cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome

The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.

This assessment will be done using the following elements:

* The score of the Quebec sleep questionnaire (QSQ), developed in 2004 by Lacasse Y. et al. This questionnaire is specific to sleep apnea and may be self-administered. The main interest of this questionnaire is to measure the change in quality of life over time.
* The Epworth Scale Score, developed in 1991 by Murray W. John. This is a self-administered questionnaire developed to measure daytime sleepiness.
* Gender, age group, BMI
* The radiological assessment
* The results of polysomnography

Patients will be followed for a period of 1 year and one month after surgery. The protocol visits correspond to the rhythm of post-surgery follow-up consultations in current practice.

These patients are followed by Dr. Pételle at Saint-Antoine Hospital. During these visits, they will complete the Quebec sleep questionnaire and the Epworth scale, at baseline, at 3 months and then at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* With obstructive sleep apnea confirmed by polysomnography
* Surgical indication for surgically maxillary expansion

Exclusion Criteria:

* - Patients refusing to participate in the survey having formulated their opposition
* Diabetes,
* Obesity (BMI\> 30)
* Failure to provide informed written consent
* Refusal or inability to return to all follow-up visits and sleep studies
* Patient pregnant or planning to become pregnant in the next 12 months or breastfeeding
* Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue or throat (Note that some previous surgeries, such as uvulopalatopharyngoplasty (UPPP), tonsillectomy or adenoidectomy, to remove obstructions related to obstructive sleep apnea are allowed)
* Obvious obstructions of the fixed upper airways (tumors, polyps or nasal obstruction)
* Patients who have undergone previous surgery on the mandible and / or maxilla, other than dental treatment.
* Patients included in another clinical study (excluding registers).
* Patients taking medicines such as opiates which may affect sleep, alertness or breathing
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women of legal age of consent who are willing to use a combination OC.
* Subjects must be under the age of 36 at the time of enrollment (visit 3).
* Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.

Other inclusions apply.

Exclusion Criteria:

A history or the presence of any of the following will prevent enrollment:

* Thrombophlebitis, thrombosis, or thromboembolic disorders.
* Deep vein thrombosis.
* Pulmonary embolism.

Other exclusions apply.
Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects

This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.

Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects.

CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.

Eligibility Criteria:
Inclusion Criteria:

* At least one ankle sprain history
* At least 2 times of sprain and feeling unstable
* Diagnosed as functional ankle instability
* Full recovered from injury
* Cumberland Ankle Instability Tool\<24
* Ankle Instability Instrument \>5 yes
* Identification of Functional Ankle Instability \>11

Exclusion Criteria:

* Diagnosis as mechanical instability
* Neurological deficits
* Lower extremity injury within the past 6 wk
* History of lower-extremity surgery
* Other conditions known to affect balance
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female 18 years or older with non-CF bronchiectasis
* Chronic sputum production on most days
* Positive sputum culture for gram-negative organisms
* Must have met lung function requirements

Exclusion Criteria:

* History of CF
* Hospitalized within 14 days prior to joining the study
* Previous exposure to AZLI
* Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
* Must have met liver and kidney function requirements
* Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)
* Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
* Other serious medical conditions.
Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management

Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged 18 - 90 years (both inclusive)
* Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four

Exclusion Criteria:

* Impaired renal function (serum creatinine ≥3.0mg/dL)
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
* Pregnancy
* Any mental condition rendering the patient incapable of giving his consent
* Terminally ill patients
* Participation in a trial within 3 months prior to this trial
* Known or suspected allergy to insulin
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with age between 20 to 65 years old (inclusive).
* Subjects who are able and willing to provide the informed consent.
* Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
* Researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities

Exclusion Criteria:

• The investigator considered that the subjects were not suitable to participate in this study.
Early Identification of Warfarin Maintenance Dosage

Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.

The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Indication to warfarin with INR between 2.0 and 3.0

Exclusion Criteria:

* Pregnancy
* Drug interactions
* Basal INR \> 1.2
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia

Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.

Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.

Eligibility Criteria:
Inclusion Criteria

* Volunteer
* Being diagnosed with fibromyalgia Exclusion Criteria
* Known neurological disorder
* Serious orthopedic disorders that will prevent him from exercising
* Cognitive impairment
* Using regular NSAIDs
* Being malnourished and malnourished
Feasibility Study: Lifting and Tightening Neck Skin in Patients

Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.

This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years
* Subject in good health
* Body Mass index of less than 30
* Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
* Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
* Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
* Willingness and ability to comply with protocol requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
* Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control

Exclusion Criteria:

* Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
* Has an active systemic or local skin disease that may alter wound healing
* Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
* Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy
Cerebral Palsy: Short-burst Interval Training

This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.

Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation.

This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III

Exclusion Criteria:

* undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior
Sex Differences, Hormones & Smoking Cessation

Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.

Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).

Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male 18 to 60 years old
* Female 18 to 50 years old
* Self-report regular smoking
* Motivated to quit smoking
* In stable physical/mental health
* Self report of regular menstrual cycles (female only)
* English fluency
* Understand the study procedures and able to provide informed consent
* Ability to participate fully in research elements for the duration of the trial.

Exclusion Criteria:

* Current or recent (\< 3 months) breastfeeding (females only)
* Current or planned pregnancy within the next three months (females only)
* Conditions contraindicated to progesterone treatment.
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)

The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study: 40 to 60 years
* With type 2 diabetes evolution \< 5 years without pharmacological treatment 1 month prior to the screening
* Fasting glucose = 130-200 mg/dL
* AIc of 7% to 9%
* Blood pressure \< 140/80 mmHg
* Ability to communicate and meet the requirements of the study
* Signed Written Informed Consent before to conducting any study
* Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2

Exclusion Criteria:

* Suspected or confirmed pregnancy
* Nursing
* Inability to secure the non-pregnant during the study duration
* Hypersensitivity to any biguanides
* Use of an investigational drug within 30 days prior to the screening
* Liver failure, heart failure, kidney failure or thyroid disease
* Periods of acute or chronic diarrhea or vomiting
* Chronic hepatic disease
* Total Cholesterol \> 300 mg/dL
* Triglycerides \> 400 mg/dL
Management and Healthcare Utilization of Patients With Chronic Airway Disease During the COVID-19 Epidemic

During the COVID-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. The purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the influencing factors during the COVID-19 epidemic.

During the COVID-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. The purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the relevant factors during the COVID-19 epidemic. Using cross-sectional research methods, telephone interviews and questionnaire surveys were used to investigate the management and healthcare utilization of patients with chronic airway disease （COPD and asthma）during the COVID-19 epidemic.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients and asthma patients in the Chronic Airway Disease Database in Peking University Third Hospital.

Exclusion Criteria:

* Refusal to participate in this study; cognitive dysfunction.
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.


Eligibility Criteria:
Key Inclusion Criteria:

* Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g
* Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to the International Classification for ROP in at least one eye as:

  * Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
  * Zone II Stage 2 plus or 3 plus, or
  * Aggressive posterior retinopathy of prematurity (AP-ROP)

Key Exclusion Criteria:

* Known or suspected chromosomal abnormality, genetic disorder, or syndrome
* Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
* Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure)
* Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study ophthalmologist
* Presence of active ocular infection within 5 days of the first treatment
* Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5)
* ROP involving only Zone III

NOTE: Other protocol defined inclusion/exclusion criteria apply.
Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.

This is a prospective randomized single-blind study involving patients adults admitted to the University Hospital of Liege for a scheduled heart surgery.

The study is based on the oral administration of baclofen (or placebo) the evening Bedrooms (10 pm). This administration begins the day before surgery and ends 5th day after. Sleep is evaluated by various questionnaires at baseline, during the protocol and the end. In addition, a 24 polysomnography is performed the day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery

Exclusion Criteria:

* Haemodynamic instability
* Epilepsy
* Psychotic disturbances
* Acute / Chronic respiratory failure
* Morbid obesity (BMI \> 45 kg/m2)
* Sleep apnea (treated)
* Severe hepatic or renal failure
* Patient refusal