cyrilzakka/clinical-trials huggingface dataset:
Bereaved Young Adults Study

Bereaved adolescents and emerging adults are at risk for developing psychological disorders and complicated grief. Clinical grief interventions and conventional wisdom reflect an implicit assumption that sharing and expressing one's feelings surrounding a loss (i.e., emotional disclosure) facilitates psychological adjustment. However, studies of emotional disclosure have yielded null results in bereaved samples. Individuals who have encountered stressful life events, including interpersonal loss, often report a desire to "give back" to others in similar situations. Empirical evidence suggests that providing support to others can be equally, if not more, beneficial than receiving support. The opportunity to support others experiencing stressful circumstances may address common feelings of powerlessness and engender a sense of meaning, enhancing positive affect and reducing distress. Interventions that leverage prosocial behaviors are associated with positive effects, including increases in wellbeing in non-bereaved populations. To date, no research has examined the utility of prosocial interventions for bereaved individuals.

The present study tests a novel expressive helping intervention that combines elements of expressive disclosure and prosocial writing. Expressive helping will be compared to traditional expressive disclosure and a neutral writing control condition in a sample of bereaved young adults. Participants (N=156) will be randomized to one of three conditions-expressive disclosure, expressive helping, or a neutral writing control-and complete three weekly 20-minute writing sessions. Measures of psychological distress, well-being, and hypothesized mediators will be administered before, immediately following (within 48 hours of the final writing session), one month, and two months after the writing sessions. It is hypothesized that the participants in the expressive helping condition will evidence greater increases in well-being and decreases in grief-related distress at the one and two-month follow-ups, as compared to the other two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Experienced the death of a loved one within the last 5 years, but more than 6 months ago.
2. Endorse having close relationship with loved one at time of their death (i.e., 5 or above on 1-10 likert scale with 1 being not at all close, and 10 being extremely close).
3. Endorse moderate to severe distress about the loss (i.e., 5 or above on 1-10 likert scale with 1 being not at all distressed, and 10 being extremely distressed).
4. Feel comfortable writing in English (due to the linguistic nature of the writing sessions).
5. Have access to the Internet and a computer to complete the assessments and writing sessions.

Exclusion Criteria:

1. Express active psychosis or suicidal ideation, or any other circumstances that, in the opinion of the investigators, compromise participant safety.
Neuroimaging Studies of Practice and Smoking

The purpose of this research study is to help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.

The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.

Eligibility Criteria:
Inclusion Criteria:

* Smoke \> 10 cigarettes per day for the last 6 months
* Smokes first cigarette within 60 minutes after waking
* Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
* Willing to complete all appointments and change smoking behaviors for 2 weeks
* No quit attempts or attempts to cut back in the last 30 days
* No plans to quit in the next 30 days
* High school graduate or General Eduction Diploma (GED)

Exclusion Criteria:

* Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment
* Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder
* Currently taking anti-seizure medication
* History of concussion
* Body mass index (BMI) over 50
* Left-handedness
* History of alcohol or other substance dependence or current abuse;
* Risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
* Pregnancy
Vitamin D Status Among Infertile Women in Sweden

The goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. The main questions it aims to answer are:

* What is the prevalence of vitamin D insufficiency?
* What are the determinants of this insufficiency? Participants will be asked to complete a questionnaire validated for dietary assessment of vitamin D intake and sun exposure habits and they will leave a blood sample for measurement of 25(OH)D concentration.

Researchers will compare the in vitro fertilization outcomes between women with vitamin D insufficiency and sufficiency to see if there is any difference.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18-38 years, who will go through in vitro fertilization for infertility.

Exclusion Criteria:

* women who will go through pre-implantation genetic testing
* women who will go through sperm- or oocyte donation treatment
* Fertility preservation cycles
Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients

Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.

Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70
2. Type 1 diabetes for more than 1 year
3. Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
4. HbA1c between 7.5 and 12%
5. Volunteer to be educated to Functional Insulin Therapy
6. Patient must be willing to undergo all study procedures
7. Patient must be affiliated or beneficiary of a social medical insurance
8. Patient has signed informed consent form prior to study entry

Exclusion Criteria:

1. Type 2 diabetes
2. Difficulties with mathematics calculation (simple algebra)
3. Patient is pregnant, or breast feeding during the period of the study
4. Manifest psychological disorders
5. Patient with eating behaviour desorder
6. Alcohol or drug addiction, as identified by investigator during screening visit
7. Persons deprived of freedom, adults protected by law or vulnerable persons
Etiology of Lymphopenia in Covid19 Infection

Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.

Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm.

Correlation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Any patient admitted with the diagnosis of Covid19 viral infection

Exclusion Criteria:

* Any patient who died within one day of admission
Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

The objective of this study is to evaluate the clinical effect and the impact on the quality of life of the coadjuvant treatment with Oxyflower® gel in cases of pericoronitis in lower third molar, compared to chlorhexidine gel and placebo gel.

This study consist of 51 participants diagnosed with pericoronitis who received coadjuvant treatment with gel. The participants were submitted to emergency treatment, with local debridement and irrigation with saline solution followed by topical application of the randomized gel: oxyflower®, chlorhexidine, or placebo gel. In cases of pericoronitis with systemic signs / symptoms, such as fever, malaise and lymphadenopathy, systemic antibiotic therapy was prescribed one hour before debridement, lasting seven days. All participants received oral hygiene guidelines and were instructed to apply the same gel twice daily for one week . After 30 days, it was performed tooth removal for cases in which there is not enough space for dental eruption; or distal wedge surgery when there is space for dental eruption with excessive gingiva in the distal. It was evaluated as outcomes: pain, quality of life, depth of probing, level of bone crest in the distal of second molar, buccal opening and extent of edema / erythema. A comparative analysis was performed between the groups, before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* signs / symptoms of pericoronitis with
* spontaneous pain
* ASA I or II
* Consent to participate

Exclusion Criteria:

* Periodontal status level IV
* Smokers
* antibiotic therapy in the last 2 months
A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

This study is being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).


Eligibility Criteria:
Inclusion criteria:

* Quantifiable serum hepatitis C virus-ribonucleic acid (HCV-RNA)
* Hepatitis C virus genotype 1
* Homeostasis Model of Assessment - Insulin Resistance (HOMA IR) \> 2.5 in two determinations made 4 weeks apart (the first HOMA evaluation is able to be made 3 weeks before screening visit)
* Previous failure to achieve SVR with PegIFN plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs
* No response, partial response, or relapse after previous therapy
* Compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis
* If heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject)

Exclusion criteria:

* Coinfection with HCV genotypes other than HCV-GT1
* Evidence of decompensated liver disease
* History of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension
* History or signs or symptoms or evidence of hepatocellular carcinoma (HCC)
* History of organ transplant
* Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Severe psychiatric disease
* Inadequately controlled thyroid function
* Other important comorbidities (cardiovascular diseases, Type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc)
* Substances abuse
* Alcohol intake \>20 grams/day for females and \>30 grams/day for males
* History of severe adverse events during previous treatment with PegIFN plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity
OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

The OSPRItaly Patient Registry has been developed to assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are eligible for and undergo OncoSil™ implantation at an eligible treatment facility according to the approved OncoSil™ System Instructions for Use (IFU), as part of their clinical care.
2. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.

Exclusion Criteria:

1. Patients participating in an interventional clinical study (company or investigator-sponsored).
2. Use of an investigational agent at the time of enrolment.
Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

To evaluate the efficacy and safety of Quantum Molecular Resonance (QMR) treatment in patients with severe dry eye disease (DED), as well as its effects on aqueous-deficient (ADDE), evaporative (EDE) and mixed (MDE) dry eye.

To evaluate the efficacy and safety of Quantum Molecular Resonance (QMR) treatment in patients with severe dry eye disease (DED), as well as its effects on aqueous-deficient (ADDE), evaporative (EDE) and mixed (MDE) dry eye.

In this prospective, interventional study, 81 patients will be randomly allocated to received 4 treatment sessions of QMR at one-week intervals (Rexon-Eye ® , Resono Ophthalmic, Trieste, Italy) (QRM group) or tear substitute 4 times daily, containing 0.15% sodium hyaluronate and 3% trehalose (Thealoz Duo ® , Thea Pharma, France) (SH-TH group).

Outcomes measures will include ocular surface disease index (OSDI) questionnaire, tear meniscus height (TMH), tear breakup time (TBUT), non-invasive breakup time (NIBUT), corneal fluorescein staining (CFS), lipid layer thickness (LLT), tear film osmolarity (OSM) and meibomian gland dysfunction (MGD) grade at baseline, 1-month and 3-months follow-up.

Eligibility Criteria:
Inclusion criteria:

-\> 18 years old with a self-reported history of DED

* OSDI score ≥ 33 points
* TBUT less than 10 seconds.

Exclusion criteria:

* skin pathologies that prevent QRM treatment
* corneal infection and corneal dystrophies
* active ocular allergies
* intraocular surgery or laser ocular surgery
Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults

The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.

Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.

Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.

Eligibility Criteria:
Inclusion Criteria:

* AHI score of ≥ 5
* Body mass index (BMI) between 30 to 49.9 kg/m2

Exclusion Criteria:

* Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event
* Currently or planning to become pregnant during the next 9 months
* Not weight stable (-4.6 kg) for 3 mos. prior to intake
* Report current participation in a weight reduction program involving diet or PA
* Unwilling to be randomized to 1 of 3 study groups
* Report symptomology of an eating disorder as determined by the Eating Attitudes Test
* Unable to participate in moderate intensity physical activity
Early Administration of L-carnitine in Hemodialysis Patients

Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.

The first aim of the study is to compare the resistance index to erythropoietin (hemoglobin level / rHuerythropoietin dose) with L-carnitine versus placebo Double blind randomized study evaluating the supplementation with L-carnitine versus placebo in patients beginning chronic hemodialysis for less than 1 month.

Primary outcome to compare rHuerythropoietin resistance index defined as hemoglobin level / rHuEPO dose ratio with L-carnitine and with placebo.

Secondary endpoints to compare acylcarnitine / carnitine ratio, number of red blood cells transfusion, physical status, quality of life, hypotensive episodes, lipid profile, diabetes profile, albuminemia, c reactive protein.

Several variables that influenced primary and secondary endpoints will be included in a multivariate analysis; albuminemia, c reactive protein, iron status, dialysis efficiency, protein intake, lipid intake, treatment with additional vitamins (C, B9, B6), treatment with statins, treatment of predialysis hypotension by midodrine, antihypertensive treatments.

Statistical analysis:

* description of the cohort
* comparisons of each evaluated variables between the 2 treatments
* ANOVA study for repeated measurements from inclusion to month-12 for Hb / rHuEPO dose to compare the course of the ratio between each group in intention to treat analysis
* analysis of the ratio Hb / rHuEPO month by month and taking into account tempera withdrawal

Following analysis in both intention to treat and per protocol analysis:

* acylcarnitine / carnitine ratio by ANOVA for repeated data
* number of predialysis hypotension by Chi2 test
* number of red blood cells transfusion by Chi2 test
* SF-36 physical status by comparison of mean
* SF-36 total score by comparison of mean
* lipid profile by ANOVA for repeated data
* HbA1c by ANOVA for repeated data
* variables that influenced primary and secondary variables will be analyzed by multivariate analysis
* statistical study of clinical events per month

Eligibility Criteria:
Inclusion Criteria:

* Patient with less than 1 month on hemodialysis.
* Treated with rHuEPO.
* Male or female aged of more than 18 years old.
* With contraception treatment for women of procreation age.
* Having received and understand information.

Exclusion Criteria:

* Patients with no need of rHuEPO
* Patients with cancer disease
* Patients with life expectancy under 6 months
* Patients having a proved carnitine deficiency before the start of hemodialysis
TVMR With the Innovalve System Trial - First In Human Israel

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF\<25%
Loss of a Healthy Weight Advantage Among Mexican-American Children

Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be changing over time. The objective of this study was to examine whether the relationship between nativity and overweight/obesity has changed over time among Mexican-American children and to investigate the implications of this pattern on overweight/obesity disparities relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and non-Hispanic white children ages 4-17 years participating in the National Health and Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by nativity status adjusting for age, sex, householder marital status, householder education, survey period and a nativity by survey period interaction. The investigators also tested another covariate-adjusted model with a 3-level ethnicity-nativity variable that included Whites and an ethnicity-nativity by survey period interaction.


Eligibility Criteria:
Inclusion Criteria:

* Mexican-Americans and white children who attended the clinical examination in NHANES III and the continuous NHANES

Exclusion Criteria:

* Reported being pregnant
An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, over 18 years of age
* Moderate to severe rheumatoid arthritis
* RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion Criteria:

* Patients with rheumatic autoimmune disease other than rheumatoid arthritis
* Patients who are not willing to sign the informed consent form
* Patients who participate in interventional trials during the period of this observational study