cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

Takotsubo cardiomyopathy (TC) is a type of non-ischemic cardiomyopathy in which there is a sudden temporary weakening of the myocardium. . In a recent study, women report more sexual dysfunction than men after 1 year after TC. Despite that a number of studies have assessed female sexual dysfunction (FSD) for TC , there is no information regarding prevalence and associated factors on FSD in women with TC. However, in a recent study on Iranian female patients with TC, more than 77% of these patients suffered from FSD. This study is aimed to assess the effectiveness of a Mindfulness-based Sex Therapy on Patients With TC.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years old at least
* confirmed diagnosis of TC by a cardiologist according Mayo Clinic diagnostic criteria; an acute left ventricular apical ballooning of unknown cause
* willingness to partaking for the duration of the trial
* a basic fluency in Persian
* living with a partner/spouse

Exclusion Criteria:

* cognitive disability
* having acute myocardial infarction
* cerebrovascular disease
* pheochromocytoma and viral or idiopathic myocarditis
* , participating in another RCT
Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children

The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.

The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone.

Intervention:

History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria.

Clinical procedure:

Intervention group:

Clinical examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec.

Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally.

The cheek will be retracted and the device will be turned on.

1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.

Control group:

AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off.

Assessment:

Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion.

Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children aged 6-7 years old.
2. Apparently healthy Children.
3. Cooperative children.
4. Children with carious maxillary bilateral primary molars indicated for extraction.

Exclusion Criteria:

1. Children who are allergic to amide group.
2. Children with Neurologic disorders.
3. Children with mental disability.
4. Presence of periapical or gingival legion.
5. Severe Gingivitis.
Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites

The primary objective of this study is to determine if the use of a bone compaction process (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental implant sites, in human subjects, results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and dental implant stability.

The proposed project will be an observational, case-series study. The investigators anticipate enrolling 40 study subjects. Treatment Procedures: Following initial treatment planning discussions between the dentists and their patients regarding all of their dental treatment options, those patients who opt to have dental implants placed will be approached to discuss participation in the current study. Before entry into the study, the Investigator or an authorized member of the investigational staff will explain to potential subjects the aims, methods, reasonable anticipated benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be informed that their participation is voluntary and that they may withdraw consent to participate at any time. They will be informed that choosing not to participate will not affect the care the subject will receive for the treatment of their condition. Subjects will be told that alternative treatments are available and that if they decline to take part in the present study that such a refusal will not prejudice future treatment. Those patients who are willing to participate will be scheduled for their initial and follow-up dental implant visits at the School of Dentistry. At the baseline visit the study outcome data will be collected; including: 1) measuring the bone-ridge width, before and after implant site preparation (drilling); 2) intraoral photographs of the prepared opening; 3) dental implant torque readings will be obtained; and 4) ISQ as measure of both initial and the dynamic development of osseointegration (the formation of a direct interface between the dental implant and bone) over time. The ISQ measurements will be collected again at three and six-weeks post treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Ages 18-80 years of age
3. Missing at least one tooth.
4. Capable of giving informed consent

Exclusion Criteria:

1. Patient is a pregnant female
2. Patient smoking more than 5 cigarettes per day
3. Patient has a history of alcoholism or drug abuse during the last 5 years
4. Patient with uncontrolled hypertension or diabetes
5. Patient has a malignant tumor
6. Patient is on daily dose of steroids
7. Patient with history of chemotherapy or radiation for the last 12 months
8. Patient who is immuno suppressed
9. Patient with titanium allergy
10. Subject should not be a homeless person
Effect of Exercise Programs on 3-dimensional Scapular Kinematics, Disability and Pain

The aim of this study is to investigate the effect of exercise program on 3-dimensional scapular kinematics, disability and pain on shoulder impingement with scapular dyskinesia.


Eligibility Criteria:
Inclusion Criteria:

* Subacromial impingement with scapular dyskinesia

Exclusion Criteria:

* Additional muscular and skeletal or systemic diseases
Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis

Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.

This is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). Both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.The treatment duration for both groups will not exceed three months, with the observation group aiming for a Sunnybrook score of ≥83 and the control group aiming for a score≥95. The primary outcome measure is Sunnybrook scores at 6 months after onset compared with baseline. Secondary outcome measures included Sunnybrook Scores, electroneurography, blink reflex, Facial Disability Index, Self-Rating Depression Scale and Self-Rating Anxiety Scale.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18-75 years.
2. Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
3. All cases have symptoms and signs or have been examined by CT, MRI, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma.
4. Those who voluntarily sign the Research Informed Consent Form

Exclusion Criteria:

1. Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
2. Pregnant or nursing patients.
3. Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
4. Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation
Reliability and Validity of the Evaluation of Hip Abductors Strength (RAVEHABDS)

The aim is to evaluate the intra- and inter-tester reliability, construct validity and feasibility of a new functional measurement procedure in a closed chain position on one leg. For this purpose, we will test the maximal voluntary isometric force, as well as the muscular contraction speed of the hip abductor muscles.

Within this Master thesis project, we will investigate intra- and inter-tester reliability, as well as construct validity of a measurement procedure to assess hip abductor strength in a closed-chain position. Additionally, we aim to investigate some aspects of feasibility using a questionnaire about the measurement procedure and by evaluating if the test can be completing in a suitable timeframe for practical use.

To investigate intra- and inter-tester reliability, as well as construct validity, we will analyze and compare the maximal voluntary isometric strength (MVIS) and the rate of force generated (RFG) of the three groups of healthy participant (group 1: 18-30 years old; group 2: 31-65 years old; group 3: 65+ years old).

Eligibility Criteria:
Inclusion Criteria:

* Persons over 18 years old, good understanding of French, German, English or Italian, with the capacity of discernment regarding their own participation in the study

Exclusion Criteria:

* Persons with cognitive impairment or who are unable to take their own decisions about participation in the study, or who have undergone surgery on the lower limb or lumbopelvic area during the last 6 months that could contradict or influence the strength tests, will be excluded from the study
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.


Eligibility Criteria:
Inclusion Criteria:

* aged older than 19 years
* more than 3 times of unformed stools passage per day
* positive results of toxin gene test: GDH (+) + PCR (+), GDH (+) + toxin (+), or PCR (+) + toxin (+)
* agree with informed consent

Exclusion Criteria:

* less than 3 times of unformed stool passage per day
* use of oral metronidazole or vancomycin more than 24 hours before enrollment
* use of laxative before enrollment
* recurrent episode of CDI
* disagree with study protocol
Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine

The study is Multicenter, phase 3, Open-Label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.

The study will include 2000 volunteers, 1,000 of whom will be vaccinated intramuscularly with a single dose of allantoic split inactivated seasonal influenza vaccine.

All participants will be observed for 6 months to evaluate the effectiveness of the vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes aged from 18 years.
* Literate and willing to provide written informed consent.
* A signed informed consent.
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Allergic reactions to chicken proteins, or any preceding vaccination.
* Acute illness with a fever (37.0 C).
* Vaccination against influenza in the 2017/2018 season.
* Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
* Hypersensitivity after previous administration of any vaccine.
* History of chronic alcohol abuse and/or illegal drug use.
* A positive pregnancy test for all women of childbearing potential.
* Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
* Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
* History of leukemia or any other blood or solid organ cancer.
* Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
* Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
* Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
Validation of Educational Effect of Nerve Tracking Function Mounted on the Ultrasound

The purpose of this study is to find out whether the nerve track function is helpful in distinguishing appropriate anatomical structures for beginners using ultrasound.

2nd, 3rd, 4th year medical school students and 1st, 2nd, 3rd year residents of anesthesiology who voluntarily signed a consent form for participation in the study are investigated for the history of previous ultrasound use and other details of the subjects before the lecture and ultrasound practice.

Well-trained pain physicians provides anatomical education on the brachial plexus supraclavicular level and the median nerve at wrist level. At this time, an ultrasound cross-sectional image of the corresponding nerve is provided. After anatomical education, research subjects (students and residents) are randomly assigned to group A or B after receiving basic education in a 1:1 ratio.

Subjects receive training for about 10 minutes to find the brachial plexus (supraclavicular level) and median nerve (carpal tunnel level) through a live demo method that directly uses ultrasound. At this time, group A receives training in the live demo method with the nerve track function, and group B receives training in the live demo method without the nerve track function.

After a 5-minute intermission, both groups A and B were asked to find the brachial plexux and median nerve without the nerve track function in the instructor's left upper limb. Each nerve is to be found within 5 minutes, and it is considered a failure after 5 minutes.

After activating the nerve track function in both groups without intermission, the educator shows the nerves corresponding to the brachial plexus at supracalvicualr level and median nerve at wrist level in the left upper limb, and conducts the same 5-minute training on finding them.

After a 5-minute intermission, with the nerve track function turned off again, ask the educator to find the brachial plexus and median nerve in the right arm.

Eligibility Criteria:
Inclusion Criteria:

* 2nd, 3rd, 4th year students at Seoul National University College of Medicine
* 1st, 2nd, 3rd year residents of anesthesiology at Seoul National University Hospital
* Those who voluntarily consented

Exclusion Criteria:

* Those who have previously identified the brachial plexus at supraclavicular level and median nerve at wrist level using ultrasound
Neurobehavioral Model of HIV in Injection Drug Users

The purpose of this R01 study is to evaluate the association between neuropsychological executive dysfunction and HIV infection among young injection and non-injection drug users. A longitudinal study will be conducted in which the cohort of seronegative drug users completing a baseline neuropsychological battery are re-assessed on three subsequent occasions, roughly six months apart. The primary aim of the longitudinal study is to estimate the magnitude of the suspected causal relationship between executive dysfunction and HIV-risk behaviors while adjusting for time-invariant (e.g. sex, ethnicity) and time-varying (e.g. degree of drug abuse) covariates. We also seek to evaluate: (1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors. If successful, this project will shed new light on significant and potentially malleable HIV-risk factors in injection and non-injection drug users. This will be important evidence because injection drug abuse continues to account for a large proportion of HIV seroconversions particularly among young women and minorities. As such, this RO1 research project serves as an important initial step in a line of innovative investigations about suspected causal associations between neuropsychological deficits and HIV-risk behaviors in drug users. Ultimately, this line of investigation should lead to changes in public and clinical practices designed to prevent HIV infection.


Eligibility Criteria:
Inclusion Criteria:

* Drug users aged 15 to 50 years old.

Exclusion Criteria:

* Acute psychotic, suicidal, homicidal ideation.
Glycemic Objectives of Women With Gestational Diabetes Mellitus

In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM.

In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)


Eligibility Criteria:
Inclusion Criteria:

* gestational age between 15 and 32 weeks since last menstrual date,
* received education on gestational diabetes mellitus,
* able to read and understand French.

Exclusion Criteria:

* known type 1 or type 2 diabetes,
* treatment interfering woth glucose metabolism,
* deficit may hinder the understanding of the study.
Resistance and/or Endurance Training, What is Most Effective in Prevention of Cardiovascular Diseases?

The aim of the present study was to evaluate the effects of aerobic interval training versus strength training or a combination of these regimes on factors comprising the metabolic syndrome in order to find the most effective exercise regime for patients with metabolic syndrome.

In the Western world, approximately 25% of young to middle-aged adults have metabolic syndrome. There seem to be a strong age-dependence in the prevalence of the metabolic syndrome, but the incidence rises rapidly within adolescents and middle-aged groups and follows the development of obesity in the general population. Metabolic syndrome confers an increased risk of coronary heart disease, cardiovascular disease, and premature death; therefore, effective and affordable strategies to combat the syndrome would be of great individual and social importance.

Despite the general agreement that moderate-intensity physical activity for a minimum of 30 min five days per week or vigorous-intensity aerobic physical activity for a minimum of 20 min three days a week promote and maintain health, the optimal training regime to treat metabolic syndrome and its associated cardiovascular abnormalities remains uncertain.

Eligibility Criteria:
Inclusion Criteria:

* Having metabolic syndrome according to international diabetes foundations definition (IDF).

Exclusion Criteria:

* Unstable angina pectoris
* Uncompensated heart failure
* Myocardial infarction during the past 4 weeks
* Complex ventricular arrhythmias
* Kidney failure
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder

The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males \& females ages 18-65;
* Body weight \>50kg; BMI between 19-32;
* Signed and dated informed consent; QTc Interval \<450 msec;

Exclusion Criteria:

* Resting blood pressure \>140/90 mmHg or HR \>100 at screening;
* History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
* Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
* Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
* history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
* history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
* clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment