cyrilzakka/clinical-trials huggingface dataset:
Evaluation and Classification of Foot Medial Longitudinal Arch Height in Adults

The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals. Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Drop(ND) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Maximum, minimum values are going to be calculated. The 95% and 68% prediction intervals will be used as cut off limits.

The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals.

Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Height(NH) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Maximum, minimum values are going to be calculated.

Participant's height, weight and foot length, from posterior aspect of calcaneus to the longest toe's tip, will be measured. Center of the medial malleolus, the navicular tuberosity and the head of the first metatarsal bone will be marked with a CD marker. With these landmarks in foot's relaxed position, neutrally, FL, NH and LAA will be measured by a ruler.

Feiss Line is a drawn line between the center of the medial malleolus to the head of the first metatarsal bone and then perpendicular line distance between this line and the navicular tuberosity will be drawn.The vertical line between the ground and the tubercle indicates Navicular Height. Center of goniometer placed at the navicular tuberosity then goniometer arms follow the medial malleolus and the head of the first metatarsal bone, degree between two arms indicates Longitudinal Arch Angle.

FL, NH, LAA mean values will be calculated. The 95% and 68% prediction intervals will be used as cut off limits.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-40
* Individuals who voluntarily agree to participate in the study

Exclusion Criteria:

* Those who have foot operation
* Foot trauma story which is causing an anatomic disorder
Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female, 18 to 55 years of age
* Continuous non-smoker.
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs.
* Has suitable venous access for repeated blood sampling.
* A female of childbearing potential must agree to abstain from sexual activity that could lead to pregnancy.
* A female of non-childbearing potential.
* Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.
* History or presence of clinically significant medical or psychiatric condition or disease.
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study.
* History of significant allergic disease requiring treatment.
* History or presence of alcoholism or drug abuse.
* History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
* History of known genetic metabolism anomaly associated with carnitine deficiency.
* Female subjects with a positive pregnancy test or who are lactating.
* Positive urine drug or alcohol results.
* Positive results for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
* QTcF interval is \> 460 msec (males) or \> 470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at the screening visit.
* Estimated creatinine clearance \< 80 mL/min at the screening visit.
* Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements.
Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.

Patients wanting STI screening can consult either they are symptomatic or not.

If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.

Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.

After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.

Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.

Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.

This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.


Eligibility Criteria:
Inclusion criteria:

* Aged more than 18 years old
* Non-opposition form given to the subject
* Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier

Exclusion criteria:

- patient's refusal to participate
The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.

The upper limbs play an essential role for safe and efficient walking in healthy persons and persons post-stroke. Nevertheless, in current post-stroke gait rehabilitation (research) the upper limbs are barely targeted. To address this gap, my project aims to investigate the selective motor control of the upper limbs during walking and the contribution of the cortical activity to the arm swing in independent walkers after stroke.

To gain insight in the direct effects of stroke on the arm swing, the primary motor control of the arm swing will be evaluated by determining muscle synergies (i.e group of muscles working together as a task-specific functional unit). Additionally, the cortical activity (EEG-analysis) during walking of persons post-stroke will be compared to healthy controls and the relationship between stroke-induced changes in cortical activity and arm swing deviations will be assessed. Furthermore, I will evaluate whether improvements in cortical activity relate to improvements in primary motor control of the arm swing.

This innovative project will be the first to investigate the direct coupling between the cortex and the muscle synergies in persons post-stroke during independent walking to investigate the arm swing. These fundamental insights in the primary motor control of the arm swing and the contribution of the cortical activity will allow to develop targeted interventions aiming to improve arm swing and as such optimize post-stroke gait rehabilitation.

Research questions:

1. How can muscle synergies explain arm swing alterations in independent walkers after stroke?
2. How do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke?
3. Are changes in primary motor control of the upper limb during walking related to normalization of brain activity in independent walkers after stroke?


Eligibility Criteria:
Stroke

Inclusion Criteria:

* First-ever, ischemic and cerebral stroke
* Maximum one-year post-stroke
* Able to walk at least 10 minutes (FAC ≥ 3)
* Presence of upper limb paresis (NIHSS item 5a/b \> 0)

Exclusion Criteria:

* Other neurological disorders

Healthy controls

Inclusion criteria:

* Older than 18 years
* Able to walk at least 10 minutes

Exlusion criteria:

* Pregnancy
Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.

Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.

A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.

The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.

The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient age: between 20 and 65
* No systematic contraindication for implant surgery
* No more than 10 cigarettes/day
* Previous horizontal bone augmentation 6 months prior to implant placement
* Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) \<20% and Full mouth plaque score (FMPS) \< 20%)

Exclusion Criteria:

* Smokers more than 10 cigarettes/day
* Pregnant/lactating women
* Alcoholics/drug addicts
* Uncontrolled diabetics, immunocompromised, blood hemostasis problems
* Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
* Patients not willing to sign the consent form
* History of radiotherapy in the head and neck region in the last 5 years
* Active periodontitis on the remaining teeth
CBT Program for Pain Management for Children and Youth With CP (CBT=Cognitive Behavioral Therapy; CP= Cerebral Palsy)

This study will focus on the feasibility of a modified cognitive behavioral program for pain management among children and youth with cerebral palsy (CP) on developing pain coping skills and reducing pain interference levels The study design is a randomized control feasibility trial. Participants will be placed randomly into one of two groups based on chance (50/50). The 2 groups are: (1) immediate treatment group and (2) delayed wait-list treatment group.

Both groups will receive the same intervention protocol.

Children with CP often experience pain that is related to their medical condition and that may limit or interfere with their everyday activities and Quality of Life (QoL).One possible way to help these children is by using a modified cognitive behavioral therapy (CBT) for pain management.

For this study, the investigators want to do a feasibility study, to see if participating in a six-week pain management CBT program for children and youth with CP and their parents, leads to better pain coping skills and lower levels of pain interference, when compared to a controlled waiting list.

Participants in both groups (immediate and delayed treatment) will participate in a 2-hour CBT session, once a week, for a total of six weeks. Following 3-months from the last CBT session, participants will be contacted for a short follow-up screening. All participants will be enrolled in the study for a total of 18 weeks.

This study will be done at the Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. Sixteen participants with CP (gross motor function classification system (GMFCS) levels I-V), age 8 to 18, with evidence of chronic pain (detailed as pain lasting more than 3 months or lasting longer than the expected time to heal) and their parents, will be recruited for participation.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CP
2. Chronic pain lasting greater than 3 months and restricting some or all activities according to child/youth/parental self-report
3. A baseline score of 70 (\~ -2 SD) on each of the three vineland adaptive behavior scales (VABS) sub-scales: communication, daily living skills and socialization
4. Successful completion of a modified sorting task including sorting cubes according to size and rating activities in order of how much they like to do them
5. Parent agreement to participate in the parents' program
6. Can communicate in English, with or without the use of augmentative communication devices

Exclusion Criteria:

Participants who meet any of the following criteria will not be eligible to take part in the trial:

1. Diagnosis of major visual or hearing impairment
2. Currently attending psychological treatment focused on pain management; (3) Uncontrolled seizure(s) (with or without medication) in the previous 12 months.
The Effects of the RSVP Bone Builders Program on Strength, Balance, Fall Risk and Life Satisfaction

The hypothesis of this study is that participation in the Retired and Senior Volunteer Program (RSVP) Bone Builders program 1 hour, twice per week, for 12 weeks may result in significant positive changes to the health status of older adult participants as demonstrated by increased leg strength and walking speed, improved balance and balance confidence, and enhanced life satisfaction. These improvements may lead to a reduction in risk of falls.

The purpose of this study was to examine the efficacy of the RSVP Bone Builders program, to document benefits this program may have for older adults and also provide additional evidence that further confirms the importance of exercise for the older adult population. Exercise has the potential to reduce falls, injuries, emergency room visits, surgeries, insurance costs, and improve the overall quality of life in the older adult population. If the RSVP Bone Builders proves to be beneficial for older adults, the program could be recommended by healthcare and exercise professionals for their patients and clients who are at risk for falls.

Eligibility Criteria:
Inclusion Criteria:

* able to walk independently with or without a cane or walker,
* not currently participating in the RSVP Bone Builders program,
* scoring at least 24/30 on the Mini-Mental State Examination (MMSE) and clearance of Physical Activity Readiness Questionnaire (Par-Q)

Exclusion Criteria:

* if they use a wheelchair in the community for mobility,
* have any known neurological, musculoskeletal, cardiopulmonary, or other medical condition that will not allow full participation in the RSVP Bone Builders program, and
* if the subjects score less than 24/30 on the MMSE
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* contraindication to beta-adrenoceptor antagonist or brimonidine therapy
Work Ability in Young Adult Cancer Survivors

To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.

This observational, cross-sectional study will recruit 220 analyzable YA survivors through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). We will evaluate the relationships among these measures using the theoretical framework to guide statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* \>= 2 to \< 10 years post-cancer diagnosis (per diagnostic pathology report)
* Diagnosed with first cancer (any type except types listed in exclusion criteria below) at age \>= 15 years
* Ability to understand and willingness to sign a written informed consent document
* Must be able to read and understand English

Exclusion Criteria:

* Currently receiving active cancer treatment (acceptable to be on maintenance or hormonal therapies)
* Life expectancy less than 6 months
* Precancerous or pre invasive conditions (myelodysplastic syndrome; carcinoma in situ; non-melanoma skin cancer) without progression to malignancy without another prior primary cancer diagnosis; (those who have had these conditions may participate IF they have a primary cancer diagnosis)
* Non-Hispanic Whites (effective 11/01/2018)
Prospective Evaluation of the Radiographic Efficacy of Enbrel

It is known from the COMET-trial that patients who start Enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. It is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine rheumatologic care and the local recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).

Therefore, no robust x-ray data are available to show/demonstrate

* the average extent of x-ray damage in routine patients on Enbrel outside clinical studies.
* if the outstanding effect on structural damage of Enbrel can be reproduced in routine practice.
* that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also for day-to-day decision making.
* the optimal onset of Enbrel treatment in the course of the disease to prevent radiographic damage

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Definitive diagnosis of RA or PsA.
* Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC).
* Inclusion of subjects pretreated with other biologics other than Etanercept is possible
* One plain radiograph of hands and feet (Anteroposterior) within 3 month prior to initiation of treatment with Etanercept and one planned consecutive radiograph of hand and feet taken over 12 to 18 months according to German recommendations for patients treated with biologics.

Exclusion Criteria:

* Receipt of any investigational drug within 3 months of study inclusion.
* Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:
* Hypersensitivity to the active substance (etanercept) or to any of the excipients.
* Sepsis or risk of sepsis.
* Active infections, including chronic or localised infections.
* Subjects who have received any previous treatment with etanercept
* Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery

Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016.Cervical erector spinae plane (ESP) block has been described to anesthetize the brachial plexus (BP), however, the mechanism of its clinical effect remains unknown. As the prevertebral fascia encloses the phrenic nerves, BP and erector spinae muscles to form a prevertebral compartment, a local anesthetic injected in the cervical ESP could potentially spread throughout the prevertebral compartment


Eligibility Criteria:
Inclusion Criteria:

* (ASA )classes I and II
* patients of either sex
* above the age of 18 who will undergo posterior cervical surgery

Exclusion Criteria:

* patient's refusal to participate
* any contraindications to peripheral nerve blocks
* history of ischemic heart disease
* patients on opioids for chronic pain
* patients with significant cognitive impairment
A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

To determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.

Patients receive high or low doses of cysteamine plus AZT or placebo plus AZT. The target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. An initial cohort of 36 patients will be enrolled in a 10-week pilot phase. Accrual will be temporarily suspended while data from the pilot phase is assessed.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator.
* Recombinant erythropoietin and G-CSF if clinically indicated.

Patients must have:

* Documented HIV infection.
* CD4 count 300 - 500 cells/mm3.
* Prior AZT therapy for at least 3 months but less than 12 months prior to study entry.
* No past or current AIDS-defining opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Kaposi's sarcoma requiring systemic therapy.
* Active malignancy other than basal cell carcinoma or in situ cervical carcinoma.

Concurrent Medication:

Excluded:

* Antiretroviral therapy other than AZT.
* Immunosuppressive drugs.
* Investigational HIV drugs/therapies other than study drug.
* Interferon.
* Steroids.
* Hematopoietins.
* Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior condition are excluded:

History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity.

Prior Medication:

Excluded:

* Prior antiretroviral therapy other than AZT.

Required:

* AZT for at least 3 months but no more than 12 months prior to study entry.