cyrilzakka/clinical-trials huggingface dataset:
Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty

The overall aim of this single-centre, prospective randomised controlled trial is to compare clinical, functional, and radiological outcomes in CO THA versus Mako THA. Patients undergoing Mako THA will form the investigation group and those undergoing CO THA will form the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patient has hip osteoarthritis requiring primary THA

  * Patient and surgeon are in agreement that THA is the most appropriate treatment
  * Patient is fit for surgical intervention following review by surgeon and anaesthetist
  * Patient age: Patients 18-80 years of age inclusive
  * Gender: male and female
  * Patient must be capable of giving informed consent and agree to comply with the postoperative review program
  * Patient must be a permanent resident in an area accessible to the study site
  * Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Exclusion Criteria:

* Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA

  * Patient is not medically fit for surgical intervention
  * Patients under the age of 18 or over 80 years of age
  * Patient is immobile or has another neurological condition affecting musculoskeletal function
  * Patient is already enrolled on another concurrent clinical trial
  * Patient is unable or unwilling to sign the informed consent form specific to this study
  * Patient lacks capacity to give informed consent
  * Patient is unable to attend the follow-up programme
  * Patient is non-resident in local area or expected to leave the catchment area postoperatively
Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain

In this study the investigators aim to examine the effects of Transcranial Direct Current Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in individuals with chronic pain of the cornea -- and also compared with healthy controls.


Eligibility Criteria:
Inclusion Criteria (for all subjects):

1. Provide informed consent to participate in the study;
2. 18 to 65 years old;

Additional Inclusion Criteria for Subjects with Chronic Corneal Pain:

1. Corneal pain for six months or more;
2. Referral from a corneal specialist (Dr. Perry Rosenthal) with refractoriness to conventional ophthalmologic treatments for corneal pain such as local topical medications and soft bandage contact lenses;
3. Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;

Exclusion Criteria (for all subjects):

1. History of alcohol or substance abuse within the last 6 months as self-reported;
2. Diagnosis of any neurological diseases (such as epilepsy);
3. Episodes of seizures within the last 6 months;
4. Unexplained loss of consciousness
5. Use of carbamazepine or neuropsychotropic drugs
6. Contraindications to tDCS

   * Metal in the head
   * Implanted brain medical devices
7. Pregnant at time of enrollment
Preoperative Optimization of Cardiac Valve Patients' Expectations

Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. However, what content works best for which patient group and how long an intervention has to be is still largely unknown. The aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. Therefore, a brief intervention has been developed. Heart valve patients who undergo a heart surgery will be randomized into two groups (Control vs. intervention group) after baseline assessment. Following this the intervention group will participate in the psychological intervention (30-40 minutes). To increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. Furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. The control group will receive the standard medical procedure. Both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective cardiac valve procedure
* Age 18 or above
* Fluency in German
* Informed consent

Exclusion Criteria:

* Comorbid medical/psychiatric condition that causes more extensive disability than the coronary condition
* Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study
* Emergency surgery
Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection

The use of inhaled medications for the treatment of pulmonary diseases allows for the delivery of a high concentration of a drug at the site of disease with reduced systemic absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully used in the maintenance treatment of CF patients with chronic colonization with PA (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung functions, decrease the density of the PA in the sputum, decrease hospitalizations, and reduce the risk of mortality.

Non CF Bronchiectasis share many features in common with CF, including frequent colonization with PA that leads to deterioration in lung function and increased morbidity. A recent Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics in the treatment of bronchiectasis, however further randomized controlled trials with adequate power and standardized end points are required.

There have been reports in the literature describing the efficacy of inhaled tobramycin the treatment of patients with non CF bronchiectasis with eradication of PA, and significant improvement in respiratory symptoms. There were however patients who discontinued treatment due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest 2005).

TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry powder formulation has not yet been trialed in patients with non CF bronchiectasis.

The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in patients with non CF bronchiectasis, and to gather more data on the benefit of continuous antibiotic therapy in patients with non CF bronchectais.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with bronchiectasis confirmed by CT
2. Chronic PA colonization with 2 documented sputum cultures positive for PA in the last 24 months.
3. Age \>=18

Exclusion Criteria:

1. Patients diagnosed with CF
2. Patients who do not tolerate Tobramycin
3. Pregnant or breastfeeding
4. Patients treated in the last 8 weeks with antibiotic therapy either inhaled or systemic (excluding Azenil PO x 3/week which is allowed)
Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography

Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony.

Patient-ventilator asynchrony (PVA) is a common phenomenon with invasively- and non-invasively ventilated patients. PVA has deleterious effects on the lungs. It causes not just patient discomfort and distress but also leads to acute lung injury and worsening hypoxemia through biotrauma. The latter significantly impacts outcomes and increases the duration of mechanical ventilation and intensive care unit stay.

However, PVA is a widely investigated incident related to mechanical ventilation, though little is known about how it affects lung aeration estimated by electric impedance tomography (EIT). EIT is a non-invasive, real-time monitoring technique suitable for detecting changes in lung volumes during ventilation.

Artificial intelligence can promote the detection of PVA by flow versus time assessment. If continuous EIT recording is correlated with the latter, impedance tomography changes evoked by asynchrony can be estimated

Eligibility Criteria:
Inclusion Criteria:

* any patient ventilated invasively
* any patient ventilated non-invasively

Exclusion Criteria:

* age under 18
Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease

Little is known about the disease caused by the nontuberculous or environmental mycobacteria (NTM) and only limited data are available showing treatment outcome. This project will study the patients with nontuberculous mycobacterial (NTM) diseases in the University of Illinois Hospital \& Health Sciences System (UIMC). The aim of study is finding treatment outcome and risk factors that are associated with treatment failure in NTM patients. This is a retrospective, observational study for collecting data on patients with NTM in UIMC. The study initially involves populating the study of NTM patients seen at UIMC during the study period. This will add our knowledge about current treatment outcome of patients with NTM diseases and will be of interest to physicians, and public health authorities.

The study focuses on collecting all mycobacterial data, clinical assessment and clinical outcomes of patients. Data collection includes demographic characteristics, medical history, clinical procedures relative to the treatment of NTM, respiratory symptoms and signs, pulmonary function tests if applicable, imaging parameters, diagnostic tests, mycobacterial smear, culture, or possible susceptibility, therapies and outcome. The study will be updated with clinical outcomes (e.g., hospitalization, surgery relative NTM, and death) during study period. The data will be collected from 1/1/2001 to 12/30/ 2011.

The confirmed NTM patient will be defined with ATS guideline for NTM as:

Clinical: Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or an HRCT scan that shows multifocal bronchiectasis with multiple small nodules and 2. appropriate exclusion of other diagnoses.

Microbiologic: Positive culture results from at least two separate expectorated sputum samples. (If the results from the initial sputum samples are nondiagnostic, we will consider repeat sputum AFB smears and cultures.) Or positive culture results from at least one bronchial wash or lavage. Or transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or AFB) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washings that are culture positive for NTM.

OBJECTIVES

1. To determine prevalence of culture-confirmed NTM infection in the UIMC in a ten- year period
2. To determine the prevalence of NTM disease based on ATS case definition the UIMC in a ten- year period
3. To determine treatment outcome of NTM disease in the UIMC in a ten- year period
4. To find the risk factors associated with treatment failure of patients with NTM diseases

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 year or older with at least one culture-confirmed NTM.

Exclusion Criteria:

* All patients aged younger than 18 years old.
* No individuals are excluded from study based on, race, ethnicity, gender, or HIV status.
Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-DOTA-BPP in subjects with triple-negative breast cancer. The visual and semiquantitative methods will be used to assess the PET/CT images

ACE is expressed in triple-negative breast cancer cells. This project develops new type of 68GA-labeled DOTA-BPP, leveraging the inherent strengths of this nuclear medicine discipline, promoted the formulation of the production of this drug To obtain 68Ga-DOTA-BPP injection that can be used in preclinical studies and meets clinical standards. Join a group In clinical patients, 68Ga-DOTA-BPP PET/CT imaging of patients with ACE-positive TNBC was performed, and ACE was obtained To provide evidence for patient screening and efficacy evaluation before targeted therapy with high expression of TNBC, and preliminatively evaluate the level of ACE against high level of ACE. The effect of tumor development can provide a practical basis for the establishment of ACE-targeted PET imaging platform

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old;
2. ECOG score 0 or 1 point;
3. Participants with confirmed TNBC cancer who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Exclusion Criteria:

1. Pregnant or nursing;
2. Severe hepatic or renal dysfunction;
3. Low WBC (less than 3 x 10\^9/L);
4. Unable to comply with the PET/CT imaging procedures
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril

This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake.

This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy defined as absence of relevant disease
* Caucasian
* Aged 18-45 years
* BMI: 18-28 kg/m2
* Signed informed consent
* Blood pressure between 110/45 and \<140/90 (twice at screening)

Exclusion Criteria:

* History of renal artery stenosis

  * angioneurotic edema
  * psoriasis
  * relevant renal diseases
* RR at screening \< 110/45 mmHg.
* Diabetes, history of hypertension, RR \> 140/90 at screening, cardiovascular disease
* Known Diabetes mellitus of parents
* HIV or Hepatitis B/C positive virology
* Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain
* Contraindications against the use of the drug according to the SmPC, history of angioedema
* Any drug intake 3 weeks prior to first study day
* History of excessive bleeding tendency / hemophilia
* Presence of relevant illness within the last 3 weeks
* Suspected non-compliance with study instructions and life-style requirements
* Alcohol or drug abuse
* Blood/Plasma donation within 4 weeks prior to study day
* Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril
* Current smoking (any quantity), (at least 6 months of non-smoking required)
Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy.

MOTIVATE is a multi-methods feasibility randomized trial. We will recruit a minimum of 30 individuals with multiple myeloma who are undergoing chemotherapy prior to a Stem Cell Transplant. The study will be conducted in two phases:

Phase I: Feasibility Study The aim of this phase is to determine the feasibility and preliminary effectiveness of a 10-week exercise intervention compared to physical activity counseling alone.

Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating Active Living (HEAL-ME) app design, program delivery/design, and perceived effectiveness of the intervention at the level of the participant.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of Multiple Myeloma
2. Be transplant eligible
3. Be undergoing chemotherapy prior to an autologous stem cell transplant as part of their cancer treatment
4. Be an Alberta resident
5. Be ≥18 years of age
6. Be able to read and understand English.

Exclusion Criteria:

1. Their disease status/comorbidities preclude exercise testing or participation
2. They are unable to commit to the 10-week exercise program and/or testing sessions at the Cancer Rehabilitation Clinic at the University of Alberta
3. They do not have regular access to the internet and/or an electronic device in the home.
Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.

Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.

Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntary and signed informed consent form
* Age 18-70，both genders.
* Nasopharyngeal cancer was confirmed by pathology.
* Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
* Primary lesions can measurable.
* Karnofsky Performance Scale \>70.
* Life expectancy of more than 6 months.
* Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
* Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L
* Hepatic function:ALAT、ASAT\< 1.5 x ULN, TBIL\< 1.5 x ULN
* Renal function: Creatinine \< 1.5 x ULN

Exclusion Criteria:

* Evidence of distant metastasis
* Primary lesions or lymph node have been operated (except of operation for biopsy)
* Previous radiotherapy
* Received other anti EGFR monoclonal antibody treatment
* Previous chemotherapy or immunization therapy
* Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
* Participation in other interventional clinical trials within 1 month
* Peripheral neuropathy is more than I stage
* Pregnant or breast-feeding women and women who refused to take contraceptive method
* History of serious allergic or allergy
* History of Serious lung or heart disease
* Refused or can't signed informed consent form
* Drug abuse or alcohol addiction
* Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)

In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.


Eligibility Criteria:
Inclusion Criteria:

* unilateral groin hernia
* planned laparoscopic inguinal or femoral herniorrhaphy
* ASA I-III
* fluent Danish

Exclusion Criteria:

* converting to open operation
* low compliance
* daily use of morphine or similar drugs daily in the last month
* complications to the operation
Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.


Eligibility Criteria:
Inclusion Criteria:

* unilateral hemiplegic stroke patient
* Fugl Meyer Assessment score between 9 to 84

Exclusion Criteria:

* difficult to understand experimental tasks because of extremely severe cognitive impairment
* history of psychiatric disease
Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 10 years of age, and otherwise healthy
* Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
* In good health with no clinically significant disease that might have interfered with study evaluations
* Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

* History of hypersensitivity or allergy to ciclopirox
* Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
* Had a history of dermatophyte infecton unresponsive to antifungal treatment
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Was unwilling to sign the informed consent
* Female who was pregnant or lactating