cyrilzakka/clinical-trials huggingface dataset:
GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

This study will assess whether the presence of a particular form of a gene, GABRA2, affects the functional responses of the human brain to alcohol administration and will evaluate that relationship in the context of factors known to increase the risk for future alcoholism.

Each subject completed a total of 2 2.8 hr-long clamping sessions.Within each session, procedures differed only by the content of the infusate. In one session, 6% ethanol was infused. In the other session, only vehicle was infused, quantifying the placebo response for every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were blind to which session was which; sessions were scheduled to occur approximately 2 weeks apart. Measures were collected before, and at beginning and end of infusion, and included subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol and acute tolerance to alcohol.

Eligibility Criteria:
Inclusion Criteria:

* European American male and females between 21-27 years of age.
* Good health as determined by medical history, physical exam, and laboratory tests.
* Females must have a negative urine pregnancy (hCG) test at the start of each study session.
* People who consume 0.10 standard drinks per week (12 g-ethanol) per liter of total body water when averaged over the preceding month, or more, OR who have consumed more than 0.10 standard drinks per liter of total body water on any one occasion in the last month.

Exclusion Criteria:

* Inability to read or comprehend eighth grade English.
* Inability to hear or comprehend verbal instructions, or inability or unwillingness to cooperate with the procedures required for the study.
* Inability to resolve 2 dots, each 2 mm in diameter with centers placed 5 mm apart on a card placed 20 inches from the bridge of the nose, or the need to wear eyeglasses to do so.
* Current or prior history of any serious disease, including head trauma causing loss of consciousness, cancer, CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or alcohol or drug dependence, but not alcohol abuse or nicotine dependence.
* Positive hepatitis or HIV test at screening, provided subject consented to these tests.
* Current or prior history of alcohol-induced flushing reactions.
* Current diagnosis of Axis-I psychiatric illness.
* Positive result on urine drug screen obtained at the face-to-face interview.
* Pregnancy, as determined by urine HcG on each day of laboratory testing, or intention to become pregnant for women.
* Use of medications known to interact with alcohol within 2 weeks of the study.
Effect of Ambient Noise on the Responses to Meal Ingestion

Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of ambient noise on the sensory responses to a standard probe meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise versus silence on the sensations induced by a probe meal. Participants (12 men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. One study day, a noise will applied via headphones for 60 min after meal ingestion and the other day headphones without sound will applied. Perception of homeostatic sensations (hunger/ satiation, fullness) and hedonic sensations (digestive well-being, mood) will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software

Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.


Eligibility Criteria:
Inclusion Criteria:

* Clean and healthy ear canal, eardrum and pinna
* Ability to keep current position (of head and body) during a period of about 5 minutes while seated.

Exclusion Criteria:

* Ear infections
* Ear wax in the ear
* Hyperacusis
* Pacemaker
* Tremor
* Disability to keep position.
The Relationship Between Idiopathic Acute Peripheral Facial Paralysis and Homocysteine Level in Adult Patients

In the etıology of Idıopathıc Acute Perıpheral Facıal Palsy, known as bell palsy, many causes have been descrıbed, such as specıfıc ımmune, ıchemıc, ınfectıous and heredıal factors. ın our study, we have observed the blood homocysteıne level that causes thrombotıc dısorders ın paralysıs patıents.

Bell's palsy, also known as "acute facial palsy of unknown cause", is a common cranial neuropathy that characteristically causes facial muscle paresis or complete paralysis on one side, occurs suddenly and may progress over 48 hours. It is accompanied by postauricular pain, dysgeusia, subjective alteration of facial sensation, and hyperacusis. Bell's palsy accounts for 60-75 percent of all cases of facial palsy. It occurs in 7-40 cases per 100,000 people each year, and the prevalence is similar in both sexes. Its cause remains idiopathic, but it is strongly associated with certain viral infections, which cause neuritis leading to focal edema, demyelination, and ischemia. Although the exact pathogenesis of Bell's palsy is unknown and is considered idiopathic, specific immune, ischemic, and hereditary factors are strongly associated with its etiology. Homocysteine is an amino acid that is not provided by the diet and can be converted to cysteine with the help of specific B vitamins or converted back to methionine, an essential amino acid. Homocysteine levels vary between men and women and are usually in the normal range of 5 to 15 micromoles/L. When homocysteine levels exceed 15 micromoles/L, it is called hyperhomocysteinemia.

The estimated prevalence of mild hyperhomocysteinemia in the general population is 5% to 7%. Several studies have shown that it is an independent risk factor for thrombotic disorders (i.e., deep vein thrombosis). It has even been reported that lowering a patient's homocysteine level by 25% reduces the risk of stroke by 19%.

A significant relationship was found in the meta-analysis conducted in the literature regarding sudden sensorineural hearing loss and high homocysteine levels. Due to the similar anatomical location of the facial nerve and N. vestibulocochlearis, it was planned to examine the relationship between acute idiopathic peripheral paralysis and homocysteine. There is no previous study in the literature. Therefore, this study will be the pioneering research in the literature regarding blood homocysteine levels in patients diagnosed with Idiopathic Acute Peripheral Facial Paralysis.

Eligibility Criteria:
Inclusion Criteria:

- Patients admitted with acute facial paralysis

Exclusion Criteria:

* Facial and ear trauma or tumor
* İatrogenic
* Cholesteatoma
* Facial paralysis due to central nervous system diseases
Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.


Eligibility Criteria:
Inclusion Criteria

* The subject is male or female, aged ≥18 and \<50.
* The subject is in good general health with no evidence of any medical problems.
* The subject is fluent in both written and spoken English.
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* The subject is obese (BMI\>30).
* The subject has a known history of heart disease, lung disease, kidney or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* The subject has any other serious systemic illness.
* The subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
* The subject has a history of fainting or vasovagal response.
* The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
* The subject has a diagnosis of Raynaud's disease.
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* The subject is pregnant, lactating or trying to get pregnant.
* The subject has a history of migraine headaches.
* The subject is currently taking antidepressants.
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Activity Pacing for Fatigue Management

This project will focus on perceived fatigue as a barrier to physical activity participation and will explore if and how activity pacing, fatigue management, and self-regulation strategies can help to overcome this barrier in adults with chronic conditions who experience fatigue symptoms. The main aims are:

1. To demonstrate the differences and similarities on activity pacing, perceived fatigue, self-regulation, physical activity, and health-related quality of life in adults who experience fatigue by comparing individuals who have been through an activity pacing program or not.
2. To explore thoughts, experiences, needs, and perspectives on activity pacing of adults with fatigue and health professionals as well as any ideas for future development of an optimal intervention.

Participants will be invited to complete questionnaires on several variables (activity pacing, physical activity, fatigue, health-related quality of life, and self-regulation of physical activity). In addition, they will be invited to wear an Actigraph for 7 full days and they will also be invited to a focus group interview.

Activity pacing is a fatigue management strategy that regulates energy and activity levels while maintaining or increasing engagement in physical activity. This approach is particularly beneficial for individuals with chronic conditions who experience significant fatigue as they often struggle with sustained physical activity participation due to recurring patterns of overexertion and subsequent fatigue or pain. Therefore, activity pacing strategies are important because individuals learn to manage fatigue symptoms, optimize physical activity behaviour, and accomplish a more stable activity pacing pattern, which will improve their health-related quality of life and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a chronic condition
* Experience fatigue
* Ambulatory

Exclusion Criteria:

* Children
* Wheelchair users
Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30 kg/m2
* Participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the Clinical Research Unit (CRU)
* Subjects must discontinue all iron preparations for 14 days prior to study drug administration

Exclusion Criteria:

* Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease
* Positive serology results for HBsAg, HCV, and HIV at Screening
* Renal impairment (estimated glomerular filtration rate (eGFR) of \<65mL/min)
* Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months
* Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug
* Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months
Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr

Patients who received a total knee endoprosthesis BPK-S Integration between 2011 and 2013 will be invited to participate in this PMCF study provided sufficient source data documentation is available regarding preoperative, intraoperative and early postoperative follow-up assessments.

Only patients providing written informed consent prior to any study data collection can take part in the study.

Preoperative, intraoperative and early postoperative data (3 months, 1 year and 2 years after implantation) will be collected retrospectively. Additional long-term follow-up of one visit (year 7 after implantation) will be documented prospectively.

Only parameters assessed in clinical standard care for follow-up (implant control) visits will be collected for this PMCF study.

Radiological assessment of the implanted prosthesis will only be conducted if medically indicated according to the investigator. No additional study related assessment will be performed.

Only anonymized data will be used in this observational study to protect patient privacy. No personally identifiable information will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients that received a total primary knee endoprosthesis BPK-S Integration (Co28Cr6Mo) between 2011 and 2013
* Patients that agree to participate and give written informed consent to the anonymized retrospective and prospective data collection within the study

Exclusion Criteria:

No study specific exclusion criteria are defined for this PMCF study.
Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* 19\~45 years old
* Healthy men

Exclusion Criteria:

* Gastroentestinal disease affecting drug absorption
Relaxation Before Debriefing and Memorization in High Fidelity Simulation in Healthcare

Resident in advanced medical training participated to high fidelity simulation education program in Lyon. Alternatively 1 or 2 resident act during a scenario while the others observe in a teletransmission closeby room. Debriefing follows the critical scenario in witch resident are involved. The investigators are testing the effects of five minute of conversational relaxation before the debriefing on the anxiety level and memorization of key points each scénario on participant and observer.

Resident in advanced medical training participated to high fidelity simulation education program in Lyon. This is part of a curriculum and each year they go throw a specific simulation session in groups of 3 to 8 residents with same specific thematic education goals. 3 to 4 differents scénario are run every simulation session during 4 to 5 hours, every day 2 similar session are run with 2 different groups of same level residents. Alternatively 1 or 2 resident act during a scenario while the others observe in a teletransmission room. Debriefing follows the critical scenario in witch resident are involved. The investigators are testing the effects of five minute of conversational relaxation before the debriefing on the anxiety level and memorization of key points each scénario on participant and observer. Relaxation is done reading a text outloud by an instructor before the debriefing. Each scenario is run in the morning and the afternoon and alternatively have relaxation or not. evaluation is done on participant of the scenario and resident observer of the situation. The Investigators ask participant for demographic data, anxiety scale test, multiple anxiety visual analogic scale. At the end of every scenario 5 clinical key point of teh scenario are exposed. At 3 month the investigators call back every participant to ask them to remember these 5 points for the scenario they were involved in and one of the other they observed.

Eligibility Criteria:
Inclusion Criteria:

* every resident going to a scheduled simulation session part of the normal education program of the residency.

Exclusion Criteria:

* no consent, or consent deleted
Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes

Currently, no clear consensus exists regarding the effect of epidural anesthesia upon breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies have failed to separate these potential mechanisms. The present study examines whether epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and 2) neonatal neurobehavioral deficits in feeding, as measured by the L\&A components of the standardized, validated LATCH scoring system.


Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery
* Delivery of a single live neonate

Exclusion Criteria:

* NICU admission following delivery
* Pitocin augmentation
A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.

Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with adult-onset Rheumatoid Arthritis (RA) \>6 months and \<3 years
* Active RA
* Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
* Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance

Exclusion Criteria:

* Subject cannot have a second non-inflammatory musculoskeletal condition
* Subject cannot have a diagnosis of any other inflammatory arthritis
* Subject cannot have any previously infected prosthesis
* Subject cannot have arthroplasties in any of the joints assessed in the study
* Subject cannot have a history of chronic infections
* Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
* Subject cannot have a history of or current Lymphoproliferative disorder
* Subject cannot have known Human Immunodeficiency Virus (HIV) infection
* Subject cannot have received a live or attenuated vaccine within 8 weeks
* Subject cannot have current or history of malignancy
* Subject cannot have a history of blood disorders
* Subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
* Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin
Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: Ramdomized Controlled Clinical Trial.

The objective of this research is to compare the diagnostic accuracy in the detection of the cementoenamel junction (CEJ) and alveolar bone ridge using guided digital planning versus conventional analog planning for patients with excessive gingival exposure in the smile (gummy smile) due, at least in part, to altered passive eruption.

Forty-four subjects will be randomly assigned to the planning groups according to a digital methodology, DM (n=22) or an analog methodology AM (n=22). Surgical guides will be developed to establish the location of the acementoenamel junction and bone crest. The digital methodology will consist of obtaining a digital scan and a computed tomography (CBCT) that will be aligned using a digital program for the elaboration of a digital wax-up and fabrication of a printed surgical template. The analog wax-up will be elaborated based on a silicone impression and periapical radiographs with parallel technique, which will allow us to elaborate an essix type surgical splint. Measurements will be recorded at baseline, on the day of surgery, at 4, 6 and 12 months of follow-up. Variables related to the patient's experience will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Presence of teeth in the second sextant (edentulous section of a single tooth with the presence of adjacent teeth on both sides of the absence is accepted).
* No sites with attachment loss (AL) \> 3 mm in the area to be treated (second sextant).
* Present full mouth plaque index (Ainamo and Bay, 1975) \<15%.
* Have bleeding on probing (BoP; Ainamo \& Bay 1975) \<15%.

Exclusion Criteria:

* pregnancy or lactation
* patients who smoke
* patients under treatment with antimicrobials and anti-inflammatory drugs in the last 2 months or with medications associated with changes in the gingival tissue (antiepileptics, calcium channel blockers, etc.)
* subjects with systemic conditions that alter the normal presentation of the gingival tissue (hereditary gingival fibromatosis) or those diagnosed with uncontrolled diabetes mellitus
* patients with severe dental malposition and/or presence of dental implants in the area to be treated
* use of orthodontic appliances
* all those who present a disability or mental disorders that make it difficult for the patient to understand or follow them during the study period. study period.
Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine

The objective of this randomized controlled trial is to describe the effect of two osteopathic techniques - "high velocity, low amplitude" (HVLA) and muscle energy (ME) - on thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day follow-up.

The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal oblique, external oblique and transversus abdominis can be altered after the application of 'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after a two-day follow-up.


Eligibility Criteria:
Inclusion Criteria:

* At least one episode of low back pain over the last three months; confirmation of lumbar spine dysfunction by an experienced osteopath; age between 18 and 40 years; do not have performed physical stress activities over the last 24 hours; do not be physically active (physical activity for at least three times a week); fulfill the orientations to the follow-up assessment.

Exclusion Criteria:

* History of surgery, fracture or fixation on the lumbar spine and/or the pelvis; being pregnant; signs of radiculopathy; disc herniation at the lumbar spine; degenerative process at the lumbar spine; have received any kind of manipulative treatments over the past four weeks;