cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)

This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up period.

This is an outpatient study in people who currently suffer a minimum of 2 migraines per month. During the study, participants will be instructed to use no more than 2 doses of the study drug INP104 within a 24-hour period, or 3 doses in a 7-day period. Participants will self-administer INP104 nasally and record their migraines in an eDiary.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of migraine with or without aura, with at least 2 attacks per month for the previous 6 months.
* Participants must be in good general health, with no significant medical history (excluding migraine).
* Participants must have the ability and willingness to attend the necessary visits at the study center.
* Participants must be able to provide the written informed consent prior to entry into the study.
* Women of childbearing potential must agree to use adequate contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose fo the study drug.
* Male participants and their partners must agree to use effective contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose of the study drug. Male participants should also refrain from sperm donation for 30 days after study completion.

Exclusion Criteria:

* Subjects with trigeminal autonomic cephalalgias (including cluster headache, hemicrania syndromes and short-lasting unilateral, neuralgiform headache attacks with conjunctival injection and tearing), hemiplegic migraine, or migraine with brainstem aura (previously referred to as basilar migraines).
* Subjects with chronic migraines, medication overuse headache or other chronic headache syndromes.
* Subjects with ischemic heart disease or subjects with clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina.
* Subjects with significant risk factors for coronary artery disease (CAD) including current use of nicotine-containing products, medical history of diabetes, uncontrolled hypertension (high blood pressure), known peripheral arterial disease, Raynaud's phenomenon, sepsis or vascular surgery (within 3 months prior to study start), or severely impaired hepatic or renal (kidney) function.
* Subjects with recurrent sinusitis or epistaxis.
* Subjects with a history or presence of alcoholism or drug abuse within 2 years prior to first study drug administration.
* Women who are pregnant, or planning to get pregnant, or who are lactating while participating in the study.
* Use of any medications prohibited by protocol.
* Use of \>12 days per month of triptan or ergot-based medication in the 2 months prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.
Investigating Stress-Induced Dopamine Release: a fMRI-PET Study

The stress response is mediated by the activation of the hypothalamo-pituitary-adrenal axis and the sympathetic nervous system, leading to glucocorticoid and catecholamines release respectively. This stress response is regulated by feedback loops, involving cortical and subcortical structures.

Non-invasive brain stimulation applied over the dorsolateral prefrontal cortex modulates the subcortical dopaminergic transmission at rest and can reduce the hormonal and cognitive alterations induced by stress. This study aims to investigate the Non-invasive brain stimulation -induced modulation of dopamine transmission in an acute stress situation.

Objective: to investigate the influence of Dorsolateral Prefrontal Cortex stimulation during acute stress on the subcortical dopamine transmission in healthy subjects.

Method: 30 healthy subjects will be enrolled and randomized into 2 parallel groups. 15 participants will receive active Transcranial direct current stimulation , the other 15 participants will receive sham Transcranial direct current stimulation.

Transcranial direct current stimulation procedure: active Transcranial direct current stimulation corresponds to 30min of stimulation at 1mA intensity . The sham stimulation corresponds to 30s of real stimulation.

Stress paradigm: In order to induce moderate stress in humans in laboratory condition, the investigators will use the Maastricht Acute Stress test . This test is a combination between physical, hand immersion in cold water and cognitive calculation stress. The test will start 5 minutes after the beginning of stimulation session.

Stress measures: the stress response will be evaluated at the following levels:

* Neurochemical level: dopamine transmission measured with positron emission tomography
* Functional brain connectivity: resting-state networks measured with functional magnetic resonance imaging
* Hormonal level: adrenocorticotropic hormone and cortisol levels measured with blood samples
* Cognitive level: decision-making and memory assessed with delay-discounting task and reality-monitoring task, respectively
* Molecular level: expression of genes involved in the glucocorticoid receptor signaling pathway measured through blood samples Exploratory measure: Brain-Derived Neurotrophic Factor and cytoplasmic catechol-O-methyltransferase polymorphisms of participants involved in differential Transcranial direct current stimulation response will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* - Men and women aged between 18- and 30-year-old
* Non-smoker
* Non-psychotropic user

Exclusion Criteria:

* - Have a psychiatric or somatic disorder
* Have a first-degree family history of a psychiatric disorder
* Pregnant or nursing women
* Be on medication, with the exception of oral contraceptives
* Contraindications to tDCS or MRI examination
* Participants with pacemaker or cardiac or cerebral implant
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

The purpose of the study is to assess the safety and efficacy of an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.

The study is being conducted in order to obtain safety and efficacy data for an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis. The subjects will be randomized to either U0279 or placebo after having been on an injectable biologic for 12 weeks previously. The subject will be on study medication for 12 weeks. The subjects must have moderate to severe Psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age or older.
* Surgically sterile females. Females who have had a hysterectomy or completed menopause are allowed.
* Affected Body Surface Area with psoriasis of ≥10%.
* Psoriasis Global Assessment rating of "moderate to severe" or "severe".
* Achieved mild to moderate improvement after receiving an injectable biologic therapy for at least 12 weeks.
* A PASI score of ≥ 50 and ≤75
* Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed

Exclusion Criteria:

* Understand that the sponsor can not pay for the an injectable biologic therapy during the course of the study; be willing to pay out of pocket or secure payment through their private health insurance for an injectable biologic.
* History of systemic infection, or other conditions that may interfere with study evaluations or may increase risk for participation. such as, tuberculosis, human immunodeficiency virus (HIV), hepatitis; congestive heart failure or demyelinating disorder.
* Used of prohibited medications or therapies
Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder

The study aims to systematically document the course of REM sleep behavior disorder (RBD) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. Participants will be clinically evaluated and 2 imaging procedures will be done.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
2. Written informed consent

Exclusion Criteria:

1. Known diagnosis of PD or other neurodegenerative disorder
2. Unequivocal signs of parkinsonism on examination
3. Narcolepsy or other known causes of RBD
4. Moderate to severe obstructive sleep apnea
5. Abnormal neurological or MRI examination
Home Phototherapy for Term Newborns With Icterus

The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. The investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc.

Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.

Background: Almost half of all newborns develops jaundice, due to elevated levels of bilirubin. If levels are high phototherapy is needed to reduce the levels of bilirubin. Presently most children with neonatal jaundice in Sweden receives phototherapy admitted to hospital. There is fiberoptic equipment available that can be used at home to treat the newborns.

Aim: Primary aim is to investigate if parent-child bonding is improved with home phototherapy compared to phototherapy performed at the hospital.

Method:The study is designed as a randomised controlled multicenter study. Eligible parents and newborns are randomised to either treatment at home or at the hospital. Demographic data about the newborn such as for example apgar score, gender, time of birth etc are registered. At time of discharge parents answers questionnaires such as for example the Postpartum Bonding Questionnaire (PBQ), the Edinburgh Postnatal Depression Scale (EDPS), the Swedish Parenthood Stress Questionnaire etc. Parents experiences from home phototherapy will also be investigated through semistructured interviews.

Parents will asked to answer questionnaires at the time of discharge as well as at 4-months after discharge.

Analysis of data will be performed by using conventional parametric and non-parametric statistical methods.

The results of the study will be reported as scientific articles and as part of a thesis.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age w36-42.
* Age of newborn 48 hours or more.
* Level of bilirubin 300-400 µmol/l

Exclusion Criteria:

* Immunisation. Bilirubin \>400 µmol/l. Asphyxia. Ongoing infection, weightloss \> 10%, other severe disease, parents who don´t speak Swedish, parents that are not expected to be able to handle the home phototherapy equipment
Survey of Blood Transfusion Practices in Critically Ill Patients at High Altitude

The purpose of this study is to describe current practice on red blood cell transfusion in critically ill patients of intensive care units located in high altitude areas

Anemia has been identified as a common complication in the critically ill patient. Approximately 40 and 60% are transfused in normal clinical practice. However transfusions are not free of adverse events including: transfusion-associated lung injury, infectious complications, progression of organ failure, fluid overload associated with transfusion, among others. Therefore, several clinical trials have been designed to define red blood cell transfusion thresholds. Mainly two groups have been compared: 1) liberal schemes in which patients are transfused with higher levels of hemoglobin (generally ≤ 10 g / dL) and restrictive regimens with lower levels (≤ 7 g / dL). Institutions such as the British Committee for Standards in Hematology have developed recommendations in favor of restrictive strategies based mainly on the TRICC (Transfusion Requirements In Critical Care) study conducted by Hebert et al.

On the other hand, it is well known that as consequences of living in places at high altitude physiological modifications occur in the human. One of these adaptations is the increase in hemoglobin levels occurring in people living at high altitude, especially in Andean residents, in whom the hypoxia promotes an increase in the production of red blood cells.

The recommendation of the restrictive strategy in the transfusion of red blood cells has been adopted in several countries with numerous populations living at high altitudes, although this practice has not been evaluated in these patients.

The purpose of this study is to describe the current practice on transfusion of red blood cells in critical patients treated in intensive care units located in high altitude areas (over 1500 m) to determine whether physicians follow the recommendations of restrictive strategies.

This is an observational, non-randomized, cross-sectional survey performed with intensivists of Bolivia, Colombia, Ecuador, México and Perú. The data will be collected from an on-line scenaries based survey. The survey is designated to assessed the effect of severity, need of surgery, severe hypoxia, and alteration in tisular perfusion as modifiers of transfusion thresholds. Besides unit characteristics as geographical altitude and type of unit will be collected.

Eligibility Criteria:
Inclusion Criteria:

Intensivists who work in intensive care units localized above 1500 meters above sea level

Exclusion Criteria:

* fellows, retired members and pediatrics intensivists
The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

The purpose of this study was to compare the treatment effectiveness of three different methods for posterior semicircular canal benign paroxysmal positional vertigo. The included methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.

This study was a prospective, double blinded, randomized, multicenter clinical trial. The enrolled posterior semicircular canal benign paroxysmal positional vertigo patients were randomized to one of the three treatment regimens when they are diagnosed with the Dix-Hallpike test. An then the patient was treated with one of the three maneuvers. After 20 minutes, the patient was examined with the Dix-Hallpike test again. The resolution of nystagmus and symptoms were checked. When the nystagmus was sustained, the same treatment was applied once again. And after 20 minutes, the patient was examined with the Dix-Hallpike test too. 1 day after and 7 days after, the patient was re-examined with the Dix-Hallpike test.

Eligibility Criteria:
Inclusion Criteria:

* a symptom of positional vertigo
* rotational and upbeating nystagmus in Dix-Hallpike test
* the nystagmus should be disappear within 60 seconds
* no spontaneous nystagmus

Exclusion Criteria:

* ages under 18 years
* suspicious or verified a central nervous system lesion
* traumatic vertigo patients
* other otologic disease(acute/chronic otitis media, otosclerosis, etc)
* other vestibular disease(vestibular neuronitis, Meniere's disease, etc)
* congenital nystagmus patients
* the patients with spinal disease
* the patients with the limitation of cervical movement
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System

The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.


Eligibility Criteria:
Inclusion Criteria:

* The Subject is at least 18 years of age at screening.
* The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
* The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
* The venous blood sample is collected no later than 12 hours from the time of head injury.
* The Subject is competent and willing to undergo the Informed Consent process

Exclusion Criteria:

* Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
* Time of suspected head injury cannot be determined.
* Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
* Blood transfusion after head injury, and prior to study blood draw
* Blood donation within 1 week of study enrollment.
* The subject is a female who is pregnant or lactating.
* The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation
Endometrial Rejuvenation Study

To evaluate the response of the endometrial lining after subcutaneous administration of the medication AMD3100. This medication mobilizes stem cells and will be used in a population of infertile women with a thin endometrium who are undergoing frozen-thawed embryo transfer. The investigators will assess associations between response to stem cell mobilization and pregnancy outcomes.

This study seeks to help each participant build a better endometrial lining which is suitable to implantation and maintenance of a healthy pregnancy. While animal models demonstrating the effectiveness of stem cell recruitment on improved endometrial thickness and pregnancy outcomes are plentiful, human studies are lacking. The use of stem cells from the peripheral circulation in humans could potentially allow for enhanced endometrial proliferation. The objective of this study is to perform a prospective randomized, controlled trial to evaluate the response of the endometrial lining after subcutaneous administration of AMD3100 (plerixafor). AMD3100 is an immunostimulant used to mobilize hematopoietic stem cells in the bloodstream. This intervention will be studied in a population of infertile women with a thin endometrium who have failed previous embryo transfer cycles and are undergoing a frozen-thawed embryo transfer. This study seeks to evaluate both the endometrial response to stem cell mobilization via AMD3100 as well as pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst.
2. Patients who have previously undergone at least 2 unsuccessful frozen-thawed embryo transfer cycles, defined as failure to achieve a clinical pregnancy (visualization of intrauterine gestational sac on ultrasound) or a cancelled embryo transfer cycle due to inadequate endometrial thickness.
3. Patients with a diagnosis of thin endometrial lining (less than 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle.
4. Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017.

Exclusion Criteria:

1. Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles.
2. Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017.
3. No euploid embryos available for transfer.
4. Mullerian anomalies, excluding arcuate uterus
5. Submucosal fibroids
6. History of uterine surgery, excluding polypectomy, D\&C, and Cesarean section
7. Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
8. Failure of patient to agree to enrollment in study with written consent.
9. History of drug sensitivity or adverse reaction to AMD3100 (plerixafor).
10. Pregnancy
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation

The aim of this randomized controlled trial was to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol.


Eligibility Criteria:
Inclusion Criteria:

Patients belonging to Poseidon group 4

Exclusion Criteria:

* PCOS
* Endometriosis
* History of recurrent abortion
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the long-term safety and efficacy of this drug is not yet clear. This study proposes to follow patients who were enrolled in the RAVE study to determine if treatment with rituximab influences long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in the RAVE trial
2. Completion of RAVE Common Closeout Date visit
3. Informed consent

Exclusion Criteria:

1. Refusal to participate
2. Inability to comply with standard-of-care, including routine clinical visits and testing.
Physical Disability in Patients Treated With Betaferon

To gather Observation data about physical disability progression, safety and adherence during the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24 months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods


Eligibility Criteria:
Inclusion Criteria:

* Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be able to join the study.

Exclusion Criteria:

* Pregnancy
* Patients with a history of hypersensitivity to natural or recombinant interferon-beta, human albumin or to any of the excipients
* Patients with a history of severe depressive disorders and/or suicidal ideation
* Patient with decompensated liver disease
* Patient with epilepsy not adequately controlled by treatment
The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance

The purpose of this project is to provide further insights into the neurophysiology behind the MF-induced impairment in endurance performance. The aim is to perform a randomized controlled trial in which we partly replicate studies of Marcora et al. (2009) and Bigliassi et al. (2017), while extensively monitoring brain activity during the entire protocol (i.e. both cognitive and physical tasks) by using EEG.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological or cardiovascular disorders)
* Male or female
* No medication
* Non-smoker
* Between 18 and 35 years old
* Recreational athlete population (performance level 2 or 3 for men according to De Pauw et al. (2013) and performance level 2 or 3 for woman according to Decroix et al. (2016)

Exclusion Criteria:

* Injuries over the last 6 months
* Suffering from any cardiovascular condition
* Use of medication
* Suffering from other health conditions at the time of testing
* Use of caffeine or alcohol 24 hours prior to each trial
* Heavy efforts 24 hours prior to each trial