cyrilzakka/clinical-trials huggingface dataset:
Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial

The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. The current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones.

The main questions to answer are:

Is parenting feedback provided by a smartphone application acceptable to caregivers? When parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?


Eligibility Criteria:
Inclusion Criteria:

* Currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD
* Ages 7 -12
* Has parent-reported impairment in homework performance defined as a score of 3 or greater on an Impairment Rating Scale measure (Fabiano et al., 2006) of homework performance
* Has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone.

Exclusion Criteria:

* N/A
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

To see if PillCam COLON will demonstrate diagnostic yield \>80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.

This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

Eligibility Criteria:
Inclusion Criteria:

* Subject was referred for colonoscopy for one of the following reasons:

  * Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
  * Any subject ≥ 18 years of age with:

    * Positive findings in the colon on a GastroIntestinal (GI) radiographic study
    * Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
    * Suspected or known ulcerative colitis

Exclusion Criteria:

* Subject has dysphagia
* Subject has congestive heart failure
* Subject has renal insufficiency
* Subject is known or is suspected to suffer from intestinal obstruction.
* Chronic use of laxatives
* Subject has a cardiac pacemakers or other implanted electro medical devices.
* Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
* Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
* Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
* Subject has any condition, which precludes compliance with study and/or device instructions.
* Age \< 18 years
* Subject suffers from life threatening conditions
* Subject is currently participating in another clinical study
* Subject has known slow gastric emptying time
Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.

Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.

To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.

In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at the Rouen University Hospital (pneumonic form requiring oxygen therapy \< 4 L/min.)
* Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020
* Age ≥ 18 years old
* Adult patient who has read and understood the information letter and signed the consent form
* Affiliation to a social security scheme

Exclusion Criteria:

* Patient with PCR-confirmed SARS-CoV-2 infection and hospitalized in intensive care units (acute respiratory distress and/or organ failure, whose pathogenesis may differ from the more frequently described forms with secondary aggravation (5)).
* Patient with PCR-confirmed but non-hospitalized SARS-CoV-2 infection (non-acute form, managed by confinement)
* A person participating in a therapeutic trial that may interfere with the procedures being investigated, including lymphocyte response prior to D+56±14 days.
* Known Pregnancy
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
* Staff at the Rouen University Hospital with SARS-CoV-2 infection confirmed by PCR and/or typical scan images during the epidemic period.
* Hospital staff who were exposed to the virus (working in a Covid unit)
Preoperative Radiation Therapy for High Risk Prostate Cancer

This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.


Eligibility Criteria:
Inclusion Criteria:

Subjects must have

* biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA \> 20, B. Gleason Score (GS) \>/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
* a negative bone scan,
* be medically fit to undergo surgery as determined by treating urologist,
* age \> 18,
* KPS must be \>/= 80,
* no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
* no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
* Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

* prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
* prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
* Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
* Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
* Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
* History of prior pelvic radiation therapy.
* History of androgen deprivation therapy or chemotherapy.
Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey

a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients.

With new evidence on the role of asymptomatic patients in spreading the disease during the Covid-19 pandemic, symptom driven guidelines for testing, hospital allocation and personal protective equipment (PPE) use do not seem appropriate to limit in-hospital transmission. At time when lockdowns are in place in most countries, hospitals can become the new source of infection.

Guidelines are very variable depending on local policies and availability of medical supplies, resulting in most hospitals taking different preventive measures.

Eligibility Criteria:
Inclusion Criteria:

general surgeon

Exclusion Criteria:

other speciality
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems

12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is appropriate for SCS implantation according to standard criteria
2. Subject is \>18 to \<75 years old
3. Subject is able and willing to comply with the follow-up schedule and protocol
4. Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Subject has no other exclusion criteria for SCS implantation according to standard criteria
2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
4. Subject has participated in another clinical study within 30 days
5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Intervention Study to Control High Blood Pressure for Korean American

The primary objective of the proposed clinical trials is to compare the differential reduction in blood pressure in underserved hypertensive adult Korean American. The study is designed to test the effectiveness of a comprehensive self-help intervention program.

CVD is the leading cause of mortality among KA. Recent statistics underscoring the high prevalence and impact of uncontrolled HBP upon this population warrant the development and implementation of effective intervention. KA experiences a great deal of social isolation, which makes it more difficult for them to make behavioral changes for health improvement. individual, family, and community behaviors are part of the HBP problem and also constitute major part of the solution. The proposed research is designed to investigate these issues in a KA population and to lay the groundwork for community-based self-help health education interventions to enhance appropriate care and BP control.

Comparison(s):This community-based self-help intervention approach offers a more culturally appropriate approach to closing the health status gap for KA. Incorporating a partnership with community leaders and health and human service care providers, this approach will utilize state-of-the-art health education strategies and a well-trained bilingual nurse from the community.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as first-generation Korean American
* Age 40 to 65 years of age
* SBP≥140 or DBP≥90mmHg on HBP medication
* resident of Greater Baltimore census tracts
* Written consent to participate in the screening/eligibility visit
* SBP≥140 or DBP≥90mmHg at the KRC HBP verification visit
* Written consent to participate in the clinical trial:agreeing to participate in study data collection procedures, receiving HBP education, using HBPMT, and permitting contact with their own medical care provider.

Exclusion Criteria:

* Acute and/or terminal condition precluding participation such as terminal cancer or acute myocardial infarction
* Psychiatric diagnosis precluding participation such as schizophrenia and cognitive impairment measured by self-report, chart review, or clinical assessment.
Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser in Root Canal Disinfection

The purpose of this study is to develop a protocol for biofilms disinfection with a FDA cleared, clinically approved and commercially available Er,Cr:YSGG laser treatments. This protocol will be testing local single topical application of Lasers within the canal system in patients going through routine endodontic treatment, evaluate its potential as anti-biofilm treatment and compare it to other currently used antibacterial protocols.

After being informed about the study and its potential risk, for all patients giving written informed consent we will screen potential participants by inclusion and exclusion criteria; clinical assessment, obtain radiographs, medical history/medications and documents to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a 1:1 ratio to Group 1: Standard of care irrigation protocol "Sodium Hypochlorite (NaOCl)", Group 2: Er,Cr:YSGG laser + standard of care irrigation protocol (NaOCl).

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female (Gender is not an inclusion or exclusion criteria), aged 18 years old or above.
* In good general health as evidenced by medical history or non-contributory medical history (Patient can be seen for regular dental appointment in Penn Dental Medicine; American Society of Anesthesiologists (ASA) classes I and II).
* Radiographic presence of periapical radiolucency.
* Negative response to thermal sensitivity testing (difluorochloromethane at -50 °C, Endo-Ice, Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or electric pulp testing.
* Enough tooth structure for adequate isolation with rubber dam.
* No history of previous endodontic treatment on the tooth.
* Teeth with single canal, 1 distal canal of lower molar, 1 palatal canal of upper molar.

Exclusion Criteria:

* Patients who report they are pregnant.
* Teeth affected by dental trauma.
* Periodontal changes (pockets 3 mm, mobility I or gingival edema).
* Radiographic presence of resorptive processes.
* Per the investigator's discretion, unable or unlikely to comply with study procedure.
* Presence of any condition which, in the opinion of the investigator, makes participation in the study not in the individual's best interest.
Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV

This pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV- volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy.

Hepatitis C virus (HCV) infects approximately 170 million people worldwide and is the leading indication of liver transplantation in the United States. HCV is primarily a blood-borne infection, and heterosexual transmission is rare. However, acute HCV infection is increasingly being reported among HIV-positive men who have sex with men (MSM) with no risk factors for parenteral HCV transmission, suggestive of a possible mucosal route of infection in these individuals. While it is possible that HCV may be transmitted into the bloodstream via mucosal tears induced by sexual activity, is also possible that a mucosal immune defect predisposes HIV+ persons to mucosal HCV transmission. Our pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV- volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy. We will isolate peripheral and mucosal mononuclear cells and we will perform HCV-specific ELISPOT and single B cell immunoglobulin (Ig) RT-PCR to assess volunteers' gut B cell repertoire. If successful, we would like to expand the study so as to better assess Ig repertoire differences among HCV+HIV+ and HCV+HIV- individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 75 years of age.
2. Ability to give informed consent.
3. Platelets greater than 70,000/mm3.
4. Hb at least 9.5 g/dl.
5. INR \< 1.5.

Exclusion Criteria:

1. Decompensated cirrhosis.
2. Serious uncontrolled medical illness.
3. Ingestion of Aspirin within 72 hours of sigmoidoscopy
4. Ingestion of non aspirin NSAIDS within 8 hours of sigmoidoscopy
5. Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide.
6. Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
7. Alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
8. Medical illness requiring prescribed Aspirin or NSAIDs.
Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative

This trial is performed for the immunological and histological evaluation of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen, rBet v1-FV

Type I allergy is an immune-disorder which stems from the formation of IgE antibodies against proteins and glycoproteins from plants, insects, animals and fungi, most of which are normally considered harmless. The cross-linking of specific IgE antibodies on effector cells by allergens activates an immunological cascade leading to the symptoms of Type I allergy including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic Rhinitis is the most common chronic atopic disease and is associated with considerable cost and co-morbidity. Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses and weeds, is characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery, red eyes.

Recombinant preparations offer various advantages over those based on natural allergen extracts. Recombinant proteins can be produced in highly purified forms of pharmaceutical quality; proteins are molecularly defined thus ensuring product consistency and minimising problems related to allergen extract standardisation; preparations only include those proteins that are considered relevant for specific immunotherapy; the risk of contamination with other allergenic material is excluded; the whole production process can be designed to exclude any risk factors for the introduction of infectious agents; the relative dosages of individual components of a final preparation can be optimised to favour better clinical efficacy. Allergy vaccination (AV) mediates the immune response to allergen exposure by altering the TH2 response in favour of a TH1 T-cell response, increasing IgG production and decreasing the production of inflammatory cytokines. rBet v1-FV is an AV designed to enhance beneficial immune responses. The investigational product has demonstrated efficacy and good tolerability in one previous pivotal Phase III and two previous Phase II studies.

Eligibility Criteria:
Inclusion Criteria:

* Positive SPT
* Positive EAST
* Positive specific provocation test

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease.
2. Relatively stable airway obstruction with post FEV1\< 80% predicted normal and post FEV1/FVC \<70%.
3. Male or female patients, 40 years of age or older.
4. Smoking history of more than 10 pack years.

Exclusion criteria:

1. Significant disease other than COPD
2. Clinically relevant abnormal lab values.
3. History of asthma.
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. History of myocardial infarction within 1 year of screening visit
7. Unstable or life-threatening cardiac arrhythmia.
8. Hospitalization for heart failure within the past year.
9. Known active tuberculosis.
10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. History of life-threatening pulmonary obstruction.
12. History of cystic fibrosis.
13. Clinically evident bronchiectasis.
14. History of significant alcohol or drug abuse.
15. Thoracotomy with pulmonary resection
16. Oral ß-adrenergics.
17. Oral corticosteroid medication at unstable doses
18. Regular use of daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
22. Pregnant or nursing women.
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who are unable to comply with pulmonary medication restrictions