cyrilzakka/clinical-trials huggingface dataset:
Wenzhou Gestational Diabetes Cohort

The Wenzhou Gestational Diabetes Cohort (WGDC) is a prospective cohort study among women with gestational diabetes mellitus (GDM) during pregnancy and their offspring living in Wenzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women with GDM over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of the WGDC is to investigate the association of dietary and physical activity together with continuous glucose change during pregnancy on the adverse birth outcomes including preterm birth, macrosomia and large-for-gestational-age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 weeks among the patients with long-term metabolic health of the women and their offspring.

In China, an alarming increase in the prevalence of GDM has been observed in the past decade. GDM is of concern because it is associated with several maternal and fetal medical disorders. Lifestyle changes such as diet and physical activity modifications are key for the prevention and treatment of GDM. However, the associations between dietary intake and physical activity and health outcomes for GDM women and their children remain unclear due to subjective measurements of diet and physical activity. Recently, the development of objective measurements such as food image identification and wearable activity trackers give an opportunity to gain more precise insight into these associations. In addition, for the same food and physical activity exposure, GDM women may have different blood glucose responses, but the nature of variation is currently poorly characterized. Therefore, the present WGDC design incorporates three unique components, 1) objective measurement of physical activity during pregnancy using accelerometer; 2) measurement of dietary intake using both Food Frequency Questionnaire and daily dietary records; 3) measurement of blood glucose levels over 2 weeks using continuous glucose monitors, with three standardized test meals during the 2 weeks. We will then follow up these women participants during and after this pregnancy, and also follow up their offspring.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older
* Women with GDM mainly at 24-28 weeks of gestation
* Women intended to deliver at Wenzhou People's Hospital
* Women intended to remain in Wenzhou with their child for ≥4 years

Exclusion Criteria:

* Women with cancer and other serious medical disorders
Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery

The aim of this study was to analyze the effectiveness of piezoelectric surgery and traditional rotating device in reducing perioperative sequelae after impacted mandibular third molar surgery in 56 subjects. Ni All subjects were randomly allocated to receive one treatment.

The aim of this study was to analyze the effectiveness of piezoelectric surgery and traditional rotating device in reducing perioperative sequelae after impacted mandibular third molar surgery. Fifty-six patients who needed surgical extraction of an impacted mandibular third molar were selected for the study. All subjects were randomly allocated to receive one of the following surgical treatments piezoelectric surgery (n = 28), traditional surgery with rotating device (n = 28). The primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at baseline, 1, 2, 5, 7, 10 and 14 and 28 days following surgery. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 32 years;
* good general health;
* the presence of one impacted third molar in the mandible with a class II position, type B impaction;
* absence of pericoronitis or signs of inflammation during the last 30 days. Panoramic radiographs were used to determine tooth position.

Exclusion Criteria:

* the presence of any systemic disease;
* consumption of oral contraceptives or other medications;
* consumption of any immunosuppressive or anti-inflammatory drugs during the 3 months prior to the study;
* status of pregnancy or lactation;
* previous history of excessive drinking;
* allergy to local anesthetic;
* smoking habit.
A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care

The purpose of this study is to determine whether using a smart phone application to foster communication between study participants and their doctor will impact care. Participants must have a history of migraine or have recently been prescribed a common medicine to treat migraine. The study will last about one year for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine (ICD10: G43.\*) since October 2015 OR a record of being prescribed a triptan prior to study
* Have not been prescribed a preventive migraine medication within the past twelve months
* Have not visited a neurologist in the past year
* Have an upcoming visit with their Atrium Health primary care provider

Exclusion Criteria:

* Do not own an iOS or Android smart phone with a data plan or are unwilling to install the app on their phone
* Are currently participating in a clinical trial involving an investigational drug
* Have previously used the app used in this study
* Are pregnant at the time of study entry
* Are not able to provide informed consent
* Cannot speak and read English fluently
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum.

The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS).

Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis.

Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.

The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women.

PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.


Eligibility Criteria:
Inclusion Criteria:

* age = or \> 18 years
* Dutch/English-speaking
* \> 33 weeks gestation
* delivering in UZ Leuven
* vaginal delivery

Exclusion Criteria:

* age \< 18 years
* not Dutch/English-speaking
* \< 33 weeks gestation
* not delivering in UZ Leuven
* non-vaginal delivery
* Any disorder, that independently from delivery, affects pelvic floor function or structure, such as, but not limited to musculoskeletal or neurologic diseases.
* any women with drug addiction, cognitive deficit, language-barrier and illiteracy
* any disorder or timing or circumstances, which in the Investigator's opinion represents an obstacle to proper informed consent, or safe and/or compliant participation.
* any prior or simultaneous treatment(s) potentially jeopardising safety or compromising trial integrity.
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee

safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee


Eligibility Criteria:
Inclusion Criteria:

* Age40-85 years
* Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.

Exclusion Criteria:

* Hyperbaric treatment (HBOT) in the last 2 years.
* Any contraindication for HBOT
* Pregnancy.
* Inability to sign inform consent
* Any contraindication for MRI
Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair

The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.

This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.

Eligibility Criteria:
Inclusion Criteria:

* Facial laceration requiring repair with sutures
* English or Spanish-speaking parent/guardian

Exclusion Criteria:

* Lacerations requiring IV sedation or subspecialist involvement
* Patient has other injuries requiring medical attention
* Patient has vital sign instability, per physician discretion
* Patient has autism spectrum disorder
* Patient has allergies to either medication
Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate hypertension

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.
Validation of Metrological Properties of Lymphoqol

The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the everyday life of the child and on the family environment. This question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. The parameters of the success of these treatments at the child are not known.

In the literature we find no specific information on the psychic and social repercussions of the lymphœdema for the child who is affected. If the psychic and social repercussions of the secondary lymphœdema in the breast cancer are well known, very few things are it on those of the primary lymphœdema. Some studies estimate globally the quality of life of the patients with a lymphœdema whatever is the origin and the etiologie. These studies of money groups suggest that the psychic difficulties and of therapeutic care are not identical. A single study approaches the specific question of the lymphœdema of the child by focusing on the real-life experience of expanding child of a primary lymphœdema.The construction and the validation of a tool measuring the quality of life of the children and the young adults affected by lymphœdema congenital appears as a starting point. A tool which would first of all allow to make the current situation for the regional level, and then can envisage national actions common. According to recent studies, the evolution of the lymphoedema is different according to the forms of initial clinical expression of the lymphoedema, we wish we can thus know during this study the impact of these various clinical forms on the quality of life of the patients. A genetic collection will be realized for that purpose (genetic research).

Eligibility Criteria:
Inclusion Criteria:

* Primary lymphedema, stage 2 or 3 ISL

Exclusion Criteria:

* Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25
Effect of Feldenkrais Method in Enhancing Postural Control for Patients with Diabetic Polyneuropathy

Background: Postural Control is a major complication of polyneuropathy, affecting patients suffering from diabetes mellitus. Purpose: To examine the effect of the Feldenkrais Method on dynamic balance, limits of stability and fear of falling in adults aged 45 to 60 years with diabetic polyneuropathy in the short and mid-term. Methods: A single-blinded, parallel, multicentric randomized control trial was conducted in two health centers. Adults aged 45 to 60 years with diabetic polyneuropathy and a history of falls or dynamic balance dysfunction were recruited from hospital databases and randomly assigned to either the study or control group. The study group received 16 sessions of Feldenkrais-based sensorimotor training. Both groups received diabetic foot care instructions and traditional balance exercises. Outcomes were measured at 3 and 6-month follow-up intervals. Dynamic balance was assessed using the Timed Up and Go (TUG) Test, limits of stability using Biodex and fear of falling with the Falls Efficacy Scale (FES).


Eligibility Criteria:
Inclusion Criteria:

* Individuals must have a diagnosis of Diabetic Polyneuropathy (DPN), confirmed by clinical examination and electrophysiological testing.
* Participants must have stable glycemic control for at least three months prior to enrollment.
* Individuals must be able to walk independently, with or without the use of an assistive device.

Exclusion Criteria:

* Individuals with severe visual or vestibular impairments are excluded from participation.
* Participants with significant musculoskeletal disorders affecting gait are not eligible.
* Individuals with severe cardiovascular or respiratory conditions are excluded.
* Participants with cognitive impairments that prevent active participation are not eligible.
* Individuals currently engaged in structured physical therapy or balance training programs are excluded.
Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery

literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations


Eligibility Criteria:
Inclusion Criteria:

* surgeries associated with either exposure of more than three vertebral bodies,
* exposures involving the C2-C4 levels,
* blood loss exceeding 300 mL
* surgical time of more than five hours,

Exclusion Criteria:

* laryngotracheobronchial pathology,
* severe cardiorespiratory disease,
* admitted for redo-surgery
* intubated prior to operation
* Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation attempts
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending intramuscular doses of MK-5720, and the safety and tolerability of multiple once-daily oral doses of MK-8189, in participants with schizophrenia. The primary study hypothesis is that the administration of MK-5720 is safe and well tolerated.

In Period 1, participants receive once-daily MK-8189 for 7 days, followed by a 72-hour washout. In Period 2, participants receive a single dose of MK-5720.

Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated
* Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia
* Can discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (which ever in longer) prior to the start of the treatment period and during the study

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator
* Has history of mental retardation, borderline personality disorder, or organic brain syndrome
* Has a history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia
* Has a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
* Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures
* Has a family history of sudden death
* Has claustrophobia to a degree that prevents tolerance of magnetic resonance imaging (MRI) scanning procedure
* Has a metallic implant of any sort that prevents MRI examination, or any other contraindication to MRI examination
* Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study
* History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
* Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
* Has received or is currently receiving treatment with clozapine for any length of time
* Has received any live vaccines within 30 days prior to the first dose of study intervention or is scheduled to receive any live vaccine through 60 days following study intervention
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.

The administration of phenobarbital to pregnant women before delivery has been thought to decrease the frequency of intracranial hemorrhage in preterm infants. To evaluate this potential neuroprotective therapy further, we determined the effect of antenatal administration of phenobarbital on the frequency of neonatal intracranial hemorrhage and early death. Women who were 24 to 33 weeks pregnant and who were expected to deliver their infants within 24 hours were randomly assigned to receive either intravenous phenobarbital (10 mg/kg body weight) or placebo, followed by maintenance doses until delivery or 34 wks gestation. Infants less than 34 wks at birth underwent serial cranial ultrasonography to detect the presence of intracranial hemorrhage. The sample size of 1038 pregnancies was based on an intracranial hemorrhage rate of 20 percent in the placebo and less than 12 percent in the phenobarbital group; 90 percent power; a 5 percent two-tailed type 1 error; and an 8 percent noncompliance rate. The twin with the highest grade of intracranial hemorrhage was included.

Degree of maternal sedation was evaluated after administration of study drug. Neonatal ultrasound exams were performed at 3-5 days, 10-14 days, and 38-42 wks postmenstrual age; neonatal medications were recorded during the first week of life; treatments, and outcomes were recorded through death, discharge, or 120 days, whichever occurred first. Neurodevelopmental outcome was evaluated at 18-22 months corrected age by certified examiners masked to treatment status.

Eligibility Criteria:
Inclusion Criteria:

* Admission to a high risk perinatal unit or labor and delivery unit;
* 24 to 32 completed weeks gestation;
* Expected delivery within 24 hrs;
* Preterm labor or no labor with planned delivery for maternal-fetal indications;

Exclusion Criteria:

* Anticipated delivery within two hours
* Multiple congenital or chromosomal abnormalities in the fetus
* Multiple gestation with more than two fetuses
* Administration of phenobarbital during the pregnancy
* Administration of indomethacin within one week before admission
* Maternal platelet count of less than 100,000 per cubic millimeter