cyrilzakka/clinical-trials huggingface dataset:
Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

This multicenter, prospective, observational cohort study will assess bone differences in women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.

Cross-sectional evaluation of clinical, biochemical and microstructural measures of bone in patients with type 2 diabetes and age-matched healthy controls. Longitudinal assessment of clinical, biochemical and microstructural measures of bone in study participants without prevalent fragility fractures.

Eligibility Criteria:
Inclusion Criteria:

- presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes)

Exclusion Criteria:

* immobility
* coexisting metabolic bone disease or comorbidities affecting bone health
* previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment
* thiazolidinedione use
Brock Exercise And Supplement Trials

This study will analyze the effects of Greek yogurt consumption and an 12 week exercise intervention on muscle size, body composition and bone health in untrained, university-aged males.

Introduction: Previous research has shown the effectiveness of dairy milk and whey protein on increasing muscle size, optimizing body composition and increasing strength in adult males. However, evidence on the use of high protein/Greek yogurt on muscle size, body composition and bone health is limited in this population. Yogurt contains similar muscle and bone supporting nutrients as milk, yet it offers a host of additional benefits including; increased satiety, probiotic cultures, greater stability, increased variety, more affordable and versatile features such as acting as a vehicle for consumption of other healthful foods. The proposed research will investigate the use of Greek yogurt as an effective post-exercise food to promote healthy body composition and bone health changes in young adult males.

Design: Parallel, randomized controlled trial.

Participants: 30 (n=15 YOG, n=15 PLA) healthy, untrained university-aged males.

Methods: Subjects will undergo a 12-week resistance and plyometric training program (exercising 3 days/week). The YOG group will consume a 200g dose (pro= 20g, carbs= 8 grams, \~110 kcals) of plain 0% Greek yogurt, while the PLA group will consume an isoenergetic, protein-void beverage comprised mainly of maltodextrin (pro= 0g, carbs= 26g, \~110 kcals). Each group will consume 3 doses per day (immediately and 1 hour post-exercise, and bedtime). Markers of bone health (CTx and P1NP) will be taken at baseline, 1 week and 12 weeks to determine acute and total changes. Muscle size, body composition, strength, vertical jump height and nutritional diaries will be measured pre and post intervention and habitual diet maintenance will be encouraged throughout the intervention.

Anticipated Results: It is hypothesized that each group will undergo positive changes in the aforementioned measures, however due to the increase in protein and calcium consumption, the yogurt group is predicted to have significantly greater increases in these variables than the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-25 years
* Normal BMI (18.5-24.9) kg/m2
* Have not participated in a resistance training program (of resistance exercise at least 2x/week or more) in the last 6 months
* Healthy and not taking any medication affecting muscle or bone
* Not supplementing with vitamins/ minerals or protein
* Speak and understand English
* No dairy allergy or lactose intolerance
Robotic-assisted Laparoscopic Sacrocolpopexy

Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.

Robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12X magnification, 4) 3-D depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. With robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. To date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assistance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women
* Age \>18 years
* Eligible for sacrocolpopexy
* Prior hysterectomy
* Stage II or greater post hysterectomy vault prolapse
* Satisfied parity
* Patients electing for an abdominal repair to posthysterectomy vault prolapse

Exclusion Criteria:

* Prisoners
* Cognitively impaired adults
* Not medically stable to undergo laparoscopic or abdominal surgery
* Previous pelvic/vaginal radiation
* Participants electing to proceed with a vaginal repair of vaginal vault prolapse
* Participants electing to proceed with the traditional abdominal sacrocolpopexy
* History of recurrent vaginal infections
* Known urologic and/or gynecologic cancer
Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.

The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.

This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.

Eligibility Criteria:
Inclusion Criteria:

* Participants were diagnosed with atopic dermatitis (AD) for at least 6 months.
* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
* Participants with body surface area (BSA) of AD involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline.
* BMI of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman.
* Be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise.

Exclusion Criteria:

* Participants with a physical condition which, in the Investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation.
* Participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection.
* Participants with known allergies to components or excipients of the test drug.
* Participants who are pregnant, nursing, or planning a pregnancy during the study period.
* Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, PDE4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer).
* Participants with the following hematologic abnormities at screening:
* Leukocytes \< 3.0 × 10\^9/L.
* Neutrophils \< lower limit of normal.
* Hemoglobin \< 10 g/dL.
* Lymphocytes \< 0.8 × 10\^9/L
* Platelets \< 100 × 10\^9/L.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
* TBiL ≥ 1.5 × ULN, or ULN \< TBiL \< 1.5 × ULN but judged by the investigator to be abnormal clinically significant;
Effect of Local Anesthesia Position of Lidocaine Injection on the Success Rate of Radial Artery Puncture Tube

Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.

Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Class I-III, patients aged 18-80 years
2. Planned surgery with radial artery catheterization
3. Allen test negative
4. Sign the informed consent form and voluntarily participate in this trial

Exclusion Criteria:

1. Inflamed skin at puncture site
2. Extremely nervous and unable to cooperate
3. Ultrasonographic assessment of aberrant radial artery
4. Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
5. The patient had undergone radial artery catheterization in the same arm in the past week
6. History of hypersensitivity to local anesthetics
Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)

This study is to test the usefulness of ultrasound dilution recirculation measurements in patients receiving venovenous extracorporeal membrane oxygenation as therapy. The ultrasound dilution measurements determine the efficiency of support provided by venovenous extracorporeal membrane oxygenation. At the present time there are no other devices available to make recirculation measurements.

At the present time there are no devices available to measure recirculation in patients on venovenous extracorporeal membrane oxygenation. The study uses an external monitor, laptop computer, clamp on flowsensors and ultrasound dilution technology to measure blood flow. Measurements are made by injecting 0.5 - 1 ml/kg of sterile isotonic saline into the patient's extracorporeal circuit. The subject will be monitored throughout the measurements. The measurements will be coordinated with the regular care of the patient and their extracorporeal circuit.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 0 and 21 years of age
* Patients receiving venovenous extracorporeal membrane oxygenation as treatment.

Exclusion Criteria:

* Patients over 21 years of age
* Patients not receiving venovenous extracorporeal membrane oxygenation.
What Women Want: Real Time Results During Screening Mammography in the Era of Patient-Experience Driven Care

This study explores why patients may want to receive real-time imaging results during a screening mammogram appointment at an MD Anderson breast imaging center. Real-time imaging results means women receive the results of the mammogram right away during the same clinic visit. Information from this study may help researchers better understand patient preferences to enhance patient-experience driven care.

PRIMARY OBJECTIVE:

I. To identify factors that may influence a patient's desire to receive real-time imaging results during their screening mammogram appointment at a breast center.

OUTLINE:

Participants complete an online questionnaire over 5 minutes regarding information on patient demographics and preferences for receiving real-time appointment imaging results.

Eligibility Criteria:
Inclusion Criteria:

* All female patients scheduled for a screening mammogram at one of our three MD Anderson Cancer Center (MDACC) Breast Imaging Houston Area Location centers
* Patient \>= 30 years of age
* Able to complete an electronic informed consent for the study

Exclusion Criteria:

* Patients not scheduled for a screening mammogram at one of the three imaging facilities
Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound Multiple Disabilities and on the Quality of Life and Feelings of Caregivers

Profound multiple disabilities also called in French polyhandicap are defined by the combination of a deep mental disability and severe motor deficit with extreme restriction of autonomy. Life in institution for people with profound multiple disabilities induces emotional and educative deficiency and often conducts to behavioral disorders. These behavioral disorders also impact on quality of life and feelings of caregivers. An intensive multimodal educative program proposed to patients with profound multiple disabilities can improve their psychic well-being, reduce chronic pain and improve also quality of life and feelings of caregivers. The intensive multimodal educative program will be compared to the usual practice of educative program.

People with profound multiples disabilities needs particular follow-up with education, care, communication and socialization.

Our hypothesis is that an intensive multimodal educative program of 5 hours a week during 12 months compared to the usual practice of 1 hour a week conducts to the reduction of behavioral disorders and improves the quality of life and feelings of caregivers.

This study is multicenter, controlled, randomized in two parallel groups and open-labelled comparing usual practice of educative program and intensive educative program during 12 months.

The evolution of predominant behavioral disorder and quality of life and feelings of caregivers is evaluated at inclusion (M0), six months after (M6) and twelve months after (M12).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient
* Age between 3 and 35 years old
* Patient with multiple disabilities defined by the following 5 criteria:

  1. reached or causal brain injury occurred before 3 years and
  2. profound mental disability (IQ lower than 35 or not assessable by psychometric tests when patients are too deficient) and
  3. motor disability (para-quadraparesis, hemiparesis, diplegia, ataxia, extrapyramidal motor disorders, neuromuscular disorders) and
  4. reduced mobility ( Gross Motor Function Classification System score: GMFCS III à V) and
  5. extreme autonomy restriction (FMI Functional Independency lower than 50)
* Patient with at least once per week of the following behavioral disorders:

  * Restlessness episodes (refusal of physical or verbal contact expressed by gestures aiming to push off other patients or caregivers and/or shouts when caregivers try to approach).

or

• Unexplained crying: according to the Riccilo S.C, Watterson T \[Riccilo 1984\] definition: fully or partially closed eyes, facial grim/wince and vocalization with or without tears.

or

* Rumination or
* Bruxism or
* Self-mutilations or
* Heteroagressif behavior (bite, pinch, hit) or
* Gestural stereotypies or
* Rythmic movements or
* Iterative frictions

Exclusion Criteria:

* No agreement of participation to the study by the holders of parental authority / legal guardian.
Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation

The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI) instrument on children aged 6 months up to 5 year old children. This procedure is usually done with sedation but the study will see if it can be done without sedation.

MRI examination of term infants without sedation at a later age (than newborn) can be feasible.

Eligibility Criteria:
Inclusion Criteria:

* Term born
* Mother is 18 years or older

Exclusion Criteria:

* Any previous or current neurological illness or other serious medical conditions
* Any conditions deemed by the investigators that are not suited for a MRI scan.
Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension

This is a randomized study with two treatment arms: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). It compares quality of life in the two arms at three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.

Subjects are randomly allocated to one of two treatment arms that examine treatment pathways, rather than comparing single treatments alone: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). We compare quality of life in the two pathways (arms) over three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.

A 'Treat in Pursuit of Control' design (TPC) compares two different routes to a pre-defined target Intraocular pressure (IOP) (pathways). It is a pragmatic study that uses published guidelines to make the complex clinical treatment choices faced in managing glaucoma, standardised between treatment arms by use of computer treatment algorithms. A UK National Institute for Health and care Excellence (NICE)-compliant evidence-based IOP Treatment Target 1 is set for each patient, according to the study treatment algorithms. They then proceed through stepped increments of treatment intensity (up to and including surgery) until a predetermined Target IOP is reached. Target IOP is reassessed in the light of objective clinical evidence of stability of glaucomatous optic neuropathy (GON) and visual function using visual field tests and automated optic nerve evaluation. Health Related Quality of Life (HRQL) and secondary outcomes are compared for patients in each pathway.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma (defined as an open drainage angle and reproducible glaucomatous visual field defects as tested by the Swedish Interactive Threshold Algorithm (SITA) algorithm on the Humphrey Visual Field or glaucomatous optic neuropathy)
* OR
* Ocular hypertension (intra-ocular pressure above 21mmHg and requiring treatment as per National Institute of Health and Care Excellence (NICE) Guidelines).
* Able to provide informed consent.

Exclusion Criteria:

* Advanced glaucoma in the potentially eligible eye as determined by Early Manifest Treatment Guidelines (EMGT) criteria 77: visual field loss mean deviation worse than -12dB in the better or -15dB in the worse eye.
* Secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis, trauma etc) or any angle closure.
* Any contra-indication to selective laser trabeculoplasty (e.g. unable to sit at the laser-mounted slit-lamp; past history of uveitis).
* Unable to use topical medical therapy due to e.g. physical infirmity and a lack of carers able to administer daily eye-drops.
Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old

The purpose of this study is to assess the prevalence of erupted supernumerary teeth among a group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.

* Clinical examination will be done for participants fulfilling the inclusion criteria after obtaining an informed consent from parents for acceptance of participation in the study after explaining the purpose of the study and the measures that will be held to the child.
* A custom made examination chart (Appendix 1) will be filled out, during face to face interview with the child and/or his parents, including: date, name, age, gender, address, medical history and previous dental treatment followed by clinical examination to detect the presence of supernumerary teeth.
* The presence of supernumerary teeth and its type and location will be recorded in the examination chart.
* Each child with supernumerary teeth will be given a letter, translated into Arabic, outlining his dental status to inform the parents about the condition and the need for treatment

Examination chart (Appendix 1 ):

Date :...................................................................

Personal information:

Name............................................. Age..........................................

Gender :.......................................... Address : ................................

Phone number : .................................................. Medical history: ......................................................... ..................................................................................

Previous dental history: ...........................................

......................................................................................

Clinical examination :

Supernumerary teeth: presence / absence Location : ........................................... Type :..................................................

Eligibility Criteria:
Inclusion Criteria:

* Positive patient and parent acceptance for participation in the study.
* Patients who are medically free from any systemic disease.
* Children aged from 6 to 15 years old.
* Both sexes will be included.

Exclusion Criteria:

* Uncooperative children.
* Handicapped children.
* Children who refuse to participate in the study.