cyrilzakka/clinical-trials huggingface dataset:
Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies

This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin K antagonist (VKA) treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years.
* Patients with a diagnosis of nonvalvular atrial fibrillation according to the criteria of the Spanish Agency of Medicines and Medical Devices (AEMPS) (2013) who are treated in cardiology practices.
* Patients about to start treatment with a vitamin K antagonist or who are in the first two months of treatment.
* Patients for whom access to at least 80% of INR tests performed during treatment with vitamin K antagonists is expected to be available.
* Patients with the mental and physical capacity to complete the study questionnaires and give their informed consent to participate in the study.

Exclusion Criteria:

* Patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty).
* Patients hospitalised at the time of inclusion in the study.
* Patients with a life expectancy of less than 13 months.
* Patients who are participating in a clinical trial.
* Patients receiving double antiplatelet therapy.
The Daily Habits Survey

Online survey for 11-17 year olds about behavior, sleep, and food consumption patterns. This survey can be completed on any computer that has internet access.

The following opportunity is a reserach project at the American University Behavioral Pharmacology and Health Promotions Laboratory (BPHP). The study population is 11-17 year olds. The 30 minute online survey asks questions about behavior, sleep, and typical food consumption. The purpose of this survey is to better understand these habits in young people and the effects of these habits on behavior and sleep. This information will provide us with a better understanding of the daily habits in young people and guide the direction of future research projects.

Eligibility Criteria:
Inclusion Criteria:

* 11-17 years old
Prediction of Acute Postoperative Pain and Analgesic Consumption

Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain.

We hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption.

Preselected preoperative predictor variables/individual patient characteristics include the following:

* Evoked brain potentials (using standard electroencephalographic brain imaging)
* Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)
* Pressure pain detection and tolerance thresholds in muscle (m.quadriceps)
* Pressure pain tolerance thresholds in bone (sternum and tibia)
* Heat pain tolerance threshold in skin (forearm)
* Responses to the Situational and Dispositional Pain Catastrophizing Scale
* Response to the State-Trait and Anxiety Inventory
* Response to the Beck's Depression Inventory

Eligibility Criteria:
Inclusion Criteria:

* Elective minimally invasive surgical correction of funnel chest (pectus excavatum
* age ≥15 years.

Exclusion Criteria:

* Previous thoracic surgical interventions
* Presence of diseases affecting the central and/or peripheral nervous system
* Presence of chronic pain conditions
* Inability to speak and/or understand Danish
* Inability to understand and participate in the experimental pain session
* Presence of psychiatric disorders
* History of frostbite in the non-dominant upper limb
* Presence of sores or cuts on non-dominant upper limb
* Presence of cardiovascular disease
* History of fainting and/or seizures
* Presence of fractures of the non-dominant upper limb
* Presence of Reynaud's phenomenon.

Secondary exclusions included:

* Insensitivity to experimental cold pressor pain
* Lack of epidural catheter placement
* Re-operation
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine


Eligibility Criteria:
Inclusion Criteria:

1. A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
2. Born at full term pregnancy (Gestational age ≥ 37 weeks)
3. Body weight ≥ 3.2 kg at the time of screening
4. Received one dose of hepatitis B mono-vaccine within seven days of birth
5. Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
6. Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
7. Written informed consent by subject's parent(s) or LAR

Exclusion Criteria:

1. Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
2. History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
3. Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
4. Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
5. Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
6. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
7. Known or suspected immune disorder or immunodeficient condition
8. Receipt of immunoglobulin or blood-derived product since birth
9. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
10. History of bleeding disorder contraindicating intramuscular injection
11. Major congenital defects or serious chronic illness
12. History of any neurological disorders or seizures
13. History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
14. History of allergic reactions to latex
15. Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
16. Plan to leave the area of the study site before the end of the study period
17. Infants who are considered unsuitable for the clinical study by the investigator
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.


Eligibility Criteria:
Inclusion Criteria:

* Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation.
* Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
* Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.

Exclusion Criteria:

* Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer
* Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation
* Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or
The Effect of Kinesio Tape on Pain Management in Laparoscopic Gynecological Surgeries.

Kinesio tapes have been used in medicine to reduce pain in various situations. It is an easy applicable and effective tape. The possible affect of this tape will be assessed in patients undergoing gynecological laparoscopic surgeries.

Kinesio tape is frequently used for pain palliation in medicine including orthopedics, physical therapy and rehabilitation, and dentistry. Recent studies show that it alleviates the amount of postoperative perceived pain in obstetrics and general surgery. In our study, we plan to contribute to the medical literature by studying its effect on pain palliation in patients undergoing laparoscopic gynecological surgery.

Eligibility Criteria:
Inclusion Criteria:

* being older than 18 years old female gender benign gynecologic conditions patients who underwent laparoscopic surgery patients who do not have any predisposing factors that aggreviate pain no history of malignancy no prior abdominal surgery patients who do not regularly take antiinflammatory medication patients who give permission to participate

Exclusion Criteria:

* being younger than 18 years old non-female gender having malignancies patients who underwent laparatomy patients with predisposing factors that aggrevate pain having prior abdominal surgery patients taking regular antiinflammatory medications who do not want to participate
Spontaneous Preterm Birth Marker Test

The prediction of preterm birth is beneficial because it initiates early treatment to minimize risk. It defines a population at risk to provide particular treatment and may lead us to a better understanding the mechanisms of preterm birth. The understanding of the mechanisms and etiology consequently leads to the possibility of early intervention and effective management aiming at preventing preterm birth. Five most common interventions for preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy. However, there are insufficient evidence showing the efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm birth; the use of certain tocolytics needs to be considered against the possible adverse effects. The early detection of pregnant women with high risk for preterm delivery would be the ideal solution to prevent preterm birth. However, to date, there is inadequate literature and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.

Exclusion Criteria:

* Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.
Strong Couples Project: Disseminating Evidence-based Relationship Education

The current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system.

The objective of the research is to evaluate the effectiveness of an online intervention (ePREP) for help-seeking couples designed to promote individual and couple well-being. Newly developed online intervention programs for distressed couples have shown to be efficacious, but their overall reach to the general population remains limited. The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the nation in a manner that allows for scalable, sustainable program delivery.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Illinois
* Married, engaged, or living with their partner for at least 6 months
* Both partners willing to participate in online relationship-focused programming

Exclusion Criteria:

* One or both partners reports sever forms of intimate partner violence occurring in the relationship
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study

Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria
* Remission according to DAS28\<=2.6 for at least 6 months
* Patients with ongoing adalimumab treatment (40 mg every other week) according to the standard regimen for at least 6 months
* A negative highly sensitive pregnancy test for women of Childbearing Potential\*
* Affiliated person or beneficiary of a social security scheme
* Informed consent signed by the patient after information

Exclusion Criteria:

* Incapacity or refusal to understand and / or sign informed consent to participate in the study.
* Existing pregnancy, lactation, or intended pregnancy within the next 15 months
* Fibromyalgia associated to RA
* A failure of previous tapering
* Any dose of prednisone for RA treatment 6 months before inclusion
* Patient deprived of liberty or patient under guardianship or curator ship.
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.

While the availability of atypical antipsychotics had increased the therapeutic options available, there remains a need for safer and more effective therapies in the treatment of manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor activity profile likely correlates with its established efficacy in schizophrenia and major depressive disorder, and may prove to be an effective target for the treatment of acute mania of bipolar I disorder.

Eligibility Criteria:
Inclusion Criteria (rollover participants from 331-201-00080 \& 331-201-00081 trials)

* Participants remaining in hospital at the Day 21 visit of trial 331-201-00080 or 331-201-00081 were permitted to enroll in the 331-201-00083 trial at the week 3 visit of the double-blind trial if they were planned to be discharged from the hospital before the week 1 visit of trial 331-201-0083. Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.
* Participants who, in the opinion of the investigator, could potentially benefit from administration of oral brexpiprazole for the treatment of bipolar I disorder and who completed 3 weeks of post-randomization treatment in Trial 331-201-00080 \& Trial 331-201-00081.

Exclusion Criteria (rollover participants from 331-201-00080 \& 331-201-00081 trials)

* Participants with a major protocol violation during the course of their participation in the double-blind phase 3 trials (331-201-00080 or 331-201-00081).
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions

In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with a novel topical application method to 12 chronically HIV-infected cART treated patients. The HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C, rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients received placebo. The immunization was performed during three cycles of 7 weeks of cART followed by four weeks of therapy interruption. After the last cycle of cART the patients were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below 350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a cell count was analysed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 60 years
2. Female, who is documented infertile or in menopause since at least 1 year, or male, who are willing not father a child for the duration of the study.
3. HIV infection detected by two serological and/or HIV plasma RNA tests
4. On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months
5. Current CD4 count above 400
6. CD4 count nadir \>200
7. Viral isolate pre ART available is preferable but not mandatory
8. Willing to consider stopping HAART repeatedly.
9. Willing to conform to a low alcohol intake (maximum of one glass per day)
10. Able to tolerate didanosine and hydroxyurea
11. Willing to change their HAART to exclude NNRTI and stavudine
12. Able to give informed consent
13. Availability for follow-up for planned duration of the study

Exclusion Criteria:

1. Patients with ongoing infection(s) other than HIV.
2. Prior or current pancreatitis or history of alcohol abuse.
3. Ongoing neuropathy and history of more than grade 1 neuropathy.
4. History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure.
5. Sun or solarium exposure at the immunizing sites one month before or during the trial.
6. Cortisone treatment, systemic or local at the immunizing sites, one month before or during the trial.
7. Patients with signs of autoimmune diseases
8. Patients with creatinine \> 2mg/dl, Hb \< 12g/dl, leukocytes \< 3,000ul, platelets \<150,000/ul and LFT \> 5x upper limit of normal
9. Patients on any immune modulating or investigational drug
10. Anamnestic allergy to kanamycin, plasmid gene products
Precision Study Measuring Potassium (K) in Capillary Specimens

Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated consent form (if required by the IRB)
* ≥ 18 years of age

Exclusion Criteria:

• Prior enrollment in the study
Effect of Metformin Use on Mortality in Diabetic and Non Diabetic Patients With Sepsis and Septic Shock.

We aimed to determine if metformin use in both diabetic and non diabetic patients with sepsis and septic shock affects 28 day mortality and its effect on inflammatory markers. Plasma rennin, serum lactate concentration and IL6 will be measured for predicting 28 days in-hospital mortality in patients with sepsis.

Sepsis, is a life-threatening condition arises when the body's response to infection causes injury to its own tissues, followed by suppression of the immune system. Signs and symptoms include fever, increased heart rate, increased breathing rate, and confusion.There may be symptoms of a specific infection, such as cough, or painful urination.

Sepsis is caused by many organisms including bacteria, viruses and fungi. . Risk factors include extreme of ages, a weakened immune system. Previously, a sepsis diagnosis required the presence of at least two systemic inflammatory response syndrome criteria.

Sepsis requires immediate treatment with intravenous fluids and antimicrobials in ICU. If fluids is not enough to maintain blood pressure, the use of medications that raise blood pressure becomes necessary. Mechanical ventilation and dialysis may be needed. A central venous catheter and an arterial catheter may be placed. corticosteroid use is controversial.

Metformin is a biguanide antihyperglycemic agent. It works by decreasing glucose production in the liver, by increasing the insulin sensitivity of body tissues, and by increasing GDF15 secretion, which reduces appetite.

Metformin is a first-line therapy for type 2 diabetes mellitus, taken by mouth and well tolerated. Common adverse effects include diarrhea, nausea, and abdominal pain.

Metformin inhibit pathways linked to inflammation, immune reactions, mammalian target of rapamycin (mTOR) signaling, and cell senescence. Some of the changes were confirmed by Western blot. Therefore, metformin prevented part of the deleterious actions of pro-inflammatory cytokines in human β-cells, which was accompanied by islet proteome modifications.

Eligibility Criteria:
Inclusion Criteria:

* both sexes aged ≥18 years old complaining of sepsis or septic shock with anticipated stay \>24 hours, and signed informed consent by patient or next-of-kin.

Exclusion Criteria:

* Age less than 18 years old, chronic kidney disease stage IV/V (baseline eGFR \<30ml/min/1.73m2), patients with acute coronary syndrome, or do not resuscitate order. Patients could be enrolled at any point during their admission.