cyrilzakka/clinical-trials huggingface dataset:
Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M CadCam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea (OSA) Therapy: ESTAMPS Study

ESTAMPS is a randomized clinical trial with a crossover design:

Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume

secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning

Hypothesis ORCADES results suggest that Narval O.R.M CC could be more efficient than Narval MRD trad to reduce AHI whatever the initial OSA severity 79% of CC MRD patients have at least an AHI reduction of 50% (vs. 61% with a trad Narval MRD, p=0.0031) 66% of CC MRD patients get a complete answer with an AHI reduction \<10 (vs. 49% with a trad Narval MRD, p=0.0017) The investigators think that differences seen in the ORCADES study between the 2 MRD is due to a different impact on upper airway volume

Eligibility Criteria:
Inclusion Criteria:

* Patients with a mild OSA syndrome (5\<AHI\<30) and mild to moderate sleepiness without cardiac comorbidities or patients with mild to severe OSA syndrome (IAH\>15) who do not tolerate or refuse CPAP therapy
* Patients ≥ 18 years old
* Patient is able to fully understand study information and provide written informed consent

Exclusion Criteria:

* MRD contraindication
* Clinical trial classic exclusion criteria
Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Upon determination of eligibility, patients will receive:

* Ifosfamide + Carboplatin + Etoposide + Rituximab

Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma
* Persistent lymphoma after one or two previous chemotherapy regimens
* Patients should not be considered candidates for high-dose chemotherapy
* Ability to perform activities of daily living with assistance
* Measurable or evaluable disease
* Age \> 18 years
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Patients with impaired bone marrow reserve
* Female patients who are pregnant or lactating
* Serious active infection at the time of treatment
* Any other serious underlying condition
* Brain or meningeal) with lymphoma
* HIV or AIDS-related lymphoma
* Received external beam radiation therapy to \> 25% of active bone marrow.
* History of other cancers, either active or treated

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort

Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head.

Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist.

The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route.

To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia.

This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route.

For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients with an indication for retinal surgery
* Not having opposed to participate in the study

Exclusion Criteria:

* Claustrophobia
* Unbalanced psychiatric pathology
* Inability to lie down
* Deprived of liberty or under guardianship.
Identification of Novel Markers of Human Lung Disease

The purpose of this study is to investigate new therapies for advanced lung disease.

This research study is being conducted to learn about the progression and cause of lung disease. By agreeing to be a part of this study, you will allow the lung tissue which would normally have been discarded after your procedure, to be used for research purposes to allow us to understand more about your condition which may potentially lead to novel treatments and therapeutics. For this study, the investigators will isolate specific cells from the lung tissue and measure cellular, molecular and genetic mechanisms responsible for regulating lung disease. No other type of research will be performed on these samples nor will the samples be given to other investigators for unrelated research.

Eligibility Criteria:
Inclusion Criteria:

* any one on lung transplant list

Exclusion Criteria:

* HIV positive
An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity

The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter \& Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips (Procter \& Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter \& Gamble™) effectiveness when the product is placed by a dental professional compared to self-placement by the person with sensitive teeth. This product is not experimental.

There are two groups in this research study: 1) The Self Applied group, and 2) the Professionally Applied group.

Once it is determined that interested individuals qualify to participate in the study and have determined that they want to participate, the group that participants are in will be determined. The study has been designed to ensure that 66% of the study participants receives strips that contain the active ingredient and 33% of the subjects receive strips without the active ingredient. This means that there is a 1 out of 3 chance that participants will be assigned to receive the strip(s) without the active desensitizing ingredient. At the end of your 8-week participation, if it turns out that participants received the strips without the active ingredient, they will be offered a sample pack with two strips that contain the active desensitizing ingredient for them to use at home.

Eligibility Criteria:
Inclusion Criteria:

* Patient presents in good general health with no allergies to commercial dental products and are currently not using any desensitizing agents.
* If participants are using desensitizing agent the participant must agree to not use any desensitizing agents in the 4 weeks leading up to the baseline data collection appointment and during the following 8 week length of the study.
* Patients with a history of having used Sensi-Stop Strips (Procter \& Gamble™) in the past will not be eligible to participate because it will not be possible to maintain blindness to the treatment that they receive.
* Patients will also have at least the following baseline measurements:

  i. Schiff Air Scale = equal to or greater than 1

ii. Verbal Rating Scale = equal to or greater than 1

iii. Recession= 1mm or greater

Exclusion Criteria:

* Any dental pathology resulting in pain that could confound the study findings would render the patient ineligible: e.g. advanced dental decay, pulpitis, fractured teeth, fractured restorations, chipped teeth, cracked teeth, severe gingival inflammation, post-restorative sensitivity, marginal leakage, severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession.
* Also, if potential study subjects are not willing to agree to avoid the use of desensitizing and/or whitening products they will not be enrolled.
* Adults lacking in the ability to give consent will also be excluded.
The Utility of Cell-free DNA Methylation Markers for Hepatocellular Carcinoma

The subjects of this study were patients with liver cancer diagnosed by physicians according to AASLD clinical criteria or pathological biopsy.

Those who plan to receive systemic drug treatment for liver cancer in National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yervoy. Weak and uncooperative patients were excluded from blood tests, which were performed with full informed consent for relevant tumor markers (AFP ,PIVKA-II and methylation analysis). The data are then counted and compared.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with liver cancer by AASLD clinical criteria or pathological slides Patients planning to receive systemic drug therapy for liver cancer at National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yevoy.
2. Over 20 years old.
3. In the case of informed consent, willing to sign the consent form of the subjects.

Exclusion Criteria:

1. Patients who are weak and unable to cooperate with blood test.
2. Kidney dysfunction, serum creatinine greater than 1.5 x UNL (normal value) and no hemodialysis treatment, who are judged to be unwell for computed tomography or MRI contrast agent injection.
Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy

The goal of this observational study is to examine whether intrahepatic blood flow occlusion strategies during partial hepatectomy are associated with postoperative cardiac injury in patients undergoing hepatectomy. The primary questions it seeks to address are:

1. Are the intrahepatic blood flow occlusion method, the number of occlusions, and the cumulative occlusion time associated with postoperative cardiac injury?
2. How do intrahepatic blood flow occlusion, intraoperative hypotension, and postoperative cardiac injury interact? Participants will contribute their inpatient medical records, including information on medical history, surgical procedures, and anesthesia details.

Liver resection is currently the primary surgical treatment for liver tumors, injuries, and other diseases. With the continuous development of surgical techniques, its application has been expanding. However, intraoperative bleeding and poor surgical field exposure remain major challenges in liver resection, seriously affecting the safety and efficacy of the operation.

Hepatic inflow occlusion is a commonly used technique to address these challenges. It can effectively reduce intraoperative bleeding and improve surgical field exposure. However, it can also lead to hepatic ischemia-reperfusion injury, which may aggravate the damage to the remnant liver and even affect liver regeneration.

Recent studies suggest that hepatic ischemia-reperfusion injury may affect distant organs such as the kidneys, brain, lungs, and heart. However, there is still insufficient clinical evidence, especially regarding myocardial injury. In addition, intraoperative hypotension is a common complication of liver resection and may exacerbate the impact of ischemia-reperfusion injury on the myocardium.

This study intends to construct a model incorporating variables related to intraoperative hepatic ischemia and reperfusion, and analyze the relationship between hepatic inflow occlusion and postoperative myocardial injury in liver resection using logistic regression, while considering the mediating effect of hypotension. The results of this study will provide important clinical evidence for optimizing liver resection strategies, reducing myocardial injury, and improving patient prognosis. This research holds significant scientific and clinical value, and is expected to improve the quality of liver surgery and patient survival rates.

Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients aged ≥18 years who underwent partial hepatectomy between November 28, 2004, and May 20, 2024.

Exclusion Criteria:

1. End-stage renal disease patients (requiring renal replacement therapy)
2. ASA score ≥ 4
3. Lack of intraoperative hepatic portal occlusion data
4. Insufficient perioperative myocardial injury biomarker measurement data
ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee

ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of cartilage defects in the knee.

Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are planned to include in this study.

Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the ChondroGide membrane.

The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture and cover of the defect using the same ChondroGide membrane.

In both groups stitches and fibrin glue will be used to fix the membrane.

Inclusion criteria:

Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size more than 2 square cm.

Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint disease, Serious illness

Preoperative examination and follow up: Clinical examination and registration of KOOS (a validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of the involved knee including weightbearing standing radiographs of both knees. Kellgren- Lawrence classification will be used for grading of OA.

Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients having a new cartilage resurfacing operation or prosthesis will be listed as failures of the initial treatment.

Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell cultivation and two surgeries).

Data will be analyzed using the SPSS statistical package.

Please see referenced articles (1-3) for details regarding ACI and AMIC

Eligibility Criteria:
Inclusion Criteria:

* age between 18-60 yrs
* informed consent signed by patient
* symptomatic cartilage defect in the knee \> 2 square cm

Exclusion Criteria:

* alcohol or drug abuse during the last three yrs
* inflammatory joint disease
* serious illness
Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation

Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.


Eligibility Criteria:
Inclusion Criteria:

- All patients screened are accepted for PVI according to the current guidelines - Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines

Exclusion Criteria:

* Persistent, long-standing persistent or permanent AF
* Left atrial diameter \> 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)
* Previous PVI ablation (epicardial or endocardial).
Chemoradiotherapy of NSCLC Stage IIIB

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (\>= 9MV)

Eligibility Criteria:
Inclusion Criteria:

* NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
* PS = 0 or 1
* Possibility of including all the targets in only one exposure field
* Slimming \< 10% of the weight of the body
* Functions hepatic, renal and hematologic normal
* VEMS \>40% and PaO2 \>60 mmHg
* written and signed informed consent

Exclusion criteria :

- NSCLC stage IV or wet-IIIB
Switching to E-cigarettes in African-American Smokers

The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in African American (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking.

African American (AA) cigarette smokers (n=500) who are interested in switching to a nicotine salt-based electronic cigarette (EC) and are not established EC users will receive a 6-week supply of the EC and assistance with switching. After six weeks, those that are dual users (n=221) will receive an additional 12 weeks of the EC and be randomized in a 2:1 fashion to receive 12 weeks of varenicline (VAR) or placebo (PBO) and additional counseling to support a complete switch. Follow-up for all participants will continue through week 52. The primary outcome is change in the potent lung carcinogen, NNAL, between exclusive EC, dual cig-EC, and exclusive cig users at week 6.

Eligibility Criteria:
Inclusion Criteria:

* African American
* ≥ 21 years of age
* Smoke \>5 cigarettes per day
* Smoked cigarettes for \> 6 months
* Verified smoker (CO \> 5 ppm)
* Functioning telephone
* Interested in switching to EC
* Willing to take varenicline and complete all study visits

Exclusion Criteria:

* Interested in quitting smoking
* Use of smoking cessation pharmacotherapy in the month prior to enrollment
* Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)
* EC use on \> 4 of the past 30 days
* Uncontrolled hypertension: BP \> 180 (systolic) or \> 105 (diastolic)
* Heart-related event in the past 30 days
* Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City metro area during the treatment and follow-up phase
* Another household member enrolled in the study
Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization.

Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.

The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Written informed consent
* Patients that speak and understand Danish
* Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting

Exclusion Criteria:

* Alcohol or drug abuse
* Cognitive dysfunction
* Known orthostatic hypotension
* Use of anxiolytic drugs
Study to Create Potential Cell-Based Therapies to Treat Human Disease and Disability

This is a research study in which your cells will be used for somatic cell nuclear transfer (SCNT), and/or genetic reprogramming research which may result in the production of stem cell lines. This study does not provide treatment.

It is thought that studies of genetic reprogramming and SCNT using human cells have the potential to give us new basic knowledge about human development. Current work will focus on developing this basic knowledge. In the future, human embryonic stem cell lines (hESC) derived from genetic reprogramming and SCNT may also have the potential to develop into cell types that are useful for cell-based therapies to treat human disease and disability.

Eligibility Criteria:
Inclusion Criteria:1. Donors with a degenerative disease phenotype or genetic disorders such as Type I Diabetes, heart disease, or infertility (azoospermia and premature ovarian failure)

Exclusion Criteria:1. Unable to read or understand English. 2. Unable to provide skin biopsy sample due to skin condition in the underarm area.