cyrilzakka/clinical-trials huggingface dataset:
Cognitively-Based Compassion Training and Mindfulness Attention Training Program

This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.

This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or mindfulness training (MT) on different aspects of behavior and stress-related biology in elementary school-age children. The program will consist of 12 weeks of CBCT or MT, and various social behavioral assessments will be conducted. Participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers C-reactive protein will be measured.

Eligibility Criteria:
Inclusion Criteria:

* age 7-12
* enrollment at the Paideia School.

Exclusion Criteria:

* poor physical health
* enrollment at a school other than the Paideia school.
Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women

A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.

A randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message modalities (video vs. comic book). The study was conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary beverage consumption and the main outcomes are individual intention to adopt health behaviors which will be measured by the increased degree of individual knowledge, attitudes, subjective norms, self-efficacy, and intention to reduce SSB consumption, as well as social level behavior changes that will be measured by the improved magnitude of public health literacy, SSB media literacy, and empowerment. Secondary outcomes of interest include the evaluations on the dimension of message themselves include participants' direct reaction to messages and their perceived effectiveness of messages, which will be measured by transportation of messages, identification of characters, emotional response of scenes, perceived effectiveness of messages, engagement with messages, and willingness to disseminate messages.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Latina or Hispanic
* Self-identify as a woman
* Self-reported as being of age between 18-29 years

Exclusion Criteria:

* Not Mexican American (defined as having at least 1 grandparent born in Mexico or self-identifying as Mexican or Mexican American)
Pharmacokinetics of Vancomycin in Adults Receiving ECMO

1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
2. There is limited data on the change of vancomycin pharmacokinetics in patients who need extracorporeal membrane oxygenation (ECMO).
3. This control trial is to understand:

   1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO
   2. design the most appropriate dose of vancomycin in adult patients using ECMO.

1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
2. Oftentimes it is used in intensive care units (ICU) for patients who need a life-saving machine for heart and lung failure called extracorporeal membrane oxygenation (ECMO).
3. There is limited data on the change of vancomycin pharmacokinetics in these patients.
4. This is a control trial using ICU patients who need vancomycin but not ECMO as a control to understand:

   1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO
   2. design the most appropriate dose of vancomycin in adult patients using ECMO.
5. After the 4th dose of vancomycin, blood was drawn at appropriate time spots (1 mL each) to determine the time concentration curve and to calculate the pharmacokinetic parameters for 2 groups of patients to determine if there is any difference.

Eligibility Criteria:
Inclusion Criteria:

* \>18 y/o
* receiving ECMO for study group
* without ECMO for control group (sex, age, creatinine clearance match with study group)

Exclusion Criteria:

* severe burn (\>30-40% BSA)
* receiving continuous renal replacement therapy or hemodialysis concurrently
Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.

COVID-19 is an aggressive and contagious virus, found to have high mortality especially in persons with comorbidities (Age\>60, hypertension \[HTN\], diabetes mellitus \[DM\], Cancer, and otherwise immunocompromised). Zinc is a supplement with possible antiviral properties, having been shown to have effect in the common cold, many of which are due to coronavirus. In addition, elderly patients and patients with co-morbidities have high incidence of zinc deficiency. We are repleting zinc in all patients and studying its direct effect in combination with hydroxychloroquine, and an antibiotic, either azithromycin or doxycycline to see if there is enhanced treatment efficacy in early COVID-19 infection and assess the safety of these two regimen.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand informed consent.
* High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by RT-PCR for confirmation of COVID-19 diagnosis
* Any gender
* Age 60 years and older
* Age 30-59 years with one or more of the following:

  * abnormal lung exam
  * abnormal oxygen staturation \<95%
  * abnormal chest x-ray or chest CT
  * persistent fever \>100.4 degrees Fahrenheit upon arrival to Emergency department (ED)
  * one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, chronic obstructive pulmonary disease, current or former smoker, or morbid obesity (Body Mass Index ≥35)

Exclusion Criteria:

* Pregnant or breastfeeding female
* Severe COVID-19 requiring admission for inpatient treatment
* Need for any oxygen supplementation
* Need for mechanical ventilatory support
* History of oxygen supplementation dependency
* History of cancer with ongoing chemotherapy or radiation therapy
* Concurrent antimicrobial therapy
* Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
* Already taking hydroxychloroquine or chloroquine within 1 month
* Known G6-PD deficiency
* History of retinopathy
* History of current cardiac diseases (heart failure, ventricular arrhythmias, Left bundle branch block and/or Right bundle branch block, QTc prolongation \>480ms), or family history of sudden cardiac death
* Ongoing use of drugs that prolong the QTc interval (antipsychotics, antidepressants, class I and III antiarrhythmics, triptans)
* Severe renal disease: glomerular filtration rate (GFR) \<30ml/min
* Severe hepatic impairment (elevated total bilirubin \>2 mg/dL, decreased albumin \<2.8 g/dL, signs of jaundice and ascites.)
* Active alcohol abuse (\>5 drinks per day or \>20 drinks per week.)
* Seizure disorder, currently on medications
* Known hypersensitivity to any tetracyclines.
Strengthening Adolescent-Adult Networks to Reduce Youth Violence

This pilot community-partnered cluster-randomized trial will examine the feasibility and acceptability of a social network-based youth violence prevention program called Strengthening Connections for Change for youth ages 13-17 and their key adult supports.

This pilot community-partnered cluster-randomized trial will examine the feasibility and acceptability of a social network-based youth violence prevention program called Strengthening Connections for Change for youth ages 13-17 and their key adult supports. Set in four lower resource Pittsburgh, Pennsylvania neighborhoods, this study brings together youth ages 13-17 and their self-identified key adult supports to focus on leadership, strengthening intergenerational networks, community engagement, and violence prevention.

Eligibility Criteria:
Inclusion Criteria:

Youth:

* Participants must be ages 13-17 (inclusive)
* Participants must speak English

Adults

* Participants must be ages 18 or older
* Participants must speak English

Exclusion Criteria:

Youth:

* Not ages 13-17 (inclusive)
* Do not speak English

Adults

* Less than 18 years of age
* Do not speak English
Modeling Amyotrophic Lateral Sclerosis With Fibroblasts

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease in adults. This longitudinal study involves three cohorts of participants: patients with sporadic or hereditary ALS, asymptomatic individuals carrying pathogenic mutations responsible for ALS, and control subjects. In this study, a skin biopsy and blood sampling will be performed at the initial visit (M0), then at M12 (+/- 2 months) for patients, and at M36 (+/- 12 months) for asymptomatic carriers of pathogenic mutations. The aim of this research is to model ALS pathology using fibroblasts derived from the patients' skin biopsies.

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease in adults. This longitudinal study involves three cohorts of participants: patients with sporadic or hereditary ALS, asymptomatic individuals carrying pathogenic mutations responsible for ALS, and control subjects. In this study, a skin biopsy and blood sampling will be performed at the initial visit (M0), then at M12 (+/- 2 months) for patients, and at M36 (+/- 12 months) for asymptomatic carriers of pathogenic mutations. The aim of this research is to model ALS pathology using fibroblasts derived from the patients' skin biopsies.

Eligibility Criteria:
Inclusion criteria common to all 3 populations:

* adults, both sexes
* with written consent to participate in the study
* affiliated to a social security scheme

ALS patients :

* patients with ALS according to the revised El Escorial criteria :
* with a hereditary form of ALS, defined by the presence of a family history of ALS or by the demonstration of a pathogenic mutation in the patient or
* with a juvenile form of the disease, defined by onset of symptoms at less than 30 years of age or
* with a sporadic form of ALS

Asymptomatic mutation carriers :

- Asymptomatic individuals who carry a mutation causing ALS but have not developed symptoms.

Healthy subjects:

* control individuals, taking into account male/female and close age matching

Exclusion Criteria:

* with a known skin disease (acne, atopic dermatitis, psoriasis, melanoma, skin carcinoma, rosacea, scabies; as referenced on http://dermato-info.fr/), which in the investigator's opinion constitutes a contraindication to skin biopsy
* have a platelet count of less than 75,000/mm3 in a laboratory test less than 3 months old,
* with a proven allergy to lidocaine or prilocaine,
* Pregnant or breast-feeding women, or subjects under guardianship, curatorship or safeguard of justice.
* Patient's condition which, in the opinion of the investigator, is incompatible with skin sampling or participation in the study.
* Participation in a clinical trial (involving a drug) or other interventional research if this interferes with FIBRALS research.
Methods Project 4: Clinical Trial

Cigarette smokers who are eligible will enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to one of the three experimental conditions for 8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.

Baseline smoking period: Subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured including a record of their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR).

Experimental Period: After the baseline assessment, subjects will be randomized to one of five experimental conditions: 1) smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus to use as they will for 8 more weeks; 2) complete substitution (i.e., no smoking) and use snus instead ; 3) partial substitution - use of both snus and cigarettes as you like. Snus, but not cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who are at least 18 years of age;
* Daily smoker;
* Generally good health;
* Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);

Exclusion Criteria:

* Unstable health
* Pregnant or breastfeeding (due to toxic effects from tobacco products).
* Unable to read for comprehension or completion of study documents.
Implementation of Pharmacogenetic Testing in Hospital Wards

The purpose of this study is to investigate whether it is feasible to implement pharmacogenetic testing as part of medication review while the patient is admitted to hospital.

Earlier studies have shown that pharmacogenetic testing may contribute to optimizing the efficacy of medication treatment and to reduce the risk of adverse effects. Inclusion of pharmacogenetic testing as part of medication reviews reveals more serious drug related problems and leads to more changes in medication treatment than medication review alone.

The use of pharmacogenetic testing as part of medication reviews has not earlier been systematically investigated in hospital patients in Norway. There is little documentation of what is needed to implement the use of pharmacogenetic testing in a hospital ward.

The investigators are conducting a descriptive study in two internal medicine wards at Akershus University Hospital. 50 patients using minimum 5 regular drugs including at least one relevant for pharmacogenetic testing will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* at least 2 long-term conditions
* at least 5 regular drugs of which at least one relevant for pharmacogenetic testing
* at least 2 years life expectancy
* able to communicate in Norwegian
* able to give informed consent
* summary care record

Exclusion Criteria:

* moderate to severe dementia
Bone Density of Newborn Infants to Mothers Treated With Selective Serotonin Reuptake Inhibitor (SSRI)

SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant women with depression or anxiety is extendent and raising. The effect of bone density of the infants was not yet evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Term newborn infants to mothers treated with SSRI and healthy controls

Exclusion Criteria:

* Preterms, major congenital malformations.
Role of Medical Treatment in Endometriosis Patients Undergoing ICSI

The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.

Patients complaining of infertility due to endometriosis diagnosed by ultrasound or laparoscopic surgery will be randomly allocated to three groups :

Group A: will receive COCPs for 3-6 months prior to starting IVF / ICSI cycle. Group B: will receive Dienogest for 3-6 months prior to starting IVF / ICSI cycle.

Group C: will be subjected to direct ICSI /IVF cycle. Then all patients will be subjected to ovarian stimulation regimen using GnRH Agonist Down-Regulation Gonadotropin Stimulation-The "Long" Protocol.

During the ovarian stimulation, the woman's response is monitored with serum estradiol levels and vaginal ultrasound examinations. The estradiol level is used to determine the dose of gonadotropins and whether under- or overstimulation occurs. The goal of the ovarian hyperstimulation is to develop at least three mature follicles that are 17 mm in diameter or larger. Once this is achieved, FSH and other medications are discontinued, and a single injection of hcg is given to mature the eggs to allow fertilization.

The hcg administration will also cause ovulation, but this does not occur until 40 hours or later after the injection. Therefore, it is standard that the hcg injection is administered 36 hours before the scheduled egg retrieval such that this will allow adequate maturation of the eggs and yet there would be little risk of ovulation.

Then the process will be continued through oocyte retrieval, oocyte maturation , fertilization by ICSI.

Each group will be followed up to detect the number of oocyte yield, fertilization rate and availability of good quality embryos and then according to the results the effect of medical treatment prior to stimulation will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Presence of Endometrioma on ultrasound.
* History of ovarian cystectomy either open or via laparoscopic surgery.
* Presence of endometriotic foci in the pelvis during laparoscopic surgery.
* Patients coming for the first ICSI / IVF cycle.

Exclusion Criteria:

* Age above 40 years
* Cases with endometrioma on ultrasound more than 3 cm size.
* Prior failed ICSI / IVF.
* Known poor responders or poor ovarian reserve, defined as AFC\<5 or AMH \< 0.5 .
* Patients with previous uterine surgery.
* Patients diagnosed to have uterine abnormalities
Project CHOICE: Efficacy Testing of CHOICE and CHOICE+Normative Feedback Interventions

This study will use a pilot test format to examine the efficacy of a brief Motivational Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.

This study will use a pilot test format to examine the efficacy of a brief Motivational Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL. The study will have two arms: one group will receive the standard CHOICE Motivational Interview (MI) while the second group will receive the CHOICE Motivational Interview with a Normative Feedback component, called CHOICE+ (CHOICE Plus). The hypothesis is that there will be no difference in outcomes between those that receive the standard CHOICE and those that receive the CHOICE+ MI.

Eligibility Criteria:
Inclusion Criteria:

* Youth 13-19 years of age (and their parents or legal guardians if their youth has been referred for an assessment with the Prairie Center counseling staff.)
* referred for an assessment to see if they need substance use disorder treatment
* have used substances on 13 or more days out of the past 90 days or scored higher than 2 on the CRAFT assessment. -

Exclusion Criteria:

* Low cognitive functioning
Treatment of Insomnia in Primary Care Study

The goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia.

The main question it aims to answer is:

• Does Sleep School (a therapy for insomnia) work well to decrease harm of insomnia? Participants will attend a group therapy intervention once a week for six weeks.

Researchers will compare Sleep School to treatment as usual (short counselling by an educated nurse) to see if the Sleep School works better than treatment as usual in decreasing the harm of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia severity index (ISI) score at least 8
* insomnia symptoms present at least for 3 months

Exclusion Criteria:

* diagnosed dementia based on medical records
* acute suicidality
* acute psychotic symptoms
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.

Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact extemporaneous formulations of omeprazole are administered to these infants. The oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. The dose range for GERD management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day.

Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.This study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease.

Eligibility Criteria:
Infants were eligible for the study if they were:

* 6-12 weeks postnatal age
* weighed more than 3 kg
* were after surgical repair for EA or CDH
* showed clinical GERD
* were to undergo the 48 hour pH measurements.

Infants were excluded if they were:

* allergic to omeprazole
* participated in other interventional trials
* used medications known to interact with omeprazole.
Bacteriological Study of Acute Follicular Tonsillitis

The objective of the study is to answer the following questions :-

1. Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes,
2. What is (are) the possible reason(s) to explain it in our locality ?

Tonsillitis is one of the most common diseases in the throat that occurs in the younger age group .

The predominant bacteria causing tonsillitis are group A b-haemolytic streptococci (GABHS), which are highly susceptible to the penicillin group of antibiotics.

It has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s.

Authors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria .

Although there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.

Eligibility Criteria:
Inclusion criteria:

patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old.

Exclusion Criteria:

1. Other causes of tonsillitis that do not cause suppuration .
2. Age below five , and above 60 years .
3. Patients who received antibiotic one week before presentation .
4. Immune compromised patients .
5. Patients with quinsy.