cyrilzakka/clinical-trials huggingface dataset:
Implementation of Evidence-based Treatments for On-campus Eating Disorders

The purpose of this study is to evaluate two training methods of IPT with mental health service providers in college counseling centers.

Although there have been major advances in developing evidence-based psychotherapies, the adoption of such treatments by community therapists has been slow. One of the problems is the difficulty therapists in practice have in learning how to conduct an evidence-based psychotherapy. Hence, this study will investigate two methods of teaching therapists interpersonal therapy (IPT), an evidence based treatment for eating disorders and depression, at 40 college or University counseling centers.

Current approaches to training therapists to conduct new treatments typically consist of a one or two day workshop delivered by an expert and provision of a manual for the therapy in question. Recent reviews have concluded that while workshops increase therapists' knowledge, their impact on skills may be short-lived without further consultation. Thus, investigators will supplement IPT training manuals and workshops by offering monthly consultation calls to participating therapists for 12 months following the workshop. The consultation calls are not designed to be case supervision per se. Rather, they are to be seen as extended training on IPT. This training condition is referred to as expert consultation.

The second training strategy, referred to as train-the-trainer, features expertise capacity building within each organization. There is a strong theoretical case for this implementation strategy as it is based on the principles of social cognitive theory, featuring active learning via modeling, feedback on performance, building self-efficacy, and supportive interactions among therapists developing IPT skills. This 'train-the-trainer' approach involves active learning which centers around development of an internal coach and champion, and has been recommended as the most effective means of changing actual therapist behaviors rather than just attitudes and self-reported proficiency. Roth et al. have made the case that effective implementation of evidence-based treatment in routine clinical services requires that the training approximate that which characterized the research context (e.g., continuing feedback and supervision and monitoring of treatment fidelity). Our train-the-trainer strategy offers a practical means of accomplishing this goal.

Eligibility Criteria:
Inclusion Criteria:

* Currently employed in a participating university counseling center
* Providing regular student-client services
Safety and Tolerability of Liraglutide in Healthy Male Volunteers

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).


Eligibility Criteria:
Inclusion Criteria:

* Male subjects of any ethnic origin
* Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
* Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
* Body mass index within the range 20-27 kg/m\^2, inclusive

Exclusion Criteria:

* Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
* History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
* Alcohol intake within 48 hours of visit
* Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
* History of significant drug allergy or drug hypersensitivity
* Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
* Subjects who drink more than 8 cups of tea/coffee per day
Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

Hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy, being a serious health problem around the world.

Previous studies have suggested that there is an association between a short period of exposure to paternal sperm of a new sexual partner and the development of an immunological reaction that could trigger a hypertensive disorder of pregnancy. For this reason we want to study the relationship between the primipaternity concept (exposure to male antigens present in semen over a short period of time previous to the pregnancy) and the development of preeclampsia in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* 19 year old or less
* Pregnancy \> 24 weeks at the moment of delivery

Exclusion Criteria:

* 20 years old or more.
* Pregnancy \< 24 weeks at the moment of delivery
Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer

The purpose of this study is to see if women with bone metastases from breast cancer will benefit from the addition of doxycycline to their standard bone-targeted therapy. Participants will be asked to take 100 mg of Doxycycline orally twice a day for 12 weeks. Blood and tissue collection will further define the mechanism of the benefits if there are any.

Potential candidates for this trial must have received intravenous bisphosphonate therapy (i.e. pamidronate or zoledronic acid) or subcutaneous denosumab for at least 3 months. Baseline patient characteristics will be recorded and screening serum PTH (to rule out primary hyperparathyroidism) and vitamin D (25OH-vit D) will be recorded. In order to fulfill the study objectives, serum will be taken for CTX (fasting morning blood sample), P1NP and BSAP as well as for the optional translational studies (e.g. MMP and TIMP levels). Optional urine will be taken for NTX. Questionnaires will also be completed for symptoms (Brief pain inventory (BPI) \[26\] and FACT-BP \[27\]) and analgesic use (converted into an oral Morphine-equivalent dose). The serum, urine and questionnaire data will be collected at: baseline, weeks 4, 8, and 12. In addition, toxicity information and questions about the occurrence of skeletal related events will be performed at baseline, weeks 4, 8 and 12. At baseline and week 12 the patient will also have a bone marrow aspirate and trephine biopsy performed from the posterior iliac crest. These specimens will be used for ER, PR and Her2 analysis (by FISH) and markers of apoptosis (TUNEL) and proliferation (Ki67) and also for optional translational studies providing tumour cells are present.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic breast cancer with radiologically confirmed bone metastases.
2. On intravenous bone-targeted therapy (bisphosphonate or subcutaneous (SC) denosumab) for at least 3 months.
3. ECOG ≤ 2
4. Life expectancy \>3 months.
5. No changes in the type of systemic chemotherapy, endocrine therapy or biological therapy (i.e. trastuzumab, lapatinib) treatment in the 4 weeks prior to study entry or anticipated changes in the 4 weeks after entering the study. (Markers of bone formation can be affected by a change in systemic therapies).
6. Ability to provide informed consent and complete study evaluations.

Exclusion Criteria:

1. Prior hypersensitivity to either IV bisphosphonate therapy or SC denosumab, doxycycline or tetracyclines.
2. Patients with myasthenia gravis
3. Patients taking hepatic enzymes inducers such as phenytoin, barbiturates and carbamazepine
4. Patients with rapidly progressive non-bone metastases for whom delaying a change in systemic anti-cancer treatment in the first 4 weeks of the study could have a detrimental impact on patient outcome.
5. Women of child bearing potential who are unwilling to use acceptable methods of contraception while on study.
6. Pregnancy or lactation.
7. Clotting disorder that would preclude bone marrow aspirate and trephine biopsy. (Patients on Fragmin or Daltaperin are allowed on study)
Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement

Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR

Calcific aortic stenosis (AS) is the most common valve disease in the western world requiring intervention,Although Surgical Aortic Valve Replacement (SAVR) was considered as the first therapeutic method, approximately one-third of AS patients cannot undergo SAVR due to its' high risk or contraindication.

Since Transcatheter Aortic Valve Replacement (TAVR)was performed for the first time in 2002,TAVR has emerged as a growing prevalent treatment on severe symptomatic AS with the procedure initially performed on the inoperable patients with intermediate and high risks.

Recently, the Food and Drug Administration had approved it on low-risk symptomatic subjects.

AS has to be considered a disease of the left ventricle (LV) rather than purely affecting the aortic valve, Approximately one-third of patients with severe symptomatic AS have LV systolic dysfunction .

Recovery of LV ejection fraction (LVEF) is associated with improvements in clinical outcomes after TAVR as shown by a lot of studies.

The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that recovery of LV function in patients with severe symptomatic AS and LV systolic dysfunction who underwent TAVR, occurs in 40% to 50% of patients .

Higher trans-aortic mean pressure gradient , less LV hypertrophy, Less LV fibrosis and absence of AF are predictors of recovery of LV function after TAVR .

However, there is still a scanty data about the predictors of LV function recovery after TAVR.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%.

Exclusion Criteria:

* Severe Rheumatic or degenerative mitral regurgitation.
* Previous Valve Replacement.
* Previous myocardial infarction.
* Previous Coronary Artery By Bass Graft (CABG)Surgery.
* Post TAVR significant paravalvular leakage
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)

Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.

The goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. The main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". Participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done They will have an MRI to measure fat in the liver, a body x-ray to measure body composition and a blood draw when they start and finish their assigned supplement.

After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.

Eligibility Criteria:
Inclusion Criteria

* Ages 13-18, Tanner stage 4-5
* Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. Their MRI liver fat \>5.5%
* Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist
* Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week
* BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories

Exclusion Criteria

* Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.
* Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
* Severe illness requiring hospitalization within 60 days
* Diabetes, defined as Hemoglobin A1C \> 6.4%
* BMI percentile less than the 85th percentile for age and sex. Waist circumference \>200 cm
* Anemia, defined as Hemoglobin \< 11 mg/dL
* Diagnosed major psychiatric or developmental disorder limiting informed consent
* Implanted metal devices that are not compatible with MRI
* Use of blood pressure medications
* Known liver disease other than NAFLD or AST or ALT \>150 IU/L
IQOS (Non-Cigarette Tobacco Product) Pilot Study

A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.


Eligibility Criteria:
Inclusion Criteria:

* daily cigarette smoker
* interested in using non-cigarette tobacco product
* have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).

Exclusion Criteria:

* additional tobacco use criteria
* additional medical criteria
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors

This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years at time of signing informed consent form (ICF)
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
* Adequate hematologic and end-organ function
* Life expectancy \>= 12 weeks
* Patients with histologic documentation of locally advanced, or metastatic solid tumor
* \[Dose-escalation Parts and Biopsy Parts\]Refractory or resistant to standard therapies or standard therapies are not available
* \[Dose-escalation Parts and Expansion Part\] Patients with confirmed availability of fresh tumor or representative tumor specimens
* \[Biopsy Parts\] Patients with accessible lesion(s)

Exclusion Criteria:

* Clinically significant cardiovascular or liver disease
* Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
* Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
* All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
* Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Active or history of clinically significant autoimmune disease
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

\[Expansion Part\]

* Prior treatment with investigational product which has MoA of Treg depletion
* Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1
Testing Automated Echocardiography

The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality). An approved ultrasound device (Lumify) will be used to obtain images prior to cardiac surgery.

This is a prospective, non-randomized, single visit clinical study. No additional interventions or follow-ups to the subject will be conducted as part of the study. All investigational scanning will be conducted using the as low as reasonably achievable (ALARA) principle to ensure the safety of the subjects. As ultrasound imaging is based on non-ionizing radiation, it is generally considered safe when used by appropriately trained health care providers. The study population will be adults. There are no specific enrollment targets, however it is expected that 120 subjects or fewer will be scanned to obtain the required 40 echocardiographic exams to complete this study. Exceeding the enrollment target of 120 subjects will require an amendment to the protocol. It is estimated this study will last for 12 months, at that time it will be evaluated and may potentially be amended.

This study is considered non-significant risk. There is no specific benefit to individuals participating in the study, however the feedback received is used to improve Philips systems and that can lead to increased diagnostic ability in future products.

Eligibility Criteria:
Inclusion Criteria:

* Patient willing and capable of providing informed consent and physically capable of performing study related activities
* Patient undergoing any of the following types of cardiac surgeries:

Aortic valve repair Aortic valve replacement Mitral valve repair Mitral valve replacement Tricuspid valve repair Tricuspid valve replacement Pulmonic valve repair Pulmonic valve replacement Ascending aorta replacement Coronary Artery Bypass Graft (CABG) surgery

Exclusion Criteria:

* Pregnant women
* Patients known to be under the jurisdiction of the Department of Corrections
* Patients with persistent arrhythmias as confirmed by the principal investigator (MacKay) on a caseby-case basis (e.g. atrial fibrillation, atrial flutter, frequent premature ventricular contractions, frequent premature atrial contractions, etc.)
* Patients with a contraindication to Pulmonary Arterial Catheter (PAC) monitoring as confirmed by the principal investigator (MacKay) on a case-by-case basis (e.g. tricuspid or pulmonic valve endocarditis, venous thrombosis present in the superior vena cava, right atrium, or main pulmonary artery)
* Patients with a contraindication to TEE monitoring as confirmed by the principal investigator (MacKay) on a case-by-case basis (e.g. previous esophageal surgery, prior gastric bypass surgery, esophageal varices).
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.

Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS or other immunocompromising condition.
* Candidal esophagitis.
* Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Evidence of non-candidal systemic fungal infection.
* Abnormalities that may preclude esophagoscopy or endoscopy.
* Unable to tolerate fluconazole.
* Unable to give informed consent.
* Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
* Other condition that would make patient unsuitable for enrollment.

Concurrent Medication:

Excluded:

* Concomitant oral or topical antifungal agent.
* Other experimental medications.

Patients with the following prior condition are excluded:

History of allergy to imidazoles or azoles.

Prior Medication:

Excluded:

* Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.
Development of 'Emma'--a Pediatric IBD Quiz

We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.


Eligibility Criteria:
Inclusion Criteria:

* Children 10-18 years of age
* Diagnosis of Crohn's disease or ulcerative colitis
* English-speaking
* Established patient of participating institution

Exclusion criteria

* Inability to understand and read English at a grade 5-12 year level, as commensurate to their chronological age
* Research denial by patient or guardian