cyrilzakka/clinical-trials huggingface dataset:
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study

A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated. This type of prosthesis is designed to allow patients to perform daily activities, even very dynamic ones, with greater ease and efficiency. The distinguishing feature of a dynamic energy storage and return prosthesis is the presence of a system that accumulates mechanical energy during the support phase on the ground and returns it during the push phase, increasing the amount of push itself. In foot prostheses, it is common to use carbon fiber blades or springs that deform during the support of the foot and then restore themselves, returning elastic energy during the subsequent push. This helps reduce the effort required to walk and allows for more fluid and natural movements. Additive Manufacturing (AM) technology is ideal for highly customized and high-value production. Orthoses/prostheses are particularly suited to exploit the potential of this technology. However, the lack of functional materials that meet different design needs, such as structure and comfort of the devices, has limited the use of AM mainly in orthoses. AM is promising for orthoses due to its customization capability and reduced production costs compared to traditional solutions. In particular, it has been shown how continuous filament carbon printing can lead to the creation of prostheses that have dynamic and energy return characteristics similar to or even superior to commercial ones. The present pilot clinical investigation aims to provide indications regarding the safety and performance of the 3D printed prosthesis - named PROFIL - in a real-world scenario. The state of the art has not yet defined the performance and safety of 3D printed prostheses with thermoplastic materials and continuous carbon fiber. Since greater comfort and the possibility of performing physical activity more easily with the use of these devices is expected, it is considered of interest for clinical practice to evaluate these prostheses. The primary objective of the study is therefore to evaluate the safety and performance of the device during walking on flat surfaces and more demanding tasks. The secondary objectives aims at evaluate usability and deformation of the 3D printed prosthesis under different loading conditions (slow and fast walking, ascending and descending ramps or steps) by mean of fiber-glass sensors integrated in the prosthesis foot.


Eligibility Criteria:
Inclusion Criteria:

* Monolateral below knee amputation
* Mobility level: K3 or K4
* Age: 18-65 years old
* Maximum weigth: 100 Kg
* Collaborative subject
* Clinically stable stump

Exclusion Criteria:

* Pregnant
* Not able to understand written and oral instructions
* Problems to the stump
Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome

This study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS).

Carpal tunnel syndrome (CTS) is one of the most common upper extremity compression neuropathies and is caused by compression of the median nerve in the carpal tunnel at the wrist.

The ultrasound (US) is a follow-up option as a diagnostic tool in CTS. It is a readily available non-invasive tool which has a shorter examination time. It can measure a number of median nerve parameters, including size, vascularity (using power Doppler) and mobility (using dynamic imaging). In addition,the US provides information on anatomical variations of the median nerve and surrounding structures that may be a causative factor in CTS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Both sexes.
* Patients with carpal tunnel syndrome.

Exclusion Criteria:

* History of wrist surgery (including carpal tunnel injection) or fracture.
* Clinical or electrophysiological evidence of an accompanying condition that mimics carpal tunnel syndrome or interferes with its evaluation, such as proximal median neuropathy, cervical radiculopathy or polyneuropathy.
* History of underlying disorders associated with carpal tunnel syndrome such as diabetes mellitus, rheumatoid arthritis, pregnancy, acromegaly or hypothyroidism.
* Electrodiagnostic findings suggestive of co-existing neurological disorders.
* Subclinical sensory polyneuropathy.
A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a diagnosis of rheumatoid arthritis based on the American College of Rheumatology Association
* The subject has active disease at both Screening and Baseline, as defined:

  * ≥4 joints tender or painful on motion, AND
  * ≥4 joints swollen;
* The subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique

Exclusion Criteria:

* No arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study.
* No intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months.
* Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels \< 9.0 gm/dL or hematocrit \< 30 % at screening visit or within the 3 months prior to baseline synovial biopsy.
* An absolute white blood cell (WBC) count of \< 3.0 x 109/L (\<3000/mm3) or absolute neutrophil count of \<1.2 X 109/L (\<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
* Thrombocytopenia, as defined by a platelet count \<100 x 109/L (\< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
* Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .
Risk Scoring Model for Endometrial Cancer

A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma


Eligibility Criteria:
Inclusion Criteria:

- All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm

Exclusion Criteria:

* all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).
Use of Allied-health Professionals to Improve Treatment of Disease

The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.

Participants will:

Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months.

After consent, a research pharmacist will virtually monitor the participant's blood pressure until the 12-month follow up visit. The research pharmacists will have access to the participant's electronic medical records to monitor and document medications and clinic blood pressures for analysis . Participants will be asked to measure and return 14 blood pressure measurements (2x per day for 7 days) using our text messaging platform. They will be allowed to choose the times that they are sent reminders to measure their blood pressure. If a participant has blood pressure values sufficient for a hypertension diagnosis, the pharmacist will communicate via electronic medical record with the participant's primary care team. If they do not have a primary care provider, the pharmacist will facilitate finding one. The pharmacist will continue monitoring the participant and making recommendations to the primary care team through the electronic medical record to quickly adjust therapy to improve blood pressure control. The pharmacists will typically contact the participants (via participant's choice of phone, text, or email) every 2-3 weeks while their hypertension is uncontrolled. Once under control, the pharmacist will continue to contact the participant at least every 2 months to support adherence and reassess control.

Eligibility Criteria:
Inclusion Criteria:

* Biological mothers delivering at UIHC or attending a well-child visit for an infant between 1 month and 9 months
* Preeclampsia during pregnancy
* Preceived prenatal care at UIHC
* Owns a smartphone

Exclusion Criteria:

* Arm circumference greater than 17 inches
* Prisoner status
* Unable to provide own written informed consent
PS-341 in Treating Women With Metastatic Breast Cancer

RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.

OBJECTIVES:

* Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib.
* Determine the toxic effects of this drug in these patients.
* Determine the progression-free survival in patients treated with this drug.

OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the breast

  * Metastatic disease
* At least 1 unidimensionally measurable lesion

  * At least 20 mm by conventional techniques OR
  * At least 10 mm by spiral CT scan
* Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab \[Herceptin\]) for metastatic disease

  * Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure
* No known brain metastases
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-2

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin normal
* SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

* Creatinine normal OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other:

* No uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
* No other prior malignancy within the past 5 years unless curatively treated and disease free
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

* Prior hormonal therapy for metastatic disease allowed
* At least 4 weeks since prior hormonal therapy and recovered

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* Prior adjuvant therapy allowed
* At least 4 weeks since prior investigational drugs and recovered
* No other concurrent investigational or commercial agents or therapies for breast cancer
* No concurrent combination antiretroviral therapy for HIV
Isobaric Spinal Ropivacaine Versus Hyperbaric Spinal Bupivacaine in Total Knee Arthroplasty in Geriatric Patients

The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing lower limb orthopedic surgery.

52 patients physical status II-III according to the American Society of Anesthesiologists classification aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Patients were randomly assigned into two equal groups of 26 patients each according to the type of local anesthetic injected in the subarachnoid space , Group I : patients who received an intrathecal injection of 12.5 mg of 0.5% hyperbaric bupivacaine , Group II: patients who received an intrathecal injection of 15 mg of 0.5% ropivacaine.

The investigators compared both groups as regards the extent and duration of sensory and motor block and hemodynamics including heart rate (HR) , non invasive mean arterial blood pressure (MAP) and respiratory depression.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II-III aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Exclusion Criteria:

* Known hypersensitivity to amide local anesthetics and contraindications to spinal anesthesia.
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients

Exclusion Criteria:

* history of intraocular surgery or laser treatment,
* any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil,
* history of allergy to any drug used, and
* hypertension
Lung Clearance Index and Lung Allograft Dysfunction

The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years.

This single center study consists of three parts:

1. Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I)
2. Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II)
3. Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)

Eligibility Criteria:
Inclusion Criteria:

* Male and female lung transplant recipients
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax)
* Acute airway infection
* Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM
Calcium Intake and Fat Excretion

The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.

Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles.

The aim of this study is to examined for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight

Eligibility Criteria:
Inclusion Criteria:

* age between 18 - 50 years
* healthy
* weight stable within 4 months prior to the inclusion

Exclusion Criteria:

* pregnant or lactating
* uses cholesterol lowering drugs
* on diet
* suffering from, now or previously, any gastrointestinal diseases
* elite athletes
* participation in other concomitant trial
Peri-operative Inflammaging in the Elderly After Surgery

The population older than 80 years will significantly increase in the near future. Older patients' cognitive and physical status is known to deteriorate after surgery, leading to a high 30-day mortality due to post-operative comorbidities. Aging and related diseases share immune-related pathomechanisms. During aging, a chronic, low-grade sterile inflammation, called inflamaging, gradually develops. This likely results from low-grade innate immune activation and a functional, epigenomic and transcriptomic reprogramming of immune cells. Based on the hypothesis that surgical trauma leads to misplaced or altered self-molecules, which exacerbate inflammation and the postoperative risk for morbidity and mortality in elderly patients. There is increasing evidence that the individual's pre-operative immunobiography determines the susceptibility to peri-operative inflammation and post-operative outcome. Current exploratory pilot study will thus perform phenotyping of patients above 80 years undergoing major surgery. Participants will be evaluated for acute and long-term outcomes, including all-cause mortality, physical and cognitive function. To assess the individual's immunobiography, participants will be characterised by inflammation biomarkers combined with immunophenotyping, functional assays, and (epi-) genomic analyses before and after surgery. The cognitive impairment will be evaluated by measuring markers of neurodegeneration and neuropsychiatric testing and relate findings to volumetric imaging using high-resolution MRI to identify brain changes associated with cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 80 years
* elective major surgery defined as knee / hip replacement, spondylodesis (\> 2 levels), gastrectomy, resection of esophagus, liver, pancreas, colon, rectum or lung

Exclusion Criteria:

* no informed consent
* not able to perform neurocognitive testing
* preexisting infection systemic: CRP\>100 mg/l, Leukos \>12.0 G/l or clinical signs

Prosthetic joint infection (MSIS 2011 criteria):

PJI is present when 1 major criteria exist or 4 out of 6 minor criteria exist

Major criteria:

* 2 positive periprosthetic cultures with phenotypically identical organisms
* A sinus tract communicating with the joint

Minor criteria:

* Elevated CRP and ESR
* Elevated synovial fluid WBC count or ++ change on leukocyte esterase test strip
* Elevated synovial fluid PMN%
* Presence of purulence in the affected joint
* Positive histologic analysis of periprosthetic tissue
* A single positive culture
* Immunosuppression (HIV, glucocorticoids, immunosupressants)
* Autoimmune diseases
* ongoing or recent (\<3 months) chemo/radiotherapy
Mindfulness-based Intervention for People with Parkinsonian Tremor

Mindfulness meditation is an approach that has shown interest in treatment of anxiety in Parkinson's disease. This pilot study aims to assess a more specific effect on tremor using Essential Tremor Embarrassment Assessment and inertial sensors allowing monitoring during sessions and in daily life. This study will focus on 20 patients (10 with and without Mindfulness based intervention and will aim to develop the interface and demonstrate proof of concept before setting up a controlled study

Methodology: Randomized, pilot study comparing 2 parallel arms (Mindfullness group versus group with routine care).

Number of patients:20

Patient selection: patients with severe rest tremor

Duration of project: 12 months

Schedule visit: 4 visits in 6 months

Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease
* Hoehn st and yahr stage \<or = 3
* Age between 35 and 85 years old
* Treatment stabilized for at least 3 months
* Disturbing parkinsonian tremor of the upper limb (item MDS -UPDRS 2.10\> 1) and lasting 2 to 6 hours per day
* patients with internet access

Exclusion Criteria:

* Presence of disturbing dyskinetic movements (Item MDS-UPDRS4.2\> 1)
* Patient who has already practiced meditation in the last 5 years
* Untreated major depressive episode
* Hallucinations (Item MDS-UPDRS1.2\> 1))
* Psychotic disorders - Confusional syndrome
* presence of signs in favor of an atypical parkinsonian syndrome (oculomotor impairment, early falls, hallucinations, MoCA \<20, early dysautonomia)
* adult protected by law (guardianship, curatorship or under legal protection)

  * deprivation of liberty by judicial or administrative decision
  * high probability of non-compliance with the protocol or abandonment during the study
* refusal to sign informed consent
* Pregnant or breastfeeding woman
* Lack of social coverage.
PRINCE22 System Complete Performance Study

The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.


Eligibility Criteria:
Inclusion Criteria:

* Experienced (minimum use duration 6 months)
* Adult (minimum age: 18 years) hearing aid users,
* Written and spoken German,
* Ability to understand instruction,
* Ability to perform tests successfully
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Healthy outer ear,
* Moderat to severe Hearing
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
* Known hypersensitivity or allergy,
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results.
A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Male/female subject aged 18 years or older.
* Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
* Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.

Exclusion Criteria:

* Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.
* Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.
* Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.
* Intake of more than two pain treatments at trial entry (screening visit) including Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or permitted opioid analgesics.
* Subject being treated with Carbamazepine for any indication.
* Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
* Subject being treated in the four weeks prior to screening visit with 'strong' opioid analgesics.

Exclusion Criteria: