cyrilzakka/clinical-trials huggingface dataset:
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).

The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.

During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* T1D ≥ 2 years
* Use of insulin pump or MDI therapy for ≥ 6 months
* Current use of insulin aspart
* HbA1c ≤ 70mmol/mol (8.5%)
* Body mass index (BMI) ≤ 30 kg/m2
* Performs exercise ≥1 time per week

Exclusion Criteria:

* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
* Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
* Known or suspected allergies to glucagon or related products
* History of hypersensitivity or allergic reaction to glucagon or lactose
* Allergy to the patch of the CGM devices
* Patients with pheochromocytoma, insulinoma or gastroparesis
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (\>12 months since last period) are not required to use contraception)
* Inability to understand the individual information and to give informed consent
* Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
NK Cell Therapy Recurrent/Refractory Elderly AML

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for recurrent refractory elderly AML.


Eligibility Criteria:
Inclusion Criteria:

1. The 2 or more than 2-cycles of standard regimen was used to treat elderly AML patients who did not achieve complete remission or relapse.
2. Patients with age 60 years to 70 years.
3. KPS greater than or equal to 60.
4. ALT and AST are less than 3 times normal.
5. Total bilirubin less than 1.5mg/dl(25.65umol/L).
6. Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
7. Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
8. No pleural effusion in lungs
9. Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
10. KIR mismatch between patient and umbilical cord blood.
11. Volunteer to participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Malignant tumor patient.
2. Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation( HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
3. Patients with HIV, HCV positive.
4. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
5. During the first 12 months of enrollment, patients with cardioangiography or stents, active angina pectoris or other clinically significant symptoms, or with cardiogenic asthma.
6. Patients receiving anticoagulant therapy or with severe coagulation disorders.
7. According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
8. Patients with allergies or history of allergies to biological agents used in this program.
9. Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
10. Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
11. Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
12. Patients participate in other clinical studies.
Demonstration of Carbonyl Stress on Hair Follicles

In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of women with telogen effluvium (ET) linked to stress of various origins (fatigue, infectious diseases, emotional stress ...).

At the cutaneous level, oxidative stress induces the formation of carbonyl compounds which, by binding to proteins, produce nonfunctional adducts inducing cutaneous aging. Is this mechanism, called "Carbonyl stress", also present in the scalp and can it be one of the mechanisms involved in the occurrence of reactive hair loss ? To demonstrate this, samples of hair follicles are made. The proteins are extracted from the samples and then assayed. The oxidized (carbonyl) proteins are labeled with specific fluorescent probes.

Eligibility Criteria:
Inclusion Criteria:

Criteria related to the Population :

* Women aged from 18 to 40 ans (included)
* Phototype I à IV included, according to Fitzpatrick Classification
* Hair length 5 cm on the sampling area (centro-parietal part)
* Last shampoo at least 2 days before the inclusion visit, without application of styling product, care or water between this last shampoo and the inclusion
* Informed consent signature

Criteria related to the studied condition:

* ET group: hair loss related to various etiologies evaluated by a questionnaire according to the investigator's opinion and positive pull test (at least 3 hair collected per lock of 50 to 60 hair) AND
* Control group : no hair loss, evaluated by the questionnaire and negative pull test (less than 3 hair collected per lock of 50 to 60 hair)

Exclusion Criteria:

Criteria related to Population :

* Menopause
* Pregnancy, breastfeeding, childbirth for less than 6 months

Criteria related to Pathology :

For both groups:

* Alopecia causing hair loss on the upper part of the scalp
* Dermatological pathology or evolving cutaneous lesion in the scalp
* Control group only:
* Chronic unstabilized condition
* Acute evolving pathology

Criteria related to theTreatments :

For both groups:

* Use for at least 1 month of Minoxidil, Aminexil in the 3 months before inclusion or ongoing
* Systemic treatment affecting hair growth
* Any treatment or dietary supplement for antioxidant or capillary

Control group only:

* Treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion
* Treatment of anemia if started less than 3 months before inclusion
* General treatment initiated or modified for less than 3 months prior to inclusion in the study
Efficacy and Safety of Longan Syrup in Healthy Volunteers With Insomnia

The objectives of this study were to evaluate efficacy and safety of longan syrup in healthy volunteers with insomnia. Subjects will take 15 ml of longan syrup once a day for 3 months. They will be investigated their insomnia using Insomnia Severity Index (ISI) questionnaire, Thai- The Pittsburgh Sleep Quality Index (PSQI) questionnaire,STOP - BANG questionnaire, Epworth Sleepiness Scale (ESS) questionnaire, Actiwatch, plasma cortisol, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine (Cr), blood urea nitrogen (BUN), fasting blood sugar, HbA1C, complete blood count (CBC), hemoglobin, lipid profile, phosphate level, saliva cortisol, and urine melatonin before and after taken longan syrup.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-65 years
* Insomnia severity index (ISI) more than 7
* Thai- The Pittsburgh Sleep Quality Index (PSQI)) more than 5
* STOP - BANG less than 5
* No diabetes mellitus and thyroid dysfunction
* Fasting plasma glucose less than 126mg/dl
* Can communication (reading and writing)
* Be willing to be subjects in this study

Exclusion Criteria:

* Know longan allergy or have history of adverse events from longan
* Take benzodiazepine, melatonin, valerian, and St Johns Wort in 1 month before this study starting
* Take medicines, herbs, or food supplements including thiazide diuretics, beta-blockers ,and estrogen that have an effect on blood sugar level in 1 month before this study starting
* Cannot control comorbidity diseases
* Irregular working hours
* Pregnancy or breast feeding
* Participated in other studies
Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)

Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour.

The purpose of this study is to test an alternative radiation boost treatment called conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete information on the overall effectiveness of IMRT compared to brachytherapy or conformal radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of side effects. We are investigating the extent to which IMRT can be used to protect normal tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how much the side effects of radiation are reduced.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven carcinoma of the cervix, uterus or vagina; FIGO stage T1B-4A, NO/1, MO, treated with definitive radiotherapy with or without chemotherapy, or Biopsy-proven pelvic recurrence of carcinoma of the uterus previously untreated or biopsy-proven vaginal carcinoma treated radically with radiotherapy but unsuitable for brachytherapy boost.
* Patients not suitable for intracavitary brachytherapy.
* ECOG performance status of 0, 1, or 2
* Age ≥ 18 years
* Ability to give informed consent.
Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

This study is aim to compare the efficacy of intravenous versus oral iron therapy regarding the hemoglobin levels, iron status and erythropoietin dosage in maintenance hemodialysis patients

Run-in phase: All eligible patients will enter run-in phase for 2 weeks. In this phase, all oral therapy that patients received before enrolment into the study will be discontinued.

Masking: Opened label

Allocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron

Safety criteria: Study participants who meet the following criteria will be discontinued from the study. All patients data will be analyzed according to intention-to-treat principles.

* Hemoglobin levels \< 6.0 g/dl
* Packed red cells transfusion is required
* Serum ferritin \>1,000 md/dl

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Hemodialysis for at least 3 months
* Hemoglobin levels between 8 and 11.5 g/dl inclusive
* Transferrin saturation (TSAT) \<50% and ferritin \<800 mg/dl
* Stable dose of epoetin of any types and iron therapy for at least 1 month

Exclusion Criteria:

* History of iron allergy
* Pregnant or lactating women
* Patients with known hematologic disorders other than anemia of renal disease and iron deficiency anemia
* Patients with hemoglobinopathy e.g., thalassemia
* Patients with iron overload or hemochromatosis
* Patients with gastrointestinal hemorrhage during 6 months before enrolment in to the study
* Patients with current severe infection
* Patients with any malignancies
* Patients with severe psychiatric illness
* Patients with any other medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
* Patients who currently receive medications that can altered gastrointestinal absorption of oral iron e.g., aluminum carbonate, aluminum hydroxide, chloramphenicol, dimercaprol
Glycaemic Responses to Cracker Snacks

The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (not less than 40% Male)
* Aged 18 - 55 years
* Non Smokers
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Not allergic to wheat, mustard, dairy, or soy
* Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent
A Study of Special Use Results Surveillance of Revlimid 5mg Capsules

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.


Eligibility Criteria:
Inclusion Criteria:

* Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

Exclusion Criteria:

N/A
Electrochemotherapy for Desmoid Tumors

The goal of this observational study is to learn about the effects of Electrochemotherapy (ECT) in patients with Desmoid Fibromatosis. The main question it aims to answer is:

Is ECT effective in reducing the size of the lesion and improving patients' symptomatology?

Patients will be followed with MRI and Quality of Life questionnaires at 3, 6 and 12 months after the intervention.

Desmoid fibromatoses are rare and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.

Other minimally invasive local treatments such as cryoablation have been shown to be effective; however, certain patients are not candidates for such treatment because of lesion location/characteristics.

An additional minimally invasive treatment with currently little evidence in the literature is arterial embolization. However, this procedure cannot be performed in the case of superficial lesions, nor in the presence of shared vasculature between the lesion and other healthy tissues or organs. In the absence of other treatments in use, electrochemotherapy treatment can be performed, which has proven effective on several other types of soft tissue and bone tumors, malignant or benign, treated at our Institute.

Electrochemotherapy is based on the principle whereby reversible electroporation causes the application of short, high-voltage electrical pulses to temporarily align water molecules on the hydrolipid layer of the cell membrane, leading to a reversible local increase in permeability by increasing the intracellular concentration of Bleomycin and its toxicity on tumor cells by a factor of up to several thousand.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Desmoid Fibromatosis and in active phase (documented growth at last follow-up)
* Patients not eligible for surgery, cryoablation, or embolization
* Signature of study-specific informed consent.

Exclusion Criteria:

* Patients with fibromatosis not in active phase, documented clinically and with imaging investigations (MRI, CT)
* Patients with documented active infection
* Previous treatment for \< 30 days
* Pregnancy and lactation status
* Patients of childbearing age without contraceptive use for at least 3 months
* Presence of metal synthetic media at the site of treatment
* COPD with FiO2 \< 30 mmHg
* Impaired renal function with eGFR
Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy

The use of contrast media is more frequent as new diagnostic and therapeutic procedures are developed. As a consequence, the occurrence of acute renal failure (ARF), also known as contrast-induced nephropathy, is more frequently seen after the realization of these procedures, representing about 10% of all in-hospital ARF. The importance of preventing this complication is related with its strong association with higher morbidity and mortality rates in patients who present it. A number of drugs and interventions have been studied for preventing contrast-induced nephropathy, including intravenous hydration with normal and hypotonic saline solutions, oral hydration, mannitol, diuretics, dopamine and its antagonists (fenoldopam), calcium antagonists, theophylline, N-acetylcysteine, natriuretic atrial peptide and hemodialysis after or during contrast media administration.

There is only one study in humans that demonstrates the utility of the sodium bicarbonate to prevent the contrast-induced nephropathy, showing a reduction in the incidence of this complication of about 13.6%. Although this result could seem convincing, its relevance has been questioned because the definition used by the authors as contrast-induced nephropathy was an increase of 25% from basal creatinine. Although when compared, the absolute differences between basal and after-procedure creatinines were not statistically significative, the sample size was small and the participants were low-risk patients to develop contrast-induced nephropathy. It is also important to note that the control group was hydrated with a dextrose 5% solution with 154 mEq of NaCl, although today's most accepted prevention therapy is intravenous hydration with normal saline solution.

Comparison: Hydration previously, during and afterwards contrast media administration with normal saline solution (0.9%), compared to hydration previous, during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Indication for coronariography and/or percutaneous coronary intervention
* Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
* A MEHRAN contrast-induced nephropathy score of six or more

Exclusion Criteria:

* Patients with chronic kidney failure requiring any kind of dialysis
* Patients unable to complete follow-up
* Multiple myeloma
* Exposure to contrast 48 hours prior to study
* Pregnancy
* Patients unable to give consent
* Already receiving sodium bicarbonate solutions
* Receiving contrast media other than non-ionic
Quality of Life Among Breast Reduction Patients

Despite the growing evidence showing that breast hypertrophy is associated with reduced Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant positive impact on HRQL, there are unresolved issues that need to be addressed. These include our ability to measure quantitatively the change that occurs after reduction and the ongoing restriction or denials of third party payments based on body mass index (BMI). The primary purpose of this study is to assess and measure the HRQL experienced by breast reduction patients using four reliable and validated HRQL measures.

Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to participate in this prospective study. Participants completed the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO) instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day pre-surgery and one, six, and 12 months post-surgery.

This study addresses the following questions of clinical and policy relevance: 1) Is the pre-surgery HRQL of these patients compromised and, if so, in which areas? 2) Do patients' HRQL improve after surgery and, if so, when and in which areas and by how much? 3) Is there a relationship between BMI and pre-/post-surgery changes in HRQL (i.e., is the pre/post effect similar for both obese and non-obese patients)? and 4) Is there a relationship between tissue re-section weight and pre-/post-surgery changes in HRQL (i.e., is the pre/post HRQL effect similar for patients having small and large amounts of tissue resected)?

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast hypertrophy
* Government approval for payment of reduction mammoplasty

Exclusion Criteria:

* Unable or unwilling to complete the quality of life questionnaires