cyrilzakka/clinical-trials huggingface dataset:
PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* body mass index (BMI) ≤ 35 kg/m²
* OSAS, as defined by the American Academy of Sleep Medicine Task Force
* apnea-hypopnea index (AHI) \< 50

Exclusion Criteria:

* Other sleep disorders (i.e. parasomnias)
* Invasive upper airway surgery for sleep-disordered breathing
* Known genetic disorders with craniofacial and/or upper airway malformations
* Use of benzodiazepine and/or antidepressants
* Known history of psychiatric disease
* Known history of fibromyalgia and/or chronic fatigue syndrome
* Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being

The purpose of this study is to assess the effect of a mindfulness-based intervention on DNAmethylation, cognitive functions, stress response, and well-being in healthy female adults.

After being informed about the study and potential risks, all volunteers giving written informed consent will undergo a 1-3 week screening period to determine eligibility for study entry. At week 0, volunteers who meet the eligibility requirements will be randomized in a 1:1 ratio to the active control group (8-week, 2 hours/week of lectures) or mindfulness-based intervention (8-week, 2 hours/week of mindfulness meditation training).

Eligibility Criteria:
Inclusion Criteria:

* (1) Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom

Exclusion Criteria:

1. clinical diagnosis of depression
2. clinical diagnosis of anxiety disorders
3. clinical diagnosis of schizophrenia
4. report of an infectious condition in the last 15 days before collecting a blood sample;
5. had previously practiced or currently practicing meditation, yoga or Tai-Chi.
The Effect of Baseline Bilateral Uterine Artery Doppler Velocimetry on Obstetric Outcomes in HRT-FET Cycles

Researchers aim to determine how baseline (pre-conceptional) uterine perfusion characteristics affect implantation rates and obstetric complications in women who underwent high-quality blastocyst transfer.

In hormonally prepared frozen embryo transfer cycles, basal bilateral uterine artery Doppler velocimetry will be performed before treatment (pre-conceptional) in each patient. Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of the specified embryos is high, possible embryo-induced implantation failure would be minimized.

Bilateral uterine artery Doppler velocimetry will be performed during the basal ultrasonography (on the 2-5th day of menstruation). Any uterine artery notch, absent diastolic or reverse flow also will be recorded. In addition, sub-endometrial (arcuate artery) blood flows will be evaluated by Doppler ultrasonography.

For endometrial preparation, estrogen replacement will be given for approximately 12-14 days as a routine In cases with endometrial thickness ≥7mm, progesterone treatment will be started and embryo transfer will be planned on the 6th day of the treatment.

A pregnancy test will be performed 9 days after embryo transfer. Pregnant patients will be called for ultrasonography control 3 weeks later to determine fetal heartbeat. Additionally, the patients will be followed till labor and any obstetric complications will be recorded.

Uterine artery Doppler ultrasonography findings in patients with and without pregnancy will be compared. Additionally, in the group in which pregnancy was achieved, obstetric results including birth weight, small-large for gestational age, presence of hypertension, and preterm labor will be correlated with baseline (pre-conceptional) uterine artery Doppler parameters.

Eligibility Criteria:
Inclusion Criteria:

* Exogenous hormone preparation of the endometrial lining
* High embryo quality ((≥2BB) according to Alpha criteria
* Embryo transfer at the blastocyst stage

Exclusion Criteria:

* Patients whose treatments were canceled for any reason before the embryo transfer procedure
* Patients who underwent embryo transfer in the cleavage stage
* Presence of low-quality (\<2BB) blastocysts
* \>15% loss of viability of the embryo during embryo thawing,
* Patients with congenital uterine malformations,
* Patients in whom Doppler velocimetry cannot be performed optimally
Probing the Role of Sodium Channels in Painful Neuropathies

Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact on patients' quality of life and health care costs. Not all individuals with neuropathy develop pain and it is not possible to predict who is more or less susceptible among those with similar risk exposure. Current inability to identify high-risk individuals hinders development and application of therapies to counteract neuropathic pain and to address targeted prevention strategies. Recently, the investigators Consortium has identified novel pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to play a critical role in the generation and conduction of action potentials in nociceptors and their terminal axons. This study was undertaken in a carefully selected group of patients with painful neuropathy using a candidate gene approach and directly revealed targets for new therapeutic strategies. This discover widened the spectrum of sodium channel-related pain disorders including conditions more common in the general population than those known so far. PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a cohort of patients with predominantly small fibre neuropathy, aims to develop this original idea in a larger and well characterized study population, to provide evidence for the reliable stratification of patients at high risk and potential new treatments tailored on patients' clinical features, in order to improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of sensory neuropathy, including pure small fibre neuropathy (SFN), based on established clinical, nerve conduction study (NCS) and skin biopsy findings (Tesfaye et al. Diab Care 2010) caused by

  1. type 1 or type 2 diabetes (World Health Organization criteria) with stable metabolic control for \>6 months (haemoglobin A1C \<9%); or
  2. idiopathic aetiology after ruling out all known causes of neuropathy including vitamin deficiencies, malignancies, toxic, drugs

Exclusion Criteria:

* any other cause of neuropathy
New Methods for Early Detection of Acute Kidney Injury After Heart Surgery

The investigators intend to study 2 new methods for the early detection of Acute Kidney Injury (AKI) after cardiac surgery and compare and combine the predictive abilities of these methods with established renal injury markers and epidemiological models to detect (AKI).

Acute Kidney Injury is common after Cardiac surgery and occurs in up to 20% of patients (Ref Rydén).

This study will evaluate two new methods for the early detection of acute kidney injury in 200 patients undergoing elective cardiac surgery at the Karolinska Hospital.

These methods are:

1. Ultrasound based measurement of the kidneys blood flow profile measured using renal resistive index (RRI). This will be measured prior and within 4 hours post surgery. Ref Herzberg, Le Dorze.
2. Urine creatinine clearance will be measured in the first four hours after cardiac surgery.

The investigators will also measure known renal injury markers in blood and urine samples post operatively. These include Neutrophil gelatinise-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases (TIMP-2), Insulin-like growth factor-binding protein 7 (IGFBP7), Kidney Injury Molecule 1 (KIM-1), Nephroclear, Interleukin 18 (IL-18), Fatty acid-binding protein (L-FABP), Fibulin-1, cystatin C och albumin.

The new methods of AKI detection will be used to build a statistical model to predict AKI after cardiac surgery. We will determine whether the addition of renal injury markers and epidemiological factors known to be associated with the development of AKI (variables such as age, known chronic renal dysfunction or heart failure) can improve precision in diagnosis.

AKI will be defined by the Kidney Disease improving Global outcomes (KDIGO) criteria (Ref KDIGO KDIGO Clinical Practice Guideline for Acute Kidney Injury, Khwaja A).

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Undergoing elective cardiac surgery (Coronary artery bypass grafting, valve surgery, aortic surgery or a combination).
* Able to understand and give written consent to partake in the study

Exclusion Criteria:

* Unable to give consent
* Previously received a renal transplant
* Renal failure requiring dialysis prior to surgery
* Persistent atrial fibrillation
Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression

The objective of this study is to examine the impact of a home-based peer support intervention for mothers affected by postpartum depression (PPD) and for their infants.

This controlled study will help establish the link between support for maternal caregiving, maternal-infant interaction, infant neuroendocrinology and infant cognitive and social development. The primary hypothesis predicts that home-based peer support will improve maternal-infant interactions. Secondary hypotheses predict that home-based peer support will: improve infants' cognitive development; improve infants' social development; decrease average daily salivary cortisol levels in infants; reduce maternal depressive symptomatology; and improve maternal perceptions of social support.

Eligibility Criteria:
Inclusion Criteria:

* Eligible mothers will be identified as experiencing symptoms of PPD and scores \>12 on the Edinburgh Postnatal Depression Scale.
* Mothers must speak English or French.
* Mothers will not be excluded for taking anti-depressant or anti-psychotic medication, using other interventions for PPD, or reporting a history of mental illness;
* The infant must be full-term, in the care of the mother and between 3 to 6 months of age at initial enrollment.

Exclusion Criteria:

* Infants who have been admitted to the NICU
* Infants will be excluded if medicated with corticosteroids
Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity

The child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. The aim of the programs is to promote weight loss, encourage physical activity and modify behavior in order to get long term results. The aim of the present study is to try and identify the demographic and behavioral characteristics of children who succeed in the program.


Eligibility Criteria:
Inclusion Criteria:

* Obese / overweight children

Exclusion Criteria:

* Children that has an organic illness that cause obesity
Brief Smartphone Treatment Study

Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentary intervention (MEMI) has targeted generalized anxiety disorder (GAD). Moreover, although theories propose that mindfulness intervention can boost attentional control (AC), executive functioning (EF), perspective-taking, and social cognition skills they have largely gone untested. Thus, this randomized controlled trial (RCT) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI (vs. placebo). Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo (SMP). Those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). Also, those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice. Comparatively, participants assigned to SMP will only be prompted to practice self-monitoring. They will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. All prompts will occur 5 times a day, for 14 consecutive days. They will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. Multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (SMP)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF (inhibition, set-shifting, working memory updating). In addition, the investigators hypothesized that MEMI (vs. SMP) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. Findings will advance understanding of the efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.


Eligibility Criteria:
Inclusion Criteria:

* Presence of Generalized Anxiety Disorder based on the Generalized Anxiety Disorder Questionnaire-IV self-report and Mini International Neuropsychiatric Interview
* Current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate through the PSU StudyFinder portal
* Expressed interest to seek treatment
* Currently not receiving treatment from a mental health professional
* Able to provide consent
* Proficient in English

Exclusion Criteria:

* Below age 18
* Failure to meet any of above inclusion criteria
* Participant currently undergoing
* Presence of suicidality, mania, psychosis, or substance use disorders
Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid

The purpose of the study is to assess the validity of the polynucleotide within the intra articular treatment of osteoarthritis of the knee, comparing it with that of hyaluronic acid, the most commonly used.

This study is double-blind, controlled, randomized.The aim of the study is to evaluate the efficacy, safety and tolerability of polynucleotides and hyaluronic acid gel (PNHA, class III medical device) for intra-articular infiltration in treating pain in osteoarthritis (OA) patients knee.

This study will involve patients with osteoarthritis who comply with the inclusion and exclusion criteria. One hundred patients between the ages of 45 and 70 will be enrolled in the study and randomized to receive one of the following treatment groups:

Group A) Polynucleotides and Hyaluronic Acid (PNHA) Group B) Hyaluronic Acid (HA) The treatment will be administered through intra-articular infiltration, a weekly infiltration in the affected knee, for a total of 3 infiltrations (T0, T1 and T2).

The use of non-steroidal anti-inflammatory drugs (NSAIDs) was permitted, but the use of paracetamol 1 cp 1000 mg every 12 hours, or Meloxicam 15 mg a tablet after meals every 12 hours, was recommended.

In case of grug taking: the number of days when the patient used NSAIDs, the commercial name and the NSAID dosage used were reported in the CRF.

Study visit:

* T0 start study: inclusion in the clinical trial and assignment of the randomization number; radiography; clinical study start-up evaluation; fill in the WOMAC questionnaire; infiltration No. 1.
* T 1 after 1 week from the beginning of the study: infiltration No. 2.
* T 2 after 2 weeks from the beginning of the study (end of treatment): infiltration No. 3.

FOLLOW UP:

* T 3 after 2 months from the beginning of the study: clinical evaluation; fill in the WOMAC questionnaire.
* T 4 after 6 months from the start of the study: clinical evaluation; fill in the WOMAC questionnaire.
* T 5 after 1 year from the beginning of the study: clinical evaluation; fill in the WOMAC questionnaire.
* T 6 after 2 years from the beginning of the study: radiography; clinical evaluation; fill in the WOMAC questionnaire.

At T6 visit, the patient completed the study. A 24-month study period is calculated for each patient.

Any adverse event that occurred during the study period was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 75 years
* Patients informed consent
* Knee OA (Osteoarthritis) (ACR classification) with a Kellgren Laurence from 1 to 4
* Knee pain from arisen at least 2 months
* BMI lower than 40

Exclusion Criteria:

* Pregnancy or lactation
* Severe systemic disorders
* History of drug abuse or alcoholism
* Hypersensibility to Hyaluronic acid or Polynucleotide
* No previous intra articular infiltration (from 3 months)
* No steroidal or anticoagulant systemic therapy from one month
* Knee articular deformity
* Patients affected by rheumatoid arthritis or other inflammatory articular pathologies and hematological disorders
* Focal skin lesion in the anatomical site of injections
Modelling Weight Reference Centiles for Preterm Infants

The aim of this study is to model longitudinal data at NICU of Assuit University Children Hospital to create predictive growth charts for weight in preterm infants from birth till discharge, that take into account the differing growth rates post-birth when compared to in-utero growth ,and to compare it with WHO chart for preterms.

It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at \<34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Data will be collected for all infants born at \<34 weeks of gestation who were delivered by vaginal or caesarian section and born at Assuit University Hospital or referred to it.

Exclusion Criteria:

* (1) Any neonate born at 34 weeks of gestation or more, (2) any neonate born at \<34 weeks of gestation who died before a second weight could be recorded.
Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection

In our study, both efficacy and safety of raltegravir(RAL)-based therapy will be assessed. 300 treatment-experienced patients with drug-resistant HIV will be randomized to two arms (2:1). Group A (n=200) will be assigned with RAL-based regimen (RAL+TDF+LPV/r).Group B (n=100) will be assigned with current second-line regimen in China (3TC+TDF+LPV/r). Both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated. This study will be the first large-scale, multicenter, randomized, prospective RAL-based therapy study in China for HIV/AIDs patients. The result will provide proves for further practical antiviral therapy for China or other resource-limiting countries.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-65 years
2. HIV seropositive and confirmed by western blot
3. have taken first line antiretroviral therapy for over one year and have any one of the criteria listed below (viral load of all the patients meeting these criteria should be confirmed at PUMCH laboratory)

   1. Viral load more than 400 copies/ml
   2. Viral rebound (confirmed by HIV RNA more than 400 copies/ml after virologic suppression)
   3. When viral load cannot be monitored, patients experience immunologic failure who meet at least one of the criteria listed below will be enrolled:

      * CD4 count equal to or lower than baseline level with first-line therapy,on two occasions over three months apart
      * CD4 count with 50 percentage fall from the on-treatment peak value
      * persistent CD4 count levels less than 100 cells/μl after over one-year antiretroviral therapy

Exclusion Criteria:

* Previous use of protease inhibitors
* Previous use of integrase inhibitors
* Pregnancy and breastfeeding
* poor compliance and drug interaction,
* opportunistic infections or malignancy at recruitment; or opportunistic infections within three months but still unstable within 14 days prior to recruitment
* HBsAg positive
* patients with the any of the following test results during screening for inclusion: WBC count\<2000/μl, neutrophil count\<1000/μl, Hb\<9g/dl, platelet count\<75000/μl, serum creatinine\>1.5 ULN, transaminases or alkaline phosphatase \>3 ULN, total bilirubin\>2 ULN, serum creatinine kinase\>2 ULN
* CCr\<60 ml/min
* Current intravenous drug use
* Severe neuropathy or mental disorder
* history of alcohol abuse and unable to withdrawal
* Severe peptic ulcer