cyrilzakka/clinical-trials huggingface dataset:
Heart Rate Variability Biofeedback for Smoking Cessation

Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with elevated emotional distress.

The investigators propose to develop and pilot test heart rate variability biofeedback (HRVB) for smokers with elevated emotional distress as an adjunct to individual smoking cessation counseling (SCT) and transdermal nicotine patch (NRT). In this open trial, all participants received the active intervention. Findings will be used to refine the protocol in advance of a subsequent Phase III randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Smoking ≥5 cigarettes, daily, for at least two years
* expired carbon monoxide analysis of breath sample ≥8 ppm
* elevated affective distress
* motivation to quit
* computer proficient

Exclusion Criteria:

* current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention for smoking cessation
* endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
* inability to provide written informed consent
* current evidence of another substance use disorder
* severe visual or hearing impairments
* self-reported medical condition or medication use that may be contraindicated for participation in a HRVB or confound autonomic parameters:
* self-reported medical issues of potential concern to nicotine patch users
Characterization and Quantification of Platelet/leukocyte Aggregates in Patients with Suspected Heparin-induced Thrombocytopenia

The investigators would like to analyze platelet/leukoplak activation, quantify and morphologically characterize these aggregates using in vitro analysis, directly on whole blood from adult patients with suspected HIT. This would enable to better describe the in vivo pathophysiology of the HIT-suspect patient, and eliminate the need for platelet donors to perform the usual confirmatory techniques, whose inter- and intra-individual variability is very high. What's more, the SRA test, evaluated as the reference test, requires the use of radioisotopes and is therefore only carried out in a few biological expertise centers, resulting in a very long delay in the delivery of results. It should also be noted that, in practice, HÉPARINE is immediately stopped in patients with suspected HIT, and they are put on an expensive anticoagulant (DANAPAROIDE SODIQUE or ARGATROBAN) in curative doses until the results of the confirmatory tests are back. In this serious, life-threatening condition, it is essential to have a sensitive, specific test to confirm HIT as quickly as possible. Each patient with suspected HIT (rapid \>30% reduction in platelet count after initiation of heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the time of suspected HIT (D0) and before any therapeutic switch (or 24 h max after switch). A new sample (4 citrated tubes) will be taken at D4, D7 and D14 during hospitalization, in patients who test positive for anti-PF4/H Ac. All patients with suspected HIT will follow the standard diagnostic pathway, i.e. a screening test (immunological test for anti-PF4/heparin antibodies, total Ig, ACL TOP, Werfen) followed by a confirmatory test (platelet aggregation on TA-8V, STAGO and/or SRA). Doppler ultrasonography of the lower limbs will be performed in HIT-suspect patients with a positive anti-PF4/H antibody test, as currently performed as part of routine care.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Any adult patient suspected of having HIT, with a positive anti-PF4/H antibody test
* Patient signed consent to study participation
* Patient with social security coverage

Exclusion Criteria:

* All adult patients with suspected HIT and negative anti-PF4/H antibody test.
* Protected adults (guardianship, under curators) or deprived of liberty
Postpartum Family Planning Utilization and Associated Factors Among Women During First Year After Childbirth in Assiut

Postpartum family planning is defined as prevention of unintended pregnancy and closely spaced pregnancies during the first 12 months after the child birth postpartum contraceptive utilization is important because some women resume ovulation after 28 days postpartum inter-pregnancy intervals shorter than 18 to 24 months have been associated with an increased risk of fetal and maternal deaths ,35% of children younger than five deaths could be avoided if births spaced 36 months

According to Egyptian demographic health survey , unmet need for family planning increased from 11.6% in 2008 to be 12.6% in 2014, contraception prevalence rate decreased from 60% in 2008 to 59% in 2014.

In Assiut Contraception prevalence rate decreased form 47.4 in 2008 to 41.4 in 2014 Total fertility rate increased from 3 in 2008 to 3.5 children/woman in 2014, Assiut Total fertility rate was 4.2 children/woman in 2014 . projections for the year 2030 estimated that total fertility rate would decline to be 2.1 births/woman if Contraceptive prevalence rate could rise to be 74.4% .

Routine childhood immunization services include more than 500 million regular contacts annually, most women seek child immunization for their children so each immunization represents an opportunity to reach women with Postpartum family planning counselling so World Health Organization recommends Postpartum family planning as a critical healthcare component and World Contraception Day 26 September 2018, Met the theme"Postpartum family planning: essential for ensuring woman health and their babies" World Health Organization for family planning research agenda listed postpartum family planning utilization as a higher priority score with score 83.90

Eligibility Criteria:
Inclusion Criteria:

* Women aged (15-49)
* and had given birth during the past 12 months.

Exclusion Criteria:

* Women that had children older than 12 months
* Pregnant women
* Sexually inactive women as widow and divorced
* Women who had done abdominal hysterectomy
Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth

Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. That is, there are still large gaps regarding fluoride varnish applications. Thus, the objective of the present project is the selection of two protocols for application of fluid applications in active drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3, 6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated clinically through the transition of ICDAS scores and assessment of the lesions (sound examination with superficial measurements) by visual examination, and the physician evaluates the efficacy and the ability to evaluate the therapeutic techniques and evaluation. treatment, cost and quality of life of participants


Eligibility Criteria:
Inclusion Criteria:

* Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth

Exclusion Criteria:

* Patients with special needs;
* Patients using orthodontic appliances;
* systemic diseases;
* Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp involvement, fistulae and / or abscesses;
* teeth with spontaneous painful symptomatology.
Application of Knee Measurements on 3D CT in TKR

A 3D Computed Tomographic Study of Vietnamese Knee Morphology for Total knee Replacement

There were controversies and inconsistent results regarding the effectiveness of PSI.

However, most authors used PSI from commercial manufacturers. From our view, the surgeon's involvement in PSI planning and design can affect the PSI's accuracy. Some other benefits of in-hospital PSI included the use of any type of implant without depending on the manufacturer's software system, faster and cheaper. Therefore, we conducted this study to evaluate the effect of in-hospital PSI in which the surgeons take part in the manufacturing job.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis, grade III, IV
* Underwent total knee replacement using patient-specific intrumentation
* With pre and post-operative whole limb CT-Scanners

Exclusion Criteria:

* Paticipants with valgus knee deformity,
* A history of hip arthroplasty,
* Large bone defect that required augments.
Questionable Health Behaviors and Their Distal and Proximal Correlates

The goals of the study:

1. to investigate the frequency of Traditional, Complementary and Alternative Medicine use (TCAM) and intentional Non-adherence to medical recommendations (iNAR) in the general population in Serbia, as well as their mutual relations.
2. to examine the distribution of irrational beliefs in the general population;
3. to explore the relationships between TCAM and iNAR behaviors on the one hand and variables of personality, thinking styles and cognitive reflection on the other, with a major assumption that these relationships will be mediated by the domain of irrational beliefs and socio-political attitudes.

Participants will respond to a battery of instruments assessing TCAM use and iNAR, as well as, sociodemographics and health-related variables (such as health status, chronic diseases, BMI, etc.), distal psychological (i.e. personality, thinking disposition and styles) and proximal psychological, variables, (i.e. the irrational mindset, as well as socio-political beliefs and attitudes).

Data will be collected on the probabilistic household sample representative for the general population in Serbia (N=1043).


Eligibility Criteria:
Inclusion Criteria:

* must be at least 18 years of age

Exclusion Criteria:

* the inability to understand the Serbian language
* failure to pass any of the four attention-check questions
Impact of Oral Probiotic Blend on Pregnancy Outcome

The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation.

Pregnant women aged \> 18 years in the \< 14th week of pregnancy willing to consume the study product once daily starting the day after V1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study.

After enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.

The study population will be recruited in a screening examination ( G1 ) by gynaecologists from Kiel area.

Primary target parameter of the study :

HOMA-IRa value in week 24-28 (V2), which is based on glucose and insulin measures during the second oral glucose tolerance test (OGTT)

Secondary target parameters :

HOMA-IR value in week 36-40 , Alteration (V2 - V1) Δ HOMA-IR, Alteration (V2 - V1) Δ QUICKI

Eligibility Criteria:
Inclusion Criteria:

* pregnant women aged \> 18 years in the \< 14 week of pregnancy
* willing to consume the study product during pregnancy ( V1 to delivery)
* willingness to abstain from probiotic food and supplements containing probiotics
* written informed consent

Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from enrollment in the study:

1. Subjects currently enrolled in another clinical study
2. Subjects having finished another clinical study within the last 4 weeks before inclusion
3. Diabetes mellitus
4. Acute metabolic disorder interfering with glucose metabolism
5. Known cancer \< 5y ago
6. Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota
7. Anus praeter
8. Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product
9. Any disease or condition which might significantly compromise the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system
10. History of active hepatitis B and C
11. History of HIV infection
12. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
13. Major cognitive or psychiatric disorders
14. Present drug abuse or alcoholism, reformed alcoholic Legal incapacity
Management of Consecutive Exotropia

Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession


Eligibility Criteria:
Inclusion Criteria:

* Patients with consecutive exotropia.
* Eight years old or more.
* Cooperative patients.

Exclusion Criteria:

* Adduction deficit.
* Mental disability.
Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers

Anonymized pre-, intra-, and postoperative data will be collected from patients undergoing VinV TAVI in a previously implanted Trifecta™ valve, Trifecta™ GT, Epic™ or Epic™ Supra valve from the largest volume implanters of the Trifecta and Epic valve in Europe until June 2020. The data will be analyzed in order to give a comprehensive description of clinical outcomes for Trifecta VinV procedures, to identify preoperative risk factors for coronary obstruction, 30-day and 1-year mortality, and other major complications, and to analyze the effects of patient characteristics and / or protective maneuvers in order to prevent coronary obstruction.

Differences of Trifecta and Epic failed patients will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a TAVI VinV procedure post-Trifecta or Epic implantation
* Patients who underwent planned or unplanned concomitant percutaneous coronary intervention (PCI) during the index hospital admission will be included, as will those undergoing emergent conventional cardiac surgery.

Exclusion Criteria:

* 1. TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
* 2. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model

The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* history of HDM rhinitis allergy for \> 1 year
* sensitized to D. pteronyssinus and/or D. farinae
* RTSS \>= 6 at least 2 time points during allergen challenge session

Exclusion Criteria:

* co sensitization to other allergen than HDM
* FEV1 \< 80%
* Asthma GINA \> 1
Novel Biomarkers of Thrombotic Risk

Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. This study is designed to assess the value of new tests. It is a prospective study that will enroll patients who have had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. Investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount of blood poses no risk to the participant. Investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. We hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment of participants will not be altered by their participation in this study.


Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction demonstrated by elevated markers of cardiac injury (troponin I (TNI) or creatine kinase (CK) MB fraction)
* the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging

Exclusion Criteria:

* Treatment with long term anticoagulants
* active infection
* malignancy
Conventional Versus Modified Laparoscopic Cholecystectomy

In conventional laparoscopic cholecystectomy, the cystic duct and artery are clipped by metal clips. we propose a new method in which the cystic duct is ligated and the cystic artery is cauterized. the investigators compare both methods.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy for symptomatic gallstones

Exclusion Criteria:

* Conversion to laparotomy
Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise

The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.

Premenstrual syndrome is characterized by the presence of both physical and behavioral (including affective) symptoms that occur repetitively in the second half of the menstrual cycle and interfere with some aspects of the woman's life(1). The core symptoms of PMS include affective symptoms, such as irritability, depression, anxiety, and somatic symptoms, such as breast pain, bloating, swelling, and headache (2). Women with moderate to severe PMS symptoms had a reduction in health-related quality of life(3) and work productivity, increased work absenteeism, and visits to ambulatory healthcare providers (4), so the treatment of this syndrome is essential.

Eligibility Criteria:
Inclusion Criteria:

* young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases

Exclusion Criteria:

* pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders
Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals

Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 30 and 40 kg/m2;
* Obstructive sleep apnea mild or severe;
* Sedentary.

Exclusion Criteria:

* Intake of any drug that interfere on metabolism such for thyroid or to lose weight;
* Be engaged in other treatment for sleep apnea or obesity;
* Present another sleep disorder;
* Being shift work;
* Present any kind of kidney disease.
Vitamin/Mineral Supplement for Children With Autism

This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.

This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and laboratory tests. Typically-developing children will be assessed at baseline only (no treatments) for comparison.

Eligibility Criteria:
Inclusion Criteria:

1. Child age 3-17 years (up until 18th birthday)
2. Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician
3. Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised.
4. No changes in any medical, nutritional, dietary, behavior, or other treatment in the last three months, and a willingness to avoid any changes during the study
5. Participant is able to wear a mask during the short visit for the blood draw.

Exclusion Criteria:

1. Parent/guardian is unable to read or speak English fluently.
2. Use of a vitamin/mineral supplement in the past 3 months
3. Previous adverse reaction to a vitamin/mineral supplement
4. Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement)
5. Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement
6. A major single-gene disorder such as Fragile X, Down's Syndrome.
7. Major brain malformation
8. Tube feeding
9. Current participation in other clinical trials
10. Females who are pregnant or who are sexually active without effective birth control.
11. Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
12. Psychotropic medication use which can affect neurotransmitter levels/function - Current or within past 2 months