cyrilzakka/clinical-trials huggingface dataset:
Motivational Interviewing

The purpose of this project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors.

The objective of this randomized control trial is to evaluate, among 190 African-American patients with poorly controlled hypertension followed in a community-based primary care practice, whether motivational interviewing is more effective than usual care (routine counseling) in achieving adherence to prescribed blood pressure medications at 12 months.

The project aims to: 1) determine whether patients who receive motivational interview counseling have greater reduction in both systolic and diastolic blood pressure than those in the control group at 12 months. Clinic blood pressure readings will be assessed at baseline and at every three months thereafter for one year and 2) assess the effect of self-efficacy and intrinsic motivation as potential mediators of motivational interview on adherence. Self-efficacy and intrinsic motivation will be assessed at baseline and every three months thereafter for one year.

Eligibility Criteria:
Inclusion Criteria:

The target population consisted of hypertensive African American patients who fulfilled the following eligibility criteria:

* Self-identification as African American
* Age 18 years or older
* Diagnosis of hypertension utilizing ICD-9 codes 401-401.9 (the code for essential hypertension)
* Taking at least one antihypertensive medication
* Uncontrolled hypertension of a clinic blood pressure reading \>140/90 mm Hg or 130/80 mm Hg (for those with kidney disease or diabetes) on two successive clinic visits prior to screening (defined per JNC VI criteria)
* Fluent in English language

Exclusion Criteria:

Participants were excluded if they:

* Had a diagnosis of cognitive impairment or serious medical condition as determined by their primary physician
* Were unable to give informed consent
* Refused to participate
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 19 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2

Exclusion Criteria:

* Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
* History of allergy or intolerance to metformin or other similar acting agents
* Prior exposure to saxagliptin
* Prior exposure to metformin within 3 months of study drug administration
* Estimated creatinine clearance (Clcr) of \< 80ml/min using the Cockcroft Gault formula
Paternal Involvement in Breastfeeding

Paternal involvement in breastfeeding has been identified as a significant predictor in maternal breastfeeding outcomes. The main aim of this study is to examine the relationship between reported paternal breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration. The hypothesis is that paternal involvement in breastfeeding increase exclusive breastfeeding rates, total breastfeeding duration and strengthen paternal-infant attachment.

Initiation, duration and exclusivity of breastfeeding are greatly influenced by paternal involvement in breastfeeding. Previous studies showed that fathers who are involved in the breastfeeding process have stronger attachments with their babies. However, research on fathers' involvement in their partners' breastfeeding is lacking and there are no comprehensive studies conducted on the effects of the paternal involvement and infant attachment on exclusive breastfeeding (EB) and total breastfeeding duration. Therefore, the aim of the study is to examine the relationship between fathers reported breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration. Data will be collected from a tertiary university hospital. The study will be conducted in two phases. In the first phase, the researcher will approach healthy, term, one month old babies and their fathers who fulfilled the eligibility criteria and will invite them to participate in the study. Informed consent will be obtained from participating fathers. The Partner Breastfeeding Influence scale will be used to measure fathers' involvement in their partner's breastfeeding, Paternal-infant attachment, paternal depression, and marital adjustment will be measured with Paternal-Infant Attachment Questionnaire, Edinburgh Postpartum Depression Scale and Marital Adjustment Scale respectively. Four sets of questionnaires will be administered at two time points for the study. The first set will be administered at postpartum first month. The second set of data will be collected at postpartum six months. In the second phase, fathers participating in the study will be interviewed for breastfeeding duration and factors associated with cessation will be explored at postpartum 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

Fathers of

* one-month-old,
* healthy,
* breastfed infants

Exclusion Criteria:

* Infants with a birth weight less than 2500 grams
* Infants who are less than 37 weeks gestation
* Infants with prenatally suspected or diagnosed congenital defects
* Parents with major depression
* Divorced or separated couples
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers

This single center, single ascending dose, double blind, randomized, placebo-controlled phase I trial will include male and female Japanese healthy volunteers. Within a 4-week run-in period before inclusion in the trial, healthy volunteers will be checked for inclusion/non-inclusion criteria and will then be randomized and administered with gadopiclenol or placebo. For each healthy volunteer, there will be a confinement period of one night before the inclusion visit and 2 days post administration at the clinical unit. The healthy volunteers will return to the clinical unit for safety visit 7 days after study product administration.

In each dose group, 6 healthy volunteers (3 male and 3 female) will receive gadopiclenol and 3 healthy volunteers (2M/1F or 1M/2F) will receive placebo (physiological saline solution, 0.9% sodium chloride) in one single intravenous administration.

Dose escalation from one group to the next group will be sequential and will be allowed only if the clinical and biological safety of all healthy volunteers from the previous tested dose is acceptable. The decision will be made by a Trial Safety Review Board (TSRB), consisting in members of Guerbet team and the principal investigator.


Eligibility Criteria:
Inclusion Criteria:

* A Japanese healthy volunteer is defined as being born in Japan and having both parents and four grandparents (maternal and paternal) who are ethnically Japanese and having Japanese lifestyle, including diet, as determined by participant's verbal report.
* Good health status as determined by investigator according to past medical history, clinical examination, including 12 lead ECG, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and laboratory tests at screening and inclusion.

Exclusion Criteria:

* Pregnant or breast-feeding female volunteer.
* Having acute or chronic renal insufficiency, defined as an eGFR (estimated Glomerular Filtration Rate) \<90mL/min/1.73 m2, calculated by using the Japanese coefficient-modified CKD-EPI formula.
* With known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to drugs from a similar pharmaceutical class.
* With known history of severe allergic or anaphylactic reactions to any allergen including drugs and contrast agents.
Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)

SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.

SPOCS is an international, multicenter, prospective observational cohort study with bi-annual follow-up over 3-years maximum follow-up of patients with SLE confirmed by American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria, who have moderate-to-severe disease by SLEDAI-2K criteria (Modified SLEDAI-2K score ≥4 and/or SLEDAI-2K score ≥6 points, at least one life-time positive serology of anti-nuclear antibody (ANA) or double-stranded deoxyribonucleic acid antibody (dsDNA), and 6-month minimum treatment duration with systemic SLE treatment beyond NSAIDS and analgesics. Participants will be followed as per local routine clinical practice. SPOCS is an observational study with no requirement for protocolized treatment interventions.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following criteria for enrollment in SPOCS:

* Adult patients aged 18 years or older
* Physician confirmation that patient meets ACR or SLICC SLE classification criteria
* Current or historic positive serology of ANA or dsDNA
* Minimum treatment duration of 6 months for active SLE with systemic SLE treatment beyond NSAIDs and analgesics
* Moderate-to-severe SLE; SLEDAI-2K Criteria: Modified SLEDAI-2K score ≥4 and/or SLEDAI-2K score ≥6. The "Modified" SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures and lupus headache.
* Patient and/or representative(s) who understands the requirements of the study and provides written informed consent.

Exclusion Criteria:

Patients meeting any of the following criteria will be determined to be ineligible for enrollment in SPOCS:

* Patients actively enrolled in interventional trials involving investigational agents
* Patient with active severe lupus nephritis with a history of a renal biopsy in the last year showing active class III or class IV +/- class V lupus nephritis and/or urine protein:creatinine ratio \>1mg/mg based on random urine collection.
* Patients unable to complete study measures
Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. This trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (HIE) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.

Eligibility Criteria:
Inclusion Criteria:

One clinical indication of hypoxic-ischemic injury

* cord gas pH ≤ 7.0 or base deficit ≥13,
* initial infant gas pH \< 7.1,
* Apgar score ≤5 at 10 minutes,
* continued resuscitation after 5 min,
* fetal bradycardia with heart rate \< 80 beats per minute lasting ≥15 min,
* postnatal event O2 sat \<70% or arterial O2\<35 for 20 min with ischemia

And two neurologic findings of neonatal encephalopathy, abnormalities of:

* tone,
* reflexes,
* state of consciousness,
* seizures,
* posturing,
* autonomic dysfunction

Exclusion Criteria:

* Maternal chorioamnionitis,
* sepsis at birth,
* birth weight or head circumference \<10%,
* presumed chromosomal abnormality
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance

The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
* with moderate to severe sleep apnea,
* no history of previously CPAP therapy and
* with an above-elementary school education.

Exclusion Criteria:

* refusal to participate,
* refusal to CPAP therapy,
* previous CPAP treatment,
* central sleep apnoea syndrome,
* Cheyne-stokes breathing pattern,
* obesity hypoventilation syndrome,
* restrictive ventilator syndromes,
* congestive heart failure,
* history of life-threatening arrhythmias,
* cardiomyopathy,
* long term oxygen therapy,
* family or personal history of mental illness,
* with drug or alcohol abuse,
* severe cognitive impairment,
* concurrent oncologic diseases and
* history of narcolepsy.
Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A

The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with midperipheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by age 50 to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on the effects of vitamin A on RP, it became apparent that another substance in the diet could be affecting the course of the disease. This prompted the present randomized, controlled trial.

This study is a randomized, controlled, double-masked trial with a planned duration of 5 years. Patients with the common forms of RP are assigned to either a test or a control group. All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of docosahexaenoic acid or control capsules. Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial. The main outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.

Eligibility Criteria:
Inclusion Criteria:

Ocular Criteria:

Retinitis Pigmentosa, typical (non-syndromic) forms Best corrected visual acuity Greater than or equal to (GE )20/100 HFA 30-2 total point score GE 250 dB (decibels) 30 (Hertz) Hz ERG cone amplitude GE 0.68 microvolts

Dietary Criteria:

Dark fish intake Less than or equal to (LE) five servings per week Dietary omega-3 fatty acid intake LE 0.41 g/d Preformed Vitamin A intake in diet and supplements LE 10,000 IU/d Supplement intake LE 5000 IU/d of Vitamin A and LE 30 IU/d Vitamin E Consumption LE 3 alcoholic beverages per day

Medical and other criteria:

Body Mass Index Less than (LT )40 and weight GE 5th percentile for age, sex, and height Serum retinol level LE 100 mg/dl and serum retinyl ester levels LE 380 nm/L Serum cholesterol level LT 300 mg/dL and serum triglyceride levels LT 400 mg/dL Agree not to know study capsule content

Exclusion criteria:

Ocular criteria:

No confounding ocular disease

Dietary criteria:

No intake of cod liver oil or omega-3 capsules

Medical and other criteria:

Not pregnant or planning to become pregnant No clinically significant abnormal result on Complete Blood Count or serum liver function profile No other disease which might affect absorption or metabolism of DHA or Vitamin A
Iodine Supplementation During Pregnancy and Neuropsychological Development

The investigators have shown that Nice area, like most of France, remains an area of mild iodine deficiency. The investigators want to assess the potential benefit of early iodine supplementation during pregnancy in women with normal thyroid function on the neuropsychological development of their children assessed at the age of two with the Bayley test.

Iodine is required for the synthesis of thyroid hormones. During pregnancy, iodine needs are increased to cover maternal and fetal thyroid hormones synthesis and the increased renal iodine clearance. Maternal hypothyroidism and/or severe iodine deficiency are associated to mental retardation in their offspring. Indeed, thyroid hormones and iodine are necessary for fetal brain development.

Iodine deficiency remains the first cause of preventable mental retardation. In France, preventive programs with salt iodine fortification are insufficient to eradicate iodine deficiency. In previous studies, we have shown that iodine deficiency is the rule for pregnant women in our area: 66 to 85% of women tested depending on the stage of pregnancy (Brucker-Davis 2004, Hieronimus et al 2009, abstract at the 2008 ETA and SFE meetings, article in preparation reporting results from our 2006 PHRC: Study of thyroid function during pregnancy with or without iodine supplementation).We will study the impact of early iodine supplementation in normal pregnant women on the neuropsychological development of their offspring assessed at 2 years of age. This is the follow-up of a cohort of children born to women enrolled in our 2006 PHRC. 110 healthy women have been included in this prospective study: they were seen early (median 8 weeks of gestation) and had strictly normal thyroid function tests, as well as no personal thyroid history. They were randomized into two groups: group A taking pregnancy vitamins without iodine supplementation (Oligobs GrossesseR 2 tablets/day) our group B taking the same vitamins but iodine fortified (Oligobs MaxiodeR 2 tablets per day, i.e. 150 mcg of iodine/day).

Eligibility Criteria:
Inclusion Criteria:

* children which mother were included in the precedent protocol(pregnancy vitamins with or without iodine)

Exclusion Criteria:

* children of more of 25 months old
* children with acute pathology
* children with chronic pathology
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients

This clinical trial aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it seeks to answer are:

1. Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients.
2. Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation.

Researchers will compare sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.

The aim of this clinical trial is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it aims to answer are:

1. Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients.
2. Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation by conducting Fugl Meyer Assessment for Upper Extremity, Box and Blog test, nine-hole peg test, and by measuring hand grip strength.

Researchers will compare experimental groups with sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke of the middle cerebral artery, confirmed by instrumental tests (CT, MRI).
2. Acute hemiplegia/hemiparesis, hand motor deficit, muscle strength ≤ 4 points (as assessed by the Lovett scale).
3. Time after the stroke before inclusion in the study is no more than 1 month.
4. No severe deficit in cognitive functions.

Exclusion Criteria:

1. Patients with implanted ferromagnetic or other metal devices sensitive to a magnetic field in the head or neck area; cochlear implants; implanted neurostimulators, pacemakers, or drug delivery pumps.
2. Complete aphasia or severe cognitive impairment.
3. Taking tricyclic antidepressants, neuroleptics, or benzodiazepines.
4. Previous skull fractures or other head injuries with loss of consciousness.
5. History of epilepsy or seizures.
6. Spasticity of the upper limb (Ashworth scale \>2 b.).
7. Pregnancy
Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics

Few data are available for the PI as a tool for evaluation of peripheral block success in pediatric patients. Furthermore, there is currently no cut-off value defined for the accuracy of the PI in the detection of successful block.

modify plan for intraoperative and postoperative analgesia. Perfusion index is an assessment of the pulsatile strength at a monitoring site; it is calculated by means of pulse oximetry by expressing the pulsatile signal as a percentage of the non pulsatile signal by a specialized probe, both of which are derived from the amount of infrared light absorbed.PI can provide useful information about the peripheral perfusion status of the patients and works as an index for sympathetic stimulation. Recent study suggested that PI could be used as an early and sensitive indicator to assess the development of sympathectomy induced by brachial plexus block in conscious adults; it is more sensitive than other parameters such as changes of skin temperature gradients or mean arterial pressure (MAP)

Eligibility Criteria:
Inclusion Criteria:

Age group: (3-14) years old. ASA class I-II

Exclusion Criteria:

* Patients with age below 3 year or older than 14 years. Parent refusal. Patients with apparent infection at site of needle insertion. Patients with any coagulation disorder. Patients with known neuropathy or brachial plexus injury. Patients with any cardiac, hepatic, renal or neurological disease