cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder

This study will evaluate the effectiveness of two different psychosocial therapies, parent management training and collaborative problem solving, in treating children with oppositional-defiant disorder.

Oppositional-defiant disorder (ODD) is characterized by a recurrent pattern of developmentally inappropriate levels of negative, defiant, disobedient, and hostile behavior toward authority figures. Behaviors associated with ODD include temper tantrums; persistent stubbornness; resistance to directions; unwillingness to compromise, give in, or negotiate; deliberate or persistent testing of limits; and verbal and minor physical aggression. The usual treatment approach for children with ODD is parent management training (PMT). PMT primarily involves teaching parents strategies to respond consistently and correctly to their child's behavior. However, PMT does not always lead to longstanding results and there is a need for alternative treatments. Collaborative problem-solving (CPS) is a treatment approach that involves both the parent and child by teaching parents to help their child control their emotions and to problem-solve as a family. This study will compare the effectiveness of CPS and PMT in treating children with ODD.

Participants in this open-label study will include children with ODD and their parents. Participants will be randomly assigned to one of three groups: CPS, PMT, or waitlist control. Parents assigned to the CPS group will be taught strategies to help their child identify and regulate emotions and to solve behavior problems together as a family. Parents assigned to the PMT group will be taught how to respond consistently and appropriately to their child's positive and negative behaviors. Participants assigned to the waitlist control condition group will wait 10 weeks before treatment begins. Participants will attend a 1-hour treatment session each week for 10 weeks. In order to determine whether treatment is effective, participants will be asked to complete a variety of questionnaires, talk with their child about solving problems, and complete a structure diagnostic interview prior to the beginning of treatment, following treatment, and at a 1-year follow-up session. Parents will be asked to submit their child's school grades and school attendance records. If granted permission by the parents, the child's teacher will complete a questionnaire regarding the child's behavior in school for the year prior to participating in the study and up to 1 year after treatment. The information collected will help to determine how treatment affects each child's progress.

Eligibility Criteria:
Inclusion Criteria for Children:

* Meets DSM-IV criteria for oppositional-defiant disorder
* Parent or guardian willing to provide informed consent

Exclusion Criteria for Children:

* History or current diagnosis of CD, autism, pervasive developmental disorders (PDD), or any psychotic disorder
* An estimated Full Scale IQ below 80
* Current suicidal or homicidal ideation
Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women

The study will include women enrolled during the second trimester of pregnancy who will be provided with a specific amount per month for 10 months to purchase produce. Women will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. The study will use a co-design approach to utilize feedback from potential participants as well as participants at multiple time points in the process to improve the intervention and make it more relevant and impactful to our population.

This protocol describes the implementation of an intervention to improve access to fruits and vegetables among pregnant Latina women in Hartford CT in partnership with Wholesome Wave of Bridgeport CT, a national leader in nutrition incentive programming and policy.

The target population are pregnant Latina women living in Hartford CT. Having access to the right foods as well as enough food during pregnancy promotes optimal fetal development. A prescription program that provides increased fruit and vegetable access to low-income pregnant women can help improve the diet of women during pregnancy.

Nutrition education sessions (either virtual or in person) will be attended by all participants with one session required and up to two additional sessions optional.

Fruits and vegetables may be purchased at diverse community locations or online for home delivery.

Eligibility Criteria:
Inclusion Criteria:

* during first or second trimester of pregnancy
* live in the city of Hartford
* low income (participating or enrolled in WIC, SNAP or Medicaid)
* speak English or Spanish.

Exclusion Criteria:

* Any individual not meeting any of this criterion will be excluded from the study.
Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery

The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.

Over half of patients who underwent anterior cervical surgery may experience dysphagia in the month following the operation. Dysphagia, characterized as difficulty swallowing foods and/or liquids, is a debilitating condition that not only reduces the quality of life for our patients but also results in poor nutritional intake, which may lead to delays in healing and recovery after surgery.

Current understanding of dysphagia following cervical surgery is very rudimentary. Many published reports were retrospective studies where the incidence of dysphagia was later found to be greatly underreported. Furthermore, many studies utilized small sample sizes producing varying data regarding the incidence and severity of postoperative dysphagia. Most importantly, a review of the medical literature failed to find any consistently proven recommendations or therapies that can reduce the incidence or severity of postoperative dysphagia.

A recently published study shows that gastroesophageal reflux disease (GERD) is also a common complaint following anterior cervical surgery. The study also shows a positive correlation between the severity of postoperative GERD and severity of postoperative dysphagia. Other studies also showed that patients suffering from GERD-associated dysphagia may be successfully treated with proton pump inhibitors. Based on these studies, along with anecdotal reports, the investigators hypothesize that proton pump inhibitors may reduce the incidence and/or severity of dysphagia following anterior cervical surgery.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age.
* Scheduled to undergo anterior cervical surgery for degenerative joint disease.

Exclusion Criteria:

* Patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease.
* Patients with preoperative dysphagia.
* Patients currently taking any acid suppressing medications (proton pump inhibitors, H2 blockers, antacids, etc).
* Patients who are pregnant or nursing.
* Patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole.
* Patients unable to attend follow-up visits or answer the dysphagia questionnaires.

Eligibility Criteria:

* Scheduled to undergo anterior cervical surgery for degenerative joint disease.
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing

Tacrolimus is a medication given to transplant patients to help prevent rejection. The purpose of this study is to see if tacrolimus can be taken once a day instead of twice a day in kidney transplant patients.

Transplant patients are required to take several medications to prevent rejection and to treat complications after their transplantation. Because of the complicated dosing schedule, it can be difficult for patients to follow their medication schedule. Taking fewer medications less frequently may help transplant patients to better manage their drug therapy.

Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken in the evening. This suggests that tacrolimus can be taken once every morning instead of twice daily in order to produce appropriate drug exposure to prevent organ rejection without increased side effects.


Eligibility Criteria:
Inclusion Criteria: 1) Kidney transplant recipients (18 years or older) at Washington University/Barnes Hospital taking tacrolimus-based immunosuppression; 2) Stable kidney transplant recipients (\>6 months post-transplantation, serum creatinine \< 2 ml/dL, no history of rejection); 3) Stable immunosuppression (therapeutic tacrolimus concentrations, no change in tacrolimus dose within one month prior to the study); 4) Subjects must agree to abstain from alcohol and caffeine for 48 hours prior to the pharmacokinetics studies.

Exclusion Criteria: 1) Pregnant women or nursing mothers; 2) Patients unwilling or unable to comply with the protocol; 3) Significant liver impairment (AST or ALT \> 2 x upper limit of normal, or total bilirubin \> upper limit of normal); 4) Anemia: Hematocrit \< 30%; 5) Use of concomitant P450 3A4/p-glycoprotein inducers or inhibitors; 6) Current smoking; 7) Patients with diabetes mellitus
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
* Participants must have experienced disease progression after treatment with available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
* ECOG performance status score of 0 or 1.
* Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory for Part 1b cohorts only.
* Presence of measurable disease according to RECIST v1.1

Exclusion Criteria:

* Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years
* Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy
* Has active autoimmune disease requiring systemic immunosuppression with corticosteroids Brain or CNS metastases untreated or that have progressed
* History of organ transplant, including allogeneic stem cell transplantation.
* Received more than 4 prior anticancer regimen(s) for advanced or metastatic disease.
* History of clinically significant or uncontrolled cardiac disease
* Active HBV (or at risk of activation), active HCV, or HIV positive
* Is on chronic systemic steroids (\> 10 mg/day of prednisone or equivalent).
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
* Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
* Significant concurrent, uncontrolled medical condition, eg:

  * Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance
* Participants with adequate laboratory values within the protocol defined ranges.
CNS Infections Effect on the Inner Ear

Study on patients with CNS infections.

Aims and objectives:

The present proposal aims to improve the outcome from central nervous system infections (CNS) by improving the understanding of when and why patients develop hearing loss and other neurological sequelae. The investigators will elucidate the temporal development and restitution of a sensorineural hearing loss and will clarify if any therapeutic window exists, where sequelae can be limited.

Also the investigators will investigate if communication between cochlea and cerebrospinal fluid is a window to the intracranial pressure.

Background:

CNS infections remain diseases with high mortality and morbidity. Among survivors from bacterial meningitis, 30 % suffer hearing loss or deafness arising from injury to the inner ear - the cochlea. From previous work it is known that brain inflammation, brain edema and subsequent pressure changes can be transduced to the inner ear due to communication between the cochlea and cerebrospinal fluid (CSF).

The viability of cochlear hair cells can evaluated by non-invasive measurement of otoacoustic (OAE) emissions which are low-intensity sounds from the cochlea (OAE).

Methods and materials:

The investigators will perform repeated measurements of OAE and Wide Band tympanometry (WBT) in all patients admitted with suspicion of a CNS infection. OAE and WBT will be compared to intracranial pressure (ICP) measured during lumbar puncture as well as clinical-, biochemical- and imaging data. An age-matched control group will be included. At discharge and at follow-up patients will receive a neurological, vestibulare examination, cognitive test and a regular hearing test.

Expected outcome and perspectives:

From repeated measures during a course of disease, the investigators will elucidate the development of a hearing loss and clarify if any therapeutic window exists, where sequelae can be limited. This is also an opportunity to assess OAE as a non-invasive measure of intracranial pressure which is believed to be among the clinical complications responsible for a poor outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a CNS infection admitted to the hospital.

Exclusion Criteria:

* Patients with known hearing loss
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.


Eligibility Criteria:
Inclusion Criteria:

* Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months
* Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline
* Participant has no known history of latent or active tuberculosis

Exclusion Criteria:

* Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis
* Participant has an active infection or history of infections
* Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
* Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment
* Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment
* Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer

The overall aim of this study is to assess the feasibility of a mHealth prehabilitation programme delivered via a mobile app for people with oesophago-gastric cancer by evaluating its user satisfaction and acceptance. The research question asks what is the feasibility of a mHealth prehabilitation programme delivered via a mobile app for patients with oesophago-gastric cancer?

The primary aim of this single centred feasibility randomised controlled trial (RCT) is to explore the recruitment, adherence, and compliance of taking part in a mHealth prehabilitation programme delivered for 6 weeks via a mobile app prior to oesophago-gastric surgery. This study will develop a prehabilitation programme to investigate the feasibility and impact of delivering prehabilitation via a mobile app to patients with a diagnosis of oesophago-gastric cancer before surgery.

The study will test a six-week mHealth prehabilitation programme delivered via a modified mobile application called the asensei app. Asensei is a commercial company who have already successfully developed a digital platform known as the asensei app that delivers tailored training with individualised programmes and automated responsive feedback for the fitness industry via mobile applications. In summary, participants recruited to the study will require three visits to the hospital for measures to be taken. Outcome measurements will be taken at baseline (T0), prior to surgery (T1) and 30 days post surgery (T2). Outcome measures relating to feasibility, physical and nutritional functioning as well as quality of life will be collected at the above specified three time points (T0,1,2). There will also be weekly phone calls and one to one discussion after the six weeks of prehabilitation to explore how useful people have found the app and how easy and engaging it was to navigate. This study will gain valuable insight into the role mHealth applications could offer in preventing functional decline, improving quality of life and preventing secondary complications in patients with a diagnosis of cancer prior to surgery.

Eligibility Criteria:
Participants will need to fulfil the following eligibility criteria:

Inclusion Criteria:

* Diagnosis of oesophago-gastric cancer awaiting surgery,
* 18 years of age or over,
* Medically stable to participate in a prehabilitation programme with exercise intervention, English speaking,
* Access to an iPhone
* Able to provide informed consent.

Exclusion Criteria:

* Medically unstable,
* Diagnosis of metastatic cancer,
* Contraindications for physical activity,
* Presence of a pacemaker or other internal medical device,
* Uncontrolled blood pressure and or heart arrhythmias.
Single Dose Study of BMS-820836

The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
* Right-handed, non-ambidextrous subjects for Part 2
* Men and women, ages 18 to 55 years, inclusive

Exclusion Criteria:

* Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* WOCBP using a prohibited contraceptive method
* Women who are pregnant or breastfeeding
* Sexually active fertile men not using effective birth control if their partners are WOCBP
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* History of cholecystectomy
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact the absorption of study drug
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate/swallow oral medication
* Difficulty with venipuncture and/or poor venous access
* Self-reported smokers
* Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
* Confirmed resting supine systolic blood pressure \> 130 mmHg
* Confirmed resting supine diastolic blood pressure \> 80 mmHg
* Confirmed QT value ≥ 500 msec
* Confirmed QTc (Bazett) value ≥ 450 msec
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
* History of peppermint allergies
* History of brain conditions (e.g. history of stroke, head trauma, etc.)
* History of or current psychiatric conditions
* History of claustrophobia
A Study Assessing Circulation Around Surgical Incisions at the Time of Laparotomy Closure

This study is being done to find out if Spectrum Near-Infrared (NIR) imaging with Indocyanine Green (ICG) dye can help measure blood flow around an incision before and after the surgeon closes the incision with staples or sutures.

The Spectrum NIR imaging system uses a handheld camera that produces a special type of light that can help surgeons see things during surgery that are difficult to see with the naked eye, for example, cancer tissue versus healthy tissue. Spectrum NIR imaging has been approved by the Food and Drug Administration (FDA) as a tool that is widely used during surgery.

ICG dye is a sterile solution that can be seen with Spectrum NIR imaging. This dye, used with Spectrum NIR imaging, allows surgeons to see blood flow to parts of the body during and after surgery. Making sure that there is enough blood flow to the surgical site helps to promote a less complicated recovery.


Eligibility Criteria:
Criteria for Eligibility Prior to Surgery

Inclusion Criteria:

* Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
* Age ≥18 years

Exclusion Criteria:

* Women with hepatic dysfunction as evidenced by elevated transaminases
* Women with a history of cirrhosis or other chronic liver disease
* Women with an allergy to iodine
* Women undergoing laparoscopic or minimally invasive surgery

Criteria for Eligibility Post-Surgery

Inclusion Criteria:

* Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
* Age ≥18 years

Subject Exclusion Criteria:

* Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
* Women with transverse laparotomy incisions
* Women with laparotomy incisions left open due to a case classification as "contaminated" or "dirty"