cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients

The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric participant, age 1 year to 17 years
* Attending an Emergency Department following an injury
* Acute pain of moderate or severe intensity
* Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion Criteria:

* Participant showing abnormal nasal cavity/airway such as:

  1. major septal deviation
  2. evidence of previous nasal disease or surgery
  3. current significant nasal congestion due to common cold
* Has received treatment with sufentanil and/or ketamine during the last 72 hours
* Known or suspected allergy to ketamine or sufentanil
* Critical, life- or limb-threatening condition requiring immediate management
Total Intravenous Anesthesia: TCI Versus MCI

test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) :

* remifentanil and propofol total dose given
* incidence of awareness or inadequate anesthesia
* number of rescue dose given


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing breast or thyroid surgery

Exclusion Criteria:

* BMI \> 35
* Surgery shorter than 30 minutes
* Patients with history of: alcol or drug abuse, kidney or liver failure, cardiovascular disease
Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support Program

The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available.

The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.

This is an observational study with focus on existing pregnancy reporting forms (retrospective part) and a patient's questionnaire which is completed at a single point of time (prospective part). Main data source for the retrospective data (from 2014 until December 2019) will be captured from multiple sclerosis service-center (MSSC) database, i.e. the entered pregnancy report (to be completed as soon as pregnancy becomes known) and pregnancy outcomes report (to be completed after completion of pregnancy).

Prospective data (December 2020 to 31 March 2021) will be captured as standardized ePDF questionnaire completed during telephone interview. If the pregnancy report or the pregnancy outcome report is incomplete, i.e. the data above was not collected, the open questions will be addressed during a telephone interview performed by the MSSC and the new information will be entered into the MSCC database. The patient questionnaire will be completed at a single point of time during the telephone interview performed by the MSSC.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) (CIS indication only applicable for interferon beta-1a)
* Exposure to either SC Peginterferon beta-1a therapy or an IM Interferon beta-1a therapy before or during pregnancy
* Registered in the PSP of the multiple sclerosis service- center (MSSC) and agreed in writing to the privacy policy of the registration form
* Reported pregnancy data (pregnancy report and pregnancy outcome report) available at MSSC. Note: only pregnancy data (i.e. obtained until 15 October 2020) will be considered.
* Pregnancy outcome in the retrospectively collected data was a live birth

Exclusion Criteria: Any criteria that does not fulfil the above-mentioned inclusion criteria.

NOTE: Other protocol defined Inclusion criteria may apply
Brazilian Randomized Study - Impact of MRI for Breast Cancer

The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density.

The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer.An accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.Currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.However, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.MRI has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Female,
* Over 18 years with breast cancer
* Clinical stages I, II and III candidates for conservative surgery

Exclusion Criteria:

* Contra-indication for breast MRI (ex. Metal implant)
* Claustrophobia
* Impossibility to stay in the prone position for more than an hour
* History of allergic reaction to the paramagnetic contrast
* History of chronic kidney disease on dialysis
* Personal history of breast cancer treated surgically in the last 12 months.
* Pregnancy or breastfeeding past 6 months
Study of Post-Training Supports for Health Workers in Benin

The objective of this study was to determine the effectiveness and cost-effectiveness of a package of interventions to support health workers in Benin (in West Africa) who had been trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines intended to improve the treatment of childhood illnesses).

Integrated Management of Childhood Illness (IMCI) is a child health strategy in developing countries with a goal of improving the treatment of illnesses at first-level health facilities through the use of clinical practice guidelines. The World Health Organization (WHO) recommends implementing the guidelines with an 11-day training course. There is a concern that health workers might not master all aspects of the guidelines and that health worker performance may deteriorate over time. In 1999, Benin (in West Africa) was planning to implement IMCI. In response to concerns about how well health workers would follow IMCI guidelines, interventions were designed to support health workers after IMCI training: 1) regular supervision of health workers; 2) supervision of supervisors; 3) job aids; and 4) non-financial incentives for health workers. These interventions were intended to be used together. The objective of this study was to determine the effectiveness and cost-effectiveness of the package of interventions to support IMCI-trained health workers in Benin.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for health facilities were: 1) public and licensed private health facilities providing outpatient services, and 2) the level of care was appropriate for use of Integrated Management of Childhood Illness (IMCI) guidelines.
* Inclusion criteria for consultations were children 1 week - 59 months old seen for any illness during regular working hours (typically 8am-6pm) on weekdays.

Exclusion Criteria:

* Health facilities in which the level of care was not appropriate for use of Integrated Management of Childhood Illness (IMCI) guidelines(i.e., one referral hospital and one sub-specialty hospital).
Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in improving patients' early recovery.

Enhanced recovery after surgery (ERAS) has been formed of procedure which contains preoperative education, improvement of anesthesia, reducing the number of drainage tubes, and early diet after surgery. In recent years, because of its positive advantages, ERAS was widely accepted in surgical fields.

For upper gastrointestinal surgery, high-carbohydrate drinks can be given 2 hours before surgery in order to guarantee the stability of blood glucose and circulation during the operation. It obviously reduce the preoperative thirst, hunger, irritability and even the incidence of postoperative complications.

However ERAS program is rarely studied in ERCP. Theoretically we can use ERAS as a strategy to reduce post-ERCP uncomfortable and complications.

Eligibility Criteria:
Inclusion Criteria:

* ERCP patients,
* Age 18-85 years old.

Exclusion Criteria:

* Coagulation dysfunction (INR\> 1.3) and low peripheral blood platelet count(\<50×109 / L) or using anti-coagulation drugs,
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, shock, liver or kidney malfunction,
* Diabetes（blood glucose fluctuations）or with complications,
* Intestinal obstruction or other contraindications with feeding and watering,
* Prior surgery of Bismuth Ⅱ and Roux-en-Y,
* Pregnant women,
* Unwillingness or inability to consent for the study.
The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control

Life style changes, particularly in dietary patterns have contributed a great deal to the incidence and risks of type 2 Diabetes. Decreased intakes of vegetables and fruits replaced by pre processed food, added sugar and those of animal origin lead towards rapid increase of adult-onset-diabetes.

In spite of the knowledge of the benefit of consuming vegetable and fruits, and people are well informed, they still need to be committed to perform a behavior and implement these intention. Behavioral approach methods have demonstrated successful adherence in health education with life style changes.

Objective: To identify the impact of The Empowerment Model to enhance vegetable intake in Type 2 Diabetes Mellitus adults in achieving glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* fasting blood glucose ≥126 mg/dL
* HbA1C \>8%

Exclusion Criteria:

* those who have serious, unstable medical conditions, or related to metabolic disorders (i.e. thyroid diseases)
* significant co-morbid illnesses such as liver disease, kidney disease, cancer, bowel diseases/ malfunction, pregnancy or nursing mothers.
Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay

Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay.

Few randomized intervention inpatient trials have been conducted in Latin America to determine optimal treatment regimens for patients with type 2 diabetes. In the absence of regional guidelines, most international societies in Latin America recommend following international guidelines for the management of hospitalized patients with diabetes. However, hospital resources, admission cause and inpatient glycemic control differ among countries. In the US, the leading cause of admission to the hospital in patients with diabetes is cardiovascular disease, whereas infections and acute complications of diabetes are more common than cardiovascular disease in some countries. The safety and efficacy of insulin regimens in non-ICU setting in Latin countries have not been determined. Objective: to compare the efficacy and safety of a basal-bolus regimen using insulin analogs with glargine once daily plus glulisine before meals to human insulin with NPH twice daily and regular insulin before meals in medicine patients with type 2 diabetes Outcome measures. To determine differences in glycemic control between groups as measured by mean daily BG concentration during the hospital stay. Secondary outcomes included differences between treatment groups in any of the following measures: number of hypoglycemic events (BG \<70 mg/dL and \<40 mg/dL), total daily dose of insulin, length of hospital stay, hospital complications and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* History of type 2 diabetes \> 1 month
* Treatment with diet alone, any combination of oral antidiabetic agents, and/or insulin prior to admission
* Absence of diabetic ketoacidosis

Exclusion Criteria:

* No history of diabetes
* Subjects expected to undergo surgery during the hospitalization course
* Clinically relevant hepatic disease
* Impaired renal function (serum creatinine ≥ 3.0 mg/dL)
* Pregnancy
* Any mental condition rendering the subject unable to give informed consent
Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
* Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels)
* Kidney transplant patients who \>90 days (+/- 2 weeks) post-transplant will be included in this study

Exclusion Criteria:

* Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
* Recipients of previous non-renal solid organ and/or islet cell transplantation.
* Infection with HIV.
* Infection with BK nephropathy.
* Patients that have nephrotic proteinuria (urine protein \>3 gm/day).
Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT

The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.

Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.


Eligibility Criteria:
Inclusion Criteria:

* Patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations;
* Age over 18 years
* Clinically stable (without hospitalization for heart failure in the last month)
* Sinus rhythm
* Social security insurance
* Signed consent form

Exclusion Criteria:

* Recent history (less than 21 days) of acute coronary syndrome or unstable angina;
* Recent history (less than 1 month) of acute heart failure;
* Right bundle branch block;
* Irregular heart rate;
* Double-chamber cardiac pacemaker
* Patients previously implanted with a single-chamber cardioverter-defibrillator must have at least 99 percent of unstimulated QRS.
* Countraindication to dobutamine therapy;
* Valvular heart disease, congenital heart disease, hypertrophic cardiomyopathy;
* Significant Ventricular arrhythmias;
* Hypertension (upper than 160/100 mmHg);
* Pregnant, breastfeeding or guardianship
Ivermectin in the Treatment of Head Lice

The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.

Head lice infestation occurs frequently, primarily in children 3 to 11 years of age. In recent years an increasing prevalence of lice infestation in schools, day care centres, and summer day camps is believed to be partly due to increasing lice resistance to currently available standard treatments for pediculosis (infestation with lice). There is a need for new effective backup treatments for this common condition of head lice infestation. This is a double-blind, randomized, parallel-group, study in several clinical centres comparing ivermectin as tablets to malathion 0.5% lotion in the treatment of head lice. All enrolled patients participate in the primary phase of the study up to the Day 15 evaluation. Patients who are still infested with lice at Day 15 (treatment failures) will enter an extension phase and be treated in a double-blind, fashion with the opposite treatment (ie ivermectin or malathion). The study hypothesis is that ivermectin will be more effective than malathion in clearing head lice infestation , as measured by the proportion of patients who are lice-free at Study Day 15.

Eligibility Criteria:
Inclusion Criteria:

* Head lice infestation confirmed by detection combing by study staff
* previous (within 6 weeks) use of a topical insecticide product
* minimum 15kg weight
* providing informed consent

Exclusion Criteria:

* pregnant or nursing patients
* households with 7 or more infested patients
* households where there are other known infested household members not participating
* head lice treatment within 2 weeks of entry
* active scalp infection
* any difficulty with combing assessment
* patient from region endemic for certain parasitic worm diseases
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses

To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. The use of the device for the treatment of peripheral arterial disease is approved by the FDA, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old
* Patient has clinical manifestations (i.e. symptoms and/or signs) of chronic DVT of an extremity. The Venous Clinical Severity Score (VCSS) will be used to determine if the patient is currently suffering from chronic DVT, with a VCSS score of 4 or greater necessary for inclusion.
* Imaging confirmation of venous occlusion or stenosis (\>50%) involving the femoral, and/or popliteal veins
* Obstructed vessel caliber can accommodate a 7FR System, from insertion site to target segment
* Patient is able to read and answer a questionnaire in English

Exclusion Criteria:

* History of life-threatening reaction to contrast material
* Unwilling or unable to provide informed consent, or return for required follow-up evaluations
* Participating in another investigational study that has not completed follow-up testing
* Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists (VKAs)
* Absolute contraindication to contrast media or renal insufficiency (baseline creatinine \>2.0 mg/dL).
* Either a history or presence of heparin-induced thrombocytopenia antibodies
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)

This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.

Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with PCOS. The aim of this study was to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
* Were between the ages of 18 and 40

Exclusion Criteria:

* Were under 18 years or greater than 40 years old,
* Were non-Caucasian
* Were pregnant, lactating or trying to conceive
* Had a body mass index (BMI) \<18kg/m2 or \>50kg/m2
* Had a recent illness or any chronic illness likely to influence results
* Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents
* Were taking nutritional supplements
* Consumed greater than 2 portions of oily fish per week