cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium

This study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses supported by six maxillary implants and opposed by distal extension removable partial denture.

thirty patients were selected for this study from a previous study who have already received previous implants in the maxillary arch. The patients were divided into two groups: Group1 received maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture, Group 2 received maxillary PEEK composite full arch fixed prosthesis and mandibular distal extension partial denture Patient satisfaction was evaluated using visual analogue scale (VAS) after one year months , Prosthetic complications were measured on the patient and implant levels after one year

Eligibility Criteria:
Inclusion Criteria:

Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space in order to have sufficient restoration space to construct FP3 prosthesis.

Exclusion Criteria:

Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day.

Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation

This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance).
* Referred for catheter ablation

Exclusion Criteria:

* Long term persistent AF (continuous episode lasting more than 1)
* Prior left atrium catheter or surgical atrial fibrillation ablation
* Patients with other arrhythmias requiring ablative therapy
* Left atrium (LA) ≥5.5 cm
* Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
* Awaiting cardiac surgery or PCI
* Myocardial infarction within three months prior to enrolment.
* Stroke or transient ischemic attack (TIA) within three months prior to enrolment
* Unstable angina
* Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
* Any condition contraindicating chronic anticoagulation
* Any untreated or uncontrolled hyperthyroidism or hypothyroidism
* Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) \< 15 ml / min)
* Patients with metallic prosthetic valves
* Pregnant or breastfeeding women
* Medical conditions limiting expected survival to \<1 year
* History of claustrophobia or panic attacks
* Left ventricular ejection fraction (LVEF) less than 35%
Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain

The MGH Center for Translational Pain Research is seeking patients with chronic pain for a research study. The study is looking at the effect of opioid (narcotic) pain medicines on pain sensation, threshold and tolerance.

The study consists of one visit, in which an interview, physical exam, lab work (urine test) and sensory testing will be done. The testing (Quantitative Sensory Testing) is noninvasive (no needles) and involves heat and cold stimulation. Compensation and some parking reimbursement provided.

Eligibility Criteria:
a. Inclusion/exclusion criteria

Inclusion Criteria for the group with chronic pain on chronic treatment with opioids:

1. Subject has chronic pain and is on stable chronic opioid treatment (morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for chronic pain for at least one month. We consider stable treatment if no change in the type and amount of daily opioid treatment for one month. Only patients with minimal daily opioid dose of at least 30 mg morphine equianalgesic dose will be included.
2. Subject is age 18 to 65 years.

Inclusion Criteria for the group with chronic pain on chronic treatment with non-opioids (currently not recruiting):

1. Subject has pain and is on stable chronic non-opioid treatment for chronic pain for at least one month.
2. Subject is age 18 to 65 years.

Inclusion Criteria for the group of opioid-naive healthy volunteers without chronic pain (currently not recruiting):

1. Subject is opioid naive meaning he/she did not receive chronic opioid treatment in the past or present, and did not receive acute treatment with opioids in the last 1 month
2. Subject does not have pain
3. Subject is age 18 to 65 years.

Exclusion Criteria for all groups:

1. Subject has lost tactile sensation in the sites for QST testing (upper extremities)
2. Subject has scar tissue or acute injury in the skin areas for QST testing (upper extremities)
3. Subject has neurological disease or a medical condition causing peripheral polyneuropathy and sensory changes (including but not limited to diabetes, alcoholism, AIDS, thyroid disease, liver or kidney disorders). It is the presence of neuropathy, not the causative disease itself, that is the exclusion criteria.
4. Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months; peripheral neurolytic block within two-months; injection therapy for pain within four-weeks; sympathetic block within six months.
5. Subject has litigation pending relative to their chronic pain.
6. Subject has major psychiatric disorder (major depression disorder; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); any known history of these conditions will exclude participation.
7. Subject has used illicit drugs within past 6 months.
8. Subject is pregnant
Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).

A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques including transanal total mesorectal excision and laparoscopic intersphincteric resection.

Ideal surgery for rectal cancer should not only obtain adequate radial and circumferential margins, but also preserve normal sphincter function.In 1990, the results of a 'close shave' at anterior resection were reported, suggesting that a resection margin of 1 cm or less produced an oncological outcome similar to that of a resection margin greater than 1 cm.

Sphincter preservation presents several advantages; The lower risk of intraoperative rectal perforation and positive circumferential margin than APR, the lower risk of damaging the pelvic branches of the pelvic autonomic nerve and The preservation of the body image that may increase quality of life.

Recently, the clinical outcome of intersphincteric resection (ISR) as a laparoscopic approach (laparoscopic ISR) has been reported, but laparoscopic ISR for patients with bulky low rectal cancer remains challenging particularly for T3 tumors in patients with a narrow pelvis, because of the difficulty in understanding the accurate anatomy of the small pelvic cavity, in dissecting the TME or the tumor specific mesorectal excision (TSME) plane, and in transecting the lower rectum safely. Moreover, numerous studies have demonstrated that laparoscopic techniques have many advantages in colorectal surgery compared with open surgery.

Although Radical resection is the gold standard for the treatment of rectal cancer, TEM offers the advantage of combining a minimally invasive technique with evident benefits in terms of postoperative morbidity and recovery, long-term functional outcomes and subsequently improved quality of life. Transanal Endoscopic Microsurgery (TEM) developed at 1984 and eliminated most of local transanal excision limitations and triggered a significant improvement in the local excision procedures of rectal lesions. While TEM became the 'gold standard' for the treatment of large rectal adenomas and early rectal cancer, there are special concerns about the lack of adequate lymphadenectomy.

Preoperative chemoradiation therapy is widely used to treat locally advanced rectal cancer to increase resectability, and to enhance sphincter preservation, local control and possibly, survival rates. Surgery is performed six to eight weeks after radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient with low rectal cancer below 5 cm from the anal verge
* Fit (Medically and surgically) for laparoscopy.

Exclusion Criteria:

* Patient with massive abdominal adhesions
* Unfit for laparoscopy
* Unwilling to share in the study
A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe rheumatoid arthritis (RA) who have previously failed 1-5 DMARDS who currently have partial clinical response to treatment with methotrexate
* Using methotrexate as a single DMARD for at least 16 weeks, of which the last 4 weeks prior to baseline on a stable oral dose greater than or equal to (\>=) 10 milligrams per week (mg/week)
* \>=21 years of age
* Swollen Joint Count (SJC) and Tender Joint Count (TJC) \>= 8 (out of 66 and 68 joints respectively)
* At least 2 of the following parameters at Baseline: C- Reactive Protein \>= 15 mg/dL; Erythrocyte Sedimentation Rate \>= 30 millimeters per hour (mm/hr); Morning stiffness \>45 minutes
* Rheumatoid factor titer \>=20 International units per milliliter (IU/mL)
* Corticosteroid (less than or equal to \[=\<\] 12.5 milligrams per deciliter \[mg/d\] prednisone or equivalent) or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are permitted if stable for at least 4 weeks prior to baseline

Exclusion Criteria:

* American Rheumatism Association (ARA) Class IV RA disease
* Concurrent treatment with any DMARD (apart from randomized treatment) or anti-TNF-alpha therapy
* Active infection or history of recurrent significant infection
* Prior history of cancer including solid tumors and hematologic malignancies (except basal carcinoma of the skin that have been excised and cured)
* Evidence of serious uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
* Bone/joint surgery within 6 weeks prior to screening
* Rheumatic Autoimmune disease other than RA
* Active rheumatoid vasculitis
* Prior history of gout
* Chronic fatigue syndrome
Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

It is known that perioperative respiratory complications occur more often in obstructive sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are prospective RCTs in this area, the need for further and larger studies remains due to the heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the respiratory adverse events are uncertain. Therefore, in this prospective observational cohort study, it was aimed to determine the incidence of postoperative pulmonary complications and the predictor factors associated with patient, anesthesia and surgery in surgical patients with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years
2. ASA physical status I-III
3. Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)
4. Surgeries performed under general anesthesia
5. Endotracheal intubation facilitated by neuromuscular blockers

Exclusion Criteria:

1. ASA physical status IV or V
2. Planned admission to the ICU after surgery
3. Cardiac Surgery
4. Non-operating room anesthesia
5. Neuromuscular disease
6. Emergency or re-operational procedure
7. Laryngectomy
8. Pneumonectomy
9. Invasive airway access
10. Pregnancy
11. Outpatient surgery
The Peer Genetic Study

This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and speak English comfortably
* With or without a personal or family history of PCA
* Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate

Exclusion Criteria:

* Do not read or speak English comfortably
* Men who participated in a focus group will be excluded from participating in the intervention
Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study

The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of refractory graft-versus-host-disease (GVHD) of the gut. FMT might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who have a gastrointestinal acute GVHD received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. Therefore, the investigation of effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of refractory GVHD of the gut. FMT might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

Eligibility Criteria:
Inclusion Criteria:

* 3-18 years of age
* Allo-SCT patients with acute steroid-resistant GI-related GVHD grade III-IV. Steroid-resistant GI-related GVHD will be defined as lack of improvement (same stage) or worsening of GI symptoms after 7 days of steroid therapy (≥ 2 ml/kg of IV methylprednisolone)
* No definite contraindication for gastrointestinal endoscopy
* Signature of informed consent by the legal guardians of patients

Exclusion Criteria:

* Prior inclusion to an interventional study
* Previous Allo-SCT
* Known multi-drug resistance carriage prior to stool collection
* Severe colitis of any etiology or a history of inflammatory bowel disease (IBD)
* Uncontrolled infection (hemodynamic instability, ongoing high fever or bacteremia within 3 days after antibiotics administration)
* Active GI bleeding
* Absolute neutrophil count \< 500 cells/microL
* Absolute platelet count\< 10 x 109 /L
* Patients who cannot give informed consent
Evaluation of an "Opt-Out" Inpatient Smoking Cessation Service on Smoking Behavior Study #1

The modest goal of this study is to replicate the behavioral outcomes of the opt out MUSC-Tobacco Treatment Program in the following three patient groups: 1) psychiatric inpatients housed in the Institute of Psychiatry (IOP) in Charleston; 2) non-IOP patients seen in Charleston; and 3) patients seen in the other four MUSC affiliated hospitals combined (i.e., Chester, Florence, Lancaster, and Marion). The aims and the design/methods utilized for evaluation will be the same for each of the three patient groups.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years and older
* hospitalized cigarette smokers eligible for either enhanced or basic care
* discharged from the hospital back to their home

Exclusion Criteria:

* patients without a phone number
* those unable to communicate in the English language
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
* Body weight (at screening);

  * female ≥40.0 kg,\<70.0 kg
  * male ≥50.0 kg,\<80.0 kg
* BMI(at screening): ≥17.6,\<26.4

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 10 days before dose is administered or is scheduled to receive medication
* History of drug allergies
* Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic disease
* Concurrent or previous heart disease
* Concurrent or previous renal disease
Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison

The goal of this clinical trial is to compare visual quality after cataract surgery between two groups: bilateral monofocal intraocular lenses (IOL) and monofocal and contralateral extended depth-of-focus (EDOF) IOL implantation. The main question it aims to answer is:

• does the combination of both monofocal and EDOF IOLs presents an advantage over bilateral monofocal IOL implantation in the daily life of patients undergoing cataract surgery without the disadvantages of bilateral EDOF IOL implantation?

Participants will:

* be randomised in either bilateral monofocal group or monofocal and EDOF group
* undergo visual acuity testing with and without correction at all distances
* be asked to complete a quality of vision questionnaire
* undergo non-invasive examinations to measure residual astigmatism, contrast sensitivity, straylight, optical aberrations, reading spead.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 50 and 90 years with bilateral cataract without concomitant exclusion criteria

Exclusion Criteria:

* prior refractive surgery
* patients with corneal opacities, retinopathy, opticopathy, glaucoma, uveitis and amblyopia
* patients with corneal astigmatism greater than 3 diopters (D)
* patients with expected postoperative astigmatism higher than 0.50D
* prior ocular surgery in the last six months
* patients with prior unilateral cataract surgery
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Age 18 years and older

Exclusion Criteria:

* Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
* Previous uveitis
* Previous intraocular surgery
* Allergy or hypersensitivity to NSAIDs
* Complicated cataract surgery
Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis

Elevated levels of D-dimer, a marker of procoagulant state, have been identified as a marker of an increased risk of recurrent VTE. Statins have proven antithrombotic properties, as suggested by the reduction of several prothrombotic markers, including D-dimer, in patients at high risk of arterial thrombosis. Such antithrombotic properties could also be observed in patients at high risk of venous thrombosis. Aim of the study is to assess the effect of statins on D-dimer levels in patients with previous VTE after oral anticoagulant treatment withdrawal.

Patients with a single episode of idiopathic VTE (either DVT or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with LDL cholesterol levels of equal to or greater than 130 mg/dL will be randomized to either atorvastatin, 40 mg, 1 tablet daily and lipid lowering diet or lipid lowering diet for 3 months. On the day of oral anticoagulant treatment withdrawal (Day 0), enrolled patients will undergo measurement of plasma D-dimer. At 30 days ± 3 (Day 30), patients will undergo measurement of D-dimer, CK, LDH, ALAT e ASAT and clinical evaluation. At 90 days ± 7 (Day 90), patients will undergo measurement of D-dimer, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides ed clinical evaluation, CK, LDH, ALAT e ASAT. At 6 months ± 1 (Day 180), patients will undergo clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a single episode of idiopathic VTE (either DVT or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with LDL cholesterol levels of equal to or greater than 130 mg/dL.

Exclusion Criteria:

* Age below 18 years,
* Pregnancy or puerperium,
* Active malignancy,
* Need for other anticoagulant treatments (unfractionated heparin, low molecular weight heparin),
* Presence of transient risk factors for VTE \[recent (\< 3 months) surgery,
* Trauma,
* Fractures,
* Acute medical disease with immobilization,
* Pregnancy or use of oral contraceptives\],
* Contraindications to statin therapy,
* Chronic renal failure (defined by creatinine clearance \< 30 mL/min),
* Ongoing treatment with statins or fibrates,
* Major indication to statin therapy \[history of cardiovascular disease, diabetes, elevated cardiovascular risk according to the ATP III criteria(19)\],
* Life expectancy of less than 6 months,
* Geographic inaccessibility,
* Concomitant enrolment in another clinical trial,
* Refused informed consent.
Transplant Optimization Using Functional Imaging (TROFI)

The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using nmon-rigid image registration methods.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Written informed consent obtained
* Patient who had undergone a lung transplant a year ago or more
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study
* The patient must be able to perform the lung monitoring at home
* Patients diagnosed with BOS 0, BOS 0-p or BOS 1

Exclusion Criteria:

* Pregnant or lactating female
* Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation