cyrilzakka/clinical-trials huggingface dataset:
The Interaction Between Calcium and Vitamin D Intake

We will study the relative importance of high calcium intake and vitamin D supplementation for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical bone markers. We also intend to examine the interaction of vitamin D and calcium intake on calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin D supplementation will lead to lower serum levels of PTH and markers of bone resorption compared with the placebo. We also theorize that when taken together, optimal calcium supplementation and optimal vitamin D intake will result in lower serum levels of PTH and bone markers compared with calcium or vitamin D taken alone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more)

Exclusion Criteria:

* Any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (BMI\>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
* Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded.
* Pregnancy.
* Use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics).
* Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator.
* Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded.
* Participation in another investigational trial in the past 30 days prior to the screening evaluation.
* Unexplained weight loss of \>15% during the previous year or history of anorexia nervosa.
* Medications that interfere with vitamin D metabolism.
* Patients with a habitual dietary calcium intake that exceeds 800 mg/day.
* Smokers greater than 1 pack per day will be excluded.
* Patients reporting alcohol intake greater than 2 drinks daily.
* Serum 25-hydroxyvitamin D level \> 75 nmol/L.
Brief Interventions for Coping with Distress

This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.

Adults living in New York City between the ages of 18-65 and experiencing elevated levels of worry, rumination, and/or self-criticism may be eligible to participate. After being informed about the study and potential risks, participants giving written informed consent will complete an online screening visit to determine full study eligibility. Eligible participant will then be randomized to complete 6-weeks of one of three self-directed, online skills training about coping with distress.

The present study is evaluating whether these skills trainings demonstrate efficacy in: 1) improving outcomes specific to an emotion regulation model of emotional distress (e.g., attentional control, decentering, reappraisal); 2) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination). Primary assessment points will take place before and after the skills training, and will include self-report measures, brief surveys during daily life, as well as computer tasks and measures of brain and body activity (e.g., EEG).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Fluent in English (and therefore able to provide consent)
* Currently living in New York City
* Access to a smartphone and the internet
* High self-reported worry, rumination, and/or self-criticism
* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder

Exclusion Criteria:

* Active suicidal ideation or intent
* Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
* Individuals currently receiving therapy or psychosocial treatment who do not plan to continue with the same treatment throughout the study period
* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
* Current students at Teachers College, Columbia University
* Individuals with cardiac conditions, diagnosed hyperhidrosis, and traumatic brain injuries or other neurological conditions (e.g., dementia, Parkinson's, epilepsy)
Intergroup Contact Intervention for Nursing Undergraduates to Improve Aging Stereotype

This study aimed to investigate the effects of intergroup contact training on the levels of aging stereotypes, intergroup anxiety, and willingness to engage in geriatric nursing work among undergraduate nursing students.

This research was designed as a pre-test-post-test randomized controlled experimental study. Nursing students from a university in Hangzhou, China served as the research subjects, who were randomly assigned to the experimental or control group. The control group received training in the regular course and was given compensatory intervention after the experiment, while the experimental group received intergroup contact training (the regular course combined with intergroup contact content). Such training was carried out in the forms of both individual and group interventions for a duration of 12 weeks. The levels of aging stereotypes, intergroup anxiety, and the willingness to engage in geriatric nursing among the nursing students were investigated before and after the training. Number, percentage, mean, standard deviation, Shapiro-Wilk, T-test, Wilcoxon signed ranks tests, and Mann-Whitney U tests were used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* full-time undergraduate students enrolled in the nursing program
* not yet enrolled in a geriatric nursing course
* agreed to participate in this study and signed an informed consent form

Exclusion Criteria:

* students in the nursing program pursuing a bachelor degree through a vocational-to-degree pathway
* Students who have taken a break from their studies
Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface.

This is a prospective study including patients visiting the outpatient glaucoma clinic of the University General Hospital of Alexandroupolis for their standard evaluation. Study population is already under treatment with a travoprost preparation without preservatives. They will be fully informed about the procedure and the purpose of the study and a written consent will be obtained. For every patient included in the study intraocular pressure will be measured using a Goldman applanation tonometer, according to the standard way of practice at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL measurements will also be obtained. The above measurements will be repeated 6 months after the initial examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma treated with travoprost without preservatives.

Exclusion Criteria:

* Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.
Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared

Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.


Eligibility Criteria:
Inclusion

* 18 years old with a diagnosis of liver cirrhosis of different etiology
* 18 years old with a diagnosis of hepatocellular carcinoma

Exclusion

* Have not signed the informed consent
* Pregnant women
Caesarean and Corticotherapy

Comparison of two randomized group :

* caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of betamethasone 48 h before.
* caesarean section planned at 39 weeks without corticosteroid.

The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour before 39 weeks), without increasing the neonatal respiratory distress rate.


Eligibility Criteria:
Inclusion Criteria:

* woman who needs elective caesarean section

Exclusion Criteria:

* multiple pregnancy
* toxaemia
* rhesus immunization
* fetal infection
* maternal gastro-duodenal ulcer
* mother HIV+
* prior injection of corticosteroid during the pregnancy
Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation

Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position

Feasibility for fiberoptical verification of pharyngeal position of supraglottic airway device

Eligibility Criteria:
Inclusion Criteria:

* will to participate

Exclusion Criteria:

* none
Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?

The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.

Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.

Eligibility Criteria:
Inclusion Criteria:

* glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
* primary open angle glaucoma
* primary angle-closure glaucoma
* pseudoexfoliation glaucoma
* pigmentary glaucoma
* traumatic glaucoma
* neovascular glaucoma

Exclusion Criteria:

* patients that are pregnant, nursing, or not using adequate contraception
* any other eye surgery except cataract surgery
* an infection, inflammation, or any abnormality preventing measurement of eye pressure
* enrolled in another investigational study
Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
* Patient is a nonsmoker and has been a nonsmoker for at least 1 year
* Patient is in good general health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
* Patient intends to move or vacation away during the study
* Patient has had any major surgery within 4 weeks of study start
* Patient is a current or past abuser of alcohol or illicit drugs
* Patient has been treated in an emergency room for asthma in the past month
* Patient had an upper respiratory infection with in 3 weeks prior to study start
Ambulatory Medication Reconciliation Following Hospital Discharge

Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research study is see if we can design an electronic tool given to your primary care provider (PCP) that will reduce adverse drug events, hospital readmissions, and emergency department visits after you are discharged from the hospital.

The objective of this research is to reduce the incidence of post-discharge medication discrepancies, preventable and ameliorable ADEs, hospital readmissions, and ED visits through the use of HIT. The proposed tool will prompt primary care physicians to perform medication reconciliation at the first post-discharge outpatient visit, clearly display and organize preadmission and discharge medication regimens, and facilitate the creation of the new post-discharge medication list with just a few keystrokes. Using methodologies from prior studies at BWH, we will evaluate the intervention in a two-site RCT. The study will be conducted at Brigham and Women's Hospital and Massachusetts General Hospital, taking advantage of our rich experience with designing and testing new informatics applications, including one for inpatient medication reconciliation.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to BWH or MGH who plan to follow up with a PCP in one of 12 primary care practices affiliated with BWH or MGH.
* Patients will need to meet the following criteria:

  * 1) be 55 years or older,
  * 2) be admitted to the participating delivery system's hospital during the study period for a non-psychiatric condition,
  * 3) have no plans to enter hospice,
  * 4) be discharged back to the community,
  * 5) be prescribed 5 or more medications at discharge, including at least one of the following:

    * antibiotics,
    * insulin,
    * antihypertensives,
    * anti-rejection,
    * antiarrhythmics,
    * inhalers,
    * antiepileptics,
    * antianginals,
    * pain medications,
    * oral hypoglycemics,
    * steroids,
    * anticoagulants.
  * These drugs were selected because they require close monitoring, increase risk for drug-drug interactions, have a narrow therapeutic window, or are known to increase risk for ADEs in the older adult population

Exclusion Criteria:

Unable to provide informed consent and has no proxy who administers patient's medications and can provide informed consent
Single Incision Laparoscopic Appendectomy in the Community Utilizing Conventional Instruments

There is a move to "scarless surgery" and this achieved by doing laparoscopic abdominal surgery though a single small umbilical incision. A technique for laparoscopic appendectomy done through a single incision utilizing conventional instruments has been developed. The operative risk of the single incision approach is no different that the standard three incision laparoscopic appendectomy. The goal is to study the operative time, length of hospital stay, and complications from this operation.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing appendectomy for acute appendicitis

Exclusion Criteria:

* pregnancy
Investigating Affective Attitude Question-behaviour Effects on Intention to Become an Organ Donor

The investigators aim to experimentally manipulate presence of questions on positive or negative affective attitudes to see if including these moderate as intention to become an organ donor. The methodology will be replicated across three international sites (RCSI Dublin, RCSI Bahrain, RCSI Perdana University).


Eligibility Criteria:
Inclusion Criteria:

* Agree to participate

Exclusion Criteria:

* Refuse to participate
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.


Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of heart failure.
* Must have ADHF, requiring hospitalization, with clinical evidence for volume overload

Exclusion Criteria:

* History of an allergic reaction to any xanthine-containing substance.
* History of seizure
* History of stroke
* Myocardial infarction
* Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
* Serious systemic infection
* Major surgical procedures within 30 days
* Acute coronary syndrome
* Cardiogenic shock
* Baseline body weight \>150 kg
* Participation in any other investigational study of drugs or devices within 30 days prior to Screening
* Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
* Presence of any clinically significant condition that might interfere with optimal safe participation in this study
Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.

The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.

Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.

Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.

Eligibility Criteria:
Inclusion Criteria:

* male or female, ≥18 years
* presence of an exuding wound, according to the clinician's assessment
* the wound is deemed suitable for treatment with DryMax Sensor
* an appropriate dressing size is available to be used according to the size of the wound
* the participant has given a written informed consent to participate in the study.

Exclusion Criteria:

* known pregnancy at the inclusion visit
* known or suspected hypersensitivity to the DryMax Sensor or its components
* mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
* ongoing treatment with systemic antibiotics
* illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study, and/or the dressing.
Study of Efficacy and Safety of ABO809 in Healthy Participants

The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).

This study was funded by the Wellcome Trust. This Phase 1 Cryptosporidium controlled human infection model (CHIM) study employed a single-center, open-label design to characterize the incidence of infection and associated symptoms following the administration of single doses of Cryptosporidium parvum oocysts (CE).

Healthy volunteers were enrolled in cohorts of approximately 10 participants who received ABO809 on the same day (Day 1). The study consisted of three sequential cohorts which were dosed one after the other for a total of 30 participants. A dose level group received the same ABO809 dose and could be comprised of multiple cohorts. The first dose level group started with a cohort of 10 participants who received ABO809 at a dose of 1x10\^4 oocysts. The study continued to enroll participants in the same dose level group if the desired incidences of infection and diarrheal illness were observed, up to a total of approximately 30 participants. If the desired incidences of infection and diarrheal illness were not observed, a new dose level group, receiving ABO809 at a dose of 1x10\^6 oocysts, could be initiated. If needed to optimize the model, intermediate ABO809 doses could be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks
* Good health
* Ability to communicate well with the Investigator

Exclusion Criteria:

- History of Cryptosporidium infection, gastrointestinal conditions (including diarrheal syndromes, gastroenteritis and gastrointestinal tract surgery), immunodeficiency, infections, significant medical concerns, hypersensitivity to nitazoxanide or other specified antibiotics.

Other protocol-defined inclusion/exclusion criteria may apply.
ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS

The law about advance directives is evolving but, in France, few people write it.

Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.

Seconds endpoints are :

For patients against or not planning to write it, understand their reasons

Estimate the proportion of patients requesting information and understand how they would like to receive it.

Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.


Eligibility Criteria:
Inclusion Criteria:

\> 18 ya

With one of the diagnoses below:

* Melanoma
* Skin lymphoma
* Meckel Carcinoma
* localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma

Exclusion Criteria:

Patients not in possession of all of its cognitive abilities Patients who can't read patients who don't speak french
Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients

The purpose of this study is to compare the tolerability and acceptability of a formulation containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance to HS.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Cystic Fibrosis (genotyping and sweat test)
* \> 8 year-old
* clinically and therapeutically stable disease in the last 30 days;
* Forced Expiratory Volume in one second (FEV1) ≥ 50% of predicted value;
* intolerance (cough, throat irritation, saltiness) to previous administration of 5.8% hypertonic saline solution.

Exclusion Criteria:

* decrease in FEV1 \>15% after first inhalation of hypertonic saline;
* Burkholderia cepacia infection;
* infective exacerbation requiring antibiotic treatment in the 15 days preceding enrolment;
* patient non compliant to standard therapy;
* Lung transplant;
* Patient unable to perform reproducible spirometry;
* Intolerance to β2 bronchodilators;
* Concurrent enrolment in other clinical trials;
* Plasmatic creatinine and transaminases more than twice the normal values.