cyrilzakka/clinical-trials huggingface dataset:
Abortive Effect of an Ear Insufflator on Migraine

Evaluate the effectiveness of air insufflation in aborting (stopping) an acute episode of migraine and compare it with a placebo effect of using the same procedure but without active insufflation. The insufflation will be used when the subject is experiencing an acute episode of migraine to determine its ability to reduce, if not to completely eliminate the migraine symptoms. Subjects receiving the placebo treatment will be offered the active treatment during the subsequent episode of migraine.

Each patient will be asked (using a questionnaire) to describe the nature of their presenting symptoms including distribution pattern, symmetry, laterality, severity and associated symptoms. Severity of migraine/headache will be recorded. The patient's description of their symptoms will be used to guide the treatment process in terms of treatment time and side (i.e. left or right ear). A tubular soft silicone ear-plug will be inserted into the patient's ear on the side of greatest reported severity. In the absence of clear laterality with respect to severity, the side associated with the greatest surface area of involvement will be selected (e.g., the patient has a bilateral headache but on the left, it is perceived as retro-orbital whereas on the right it is retro-orbital and temporal, therefore the right side will be selected), In the absence of lateralizing features, the initial treatment side will be randomly selected. Then the air insufflation will start. The patient will be encouraged to relax during the process and the extent of the insufflation will be maintained a level that is comfortable for the patient. The patient will be asked to report any sense of aggravation of their symptoms, which would prompt the examiner to suspend the treatment. The patient will not know if the treatment received is the active or the placebo one.

Following insufflation, the ear plug will be removed and the patient will be asked to rate the severity of their symptoms and describe any changes in characteristics. A significant reduction in pain level will be considered an indication that the treatment is appropriate for that patient and the treatment will then continue on the ipsilateral side. If the patients will describe resolution of their symptoms in a hemi-distribution of the head ("the symptoms are gone from this side of my head but they're still left on the other side"), the treatment process will be repeated on the contralateral side until resolution (or maximal reduction in symptoms) will be achieved. Treatment session in this study will last 20 minutes.

There will be a followup at 2h and 24h post treatment to monitor the status of the patient and they will all be invited back for a second treatmentduring the subsequent episode of migraine.

Vitals (blood pressure, heart rate, pulse oxygenation and temperature) will also be monitored to see if there are any changes before and immediately after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects suffering from acute migraine episodes
* Possibly located in the Phoenix, AZ area

Exclusion Criteria:

* Pregnant/nursing women
EUS for Gastrointestinal Disorders: a Registry

The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the management of gastrointestinal disease. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective registry study.


Eligibility Criteria:
Inclusion Criteria:

* All patients submitted to EUS,
* Informed consent.

Exclusion Criteria:

* Age less than 18 y
* Patient who did not give the consent to the processing of personal data.
Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.

Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast cancer will undergo standard diagnostic procedure. Concurrently these patients will have additional FNA fluid tested using the portable novel nanosensor-based device (CEM). Diagnosis made from standard anatomic pathology, flow cytometry, and/or cytology will be compared with the diagnosis made using the CEM platform. Assessment of the feasibility and acceptability of the CEM platform will be performed. Assessment of training requirements for CEM platform will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Botswana citizen
* Age 18 years or older
* Able and willing to provide informed consent
* Undergoing diagnostic procedure for palpable abnormality (biopsy, node/mass resection, or fine-needle aspirate) for diagnosis of possible lymphoid malignancy or breast cancer

Exclusion Criteria:

* Involuntary incarceration (prison, jail, etc.)
* Procedures involving internal organs or locations expected to have elevated risk of complication
* Increased risk for severe bleeding as defined as known hemophilia or other bleeding disorder, use of anticoagulants in past week (not including aspirin or other NSAIDS), advanced liver disease, or other condition determined by clinician to significantly increase bleeding risk of procedure
* Known pregnancy
* Critical illness as defined by current intensive care admission, hypotension (systolic BP\<100mmHg), hypoxemia (O2 saturation \<94% on room air), or other condition determined by clinician to significantly decrease physiologic tolerance of procedure
* Other condition felt by the clinician performing procedure to significantly increase risk of procedure
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children

The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Newborn

Exclusion Criteria:

* Syndromes
Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery

Comparing 2 different anaesthetic methods during abdominal aortic aneurysm surgery. The patients will be followed up 30 days postoperative. Number of patients included will be 200. Perioperative details will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned for open, elective abdominal aortic aneurysm surgery.
* ASA group 1-4.

Exclusion Criteria:

* Patients below 18 years.
* Patients who are included in other pharmaceutical studies.
* Opioids-, benzodiazepins-, antiepileptic drugs-, alcohol- and α2-agonists abuse.
* Pregnant and breastfeeding women.
* Patients with familiar history of malignant hyperthermia.
* Patients with known hypersensitivity for opioids, propofol or volative anaesthetics.
* Patients with considerable arrythmia (atrial fibrillation /atrial flutter is acceptable). Uncontrolled hypertension, serious psychiatric disease.
* Patients with unstable angina pectoris or myocardial infarction last month before inclusion.
* Acute abdominal aortic surgery. Acute dissection or rupture.
* Planned laparoscopic abdominal aortic aneurysm surgery.
Second Line Chemotherapy for Advanced Pancreatic Cancer

No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen.

Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy.

An exploratory study in this setting seem warranted.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent prior to beginning protocol specific procedures
* Previous chemotherapy with Gemcitabine plus or less Platinoids
* Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
* Male or female less than 75 years of age
* Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced (non-resectable) or metastatic pancreatic cancer
* Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
* ECOG performance status 0 to 1 at study entry
* Life expectancy: more than 3 months
* Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
* Bilirubin level either normal or less than 1.5 x ULN
* ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
* Serum creatinine less than 1.5 x ULN
* Amylase normal or less than 1.5 ULN
* Effective contraception for both male and female patients if the risk of conception exists
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial

Exclusion Criteria:

* Brain metastases
* Previous treatment with irinotecan or fluoropyrimidines
* Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
* Significant gastrointestinal abnormalities
* Gilbert's Syndrome
* Any uncontrolled infections
* Known HIV infection
* Radiotherapy within 4 weeks prior to study entry
* Any investigational agents 4 weeks prior to entry
* Known grade 3 or 4 allergic reaction to any of the components of the treatment
* Known drug abuse or alcohol abuse
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
* Women who are pregnant or breastfeeding
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
* Legal incapacity or limited legal capacity
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years
* Have undergone the TIF procedure within the past 2 years
* History of daily proton pump inhibitor (PPI) use for \>6 months
* Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
* Deteriorated gastroesophageal junction (Hill grade II or III)
* Availability for a follow-up visit at 6,12 or 24 months
* Willingly and cognitively signed informed consent

Exclusion Criteria:

* Procedure not completed or performed following a non-standardized TIF protocol
* Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
* Pregnancy
* Enrollment in another device or drug study that may confound the results
Virtual Reality Exposure in Spider Phobia

While knowledge on the neurobiological signatures of fear and anxiety disorders and, in particular, their association with treatment outcome is accumulating, clinical translation still awaits empirical proof of evidence. Exposure-based cognitive-behavioral therapy (CBT) is a first-line treatment, but clinically significant change is only seen in approx. 50-65% of patients. Patient stratification is a powerful option to increase treatment response; however, developing prognostic markers suitable for single-patient predictions still is in its infancy and crucially requires external cross-validation embedded within an a priori prediction approach - a procedure yet largely missing in the field of biomarker research. Employing a bicentric strategy the aim of this study is to test the hypothesis that a priori prediction of treatment outcome based on neurobiological measures is possible in a second, independent sample. Building upon findings from previous mechanistic studies, These will be incorporated into the development of a predictive pattern comprising fear-relevant genotypes and molecules targeting neuropeptides, related epigenetic signatures as well as neurofunctional activation patterns associated with fear circuitry functions, and clinical data. Pre-treatment neurobiological signatures will be tested for their potential as a predictive response marker towards behavioral exposure (virtual reality exposure treatment (VRET) and an in vivo behavioral avoidance test) in a model disorder of fear circuitry dysfunctions (spider phobia). Multivariate pattern analyses employing a machine learning framework will be used to generate predictions on the individual patient level and to cross-validate markers in a second, independent sample. While at site A predictions will be generated following completion of the treatment, response will be predicted at site B a priori, but in a double-blind manner. Comparison of observed vs. predicted response rates will serve as a test of hypothesis. In addition, neuroplastic (on a subsample) and epigenetic changes induced by VRET treatment will be assessed following treatment and, in case of epigenetics, also after 6-months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* specific phobia (animal subtype: spider phobia) according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-5)
* right-handedness
* Caucasian descent
* willingness to participate in massed exposure

Exclusion Criteria:

* patients exhibiting a primary other anxiety disorder (panic disorder, agoraphobia, social phobia, generalized anxiety disorder), acute suicidality, psychotic, bipolar I, obsessive-compulsive disorder, posttraumatic stress disorder, severe major depression, borderline personality disorder or substance dependency (except nicotine)
* patients fulfilling MRI-related exclusion criteria
* patients with current pharmacological or psychotherapeutic treatment, as well as those already previously treated with exposure-based CBT
* pregnancy or lactation
Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants

This is a randomized, Phase I, open-label, single-dose study to evaluate the PK, safety, and tolerability of anifrolumab administered to male and female healthy Chinese participants aged 18 to 55 years. Approximately 24 participants, who fulfill the eligibility criteria, will be administered anifrolumab via SC route or IV route, and participants will be randomized to the two arms in a 1:1 ratio.

The purpose of this study is to evaluate the PK, safety, and tolerability of a single dose of anifrolumab subcutaneously or intravenously administered to healthy Chinese participants aged 18 to 55 years. The primary study endpoints are PK standard endpoints. The secondary study endpoints are standard endpoints for safety assessment, including adverse events, serious adverse events, and clinical safety laboratory measurements. The participants must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.

Eligibility Criteria:
Inclusion Criteria:

* Able to complete the follow-up visit as required by the protocol.
* Participant must be 18 to 55 years of age (both inclusive), at the time of signature of the ICF.
* A body mass index of ≥ 18.5 to ≤ 26.0 kg/m2 and body weight of at least 45 kg for females and 50 kg for males at screening.
* Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

* History of malignancy with some exceptions
* History of alcohol or drug abuse within the past 2 years.
* Any significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
Multimodal Investigation of Post COVID-19 in Females

The purpose of this study is to investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers experience "brain fog".

Long COVID is a post-viral illness estimated to affect 10-30% of COVID-19 patients. Post-COVID symptoms can last for months and affect multiple organs. Major risk factors of long COVID include the female sex and pre-existing anxiety/depression. Because women already have higher rates of anxiety/depression, the combined risks could exacerbate their susceptibility.

Based on the rationale that long COVID symptoms significantly overlap with functions of the vagus nerve, which serves as a conduit between the brain and body, the investigators propose to use non-invasive transcutaneous vagus nerve stimulation (t-VNS) as a novel treatment for long COVID in 20 female participants.

This pilot study will utilize a holistic approach by integrating neuromodulation, neuroimaging, genetics, blood biomarkers, behavioral assessments, and wearable technology to examine the effects of VNS therapy on post COVID-19 symptoms and to identify factors that influence susceptibility and recovery, particularly in the cognitive domain, as over 80% of long-haulers report experiencing "brain fog" (i.e., cognitive disruptions).

Eligibility Criteria:
Inclusion Criteria:

* Biologically female at birth and at time of enrollment
* At least 18 years of age or older
* Experiencing persistent symptoms of brain fog/cognitive impairment beyond 3 months of COVID-19 infection that are not explained by an alternative diagnosis

Exclusion Criteria:

* Not t-VNS compatible (e.g. pacemaker implants)
* Not MRI compatible (e.g. metal implants, claustrophobia)
* Currently pregnant
* Long COVID without cognitive impairment
* History of neurological conditions prior to COVID-19 infection
Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury

The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).


Eligibility Criteria:
Inclusion Criteria:

* less than 15 years of age
* evidence of intracranial bleed on CT scan or GCS \<12

Exclusion Criteria:

* No intracranial hemorrhage or
* GCS 13 - 15
A Single Session Community-Based Body Empowerment Session

This present study will examine the effectiveness of a single session, virtually delivered body empowerment program for decreasing participants thin ideal internalization. The intervention asks participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals. Participants will answer questions about thin ideal internalization before and after the program.

A body empowerment program rooted in the psychological theory of cognitive dissonance has been shown to be effective to reduce the value of the thin beauty ideal. This theory proposes that humans are motivated to maintain consistency in their beliefs and actions, and inconsistencies will result in psychological discomfort (or cognitive dissonance). A shift in beliefs or actions is required to resolve this discomfort and maintain consistency. However, the accessibility of this program is lacking. The proposed study will examine the effectiveness of a single session, virtually delivered body empowerment program designed to create cognitive dissonance by asking participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals through a series of interactive activities in a fully virtual, self-paced module. Challenging these ideals (e.g., identifying how ideals represent very narrow identities and are informed by oppressive value systems, stating the psychological costs of trying to change your body to match ideals) theoretically creates cognitive dissonance in those who have internalized the value of pursuing those ideals. This dissonance is resolved through a reduced investment in the ideals and then hypothesized to lead to more positive attitudes about body image, dieting, and other unhealthy weight control behaviors. The program consists of a single 45-minute self paced, interactive, virtual module. Primary assessments will be completed at pre-intervention and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Able to reliably access internet
* Can speak and read English
* Completed the body empowerment program

Exclusion Criteria:

* None
Aggressive Weight Loss Program in Chronic Plaque Psoriasis

Chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. Besides, clinical improvement has been directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic diets are responsible for substantial weight loss and attenuate systemic inflammation to a higher extent than moderately hypocaloric diets. This intervention has been recently demonstrated to restore, after only 4 week, the response to biological therapy in a patient suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic induction phase in a single-arm trial that could provide the rationale for a large randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Stable chronic plaque psoriasis
* Overweight/obese (body mass index \>25 kg/m2)

Exclusion Criteria:

* pregnancy and/or lactation
* insulin-dependent diabetes mellitus
* a psychiatric disorder
* current or previous (\<1 year since last chemo- or radiotherapy) neoplastic disease
* established vascular disease
* recent (6 months), history of diet-induced or unintentional weight loss
* moderate-to-severe heart failure
* arrhythmia or conduction disorder
* renal failure (creatinine \>1.5 mg/dL)
* liver failure (Child-Pugh ≥ A)
* any type of gastrointestinal disease
* moderate-severe hypoalbuminemia (\<3.0 g/dL)
* altered serum electrolytes
* refusal to give written informed consent