cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy

The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 years old, newly implanted, in accordance to the latest European guidelines, with a CRT-P or CRT-D device (upgrading is tolerated but no device replacement), with Home-Monitoring® activated
* Patient willing and able to comply with the protocol and who has provided written informed consent

Exclusion Criteria:

* Lead model under advisory
* Non-functional lead except particular case of non-functional or deactivated right atrial lead due to atrial fibrillation
* Known drug or alcohol abuse
* Pregnant woman or woman who plan to become pregnant during the trial (the data will be collected by querying the patient without a pregnancy test is required)
* Participation (ongoing or planned during the trial) in another interventional clinical study, and/or another remote monitoring and/or follow-up concept, unless authorized by the Executive Committee
* Participation (ongoing or planned during the trial) in an investigational HF program (e.g. PRADO, PIMPS, OSICAT, CARDIAUVERGNE)
* Estimated life-expectancy, regardless of the cardiovascular condition, \<1year
* Patient under- or planned for - ventricular assistance
* Patient not living in Metropolitan France and/or not geographically stable
Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma in stomach
* Scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third)
* Planned with gastrojejunostomy after gastrectomy
* Clinical stage T1N0M0 or T2N0M0
* ECOG 0 or 1 (The Eastern Cooperative Oncology Group)
* ASA score class I-III (The American Society of Anesthesiologists)
* patient has given their written informed consent to participate in the study

Exclusion Criteria:

* Simultaneously combined resection of other organ (including cholecystectomy)
* Active other malignancy
* Requiring total gastrectomy
* Chronic inflammatory bowel disease or other chronic disease related to bowel motility
* Uncontrolled diabetes or patients with diabetic complications
* Vulnerable patients
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
* Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
* Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion Criteria:

* Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to

  * gastric bypass
  * sleeve gastrectomy
  * restrictive bariatric surgery, such as Lap-Band gastric banding, or
  * any other procedure intended to result in weight reduction.
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
* Have type 2 diabetes or have a HbA1c \> 6.4% at screening
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.

Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum.


Eligibility Criteria:
Inclusion Criteria:

* presence of delirium

Exclusion Criteria:

* presence of Alzheimer's disease
* any mental disorder
* presence of cancer
A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.

The aim of this study is to examine the use of Near Infrared Fluorescence imaging on lymphatic vessels in humans.

Different parameters that reflect lymphatic function will be tested for intra and inter individual reproducibility.

We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy men between the ages of 20 and 30.

When the fluorescent dye "indocyanine green", has been injected into the skin on the patients feet, it will be transported through the lymph vessels, resulting in clear visualization of the vessels, using a laser and a EM-CCD camera.

On both legs we examine the frequency of vessel contraction and the velocity of lymph moving in vessels. We furthermore use several methods to quantify the vessel function such as the refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and pumping pressure (at what pressure lymph can pass a blood pressure cuff).

We investigate the activity of vessels over time, and after several interventions such as exercise, and water baths of the foot at different temperatures.

The patients are examined for approximately 4 hours and wil be examined again 14 days later.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* lymphedema, edema or vascular disease.
COVID-19 Survivorship Registry

COVID-19 is associated with acute pulmonary and cardiac injury. To better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of COVID-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of COVID-19.

The objectives for this study include providing structural and function information about lung and heart using chest imaging, MRI, Echo, Spirometry, and blood markers in order to assess severity of cardiopulmonary injury and short- and long-term sequelae of COVID-19 infection as well as assess indicators of mental health and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* have tested positive for SARS-CoV-2 and discharged from the ICU or,
* have tested positive for SARS-CoV-2 and have been discharged from hospital or,
* have tested positive for SARS-CoV-2 but was NOT hospitalized
* ages 18 and over, and
* competent and willing to sign informed consent and comply to all aspects of the protocol

CONTROL Inclusion Criteria

* No clinical history of COVID-19,
* No active clinical symptoms indicative of possible COVID-19,
* Ages 18 and over,
* competent and willing to sign informed consent and comply to all aspects of the protocol

Exclusion Criteria:

• Participants cannot sign consent

Any individual who meets any of the following criteria will be excluded from participation to the MRI or x-ray portion of the study:

* Participants who are pregnant or currently trying to get pregnant
* Participants unable to comply with any portion of the protocol (i.e. removing metals prior to entering the MRI scan room) or who have contraindications to MRI scanning (i.e., non-MRI-conditional pacemakers/defibrillators, pregnancy, ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
* Persistent symptoms related to COVID-19 (in which case the patient may be re-screened later) As is done for all patients undergoing clinical MRI in our department, each patient will be screened for contraindications to MRI with a routine questionnaire prior to scanning.

CONTROL Exclusion Criteria

Patients with any of the following are excluded from as controls:

* Pace maker
* Poorly controlled diabetes
* Poorly controlled Restrictive lung disease
* Heart failure
* Parkinson's Disease
* Hypertension
* Any diagnosis or history of autonomic neuropathy
Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1


Eligibility Criteria:
Main Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity.
3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or physical examination with measurable disease as per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1

For phase II cohorts:

* Cohort #1: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent
* Cohort #2: Patients with R/M SCCHN not amenable to therapy of curative intent, who have received a maximum of two prior systemic regimens in the R/M setting and who have received prior PD-(L)1 blockers
* Cohort #3: Patients with R/M SCCHN who have not received prior systemic regimens in the R/M setting and who have not received prior PD-(L)1 inhibitors

Main Exclusion Criteria:

1. For phase II cohort #1 and cohort #2: Patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part of the trial).
2. For phase II cohort #1 and cohort #2: Patients who received cetuximab or another inhibitor of epidermal growth factor receptor are excluded from the phase II of the trial, except if cetuximab was given as part of a primary treatment approach, with no progressive disease for at least 4 months following the end of prior cetuximab treatment.
Explorative Assessment of Biomarkers in Overweight and Obese Subjects

The rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected population of subjects.

The pre-screening assessments are designed to characterize the metabolic risk profile / prediabetic status in an unselected population of overweight and obese volunteers, aiming to pre-select high risk and prediabetic subjects as a target population who may specifically profit from primary diabetes intervention (prevention) strategies.

Eligibility Criteria:
Inclusion Criteria:

* Obese and overweight subjects
* Considered generally healthy

Exclusion Criteria:

* Clinically significant acute illness within 2 weeks before study procedures
Telocytes in Placental Tissues of Patients With Gestational and Pre-gestational Diabetes

Examining the expression of telocytes in the placental tissues and umbilical cord of patients with gestational or pregestational diabetes during pregnancy compared to control.

this is an observational study, patients with gestational or pre-gestational diabetes undergoing elective (pre-labour) Cesarean section will be asked to participate in the study. Samples of placenta and umbilical cord will be taken postpartum and will be fixed and examined using immunohistochemistry to measure abundance of telocytes in these tissues. another group of patients with non complicated pregnancies will be asked to join as a control. As the topic was never studied before, a pilot phase of 10 patients per group will be done followed by sample size collection based on SD of number of telocytes in each group. Diabetes patients will divided in 3 subgroups; Gestational diabetes and pre-gestational diabetes type 1 or 2. Each group will be further subdivided according to HBA1C level collected at the time of delivery into controlled or non controlled.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women presented at the delivery ward in Sohag University Hospital, Sohag, Egypt with the following criteria:

  1. Study group: Singleton pregnancies complicated with diabetes undergoing pre-labour CS at gestational age (37+0 to 40+0). These will be divided into 3 groups according to the type of disease either Gestational diabetes (Group A), pregestational diabetes type 1 (Group B) or type 2 (Group C). 2-Control group: Singleton pregnancies undergoing elective pre-labour CS at gestational age (37+0 to 40+0) that are otherwise healthy

Exclusion Criteria:

* Women with history of medical co-morbidities other than diabetes are excluded from the study. This includes the following: Chronic hypertension, renal diseases, autoimmune diseases, history of organ transplantation and immunosuppressive therapy, hematological diseases, history of thrombotic events, cardiopulmonary diseases, liver diseases Acute and chronic inflammatory diseases.
* Pregnancy induced medical disorders like: Gestational hypertension, preeclampsia, Gestational thrombocytopenia, and proteinuria.
* Multiple pregnancies.
* Abnormal placentation, i.e. Placenta previa and Morbidly adherent placenta.
* Fetal anomalies.
* vaginal deliveries and CS in labor.
* Spontaneous delivery.
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.

Based on diagnosis and clinical history, a determination of the most appropriate regimen will be made based on the following prep plans:

Arm A: Fully Myeloablative Preparative Regimen, Arm B: Reduced Toxicity Ablative Preparative Regimen, Arm C: Reduced Intensity Conditioning, Arm D: No Preparative Regimen

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of immunodeficiency or histiocytic disorder including the following:

  * Severe combined immunodeficiency (SCID - all variants)
  * Second bone marrow transplant (BMT) for SCID (after graft rejection)
  * Omenn's Syndrome
  * Reticular dysgenesis
  * Wiskott-Aldrich syndrome
  * Major histocompatibility complex (MHC) Class II deficiency (bare lymphocyte syndrome)
  * Hyper IgM Syndrome (CD40 Ligand Deficiency)
  * Common variable immunodeficiency (CVID) with severe phenotype
  * Chronic Granulomatous Disease (CGD)
  * Other severe Combined Immune Deficiencies (CID)
  * Hemophagocytic Lymphohistiocytosis (HLH)
  * X-linked Lymphoproliferative Disease (XLP)
  * Chediak-Higashi Syndrome (CHS)
  * Griscelli Syndrome
  * Langerhans Cell Histiocytosis (LCH)
* Acceptable stem cell sources include:

  * HLA identical or 1 antigen matched sibling donor eligible to donate bone marrow
  * HLA identical or up to a 1 antigen mismatched unrelated BM donor
  * Sibling donor cord blood with acceptable HLA match and cell dose as per current institutional standards
  * Single unrelated umbilical cord blood unit with 0-2 antigen mismatch and minimum cell dose of \>5 x 10\^7 nucleated cells/kg as per current institutional guidelines
  * Double unrelated umbilical cord blood units that are:

    * up to 2 antigen mismatched to the patient
    * up to 2 antigen mismatched to each other
    * minimum cell dose of at least one single unit must be ≥ 3.5 x 10\^7 nucleated cells/kg
    * combined dose of both units must provide a total cell dose of ≥ 5 x 10\^7 nucleated cells/kg
* Age: 0 to 50 years
* Adequate organ function and performance status.

Exclusion Criteria

* pregnant or breastfeeding
* active, uncontrolled infection and/or HIV positive
* acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Cubital Tunnel Syndrome and Diffusion MRI: A Proof of Concept Study

Cubital Tunnel Syndrome (CTS) results from compression of the ulnar nerve at the elbow (colloquially termed the "funny bone"). CTS affects up to 6% of the population and 6000 patients undergo surgery annually in the UK. Surgery is the only proven treatment for CTS, although up to 30% of patients do not improve. Therefore, there is a pressing need to develop a reliable test to diagnose CTS to improve the selection of patients for surgery.

New techniques in the field of magnetic resonance imaging (MRI) allow the visualisation of nerve structure and function. Diffusion tensor MRI, also known as diffusion tensor imaging (DTI), can diagnose CTS with superior diagnostic accuracy and could enable the reliable diagnostic of CTS, improving the selection of patients for surgery.

The study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned preoperatively and postoperatively using cutting-edge diffusion MRI techniques. The primary outcome will be change in the MRI-derived diffusion metrics following surgery. Secondary outcomes will consider how MRI relates to patient-reported outcomes and conventional clinical tests (ultrasound and nerve conduction studies).

Leeds is the ideal location for this research because a) Leeds institutions are the most highly cited organisations in musculoskeletal research, b) Leeds houses the National Centre for Hyperpolarized MRI and a state-of-the-art MRI scanner, and c) Leeds is an internationally recognised centre of excellence for complex upper limb surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.

Exclusion Criteria:

* Unable to get into the MRI scanner due to habitus or claustrophobia
* Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)
* Intraocular or intracranial metallic foreign bodies
* Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve stimulators, etc) which are not MRI safe or conditional.
* Pregnancy - whilst there are no known adverse effects of MRI16-18 to the mother or fetus, MRI is generally avoided in pregnancy due to the acoustic trauma19 and inductive heating generated by alternating magnetic fields.
* Any metallic implants in the elbow
Study: Manometry With & Without Lidocaine

The purpose of this study is to determine whether subjects report a difference in comfort with High Resolution Pharyngeal Manometry (HRPM) conducted following application of lidocaine as an anesthetic as compared to HRPM conducted without anesthetic.

High resolution pharyngeal manometry (HRPM) is used for assessing swallowing pressure along the length of the pharynx and upper esophageal sphincter. Pressure measurements in the region of the velopharynx, tongue base, and upper esophageal sphincter are obtained by passing a catheter with pressure sensors through the patient's nose and past the upper esophageal sphincter. Patients are presented various volumes of liquid to swallow and potentially asked to perform postural strategies such as a head turn or chin tuck during swallowing while the catheter is in place. Clinically, approximately 90% of patients report various discomfort associated with the procedure. Discomfort can result in patient refusal to participate or an inaccurate picture of a patient's swallowing pressures. Conversely, use of anesthesia can potentially alter swallowing physiology.

Recent studies have studied the effects of lidocaine on penetration/aspiration and subject discomfort during flexible endoscopic evaluations, yet findings are inconclusive or contradictive. Investigators aim to determine whether subjects report a difference in comfort with HRPM conducted following application of lidocaine as an anesthetic as compared to HRPM conducted without anesthetic.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female adults 18-65.
2. All races.
3. Able to consent for self.

Exclusion Criteria:

1. History of dysphagia.
2. History of previous pharyngeal or esophageal manometry.
3. History of facial fracture or abnormalities precluding passage of catheter through nares.
4. History of esophageal pathology including previous resection or perforation.
5. Pregnant
6. Known lidocaine allergy or sensitivity
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

1. General

   - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
2. Laparoscopic surgery

   * at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
   * with or without anchoring transparietal sutures or double crown technique


Eligibility Criteria:
Inclusion Criteria:

* written informed consent from the patient or his/her legal representative
* ventral hernia requiring elective surgical repair

Exclusion Criteria:

* no written informed consent
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* parastomal hernia
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice

To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice


Eligibility Criteria:
Inclusion criteria:

Patients diagnosed with Alzheimer's Disease and administered Aricept for the first time.

Exclusion criteria:

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.