cyrilzakka/clinical-trials huggingface dataset:
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.

The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.

Eligibility Criteria:
Inclusion Criteria

* Wheelchair user
* Spinal Injury Levels of C4 down to L5
* Has no outstanding skin integrity issues that could be effected by the REX device
* Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:
* Upper leg length : 380 - 470 mm
* Lower leg length : 366 - 470 mm
* Heel position (Ankle to hind foot) : 40 - 92 mm
* Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm
* Has a skeletal hip width of 380 mm or less (limit imposed by REX)
* Is between 40 kg and 100 kg weight (limits imposed by REX)
* Has the manual dexterity to work a joystick
* Sufficient passive range of motion in the Hip, Knee and Ankle of at least
* Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction
* Knee 0 degrees extension 93 degrees flexion
* Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion
* Thigh lateral diameter of \< 135 mm (230 mm above the knee joint line)
* Calf lateral diameter of \< 100 mm (90 mm below the knee joint line)
* Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button
* No contraindications to standing or mobilising
* Patients must choose to participate, and must have signed the informed consent document

Exclusion Criteria:

* Patients who do not meet inclusion criteria or physician discretion.
* Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.
* Patients contraindicated to walk or stand
* Patients with spinal injury outside Inclusion criteria
* Withdrawal or refusal to sign informed consent
* Any other contraindication based on physician discretion
* Known allergy (skin contact) to materials used in Rex
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab together with simvastatin may kill more tumor cells.

PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in treating patients with advanced or metastatic colorectal cancer.

OBJECTIVES:

Primary

* To determine the percentage of patients with k-ras mutant, advanced or metastatic colorectal cancer who are free from progression and alive after 12.5 weeks following the first dose of cetuximab in combination with simvastatin.

Secondary

* To determine the correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy.
* To determine the predictive value of PTEN, PIK3CA, b-raf, and ERK and MEK status. (exploratory)
* To determine the predictive value of SNPs, proteomics, and circulating DNA. (exploratory)
* To evaluate cholesterol, proteomics, and circulating DNA as biomarkers in this setting. (exploratory)

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV weekly and oral simvastatin once daily on days 1-7. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected for laboratory studies at baseline, during study, and after completion of study.

After completion of study therapy, patients are followed up for 30 days.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of advanced or metastatic colorectal cancer
* Progressive disease in the past 3 months
* Failed prior oxaliplatin-, fluorouracil (5-FU)-, and irinotecan-containing regimens AND have the presence of a k-ras mutation within codon 12, 13, or 61

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Adequate organ function
* No history of toxicity during statin use
* No other malignancy within the past 5 years
* No history of severe pulmonary disease
* No clinically relevant coronary artery disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior epidermal growth factor receptor (EGFR)-targeting agents
* No concurrent verapamil or amiodarone
Effects Of Antidepressants On Sexual Functioning In Adults

This study will evaluate the effects of two antidepression medications on sexual functioning.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
* Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
* Subject must have normal orgasmic function and be willing to discuss with investigator.

Exclusion Criteria:

* Subjects that have arousal or orgasm dysfunction.
* Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
* Subject has other unstable medical disorders.
* Subject has a positive urine test for illicit drug use at screening.
Automated Quantitative Ulcer Analysis Study

This is a multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis.

The primary objective of this study is to determine associations between participant features (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on slit lamp photography and supplemented by other imaging markers will be collected for review. A medical record review at one year following participants initial visit will record any corneal procedure and visual acuity testing that occurred during this window. Participants will complete demographic, clinical, and standardized health surveys.

Eligibility Criteria:
Inclusion Criteria:

* Cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥2mm stromal infiltrate
* Controls- Inflammatory, viral, Acanthamoeba, or other keratitis

Exclusion Criteria:

* Pregnancy
* Prior incisional corneal surgery
* No light perception vision
* Corneal perforation or impending perforation
* Inpatient status
* Institutional status
* Cognitively impaired
* Prisoner
Identifying Physical Activity Intensity Through Accelerometry in Heart Failure

The primary objective of this study is to identify and evaluate the range of values provided by accelerometers during a variety of typical daily lifestyle activities for heart failure patients, and to relate these to the measured intensity of performing each activity in the heart failure population.

The precise measurement of physical activity is now possible with advances in wearable technology, namely accelerometers. This is useful in order to properly evaluate interventions such as cardiac rehabilitation that aim to increase physical activity. One of the challenges with accelerometry is the need for raw data to be translated into meaningful behavioural units. This is addressed through a calibration study, where accelerometry data is related to oxygen consumption and cut points are derived where activity is considered light, moderate or vigorous intensity. However, calibration studies have only been done in young and healthy adults, not in the elderly or those with chronic disease such as heart failure where movements are slower and exercise capacity is reduced. This means there is a risk of underestimating the true level of physical activity in this population. Therefore the aim of this study is to run a calibration study with 18-30 heart failure patients.

Adults (aged 18 years and older) diagnosed with heart failure, with stable symptoms that are willing and able to give informed consent will be eligible for the study. Patients with contraindications to physical activity will be excluded from the study. Patients will be identified from the Royal Devon \& Exeter NHS Foundation Trust and the study will be conducted in the sports science laboratory at St Luke's Campus, University of Exeter. Each patient will be required to attend a single study visit that should last approximately 3 hours in total. During the visit patients will be required to complete a number of physical activity tasks (such as lying, sitting and walking) whilst wearing various accelerometers and gas analysis equipment.

Eligibility Criteria:
Inclusion Criteria:

* Patient willing and able to give written informed consent to participate in study
* Adult (aged ≥18 years)
* Patients with confirmed diagnosis of heart failure
* Stable symptoms of heart failure

Exclusion Criteria:

* Patients with contraindications to exercise testing or physical activity
* Patients who are in a long term care establishment or who are unwilling or unable to travel to research site
* Patients who are unable to understand the study information.
* Patients judged to be unable to participate in the study for any other reason (e.g. diagnosis of dementia, psychiatric disorder, life-threatening comorbidity).
Impact of Postoperative Transitional Pain on Recovery After Thoracic Surgery

Postoperative transitional pain corresponds to the pain occuring between acute postoperative pain and chronic postsurgical pain (defined as pain persisting for at least 3 months after surgery). We hypothesized that both trajectory and neuropathic component of transitional pain may influence the quality of recovery after thoracic surgery. To test this, we designed an observational study to identify risk factors for incomplete recovery assessed through the QoR-15 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* patients scheduled for thoracic surgery (thoracotomy or video-assisted thoracic surgery or surgery for thoracic outlet syndrome)
* patients who do not object to the study

Exclusion Criteria:

* patients non francophone
* emergency surgery or revision surgery
* patients already included in the study during the previous 6 months
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy

To assess CDK4/6i toxicity and effect on PFS in the Egyptian population


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients aged 18 years old or more
* Female patients
* Histologically proven invasive breast cancer
* Histologically proven HR-positive and HER2-negative breast cancer
* Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3.
* Adequate hematological and organs function
* Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment

Exclusion Criteria:

* - Male breast cancer patients
* Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
* Prior treatment with any CDK 4/6 inhibitor.
* History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
* Have active bacterial or fungal infection, or detectable viral infection.
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.


Eligibility Criteria:
Inclusion:

* 18 years or older
* Has type 2 diabetes, starting on basal insulin therapy
* Hemoglobin A1c between 9-14%
* Has Wi-Fi internet connection at home
* Is willing to monitor blood glucose at least once per day
* Is willing to inject and self-titrate insulin dose
* Able to read and communicate in English proficiently

Exclusion:

* Has severe visual impairment impacting visual acuity
* Has severe hearing impairment impacting communication
* Has Type 1 diabetes
* Pregnant or lactating women
* Alcohol dependency
* Require multiple daily insulin injections
Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care

The purpose of this study is to determine whether a computer-driven system (Smartcare/PS) decreases weaning duration from mechanical ventilation when compared to usual care in children.

Baseline data: All subjects included into this RCT will undergo routine examination upon admission to the hospital. These examinations include physical, medical/medication history (on the last year for medical history and the last 3 months for medication history (if available), vital signs, radiologic data and laboratory tests.

Intervention: A pre-inclusion test (pressure support test) with a level of pressure support of ± 5 cmH2O of the P plateau, but no greater than 30 cmH2O (pressure-support level plus positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this ventilation mode; the test is repeated daily until positive. The test could be stopped before 30 minutes if the patient showed evidence of respiratory distress (respiratory rate \> 40 breaths per minute and FiO2 \> 60% in order to obtain pulse oxymetry ≥ 95%). The test is considered positive when, after 30 minutes, the patient remained clinically stable with a respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than 6 ml per kilogram of body weight within the authorized pressure-support range, with pulse oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than 60 percent. When the pressure-support test is positive, the patient is randomized either to Arm 1 where the intervention is weaning with the support of Smartcare/PS or to Arm 2 where the intervention is weaning based on usual care. Both group are ventilated with the same ventilator: Evita XL.

Eligibility Criteria:
Inclusion Criteria:

* The attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously.
* No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (\< 5 µg/kg/min)
* Slight or no endotracheal tube gas-leakage (\[Vti - Vte\]/Vti ≤ 20%)
* Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP
* PEEP ≤ 8 cmH2O
* FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95%
* PaCO2 \< 70 mmHg on the last blood gases
* Extubation not expected the day of inclusion

Exclusion Criteria:

* N/A
Genetic Characteristics of Metastatic Breast Cancer Patients

Genomic analysis for metastatic breast cancer(MBC) patients

* Participant (Inclusion criteria)

  1. Patients who diagnosed metastatic/stage IV breast cancer
  2. Patients who were not received treatment for metastatic breast cancer on palliative setting
* Process

  (1) Tissue/ Blood sample
* At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
* At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional)

  (2) WES, RNASeq, ctDNA, Exosome
* We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.


Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed ad metastatic breast cancer
* Patients who were not received treatment on palliative setting

Exclusion Criteria:

* Patients who did not agree this study
* Patients who did not have any pathologic specimen at MBC diagnosis.
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)

This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.

Exclusion Criteria:

* Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.
* Any upper respiratory illness within last 2 weeks
* TSS will be measured at baseline as described above and must be \<9 for inclusion (Eccles etal).
* Topical decongestant use in last week
* Current nasal crusting or history of ulceration or perforation
* History of severe nose bleeding within last 3 months
* Known pregnancy
* Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy
* Allergic sensitivity to silicone or any other component of device
* Inability to read and understand English
* Inability to perform treatment due to underlying medical condition
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease.

Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing, and immunohistochemistry techniques. Differences between patient groups are statistically evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patient with diagnosed BPS/IC, OAB or healthy controls
* included healthy controls must have another pelvic surgery planned (e.g. hysterectomy)
* being able to act and judge

Exclusion Criteria:

* unstable endocrinological situation
* severe illness
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men

This study looks at how the new medicine called NNC0480-0389 works in the body of Chinese men when it is given at different doses together with a fixed dose of semaglutide. Participants will get one injection of NNC0480-0389 and one injection of semaglutide - which dose of NNC0480-0389 participants get is decided by chance.

NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities.

Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes.

NNC0480-0389 is being developed to be given together with semaglutide. NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood in people with type 2 diabetes.

Participants will get 2 injections of the study medicine (one of each). It will be injected with a needle into a skin fold on participants abdomen.

The study will last for a maximum of 72 days. Partcicipants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights). The study includes blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* Chinese male participants aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 20.0 kg/m\^2 and 27.9 kg/m\^2 (both inclusive).
* Body weight equal to or greather than 54.0 kg.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) geather han or equal to 6.5 % (48 mmol/mol) at screening.
* Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine), except routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Diode Laser Therapy As An Adjunct To Scaling And Root Planing

Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).

Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.

The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.

Eligibility Criteria:
Inclusion Criteria:

* 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
* Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm

Exclusion Criteria:

* Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
* Subjects on antibiotics or immunosuppressants.
* Chronic smokers, alcoholics, smokeless tobacco users.
* Subjects with acute illnesses/acute intraoral lesions.
* Pregnant women
* Subjects who had undergone extensive restorative dental treatment.