cyrilzakka/clinical-trials huggingface dataset:
Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency

OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at fasting in a patient with methionine adenosyltransferase deficiency, and if the choline levels are low, determine whether choline levels respond to dietary supplementation with phosphatidylcholine.

II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.

PROTOCOL OUTLINE:

Blood is drawn for liver function tests and measurement of plasma choline levels and breast milk samples are taken for measurement of breast milk choline levels at fasting and at 1 hour after breakfast on day 1. The patient then undergoes magnetic resonance spectroscopy of the liver to assess liver density and choline compound mass. The patient then receives oral phosphatidylcholine supplement, and plasma and breast milk samples are taken at 3 and 6 hours after the dose. Oral phosphatidylcholine supplements continue for 30 days. The above studies are repeated on day 31.

Eligibility Criteria:
* Patient with methionine adenosyltransferase deficiency who is nursing
Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.

Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory factors are involved. Several ways of preventing SUDEP have been identified. These include seizure control, stress reduction, physical activity, family's ability to perform CPR, and night supervision.

A mattress alarm system that monitors nocturnal seizures can alert family members of night time seizure activity. Thus, a family member could provide aid and therefore potentially avoid SUDEP. The Emfit monitor is intended to perform these tasks.

Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device has a high predictive value for detection of generalized convulsions and that it can notify caregivers in the early stages of convulsive activity.

This study will further investigate the upgraded (connected to a cloud server via an integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification system.


Eligibility Criteria:
Inclusion Criteria:

* Overnight Epilepsy Monitoring Unit admission

Exclusion Criteria:

* 12 hours or shorter Epilepsy Monitoring Unit admission
A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation

The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.

Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) that inhibits a specific DNA repair pathway known as base excision repair (BER). PARP inhibitors (PARPi) have been shown to effectively kill tumors with a defect in BRCA1 or BRCA2. Clinical benefit has been observed in patients with a gBRCA mutation as well as in those with a somatic BRCA (sBRCA) mutation. Clinical data have also shown that pancreatic cancer patients with a gBRCA mutation benefit from PARPi treatment. Clinical activity of PARP inhibitors in BRCA-mutated pancreatic cancer combined with the paucity of 2nd line therapies support evaluation of rucaparib in pancreatic cancer patients known to harbor a deleterious BRCA mutation.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of pancreatic cancer (ductal adenocarcinoma and related subtypes eligible; endocrine and neuroendocrine tumors excluded)
* Received at least 1, but no more than 2, chemotherapy-based regimens for locally advanced or metastatic disease and has relapsed or progressive disease. Patients no longer able to continue treatment with chemotherapy due to intolerable toxicity may be considered for study participation provided that radiology assessment confirms either stable disease or disease progression (i.e. no response to treatment)
* Documented deleterious or suspected deleterious (or equivalent interpretation) BRCA mutation (germline or somatic) as assessed by a local laboratory
* Measurable disease

Exclusion Criteria:

* Presence of another active cancer
* Prior treatment with any PARP inhibitor, including rucaparib. Patients treated with prior iniparib are eligible.
* Symptomatic and/or untreated central nervous system metastases.
* Clinical evidence of malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of rucaparib.
Electrocardiogram Clinical Validation Study

The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 22 years of age and older
* Able to read, understand, and provide written informed consent
* Willing and able to participate in the study procedures as described in the consent
* Have a wrist circumference that fits within the band
* Able to communicate effectively with and follow instructions from the study staff
* For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening

Exclusion Criteria:

* Physical disability that precludes safe and adequate testing
* Mental impairment resulting in limited ability to cooperate
* Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD)
* Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable
* Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening
* Stroke or transient ischemic attack within 90 days of screening
* Subjects taking rhythm control drugs
* Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis on both wrists or over electrode attachment sites
* Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices
* A history of abnormal life-threatening rhythms as determined by the investigator
* Significant tremor that prevents subject from being able to hold still
* Pregnant women: Women who are pregnant at the time of study participation
* For subjects enrolled into the sinus rhythm population, they must not have any diagnosis of AF
AVERT Plus Post-Market Registry

The devices used in this observational registry are the Osprey Medical Contrast Monitoring System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark designations. The purpose of this registry is to evaluate the usability characteristics of the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal clinical use.

This is a prospective, single-center, non-randomized, single arm, observational registry of the AVERT System used in combination with the Contrast Monitoring System. Patients undergoing manual manifold injection coronary artery imaging for diagnostic or PCI procedures that utilize the AVERT System and the CMS will be included in this registry. Device use characteristics including, measurement of contrast media volume used, contrast media volume saved by the use of the AVERT System, evaluation of angiographic image quality, and physician feedback on device features and function will be obtained. All data will be collected on the day of the procedure and there will be no long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and CMS according to the labeled indications for these devices.
* Patient consent to participate

Exclusion Criteria:

* None
Training of Arms to Reduce Pain With Peripheral Venous Catheter

Female patients undergoing chemotherapy for breast cancer often experience pain and discomfort when a peripheral venous catheter is inserted.

This randomized, controlled trial investigates whether there is a difference in the degree of pain during PVC insertion in patients who exercise their arms, and whether exercise improves vein status.

Participation involves:

* Everyone must have had their peripheral venous catheter (PVC) inserted at least five times in the DROP-IN, which is an outpatient clinic staffed by anesthesia nurses who are specialists in applying PVCs.
* Everyone will three times be asked to answer some questions in the DROP-IN, have their grip strength measured in both hands, and have the course of the veins in their arms clarified.
* The training group must do arm training exercises daily for at least eight weeks (training equipment is provided)
* Ten participants will at the end of the project period be invited to participate in a telephone interview about experiences of vein status during a cancer treatment course.


Eligibility Criteria:
Inclusion Criteria:

* Planned neoadjuvant or adjuvant chemotherapy via intravenous peripheral venous cannula placed under ultrasound guidance
* PVC insertion is performed in the DROP-IN outpatient clinic, Department of Anesthesiology, Vejle Hospital, at least four times
* The patient has provided written and orally informed consent
* The patient must be cognitively well preserved and able to understand information

Exclusion Criteria:

* Patients who cannot read and understand Danish
* Patients \<18 years
Study of Bladder-sphincter Symptoms in Functional Neurological Disorders

A significant proportion of patients with functional neurological disorders (FND) report urinary, anorectal or genitosexual disorders. However, until now, no study has focused on bladder-sphincter disorders in patients with FND. The symptoms of this pathology are, therefore, not precisely characterized.

Thus, the objective of this research is to specify if urinary, anorectal or sexual disorders can be observed in patients suffering from functional neurological disorders and to better describe them in order to propose better therapeutic options.

In this clinical study the investigators want to prospectively include all patients presenting to a neurology consultation or day hospital for management of a motor or sensory FND.The patients will first be evaluated for their sphincter functions by self questionnaires. For those where a vesico-sphincter complaint is demonstrated, a neuro-urological consultation will be proposed. A follow-up will then be done, if necessary, in neurology and neuro-urology.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Diagnosis of Functional Neurological Disorders according to DSM 5 criteria
* No neurological comorbidity that could account for the sphincter disorders
* Normal cerebral and spinal cord magnetic resonance imaging.
* Patient affiliated to a French social security system
* Patient informed and not objecting to participate in the study

Non inclusion Criteria :

* Presence of neurological comorbidity that can account for sphincter disorders (e.g. multiple sclerosis, chronic neuropathy, etc.)
* Pregnancy in progress
* Candidate for surgery or locoregional treatment
* Patient subject to legal protection measures.
* Patient under state medical assistance
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.

This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.

This study is designed to reduce the load of knee osteoarthritis patients in society so that the individual lives a healthy life without getting caught in any form of disability. Knee osteoarthritis is a progressive and degenerative disease of a joint that includes focal cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of periarticular ligaments and peripheral muscles.

There are several techniques used to overcome the individual's pain, for instance, the mobilization of the joint, prolotherapy, and the use of different electrical modalities. meanwhile, an elliptical workout provides a positive result in reducing the progression of overall knee joint and cartilage defects. elliptical training is included in low-impact activities which are proven joint-friendly activities for the better improvement of the knee joint.

This activity works on a similar principle of cyclic compressive loading as occurs in the manual mobilization of the knee joint. This activity brings out the fluid from the synovial membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and nutrients, which crosses the synovial barrier into the synovial fluid through a double diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to the multiple layers of chondrocytes for the growth of the cartilage in OA.

Eligibility Criteria:
Inclusion Criteria:

* 40- to 65-year-old.
* Diagnosed cases of Grade 1 and 2 Knee OA.
* Healthy and overweight patients will be included. (18.5- 29.5)

Exclusion Criteria:

* Acute musculoskeletal injury.
* Low back pain and Sciatica.
* Hip and ankle pathology.
* Acute infection, fever.
* The patient taking supplements and medications.
* Any knee deformity.
Can Airflow Limitation in Chronic Obstructive Pulmonary Disease (COPD) be Reversible by Drugs?

Critical combination of various approved drugs in management for patients suffering with COPD.


Eligibility Criteria:
Inclusion Criteria:

* current or past smoker COPD

Exclusion Criteria:

* history of significant occupational or other environmental exposures or a connective tissue disease
EC_ItaLynch: Mainstreaming the Diagnosis of Lynch Syndrome

Lynch syndrome (LS) is the most common cause of hereditary endometrial cancer (EC) and is associated with an increased risk of colorectal (CRC), ovarian, gastric, small bowel and urinary tract cancer. LS is determined by germline pathogenic variants in the DNA mismatch repair (MMR) genes (MLH1, MSH2, MSH6, PMS2) or in EPCAM.

Approximately 20-30% of ECs exhibit somatic MMR deficiency (dMMR), and among these patients approximately 10-30% are affected by LS. This estimate suggests that the prevalence of LS among all EC patients is roughly 3-5%. Prior to the introduction of Universal Screening, the diagnostic management of LS was mainly based on Selective Screening, which included clinical criteria based on the evaluation of family and personal history and the clinicopathological features of the tumor (Amsterdam criteria 1990, Bethesda criteria 1997). However, these have been limited in their application to clinical practice due to their complexity and the frequent lack of complete family history data. Therefore, Universal Screening for LS diagnosis by the identification of dMMR in the tumor tissue of all newly diagnosed CRC and EC cases has recently been proposed.

Universal Screening for LS in tumor tissue includes an immunohistochemistry based (IHC) test to assess loss of MMR protein expression or a polymerase chain reaction (PCR) test for microsatellite instability.

In the traditional diagnostic pathway for LS, genetic counseling and testing are always recommended for EC patients who are found to have loss of expression of any of the proteins encoded by the MSH2, MSH6, or PMS2. In case of MLH1 loss, genetic counseling and genetic testing are recommended for patients without hypermethylation of the MLH1 promoter.

Recent findings suggest that incorporating genetic testing in an oncologist-driven diagnostic algorithm (mainstreaming of genetic testing) could enable increased diagnostic rates, offering the benefits of precision medicine and a streamlined pathway of care to patients and their families.

The study consists of two parts:

1. In the first part the aim of the current study is to compare the knowledge, experience and understanding of genetic testing among patients pursuing genetic testing using mainstreaming or standard genetic counseling through modified Modified Royal Marsden Patient Satisfaction Questionnaire.
2. If the first aim will be achieved, a second part will be conducted, to evaluate the feasibility of the mainstreaming diagnostic pathway for LS.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of stage I-IV EC with dMMR
2. Only for part I presence of Lynch alert.
3. Signed Informed consent to participate in the study.
4. d. Patient must be ≥18 years

Exclusion Criteria:

1. Histologically confirmed diagnosis of stage I-IV EC with pMMR.
2. Significant psychiatric or clinical impairment compromising consent to the study.
3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules

In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called "nodules", which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years.

Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause.

Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.


Eligibility Criteria:
Inclusion Criteria:

* Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules.
* History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked).
* Age \>18
* Nodule size 5 to 15 mm in diameter.

Exclusion Criteria:

* Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS)
* Active lung cancer or metastasis to the lung.
* Contraindication to needle biopsy.
* Pneumonectomy
* Need for supplemental oxygen.
* Radiation pneumonitis
* Interstitial lung disease.
Influence of RIC on the Orthostatic Competence of the Microcirculation

The goal of this clinical trial (pilot study) is to learn about the microcirculatory regulation of the lower extremity under orthostatic stress with and without RIC - Remote Ischemic Preconditioning in healthy participants. The main question it aims to answer are:

Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower extremity microcirculation in ortho-statically stressed subjects? Is there a relationship/correlation between the variables of microcirculation and hemodynamics in the context of RIC and orthostatic loading?

The use of free flaps is a standard procedure in reconstructive plastic surgery, in which a wide variety of tissue units are microsurgically transplanted, often to cover defects on the body surface. Microvascular tissue transplants depend on an adequate blood supply, which is particularly vulnerable in the first postoperative phase. In the case of reconstructions of the lower extremities in particular, the flap perfusion is stressed during the first mobilizations due to the orthostatic load. For this reason, the mobilization of the patients is gradually increased from day to day with precise monitoring of the blood flow (so-called flap training).

A procedure for temporarily improving the blood flow in free flaps is ischemic preconditioning (RIC - Remote Ischemic Preconditioning). Repeated, short cycles of ischemia/reperfusion applied to a circumscribed vascular territory (e.g. supra systolic tourniquet arm) lead to an increase in tissue perfusion, even outside the area of application (arm).

RIC could have the potential to optimize the tissue perfusion of flaps even under orthostatic stress and to promote an earlier mobilization of patients. Our work investigates the influence of RIC on orthostatic competence (as part of a standardized orthostatic load with a tilting table) of the microcirculatory system in the lower extremities and the orthostatic hemodynamic regulation itself.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* No diseases relevant to circulation and blood flow (arterial hypertension, peripheral arterial occlusive disease, chronic venous insufficiency)
* Subjects must be capable of insight. Anyone who can understand the nature, significance, and scope of the clinical trial and determine their will accordingly is capable of insight.

Exclusion Criteria:

* Non-consent
* Lack of compliance
* Syncope tendency
Initial Development and Dissemination of OC-Go

The clinical component of Phase I application development examines the clinical utility, feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving treatment through the pediatric OCD treatment programs in the UCLA Division of Child and Adolescent Psychiatry

This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for Obsessive Compulsive Disorder (OCD), a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.

Eligibility Criteria:
Inclusion Criteria:

* Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents

Exclusion Criteria:

* None