cyrilzakka/clinical-trials huggingface dataset:
REDAPT Retrospective-Prospective Modular Stem Study

A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.

The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years.

The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium \> 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.

Eligibility Criteria:
Inclusion Criteria:

Retrospective Limited Data Collection/Enrollment Phase:

• Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval ofthe original version 1.0 protocol at the study site.

Retrospective Expanded Data Collection \& Prospective Follow-Up Phase:

* Subject completed limited retrospective data collection phase and willing to consent to expanded retrospective data collection and the prospective phase of the study;
* Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion Criteria:Retrospective Limited Data Collection/Enrollment Phase:

• Not applicable

Retrospective Expanded Data Collection \& Prospective Follow-Up Phase:

* Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse; or
* Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser

Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful

Numerous light based therapies are currently being used for the treatment of acne. Non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and improving acne scars. Specifically, the 1450 nm laser has been shown to be quite effective. However, it is associated with considerable pain at higher fluences despite topical anesthetics, especially when treating inflammatory acne. The goal of this study was to determine the possibility of using low fluence settings to treat moderate to severe acne at a more tolerable pain level without compromising treatment effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* acne lesion count of at least 10 inflammatory papules on each side of the face and a severity grade consistent with color photographs in the Allen \& Smith grading scale of greater than or equal to grade 3 and no worse than grade 5

Exclusion Criteria:

* Exclusion criteria included the use of oral retinoids or systemic corticosteroids within the past 6 months and the use of all prescription topical or systemic anti-acne medications 4 weeks prior to the initiation of the study
iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction

In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved outcome after direct revascularization of noninfarct lesions. It is undesirable to risk procedure-related complications by treating noninfarct lesions without impaired flow. It is currently unknown whether pressure guided revascularization of noninfarct lesions in the acute phase improves outcome compared to the current guidelines.

The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel lesions.

Study design:

The study is a prospective, randomized controlled, multicentre study.

Study population:

The research population will be recruited from the general patient population presenting with an acute STEMI. Patients treated with successful primary PCI and one or more additional significant coronary lesions in another coronary artery will be enrolled in the study. A total of 1,146 consecutive patients will be included.

Intervention:

The patients will be randomized 1:1, to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \>50% and iFR ≤0.89; (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.

Main study parameters/endpoints:

The primary end point consists of a combined outcome, including all-cause death, recurrent MI and hospitalization for heart failure at 3 years follow-up.

Duration:

Anticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3 years and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical presentation of STEMI and successful primary PCI within 12 hours from onset of symptoms.
* One or more other, noninfarct coronary artery lesions of \>50% stenosis and feasible to be revascularized (i.e. minimal diameter 2mm).

Exclusion Criteria:

* History of myocardial infarction.
* Hemodynamic instability, respiratory failure, Kilips class ≥III.
* Known GFR\<30 ml/min.
* Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants, severe renal failure, severe astma).
* Refusal or inability to provide informed consent.
* Life expectancy due to noncardiovascular co-morbidity of less than 12 months.
* Chronic total occlusion.
* Left main stem stenosis (\>50%).
* Residual noninfarct lesion in infarct coronary artery.
* Complex (e.g. bifurcation) noninfarct target lesions.
Dyspnea and Psychosocial Effects of Hand Fan Application in COPD Patients

This randomized controlled trial aims to evaluate the effects of hand fan application on dyspnea, illness perception, anxiety, and depression in COPD patients. A total of 56 voluntary COPD patients (28 experimental, 28 control) will be recruited from Ardahan State Hospital Chest Diseases Clinic.

Patients will be randomly assigned to the experimental or control group. The experimental group will receive a hand fan and use it for 10 minutes daily for six weeks, while the control group will receive standard care. Dyspnea, illness perception, anxiety, and depression will be assessed using the Visual Dyspnea Scale, Illness Perception Questionnaire, and Hospital Anxiety and Depression Scale at baseline and after six weeks.

Data will be analyzed using statistical software. This study is expected to contribute to the literature by evaluating a non-pharmacological intervention for COPD-related dyspnea and psychological outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Orientation and cooperation
* No communication problems

Exclusion Criteria:

* Having a COPD exacerbation in the last 4 weeks
Continuous Wound Infusion in Lumbar or Thoracic Surgery

Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.

Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".


Eligibility Criteria:
Inclusion Criteria:

* adults
* \> 18 years
* Physical status score I, II or III (American Society of Anesthesiologists)
* lumbar or thoracic spine surgery with arthrodesis through posterior only approach
* signed informed consent
* beneficiary of social security

Exclusion Criteria:

* vulnerable persons according to law
* scoliosis surgery
* local anesthetic allergia
* contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
* long term anti platelet aggregants
* inability to comply to protocol requirements
* psychiatric disorders or cognitive disabilities
* chronic pain or long term opioids consumption
* diabetes
* obesity (BMI \> 30)
* pregnancy or lactation
Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels

Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and have a clinical review in clinic.

Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision hip replacements being performed each year pre-covid(1). Often this is very complex with destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring appropriate positioning of the socket within the confines of the patient's anatomy.

The Lima Corporate Delta systems are designed to help surgeons with this very problem by providing the option of a 'face changer' allowing surgeons to place a socket within a socket.

To allow for this function, the 'face changer' must connect with the acetabular cup (socket).

140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 \& 2014, going into 2015. The aim of this study is to therefore identify the survivorship of these implants at 10 years.

Eligibility Criteria:
Inclusion Criteria:

All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.

Exclusion Criteria:

Deceased patients Patients who have undergone a subsequent acetabular revision Patients that lack capacity Prisoners in the custody of HM Prison service or who are offenders supervised by the probation service in England or Wales.
Gazyva Infusion Reaction Investigation

The study evaluate safety and effectiveness of chlorambucil and obinutuzumab in routine clinical practice in patients with chronic lymphatic leukemia and with certain comorbidities (any cardiac pathology, diabetes mellitus (DM), kidney pathology or cytopenia), whom obinutuzumab \& chlorambucil have been applied according to indications before enrollment in the study.

MRD (Minimal residual disease) evaluation was chosen as a primary measure outcome as it is considered as prognostic marker for long-term progression freee survival (PFS) and as a potential therapeutic goal in chronic lymphocytic leukemia/ CLL .

Minimal residual disease (MRD-negative) is assessed in the clinic by 8-color flow cytometry giving the sensitivity level of MRD detection 10-5; MRD is measured in real clinical practice at this clinical center according to National recommendations in diagnostics and treatment of lymphoproliferative disorders.

To achieve study objectives medical patients' charts will be analyzed retrospectively. In the frame of this program 104 patients' charts treated in defined clinical site, are planned to be analyzed. This number of patients corresponds to the patient flow with this pathology at a defined clinical site for 1 years.

Data collection is considered to be retrospective as data will be transferred to e-CRF from patient medical charts. During this study no further specific extra procedures for data gathering is expected.

But since patients included in the study will be at the center of ongoing therapy, the study was called a prospective.

Eligibility Criteria:
Inclusion Criteria:

1. CD20+/ (cluster of differentiation antigen 20 positive) B-CLL pts on the 1st line treatment therapy, whom have been already applied Obinutuzumab and chlorambucil
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group Scale (ECOG) 0-2.
4. Total Chronic Illness Resources Survey scale (CIRS) score \>6 or creatinine clearance \<70 ml/min or both for patients ≥ 18 years old or all CLL pts ≥ 75 years old
5. Any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb \<100 g/l, Platelets \< 100 x 109/l)
6. Life expectancy more than 6 months according to the physician's opinion.
7. Signed informed consent that allow personal data and data that refer to patient confidentiality processing

Exclusion Criteria:

The refusal of the patient to participate in the observational study and the withdrawal of informed consent that allow processing of personal data and data that refer to patient confidentiality.
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

Among the bifurcation type, bifurcation lesion without significant side branch stenosis (\<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size \>2.0 mm. DS\>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.

Eligibility Criteria:
Inclusion Criteria:

* Clinical

  * Patients with angina and documented ischemia or patients with documented silent ischemia
  * Patients who are eligible for intracoronary stenting
  * Age \>18 years, \<75 ages
* Angiographic

  * De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
  * Main vessel : \>= 2.5 mm in vessel size, \>= 50% in diameter stenosis and =\< 50 mm in lesion length by visual estimation, in which the lesion is covered with =\< 2 stents
  * Side branch :\>= 2.0 mm in vessel size and \< 50% diameter stenosis by visual estimation

Exclusion Criteria:

* History of bleeding diathesis or coagulopathy
* Pregnant
* Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus
* Limited life-expectancy (less than 1 year) due to combined serious disease
* ST-elevation acute myocardial infarction =\< 2 weeks
* Characteristics of lesion:

  * Left main disease
  * In-stent restenosis
  * Graft vessels
  * TIMI flow =\< grade 2 in the side branch
  * Chronic total occlusion
* Renal dysfunction, creatinine \>= 2.0mg/dL
* Contraindication to aspirin, clopidogrel or cilostazol
Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease

We propose to study the intestinal secretion of ASCA by evaluating them in biopsy culture supernatants from a cohort of patients suffering from CD (n=80) and a cohort of control patients (UC (n=40) and patients without IBD (n=40 )).

Its diagnosis is based upon clinical, endoscopic and histological parameters but recent studies have shown that seric evaluation of immunological markers (anti-Saccharomyces cerevisiae antibodies (ASCA), anti-neutrophil cytoplasmic auti-antibodies (ANCA)) could be useful. Crohn's disease (CD) is an inflammatory bowel disease (IBD) of the young people. Antibodies anti-chitobisoside carbohydrate (ACCA), anti-laminaribioside carbohydrate (ALCA) and anti-mannobioside carbohydrate (AMCA) have been described as new serological markers of CD.

Eligibility Criteria:
Inclusion Criteria:

* Patients reached by disease of crohn
* patients reached by hemorrhagic first side-colitis

Exclusion Criteria:

* Forms ileales or ano-périneales pure of disease of crohn
* indefinite colitis
Comparing the Effects of Different Types of Exercise on Glucose Handling

The purpose of the proposed study is to compare the acute effects of different types of exercise modalities on glucose handling in young, healthy males and females. The exercise modalities that will be compared include: a high intensity interval exercise (HIIE) protocol, a moderate intensity continuous exercise (MICE) protocol and a low-load, high-repetition (LL-HR) resistance exercise protocol.

The purpose of this study is to compare the effects of different exercise modalities (High intensity interval exercise, Moderate intensity continuous exercise, and Low-load-high repetition resistance exercise) on blood sugar control in young healthy, males and females. To test this theory, a sugar challenge (oral glucose tolerance test - OGTT) will be performed during the pre-testing visit to determine the baseline blood sugar response. An OGTT will also be performed 2 hours after each single exercise session to determine how each type of exercise affects the blood sugar response. Investigators will take multiple blood samples throughout the trial to allow us to measure blood sugar, insulin and concentrations and oxidative stress. Muscle biopsies will be taken before and after each exercise bout so that investigators can examine the underlying mechanisms that contribute to the effectiveness of the different types of exercise on blood sugar control. Investigators will also use an ultrasound to measure factors related to of cardiovascular health such as artery stress and vascular conductance during the exercise bouts. Direct benefits of this study include characterizing sex differences of blood sugar handling after single exercise sessions. This study could have direct benefits on deterring the effectiveness of different forms of exercise on blood sugar levels.

Eligibility Criteria:
Inclusion Criteria:

* In order to participate in this study, participants must be a healthy man or woman between the ages of 18 and 30 years.

Exclusion Criteria:

* Presence of chronic health condition(s) \[i.e. metabolic (i.e. Type 1 or type 2 diabetes), cardiovascular (i.e hypertension), respiratory (i.e. chronic pulmonary obstructive disorder) or digestive (i.e. ulcerative colitis) disorders.

  * Are pregnant, or suspect that they may be pregnant, or nursing
  * Inability to complete the single exercise sessions.
  * Regularly participate in cardiovascular (\>3 sessions/week) or resistance training (\>2 sessions/week) exercise.
  * Have an allergy to local anesthetic (or family history of allergy)
  * Have undergone a barium swallow or an infusion of a contrast agent in the past 3 weeks
  * Are taking prescription anti-coagulant or anti-platelet medications (e.g., warfarin, heparin, clopidogrel)
  * Inability to exercise as suggested by the get active questionnaire (GAQ)
  * BMI \> 27 kg/m2
BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain

This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living.

This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living. Patients will start a 30 minute treatment session with either BioWave therapy or TENS device followed by a 30 minute washout and ending with a final 30 minute treatment. Patients will then be instructed to perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up will be after 2 weeks and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow and the patients will crossover to receive the alternative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have signed consent before study entry
* Subject must have a body weight of 45 kg or more and a body mass index (BMI) of 40 kg/m2 or less.
* Subject must be aged 18-85 on the date of enrollment and subjects consecutively enrolled
* Subject must have a qualifying baseline pain score of≥5
* Subject must have a stable pain medication regimen for a period of at least 2 weeks prior to study enrollment. Both medication dosages and total number of medications must be stable prior to initiation.
* Subject's pain indication must be defined as chronic low back pain

Exclusion Criteria:

* Subject has a known history of allergic reaction or clinically significant intolerance to medical adhesives, glues, or textiles.
* Subject is currently receiving chronic opioid therapy defined as \>30 morphine equivalents units per day (daily use for \>2 weeks)
* Subject has an implanted spinal cord stimulator (SCS).
* Subject has any clinically significant clinical, physical, laboratory, or radiographic finding at Screening that, in the opinion of the investigator, contraindicates study participation.
* Subject is currently pregnant.
* Subject has history of or current medical, surgical, post surgical, or psychiatric condition that would confound interpretation of safety, tolerability, or efficacy, (eg, uncontrolled diabetes mellitus, uncontrolled hypertension, hemodynamic instability, or respiratory insufficiency, cancer or palliative care).
* Subject received an experimental drug or used an experimental medical device within 30 days prior to Screening or has previously participated in this trial.
* Subject is unable to comply with the requirements of the study