cyrilzakka/clinical-trials huggingface dataset:
Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector

Traumatic brain injury is one of the most common reasons for visits to the Emergency Department. More than 90% of patients who have suffered from head trauma present with a mild traumatic brain injury. Most of these patients do not present any symptom at the time of diagnosis thus delaying the detection. CEREBO®, a non-invasive, portable, rapid, point-of-care intracranial haemorrhage detector can avoid delayed detection by decreasing the time from injury to the initial CT scan. The study aims at assessing the summative usability of the device by determining its ease of use, ease of learning and satisfaction among the medical health professionals. The participants will be trained before the study and will be assessed periodically. Each participant will use the device on at least 10 subjects.

A prospective interventional study designed to assess the summative usability and rapidity of CEREBO® - a portable device to detect intracranial haemorrhage. 10 participants from a Primary Health Centre will be enrolled in this study. The participants will be trained by the study staff before the study. The participant will fill in a questionnaire periodically. At the end of the study, the statistical analysis will be performed on the recorded data to establish the ease of use, ease of learning and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Operators

* Medical health professionals \>18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.
* MBBS
* Ayush
* Nurse
* Others

Subjects

* Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects

* Cognitively impaired subjects unable to understand the study procedure
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)

The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Age \> 55 years (biological age)
* Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL)
* Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia
* Only pre-phase chemotherapy prior to study start
* World Health Organization (WHO) status 0, 1 or 2
* Voluntary written informed consent

Exclusion Criteria:

* Creatinine levels more than 2 x the upper limit of normal (ULN)
* Total serum bilirubin more than 1.5 x the ULN
* AST (SGOT) or ALT (SGPT) more than 5 x the ULN
* Any other prior antineoplastic treatment except for pre-phase chemotherapy
* Active central nervous system (CNS) leukemia
* New York Heart Association (NYHA) grade 3/4 cardiac disease
* Active severe infection
* Serious concomitant medical condition
* Patients with a history of non-compliance to medical regimens
Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

A growing number of critically ill patients survive intensive care to be discharged from hospital. However, critical illness and prolonged bedrest are associated with muscle wasting with subsequent implications for recovery of normal physical function. Thus, one year after discharge, survivors of septic shock have reported prolonged and severe impairment of physical function.

Early interventions employed in the ICU to counteract loss of muscle mass may potentially improve physical outcome and reduce the overall burden of critical illness. As a potential supplement to physical therapy, transcutaneous electric muscle stimulation (TEMS) is a non-invasive method directed at maintaining skeletal muscle function through artificially induced contractions that are independent of patient efforts. TEMS has previously proven effective at preventing loss of muscle mass and force in a number of non-ICU patient groups, but has only been assessed sparsely in an ICU population where both immobilisation and systemic inflammation are present.

Therefore, the aim of the present study was to assess the effect of early TEMS on muscle volume in patients admitted to the intensive care unit with septic shock. The investigators hypothesized that this intervention would preserve muscle volume during septic shock.

To ensures baseline comparability, eliminates many of the inter-individual confounding factors often present in ICU patients and enhances statistical strength we designed a study where we included a well-defined group of patients with septic shock in a single-legged exercise design, using the contralateral leg as the (paired) control and used a two-channel stimulation approach with 3-D evaluation of muscle volume changes based on CT scans.

After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day. All patients undergoes CT scans of both thighs before and immediately after the 7-day treatment period. The quadriceps muscle is then manually delineated on the transverse CT slices, and muscle volumes are calculated after 3-D reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* patients with septic shock admitted to the ICU of Rigshospitalet
* written informed consent from patient or proxy

Exclusion Criteria:

* diabetes
* a focus of infection in or trauma to the lower extremities
* a predicted ICU stay of less than seven days
* severe respiratory or circulatory instability that precluded transportation of the patient to the CT scanner
* patients receiving hihg dose corticosteroids (equivalent to methylprednisolone 1mg/kg/day or more)
* pregnancy
* severe psychiatric disorder
* \> 72 hours since the diagnosis of septic shock was established
* \> 7 days immobilisation prior to time of inclusion
* patient receiving neuromuscular blocking agents
* pre-existing neuromuscular disease
* acute compression/affection of central or peripheral nerves relevant to the lower extremities
* BMI \> 30
Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome

This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome

HYPOTHESES

It will be hypothesized that:

1. There will be no statistically significant effect of Visceral Manipulation on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome
2. There will be no statistically significant effect of the Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome.
3. There will be no statistically significant difference in the effect of visceral manipulation versus the integrated neuromuscular inhibition technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome.

This study will be conducted to answer the following questions:

Is there an effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome?

Eligibility Criteria:
Inclusion Criteria:

* -active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks
* BMI between 25 and 30 Kg/m².

Exclusion Criteria:

* a previous fracture in the cervical spine or shoulder surgery
* acute inflammatory condition.
* Malignant tumor.
* Multiple osteophytes.
* Cervical posture abnormalities.
* Osteoporosis.
A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.


Eligibility Criteria:
Key inclusion criteria:

* Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology
* Eligible for R0 resection with curative intent at the time of screening
* Adequate pulmonary function to be eligible for surgical resection with curative intent
* Eligible to receive a platinum-based chemotherapy regimen
* Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Availability of a representative tumor specimen that is suitable for determination of PD-L1 status
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Normal life expectancy, excluding lung cancer mortality risk
* Adequate hematologic and end-organ function
* Negative human immunodeficiency virus (HIV) test at screening
* Negative serology for active hepatitis B virus (HBV) and active hepatitis C virus (HCV) at screening

Key Exclusion Criteria:

* NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified
* Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC
* Any prior therapy for lung cancer
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Active tuberculosis
* Significant cardiovascular disease
* NSCLC with an activating EGFR mutation or ALK fusion oncogene
* Known c-ros oncogene 1 (ROS1) rearrangement
* History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death
* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
* Prior treatment with CD127 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents
* Treatment with systemic immunosuppressive medication
* Pregnancy or breastfeeding
The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC) Pilot Feasibility Study

The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. Patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations.

The study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer.

The study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men with prostate cancer \> 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of ADT
* Patients must be able to read and understand English.

Exclusion Criteria: n/a
Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome

The purpose of this study is to determine whether radio-frequency (RF)-based plasma micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40). Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and 1-year.


Eligibility Criteria:
Inclusion Criteria:

1. a skeletally mature patient who agreed to participate in the study
2. shoulder impingement syndrome was diagnosed by one senior surgeon (CYJ) and without any sign of rotator cuff tear both on pre-operative MRI or intra-operative arthroscopic view
3. supraspinatous tendinosis was confirmed on preoperative MRI
4. the symptoms were not relieved by a standardized conservative treatment regime
5. patient underwent standard arthroscopic subacromial decompression surgery.

Exclusion Criteria:

1. any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding
2. concomitant biceps lesions or internal impingement
3. any history of surgical treatment on the same shoulder.
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with metformin for at least 2 months
* Has HbA1c 7.0% to 11.0%, inclusive, at screening
* Body mass index (BMI)25 kg/m\^2 to 45 kg/m\^2, inclusive
* List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:

  * Hormone replacement therapy (female subjects)
  * Oral contraceptives (female subjects)
  * Antihypertensive agents
  * Lipid-lowering agents
  * Thyroid replacement therapy

Exclusion Criteria

* Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
* Received any study medication or participated in any type of clinical trial within 30 days prior to screening
* Has donated blood within 60 days of screening visit or is planning to donate blood during the study
* Treated with any of the following medications:

  * Sulfonylurea or Thiazolidinedione within 3 months of screening;
  * Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
  * Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
  * Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
  * Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption;
Ranibizumab Treatment for Retinal Vein Occlusion

In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Male or female of aged 18 years or older
* Macula edema secondary to BRVO/CRVO
* Decrease of VA due to macular edema

Exclusion Criteria:

* Prior episode of RVO
* Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
* Ocular disorders in the study eye that may confound interpretation of study results
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
* The pregnant or lactating woman
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-12
* Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
* Current medication with either 20 mg or 40 mg immediate release methylphenidate

Exclusion Criteria:

* Concomitant psychiatric disorders requiring pharmacological treatment
* Concomitant severe somatic disorders
* Eating disorders
* Addiction disorders
* Very high or low body weight according to age
* Known hypersensitivity to methylphenidate
* Contraindications for methylphenidate

Other protocol-defined inclusion/exclusion criteria applied to the study.
Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus

Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.

Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.

Therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).

Eligibility Criteria:
Inclusion Criteria:

Study-Arm PAD:

* leg edema
* symptomatic PAD (Fontaine stage II)
* no palpable foot pulses
* ABI \<0.9 and \>0.6, absolute ankle pressure \> 60mmHg

Study-Arm Diabetes:

* leg edema
* Diabetes mellitus Typ 2 (history of longer than 2 years)
* palpable foot pulses
* Pallaesthesie \>6
* Wagner Score 0

Exclusion Criteria:

Study-Arm PAD:

* Critical limb ischemia
* ABI \< 0.6
* simoultaneous Diabetes Mellitus

Study-Arm Diabetes:

* Wagner Score \>0
* Pallasthesie \<6
Study of Tibial Shaft Fractures in Children

Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5).

The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study


Eligibility Criteria:
Inclusion Criteria:

* Patients between 4 and 14 years of age (open physis)
* Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury
* All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern

Exclusion Criteria:

* Fractures with greater than 2 cm of initial shortening
* Open fractures
* Patients that have other orthopaedic medical issues such as hemophilia
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation

The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.

The purpose of this pilot study is to identify the optimum combination of acupuncture points and treatment sequence in the treatment of post amputation limb pain in terms of the change in Phantom Limb Pain (PLP) and/or Residual Limb Pain (RLP) as measured by the Visual Analogue Scale (VAS) and the McGill Short Form Pain Questionnaire (SF-MPQ). Further, any side effects associated with the acupuncture treatment regimens, time requirements, and patient compliance with the treatment regimens will be estimated.

Study participants will be randomized to one of three acupuncture treatments: Chinese Scalp Acupuncture, French Auricular Acupuncture, or a combination of both.

Eligibility Criteria:
Inclusion Criteria:

* Amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease
* Amputees who have been cleared to begin prosthetic fitting
* Phantom and/or residual limb pain reported must be \>/= 3/10
* Active duty military or dependent eligible for military benefit \>/=18 years old

Exclusion Criteria:

* Congenital limb absence
* Pregnancy
* Any skin changes on the ear or scalp that would preclude placement of acupuncture needles
* Patients intubated and unable to give consent
* Patients with traumatic brain injury (TBI) diagnosed as greater than mild