cyrilzakka/clinical-trials huggingface dataset:
Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study

Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice.

This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated.

Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed.

Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Being a patient at a specialist outpatient clinic treating these patient groups
* Insomnia disorder or sleep problems of insomnia type
* Over 10 points on the Insomnia Severity Index (ISI)
* Adequate skills in written and spoken Swedish
* No practical barriers to participate in the group treatment

Exclusion Criteria:

* night shift work
* ongoing alcohol or drug abuse that required treatment at a specialised unit
Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine


Eligibility Criteria:
Inclusion Criteria:

* Subjects 19 to 55 years of age
* Written informed consent
* Available for all visits and telephone calls scheduled for the study

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitidis
* Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
* Serious acute, chronic or progressive disease as determined by investigator
* History of alcohol or substance abuse
Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 8-35 years old
2. Body weight \> 36 Kg
3. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria
4. Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
5. Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug
6. Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
7. Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies at screening:

   * Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
   * Glutamic acid decarboxylase (GAD) autoantibodies, or
   * Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive).

Exclusion Criteria:

1. Prior administration of a monoclonal antibody-within the 1 year before randomization
2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
4. Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
5. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
6. Current treatment with oral antidiabetic agents
7. Evidence of active or latent tuberculosis
8. Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 of the study.

   * Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle.
   * Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
9. Any infectious mononucleosis-like illness within the 6 months before randomization
Metabolic Control and Patient Well-being in Phenylketonuria: do Guidelines Make a Difference?

Treatment of PKU implies for most patients that with strict adherence to dietary treatment they can achieve excellent neurocognitive outcome. Dietary treatment, though, is hard to comply to every day and with every single meal. Unsurprisingly, health-related quality of life (HrQol) is negatively affected if patients have to follow a dietary regime of this kind. Adherence to treatment in PKU is very variable. Factors of significant impact on adherence to treatment and well-being in chronic disease such as self-efficacy or parenting stress have not yet been widely investigated in PKU patients.

The ideal treatment prescription (and guideline) recommends as much as necessary and as little as possible, based on the best evidence available. Patients should neither be deprived of treatment options nor be exposed to overtreatment.

This study investigates adherence, metabolic control, HrQol in PKU patients treated by centres which follow different guidelines


Eligibility Criteria:
Inclusion Criteria:- Patients with PKU from age 10 years requiring dietary and / or pharmacological treatment according to locally applied guidelines

* Parents of patients with PKU aged 10 to 18 years requiring dietary and / or pharmacological treatment according to locally applied guidelines
* Ability and willingness to answer the questionnaires and follow the study procedures
* Informed consent as documented by signature

Exclusion criteria for patients and parents :

* Inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status
* Pregnant patients or patients who have disclosed to their physician that they are planning a pregnancy in the near future
* Hyperphenylalaninaemia or mild forms of PKU or other inborn errors associated with elevated Phe but not requiring dietary and / or pharmacological treatment according to locally applied guidelines
* No inform
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for CI surgery according to clinical routine
* Subjects who will receive a cochlear implant
* Signed and dated informed consent form

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Age under 18 years
* Pregnancy
* Distance of the planned trajectory to the facial nerve is \< 0.4 mm as per screening CT scan
* Distance of the planned trajectory to the chorda tympani is \< 0.3 mm as per screening CT scan
* A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
* Individuals where image guidance or robotic procedures are not indicated
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients

This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adults 21-79
* Body mass index (BMI) of 30-40 kg/m2
* Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of \> 6.4% and/or fasting plasma glucose of \>125 mg/dL or current anti-diabetic medication)
* AA-induced platelet aggregation response of \>60% within 3 hours prior to initial dose of study drug administration

Exclusion Criteria:

* Contraindications to aspirin
* Previous history of vascular disease
* Patient requires insulin
* Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization
Comparison of Ease of Use and Acceptability of Intranasal and Injectable Glucagon Among Providers Administering it to Children or Adolescents With Type 1 Diabetes (BETTER-ING)

Background : The benefits of good glycemic control are clearly established. However, achieving glycemic targets comes at the expense of the risk of hypoglycemia. Repeated episodes of severe hypoglycemia can affect long-term cognitive function, especially in developing brains. Fear of hypoglycemia, both in children and their parents, has an impact on participation in physical activity, quality of life and optimal diabetes control. During an episode of severe hypoglycemia, i.e., when accompanied by severe cognitive dysfunction requiring assistance from others, it is impossible to administer oral glucose. Glucagon administration is particularly useful in this situation, as it rapidly raises blood glucose levels and restores consciousness. Injectable glucagon was the only form approved in Canada prior to 2019. A new formulation of glucagon for intranasal administration has recently been approved by Health Canada. The arrival of this formulation seems promising because of its ease of use while ensuring similar efficacy to injectable glucagon. Furthermore, the ease of learning how to use each of the devices through a simple multimedia tool is unknown. Indeed, current studies have not focused on a virtual teaching method. The latter is of particular interest in the context of a pandemic and in order to make information more accessible to a broader population that may not be present at family glucagon education (e.g., school-based caregivers).

Objective : Compare the performance (time to prepare and administer, success rate) of the intranasal versus injectable glucagon administration procedure after a short video training 3 months earlier among parents/primary caregivers and school workers who may administer glucagon to children with type 1 diabetes.

Secondary objectives :

1. To assess stakeholder administration procedure preferences for the two glucagon formulations in the two groups ;
2. To explore the barriers and emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups;
3. Explore the participants' preferences in relation to the teaching method of administering the two forms of glucagon.


Eligibility Criteria:
Inclusion Criteria:

* Parent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes OR
* Any adult who works or will work in a school or daycare setting who is likely to administer glucagon to a child or adolescent with type 1 diabetes (e.g. teachers, animators, teacher candidates, etc.) AND
* Legal age
* Able to participate

Exclusion Criteria:

* Working in the health field and teach glucagon injection or use it regularly in their duties
* Not understanding French (for viewing the videos)
Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)

After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade).

After the KFDA approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade). We will collect the response rate according to the EMBT (European Group for Blood and Marrow Transplant; a non-profit organization based in the Netherlands that promotes the transplantation of haemopoietic stem cells from all donor sources and donor types and related basic and clinical research, education, standardization, quality control, and accreditation for transplant procedures) or IMWG (the International Myeloma Working Group) criteria and the adverse events to assess the efficacy and safety. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma

Exclusion Criteria:

* Patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity
* Patients with severe hepatic impairment
* Pregnant women
Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment

Background:

Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.

Primary aims

- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.

Secondary aims

* To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
* To create a database in order to record clinical and biological follow-up data
* To create a research biobank for future research projects

Multicentric study: HUG, CHUV, UKBB


Eligibility Criteria:
Inclusion Criteria:

* Prepubertal patients aged 3 months and older
* Peri and pubertal patients after failure of sperm cryopreservation
* Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
* Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

Exclusion Criteria:

* Patients under the age of 3 months
* Refusal of the patient and/or his parents
* Treatments that are not highly gonadotoxic
A Study of Lanabecestat (LY3314814) in Healthy Participants

The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the body absorbs the new tablet formulation will also be evaluated. In addition any side effects of the study drug using both the new and current tablet formulations will be evaluated. The study will last about 22 days, with screening required within 30 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

- Male participants: Will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product

- Female participants: Women not of childbearing potential due to surgical sterilization or confirmed by medical history or menopause

- Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by the food restrictions throughout the study

Exclusion Criteria:

* Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
* Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* History of previous or ongoing psychiatric disease/condition
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study, or have a history of significant dysrhythmias or atrioventricular (AV) block (including first degree AV block). Participants with history of persistent PR interval greater than (\>)200 milliseconds (msec) will be excluded
* Have prolonged Fridericia-corrected QT interval (QTcF) of \>470 msec
* Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Are unwilling to comply with the dietary requirements/restrictions during the study
* Evidence of active renal disease (e.g, diabetic renal disease, polycystic kidney disease) or calculated creatinine clearance \<50 milliliters per minute (mL/min)
Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

Exclusion Criteria:

1. Sex and Reproductive Status:

   1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
   2. Women who are pregnant or breastfeeding
   3. Women with a positive pregnancy test at screening or prior to study drug administration
2. Prohibited Medications:

   1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
   2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
   3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
   4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
   5. Subjects taking a prohibited medication as defined per protocol
Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones

This study aims to compare the overall rate of endoscopic clearance of complicated bile duct stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic lithotripsy versus conventional BML.

Currently, complicated bile duct stones are removed during endoscopic retrograde cholangiopancreatography (ERCP) by conventional mechanical lithotripsy, which means using a metal wire basket to capture the stone and crush it to make it easier to remove. This is successful in approximately 70% of patients, with the success rate inversely correlated to the size of the stone. Unsuccessful stone removal would require additional endoscopic, percutaneous or surgical interventions. Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy is a recent alternate method for managing complicated bile duct stones. Also performed during ERCP, a thin flexible camera (called Spyglass DS peroral cholangioscope) is inserted into the bile duct to visualize the stone which can then be targeted by a laser beam for fragmentation (also known as laser lithotripsy). The smaller pieces are then removed. Direct comparisons of these procedures' efficacy however have not been performed.

The purpose of this study is to compare the efficacy and safety of Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy (the laser arm) versus conventional basket mechanical lithotripsy alone (the conventional arm) for fragmentation and clearance of complicated bile duct stones.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complicated biliary stones
* Patients older than 18 years old
* Patients where informed consent can be obtained

Exclusion Criteria:

* Patients who cannot give informed consent
* Patients under 18 years old
* Pregnant or lactating patients
* Patient with altered gastrointestinal/biliary anatomy
* Patients with distal CBD malignant stricture from intrinsic or extrinsic causes
* Patients with ongoing cholangitis or biliary pancreatitis
* Patient with refractory bleeding tendencies (Platelet count \<50,000/mm3 or International Normalized Ratio \>1.5 despite correction with platelet or fresh frozen plasma transfusions)
* Patients with intrahepatic segmental stones
* Patients with contraindications to endoscopy due to comorbidities