cyrilzakka/clinical-trials huggingface dataset:
Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.

The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.

Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of OCD as defined by DSM-5
* a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS
* age between 12 and 17 years
* ability to read and write Swedish
* daily access to the internet
* a parent that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder
* suicidal ideation
* ongoing substance dependence
* subject not able to read or understand the basics of the ICBT material
* completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
* ongoing psychological treatment for OCD or another anxiety disorder
Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 or older
* Outpatient colonoscopy

Exclusion Criteria:

* constipation
The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy

Liver tumors are hard to treat with radiation because the liver moves every time you breathe. The purpose of this study is to test a new and possibly more accurate way of treating liver tumors. When a person is asleep under anesthesia, it is safe to stop breathing motion for a while. The liver will stop moving and radiation can be given to a liver tumor. The study is being done to see if radiation can be given to liver tumors safely and accurately in this way.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible to receive external beam intensity modulated radiotherapy for liver cancer
* Age:21\<80
* KPS \> or = to 80
* Able to tolerate immobilization cradle positioning
* Able to give informed consent
* Histologically confirmed diagnosis of solid tumor malignancy
* Liver metastases visualized on CT imaging (obtained within approximately 6 months from enrollment).
* Target lesion ≤ or = to 8 cm in maximal diameter
* In the case of multiple liver metastases, only one lesion will be targeted per treatment session. Typically the target lesion will be the lesion which is progressing or the cause of symptoms. The target lesion will be picked in consultation with the referring physician.

Exclusion Criteria:

* Lymphoid primary histology (lymphoma/leukemia)
* Single metastasis in an operable patient. Operable lesions will only be considered for enrollment in the protocol if the patient refuses resection of the metastasis.
* Target lesion \> 8 cm in maximal diameter
* Cirrhosis of the liver (Child's C)
* Liver function enzymes (AST, ALT) \> 3x normal , obtained within 1 month of treatment.
* \< 500 cc uninvolved liver
* Unable to tolerate intravenous CT contrast
* Serum Hemoglobin \< 9.0 (obtained within 1 month of treatment)
* Presence of untreated brain metastases
* Severe pulmonary disease (O2 dependent, unable to walk a flight of stairs)
* Unstable cardiac status
* Unstable angina
* Significant abnormal 12 lead EKG (non sinus arrhythmia or ischemia unsuitable for general anesthesia)
* Congestive Heart Failure
* Abnormal kidney function (serum creatinine \> 1.5) obtained within 1 month of treatment
* Platelet count \<70.000. (obtained within 1 month of treatment).
* INR \> 2.0 (obtained within 1 month of treatment)
* Marker seed placement not possible
* Implanted defibrillator/pacemaker
* Evidence of increased intracranial pressure
* Significant ascites
* Morbid Obesity
* Pregnancy
Post-operative Sensitivity in Composite Restorations

Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks.

After the approval from ethical research committee, a written informed consent taken. Participants were briefed about the intervention with its associated merits and demerits. The restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. The principles of minimally intervention and adhesive dentistry were employed. Participants were allocated into two groups. In group A, restorative interventive was performed using Oblique incremental placement while in group B, Bulk-fill technique was used. Post-operative sensitivity was recorded at one day, one week and two week follow up using a Visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years of age with good general health
* Vital and Periodontally stable teeth
* Class-II primary carious lesions with a cavity depth of 3 to 5 mm
* Established contact with adjacent and opposing natural or prosthetic teeth
* Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining)

Exclusion Criteria:

* Teeth with a history of spontaneous pain
* Compromised oral health status
* Patients with parafunctional habits or temporomandibular disorders
* Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis
* Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks
The Differential Effects of 3 Different Immunosuppressive

The study is a laboratory investigation comparing the regulatory effects of different immunosuppressive therapies in an in vitro human MLR assay of selecting specific immunosuppressive therapy to promote a regulatory profile and determining possibly newer accepted dosing and drug concentrations for agents most associated with this regulatory profile.

Life-long immunosuppressive (IS) therapy is typically required in the great majority of organ transplants. Immunobiologically correct IS dosing, tapering to low levels and/or monotherapy could lower the incidence of complications related to IS and improve long term graft and patient survival. The current standard of IS care for liver transplant recipients are the calcineurin-inhibitors (CNIs) tacrolimus (TAC) and cyclosporine (CSA), although alternative IS drugs such as mycophenolate mofetil (MMF) and sirolimus (SRL) are available for use in select patients. This is also true for kidney, pancreas and heart transplant recipients, with TAC being favored in each case. The ideal IS agent is one that can be given at low levels such that both rejection and long term toxicity are minimized. Directly related to IS minimization might be the development of a regulatory, "tolerance profile", as assessed by ex vivo immunophenotyping and functional assays that might test these specific IS agents singly, in combination or even in sequence.

Human Tregs and DCregs can be more predominantly generated in the presence of one of three IS agents with different modes of action, i.e., TAC, MMF or SRL, and in different conditions of antigen presentation and alloimmune incompatibility.

This is a bench protocol studying the effects of TAC, MMF and SRL on pre operative living renal recipient donor pair.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of Age or Older
* Undergoing living donor renal transplant

Exclusion Criteria:

* No active infection or history of malignancy
* No HIV infection
* No Hepatitis C (HCV) infection
* No prior transplant (kidney or other organ)
* No chromic use of immunosuppressive therapy or history of autoimmune disease
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult subjects 18 to 64 years of age,
2. Individuals willing to provide written informed consent,
3. Individuals in good health,
4. Individuals willing to allow for their serum samples to be stored beyond the study period.

Exclusion Criteria:

1. Individuals not able to understand and follow study procedures,
2. History of any significant illness,
3. History of any chronic medical condition or progressive disease,
4. Presence of medically significant cancer,
5. Known or suspected impairment/alteration of immune function,
6. Presence of any progressive or severe neurologic disorder,
7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
8. History of allergy to vaccine components,
9. Receipt of any other investigational product within 30 days prior to entry into the study,
10. History of previous H5N1 vaccination,
11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
12. Receipt of any other vaccine within 2 weeks prior to entry into the study
13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
14. Pregnant or breast feeding,
15. Females of childbearing potential refusing to use acceptable method of birth control,
16. Body mass index (BMI) ≥ 35 kg/m2,
17. History of drug or alcohol abuse,
18. Any planned surgery during study period,
19. Individuals conducting the study and their immediate family members,
20. Individuals with behavioral or cognitive impairment or psychiatric diseases.
Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth

This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.

For the Yes and Know study, cohorts of 5-15 participants will be recruited and randomized into one of the two study conditions: Yes and Know: Life Skills intervention (intervention condition) or Yes and Know: Nutrition Skills intervention (comparison condition). The programs will be delivered by trained health educators through synchronous virtual sessions. Participants can access the supplemental resources and activities for their respective programs on the program's website. Each cohort will be recruited from a local partner site (with a focus on rural communities in the South and Southeast regions of the United States), and young people must have consent and provide their assent to be part of the study. Yes and Know: Sexual Health and Life Skills covers sexual and reproductive health, healthy relationships, life skills, and educational and career success. Yes and Know: Nutrition Skills covers learning to make healthy decisions about food, weight and disordered eating, and creating nourishing meals. Both programs consist of nine 60-minute synchronous group sessions, totaling nine hours, to be taught at least once a week (or more frequently depending on sites' scheduling).

Eligibility Criteria:
Inclusion Criteria:

* Ages 14-19; and
* English speaking.

Exclusion Criteria:

- Anyone not meeting inclusion criteria.
Caregivers' Knowledge of Emergency Department Discharge Instructions Improves With the Use of Video

Previous studies demonstrate that patients often have difficulty understanding their discharge instructions. Video discharge instructions have the potential to mitigate factors such as illiteracy and limited physician time, which may affect comprehension. Our goal is to determine if adding video discharge instructions affects caregivers' understanding of their child's emergency department (ED) visit, plan and follow-up.

Caregivers of patients, age 29 days to 18 years, with a diagnosis of fever, vomiting or diarrhea, and wheezing or asthma were randomized into written or video discharge instruction groups. In the ED, caregivers read standard written discharge instructions or watched a 3-minute video based on their child's diagnosis. They were then asked questions regarding information covered in these instructions. After completing the 20-point questionnaire, standard discharge procedure was followed. Caregivers were contacted by phone 2-5 days after discharge for a follow-up questionnaire. Usefulness of the discharge instructions was also assessed.

Eligibility Criteria:
Inclusion Criteria:

* caregivers of pediatric patients age 29 days to 18 years old diagnosed with wheezing or asthma exacerbation, fever, or vomiting and/or diarrhea.

Exclusion Criteria:

* Caregivers of patients who were critical in the ED,
* Admitted to the hospital, or given an alternate diagnosis prior to discharge were excluded from the study.
* Also, non-English speaking caregivers were excluded.
To Evaluate Long- Term Safety and Efficacy of Luspatercept

An observational study to evaluate long-term safety and efficacy of luspatercept in subjects with transfusion dependent who received the first dose of luspatercept after its introduction in the clinical practice

Luspatercept represents the first and only erythroid maturation agent (EMA) approved by the European Commission (EC) and the Food and Drug Administration (FDA) capable of enhancing advanced erythrocyte maturation. The efficacy of luspatercept was demonstrated in the phase III clinical trial called "BELIEVE." With market authorization, the drug is used in less selected patients with potentially more complex medical histories than those enrolled in the registration study. In addition, it is now also possible to prescribe the drug in patients with blood consumption at baseline between 20 and 24 blood units in the 24 weeks before the drug was prescribed, who could not be included in the "BELIEVE" study. Gathering data on the clinical characteristics of patients who are prescribed luspatercept in normal clinical practice, and of safety and efficacy in this setting, is essential to enrich the available information on this new therapy.

Eligibility Criteria:
Inclusion criteria:

Subjects who received at least one dose of luspatercept after its introduction in the clinical practice

Exclusion Criteria:

* Subjects who received luspatercept after participating in the "compassionate" use program
* Subjects unwilling to sign informed consent
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients

In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.

In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls

Eligibility Criteria:
Inclusion Criteria:

* candidate for high-dose chemotherapy and autologous hematopoietic stem cell transplantation
* Karnofsky performance status \>/= 60%
* scheduled to receive one of the following conditioning regimens
* BEAM
* Oral Busulfan/cyclophosphamide with or without etoposide
* Carboplatin/Etoposide
* Melphalan
* Negative pregnancy test
* Must be able to complete a daily nausea/vomiting questionnaire and Quality of Life

Exclusion Criteria:

* Active infection requiring IV antibiotics
* Known active hepatitis B and/or hepatitis C or HIV infection
* prior non-hematological malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer or other cancer from which the patient had been disease free for \>/= 5 years
* Uncontrolled medical problems including any of the following
* Diabetes mellitus
* Cardiac, pulmonary, hepatic or renal disease
* myocardial infarction within the past 6 months
* Morbid obesity (BMT \>40)
* History of CNS metastases, psychiatric or CNS disorders interfering with the ability to comply with the study
* Known hypersensitivity to 5-HT3 antagonists, dexamethasone and/or their components
* Intrathecal therapy within 24 hours before starting preparative regimen
* Receiving any antiemetic therapy 24 hours before starting preparative regimen
* Any 5-HT3 antagonist used as a rescue medication
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged ≥18 and ≤70 years;
* Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment);
* Completed neoadjuvant treamtment and surgery (within 4 years after surgery);
* Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen);
* ECOG 0-1

Exclusion Criteria:

* Metastatic disease (Stage IV);
* Female patients who are pregnancy or lactation;
* Uncontrollable puncture site infection or systemic infection;
Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)

This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.

Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. The appropriate interface is necessary to provide comfort and lead to the success of NIV.

NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient.

Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema

Exclusion Criteria:

1. Age less than 18 years old
2. Low GCS (less than 8), altered mental status
3. Hemodynamic instability, impending cardiopulmonary arrest
4. Use of vasopressors, inotropes
5. Exacerbation of asthma or chronic respiratory failure
6. Urgent need for endotracheal intubation
7. Absence of airway protective gag reflex
8. Elevated intracranial pressure
9. Tracheostomy
10. Pregnant
11. Upper airway obstruction
12. Injuries or surgery to head and neck less than 6 months upon presentation
13. Claustrophobia
14. Blind or poor vision
15. Medico-legal related cases
Impact of AIT on Allergic Rhinitis and Asthma

The study will assess the effectiveness of AIT treatment in real clinical practice in Germany.

Allergic rhinitis (AR) affects 23-30% of the European population and is associated with a major burden on public health. AR and asthma frequently coexist, and may both be caused by allergen exposure. While the efficacy of AIT, i.e. reduce symptoms and medication use in patients with AR and asthma, has been demonstrated in several randomized clinical trials, little is known about the use and effectiveness of AIT in real world clinical practice.

This study is a retrospective database study that uses real-world data from Germany. The study population consists of AR patients with and without asthma treated with AIT and matched controls not treated with AIT. Information about the patients and treatments will be obtained from the 'BKK German Sickness Fund Database' from 2007 until 2017.

Eligibility Criteria:
Inclusion Criteria for the AIT cohort:

* At least two index-AIT prescriptions during the first FU-year
* At least one confirmed AR diagnosis during the study period
* Continuous enrollment (no gaps in insurance time-defined by days) for 12 months before the index event (in the pre-index period)
* Continuous enrollment (no gaps in insurance time-defined by days) for at least 12 months after the index event (in the post-index period)

Inclusion Criteria for the Control Cohort:

- For the control groups, the same inclusion criteria will apply, with the exception of inclusion criterion 1, i.e. controls have not received AIT before baseline.

Exclusion Criteria:

- AIT prescription 12 months before the index event (in the pre-index period) for the AIT treatment group