
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation

This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.

Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation

Eligibility Criteria:
Inclusion Criteria:

* Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain.
* Development of constipation symptoms since starting opioids.
* Taken laxatives to help with bowel movements for at least four days over the past 2 weeks.

Exclusion Criteria:

* Receiving opioid regimen for treatment of pain related to cancer.
* Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year.
* History of cancer within 5 years from the time of screening.
* Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation).
* Has irritable bowel syndrome (IBS) or chronic functional constipation.
Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

This randomized controlled trial uses a modularized cognitive behavioral resilience training (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma psychopathology. Ninety participants with a history of interpersonal trauma during childhood or adolescence and mild to moderate distress will be randomized to MCBRT or a health education control condition. The primary aims of this proposal are to examine whether individuals who receive MCBRT demonstrate increases in psychological resilience, biological resilience, and extinction learning compared to those in the control group. This study will also explore associations between these psychobiobehavioral risk and resilience factors.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. fluent in English
3. history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18)
4. mild to moderate distress indicated by a score of 10-20 on the depression scale, 8-14 on the anxiety scale, or 15-25 on the stress scale of the DASS-21.

Exclusion Criteria:

1. severe distress indicated by a score \>20 on the depression scale, \>14 on the anxiety scale, or \>25 on the stress scale of the DASS-21
2. DSM-5 criterion A trauma in the past month
3. color blindness based on self-report (because of inability to complete the fear conditioning task)
4. auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task)
5. lifetime psychotic or bipolar disorder
6. substance abuse or dependence within past 6 months
7. concurrent psychotherapy initiated within 3 months of randomization
8. ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., CBT)
9. must be on a stable dose of psychotropic or adrenergically-active medications (e.g., beta blockers) for at least 6 weeks prior to eligibility screening
10. mental retardation or significant cognitive impairment
11. serious medical illness or instability for which hospitalization may be likely within the next year
12. significant suicidal ideation indicated by "yes" on Columbia Suicide Severity Rating Scale item 4 (active suicidal ideation with some intent to act) or enacted suicidal behaviors within 6 months prior to eligibility
13. current legal actions related to trauma.
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF

The aim of the study is to study the effect of an antioxidant food supplement associated with probiotics on the oocyte quality response, oxidative stress and microbiota function in an in vitro fertilization cycle in patients with polycystic ovarian syndrome

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the antioxidant supplementation associated with probiotics (Myo-Inositol, D-Chiro-Inositol, folic acid, selenium, vitamin D, Melatonin, Lactobacillus rhamnosus, Lactobacillus cripatus and Lactobacillus plantarum) or placebo (folic acid) once daily.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-38 years old
* Diagnosis of PCOS according to compliance with the Rotterdam criteria
* BMI \>= 25

Exclusion Criteria:

* Hormonal contraceptive, insulin sensitizers such as metformin, inositols, antioxidants, vitamin supplements except folic acid, GnRH analogs, steroidal drugs or others with anti-inflammatory properties, antibiotics, probiotics, laxatives use in the 3 months prior to recruitment
* Tobacco consumption in last 12 months
* Endometriosis, hydrosalpinx not surgically treated, acute or chronic inflammatory diseases, systemic immune diseases, other endocrine diseases or dysfunctions except for PCOS and subclinical hypothyroidism treated with low doses of levothyroxine (eg congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, Diabetes Millitus, hyperprolactinemia, hyperglycemia), active neoplastic disease or without evidence of complete remission for at least 5 years,
* Active participation in an active weight reduction program or hypocaloric diet during the study period. No change in habits will be taught during the study period
* Hypersensitivity to any of the components in the Fertybiotic Mujer Plus® formulation
Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.

Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension \>60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged \>=40 years old
* current or ex-smokers with a smoking history of at least 10 pack-years
* mild to moderate stable COPD (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Stage I and II according to the 2010 GOLD guidelines (a post-bronchodilator forced expiratory volume in the first second (FEV1) ≥80% of predicted for stage I and 50% ≤ FEV1 \< 80% of predicted for stage II, with a post-bronchodilator FEV1/forced vital capacity (FVC) ratio \<0.70 at screening)
* waking arterial oxygen tension (PaO2) ≥60 mmHg

Exclusion Criteria:

* refusal to participate
* respiratory tract infection within 4 weeks prior to screening
* COPD exacerbations requiring treatment with antibiotics and/or oral corticosteroids and/or hospitalization within 6 weeks prior to screening
* concomitant pulmonary diseases other than COPD
* asthma
* evidence of sleep apnea on baseline sleep studies
* obesity hypoventilation syndrome
* respiratory failure
* congestive heart failure
* a history of life-threatening arrhythmias
* cardiomyopathy
* long-QT syndrome or QTc \>450 ms at screening
* diabetes
* long-term oxygen therapy
* symptomatic prostatic hyperplasia
* bladder-neck obstruction
* moderate/severe renal impairment
* urinary retention
* narrow-angle glaucoma
* family or personal history of mental illness
* drug or alcohol abuse
* severe cognitive impairment
* concurrent oncological diseases
* history of narcolepsy or restless legs syndrome
* known history of alpha-1 antitrypsin deficiency
* participation in the active phase of a supervised pulmonary rehabilitation program
* hypersensitivity to any of the test ingredients
* history of adverse reactions to inhaled anticholinergics.
Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis

The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histological confirmation of breast or chest wall malignancy
* Primary or recurrent disease eligible
* Post-mastectomy with or without reconstruction
* Undergoing unilateral external beam radiotherapy at the Mayo Clinic - Rochester, MN or Mayo Clinic - Eau Claire, WI
* Ability to complete questionnaire(s) by themselves or with assistance
* Provide informed written consent
* Willing to consent for photography of radiation field
* Available to return to Mayo Clinic in within 6 weeks post-treatment for assessment
* Able to initiate thin film usage within first 3 days of the initiation of treatment

Exclusion Criteria:

* Documented history of adhesive or tape allergy
* Unable to provide written consent
* Patients with prior radiotherapy to any portion of the planned treatment site
* Brachytherapy patients
* Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
* Gross dermal involvement at initiation of radiotherapy
* Recent use of systemic or topical antibiotics or antifungal medications within 14 days of swab collection
* Recent use of any of the following within 14 days of swab collection:

  * Systemic or topical steroids
  * Use of systemic immunosuppressant drugs
  * Use of ultraviolet light therapy
* Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
* Prior organ or bone marrow transplant
* Current lactation
* Undergoing bilateral radiation
IFN-DLI for Relapsed Acute Leukemia After Allo-SCT

This trial is designed to determine the feasibility of conventional induction chemotherapy, IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.


Eligibility Criteria:
Inclusion Criteria:

DLI Recipient

* Relapsed AML or ALL ≥ 60 days after allogeneic SCT.
* Evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment).
* Age ≥ 18 years of age,
* Karnofsky performance status ≥ 60%.
* Absence of active GVHD and off immunosuppression. Subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered. We suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible.
* Adequate organ function: Cr ≤ 2 mg/dL; ALT/AST \< 3x ULN, direct bili \<3x ULN.
* Matched sibling or un-related donor (A, B, C, and DR) available to undergo leukopheresis.
* Subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
* Willing to provide blood samples for research purposes.
* Willing to adhere to medically accepted form of birth control to prevent pregnancy (includes: complete abstention from intercourse, condoms, diaphragms, cervical cap, intra-uterine device, history of surgical sterility - tubal ligation or vasectomy in patient or partner, or oral contraceptive).

DLI Donor

1. HLA identical to recipient subject.
2. Considered medically eligible for leukopheresis procedure by independent donor physician (University of Pennsylvania physician who is not the recipient's primary transplant physician for related donors; physician designated by National Marrow Donor Program for unrelated donors).
3. Considered medically eligible to receive G-CSF (filgrastim) by independent donor physician.

Exclusion Criteria

Recipient

* Prior cell therapy for relapse within the past 90 days.
* Requirement for active immunosuppression to treat GVHD.
* Pregnant or lactating women. The safety of this therapy on unborn children and effects on breast milk are not known.
* Uncontrolled active infection
* Any uncontrolled active medical disorder that would preclude participation as outlined.

Donor

- Unable to participate in a leukopheresis procedure or receive G-CSF (filgrastim).
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device PROCTOeze® PLUS in the Relief of Haemorrhoidal Disease and Anal Irritation Symptoms

This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification) haemorrhoids as assessed by the patient and the Investigator at the end of the treatment period.

The protocol is based on what is already known on both the topic object of the study, i.e., the symptomatic treatment of haemorrhoids, and the investigational medical device - PROCTOeze® PLUS - which is a specific adjuvant for the symptomatic relief of internal and external haemorrhoids and anal irritation. Due to its formulation, it contributes to the physiological restoration of the anal and perianal tissues.

The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyse, the data needed to study the relationships between different variables.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years old.
* Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline.
* Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation.
* Patient free from the following treatments for haemorrhoids for at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics, any anti-haemorrhoidal treatment, anticoagulants, and antiplatelet agents.
* Patients able to communicate adequately with the Investigator and understand the tral questionnaire.
* Patients able to understand and who can provide valid informed consent to the trial.

Exclusion Criteria:

* Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease).
* Frequent hemorraidal bleeding
* Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.
* Patients with known sensitivity to the tested medical device or its components.
* Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study.
* Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
A Mobile App to Address Student Loneliness

The purpose of this trial is to assess the effects of a positive psychology and CBT-based skills intervention-delivered through a mobile app called Nod-on loneliness and other mental health and institutional satisfaction outcomes. The primary outcome is self-reported loneliness at 2 and 4-weeks post baseline.

This study is a pilot eight-week randomized controlled intervention. It employs a "waitlist" control strategy for the first 4 weeks of the study (considered to be the active study period).

Randomization will be to one of two conditions:

1. Experimental group: Immediate access to the Nod app
2. Waitlist control group: Participants will be granted access to the app four weeks after the experimental group

Assessments will occur at baseline, 2, 4, and 8 weeks follow up. Assessments will include measures of loneliness, and other mental health and institutional satisfaction measures listed in the secondary outcome measures section.

Eligibility Criteria:
Inclusion Criteria:

* Incoming college first years
* Live away from home without parents/guardians upon beginning college
* Read English
* Between 18 and 25 years of age
* Own a smartphone

Exclusion Criteria:

* Do not read English
* Under 18 years of age
* Over 25 years of age
* Do not own a smartphone