cyrilzakka/clinical-trials huggingface dataset:
Smartphone Behavior and Epilepsy Management

In this prospective cohort study smartphone behavior surrounding epileptic seizures will be quantified, using a smartphone app, in order to optimize epilepsy evaluation and treatment

Rationale:

The unpredictability of seizures and the unclear behavioral outcomes are major concerns for people with epilepsy and may surface as increased anxiety about independence. This unpredictability is also a true obstacle in capturing and studying seizure-related neurobehavioral alterations themselves. Also, seizures often impact consciousness and thus may go unnoticed. As a result, subjective seizure diaries are unreliable. Continuous smartphone-based monitoring of behavioral output is a fast-emerging topic and proven fruitful in monitoring other neurological disease states. In the field of epilepsy, these tools are yet to be introduced.

Objective:

The investigators hypothesize that quantifying smartphone behavior will help obtain a detailed and objective behavioral map of seizures that can complement existing subjective seizure diaries and thereby improve the way epilepsy treatments are evaluated in daily practice.

Study design:

A multicentre observational prospective cohort study with at least 3 months follow-up.

Study population:

100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month.

Main study parameters/endpoints:

Change in touchscreen interactions (tapping speed, texting speed, apps used, location, sleep-wake cycles) surrounding reported epileptic seizures.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* clinical diagnosis of refractory focal epilepsy meeting ILAE criteria16, 17
* supported by at least one of the following; (1) interictal EEG with epileptiform discharges, (2) epileptogenic lesion on MRI corresponding to the presumed seizure onset zone, or (3) seizure recorded during a video-EEG
* have a seizure frequency of ≥ 1 per month
* only one seizure type, or in case of multiple seizure types only seizures that correspond to one probable onset zone (e.g. focal and focal to bilateral tonic-clonic seizures)
* have daytime seizures (exclusively or both daytime and night-time seizures)
* mentally competent and with no learning disabilities
* able to keep a seizure diary including time and date (as judged by the treating physician)
* have an Android-operating smartphone
* use their phone with at least 5 distinct smartphone apps at a minimum of 5 days a week

Exclusion Criteria:

* not fulfilling the above mentioned inclusion criteria
AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer

This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
2. ≥18 years old and ≤ 75 years (regardless of sex).
3. ECOG performance status 0-1
4. Life expectancy longer than 3 months.
5. Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC).
6. No prior systemic anti-tumor therapy for metastatic PDAC.
7. Adequate organ function.
8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Exclusion Criteria:

1. Histological or cytological diagnosis of other pathological types.
2. BRCA1/2 or PALB2 mutations.
3. Participating in another clinical research.
4. Active central nervous system (CNS) metastases.
5. Undergoing systemic antiangiogenic therapy.
6. Acute or subacute pancreatitis.
7. Other known malignancies within five years.
8. Active infection requiring systemic therapy.
Quality of Life and Sexual Life in Hemodialysis Patients: Effects of an Intradialytic Exercise Program

The aim of the study is to investigate whether an intradialytic exercise program can improve the quality of life, sexual function, and sexual satisfaction in patients undergoing hemodialysis.

When diagnosed with Chronic Kidney Disease phase 5, patients are dialyzed to remove waste products and toxins from the blood that kidneys can´t longer filter. Although hemodialysis removes most of the toxins and allows health improvement, patients continue reporting a low quality of life and limitations in their functional independence.

Within the context of quality of life, sexuality is an important factor; a high incidence of sexual dysfunctions has been reported among hemodialysis patients. Although poorly addressed, it impacts family and couple relationships, emotions, and mental health.

Exercise interventions improve physical function and quality of life, and since some of the mechanisms involved in exercise are also involved in sexual activity, an exercise intervention could be an effective approach to sexual dysfunctions without the risk and stigma of sexual or drug therapy.

Therefore the study aims to implement an intradialytic exercise program involving aerobic, resistance, and Kegel exercises (specific to the pelvic floor) and determine its effects on quality of life, sexual function, and sexual satisfaction in patients undergoing hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Participants with stage 5 of Chronic Kidney Disease
* Participants that are undergoing hemodialysis for at least 3 months
* Participants between 18 and 70 years old
* Their participation is voluntary and they have signed the informed consent form
* Participants that have medical approval from their nephrologist

Exclusion Criteria:

* Participants with severe cardiovascular damage (NYHA \>3)
* Participants with a high probability of receiving a transplant within 6 months
* Participants with psychiatric or psychological disorders such as severe depression (Beck Index) that can affect their ability to consent or participate in the study
* Participants that perform physical exercise at least 2 times a week for the last 3 months or more
* Participants with bilateral lower limb amputation
* Participants with vascular access located in lower limbs
* Pregnant participants
PBPK Modelling Applied to Acetaminophen Poisoned Obese Children

Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. In practice, clinicians use weight to assess intoxication severity, but depending on the weight chosen (actual weight, lean body weight, ideal weight,..) the severity assessment can change as well as medical care needed. In this context we hypothesize that a PBPK modelling would be helpful to predict toxic dosing in obese population and especially in obese adolescent or children. The primary objective of this study is to collect data related to acetaminophen-poisoned patient with at least one acetaminophen concentration sampling and whose clinical outcome is known in order to refine and validate such a PBPK model.


Eligibility Criteria:
Inclusion Criteria:

* All subjects \>/= 10 year old
* Availability of at least one positive acetaminophen concentration with its associated sampling time
* Known clinical outcome

Exclusion Criteria:

* \< 10 year old
* lack of data-
Acute Application of Pegvisomant and Octreotide in Acromegaly

The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with acromegaly currently on stable pegvisomant therapy
* patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study
* patients must not be co-treated with any other medication for acromegaly

Exclusion Criteria:

* radiotherapy within the last 2 years
* any relevant acute disease
* history of hypersensitivity against any of the used drugs
* pregnancy or lactation
* abnormal baseline findings
ToleroMune Grass Follow on Study

Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately one year after the start of treatment.

Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Eligibility Criteria:
Inclusion Criteria:

* Previously randomised into study TG002, completed all treatment visits and PTC during calendar year 2012.

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to grass allergen
* FEV1 \<80% of predicted.
* Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactive drugs
* Symptoms of a clinically relevant illness
* Subjects who cannot tolerate allergen challenge in the EEC
90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma

This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).

The patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL) are known to have a poor prognosis as like to those with advanced disease. However, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. Defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. We assessed the clinical efficacy and toxicity of 6th R-CHOP chemotherapy and followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky DLBCL.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed CD20+ DLBCL
* Patients with stage I/II
* Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm)
* Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy
* Aged over 18 years
* ECOG performance status 0-2.

Exclusion Criteria:

* Previous history of chemotherapy for diffuse large B cell lymphoma
* Prior myeloablative therapy
* Prior external-beam radiation to \>25% of active bone marrow
* Pregnancy and lactation
* \>25% bone marrow infiltration
* Platelet counts \<100 000/µl, neutrophil counts \<1500/µl
* Children and adolescents under 18 years of age
* Presence of CNS involvement with diffuse large B cell lymphoma
* Positive HIV serology
* Seriously uncontrolled, current infections or other concomitant
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine

This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.

The overall objective of this study is to evaluate the role of gut microbiome in influenza or COVID-19 vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to vaccines.

It is known that patients with IBD have dysbiosis of their gut microbiome and those immunosuppressed may have a lower vaccine response. In this aim, the investigators will evaluate whether differences in microbial diversity predict immune response to the influenza and COVID-19 vaccine.

In this prospective study, immunosuppressed IBD patients will be vaccinated per standard of care and blood will be collected to measure the immune response. A fecal and saliva sample will be collected to characterize the gut microbiome. The investigators hypothesize that reduced richness / alpha-diversity in gut microbiota will correlate with those with a blunted vaccine response.

Eligibility Criteria:
Inclusion Criteria:

* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria
* Currently one of the following groups:

  1. Group A: Anti-TNF Therapy Group

     * Maintenance monotherapy: infliximab (at least every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
     * Combination Therapy: Anti-TNF Combination Therapy Group on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP
  2. Group B: Non-TNG biologic

     * Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
     * Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
     * Risankizumab Therapy: 360mg at least every 8 weeks
  3. Group C: Janus Kinase Therapy

     * Tofacitinib Therapy: at least 5mg PO BID
     * Upadactinib Therapy: at least 15mg PO daily
* Patient has been on stable treatment for IBD for at least three months
* Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.

Exclusion Criteria:

* Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
* Recent oral antibiotics within previous 2 months
Recurrent Collection By Medical Student in General Medicine

The project for the recurrent collection of data from interns in general medicine is a formalized description of the consultations attended by medical students during their outpatient training. This formalization uses the International Classification of Primary Care. This project aims to create a research network between general medical interns, mainly for their thesis, which pools their observations in a database accessible to all participants.


Eligibility Criteria:
Inclusion Criteria:

* consultation of his general practitioner

Exclusion Criteria:

* None
Caffeine Study for Pain Control Following Total Joint Replacement

A prospective, double blinded, single center, randomized controlled study to evaluate the efficacy of caffeine in combination with acetyl salicylic acid (ASA) in the management of postoperative pain in patients undergoing total joint arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 18 years old at the time of the surgery.
* Patient is treated by Rothman Orthopaedics institute and is scheduled for the surgical procedure at AtlantiCare Regional Medical Center.
* Patient is undergoing total hip or total knee arthroplasty.
* Patient has the diagnosis of Osteoarthritis of the hip or the knee, or other noninflammatory disease that results in joint damage to the hip or the knee.

Exclusion Criteria:

* Patient has known history of opioid addiction and/or has taken opioids preoperatively.
* Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
* Patient has a known allergy to aspirin or caffeine.
* Patient has history of chronic pain that required the intervention of a pain management doctor.
* Patient has an active infection at the time of surgery (systemic or localized) or history of chronic infections that affected the lower extremities.
* Patient has history of cancer that would affect patient reported outcomes including pain.
* Patient has history of neuropathic pain or nerve degenerative disease.
* Patients undergoing revision surgery would be excluded.
* Patients who require alternate DTV prophylaxis other than ASA.
Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction

To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI) within 12 hours of symptoms onset.

* Control group: PPCI only
* Study group: PPCI + RIPC

Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR) at 6 months after the index procedure

ST-elevation myocardial infarction (STEMI) is a leading cause of mortality and morbidity. Early myocardial reperfusion with either of thrombolytic therapy or primary percutaneous coronary intervention (PPCI) is the most effective strategy for reducing the size of a myocardial infarct and improving the clinical outcome. Although this process can restore blood flow to the ischemic myocardium, it can induce injury. This phenomenon termed myocardial reperfusion injury can paradoxically reduce the beneficial effects of myocardial reperfusion. The pre-clinical study in animal models of acute myocardial infarction suggests that lethal reperfusion injury accounts for up to 50% of the final size of a myocardial infarct.

Remote ischemic conditioning uses brief ischemia and reperfusion of a distant organ to protect the myocardium. In animal study, remote ischemic postconditioning seems to be more effective than local postconditioning in experimental myocardial infarction.Bøtker et al. has reported remote ischemic preconditioning before hospital admission increase myocardial salvage in patients with acute myocardial infarction.

The objective of this study is to evaluate whether remote ischemic per-conditioning (RIPC) can reduce late infarct size in patients with STEMI treated with PPCI within 12 hours of symptoms onset. To test this hypothesis, we will randomize patients into PPCI + RIPC or PPCI alone. We will evaluate marker of reperfusion injury using contrast cardiac magnetic resonance image.

Eligibility Criteria:
Inclusion Criteria:

* Age \>19 years
* Presenting within 12 hours of symptom onset
* \>20 min of chest pain
* ST-elevation myocardial infarction defined as ST-segment elevation (\>0.1 mV) in at least 2 contiguous precordial leads

Exclusion Criteria:

* Previous myocardial infarction
* Presence of chronic total occlusion
* Evidence of retrograde filling by collaterals at coronary angiography (Rentrop 2 or 3 collateral flow)
* Severe multi-vessel coronary artery disease to require further interventions before follow-up CMR
* Cardiac arrest before randomization
* Arrhythmias requiring external electric shock before randomization
* Unwillingness to participate
* External electric shock for cardioversion within first 3 days
* Cardiac surgery within first 3 days
Yale Swallow Protocol in Extubated Patients

The purpose of this study is to determine if the Yale Swallow Protocol is an effective screen for aspiration in recently extubated patients.

Dysphagia is prevalent in recently extubated patients with estimates ranging from 29-84% of recently extubated patients having some form of dysphagia with elevated risk for silent aspiration.One challenge providers face when managing post extubation dysphagia (PED) is that there are no best practice guidelines on how to evaluate for PED, specifically how to evaluate for silent aspiration (aspiration without cough response).

One method that has been suggested is the Yale Swallow Protocol (YSP), a pass/fail screen for aspiration consisting of a three ounce water challenge as well as a brief cognitive screen and oral motor exam. The assumption of the YSP is that silent aspiration (aspiration without a cough response) is volume dependent. This is based on a study of over 4000 patients that underwent both a FEES (5mL puree and 5mL liquid boluses) and a 3oz water challenge. Results from previous literature indicated that the 3oz water swallow had a high sensitivity for detecting aspiration (98%). This was again studied with a double blind research design with 25 patients, comparing results of the 3oz water challenge with results of videofluoroscopic swallow study. This showed 100% sensitivity for detecting aspiration, 64% specificity, 78% positive predictive value, and 100% negative predictive value. However, no published study has evaluated the YSP in recently extubated patients and so it is unclear if the high sensitivity and specificity would be retained. Investigators aim to determine the sensitivity and specificity of the Yale Swallow Protocol in identifying aspiration in recently extubated patients.

Eligibility Criteria:
Inclusion Criteria:

1. Intubation greater than 24 hours
2. Age 18 and older
3. All races
4. Males and females
5. English speaking
6. Swallow consult ordered by the team within 48 hours of extubation

Exclusion Criteria:

1. Known history of oropharyngeal dysphagia
2. Contraindication for FEES due to facial fractures, nothing by mouth (NPO) status for other procedures, elevated bleeding risk, reduced level of alertness, or significant agitation.
3. Allergy to dairy