cyrilzakka/clinical-trials huggingface dataset:
Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

The objective of this study is to test whether an individualized carbohydrate intake based on weight and pre physical activity glucose level is more effective than usual camp care to improve glucose control in children and adolescents engaging in team sports (basketball, soccer, hockey) during a summer camp.

At the enrollment interview, in addition to collecting patient's information (age, sex, diabetes duration, recent A1c, type of treatment, insulin doses body weight, concomitant diseases, diabetes complications and history of severe hypoglycemia), a continuous glucose monitoring system (FreeStyle Libre) will be installed by a nurse. At least, eight sports sessions per participant are planned for this study. In a randomized order, the individualized carbohydrate intake will be applied during at least 4 interventions sport sessions while at least 4 with matching types of sports will be used as control sessions. Two sport sessions are routinely scheduled at the camp each day; from 9h:30 to 10h:30 and from 11h:00 to 12h:00. For intervention sessions that involve individualized carbohydrate intake, the FreeStyle Libre will be scanned 0-10 minutes before the start of the team sport. Carbohydrates will then be given in the amount of 0.5g/kg for glucose levels between 4.5 to 7.0 mmol/L and 0.25g/kg for glucose levels between 7.1 to 10.0 mmol/L and none will be given if glucose levels are between 10.1 and 15.0 mmol/L. When glucose levels are below 4.5 mmol/L or above 15.0 mmol/L, the camp staff will take care of hypoglycemia/hyperglycemia treatment. During control sessions, as per camp routine care, there will be no measurement of glucose levels before the start of physical activity.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females between the 7 and 16 years of old.
2. Clinical diagnosis of type 1 diabetes for at least 6 months.
3. Using continuous subcutaneous insulin infusion therapy or multiple daily injections.
4. HbA1c ≤ 12.0%.
5. Practicing team sports (soccer, basketball, hockey, tennis) at the summer camp.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
2. Severe hypoglycemic episode within two weeks of inclusion in the study.
3. Using the Medtronic 670G Insulin Pump as a treatment Mode
4. Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
5. Acute disease in the last 3 months that would affect ability to do physical activity.
6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
Tricuspid Regurgitation in the ElderlY

Tricuspid regurgitation (TR) is the second most common VHD after MR. Its prevalence also increases with age, with an estimated incidence of up to 6% in elderly population. When adjusted to age (among other confounders), survival is worse for patients with moderate and severe TR. We aim to explore the prevalence, mechanisms, and clinical implications of tricuspid valve regurgitation in elderly subjects screened at a tertiary center in Cairo, Egypt.


Eligibility Criteria:
Inclusion Criteria:

* All comer patients ≥60-year-old presenting to the echocardiography clinic

Exclusion Criteria:

* Poor acoustic window.
Reproductive Hormones During Sustained Administration of Kisspeptin

We want to find out what happens to reproductive hormone levels; Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), testosterone and oestradiol when kisspeptin is administered to people for a period of 8 days each month, using either placebo (saline) or kisspeptin in doses of 0.1, 0.3 or 1.0 nmol/kg/hour.

Participants will be invited to have an initial baseline study to look at the hormone levels at regular intervals over the course of a day (8hours).

Following this, on a different day, volunteers will have an infusion of kisspeptin, which will be administered by a small pump to deliver the hormone into subcutaneous tissue (fatty tissue just below the skin surface). On day 1 of the pump infusion there will be another day of regular blood sampling for 8 hours. After this the kisspeptin pump will continue and the participants will return to the research unit on day 3 for a review and a single blood test. On day 5 the participants will have a review, a blood test and the kisspeptin pump will be changed. Kisspeptin infusion will continue and on Day 8 the participant will return for another 8 hour study. At the end of this the kisspeptin pump will be removed.

The above will be repeated using either placebo (saline) or kisspeptin in doses of 0.1, 0.3 or 1.0 nmol/kg/hour during the early follicular phase of 4 separate menstrual cycles.

Eligibility Criteria:
Inclusion criteria:

* Aged 18-60 years old
* Ability to give informed consent
* Secondary hypogonadism (or healthy participant)

Exclusion criteria:

* anaemia
* medical problems such as severe heart, kidney or liver disease
* blood donation in the last three months or intention to donate blood within 3 months of the end of the study
* needle phobia
* Poor venous access
* Active psychiatric illness
* Severe allergies
* Impaired ability to provide full consent to take part in the study
* Current alcohol or illicit drug dependence
* Current pregnancy or breast feeding
* Plans to conceive within 3 months of starting the study (barrier contraception must be used during and for 3 months after the end of the study)
* Arthritis or any impairment of hand coordination which would preclude using a hormone pump
Relaxation Response Training for the Treatment of Rheumatoid Arthritis

This study will evaluate the relative effectiveness of Relaxation Response (RR) training for the treatment of rheumatoid arthritis (RA). The study will compare RR training to RR training with cognitive behavioral therapy and to a standard RA education program.

RR training is a part of most multi-component psychosocial therapies for RA. RR training may decrease perceived psychosocial stress and autonomic tone, which in turn diminishes pain and the anticipatory anxiety associated with pain. RR training involves learning relaxation techniques which include diaphragmatic breathing, progressive skeletal muscle relaxation, and the induction of a state of focused attention on a chosen word, phrase, or image.

In clinical practice, RR training is generally administered as one component of RA therapy. In this study, the effectiveness of RR training will be evaluated when RR training is administered alone and in combination with a cognitive behavioral therapy program. The cognitive behavior techniques include problem solving, relabeling, enhanced awareness of pain behaviors, and attention refocusing. The effectiveness of RR training will be evaluated in comparison to standard RA education that includes topics such as the nature of RA disease, medical therapies, physical activities, nutrition, and pain mechanisms.

After a baseline assessment of health beliefs, RA severity, social support, and psychological distress, patients will be randomized to one of three study arms. Patients in Arm A will complete six individualized weekly RR training sessions. Patients will receive a 20-minute audiotape to guide them through the exercise; they are asked to practice 5 to 7 times per week. Patients in Arm B will learn cognitive behavioral and RR techniques during eight weekly sessions. Patients in Arm C will receive standard RA education. After the initial training, all patients will be followed up with monthly telephone conversations for 4 months. Patients will have follow-up study visits at Months 6 and 12. Follow-up study visits include a medical interview, physical exam, and blood tests.

Eligibility Criteria:
Inclusion criteria

* RA as defined by the American College of Rheumatology
* English literacy and fluency

Exclusion criteria

* Major medical condition or illness which limits life expectancy or results in severe symptoms or functional disability (Duke Severity of Illness score \> 0.85)
* Fibromyalgia
* Received or currently receiving psychosocial treatment for RA
* Unavailability for Month 12 follow-up
Differential Expression of CD200 in B-chronic Lymphoproliferative Disorders by Multicolour Flow Cytometry

The investigator's goals in this study are to assess :

1. Differential expression of CD200 by using flow cytometric immune-phenotyping in broad range of patients with B-chronic lymphoproliferative disorders (B-CLPD)
2. Role of CD200 in diagnosis , classification and potential value in differential diagnosis
3. CD200 expression level at different anatomic sites

B-Chronic lymphoproliferative disorders (B-CLPDs) are heterogeneous group of disorders with variable clinical presentations and outcomes. They are classified into : chronic lymphocytic leukaemia (CLL), B-cell prolymphocytic leukaemia (B-PLL), hairy cell leukaemia (HCL), and mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL) and lymphoplasmacytic lymphoma/WaldenstrÖm macroglobulinaemia (LPL/WM) in leukaemia phase.

Characterization of CLPDs by immunophenotyping (IPT) has become an important and widely used method in hematology. Immunophenotyping is indispensable for the diagnosis of B-CLPDs through recognition of restricted light chain expression and characteristic phenotypes of separate entities.

Immunophenotypic characterization of lymphoid neoplasms is important for diagnosis, sub-classification, and staging and can also play a role in monitoring minimal residual disease. However, the differential diagnosis may be difficult to resolve in some cases, for example, between B-cell neoplasms with full or partial CD5 expression.

CD200 has recently been identified as a potentially useful antigen for flow cytometric immunophenotyping of lymphoid neoplasms, particularly those of the B lineage.

CD200 belongs to the immunoglobulin superfamily and is composed of a light chain-like structure with two extracellular variable- and constant-like domains followed by a transmembrane segment and a cytoplasmic tail.5 CD200 is expressed by various cell types, including B cells, a subset of T cells (including activated T cells), thymocytes, endothelial cells, and neurons .

CD200 generates an immunosuppressive signal by binding to its cognate receptor, CD200 receptor 1 (CD200R1) , which is expressed specifically in granulocytes and monocytes and in a subset of T cells. CD200 appears to play a role in the regulation of antitumor activity and these findings are the basis for ongoing clinical trials using anti-CD200 therapy for chronic lymphocytic leukemia (CLL)

Eligibility Criteria:
Inclusion Criteria:

* All newly diagnosed patients with B-chronic lymphoproliferative disorders

Exclusion Criteria:

* 1) Patient refusal 2) Patients diagnosed T-cell non-hodgkins lymphoma 3) Patients receiving chemo and/or radiotherapy 4) Patients on steroid therapy for any other cause 5) Patients receiving any immunosuppressive drugs
Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL

The primary objective of this study is to assess the safety profile of copanlisib at the recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients will be determined in the dose escalation/safety evaluation part.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:

Follicular lymphoma (FL) grade 1-2-3a Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 109/L at the time of diagnosis and at study entry Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM) Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

* Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have previously received rituximab and alkylating agent(s).
* Japanese patients ≥ 20 years of age
* ECOG performance status ≤ 2 (Eastern Cooperative Oncology Group:ECOG)
* Life expectancy of at least 3 months
* Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
* Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the Institution
* Availability of fresh or archival tumor tissue

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg, defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management)
* Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 (NCI-CTC version 4.0) within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events, NCI: National Cancer Institute).
* History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
* Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia.
* Prior treatment with PI3K inhibitors
* Systemic corticosteroid therapy (ongoing)
* Type I or II diabetes mellitus with HbA1c \> 8.5% or fasting plasma glucose \> 160 mg/dL at Screening
* Known history of human immunodeficiency virus (HIV) infection.
* Hepatitis B or C requiring treatment
* Cytomegalovirus (CMV) PCR positive at baseline
* Known lymphomatous involvement of the central nervous system
Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL).
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
* Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.
* Willing and able to comply with the requirements for study specific procedures and visits.
* Able to complete a written questionnaire in English.

Exclusion Criteria:

* Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
* Pre-existing macular disease in either eye.
* Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
* History of uveitis in either eye.
* Evidence of ectasia in either eye.
* Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Subjects taking systemic medication that may increase sensitivity to UV light.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* History of ocular herpes simplex virus in either eye.
Time-differentiated Therapeutic Hypothermia

The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Out of hospital cardiac arrest of suspected cardiac origin
2. Return of spontaneous circulation (ROSC)
3. Glasgow Coma Score \< 8
4. Estimated time interval from cardiac arrest to ROSC ≤ 60 min

Exclusion Criteria:

1. OOH-CA of suspected origin other than cardiac
2. In hospital Cardiac arrest
3. Terminal disease
4. Coagulation disorders
5. Unwitnessed asystolia
6. Time from cardiac arrest to start of hypothermia treatment \> 240 min
7. GCS ≥ 8
8. Pregnancy
9. Persistent cardiogenic shock (Systolic blood pressure \< 80 mmHg despite inotropic treatment and aortic balloon pump).
10. CPC 3-4 before cardiac arrest
11. Acute intra cerebral bleeding
12. Acute stroke
13. Acute coronary artery bypass grafting
Effectiveness of GentleWave System in Endodontic Treatment

This study aims to evaluate the efficacy of the GentleWave® System compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment.

New irrigation modalities such as the GentleWave® System, which integrates advanced multisonic ultrasound technology, have been developed to overcome limitations and improve root canal treatments success rates, by ensuring comprehensive cleaning while minimizing mechanical instrumentation. This system, featuring CleanFlow technology, optimizes the delivery of irrigants and promotes efficient root canal debridement. Postoperative pain is common, usually peaking within the first 24 hours after treatment and decreasing thereafter.

In the presence of necrosis, microorganisms can colonize anatomical complexities, such as isthmuses, ramifications and dentinal tubules causing symptoms such as pain, inflammation, and in some cases even odontogenic sinusitis. Conventional Syringe Irrigation (CSI), which delivers irrigants (NaOCl, EDTA) through a needle-syringe system, often fails to reach the entire working length and the intricate anatomy of the root canal. This inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure; furthermore, positive pressure exerted during CSI may cause the extrusion of irrigants beyond the apex, leading to complications.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from 18 years age or older (maximum of 80 years of age), both genders.
* The patients in need of an endodontic intervention.
* All dental groups in both arches were eligible.
* Patients who do or do not experience symptoms after the endodontic intervention.
* Patient-signed informed consent/assent form

Exclusion Criteria:

* Patients\< 18 years old.
* fractured teeth.
* Patients who were recommended extraction after the endodontic evaluation.
EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary observational study is to optimize risk prediction accounting for the social determinants of health, and establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will (Aim 2) Develop algorithms to optimize prediction of sepsis around delivery and postpartum.

In the UG3 phase, robust community engagement and research infrastructures were established to: Aim 2a. Create a rich electronic health records (EHR) database from the Perinatal Research Consortium (PRC). Aim 2b. Collate neighborhood-level datasets characterizing social determinants of health (SDOH)

In the UH3 phase, the investigators will Aim 2c. Harmonize patient-level EHR and neighborhood-level SDOH datasets and use machine learning models to analyze the individual and joint contributions of patient and neighborhood factors to optimize sepsis risk prediction within the PRC sample.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older
* Delivery admission (and) postpartum readmission at one of the Perinatal Research Consortium sites 2014-2021

Exclusion Criteria:

* Under 18 years old
* Delivery admission (and) postpartum readmission at hospital that is not in the Perinatal Research Consortium
* Delivery admission before 2014 or after 2021
A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study

The purpose of this study is to provide continued access to mitapivat for participants who completed an Agios-sponsored mitapivat study (antecedent) and do not have commercial access to mitapivat.

Participants will continue the mitapivat dose regimen that they were receiving at the final visit of their antecedent study.

Eligibility Criteria:
Inclusion Criteria:

* Has completed an Agios-sponsored adult pyruvate kinase (PK) deficiency study of mitapivat within 1 day of enrollment in this rollover study;
* Is unable to obtain mitapivat treatment due to country regulations or lack of commercial access;
* Was deriving clinical benefit from mitapivat treatment at the completion of the antecedent study, in the opinion of the Investigator;
* For women of childbearing potential, must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method;
* Written informed consent from the participant before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study;
* Agrees not to participate in other interventional clinical studies, including other studies of mitapivat, during participation in this study.

Exclusion Criteria:

* Has discontinued treatment with mitapivat before completing the antecedent study;
* Known allergy or other contraindication to mitapivat or its inactive ingredients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, Opadry II Blue \[hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD\&C Blue #2\]);
* Any medical, hematologic, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study also excluded are:

  * Participants who are institutionalized by regulatory or court order
  * Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor).