cyrilzakka/clinical-trials huggingface dataset:
Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

This study represents the first research program to assess the efficacy of transdiagnostic cognitive behavior therapy (T-CBT) delivered via internet for anxiety and depression in adolescents. The primary aim of the study was to implement the program AMTE (Aprende a Manejar tus Emociones \[Learn to Manage Your Emotions\]), an internet delivered T-CBT protocol designed to target both anxiety and depression symptoms and disorders (major depression disorder, dysthymic disorder, panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) in adolescents, and to establish its preliminary efficacy on anxiety and depressive symptomatology. A secondary objective is to demonstrate its potential effect regarding: (a) transdiagnostic measures associated with etiology of emotional disorders including negative affect, anxiety sensitivity, and emotional avoidance, and (b) positive factors including satisfaction with life and positive affect. It is expected that the T-CBT condition will be more effective than the waitlist (WL) control group on the primary (anxiety and depression) and secondary (transdiagnostic and positive factors) outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Having identified Spanish as the first official language spoken and having good reading comprehension in Spanish.
* Reliable internet access.
* Meeting the DSM-IV diagnosis criteria for more than one emotional disorder (separation anxiety disorder, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, specific phobia, major depression disorder, and dysthymia).
* No current participating in cognitive-behavioral therapy.
* No changes in medication for 4 weeks prior to the study; no changes in medication for the next 3 months.

Exclusion Criteria:

* Presence of psychotic symptoms or severe depression.
* Being diagnosed an alcohol and/or substance dependence disorder.
* The presence of high suicidal risk.
* A medical condition which prevents the participant from carry out the psychological treatment.
Allogeneic Stem Cell Transplantation for Children With CML

In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC), consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of the protocol.

Chronic myeloid leukaemia (CML) is a rare disease in children with an incidence of 3-5% of all paediatric leukaemias. Since the introduction of tyrosinkinase inhibitors (TKI) stem cell transplantation (SCT) is no longer the first choice treatment for patients with early phase CML.

However life-long treatment with TKI may not be feasable in several cases due to side effects such as growth retardation, non-compliance and resistance. This protocol evaluates the feasibility of SCT following a reduced intensity conditioning regimen (RIC) consisting of fludarabine, melphalan, thiotepa and thymoglobuline (ATG). Matched siblings and matched unrelated donors are permitted for stem cell donation. In case of unrelated donors tissue typing has to be done by high resolution molecular typing. Donors with 10/10 or 9/10 identical allels in the human leukocyte antigen (HLA) system are accepted. Preferred stem cell source is bone marrow but peripheral blood stem cells and umbilical cord blood are also allowed. Graft-versus-Host-Disease (GvHD)-prophylaxis is achieved with cyclosporine A and mycophenolate mofetil.

Monitoring of the breakpoint cluster region - Abelson (BCR/ABL) rearrangement is performed monthly in the first year after SCT. In case of BCR/ABL positivity TKI are given in the first year after SCT. Followed by donor lymphocyte infusions (DLI) later on if BCR/ABL positivity persists.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents with BCR/ABL positive CML in chronic phase, who are eligible for allogeneic stem cell transplantation, irrespective of the previous treatment strategy
* availability of a HLA matched sibling donor (MSD), a matched family donor, a matched unrelated donor or a matched unrelated cord blood (MD)
* informed consent

Exclusion Criteria:

* unavailability of MSD or MD
* patients in accelerated phase or blast crisis
* pregnancy
* previous autologous or allogeneic SCT
* no informed consent
Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee

The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.


Eligibility Criteria:
Inclusion criteria patients with osteoarthritis

Exclusion criteria
Registry of Patients in Shock Treated With Vasopressin

Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin).

Septic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up.

The Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1.

The rationale for its use in septic shock would be:

* endogenous vasopressin deficiency present in septic shock;
* as a catecholamine-sparing strategy, reducing the side effects of catecholamines;
* its potential nephroprotective effect;
* its use should be early.

The uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.

The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline.

The secondary objectives are:

* to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose;
* to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen);
* estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice;
* observe when AVP is stopped, how (abruptly or progressively);
* describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients;
* assess medium/long-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement.

Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and/or critical care unit, according to best clinical practice.

Exclusion Criteria:

* Non-consent by patient/legal representatives
Magnetic Stimulation of the Human Nervous System

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, spinal cord and nerve roots). The procedure is conducted by transmitting a magnetic signal into the brain to stimulate an area of the body. Electrodes (small pieces of metal taped to areas of the body) are used in order to measure electrical activity. A magnetic signal is sent from a metal instrument held close to the patient's head, to an area of the brain responsible for motor activity of a certain area of the body. The electrodes pick up and record the electrical activity in the muscles.

This study will employ the use of TMS to diagnose neurological disorders that affect the motor cortex or the corticospinal tract. Normal subjects are sometimes studied to investigate normal activity of the nervous system and to train doctors in clinical neurophysiology and electrodiagnostic medicine at the National Institutes of Health (NIH).

This protocol outlines the use of magnetic stimulation as a diagnostic tool in patients with suspected dysfunction of central motor pathways or nerve roots and as a tool to localize and characterize suspected corticospinal abnormalities in neurologic disorders and systemic disorders with neurological manifestations. The protocol is intended for clinical use.

Transcranial magnetic stimulation has been used for diagnosis of neurologic disorders since 1987. The principles of magnetic stimulation and its use for diagnosis are described in current textbooks of clinical neurophysiology as a routine procedure and should be included in the training program for fellows in clinical neurophysiology and electrodiagnostic medicine at NIH.

The magnetic stimuli are to be given as single or paired pulses at repetition rates less than 1 per second.

Eligibility Criteria:
INCLUSION CRITERIA:

Adult patients with weakness or motor dysfunction.

Children and adolescents with corticospinal tract signs.

Normal volunteers, adults.

Normal volunteers, children aged 4-17.

EXCLUSION CRITERIA:

Pregnant women.

Subjects with implanted devices: pacemakers, medication pumps or defibrillators.

Subjects with metal in the cranium except the mouth.

Subjects with intracardiac lines.

Normal subjects with history of seizures.
CBD for Dental Pain

The purpose of this study is to evaulate CBD as a therapeutic approach for dental pain. Eligible subjects presented with emergency dental pain will be give a single dose of Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms and psychologic effects.

CBD is a non-psychoactive, non-addictive compound of cannabis that has shown analgesic and anti-inflammatory properties. Epidiolex is the only FDA-approved oral CBD solution and will be the drug of choice in this study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-75 years old, ASA I or II
* permanent tooth with moderate to severe odontogenic pain, i.e. ≥30 on a 100mm VAS,
* clinical pulpal diagnosis of irreversible pulpitis or pulpal necrosis, and periapical diagnosis of symptomatic apical periodontitis
* test negative for recent cannabis use and/or other drugs of abuse including alcohol (urine tests collected at screening visit), and participant
* able to understand the forms (English or Spanish) and provide informed written consent.

Exclusion Criteria:

* ASA Class III or IV
* patients with hepatic impairment
* pregnant or lactating women
* Patients on drugs metabolized by enzymes that also metabolize CBD (e.g. clobazam, diazepam, topiramate, warfarin)
* self-reported prior experience inhaling cannabis (either via smoking or vaporization), use of opioids in the month prior to screening/treatment visit, and/or NSAIDS or acetaminophen 6 hours prior to treatment
* unwilling to participate.
Preoxygenation for Difficult Airway Management

Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation

This study will be designed as followed: Patients will be randomized in 2 groups:

* Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation.
* Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of aged and over
* And anticipated difficult intubation
* And requiring a rapid sequence induction for laryngoscopic intubation
* Or requiring a fiberoptic intubation

Exclusion Criteria:

* BMI \> 35
* Pulse oxymetry \< 90% in ambient air
* Haemodynamic instability
* Pregnancy
* Protected adult
* Lack of consent
* Patient already enrolled in another randomized study looking forward improving preoxygenation quality.
Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

The purpose of this study is to measure the effects of LiQ-NOL supplementation on language production using the Clinical Evaluation of Language Fundamentals test, language sampling using the mean length of utterance test, and speech articulation using the Goldman-Fristoe Test of Articulation.

This is a randomized, double-blind, placebo-controlled clinical study of CoQ efficacy in a crossover design. Patients will be screened, enrolled, and studied in the outpatient clinic of the Thomas Center for Down Syndrome at CCHMC. All patients will be randomly assigned to either a liquid product (LiQ-NOL®) and an identical placebo liquid. Study drug and placebo will be administered twice a day (morning and evening).

Eligibility Criteria:
Inclusion Criteria:

* Patients ranging from 6.0 years to 16 years of age.
* Patients will have proven Trisomy 21.
* Females, incapable of bearing children or capable of practicing adequate birth control methods. Abstinence will be acceptable.
* Written informed consent will be obtained from parents of all subjects prior to enrollment. Verbal assent will be obtained from all patients with DS who have sufficient decision making ability and are at least 11 years old.

Exclusion Criteria:

* Patients who have insufficient mental and/or motor capacity to complete testing measures.
* Patients less than 6 years or older than 16 years of age.
* Patients receiving CoQ supplementation within one month prior to the study.
* Patients with evidence of disease which may adversely affect CoQ absorption, e.g. chronic diarrhea or inflammatory bowel disease.
* Patients participating in other research studies or having exposure to investigational drugs within one month prior to this study.
* Females, capable of bearing children, who are unsure of their pregnancy status or not practicing adequate birth control methods.
* Females who are pregnant.
* Patients with a known allergy to CoQ.
* Patients receiving drug treatment which is know to affect CoQ, e.g. cholesterol-lowering drugs such as "statins".
Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma.

Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status.

Exclusion Criteria:

* Brain mets
A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment

A post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer treated with Erbitux as final evaluable cases.


Eligibility Criteria:
Inclusion Criteria:

* EGFR expressing, KRAS wild-type subjects with metastatic colorectal cancer, who are indicated for Erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy)

Exclusion Criteria:

* Subjects who are not eligible for Erbitux treatment according to the indication in national label; or with hypersensitivity reactions (grade 3 or 4) to Erbitux
LOXL1 Polymorphism in Pseudoexfoliation Syndrome

To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene were analyzed by direct sequencing.

To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, peripheral blood sampling will be done from the patients with pseudoexfoliation.

And genotypes of the three single nucleotide polymorphisms of lysyl oxidase-like 1 gene , rs1048661, rs3825942, rs2165241 were analyzed by direct sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Pseudoexfoliation

Exclusion Criteria:

* medical condition that peripheral blood sampling cannot be done
Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain

Anterior Knee Pain (AKP) is a common condition that can be challenging to treat effectively. The main goal of treatment regimens is to improve the function of the knee. However, treatment can be challenging due to the knee pain experience. Cingal™ contains hyaluronic acid (HA), which acts as a joint lubricant, and the corticosteroid triamcinolone hexacetonide (TH). Some studies have shown that Cingal™ can improve joint function and provide short-term pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 35 years
* Standard weight-bearing AP and skyline view knee x-rays
* Retropatellar or peripatellar knee pain for a minimum of 2 months
* Confirmed diagnosis of AKP that has failed to improve with a minimum of 6 weeks of conservative treatment (activity modification, supervised physiotherapy, exercise therapy, taping or bracing, NSAIDS)
* Pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion.

Exclusion Criteria:

* X-ray evidence of knee osteoarthritis or fracture
* Meniscal or ligamentous injury assessed or suspected on clinical examination
* Previous knee surgery
* History of patellar instability
* Any contraindication to knee injection (overlying skin condition, joint infection, significant joint effusion, coagulopathy, previous adverse reaction, etc.)
* Known allergy to Cingal™ or its constituents
* Previous knee injection within the last 3 months
* BMI greater than 30 kg/m2
* Diabetes, inflammatory conditions (rheumatologic disease, ankylosing spondylitis), or concurrent medical conditions which may result in chronic pain or altered pain sensation
* Pregnant or breastfeeding
* Workers Compensation Board case
* Patient involved in litigation
Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.

The objectives are:

* to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
* to investigate if these effects are related to the volunteers individual pain sensitivity

Please refer to:

Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 \[doi\];jpr-6-023 \[pii\].

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* adequate psychomotor performance to perform pain tests
* pain-sensitive or pain-nonsensitive according to prespecified criteria

Exclusion Criteria:

* known allergy to morphine or buprenorphine
* prior adverse experiences with opioids
* history of abuse
* females not taking P-pills
* skin lesions on the test-sites
* suffering from chronic pain
* medication with analgesics
* BMI \> 28
* smoker
Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function

To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.


Eligibility Criteria:
Inclusion Criteria:

* Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery
* Women who had undergone pelvic reconstruction surgeries in our hospital

Exclusion Criteria:

* Pregnant woman.