cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of A Telehealth Postural Awareness Program Combined With Exercise In People With Neck Pain

People with neck pain often experience pain, neck disability, and poor quality of life. Postural-based awareness programs are evidence-based interventions for postural problems and neck pain disorders. This study aims to determine the effectiveness of a telehealth physiotherapist-delivered postural awareness program combined with exercise in people with neck pain. Pain, neck disability, leisure time management, and exercise stage of change were evaluated.

Pain with visual analog scale, neck disability with Neck Disability Index, Leisure time management with Leisure Time Management Scale, and exercise stage of change with exercise Stage of change Scale were determined. The authors aim to find out if there are any changes before and after the program on the pain, neck disability, and evaluation subscale of the leisure time management scale, and exercise stage of change of participants.

Eligibility Criteria:
Inclusion Criteria:

* being aged 18 years or over,
* volunteering to take part in the study,
* being a student of online education,
* without a history of any neurological or orthopedic problem,
* with resting neck pain (as measured by the VAS) lasting ≤30 days
* that is aggravated by movement without extending distal to the shoulders.

Exclusion Criteria:

* rheumatological diseases, malignity or structural deformities,
* previous surgical intervention related to the neck region,
* severe pain (more than 7 in 0 to 10 VAS)
Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. The confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.

All subjects will undergo standard management (colposcopy) for their cervical lesion as scheduled. For cervical sites suspicious of dysplasia, acriflavine hydrochloride 0.05% solution will be applied topically, then rinsed with saline prior to in vivo confocal imaging with the hand-held probe. Following that, a biopsy of the suspicious site will be performed irrespective of the confocal microscopy finding. A biopsy of the normal site will be taken for research purposes. The confocal probe imaging will not alter where and how the biopsies will be taken (no change to size of biopsy or location on cervix).

The procedure will add approximately 15 minutes to the duration of the standard outpatient procedure. During each examination, the anatomical location of all tissue areas in question will be recorded using the clock-position nomenclature system. Some normal areas will be also localized and recorded as control. Digital images will be recorded in the computer.

Eligibility Criteria:
Inclusion Criteria:

* indicate understanding of the study
* provide informed consent to participate
* 18 years old or older
* not pregnant and have negative urine pregnancy test
* be schedule for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic

Exclusion Criteria:

* they are breast-feeding
* they had an operation to remove their cervix
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, best corrected visual acuity, intraocular pressure, pupil diameter, corneal endothelial cell count, fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage pupilloplasty. The modified iris cerclage pupilloplasty was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of aphakia
* permanently dilated pupils
* history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma

Exclusion Criteria:

* iris defects
* severe diseases such as cyclodialysis cleft, uncontrolled IOP, retinal detachment
* poorly controlled systemic diseases such as diabetes and hypertension
* corneal endothelial cell counts of \<1000/mm2
* \<6 months of follow-up
Evaluating PEGASUS - a Group Intervention for Young People With an Autism Spectrum Disorder

When a clinician gives an autism spectrum disorder (ASD) diagnosis they hope this will be helpful to the person receiving it and their family. In reality children with an ASD describe few benefits to receiving this diagnosis - they often report feeling confused and stigmatised by it. Parents can also struggle to understand their child's diagnosis and report needing greater support from professionals in this respect (Midence \& O'neill, 1999; Osborne \& Reed, 2008).

Little is known about how to help children and families integrate their ASC 'label' in a positive way. Whilst there is anecdotal evidence that psychoeducation after diagnosis can help, there has been no formal evaluation of this approach and no evidence-based programmes of this type are available. In the current study the investigators aim to test empirically a psychoeducational programme for children with an ASD ('PEGASUS'), using a randomised controlled design. The investigators aim to evaluate whether this psychological and educational intervention impacts positively upon understanding of ASC, self-esteem, functional adaption, well-being and family functioning.


Eligibility Criteria:
Inclusion Criteria:

1. Received an ASD diagnosis from Child and Adolescent Psychiatrist, Clinical Psychologist or Paediatrician.
2. Aware of ASD diagnosis.
3. Aged between 9 and 14 years.
4. Able to function in group setting, as evidenced in educational context.
5. Speaks English

Exclusion Criteria:

1. No generalised Intellectual Disability as indicated by IQ below 65.
2. Not engaged in additional formal psychosocial intervention during study period.
3. Not taking psychiatric medication at baseline assessment, or taking a stable dose of psychiatric medication expected to remain constant throughout study participation.
Avatar Contraception Communication Training

In order to support the desire of most adolescents to delay pregnancy (parenting) until their own adulthood, pediatricians must be comfortable and skilled in having reproductive health conversations with adolescents and the mothers of adolescents. Advocates for Youth (AFY), a national, youth-facing, well-established, non-profit, is known for innovative sexual and reproductive health programs. AFY successfully implemented a virtual simulation for schoolteachers to practice sex education scenarios by interacting with culturally diverse student avatars. We will partner with AFY to adapt their novel simulation-based approach to train medical residents in using SDM with youth and parent avatars. Our long-term goal is to build clinician confidence in SDM and actual skills via simulation training with dyadic avatars. We will also explore how evaluation of clinician communication skills varies from youth-, parent-, and clinician-viewpoints.

Specific Aims seek to (1) iteratively adapt and refine the simulation training (1a) and measurement tools (1b) with three community advisory boards (CAB) of separate groups of teens, parents, and clinicians; and (2) conduct a proof-of-concept pre-post evaluation of clinician confidence in counseling dyads after one-time exposure to the simulation (n=100 medical residents). We will record residents' communications in the simulation and a subset of clinicians, parents, and adolescents from each CAB will evaluate residents' SDM skills via the Person-Centered Contraception Counseling (PCCC) scale. Hypothesis: Most medical residents (75%) will self-report improvement or stability in confidence with high acceptability of the simulation training. We will explore 1) overall concordance between self- and expert-reported evaluation outcomes (SDM skills, PCCC scale); 2) compare the distribution of each evaluation item by evaluator; and 3) explore correlations between scales by evaluator. Impact: This proof-of-concept study, co-developed and co-evaluated with community members and families, fills a gap in communication training to inform a future fully powered ORBIT stage 3 efficacy trial to test actual triadic communication in the real-world with comparator groups of medical residents across national training programs.

Eligibility Criteria:
Inclusion Criteria (providers):

* Providers (medical residents, fellows, attendings)
* Recruited from the Adolescent and Young Adult (AYA) Medicine Clinic at Children\&#39;s Medical Center of Dallas.

Exclusion Criteria:

* Unable to speak or read in Spanish/English
Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer

The purpose of this study is to see whether providing radiation on a shortened (compressed) schedule of 5 days in a row is a safe and effective approach to prevent cancer from coming back in people who have had a mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients with invasive breast cancer who have had mastectomy and have a chest wall reconstruction in progress or completed.
* Age ≥ 30 years
* Final AJCC Stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status). Pathological stage for all patients not receiving neoadjuvant chemotherapy. Higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy. T3N0 patients, either clinically by imaging before neoadjuvant chemotherapy, or by pathological stage at the time of surgery, are eligible. Exceptions to these criteria (e.g. for T4 or N3 patients) are possible after discussion with PI.
* Histologically negative tumor margin.
* ECOG Performance Status of 0 or 1

Exclusion Criteria:

* Patients with distant metastasis.
* Patients who are pregnant or breastfeeding.
* Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
* All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) will not be eligible to enroll.
* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at \<5% risk of relapse within 3 years.
* Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. However endocrine therapies (tamoxifen or aromatase inhibitors), anti-HER2 therapy and bisphosphonates are permitted without restriction even during protocol treatment. Standard-of-care maintenance treatments such as pembrolizumab and capecitabine are permitted during protocol treatment. All of these treatments are delivered routinely as SOC during conventional radiotherapy.
* Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Functional Outcome Assessment After (Calcaneal) Trauma Surgey

To include patient after traumatic (calcaneal) fractures for this study. They can be included to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided tape on anatomical points. After that gait will be recorded with infra-red camera's and an animation model will be formed. With this model further analysis can be made to range of motion between different segement of the foot. These results will be compared with patient with an arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic findings will be correlated.

All subjects are asked to come to the movement laboratory of Maastricht University Medical Centre on one individual day. Before gait analyses the following characteristics were measured; height, weight, BMI, knee and ankle width (measured between the two condyles of the knee and the measured between the two malleoli of the ankle) and leg length . All measurements are performed by researchers who was trained in the examination of the foot. At least one static trial was performed with all 42 markers, with the subjects in stance phase in an anatomic neutral position. After calibrating the markers and calculating the subject-specific joint axes in the static trial, 6 markers were removed, according to the OFM protocol. After that the subjects were asked to walk barefoot in normal speed after a number of practice trials. For this speed at least 8 proper recordings were made during walking. The healthy subjects were also asked to walk in slow speed and 8 proper recordings were made during this slow-speed walking. One whole step was considered complete from heel landing (initial contact) to toe-off. A force plate was used to determine the heel-strike and toe-off phase during walking. Corrections in the axes of the knee and ankle were made if necessary and tiles were saved for further data output.

Eligibility Criteria:
Inclusion Criteria:

* patients with foot and ankle fractures

Exclusion Criteria:

* concomitant surgery for fractures of contra lateral leg/ankle or pre-existent abnormalities of the lower extremities, neurotrauma, spinal or neurological injury, pathologic fractures and people dependent in activities of daily living
Immunmodulation in Patients With HHT

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder. Literature suggests that HHT is often associated with higher frequency of infectious diseases.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. Literature and the investigators' observation suggest that HHT is often associated with higher frequency of infectious diseases. This might be a hint for a immunocompromised situation.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or over, HHT

Exclusion Criteria:

* Unable to provide informed consent
Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke

The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic disease.

The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic disease. It has been validated in three clinical trials, including orthopaedic patients, Parkinsons disease and 9 chronic stroke patients. Its unique feature uses adaptive, progressive robot-aided therapy to achieve intensive, task specific wrist movements.

In the context of the proposed project we will target the stroke population. Integration refers here to the system's ability to perform the assessment of proprioceptive status and proprioceptive training in a single device. The scope of the current project is investigating the efficacy of the proprioceptive assessment of the WristBot and correlating the result throughout the rehabilitation protocol. The proposed technology comprises a hardware device with four motors that can apply torques to the human wrist about its three degrees of freedom (i.e. axes of rotation: wrist flexion/extension,abduction/adduction and forearm pronation/supination). This allows for guided and controlled movements of the wrist by delivering assistive, resistive, perturbation or no forces (patient actively moves the wrist). It contains a set of specialized software modules that a) allow for the objective, psychophysical assessment of sensory dysfunction in patients, and b) provide specialized training modules designed to improve sensory and motor functions of the wrist.

Eligibility Criteria:
Inclusion Criteria:

* First clinical stroke (ischaemic or haemorrhagic) diagnosed by brain imaging CT or MRI
* Age 21 years to 85 years, both males and females.
* \< 90 days of stroke on admission to rehabilitation
* Presence of either motor and /or sensory deficit detected by clinical examination.
* Ability to understand simple instructions.
* Ability to give own consent.
* Ability to sit supported in a chair for 60 minutes with appropriate rest breaks.

Exclusion Criteria:

* Non stroke -related causes of motor/sensory deficits
* Tetraplegia or tetraparesis
* Known diagnosis of cervical myelopathy, lower motor neuron weakness (Post polio, brachial plexopathy, peripheral neuropathy (Diabetic, carpel tunnel syndrome, B12 deficiency)
* Concomitant orthopaedic condition limiting wrist range of motion: active arm/wrist fractures, fixed contractures of the wrist joint, wrist joint arthritis, wrist fusion.
* Arm or wrist joint pain (Visual Analogue scale VAS \>5/10) or instability
* Severe hemispatial neglect.
* Significant wrist spasticity with modified Ashworth Scale score 2 and above.
* Life expectancy \<6 months, end stage renal or liver disease, terminal cancer.
* Pregnancy and lactation in female patients.
* Postural hypotension on sitting up
* Active skin conditions over wrist joint area which could be worsened by robotic fit (e.g. severe eczema, burns)
Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the composition of gut microbiota before and after the therapy of sitagliptin.

The present study will included 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. These patients will receive 75g oral glucose tolerance test and fasting plasma glucose levels, lipids levels, fasting insulin levels and 2 hour post-load plasma glucose levels will be measured. Stool samples will be collected before the initiation of the use of sitagliptin. After 12 weeks, all patients will have fasting plasma glucose levels, lipids levels, fasting insulin levels tested. Stool samples will be collected again.

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed type 2 diabetic patients aged between 40-70 years

Exclusion Criteria:

* Any chronic disease (other than diabetes)
* Alcohol consumption/smoking
* Pregnancy/breastfeeding
* The use of antibiotics, pro-prebiotics within 3 months
* History of intestinal surgery
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients

The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 65 years old
* Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function)
* patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures.
* patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department

Exclusion Criteria:

* patient with contraindication to synthetic erythropoietin
* Patient with intravenous iron contraindication
* pregnant patient or with a risk of pregnancy
* patient who has not given his consent or does not understand the protocol
* Patient with hemodynamic instability
* patient participating in another research protocol for less than 3 months.
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus

Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age or older
2. Willingness to provide signed, informed consent to participate in the study
3. Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) \>/= 1
4. Willingness to adhere to study treatment and follow-up schedule
5. Willingness to adhere to post-treatment care instructions
6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
7. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study

Exclusion Criteria:

1. Pregnant, planning pregnancy during the study, or breast feeding
2. Blonde, grey, or white hair in subjects seeking hair removal
3. Tattooed skin in the intended treatment area
4. Active sun tan in the intended treatment area
5. History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
6. History of melanoma
7. History of vitiligo in the intended treatment area
8. History of keloid or hypertrophic scar formation
9. History of Melasma in the intended treatment area or per Investigator's discretion
10. Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
11. Open wound or infection in the intended treatment area
12. History of light induced seizure disorders
13. The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety
14. Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study
Study of Omalizumab in Moderate to Severe Bronchial Asthma

This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.


Eligibility Criteria:
Inclusion Criteria:

* Allergic asthma patients
* Inadequately controlled patients

Exclusion Criteria:

* - History of severe anaphylactoid or anaphylactic reactions
* Previous treatment with omalizumab
* History of cancer or cancer

Other protocol-defined exclusion criteria may apply