cyrilzakka/clinical-trials huggingface dataset:
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy

More than 70% of birch pollen allergic patients suffer from allergic reactions to certain foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy (SIT) with birch pollen extract is not effective for the treatment of associated food allergy in a substantial number of patients. Based on our previous clinical and immunological investigations of birch pollen related food allergy (BPRFA) the investigators hypothesize that for effective SIT of this abundant food allergy the disease-eliciting food allergens should be employed. To prove this concept, the investigators aim to sublingually administer the major apple allergen, Mal d 1, to birch pollen-allergic patients with concomitant apple allergy and evaluate clinical and immunological effects of this treatment. The investigators choose Mal d 1 as model food allergen because (i) its cross-reactivity with Bet v 1 has been well characterized,(ii) apple is the most frequent trigger for BPRFA and (iii) recombinant(r)Mal d 1 was well tolerated after sublingual administration to 20 birch pollen-allergic patients in a previous study. Sublingual administration of a defined concentration of GMP-rMal d 1 will be compared with equal doses of GMP-rBet v 1 as a positive control and placebo-treatment. Clinical parameters will include skin prick tests (SPT) and objective and subjective assessment of apple and birch pollen-induced allergic symptoms. Immunological parameters will comprise the analysis of antibody and T cell responses to Mal d 1 and Bet v 1 as well as the evaluation of basophil activation.

The proposed pilot study will be a first investigation of the concept to specifically treat BPRFA with the involved food allergens and thus, represents an important step in the development of an efficient and safe therapy in the future.


Eligibility Criteria:
Inclusion Criteria:

* otherwise healthy persons between 18 und 50 years of age;
* positive history of rhinoconjunctivitis to birch pollen
* oral allergy syndrome(OAS) to apple
* positive skin prick test (SPT) reaction to birch pollen and apple
* specific IgE for Bet v 1 and Mal d 1

Exclusion Criteria:

* Exclusion criteria
* Persons who due to their physical or mental state are not able to provide informed consent.
* Persons with underlying illnesses such as severe cardiopulmonary, malignant and/or autoimmune diseases
* Persons suffering from Hyper-IgE syndrome
* Persons receiving SIT during the past 5 years
* persons suffering from severe allergic reactions to apple such as generalized urticaria, asthma and/or anaphylaxis
* persons suffering from severe bronchial asthma to birch pollen
* persons suffering from pathological alterations of the lips and oral mucosa
* persons who are prescribed a treatment with immune-suppressive drugs, anti-histamines, leukotriene-antagonists or psychotropic drugs with anti-histaminic effects
* persons using ß-blockers
* Pregnant woman
Efficacy of Mental Health Self-Directed Care Financing

Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness.

Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness. Adults with serious mental illness served in the Texas public health system will be randomly assigned to SDC versus services as usual and assessed at baseline, 12-month, and 24-month follow-up. Mixed effects random-regression analysis will test for longitudinal changes in outcomes between the two study conditions. Differences in service costs will be analyzed using generalized linear models with negative binomial and zero-inflated negative binomial distribution. Non-traditional expenditures by the SDC participants will be examined descriptively. Service satisfaction in both study conditions will be assessed at one- and two-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* receiving mental health services at a Texas Department of State Health Services-funded mental health program
* diagnosis of serious mental illness consistent with federal Public Law 102-32
* assigned to a level of care eligible for a package of comprehensive clinical and rehabilitation services known as Service Package 3
* 18 years or older
* able to understand spoken English.

Exclusion Criteria:

* cognitive impairment
* homeless at time of recruitment
* history of violent behavior resulting in arrest and conviction in the past 10 years
* active substance use in the absence of substance use treatment
* enrollment in Medicare or dual beneficiary
* finances controlled by a third party (e.g., representative payee)
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia

This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVE:

I. To assess incidence of major molecular response (MMR) at 12 months.

SECONDARY OBJECTIVES:

I. To assess progression free survival (PFS) at 12 and 24 months.

II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12 and 24 months.

III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.

IV. To assess safety.

V. To assess patient reported outcomes (PRO).

TERTIARY OBJECTIVES:

I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on diagnostic bone marrow.

II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine kinase inhibitors (TKIs) discontinuation trials.

OUTLINE:

Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.

After completion of study treatment, patients are followed up at 2 weeks and then up to 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization \[WHO\] definition) (hydroxyurea permitted up to 7 days prior to enrollment)
* Clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications
* Able to give written informed consent and comply with all study visits and procedures

Exclusion Criteria:

* Chronic myeloid leukemia (CML) in AP or BP
* Unable to receive TKI for insurance reasons (uninsurable)
* Refuse or unable to perform telephone or video conferences with research coordinator
* Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
* Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject
Effects of Dextromethorphan on Opioid Tolerance in Methadone Patients - 1

The purpose of this study is to determine if addition of dextromethorphan to a stable dose of methadone in opioid dependent subjects will significantly affect physical and psychological aspects of opioid tolerance.


Eligibility Criteria:
Please contact site for information.
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision

When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al., 2013). The objective of this trial is to investigate whether the use of a micro-electrode assisted technique improves targeting precision in DBS at the BNST.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
* Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
* Failure of documented trial of cognitive and behavioural therapy
* Duration of illness: min. 5 year
* Y-BOCS (Yale-Brown Obsessive Compulsive Scale) at least 30/40.
* Age: 20-65 year

Exclusion Criteria:

* DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
* DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
* Present or past history of psychotic symptoms.
* Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
* Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
* Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
Middle Meatal Bacteriology During Acute Respiratory Infection in Children

The purpose of this study is to find out whether the children with respiratory infection and the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus benefit from antimicrobial treatment.

Acute sinusitis is one of the most common disease in children requiring antimicrobial treatment. The diagnosis and treatment outcomes of acute sinusitis are contradictory, and better diagnostic criteria are needed. In adults with acute maxillary sinusitis, bacterial culture results obtained from the nasal middle meatus are comparable to those obtained from sinus puncture and aspiration. In children, the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection predicts longer duration of signs and symptoms of common cold.

In this randomized placebo-controlled study, the effect of the antimicrobial treatment (amoxicillin-clavulanate) is examined in children with pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection. The duration of the symptoms and speed of recovery is recognized by daily symptom-diary, the results are compared between the treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* acute respiratory infection with nasal symptoms (nasal obstruction or discharge)
* seeking medical help from health centre for the respiratory symptoms
* pathogenic bacteria (S pneumoniae, H influenzae or M catarrhalis) identified from right or left nasal middle meatus in the endoscopically taken swab culture sampling taken by a study investigator (all microbiological analyses are done by the National Public Health Institute´s microbiological laboratory in Oulu)

Exclusion Criteria:

* otitis, tonsillitis or other disease requiring antimicrobial treatment
* respiratory infection within 4 weeks of screening
* antimicrobial treatment within 4 weeks of screening
* allergy to penicillin or amoxicillin
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy

Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* First time administration of ICI
* Willing and able to return in 4-6 weeks for follow-up study
* Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing)

Exclusion Criteria:

* Age \< 18 years
* Women who are pregnant, or breast-feeding.
* Unable or unwilling to give consent to undergo PET/CT.
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.


Eligibility Criteria:
Inclusion Criteria:

* Children must be healthy to participate

Exclusion Criteria:

* Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
* Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
* They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
* Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
* Children must not have been vaccinated against varicella.
* They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
* New-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
Serum Vasopressin Levels and Severe Hemorrhagic Shock

The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).

For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of the effect of exogenous vasopressin use exist, although case reports have suggested it may be of benefit. Even some moribund patients with "irreversible" shock survived severe hemorrhagic shock after administration of vasopressin. This suggests that at least some patients suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and notable research consortiums have suggested that AVP shows promise for human resuscitation and have called for further human studies.

This is a prospective, single-center observational study designed to evaluate (1) whether vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin levels (now a continuous dependent variable) will be correlated with each of three outcomes-death, ARDS, and sepsis.

Eligibility Criteria:
Inclusion Criteria:

Patients with a minor injury or injuries, defined as:

1. no episodes of systolic blood pressure \< 90 mmHg between occurrence of injury and admission;
2. no blood transfusion requirement;
3. base deficit \< 5 mEq/L;
4. no requirement for mechanical ventilation other than transiently during orthopedic surgery.

Exclusion Criteria:

1. Pregnancy
2. corticosteroid use,
3. prisoners, and/or
4. head trauma as determined by computed tomography (head trauma may itself induce diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or
5. evidence of spinal cord injury (another cause of vasodilatory shock).

Patients will also be excluded if pre-hospital provider information cannot be obtained, or indicates that the trauma occurred more than one 1 hour prior to emergency department admission.
Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

A double-blind randomized study conducted on 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 women) after fetal extraction and before placental removal.

Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Eligibility Criteria:
Inclusion Criteria:

* All participants are at 37 - 40 weeks of gestational age
* Noncomplicated pregnancy.
* obese women with BMI \> 30.

Exclusion Criteria:

* Participants with placenta previa,
* coagulopathy,
* preeclamptic
* known sensitivity to carbetocin,oxytocin or methergine were excluded
Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire

The aim of our research is to be able to use the questionnaire 'Prosthesis Evaluation Questionnaire' (PEQ) in Dutch. The PEQ is a validated and reliable questionnaire for research into the quality of life in adults with a lower limb prosthesis. The research consists of two phases. The first phase is the translation of the PEQ and the second phase is the validation of this questionnaire. To validate the questionnaire, we want to include 84 participants who have to complete questionnaires three times within a period of three months.

The study consists of two phases. The first phase is the translation of the Prosthesis Evaluation Questionnaire (PEQ) and the second phase is the validation of this questionnaire.

Phase 1 translation PEQ: The Beaton guidelines were followed for the translation of the questionnaire. After translation and back-translation, version A of the translated PEQ was created. This version was tested on 30 adult patients with a lower leg prosthesis. Based on the feedback from the patients, the Dutch language version of the PEQ was created (PEQ-DLV).

Phase 2 validation PEQ-DLV: For the process of validation three questionnaires were used: a general survey, the PEQ-DLV and the RAND-36. The participants were approached via a large orthopedic workshop and the national patient association KorterMaarKrachtig (KMK). The aim was to include 84 lower limb prosthesis users with an unilateral amputation at ankle level or higher. At baseline (T0) patients received a digital consent form, the general survey, the PEQ-DLV and the RAND-36. Two weeks (T1) and three months (T2) after baseline, the participants who completed all questionnaires, received the PEQ-DLV again. For motivation and as a token of appreciation, participants received a compensation of 20 euros after filling in all questionnaires.During the analysis the internal consistency, floor-ceiling effects, test-retest riliability, responsiveness and contruct validity are calculated and determined.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Unilateral lower limb amputation at ankle level or higher
* Mastering Dutch language

Exclusion Criteria:

* Children
* Bilateral or foot amputations
Prognosis of Anxiety in Intensive Care Unit

Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to a threat. Anxiety is a consequence of the reciprocal interaction between stress and the neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of anxiety in critically ill patients has never been done. Our hypothesis is that high levels of anxiety at ICU admission are associated with death or the occurrence of one or more organ failure during the first 7 days, and that anxiety should be considered as a "warning sign" in critically ill patients.

Multicentre prospective study. Demographic data, diagnosis, severity scores and vital signs will be assessed at admission.

Within the first 12 hours, and at day 4 and day 7, anxiety will be assessed by the STAI scale, Geriatric Anxiety Inventory (GAI) scale, and a specific questionnaire assessing anxiety in the intensive care (REAX). Visual Analogue Scale (VAS) scoring for anxiety, starvation, thirst, pain and dyspnoea will be collected daily. Anxiety and depression will be evaluated by the Hospital Anxiety and Depression Scale (HADS) on day 7. Patients will be assessed by psychologists or trained doctors, the team in charge of the patient will not be aware of the result of this evaluation.

Clinical and biological data regarding the hemodynamic, neurological, respiratory and renal status will be collected from admission to day 7, as well as parameters required for computing the Sequential Organ Failure Assessment (SOFA) score.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the ICU
* Patient without delirium at admission (assessed using the CAM-ICU score)

Exclusion Criteria:

* Severe hearing impairment or poor understanding of French language
* History of serious psychiatric illness
* Comatose or sedated patient at admission
* Diagnosis of voluntary self-poisoning, or polytrauma at admission