cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants mechanically ventilated
* requiring peripherally induced central catheterization
* with informed consent of their parents

Exclusion Criteria:

* major congenital anomalies
* cardiopulmonary instability
* use of sedative, antiepileptic drugs or anesthetic drugs
* grade III or IV intraventricular hemorrhage
Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan

the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.

The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of eclampsia
* must accept to participate in the study

Exclusion Criteria:

* epilepsy
Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms

This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated and require medical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 4 to 75 years (inclusive)
* Body weight ≥ 12 kg and \< 100 kg.
* Females of child-bearing potential must have a negative pregnancy test. Additional birth control details to be provided at screening.
* Documented molecular diagnosis of NALP3 mutations and clinical symptoms that are either untreated or insufficiently treated and require medical intervention.
* Patients under anakinra therapy or any other IL-1 blocking therapy, whose clinical symptoms improved under treatment and are willing to discontinue that therapy until a relapse becomes evident.
* Patients with a very severe characteristics requiring oral prednisone are eligible if the dose is stable (≤ 0.4 mg/kg/day or ≤ 20 mg/day, whichever is lower) for at least 1 week prior to the screening visit. Steroid therapy may be tapered during treatment with ACZ885 at the discretion of the investigator.
* Parents' or legal guardian's written informed consent (patient's informed consent for ≥ 18 years of age) and child's assent, if appropriate, are required prior to study participation.

Exclusion Criteria:

* Participation in any clinical trial investigation (except trials with anakinra) within 4 weeks prior to dosing or longer per local regulation
* Antiinflammatory therapy with colchicine, chlorambucil, dapsone, azathioprine, mycophenolate mofetil, within 3 weeks prior to dosing. Therapeutic antibodies (e.g. anti-TNF-alpha antibodies) must be discontinued at least 60 days before dosing.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* A past personal or close family medical history of clinically significant ECG abnormalities or prolonged QT-interval syndrome.
* History of

  * Immunocompromise, including a positive HIV result.
  * Positive Hepatitis B surface antigen or Hepatitis C test result.
  * Drug or alcohol abuse within the 12 months prior to dosing.
  * Tuberculosis.
  * Renal transplant.
  * Evidence of lymphoma.
* Active medical condition preventing participation in the study such as infection, poorly controlled diabetes etc.
* No live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)

The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if:

* they are toddlers, aged 12 to 18 months
* they are clinically healthy (i.e. the physician would have no reservations vaccinating with a MenC conjugate vaccine, and/or PCV7 outside the scope of a clinical trial)
* their parents/legal guardian(s) understand the nature of the study, agree to its provisions, and provide written informed consent
* their parents/legal guardian(s) agree to keep a Subject Diary
* they have received a complete primary series of pneumococcal conjugate vaccine (3 vaccinations with PCV7 in the first year of life according to the official vaccination calendar recommendations)

Exclusion Criteria:

Subjects will be excluded from participation in this study if:

* they have a history of any vaccine-related contraindicating event, e.g. serious reactions after first application of a PCV7 vaccine or high fever \>= 40ºC associated with any vaccination, or generalized allergic reaction within 48 hours of a first application of vaccine
* they have a known sensitivity or allergy to any components of the vaccines
* they have previously been vaccinated with MenC vaccine
* they have already received a PCV 7 booster (4th vaccination)
* they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation
* they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
* they have a history of meningococcal serogroup C and/or invasive pneumococcal infection
* they have received any blood products or immunoglobulins within 90 days of study entry or the administration of such products is planned during the study period
* currently have or had a history of any serious disease (e.g. cardiac, renal, autoimmune, neurologic)
* were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
* they or their parents /legal guardian(s) are in a dependent relationships with the study investigator or with a study team member. Dependent relationships include close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
Prospective Study to Determine Impact of Early Palliative Care Consult on Quality of Life (QOL), Cancer Related Symptoms In Advanced Lung Cancer Patients: Thoracic Pilot Project

The goal of this study is to learn about the quality of life (QOL) in participants with advanced lung cancer.

Advanced lung cancer (ALC) will be assessed for participant outcomes in a sample which is prior initiation of palliative consultation and in a sample after the initiation of early palliative consultation.

Study goals are:

I. To determine the differences in participant outcomes including quality of life (QOL); symptom distress \[Edmonton symptom assessment scale (ESAS)\] and caregiver outcomes \[Zarit Burden Interview {ZBI}, Hospital Anxiety and Depression scale(HADS) and FAMCARE\] at week 12 in advanced lung cancer (ALC) patients receiving early palliative care consultation versus those who don't.

II. Identify the cellular, molecular, and immune basis for the development of symptoms in patients with ALC.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnoses of advanced NSCLC (defined as locally advanced or metastatic)
2. Have no clinical evidence of cognitive failure, as evidenced by a Memorial Delirium Assessment Score of less than or equal to 7 of 30 ⁭at the time of consent.
3. Be at least 18 years of age.
4. Be able to understand the description of the project and give written informed consent.
5. Plan to receive their cancer treatment at MD Anderson Cancer Center.
6. Individuals with advanced cancer who are able to identify a primary caregiver who also agrees to participate (in person or by telephone) in the study. A caregiver will be defined as a spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living.

Exclusion Criteria:

1. Patients to be excluded from the study will be those unable to complete the baseline assessment forms or to understand the recommendations for participation in this project.
2. Patients seen at the Thoracic center at UT MD Anderson Cancer Center after 8 weeks of the initial diagnosis (first cohort only - patients using the current Palliative Care referral practices prior to the implementation of the early palliative care program).
Effect of COVID-19 Lockdown on Alcohol and Tobacco Use in Two Chilean Universities

This is a longitudinal study of participants from two university communities in Chile. The primary objective is to examine the effect of a regional lockdown on alcohol and tobacco use, using a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.

The COVID-19 pandemic is spreading worldwide. Countries have adopted public health and social measures that, together with a direct effect of the pandemic, can affect alcohol and tobacco use. The most stringent measures are lockdowns and curfews that include statutory restrictions on people's mobility. Research to date has shown mixed effects of the COVID-19 pandemic and lockdowns on alcohol and tobacco use. Importantly, previous studies have not been able to differentiate the effects of the pandemic itself with those from lockdown and curfew policies. They have also been restricted to countries in Europe, the United States, Australia and New Zealand.

The study will advance prior knowledge by providing evidence from a country in Latin America, one of the worst-hit regions worldwide. Latin America accounts for 8.4% of the global population, but 20.3% of the total SARS-COV2 cases and 30.2% of the COVID-19 deaths to date. In addition, the study will exploit the variation in lockdown policies in two regions in Chile to disentangle the effects of the COVID-19 pandemic with those from a lockdown.

The aim of the study is to examine the effect of a regional lockdown on alcohol use in two university populations in the Araucanía and Coquimbo regions in Chile. The investigators will use a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.

Eligibility Criteria:
Inclusion Criteria:

* People with study rights either at the undergraduate and postgraduate levels by July 27, 2020 at the Universidad de la Frontera or Universidad Católica del Norte; OR
* Workers with a full-time or part-time contract with either University, including academics, administrative and assistant personnel; AND
* Having an email registered in the Human Resource Office of each university

Exclusion Criteria:

* People without valid study rights at either university
* People without a working contract with the university
* Not having an email registered at the Human Resource Office
The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* Current basal-bolus insulin therapy
* HbA1c \< 10%
* BMI \< 32 kg/m2

Exclusion Criteria:

* Proliferative Retinopathy / Maculopathy
* Recurrent major hypoglycaemias
* Impaired hepatic or renal function
* Cardiac Problems
* Uncontrolled hypertension
Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients

Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

We designed a randomized double blinded study to evaluate the efficiency of UDCA in the treatment of duodenal adenomas. One hundred patients are planned to be included. Fifty will receive UDCA and fifty a placebo. Three duodenoscopies are planned: one before inclusion, one at the end of the first year of follow-up and one after two years of follow-up at the end of the protocol. These duodenoscopies are associated to endoscopies of the ileal reservoir performed at the time of restorative proctocolectomy and are recorded numerically. Severity of the duodenal adenomas are evaluated according to the SPIGELMAN score. Patients are seen every 6 months. Before each endoscopy, blood samples are collected for biliary acid profile analysis. Moreover, during endoscopies, duodenal fluid and ileal fluid are collected for biliary acid profile analysis, also.

At the end of the follow-up of the last patients included (nov 2008), biliary acid profile analysis will be performed and statistical analysis of the results will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 65 years of age
* Weight less than or equal to 100 kg
* Restorative proctocolectomy
* Activated protein C (APC) mutation identified or more than 100 polyps on the colectomy specimen
* SPIGELMAN score of duodenal adenoma greater than or equal to 1
* Efficient contraceptive treatment for pre-menopausal women
* Cooperative patient
* Signed consent
* Social security insurance

Exclusion Criteria:

* SPIGELMAN score of duodenal adenoma equal to 4 with severe dysplasia
* Hepatic disease
* Intermesenteric desmoid tumour
* Any severe disease
* Daily use during the last 3 months of:

  * aspirin;
  * non-steroid anti-inflammatory drugs;
  * tamoxifen;
  * cholestyramine.
* Pregnancy
* Breast-feeding
Tracking Renal Tumors After Cryoablation Evaluation

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

The registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject. A subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care. Physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of TRACE. Subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician. The enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.

Eligibility Criteria:
Suggested Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient has a renal lesion suspicious for malignancy.
* Patient is to undergo renal lesion cryoablation via a Galil Medical cryoablation system using Galil Medical needles for treatment of primary or recurrent disease.
* Patient is to be available for long-term follow-up per the enrolling physician's standard care practices.
* Patient has provided written informed consent.

Suggested Exclusion Criteria:

* Patient is either currently using or has used within the last 30 days an investigational product of any type.
* Patient has metastatic disease to or from the kidney.
* Patient has had previous therapy on the index lesion (e.g. radiofrequency, cryoablation, partial nephrectomy).
Helping Moms to be Healthy After Baby

Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:

Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.

Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.

Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.

Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman (≥18 and \<50 years old).
* Enrolled in WIC or with an infant enrolled in WIC.
* 3-12 months postpartum.
* A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy).
* Postpartum body mass index between 25 and 50 kg/m2.
* English- and/or Spanish-speaking.
* Owns a mobile phone with texting functionality in order to receive texts during the trial.

Exclusion Criteria:

* Health conditions impacting weight or ability to participate in a weight loss trial.
* Pregnancy or planned pregnancy in next 5 months.
* Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise.
* Medical provider recommendation to avoid exercise.
* Plans to be in a different geographic area within the next 5 months.
* Plans to stop coming to Aurora WIC in the next 5 months.
* Unable to give informed consent.
* Not able to read and understand English or Spanish at an 8th grade level.
* Not willing to create a Facebook account if they do not already have one.
* Asked to follow-up in \< 3 months at most recent WIC visit.
Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)

The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
* Adequate organ and bone marrow function

Exclusion Criteria:

* Presence of brain or central nervous system (CNS) metastases, unless successfully treated
* Prior therapy with rapamycin or rapamycin analogs
* Ongoing toxicity associated with prior anticancer therapy
* History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient
MIN PLAN VS CBT for Suicide Prevention

1. To investigate the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) in University students with Suicide Risk
2. To compare the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) against MinPlan tool in University students with Suicide Risk


Eligibility Criteria:
Inclusion Criteria:

* Participants who are not taking any psychological help or psychotherapy in the past and present.
* Participants who are at risk of suicide without a history of suicidal attempts but with a history of suicidal ideation in the past two months will be included.

Exclusion Criteria:

* Participants with a history of substance misuse/drug dependence/alcohol dependence and psychosis.
* Participants diagnosed with dementia, schizophrenia, delirium, bipolar disorder, and learning disability.
* Participants with a diagnosis of DSM-V mental disorders due to general medical condition.
* Participants who are taking any psychiatric medication.
* Participants residing on a temporary basis in the study area.
Fats And Carbohydrates Quality on Postprandial glycemIc Response in Type 1 Diabetes

The purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. This interaction between quality of fat and glycemic index of carbohydrates may have clinical implication for the calculation of prandial insulin dose in these patients.


Eligibility Criteria:
Inclusion Criteria:

-Type 1 diabetes treated by insulin pump

Exclusion Criteria:

* Pregnancy
* Celiac disease