cyrilzakka/clinical-trials huggingface dataset:
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension

The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.

The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).

Eligibility Criteria:
Inclusion Criteria:

* • Patient must be 18 years of age or older

  * Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
  * Patient must be willing and able to complete the protocol required follow-up
  * Patient has participated in the study-related informed consent process
  * Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent

Exclusion Criteria:

* • Simultaneous bilateral TKA

  * Staged bilateral TKA less than 6 months from indexed procedure
  * Patient is a current alcohol or drug abuser
  * Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
  * Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
  * Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
  * Patient with Neuropathic Arthropathy
  * Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
  * Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension

Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension

This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients (\>18years)

  * ASA I-II

Exclusion Criteria:

* • ASA physical status \> II

  * Dyspnea
  * Systolic blood pressure ≥ 180 mmHg
  * Systolic blood pressure \< 90 mmHg
  * Agitation (RASS \> 1)
  * IVC non visualized
  * Epidural catheter in use
  * Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
  * Pregnancy
Tiara™ Transcatheter Mitral Valve Replacement Study

To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral regurgitation
* High surgical risk for open mitral valve surgery
* Subject meets anatomical eligibility criteria

Exclusion Criteria:

* Deemed too frail by objective frailty assessments
* Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
* Unsuitable cardiac structure
* Clinically significant untreated Coronary Artery Disease (CAD)
* Subjects on chronic dialysis
* Pregnant or planning pregnancy within next 12 months
* Documented bleeding or coagulation disorders
* Active infections requiring antibiotic therapy
* Subjects with a life expectancy less than 12 months
Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility

The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting.

The main questions it aims to answer are:

* Is the intervention we developped feasible
* To what extent will the intervention be implemented in nursing homes
* To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants

Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work.

Researchers will compare this intervention to usual care, to see if the intervention is feasible, and to gather first data on intervention effectiveness in benzodiazepines deprescriping.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old and older
* Taking at least one benzodiazepine or Z-drug for 4 weeks or more

Exclusion Criteria:

* Unability to communicate in French
* Palliative care
* Ongoing benzodiazepine withdrawal
* Ongoing alcohol withdrawal
* Severe anxiety
* Severe depression
Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of gastric cancer was confirmed by pathological examination
* Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
* No accompany with another cancer
* ECOG 0-1
* ASA I-III
* Agreement

Exclusion Criteria:

* Pregnant or suckling period
* Patients with a history of preoperative chemoradiotherapy
* Patients with unable to finish D2 lymphadenectomy or R0 resection
* Laparoscopic surgery contraindications
* Serious organ disfunction
* Accompany with serious mental disease
* Continuous treatment with steroid in 1 month
* Disagreement
Evaluation of PKU Start

To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new Phe free protein substitute for the dietary management of PKU in infants from birth.

This is an assessment of ten (10) infants who require a protein restricted diet that is low in Phe. Infants who routinely use a Phe free infant formula as part of their dietary therapy will be recruited for a 28-day assessment of PKU Start, to evaluate tolerance and acceptability.

The outcome of this assessment will be used in a submission to the regulatory authorities, Advisory Committee on Borderline Substances (ACBS), for PKU Start to become reimbursable on prescription in the UK.

The participant's dietitian will advise on an appropriate amount of PKU Start based on individual requirements. Parents/carers will be asked to substitute their usual Phe-free infant formula with PKU Start for one (1) month. The sponsor will supply PKU Start free of charge.

Prior to starting PKU Start, parents/carers will be asked to record information about the infant's usual GI tolerance and feeding pattern for a period of three (3) days, to allow for comparison between their existing formula and PKU Start.

They will be asked to record information about the following:

Stools Vomiting and Spit-up Feed / Fluid Intake and Compliance Phenylalanine Levels Final Evaluation about the presentation of the product, ease of preparation and how PKU Start flowed through the teat of a bottle.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of classical or severe PKU on new-born screening (For the purposes of this study, 'severe' is defined as phe concentrations between 120 and 600 µmol/L at diagnosis)
2. Taking a minimum of one (1) feed of a Phe-free infant formula
3. A minimum period of four (4) weeks from the time of diagnosis to initial approach to parents

Exclusion Criteria:

1. Diagnosed with mild PKU or hyperphenylalaninaemia (For the purposes of this study, 'mild' is defined as phe concentrations between 120 and 600 µmol/L at diagnosis)
2. Diagnosis of a congenital condition
Validation of a Multimodal Indicator of Depth of Anesthesia

The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28).

The indicator previously developed shall now be tested on an independent set of data.

The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers.

The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* elective surgery under general anesthesia
* anticipated operating time of about one hour or longer
* ASA physical status I-III
* written informed consent

Exclusion Criteria:

* chronic intake of CNS affecting drugs
* alcohol or drug abuse in the last three months
* CNS or psychiatric disease
* hardness of hearing or deafness
* abnormal gastrointestinal motility
* non-adherence to fasting guidelines, emergency surgery
* anticipated difficult airway
* pregnancy
* cardiac surgery and surgery involving the head and/or neck
* postoperatively prolonged intubation
* pre- and/or postoperative intensive care treatment
Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery

In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), and one day after surgery (postoperative).

To determine the difference of myocardial injury upon using different anesthesia regimens: remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.

Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration0.35-0.75 ng/ml) (Group-SS).

Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), 1 day after surgery (postoperative).

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing OPCAB surgery
* patient signed written informed consent

Exclusion Criteria:

* patient with Intra-aortic balloon pump
* patient with renal replacement therapy
* patient wants to withdraw the participation to the study
Yoga@Work Intervention to Reduce Work-related Stress Among Information Technology Workers

Over the last several decades, occupational stress at workplace comprise a major burden. Office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. Workplace wellness programs has been very feasible access to employees at their own convenience and need. Yoga@Work Program was developed to suit the need for information technology workers.


Eligibility Criteria:
Inclusion Criteria:

* Information Technology employee, or trainee willing and able to participate in a 6-week self-care program during the work day.
* Willing to give informed consent

Exclusion Criteria:

* medical or psychiatric conditions limiting practice of yoga in general
* Cognitive impairment
Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy

The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* is \>/= 18 years of age
* Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
* Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
* has signed the HIPAA authorization

Exclusion Criteria:

-
Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.

This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Have been diagnosed with early stage (I-III) prostate cancer.
2. Have completed cancer treatments six months prior.
3. Presence of incontinence symptoms

Exclusion Criteria:

1. Receiving hormonal treatment.
2. Urinary tract infection or urinary retention.
3. Cognitive impairment.
4. Having an implant
Treatment of IPF With Laparoscopic Anti-Reflux Surgery

This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER) will slow the decline of forced vital capacity (FVC) over 48 weeks.

This protocol proposes to test the following hypothesis: Treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal (GER) reflux will slow the decline of forced vital capacity (FVC) over 48 weeks. This study will randomize approximately 58 subjects with IPF and abnormal acid reflux on 24-hour impedance / pH monitoring to laparoscopic anti-reflux surgery or standard care (randomization ratio 1:1). Subjects will be followed for 48 weeks or until the time of lung transplantation or death.

We aim to achieve the following: determine the impact of laparoscopic anti-reflux surgery on change in FVC over 48 weeks in patients with IPF and abnormal GER; correlate the reduction in acid and non-acid reflux events with the change in FVC over 48 weeks in patients with IPF and abnormal GER; determine the safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER; explore the impact of laparoscopic anti-reflux surgery on key secondary endpoints over 48 weeks in patients with IPF and abnormal GER; identify molecular markers of IPF disease activity and gastroesophageal reflux in biological samples from patients with IPF and abnormal GER.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of idiopathic pulmonary fibrosis
* Abnormal GER on 24-hour pH monitoring (DeMeester score \> 14.7)
* Able to provide informed consent
* Willing to undergo laparoscopic anti-reflux surgery

Exclusion Criteria:

* FVC \< 50% predicted
* FEV1/FVC ratio \< 0.65
* Resting room air PaO2 \< 60mm Hg
* Unable to walk 50 meters on 6 minute walk test
* Acute respiratory illness in last 12 weeks
* Experimental medication for IPF in last 28 days
* Listed for lung transplantation at screening
* Unable to safely undergo surgery
* History of esophageal / bariatric / gastric surgery
* History of cancer (other than non-melanoma skin cancer) in last 3 years
* Pregnant at time of screening or enrollment
* Unable to obtain pre-authorized approval from a third party payer for surgery and related costs
* Life expectancy \< 48 weeks due to another illness
* BMI \> 35
* Known severe pulmonary hypertension (mean pressure \> 35 mm Jg on RHC; RVSP \> 50 mm Hg on ECHO)
Evaluating Genes in Sputum to Measure Drug Response in COPD

The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD.

We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.


Eligibility Criteria:
Inclusion Criteria:

* Twenty adult subjects ≥ 40 years of age and ≥ 10 pack/year cigarette history will be evaluated.
* Subjects will be recruited such that one-half are current smokers and one-half are former smokers.
* All subjects will have COPD (FEV1/FVC \< 70% and FEV1 =\> 40% predicted).
* Airway hyperresponsiveness and diffusion capacity for carbon monoxide will also be performed to more precisely characterize the physiologic phenotype in these subjects.

Exclusion Criteria:

* Subjects will be excluded if they have used inhaled or systemic corticosteroid or antibiotic use within 6 weeks or if they are currently treated with theophylline.
* A 6 weeks run off after an upper respiratory infection will be required for qualifying subjects.
Prospective Evaluation of FibroScan in Patients Treated With Methotrexate

The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.

Methotrexate (MTX) is an effective treatment for induction of remission and maintenance in patients with Crohn's disease, rheumatoid arthritis, or psoriasis which may induce liver fibrosis with high cumulative doses. Transient elastography (FibroScan) is a new non-invasive rapid, reproducible and bed-side method, allowing assessment of liver fibrosis by measurement of liver stiffness. A preliminary study (Laharie et al, Alimentary Pharmaceutical Therapeutics 2006) had shown that significant liver fibrosis was rare in Crohn's disease patients treated with a high dose of methotrexate. FibroScan was a reliable non-invasive method to detect liver fibrosis which could be recommended in these patients. Therefore, liver biopsy could be performed only with patients with high FibroScan values and/or with chronic liver enzymes abnormalities. However, further longitudinal and prospective studies are mandatory to confirm these preliminary data, in patients with crohn's disease but also with rheumatoid arthritis and psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, ≥18 years of age.
* Patient treated with Methotrexate.
* Written informed consent

Exclusion Criteria:

* Patients refusing to participate to the study and to provide written informed consent
* Pregnant women
The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region

The concept of immediate implant placement at the time of tooth extraction was first introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining different variables have supported the concept of immediate implant placement. pioneered a major contribution to immediate implant placement in human studies which recommended the insertion of an implant into a fresh extraction socket.

They advocated immediate implant placement primarily to reduce the number of surgical interventions needed to perform an implant-supported rehabilitation and shorten the treatment time.

Placement of implants immediately into extraction sites allow the surgeon to idealize the position of the implant appropriately with a better rehabilitation of the normal contour to the facial aspect of the final restoration.

Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption. Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support.

Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of biological functions including structural integrity, and the regulation of embryologic development. It is described as a natural organic substance, with physiological therapy activity, main component of the extracellular matrix of many tissues such as the skin, synovial joints and periodontal tissues .


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-60.
2. Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
3. Absence of any peri-apical pathosis.
4. Patients with intact buccal plate of bone.
5. Patients with adequate bone volume for the dental implant procedure.
6. Patient consent approval and signing.

Exclusion Criteria:

* 1. Smokers. 2. Systemic disease that may affect the final outcome of the surgical procedure.

  3. No or poor patient's compliance. 4. Patients with psychological problems. 5. Pathology at the site of intervention. 6. Pregnant patients. 7. Patients refuse to sign an informed consent.