cyrilzakka/clinical-trials huggingface dataset:
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.


Eligibility Criteria:
Inclusion criteria:

* Signed and dated written informed consent
* Male or female patient receiving insulin for treatment of T1DM for at least 12 months
* C-peptide \< 1.5 ng/mL
* Age 18 to 65 years
* HbA1c of 7.5% to 10.5%
* Multiple daily injections (MDI) of any type of insulin
* Willing to follow an established and individualized carbohydrate counting method and an insulin administration algorithm
* Body Mass Index of 18.5 to 35.0 kg/m2
* Estimated glomerular filtration rate 60 to 150 mL/min/1.73 m²
* Able and willing to perform study assessments according to investigator's judgement
* Compliance with trial drug administration 80% to 120% during run-in period
* Willing not to take any paracetamol containing drugs during the trial

Exclusion criteria:

* Acute symptomatic urinary tract infection or genital infection, chronic or recurrent cystitis
* History of type 2 diabetes mellitus, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
* Pancreas, pancreatic islet cells or renal transplant recipient
* Type 1 diabetes mellitus treatment with any other antihyperglycaemic drug except insulin within last 3 months or history of clinically relevant hypersensitivity
* Occurrence of hypoglycaemia that required hospitalization or treatment by an emergency physician or paramedic within last 3 months
* Hypoglycaemia unawareness or frequent episodes of unexplained hypoglycaemia
* Occurrence of diabetic ketoacidosis that required hospitalization or treatment by an emergency physician or paramedic within last 12 months
* History of macrovascular disease including cardiovascular, cerebrovascular and peripheral artery disease
* Autonomic neuropathy with gastroparesis
* Brittle diabetes
* Liver disease
* Treatment with anti-obesity drugs, surgery or aggressive diet regimen leading to unstable body weight
* Treatment with systemic corticosteroids
* Change in dose of thyroid hormones within last 6 weeks or planned change or initiation of such a therapy
* Medical history of cancer or treatment for cancer in the last five years
* Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
* Alcohol or drug abuse that would interfere with trial participation or any ongoing clinical condition that would jeopardize patient's or site personnel's safety or study compliance
* Intake of an investigational drug in another trial within last 30 days
* Not able to understand and comply with study requirements
* Pre-menopausal women who are nursing or pregnant or of child-bearing potential and are not practising an acceptable method of birth control
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty. A Prospective Randomized Study

Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty • Patients aged 40-80 years with a body mass index of 18-36 kg/ m2 and an American Society of Anesthesiologists functional status of I-III Planned use of regional anesthesia

Exclusion Criteria:

* • Patients younger than 40 years old and older than 80years.

  * Hepatic or renal insufficiency.
  * Patients undergoing general anesthesia.
  * Allergy or intolerance to one of the study medications.
  * BMI \> 36
  * Diabetes
  * ASA of IV
  * Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment

The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study are: Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), Bromocriptine (Parlodel). Specifically, the study will collect nasal swabs of participants partitioned into two groups, those who have not used a dopamine agonist or been on a dopamine agonist for less than 1 month compared to those who have been on the medication for 6 or more months. This research could provide insight into changes in dopaminergic gene expression associated with Augmentation Syndrome (AS) which occurs after long term dopamine agonist treatment in RLS patients.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide Informed Consent
* Clinical diagnosis of Restless Legs Syndrome (RLS)
* On-going Treatment with a dopamine agonist

Exclusion Criteria:

\* Use of any medication that might affect nasal epithelial cell collection with a nasal swab
A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires

The objective of this observational study of dengue seroprevalence in the metropolitan area of Buenos Aires is to know what percentage of the population has antibodies against dengue in persons 18 years of age or older who are residents of the city of Buenos Aires or its metropolitan area. The main questions to be answered are:

* What is the seroprevalence of antibodies against dengue measured by Immunoglobulin G determination by ELISA
* Characterize the different dengue serotypes in the affected population. Participants will undergo a small blood draw to determine the presence of Immunoglobulin G antibodies against dengue.
* Tests will also be performed to determine infection by flaviviruses other than dengue virus.

A two-stage stratified design will be used. The primary sampling units will be mostly defined as the census sections of the 2010 National Census of Population, Households and Dwellings. It has 5 strata, constructed through a functional relationship between the income quintiles obtained in the Annual Household Survey (AHS) and the variables that were surveyed in the census. Stratum 1 corresponds to the lowest income population, while stratum 5 corresponds to the highest. The first stage of sampling in this framework will consist of about 100 to 300 primary sampling units, called primary units areas, selected with a probability proportional to size, the measure of size being the total number of dwellings.

A sample of 1,487 dwellings is proposed. In each primary unit area, a number of dwellings will be selected to be visited by enumerators, who will make a list of all members residing in the dwelling (regardless of whether they are from the same household) and select a member aged ≥18 years to proceed with the survey. This last selection is a 3rd and final sampling stage that will define the sample of 1487 participants to be tested. The sample size was calculated based on the estimated probability of pre-infection for each of the municipalities and localities participating in the survey.

Eligibility Criteria:
Inclusion Criteria:

* - Age ≥18 at the time of signing the informed consent.
* - Resident of the Buenos Aires metropolitan area

Exclusion Criteria:

* To be ≤17 years old.
* Inability to give informed consent.
Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound

Children with clinical signs of severe dehydration will be examined by ultrasound in a supine position during admission. Children aged between 1 and 15years will be divided into three weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver will be recorded. After a defined fluid infusion within 60 minutes, a second examination will be evaluated and compared with the first one. The investigators considered also echocardiography to measure CO changes however they wanted to make it as simple as it might be at emergency during the night shift without an experienced cardiologist.

Only children admitted to the hospital with clinically detectable dehydration (weight loss, dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine position, the ultrasound probe will be placed in the substernal area, in the longitudinal and transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI max x100). Immediately after this examination measurement of the right VJImax, min and the left VJImax, min will be measured again in the supine position, then after passive leg raise (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will be measured. The collapsibility index for right and left VJI would be calculated according to the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI will be evaluated the same way as first and compared with the previous one.

Eligibility Criteria:
Inclusion Criteria:

* previously healthy children
* history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)

Exclusion Criteria:

* congenital heart diseases
* intestinal obstruction
* any signs of abdominal hypertension
* any illnesses known to affect the volume status
Peer- and Self-rating of Open Surgery Skills

The study group want to investigate whether doctors, who are in the beginning of their training to become surgeons, can rate themself and their peers using Objective Structured Assessment of Technical Skills. Participants have participated in a 6 weeks course in basic open surgical skills. At the end of the course the participants will be examined at at videotaped test. The participants will be asked to rate their own video and two videos of other trainees' performances. Ratings will be compared to expert ratings.

The study is a prospective, descriptive study investigating whether doctors are able to rate their own and their peers' performance in a basic open surgery skill course. At the end of the course in basic open surgery, participants will be examined at the post-test as described in the protocol "The effect of group dynamics in surgical skill training". After the participants complete the post-test, participants will be asked to participate in this additional study. The participants will receive no instructions on this additional study, before they complete the study "The effect of group dynamics in surgical skill training".

Eligibility Criteria:
Inclusion Criteria:

* Participants are medical doctors and medical students who completed the study "The effect of group dynamics in surgical skill training" as part of the control group.
* The participants must be willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Participants who do not finish the basic open surgery course
* Medical doctors and medical students enrolled in the study "The effect of group dynamics in surgical skill training" that are randomized to dyad training
Trial of Malaria Seasonal IPTc Combined With Community Case Management

Malaria is a major public health problem. 250 million cases annually leads to approximately 1 million deaths. Over 80 per cent of these deaths occur among African children under age five. The main interventions covered treatment with Artemisinin Combination Therapies (ACT), long lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria diagnosis. This has led in Senegal to a substantial decrease in the incidence of malaria, in 2009. However the recent overall decline hides the fact that malaria incidence remains very high in the south of Senegal. That's why Home-based management (HMM) for malaria is being introduced in selected areas. Intermittent Preventive Treatment (IPT) by monthly administration of a therapeutic dose of antimalarials can achieve a very high degree of protection from attacks of clinical malaria in children. The purpose of this project is to evaluate the effectiveness of combining IPTc with HMM in southern Senegal

The study objectives are to :

* Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in areas with a longer transmission season,
* Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine + Amodiaquine can offer in populations where a rapid and early care with home management of malaria is already established.
* Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized controlled trial has been designed to evaluate the effectiveness of adding seasonal IPTc with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in villages where home-based management of malaria is implemented. All villages in Saraya district, excluding 7 villages with a health post, will be eligible to participate. Saraya villages will be combined to form 24 clusters which will be randomized to receive HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community Medicine Distributors (CMD) will provide HMM. The primary endpoint will be the incidence of clinical malaria with fever or history of fever and parasitaemia with density of at least 3000/ul. Secondary outcomes will include the safety, the tolerability, the coverage and acceptability of the intervention. Both the recurrent and capital costs to the health service of training staff and delivering the interventions will be estimated. Both direct and indirect costs to users of the services (children and their families) will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* age between 3 to 120 months
* consent participation given by parents or guardians
* willing to remain in the study area in the next 6 months

Exclusion Criteria:

* Known allergy to the study investigational drug
* Any underlying chronic or severe condition.
* Participant under Treatment with sulfamides
Ultrasound Guided Peripheral Intravenous Catheterization in the Pediatric Intensive Care Unit.

This is a randomized controlled prospective study. The purpose of this study is to compare a recently described technique of ultrasound (US) guided, dynamic needle tip positioning (DNTP), to the traditional technique of vein visualization and palpation for peripheral venous cannulation in intubated, sedated, and mechanically ventilated pediatric intensive care unit (PICU) patients. First attempt success rate, overall success rate within 3 attempts or 10 minutes (whichever comes first), number of attempts to success, time to success and cannula sizes will be compared between the 2 techniques. The study will include intubated, sedated and mechanically ventilated children, aged 0-18 years, hospitalized in the PICU who require peripheral intravenous (PIV) access for their management.


Eligibility Criteria:
Inclusion Criteria:

1. Invasively ventilated
2. Younger than 18 years
3. Peripheral venous access required
4. Difficult intravenous access (DIVA) score of 4 or greater (on a scale of 0-10 with higher scores implying more difficult access)

Exclusion Criteria:

1. Refusal to consent
2. Research staff not available
Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.

Epidermal growth factor receptor(EGFR) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. EGFR tyrosine kinase inhibitor(TKI), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with EGFR gene mutation. In addition, monoclonal antibodies to EGFR, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer.

The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80%. Clinical features include acneform folliculitis, xerosis, paronychia, and itching. Of these, about 10% of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results.

There have been many attempts to prevent or treat such skin toxicity. However, there has been no scientifically proven treatment until now.

There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors, as a result of studies that improve acne significantly compared to placebo.

The purpose of this study is to evaluate the preventive efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* Patients scheduled to receive EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) as malignant tumors
* Patients who can understand and follow the protocol
* Patients who spontaneously agreed to the study

Exclusion Criteria:

* Patients with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks of other skin disorders
* Patients with existing acne history
* Breastfeeding or pregnant women
* Patients who are deemed unsuitable for the examination by the researcher's judgment
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches

This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal, non-pregnant, non-lactating
* History of migraine headaches without aura for at least 6 months
* History of migraine headaches associated with menstruation
* Others as directed by FDA-approved protocol

Exclusion Criteria:

* History of migraine headaches with aura or focal neurological symptoms
* Any contraindication to the use of oral contraceptives
* Others as dictated by FDA-approved protocol
Effect of Oliceridine on Rebound Pain

The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old;2. Body mass index (BMI) 18-30kg /m2;3. American Society of Anesthesiologists (ASA) Grade I to II;4. Hospital stay \>24h.

Exclusion Criteria:

1. Patients who cannot understand the numerical rating scale score and give feedback;2. Known allergy to the drug in the study;3. Infection of puncture site with nerve block;4. Oral analgesics for more than 2 weeks before surgery;5. Long-term use of glucocorticoids;6. Simultaneous surgery on both limbs;7. A psychopath;8. Severe compound trauma;9. Pregnant and lactating women.
Gender Identity and Own Body Perception

This study will provide valuable information on the neurobiological underpinning of gender dysphoria (GD) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment.

The purpose of this study is to understand the neurobiology of gender dysphoria (GD) and the interactions between cross hormone treatment, the brain, and the body phenotype. The investigators also aim to identify pre-treatment neurobiological and other factors to help predict body congruence and quality of life outcomes from hormone treatment. There is mounting interest in gender identity issues worldwide, as requests for gender-confirming treatments have increased in the past 3 decades, and alarmingly high suicide rates have recently been reported in those with GD. Despite this, little is known about neurobiological or other etiological factors contributing to GD or gender incongruence. This study will address a core feature of GD that has been little studied in terms of the neurobiology: the incongruence between perception of self and one's own body.

Eligibility Criteria:
Participants with gender dysphoria (GD)

Inclusion Criteria:

* Females and males from any racial or ethnic background, between the ages of 18 years and 40 years.
* Participants must meet Diagnostic and Statistical Manual-5 criteria for GD (302.85)
* Intelligence quotient (IQ) \> 80

Participants with GD

Exclusion Criteria:

* Previous or on-going sex hormone medication
* Previous sex reassignment surgery
* Oral contraceptives
* Participants with GD are not be taking any other psychotropic medication. (No participant will be recommended to discontinue or taper medications for the purpose of participating in the study.)
* Irregular menstrual cycles

Control participants

Inclusion Criteria:

* Females and males from any racial or ethnic background, between the ages of 18 and 40.
* IQ \> 80

Control participants

Exclusion Criteria:

* Psychiatric medications
* A score of ≥ 1 standard deviation higher than population norms on the MADRS depression or the Hamilton anxiety scale (HAMA)
* Sex hormone treatment
* Irregular menstrual cycles

Exclusion criteria for all participants:

* Any known chromosomal or hormonal disorder
* Current substance abuse or dependence
* Current neurological disorder or psychiatric disorder
* Pregnancy
* Current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
* Head trauma associated with loss of consciousness
* HIV positive individuals
* Individuals with ferromagnetic metal implantations or devices. This includes any electronic implants or devices, braces, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates
* Visual acuity worse than 20/35 for each eye as determined by Snellen close vision acuity chart. Acuity may be met with corrective lenses