cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir

The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.

The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.


Eligibility Criteria:
Inclusion Criteria:

* Women between 20-40 years of age with regular monthly menses
* If over age 35 then must not use tobacco
* Negative pregnancy test
* No known allergy to raltegravir
* No known history of phenylketonuria
* Undetectable HIV viral load
* No active liver disease as determined by medical history and normal AST and ALT
* No history of hepatic adenomas, carcinomas or benign liver tumors
* Ho history of thrombophlebitis of thromboembolic disease
* No history of deep vein thrombosis
* No history of cerebral vascular or coronary artery disease
* No known or suspected carcinoma of the breast
* No undiagnosed abnormal genital bleeding
* Not taking concomitant CYP 450 inducing medications such as anti-seizure medications
* No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening
* No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
* Has used raltegravir prior to screening
* Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)
* Must not have had an abnormal pap test defined without resolution in the last 18 months.
Vitamin D Testing and Treatment for COVID 19

This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.

Protocol for Part 1:

* A single blood draw at SCNM to measure levels of vitamin D and other nutrients, comprehensive metabolic panel, and complete blood count with differential
* Completing a medical history/symptom form
* Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks
* Authorization for release of medical records related to COVID 19 testing and/or treatment.

Protocol for Part 2:

* Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
* After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels of vitamin D, comprehensive metabolic panel, and complete blood count with differential. If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
* Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment begins (5 minutes each time).

Eligibility Criteria:
Inclusion Criteria for Part 1 (testing):

1. Adult age 18 or older
2. Previous positive test result for COVID 19
3. Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none

Inclusion Criteria for Part 2 (Vitamin D supplementation)

1. Participation in Part 1
2. Vitamin D level below 30 ng/ml
3. No abnormalities on the comprehensive metabolic panel that are clinically significant to increasing the risk of an adverse reaction to vitamin D supplementation

Exclusion Criteria for Part 2 (Vitamin D supplementation):

1. Liver impairment
2. Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
3. Pregnancy
4. No symptoms for 2 weeks after positive COVID 19 test
5. Recovered from symptoms
Obstetric & Pediatric Evolution Following Parental Refusal for Early Termination of Pregnancy Despite Fetal Risk

More and more parents decide to maintain pregnancy which could have been interrupted because of serious fetal pathologies.

In this observational study, the investigators examine obstetrical and pediatric evolution of these pregnancies, from 2006 to 2016 in Montpellier University Hospital.


Eligibility Criteria:
Inclusion criteria:

- refusal of termination of pregnancy despite serious fetal pathology

Exclusion criteria:

* termination of pregnancy
* termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with Diabetes Mellitus, it is important to determine the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of type 1 or type 2 diabetes.
* Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period.
* Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period.

Exclusion Criteria:

* Lab abnormality.
* Uncontrolled diabetic mellitus(HbA1c \> 12%).
* High or low blood pressure, orthostatic hypotension.
* Hyper- or hypo-thyroidism.
Cow's Milk Allergy and Functional Gastrointestinal Disorders

Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. It has been demonstrated that it could be a risk factor for the development of the functional gastrointestinal disorders in children. Intestinal microflora has been indicated as potential target for the management of CMA and FGDIs through the use of probiotics. Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following the addition of LGG, satisfying both the American Academy of Pediatrics guidelines. Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and exerted at different levels: epithelium, immune system and enteric nervous system. Studies and meta-analyses showed that LGG increases treatment success in children with functional gastrointestinal disorders.


Eligibility Criteria:
Inclusion Criteria:

* Children (aged from 4 to 6 yrs) with a history of sure diagnosis of cow's milk allergy obtained in the first year of life treated with hypoallergenic formula

Exclusion Criteria:

* Age higher than 12 months,
* concomitant chronic systemic diseases,
* congenital cardiac defects,
* active tuberculosis,
* autoimmune diseases,
* immunodeficiency,
* chronic inflammatory bowel diseases,
* celiac disease,
* cystic fibrosis,
* metabolic diseases,
* malignancy,
* chronic pulmonary diseases,
* malformations of the gastrointestinal tract,
* suspected eosinophilic esophagitis or eosinophilic enterocolitis,
* suspected food-protein-induced enterocolitis syndrome,
* suspected cow's milk proteins-induced anaphylaxis.
Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam

The purpose of this study is to develop and then test the feasibility, acceptability, and preliminary effect of a bidirectional text message smoking cessation intervention among Vietnamese smokers in Hanoi, Vietnam. The specific aim are: 1) To develop a smoking cessation text message library among Vietnamese smokers; 2) To evaluate message preferences, and the feasibility and acceptability of the bidirectional text message smoking cessation intervention; and 3) To assess the preliminary effect of a bidirectional mobile phone text message intervention on biochemically validated smoking abstinence.

For two-arm randomized control (RCT) pilot study (AIM 3), 100 current smokers will be observed to examine the preliminary effect of bidirectional SMS smoking cessation intervention. Subjects will be randomized into two groups (intervention vs. control), and compare the carbon monoxide (CO) validated 7-day point prevalence smoking abstinence rates at 4-week follow-up between intervention group (SMS smoking cessation treatment) and control group (assessment texts only).

Investigators will administer surveys at baseline, 4- and 12-weeks, and assess daily cigarette consumption using text message surveys. After the intervention, they will randomly select 10 participants from the intervention group to attend semi-structured interviews to obtain more in-depth understanding about the usefulness, usability, and acceptability of the intervention. Findings from the pilot RCT will be used to derive an estimate of the effect size, power, and sample size for a full-scale efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

* smoke ≥10 cigarettes per day
* capability to read and communicate
* plan to quit in the next 30 days
* has a mobile phone
* has experience using mobile phone text messaging during the past 6 months.

Exclusion Criteria:

* Under smoking cessation treatment or is participating in other tobacco cessation intervention
* pregnant or breastfeeding.
Dexmedetomidine and Vasopressin in Septic Shock

Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.

The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.

The investigator will include 260 patients with septic shock. The study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the DecatSepsis trial versus the standard of care. The standard of care is guided by the Surviving Sepsis campaign in 2021.

The main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, ICU scores, and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence of sepsis (≥2 SIRS criteria plus suspicion or confirmation of infection).

Exclusion Criteria:

* Patient refusal or inability to obtain consent
* Failure of hemodynamic stabilization or hemoglobin \<7 g/dL at the time of inclusion
* Severe cardiac dysfunction \[i.e., ejection fraction (EF) \<30%\]
* History of heart block or patient on pacemaker
* Severe valvular heart disease
* Chronic liver disease (Child-Pugh classification C)
* Pregnancy
* Patients with traumatic brain injury
Study of Histological Samples From Patients With Hereditary Haemorrhagic Telangiectasia

In this study the investigators will obtain histological samples from people with hereditary haemorrhagic telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome).

HHT is an inherited condition that leads to the development of dilated and fragile blood vessels. We propose to obtain small skin samples from patients with HHT in order to analyze the samples using histological methods, and study the properties of vascular endothelial cells derived from patients. We hypothesize that these cells will show differences when compared to normal endothelial cells, which may be confirmed in single time point analyses in histological samples. We anticipate that that these findings may help to explain aspects of the HHT disease phenotype.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Hereditary Haemorrhagic Telangiectasia

Exclusion Criteria:

* Unable to provide informed consent
Core Competency Model for Corrections

The overall goal of this project is to design, implement, and revise the Core Competency Model for Corrections (CCM-C), an evidence-based Self-Directed Violence (SDV) prevention training program for correctional mental health providers in the North Carolina Department of Adult Corrections (DAC). The proposed specific aims are:

Aim 1: To create the CCM-C training program. Aim 2: To assess preliminary training effectiveness. Aim 3: To gather training program quality improvement feedback from corrections stakeholders.

Investigators will conduct a pilot feasibility and preliminary effectiveness evaluation of the Core Competency Model for Corrections (CCM-C; Cramer et al., 2022). This training approach involves psycho-educational content, self-assessment tools, interactive exercises to address 10 clinical care and practitioner-focused skill sets for suicide and self-injury risk assessment and management. The protocol employs a waitlist control sequential cross-over design and mixed-method evaluation approach targeting 50-100 NC correctional behavioral health clinicians (BHCs). Through an ongoing academic-community partnership, investigators will employ a Corrections Advisory Panel (CAP) to provide expert review of training. The CAP will comprise six NC-DAC BHCs and 4-6 external BHCs with experience in correctional behavioral health. Two training groups will each provide three assessments via an online self-report evaluation battery gathering information regarding participant demographics; SDV prevention knowledge, attitudes, and perceived skills; incarceration-related attitudes; and perceived importance of and intention to use SDV prevention practices.

Eligibility Criteria:
Inclusion Criteria:

* Behavioral Health Clinician (BHC)
* 18 years of age or older
* Living in the U.S.
* Currently employed by the NC DAC

Exclusion Criteria:

* Decisional or cognitive impairments that preclude being able to consent to study participation
* Being a member of the study correctional advisory panel (CAP)
A Study to Learn About Metachromatic Leukodystrophy (MLD) in Children in Spain

The main aim of this study is to learn about metachromatic leukodystrophy (MLD) in children and teenagers in Spain. This includes checking the number of new MLD cases and the frequency of children with MLD in 2022 in Spain.

There is no treatment involved in this study. Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care between 01 January 2000 and 31 December 2022.

This is a non-interventional, retrospective study of participants diagnosed with late infantile or juvenile MLD whose data will be retrieved from existing health records.

Data from all participants, diagnosed with MLD from 01 January 2000 to 31 December 2022 will be collected from health records, including demographic and clinical data from the pre-diagnosis until the date of data collection or death, whatever occurs first.

The study will be conducted in Spain. The overall duration for data extraction is up to approximately 23 years.

Eligibility Criteria:
Inclusion Criteria:

• Diagnosed with late infantile or juvenile MLD at any time between 01 January 2000 and 31 December 2022 (genetically and/or biochemically confirmed).

Exclusion Criteria:

• This study has no exclusion criteria.
Bupropion & Cardio Birth Defect (Slone)

Bupropion is a unique drug that is used both to treat depression and as an aid in smoking cessation. In 2008, the final report from the Bupropion pregnancy registry described 24 congenital malformations among the 675 women exposed to bupropion in the first trimester of pregnancy. Of these, 9 had congenital heart disease of varying severity, including a number of infants with ventricular septal defects (VSDs); of note, 2 of these 9 had coarctation of the aorta. More recently, Alwan et al, in an analysis of data from the Centers for Disease Control and Prevention's case-control National Birth Defects Prevention Study, reported an increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that includes coarctation of the aorta and hypoplastic left heart syndrome.

Data from the Slone Epidemiology Center Birth Defects Study will be used to test these observations. The outcomes of primary interest will include those hypothesized to be associated with bupropion in recent studies: left outflow tract defects considered as a group. Coarctation of the aorta and hypoplastic left heart syndrome will also be examined separately. All infants with congenital heart defects are further classified into subgroups that are embryologically meaningful, including left outflow tract defects. In secondary analyses, other heart defect classes for which there are adequate numbers of cases will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with congenital heart defects who are born within the catchment areas of the 4 study centers
* A sample of nonmalformed infants born at participating hospitals
* Subjects who were interviewed in 1992 or later
* Women who complete the study interview within 6 months of the infant's birth

Exclusion Criteria:

* Infants with chromosomal anomalies
Can Genetics Predict Treatment Response to a Computerized Self-help Program for Depression?

The goal of this project is to determine whether genetic information can be used to predict response to an internet-based treatment of depression. Several studies now indicate that completing an internet-based treatment for depression, called Deprexis, can significantly improve symptoms of depression. However, not everyone improves. The purpose of this study is to determine whether genetic profile can predict who is likely to improve.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Have reliable access to the internet (i.e., dialup or broadband access)
* Be willing to donate saliva for DNA research
* Have a current symptoms of depression
* Be stable on medication and/or therapy (i.e. no changes within 2 weeks of study entry)

Exclusion Criteria:

* Any diagnosis of a psychotic or bipolar disorder
* Meeting for alcohol/drug dependence in the past year
* Having current suicidal risk warranting crisis intervention
Impact of RBC Transfusion Less Than 14 Days on Morbidity and Mortality in Cardiac Surgical Patients

The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.

Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.

However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients male or female over the age of 18 years
* Patients able to understand the benefits and risks of testing
* For the study population: patients who underwent cardiac surgery (all surgery combined) scheduled or emergency December 2008 to May 2009, having been transfused intraoperatively and until the seventh postoperative day .
* For the reference population: patients who have undergone elective or emergency cardiac surgery from December 2007 to May 2008 and from December 2009 to May 2010, having been transfused intraoperatively and until the seventh postoperative day.

Exclusion Criteria:

* Inability to understand the advantages and disadvantages of the study, psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
* Patients who have expressed opposition to his participation in the study.
* For the study population: patients were transfused within seven days before the start of the observation period.
* For the study population: patients with transfusion of red blood cell more than 14 days
* For the reference population: patients were transfused within seven days before surgery.
Effects of Axle Positions on Wheelchair Skills in Manual Wheelchair Users

The aim of this study is to investigate the effects of altering the wheelchair set-up on mobility and safety by changing the rear-axle position on a manual wheelchair.


Eligibility Criteria:
Inclusion Criteria:

* manual wheelchair users
* minimum of 17 years of age
* at least one week experience in a manual wheelchair, for at least an hour a day
* alert
* able to answer questions
* able to fit in the testing wheelchairs
* permission to participate from the attending physician

Exclusion Criteria:

* significant visual impairments
* unstable medical conditions (e.g., angina)
* emotional/psychological problems that may make testing unpleasant
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Agree to use back-up non-hormonal contraception for study period

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \>10 cigarettes per day