cyrilzakka/clinical-trials huggingface dataset:
Vitamin D and Microvascular Function in Postmenopausal Women

Many observational studies have demonstrated links between serum levels of 25-hydroxyvitamin D \[25(OH)D\] and cardiovascular risk (CVR) factors. Microvascular dysfunction relates not only to CVR but also to metabolic disease. Since cardiovascular disease (CVD) is the leading cause of death in postmenopausal women, it would be relevant to confirm this relationship. Maybe further studies would show that the correction of hypovitaminosis D could minimize the CVR. Our objective with this clinical trail is to analyze if vitamin D status is related to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women. For that we enrolled, in a pilot cross-sectional study, 39 non-smokers, low CVR postmenopausal women, with less than 10 years of hypoestrogenism and associations of 25(OH)D to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile, HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at cutaneous site, were investigated.


Eligibility Criteria:
Inclusion Criteria:

Women between 45-60 years with clinical/laboratory criteria of menopause and duration of hypoestrogenism \< 10 years. Menopause was spontaneous (at least one year of amenorrhea) or surgical (after bilateral oophorectomy). In hysterectomized women, ovarian failure was estimated by the history of vasomotor symptoms and serum levels of follicle-stimulating hormone (FSH) \> 35 mU/mL and estradiol levels \<20 pg/mL.

Exclusion Criteria:

Current smokers, body mass index (BMI) \>35 kg/m², systolic BP \>160 mmHg and or diastolic BP \> 100 mmHg, total cholesterol \>280 mg/dL, presence of T2D, renal dysfunction and or liver disease, clinical manifestations of coronary heart disease, and previous history of revascularization or cardiovascular event.
Preoperative Versus Postoperative Ultrasound-guided Rectus Sheath Block for Sleep Quality and Cytokines of Patients

Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with a midline incision. It has proved to be effective in preoperative block, but it has not been previously compared with postoperative block. The aim of the present study is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus postoperatively.

Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with a midline incision. It has proved to be effective in preoperative block, but it has not been previously compared with postoperative block. The aim of the present work is to evaluate the postoperative sleep quality and changes in cytokines of patients undergoing gynaecological operation with RSB preoperatively or postoperatively.

Methods/Design This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing transabdominal gynaecological operation will be randomized 1:1 to the treatment intervention with general anaesthesia as an adjunct to RSB preoperatively or postoperatively. The objective of the trial is to evaluate the postoperative sleep quality and changes in cytokines of patients undergoing hysterectomy with RSB preoperatively (n=32) or postoperatively (n=32). All of the patients, irrespective of group allocation, will receive patient-controlled intravenous analgesia with oxycodone.

The primary objective is to compare the interval between leaving the post-anaesthesia care unit and receiving the first PCIA bolus injection on the first postoperative night between patients who receive preoperative versus postoperative RSB. The secondary objectives will be to compare (1) cumulative oxycodone consumption at 24 h after surgery; (2) postoperative sleep quality, as measured using a BIS-Vista monitor during the first night after surgery; and (3) cytokine levels (interleukin-1, interleukin-6, tumour necrosis factor-α and interferon-gamma) during surgery and at 24 and 48 h postoperatively.

Eligibility Criteria:
The inclusion criteria are as follows: (1) an age of 18 to 65 years old; (2) scheduled to undergo elective midline incision transabdominal gynaecological surgery for benign mass; and (3) American Society of Anaesthesiologists (ASA) risk classification I-II.

The exclusion criteria are as follows: (1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) liver or renal insufficiency; (5) a history of psychiatric or neurological disease; (6) deafness; (7) previous open surgery; (8) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and (9) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score of higher than 6
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model.

Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91.

Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8).


Eligibility Criteria:
Inclusion Criteria:

* ICH as documented by CT scan within 6.0 hours of symptom onset
* Baseline ICH volume \> 5mL and \< 60 mL

Exclusion Criteria:

* Deep coma (Glasgow Coma Scale \< 6)
* Modified Rankin Score \> 3 prior to ICH onset
* Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to screening
* Known prothrombotic disorders
* Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies obtained as part of the standard of care may be used to assess eligibility.
* Known use of oral anticoagulant(s)
* Known use of low-molecular weight heparin or heparin
Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis

Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.

Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.

Eligibility Criteria:
Inclusion Criteria:

* Both sex
* Between 18-28 or 65-75 years old
* ASA physical status I or II
* no pre-anesthetic medications prescribed
* scheduled for surgery under general anesthesia
* willing to participate and sign informed consent.

Exclusion Criteria:

* Contraindications for propofol usage
* history of neurologic or psychiatric diseases
* drug abusers
* users of drugs that alter central nervous system
* pregnancy
* emergency surgeries
* rapid sequence intubation.
Gamification in Family Planning Education: Impact on University Students

More than 3 billion of the worlds population are young people under the age of 25. According to WHO data, one million girls under the age of 15 give birth each year, mostly in low- and middle-income countries, and 3 million adolescent girls between the ages of 15 and 19 are exposed to unsafe abortions. Failure to meet the family planning needs of young people in a timely, adequate and appropriate manner can have significant public health impacts. According to World Health Statistics, the global birth rate for girls between 15 and 19 years of age is 49 out of 1000, and early pregnancy and childbirth can lead to serious health and social problems. In addition, this age group does not have sufficient information about pregnancy and its complications, and their access to and utilization of health services is low. Inadequacies in the education of adolescents on sexual issues and sociocultural differences further increase the sexual and reproductive health risks of young people in the university period. Information and services that will enable individuals to understand their sexuality and help them protect themselves from sexual risks should be provided specifically for that age. Therefore, it is important for young people to know family planning methods. In this study, it was aimed to examine the effect of family planning education to be given with gamification method, which is different from the classical method in the literature, on the knowledge and attitudes of university students.

Location of the research: The research will be conducted with students studying at Lokman Hekim University.

Time of the research: The research will be conducted in the fall semester of the 2023-2024 academic year.

Population, sample and research group: The population of the study will consist of students studying in the midwifery department. Students who agree to participate in the research will constitute the sample of the research.

Type of research: The research was planned as a one-group pretest-posttest quasi-experimental type with the aim of evaluating the effect of the education given with gamification method on the knowledge and attitudes of university students.

Eligibility Criteria:
Inclusion Criteria:

* not having received family planning training before
* having a smartphone

Exclusion Criteria:

* to have received family planning training before
Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.

Specific Aim 1: Compare the efficacy of daptomycin to the efficacy of vancomycin for the treatment of complicated skin and skin structure infection in the ED. Patients eligible for the RDTC Cellulitis Treatment Protocol will be screened for inclusion in the study. After informed consent, patients will be randomized to receive either daptomycin or vancomycin (1:1 ratio). A case report form (CRF) detailing medical history, clinical characteristics, and treatments will be completed. The patients will be evaluated for meeting RDTC discharge criteria. The following time points will be collected: 1. actual time patient meets discharge criteria based on the RDTC cellulitis protocol; 2. time of disposition defined as the time treating physician writes discharge orders; and, 3. time the patient actually leaves the emergency department. Subsequently, the patient will be followed up by telephone to ascertain whether a change in antibiotic therapy or a return ED visit for complicated skin and skin structure infection occurred within 30 days of the initial RDTC enrollment Specific Aim 2: Compare the change in area and erythema of the cellulitic lesion between patients treated with daptomycin and patients treated with vancomycin. Patients enrolled in the study will have serial digital photographs of their primary lesion taken. The images will be processed blinded to clinical data and asynchronous to the ED stay. The change in lesion area and erythema will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to RDTC to the Cellulitis Protocol
* 18 yrs old or greater
* Able and willing to give informed consent
* Hemodynamically stable (systolic blood pressure \>90mmHg and heart rate \<120 beats per minute)

Exclusion Criteria:

* Antibiotics given prior to enrollment
* Suspected necrotizing infection
* Diabetic foot ulcer
* Genitourinary involvement
* Post operative infection (not including simple wound closure infection)
* Suspected gouty or septic arthritis
* Chronic Lymphangitis
* Requiring routine hemodialysis
* Patient reported allergy to Vancomycin
* Patient reported allergy to Daptomycin
* Participation in another investigational treatment study within 30 days prior to enrollment
* Prisoner
* Pregnant or breast-feeding
* Complicated skin and skin structure infection of the face
Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
* Stable symptoms and dose of Quetiapine or Risperidone

Exclusion Criteria:

* First diagnosis in the past year
* Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)

Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects who are 18-65 years of age.
* Non-childbearing potential females or those using birth control.

Exclusion Criteria:

* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
* History of significant gastrointestinal disease
* Any significant medical illness
* Gastrointestinal disorder or surgery leading to impaired drug absorption
* Currently using gastrointestinal medications
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
2. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

   * Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
3. Participants who meet both of the following based on polysomnogram (PSG) in observation period:

   * Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
   * Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

1. Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
3. Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
4. Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
5. Participants with organic mental disorder.
Evaluation of Electrical Activity Tibial Muscle and Postural Control of Individuals With Hemiparesia Post TDCS Associated With FES

Introduction: It is suggested that increased cortical activity, induced by cerebral stimulation associated or not with other rehabilitation techniques, may potentiate the motor and functional therapeutic effects in individuals with neurological deficits. Objectives: To evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of individuals with hemiparesis due to stroke following treatment with transcranial direct current (tDCS) stimulation and functional electrical stimulation (FES), associated or isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both of which were collected at four different time points: pre-treatment, immediately after 10 treatment sessions, and 30 days follow-up after the interventions. Patients will be randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and FES over hemiparetic TA by a researcher who will not be the one who will evaluate the anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20 minutes.


Eligibility Criteria:
Inclusion criteria:

* Individuals with hemiparesis due to stroke;
* Both sexes;
* Agree to sign the free and informed consent form.

Exclusion criteria:

* Positive cut-off point for the Mini Mental State Examination (MMSE) of less than 11 points already corrected for schooling;
* Ankle mobility reduced by history of fracture or use of ankle fasteners;
* Irreducible equine deformity;
* Muscle strength level of AT less than 1 by the scale of Kendall;
* Patients with reported severe visual impairment;
* Contraindications to the use of transcranial direct current stimulation (history of seizure or recurrent epilepsy, brain tumors at the stimulation site, metallic materials implanted in the brain);
* Individuals with cutaneous infection at the point of application of FECC or FES;
* Individuals who presented anesthesia or hyperesthesia at the point of application of the ECTS;
* Individuals diagnosed with deep venous thrombosis (DVT);
* Individuals diagnosed with degenerative diseases or polyneuropathies.
* Individuals who do not present complementary tests that diagnose the lesion site.
IgG-mediated Food Test for Weight Loss

This study assessed the effect of an IgG-mediated food sensitivity test in combination with a food elimination diet on body composition and secondary outcomes in people who were overweight.

This study looked at foods that stimulated IgG food antibody production, which may play a role in certain conditions, such as irritable bowel syndrome, obesity, type I diabetes, and migraine headaches.

Using a proprietary blood test, the Immuno Bloodprint, to determine which foods stimulate IgG food antibodies in each person, this study detailed a personalized list of reactive foods that stimulated such antibodies for each participant. The participant was then advised to eliminate as much as possible the reactive foods for 90 days.

Eligibility Criteria:
Inclusion Criteria:

* BMI above 20
* Express an interest in losing weight

Exclusion Criteria:

* Less than 18 years of age
* Currently participating in another research trial for weight loss
* Suffering from serious medical complications that might limit their participation, such as recent heart attack, stroke, or chronic kidney disease
* Pregnant