cyrilzakka/clinical-trials huggingface dataset:
Association Between Fear of Falling and Spinal Stiffness.

1. / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
2. / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)

1. / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
2. / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)

Eligibility Criteria:
Inclusion Criteria:

* over 75 years old,
* Ability to understand and answer a questionnaire in French
* Ability to stand up
* Patient from the Melun hospital (santé pole center + nursing home of the GHSIF)
* Affiliated with a social security scheme

Exclusion Criteria:

* mental disorders,
* lumbar surgery
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye for at least 6 months
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
* Have a Schirmer's Test score of ≤10mm and ≥1mm
* Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds
* Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;
* Have an IOP \> 25 mmHg at Visit 1;
* Have any planned ocular and/or lid surgeries over the study period;
* Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
* Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
* Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
Effect of Very Low Carbohydrate Diet on Glycemic, Metabolic, Glycated and Inflammatory Markers in Gestational Diabetes Mellitus

Uncontrolled Gestational Diabetes Mellitus may leads to maternal and fetal complications. These complications can be avoided by adopting the dietary modifications along with medications. Previous studies suggested that consumption of low Carbohydrate diet improves Gestational Diabetes and related complications. Therefore, this study aims to investigate the effect of very low carbohydrate dietary intervention on glycemic, glycemic, metabolic, glycated and inflammatory markers.

This will be randomized controlled trial of 80-100 Gestational diabetic women of second trimester to investigate the effect of very low carbohydrate dietary intervention on glycemic, metabolic, glycated and inflammatory markers.

Subjects will be recruited from ob/gyn outpatient of different hospitals. Eligible subjects will be enrolled in the study and will be allocated into two groups. One will be intervention and other will be control group. At baseline fasting blood samples from both group will be taken and will be analyzed for different biomarkers. Thereafter, the experimental group will be counseled about their modified diet (very low carbohydrate diet \<10%,40-50% protein and lipid in diet). Control group will be allowed to continue their routine diet counselled as part of their antenatal care.

Eligibility Criteria:
Inclusion Criteria:

* 2nd trimester women with GDM
* Either taking or not taking oral hypoglycemic agent or insulin

Exclusion Criteria:

* Previously known type 1 or type 2 Diabetic patients
* Age less than 18 and above 40 years
* Any other chronic disease
Serum Albumin Ratios Can Improve Sepsis Mortality Prediction

Sepsis remains a leading cause of mortality in hospitalized patients, despite advancements in critical care. Existing clinical scores for predicting sepsis outcomes often lack generalizability and complexity, hindering accurate risk assessment and timely intervention. This study aimed to evaluate the prognostic performance of serum albumin ratios to C-reactive protein (CRP), procalcitonin (PCT), and lactate in predicting 28-day morbidities and mortality in sepsis patients admitted to surgical ICUs. By incorporating these albumin ratios into clinical decision-making, we hypothesized that clinicians could more accurately identify patients at high risk of adverse outcomes and tailor treatment strategies accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly admitted to ICU with sepsis or septic shock;
* Patients were free of exclusion criteria.

Exclusion Criteria:

* Patients with acute kidney injury;
* Patients with hemorrhagic shock;
* Patients with immunosuppressive or autoimmune disorders;
* Patients suspected to die in ICU.
Physica KR Fluoroscopy Study

The aim of this study is to assess the in vivo kinematics and range of motion of a single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the normal healthy knee.

Patients would be evaluated by fluoroscopic examination during weight bearing activities (lounging, kneeling and stairs climbing).


Eligibility Criteria:
Inclusion Criteria:

1. Patientsoperated in The Royal Bournemouth Hospital NHS Foundation Trust and who has received a Physica KR implant
2. Patients achieving a ROM ≥ 100° at 6 week follow-up in the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
3. Patients affected by primary or secondary OA before surgery;
4. Patients with an appropriate intial fixation and stability of the knee prosthesis;
5. Patients with undamaged and functional collateral and posterior cruciate ligaments (no ligamentous imbalance or pain);
6. Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
7. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.

Exclusion Criteria:

1. Patients with a ROM \< 100° at 6-week follow-up in Physica KR clinical trial (K-06- Study protocol 30/10/2013 v 1.0);
2. Patients affected by rheumatoid arthritis;
3. Patients with malalignment or axial malrotation of the knee prosthesis;
4. Patients who had or have planned a surgery on their uninvolved knee within a year;
5. Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance;
6. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
7. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
8. Any psychiatric illness that would prevent comprehension of the details and nature of the study;
9. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit, excluding the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
10. Female patients who are pregnant, nursing, or planning a pregnancy.
Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis

evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.

Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.

Eligibility Criteria:
Inclusion Criteria:

* The patients were selected according to the following inclusion criteria:

  1. Completely edentulous maxillary and mandibular ridges
  2. Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness.
  3. All of the patients were dissatisfied with the retention and stability of their maxillary conventional dentures and expressed a strong desire for a more stable prosthesis.
  4. Sufficient bone quantity and quality in the front and posterior maxillary regions, as determined by preoperative CBCT, to accommodate six implants with a diameter of at least 3.5 mm and a length of at least 10 mm.
  5. Enough restorative space (from the mucosa covering the crest of the maxillary residual ridge to the occlusal plane) to allow the fixed prosthesis to be constructed ,preliminary jaw relationship revealed this.
  6. It's been at least a year since the last extraction.

     Exclusion Criteria:

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  1. Systemic diseases that may alter tissue response to implantation and affects osseointegration (radiation, diabetes, osteoporosis, bleeding disorders or hepatic patients)
  2. Long term immunosuppressive and corticosteroid drug therapy.
  3. Patient with abnormal habits as clenching and bruxism.
  4. Smoking patients.
  5. Patients with problems in TMJ.
  6. Neuromuscular diseases.
Heart Rate Variability in Children With a Functional Gastrointestinal Disorder

The current study is designed to assess relationships between anxiety/stress, autonomic nervous system balance, and electrical activity in the stomach before and after eating/drinking in children with abdominal pain.

Chronic or recurrent abdominal pain in children is a very common complaint in children and adolescents, and is most often associated with the presence of a functional gastrointestinal disorder (FGID). It is likely that the clinical symptoms in FGIDs are the result of an interaction between biologic, psychologic, and social factors. The psychologic factor most implicated is chronic stress or anxiety. Stress may influence gastrointestinal function and symptoms through altering the balance of the autonomic nervous system (ANS). Imbalance in the ANS has potential effects on gastrointestinal mechanosensitivity, motor function (e.g. stomach emptying and accommodation), and electrical rhythms. All of these can be associated with abdominal pain. Theory and early evidence from studies done with healthy adult populations suggest that ANS imbalance can reduce the body's ability to respond electrically to food/water consumption. However, the relationships between chronic stress/anxiety, ANS balance/imbalance, and electrical activity in the stomach before and after eating/drinking remain to be fully explored in children with FGIDs. The current study is a two-part pilot study designed to assess these relationships. Part I involves assessment of anxiety/stress (i.e., BASC parent- and self-reports) along with ANS balance (i.e., heart rate variability) and electrical activity in the stomach (i.e., electrogastrography) measured in the fasting state and following a test meal. Part II involves the same assessments with rapid water loading replacing the test meal. Results will be analyzed by specific FGID, as well as for the group as a whole. We expect to enroll 75 children ages 8-17 in each part, including 30 healthy controls and 45 children with an FGID. Elucidating these relationships is a necessary first step in developing more effective treatments for children with recurrent abdominal pain and, ultimately, reducing the personal and societal costs of this common pain entity.

Eligibility Criteria:
Inclusion Criteria:

* Ages 8 - 17 years
* Evaluated in Abdominal Pain Clinic at Children's Mercy Hospital or the Gastroenterology Clinic at Children's Mercy South for abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for FD, IBS, or FD/IBS.

Exclusion Criteria:

* Previous abdominal surgery
* Chronic disease requiring regular medical care (e.g. gastrointestinal diseases, diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer).
* Non-English speaking

NOTE: Control subjects will meet all patient inclusion/exclusion criteria except for Inclusion Criteria #2. Control subjects will be excluded for history of abdominal pain, nausea, vomiting, diarrhea, constipation, or bloating.
Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning

The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.

10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The subjects will be awake and un-sedated.

The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be over the age of 18
* Subjects must be able to give informed consent
* Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects with the inability to swallow pills and capsules.
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
* Subjects who have a bleeding disorder and are currently on anti-coagulants.
AR08 for Treatment of ADHD in Children

This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator
2. Minimum score of 28 on the ADHD-RS-IV at Baseline
3. Male or female ages 6 - 17 years, inclusive, at the time of Screening
4. Weighs ≥21 kg (46 pounds).
5. Is functioning at age appropriate levels intellectually, as deemed by the Investigator.

Exclusion Criteria:

1. Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview).
2. Has a positive response to either question 4 or 5 of the Baseline /Screening version of the pediatric Columbia Suicide Severity Rating Scale (C-SSRS)
3. History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening
4. Current usage of medications known to cause QTc prolongation or ADHD medications.
Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients

The aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis.


Eligibility Criteria:
Inclusion Criteria:

* patients aged over 18 positive for COVID-19 by polymerase chain reaction assay for rhino-pharyngeal swab

Exclusion Criteria:

* Under 18 aged
Clinic-Based Atopic Dermatitis Therapeutic Patient Education

The primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (TPE) based on clinical outcomes than paper handouts in Spanish and English-speaking communities. The clinical outcomes being measured are the severity, sleep affected by atopic dermatitis (AD), and the amount of itch experienced.

Patients will be recruited, stratified, and then randomly assigned into one of two intervention groups.The patient participants will be children anywhere on the spectrum of mild to severe AD and they will be stratified into four strata: a) Those with severe AD and no medical intervention escalation, b) Those with mild AD and no medical intervention escalation, c) Those with severe AD and medical intervention escalation, and d) Those with mild AD and medical intervention escalation. Group 1 will be a paper handout for group 1 and an educational video for group 2 as a form of TPE. Subjects will be recruited in clinic after they are screened for AD during their regular dermatology appointment. The research team will provide the patient and parent with a brief introduction to the study, what it involves for the patient, any foreseeable risks, and the compensation. If they agree to participate, a consent/permission form will be given to the parent/guardian to sign. After an initial evaluation of the patient's AD, subjects will receive an initial survey and POEM questionnaire on an iPad via RedCap that will address the condition of their AD. The patient will be administered a form of TPE as the intervention. The intervention will first be viewed/read in clinic, followed by a brief set of questions from the research team to determine the amount of information retained on an immediate level. A follow-up appointment will be scheduled for the patient. Group 2 will receive a slip of paper with a link to the videos, so the TPE will be accessible outside the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Boston Medical Center (BMC) patients under the age of 18 diagnosed with AD and their parents/legal guardian
* Spanish or English speakers
* Have access to the internet

Exclusion Criteria:

* None
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Eligibility Criteria:
Inclusion Criteria:

* Woman aged 18 years or older.
* Confirmed pathologic diagnosis of breast cancer.
* Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
* Surgically sterile or postmenopausal woman.
* Documented ER+ and/or PgR+ and erbB2- tumor.
* Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.

Exclusion Criteria:

* Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
* More than 1 prior endocrine treatment for locally advanced or MBC.
* More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
* Bone or skin as the only site of disease.
Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

The majority of data documenting the outcomes for the adjustable gastric band (LAGB) originate from non-publicly funded surgical centres. The investigators aim to investigate the clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This program recognized obesity as a chronic disease, providing extensive pre-operative multidisciplinary assessment and long term patient follow-up. Patients are selected for surgical management carefully by a multidisciplinary team and the LAGB is presented as one option to surgical management. Further, the investigators will investigate the operational impacts, including direct and indirect costs related the LAGB, to determine long term impacts on publicly funded hospitals within Canada.


Eligibility Criteria:
Inclusion Criteria:

* All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Exclusion criteria:

* Patients who have undergone selection for surgery outside this process, or who have had surgery elsewhere.