cyrilzakka/clinical-trials huggingface dataset:
Hypertension in Families of African Origin

To investigate familial patterns of hypertension and related cardiovascular (CV) risk factors in the United States and Nigeria.

BACKGROUND:

It has been known for many years that African Americans experience twofold higher rates of hypertension than do whites. The underlying biological mechanisms which lead to this differential are still not understood, however. Despite widespread speculation that persons of African descent are genetically susceptible to hypertension, few direct studies have been carried out. Rates of hypertension remain low in West Africa, and this study will provide a contrast between populations of similar genetic background in a low versus high risk environmental setting

DESIGN NARRATIVE:

A total of 240 families were identified from completed community surveys in Maywood, Illinois and Ibadan, Nigeria. Probands were ages 45-55 and equally divided between males and females. A minimum of five first-degree relatives were examined in each family to obtain information on the following variables: blood pressure (BP), obesity, urinary sodium and potassium, socioeconomic status and physical activity. In addition, plasma and DNA were collected and stored for future studies of relevant physiologic intermediate phenotypes and candidate genes for hypertension in the two contrasting populations. These data provided the basis for examining familial aggregation of blood pressure/hypertension and related CV risk factors. Three primary goals were addressed: 1) to determine whether the familial aggregation of blood pressure in Black populations was influenced by the overall distribution of environmental factors at the population level, by contrasting the distribution of familial correlations of blood pressure and the familial aggregation of hypertension, in Nigeria and the United States; to determine the significance of measured environmental correlates of blood pressure by comparing the magnitude of variance components for probands and relatives in each setting; and 3) to use path analysis to obtain estimates of genetic and cultural heritability of blood pressure, controlling for clustering environmental factors at the household level. Plasma and DNA samples collected in this study provided additional valuable resources for future molecular research.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes

The aim is to expand evidence about the importance of the mediodorsal nucleus of the thalamus as a key node in human higher-order cognitive functions such as learning, decision-making, and adaptive behavior. Thus, the project proposes to assess global cognition along with higher-order cognition integrity via sensitive behavior tasks in patients with well localized lesions (mediodorsal thalamic infarcts) compared with healthy participants.

The recruitment of patients with isolated thalamic lesion after stroke is known to be a challenge that the investigators overcame through the expertise of neurologists within their stroke unit.

First, they will describe the cognitive profile consecutive to a lesion of the thalamus, assessed with standardized neuropsychological tests.

Second, and more specifically, they will study performances at experimental tasks focusing on higher-order cognition (decision-making, updating, interference managing, multitasking).

They will use the automatic localization method already performed : the lesions will be manually segmented from T1 morphologic sequences, and then normalized in a template. Finally a numerical atlas of thalamus will be applied on the lesions, determining the injured substructure and the lesion volume.

Besides, this method will be compared with new high resolution thalamus-centered anatomical sequences allowing direct and individual identification of the involved thalamic nucleus.

Eligibility Criteria:
Inclusion criteria for patients:

* French as their mother tongue
* Absence of cognitive deterioration before the stroke.
* Visual, auditory (equipment authorized) and oral or written skills sufficient for the proper assessment using neuropsychological tests.
* First infarct affecting the thalamus.
* At least seven years' schooling from primary school
* Signed informed consent
* Chronic lesion (\> 3 months)

Inclusion criteria for controls:

* French as their mother tongue
* Absence of cognitive complain
* Visual, auditory (equipment authorized) and oral or written skills sufficient for the proper assessment using neuropsychological tests.
* At least seven years of school from primary school
* Signed informed consent

Exclusion criteria for patients:

* Neurological deficit or significant residual disability at inclusion.
* Aphasia, agnosia, apraxia or severe neglect, as demonstrated by clinical examination and neuropsychological tests.
* Subjects with a contraindication to MRI.
* General, neurological or psychiatric progressive disease.

Exclusion criteria for controls:

* Subjects with a contraindication to MRI.
* General, neurological or psychiatric progressive disease.
Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.

A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients

Eligibility Criteria:
Inclusion Criteria:

1. Male or eligible female subjects aged 15 years or more
2. A female is eligible if she is of:

   * Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
   * Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
   * Negative pregnancy test at screening
3. Non-smoker for at least 1 year, a pack history of ≤ 10 pack years
4. Symptom of persistent asthma, as defined by the National Institute of Health (NIH) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)

6.FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.Appropriately signed and dated informed consent has been obtained

Exclusion Criteria:

1. Active upper or lower respiratory tract infection within 3 weeks before visit 1
2. Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
3. Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
4. Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
5. Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
6. Clinically significant and uncontrolled psychiatric disease
7. history of drug or alcohol abuse
8. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
9. Change of Immunotherapy within 6 months before visit 1
10. Administration of the antiasthma agent within 1 week of visit 1
11. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
12. Participation in study using an experimental medication within 1 month before visit 1
13. Other ineligible subject in the opinion of the investigator
Improving Access to Care: Testing an Integrated Care Mobile Health Intervention

This study aims to evaluate the feasibility, effectiveness, and dissemination potential of an innovative strategy for improving access to effective sleep health care for adolescents. The study will test an adaptation of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), a brief sleep intervention with demonstrated efficacy for improving sleep and mental health outcomes in youth.

This adaptation is designed to address the following key challenges to accessing care: (1) to overcome the challenge of low availability of qualified providers as a barrier to treatment access, we have adapted TranS-C for online and mobile device delivery (referred to as mTranS-C), thereby leveraging the high rates of mobile phone and internet use in adolescents; (2) to further increase access we will disseminate mTranS-C within primary care services, a proven strategy for improving access to behavioral health care; and (3) we focus on low-income communities, where there is a higher prevalence of sleep problems and low access to services.

Eligibility Criteria:
Inclusion Criteria:

* age 12-18 years
* a sleep health deficit
* youth has access to a mobile phone or internet
* youth is fluent in English.

Exclusion Criteria:

* current use of medications or herbs with known effects on sleep
* current substance use disorder
* current suicidality/thoughts of death
* thought disorder
* unstable major medical conditions
* current psychotherapy for sleep health deficits
Low Friction Bed Sheet

Introduction:

It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI.

Method:

Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.


Eligibility Criteria:
Inclusion Criteria:

* SCI patients without a presser ulcer for the last 2 months
* Paraplegic and tetraplegic patients
* complete and incomplete lesion (AIS A, AIS B, AIS C, AIS D)
* caused by illness or traumatic event
* smoker and non-smoker

Exclusion Criteria:

* progressive disease
* severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function

Inhalation treatment with mucolytics is one of the cornerstones of CF treatment for respiratory problems.

The efficacy of inhalation treatment with recombinant DNAse and hypertonic saline is well established. The North American CF foundation reported that there is insufficient evidence for or against the chronic use of inhaled N-Acetylcysteine (NAC) to improve lung function and reduce exacerbations .

In vitro tests proved the positive effect of NAC on sputum rheology . Evidence based research however on the in vivo effect of NAC on visco-elasticity and lung function is rare. There are only three randomized controlled clinical trials on nebulised NAC, none of them showing a statistically significant or clinically relevant beneficial effect. Nevertheless at least in Europe for many years inhalation treatment with NAC is advised. Because of the disgusting sulphur odour, many patients are reluctant to use this inhalation medication.

We intend to start an open placebo controlled in vivo cross-over study to evaluate the effect of Acetyl cysteine compared to normal saline on the sputum visco-elasticity and on the short term effect on lung function.

Sputum producing CF-patients, able to perform lung function tests will be enrolled.

Sputum viscoelasticity will be measured by a controlled-stress rheometer (AR 1000-N; TA-Instruments, Ghent, Belgium) at 20° C, using a cone-plate geometry 8.

Lung function measurement (FVC, FEV1, FEF 25-75) will be done in a Masterlab body plethysmograph (Jaeger®) Sputum samples will be collected before lung function test on a regular control visit. Three ml of NAC or 4 ml of normal saline will be inhaled, afterwards a second sputum sample will be collected and a control lung function test will be performed. Visco-elasticity measurements will be done on sputum samples before and after inhalation of NAC or normal saline. Patients will continue to inhale N-acetylcysteine or normal saline two times per day for one month. After one month a control lung function and a third sputum sample will be collected, visco-elasticity and lung function will be measured and compared to the initial values in both groups and between groups. After a wash-out period of normal saline inhalations during 2 weeks in both groups, patients in the initial control group will be asked to switch to inhalation of 3 ml of NAC two times per day and the former NAC group will continue to inhale two times 4 ml of normal saline during four weeks. After one month the same measurements of visco-elasticity and lung function tests will be done.


Eligibility Criteria:
Inclusion Criteria:

* Patients who can perform lung function tests and who can produce sputum (\> 5 years of age)
* (Fe)males between 6-64 years

Exclusion Criteria:

* Patients on the waiting lists for lung transplant.
* Pregnancy or breast feeding
* Patients can not take part in another 'inhalation'trial for Cystic Fibrosis
Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity

Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.

This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the age of 20 and 80 years, of any socio-economic status
* Diagnosed as having DHS, i.e. having at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
* Showing a sensitivity response to both tactile and cold air stimulus delivered by a Yeaple probe and a one-second blast of cold air respectively
* Patients must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions
* Patients must be able to read, comprehend, and sign the informed consent form
* The teeth and sites to be tested should be on the buccal/labial surfaces of incisors, canines, premolars or molars where the affected sites are accessible
* Teeth selected for testing should have a plaque index of ≤ 2

Exclusion Criteria:

* The sensitive tooth is associated with concomitant oral pain due to any other condition such as soft-tissue lesions, tooth-ache ascribable to dental caries, tooth fracture, or cracked tooth syndrome, or pain due to other surgical procedures or injuries.
* The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth
* The sensitive tooth is associated with mobility \>1
* The sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns
* Patients having pain from periodontal-related causes but not DHS
* Previous professional desensitizing treatment
* Patients using medication which could interfere with the perception of pain
* Medical histories marked by chronic use of anti-inflammatory agents, daily analgesics, anticonvulsants, antihistamines, antidepressants, sedatives and/or other psychotropic drugs
* Pregnancy or breastfeeding
* Allergies and idiosyncratic responses to toothpaste ingredients
* Eating disorders or conditions associated with vomiting
* Systemic conditions that are etiologic or predisposing to DHS
* Excessive dietary or environmental exposure to acids
* The sensitive tooth was restored in the preceding three months
* The sensitive tooth is an abutment tooth for fixed or removable prostheses
* The sensitive tooth has extensive restoration or restorations extending into the test area
* Patients below 20 years or above 80 years of age
* Smokers
Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)

The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.

The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* History of drug-resistant mesial temporal lobe epilepsy (MTLE)
* If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months
* On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use
* An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
* Seizure symptoms and/or auras compatible with MTLE
* Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE
* MRI has evidence consistent with mesial temporal lobe sclerosis
* Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure
* Willing and able to comply with protocol requirements
* Able to complete study assessments in English or Spanish language

Exclusion Criteria:

* Unwilling or unable to sign the study informed consent form
* Pregnant or intends to become pregnant during the course of the study
* Currently implanted with a device contraindicating MRI
* Progressive brain lesions and/or tumors not associated with epileptic disease state
* History of previous intracranial surgery for treatment of epileptic seizures
* Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG
* Seizures with contralateral or extra-temporal ictal onset on EEG
* Aura and/or ictal behavior suggest an extra-temporal focus
* MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture
* If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation
* Non-compliance with AED requirements
* IQ \< 70
* Dementia or other progressive neurological disease
* Unstable major psychiatric illness, psychogenic non-epileptic seizures, or medical illness that would contraindicate the Visualase procedure or affect the neuropsychological assessments
* Participation in other research that may potentially interfere with SLATE endpoint(s)
* Allergy to gadolinium
The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications.

The purpose of this study is to compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors.


Eligibility Criteria:
Inclusion Criteria:

* mild hypertension and high cholesterol

Exclusion Criteria:

* diabetes and heart disease
To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371

The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.

A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening
2. Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
3. Capable of performing follow up visit, blood sampling
4. Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
5. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics(except non active allergic rhinitis)
4. History of drug abuse or positive result at urine drug screening test at screening visit
5. Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
6. Other: Patients considered unable perform for the study by the investigator concerning
Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective abdominal surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurements at four different standardized times.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled abdominal surgery
* ASA I-II

Exclusion Criteria:

* History of eye deformity, invasive ophthalmologic surgery, impaired pupil reflex in advance
* Kown cranial nerve(s) deficit
* Infection of the eye
* Predicted difficult airway management (DAF Guidelines)
* Chronic opioid use (\>3 months)
* Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine