cyrilzakka/clinical-trials huggingface dataset:
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease

The purpose of this study is to determine how using auditory cues of a metronome and music at various frequencies impacts the gait mechanics in people with Parkinson's disease when walking over ground and on a treadmill.

The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired subjects.

Participants will complete 7 different treadmill walking conditions and overground walking conditions while the investigators measure step length, cadence, gait speed, and variability of movement.


Eligibility Criteria:
10 unimpaired controls and 30 subjects with Parkinson's Disease (described in detail below - see inclusion/exclusion criteria). The 30 subjects with Parkinson's Disease will be assigned into 3 groups (10 with H\&Y Stage 1, 10 with H\&Y Stage 2, and 10 with H\&Y Stage 3).

Inclusion Criteria:

* Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk \>10 m overground as well as walk on a treadmill for a total of 14 minutes with rest breaks as needed, and be classified as Stage 1, 2, or 3 on the Hoehn and Yahr Scale since these stages have the most independence with mobility (Goetz et. al, 2004).

Exclusion Criteria:

* Exclusion criteria include Hoehn and Yahr Stage 4 and 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.
A Study to Assess the Efficacy of Early Physical Therapy Intervention Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer

This study will determine whether patients who receive regular physical therapy immediately following a modified neck dissection surgery will report decreased shoulder disability, decreased pain, improved or maintained shoulder range of motion and strength, and improved quality of life than those who receive only home instruction.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-85, able to give informed consent
* Subject has provided written informed consent
* Received Modified Unilateral Neck Dissection with sparing of the SAN
* Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality
* Not currently receiving acupuncture as a pain relieving modality
* Able to participate with treatment group protocol including physical therapy appointment every other week

Exclusion Criteria:

* History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty.
* History of CVA with hemi paresis
* Bilateral neck dissection
* Known severed SAN
Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study

This study aims to investigate the acute effects (i.e. 4 days) of paclitaxel or paclitaxel vs trastuzumab or paclitaxel and carboplatine on skeletal muscle of breast cancer patients. Muscle biopsies will be performed, as well as measurements of body composition strength, muscle architecture and quality of life.

Breast cancer patients are commonly treated with chemotherapy, which is known to induce severe side effects such as skeletal muscle deconditioning, characterized by skeletal muscle atrophy and major mitochondrial alterations. These maladaptations, observed in patients treated with epirubicin-cyclophosphamide (EC) followed by weekly paclitaxel (TAX), ultimately lead to reduction in exercise capacity and quality of life. However, little is known about the specific effect of each type of chemotherapy.

In our recent article (see Citations field in the References module), The investigators demonstrated that chemotherapy effects on skeletal muscle are drug-dependent. Using muscle biopsies before and 4 days after the first administration of EC or TAX, we demonstrated that unlike TAX, EC induced severe muscle atrophy and mitochondrial alterations. Of note, patients in the TAX group had already received EC during the preceding weeks (Figure 1). Therefore, these patients had already begun to have altered skeletal muscle homeostasis, which might have limited the influence of TAX compared with that of its administration in isolation (i.e., without other previous chemotherapy administrations). In addition, some patients had received, concomitantly with TAX, Trastuzumab (TRASTU) due to HER tumor mutation. Also, in triple negative breast cancers, the recommendations concerning neo(adjuvant) chemotherapy have recently changed and recommend starting treatment with the use of paclitaxel + carboplatin (TAX + CARBO).

Eligibility Criteria:
Inclusion Criteria:

TAX group :

* Female ≥ 18 years
* Stage I to III breast cancer
* Patient who has not yet started treatment with TAX
* Enrolled in a social security scheme
* Able to speak, read and understand French

TAX+TRASTU group :

* Female ≥ 18 years of age
* Stage I to III breast cancer
* Patient who has not yet started treatment with TAX+TRASTU (Tolaney regimen)
* Enrolled in a social security scheme
* Able to speak, read and understand French

Exclusion Criteria:

* Prior exposure to chemotherapy
* Musculoskeletal disorders, autoimmune, vascular or neuromuscular disease
* Implantation of a pacemaker
* Contraindications to fitness evaluation
* Contraindication to local anesthesia for microbiopsy
* Minor or protected adult
* Pregnant women
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.


Eligibility Criteria:
Inclusion Criteria:

* Participant able to provide written informed consent
* Participant is 18 to 65-years old
* Participant has confirmed opioid use disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5
* Participants is entering an OUD treatment program

Exclusion Criteria:

* Participant requires tapering from another substance at entry to treatment
* Participant is pregnant or lactating
* Participant has a history of hemophilia or psoriasis vulgaris
* Participant has a cardiac pacemaker implant device
* Participant has irritated or broken skin at the site of intended device placement
* Participant is currently participating in, or was enrolled in another clinical trial within the last 30 days
* Participant has a history of poor wound healing
* Participant has a severe autoimmune disease or uncontrolled diabetes
* Participant has an open wound/abscess infection/MRSA
* Participant has a history of a chronic pain in the last 90 days
* Participant has a serious medical condition which in the judgment of the principal investigator or his/her designee would make study participation unsafe, or would make intervention compliance difficult
* Participant has a psychiatric illness (bipolar disorder, schizophrenia, or other psychotic disorder, active suicidal ideation with a plan within the last month or suicide attempt)
Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.


Eligibility Criteria:
Main Inclusion Criteria:

* Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study
* Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy.
* Mean Worst Daily Leg Pain score of ≥5.0 and ≤9.0
* Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing

Main Exclusion Criteria:

* Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics
* Is pregnant or lactating
* Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening
* Has a BMI greater than 40 kg/m2
* Has radiological evidence of clinically significant foraminal stenosis at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
* Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
* Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain
* Has had lumbar back surgery
* Has received an implantable device for pain management
Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

This study will evaluate acupuncture's effect of preventing vasospasm after SAH.

A total of 80 participants will be recruited and will be randomized to a study group or a control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at every session in a study group, while mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture will be carried out in a control group.

Intervention starts within 96hours after SAH, after ruptured aneurysms have been secured by endovascular coiling or surgical clipping. Intervention is applied once a day, 6 days a week for 2 weeks(total 12 sessions) in addition to standard treatment such as prophylactic HHH therapy and nimodipine. Sterile disposable, stainless steel acupuncture needles are used.

Primary outcome measurement is the occurrence of delayed ischemic neurological deficit between the study group and the control group. Moreover, the incidence of angiographic vasospasm, TCD vasospasm, and vasospasm-related infarct on CT or MRI, the change of nitric oxide(NO) and endothelin-1 in plasma, mortality and participant's functional status using mRS will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Participants conforming to all the following conditions will be included: 1) SAH verified by CT and cerebral angiography; 2) aneurysm treated by endovascular coiling or surgical clipping; 3) age \> 18 years; 4) HHS 1-4; 5) acupuncture treatment can start within 96 hours after SAH; 6) participation is voluntarily and the informed consent signed.
* Healthy controls who matched with patients in gender and age

Exclusion Criteria:

* Participants with any of the following conditions will be excluded: 1) traumatic or infectious SAH; 2) HHS 5; 3) Transcranial Doppler (TCD) cannot performed; 4) heart, liver or renal failure; 5) presence of cardiac pacemaker.
Efficacy Study of Botox to Treat Neuropathic Pain

Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)

The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
* limited area of pain
* mechanical allodynia in the painful area

Exclusion Criteria:

* contraindication to BTXA formulation
* coagulation disorders
* another painful condition
* current major depression
* history of drug or alcohol abuse
* compensation claim or litigation
* facial neuropathic pain
Clinical Evaluation of Different Resin Composite Restorations

Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.


Eligibility Criteria:
Inclusion Criteria:

inclusion criteria of participants:

* Male gender
* Good oral hygiene
* Only Cooperative patient
* Medically free patient
* Age range 18-24

inclusion criteria of the teeth:

* Vital teeth with no periapical lesion or radiolucency.
* Prepared cavity with no undermined enamel walls.
* Functioning tooth with presence of an opposing.
* Healthy periodontium.

Exclusion Criteria:

* exclusion criteria of participants:

  * Old age patients
  * Patients have systemic disease or sever medically compromised
  * Patients with bruxism, clenching or temporomandibular joint disorder.
  * Por oral hygiene

exclusion criteria of teeth:

* Teeth with periapical lesions.
* Teeth with visible cracks.
* Teeth with mobility.
* Non-functioning tooth with no opposing tooth.
* Heavy occlusion or signs of sever attrition.
* Tooth with Periodontal affection.
Point of Care Evaluation of High-sensitivity Cardiac Troponin

In this observational research project the investigators wish to test new technologies that could allow them to either detect or rule out heart attacks earlier.

Currently, when a patient attends the Emergency Department with symptoms that could be due to a heart attack, the patient has a blood test taken from a vein in the arm. This is sent to a laboratory to measure the level of a protein called troponin that is released from the heart when it is damaged. Doctors and nurses use the level of troponin measured in that blood sample, along with a tracing of the heart and an assessment of symptoms, to decide whether the patient is having a heart attack. On average, it takes about 2 hours from the patient arriving at hospital to the doctor or nurse receiving the blood test result so they can make this diagnosis.

A device has been designed that can measure troponin by using a drop of blood from a finger prick with the result available in around 10 minutes. This means that if a patient is having a heart attack we can diagnose it earlier and give them treatment. Previous studies have also showed that the majority of patients who attend hospital with chest pain ultimately do not have a heart attack. With this new device the investigators hope to be able to reassure these patients that their symptoms are not due to a heart attack, so the clinical team can concentrate on finding out what else could be causing their chest pain, and ultimately discharge them earlier.

The investigators aim to find the best way to use this new device and look at the impact this device has on the length of time from sample to diagnosis and time spent in hospital.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to hospital with symptoms of suspected acute coronary syndrome
* Age 18 years and over

Exclusion Criteria:

* Patients with ST-segment elevation on the electrocardiogram
* Patients presenting with an out-of-hospital cardiac arrest
* Patients unable or unwilling to give informed consent
* Patients unable or unwilling to comply with study protocol
* Previous enrolment in this study
Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).

After agreement with the written informed consent, 35 subjects with severe heart failure were included in this study. They were randomized in three groups: controls, low-intensity and moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention. Cardiac events were registered following two years from baseline. The present study aimed to assess the effects of a combined program of inspiratory and peripheral muscle training on respiratory and general functional capacity and quality of life in patients with chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure (functional class from NYHA II and III),
* left ventricle ejection fraction bellow or equal 40%.

Exclusion Criteria:

* uncontrolled arrhythmia
* pulmonary edema or pulmonary congestion in the last 30 days
* peripheral oxygen saturation bellow 92% in resting condition
* respiratory infection in the previous 30 days to the enrollment into the study
* cognitive, neurological or orthopedic limitations
A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children

The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 3-12
* About to undergo venipuncture or peripheral venous cannulation at the back of the hand or antecubital fossa
* Have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES scale (age 3-12) and the extremes of pain on a 100 mm visual analog scale (VAS) (ages 8-12)
* Signed informed consent, cooperative and agree to attend follow-up visits

Exclusion Criteria:

* Any medical condition, non-compliance or instability (including but not limited to exceptionally upset, crying, anxiety) that in the judgement of the investigator might adversely affect the conduct of the study
* Used any (including external or inhaled) sedatives, analgesics, anaesthetics or other agents/device that may affect the efficacy assessment
* Subjects with tattoos, surgical scars, ports, implantable devices or a skin condition (e.g. excessive body hair) that may have interfered with the placement of Zingo or skin site assessments
* Active local infection or other skin pathology at the site of venipuncture or peripheral venous cannulation.
* Venipuncture of peripheral venous cannulation at the proposed site within the prior two weeks (longer if the wound is apparent)
* Previous history of allergic reactions to any local anaesthetic or tape/adhesive dressing.
* Participated in a clinical trial within three months prior to administration of study drug, or have already enrolled in a Zingo clinical trial before
* At the discretion of the investigator, any subjects that may have to be withdrawn from the study
Drug Use Survey of RESPIMAT in Patients With COPD

To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.


Eligibility Criteria:
Inclusion criteria:

Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.

Exclusion criteria:

There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.

The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.

Eligibility Criteria:
Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

1. Man, 55 to 75 years of age.
2. Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
3. A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
4. Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

1. Previous surgery of the prostate.
2. Previous treatment with GnRH agonists or GnRH antagonists.
3. Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
4. Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
5. Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).