cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

Evidence regarding the performance of digital obturators totally fabricated using 3D printing is insufficient. This prospective randomized crossover study aimed to evaluate patient satisfaction with conventional maxillary obturator and totally full digitally fabricated obturator. Patient satisfaction was evaluated using two scales: The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.

The use of digital technologies in the fabrication of maxillofacial prostheses has been described. Additive manufacturing offers a more convenient and more efficient process with reduced material waste compared with traditional subtractive technique. Although Prosthetic rehabilitation with Conventional maxillary obturator prosthesis fabricated with a casted metal framework using, heat-cured acrylic resin can restore oral function and facial esthetics following maxillectomy. But it is time-consuming and labor-intensive. Multiple sources of errors can accumulate during the laboratory steps, resulting in a misfit of the framework. In this study All patients received a conventional obturator for 6 months, after a washout period of one week, they use the digital one. The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* patients with hemimaxillectomy defect (Aramany class 1)
* almost edentulous mandible with healthy remaining teeth,
* mouth opening is not less than 25 mm, intact soft palate
* participants were not exposed to radiotherapy or chemotherapy in the previous year

Exclusion Criteria:

* patients with physical or mental disorders.
* patients still receiving radio or chemotherapy
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.

A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with pulmonary fibrosis by high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using one of the following guidelines, as per American Thoracic Society (AGS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):

  * Major idiopathic interstitial pneumonias (IIPs) diagnosis or suspected as one of the following:

    * Idiopathic pulmonary fibrosis
    * Idiopathic nonspecific interstitial pneumonia
    * Respiratory bronchiolitis-interstitial lung disease
    * Desquamative interstitial pneumonia
    * Cryptogenic organizing pneumonia
    * Acute interstitial pneumonia
  * Rare IIPs diagnosis by one of the following:

    * Idiopathic lymphoid interstitial pneumonia
    * Idiopathic pleuroparenchymal fibroelastosis
  * Unclassifiable idiopathic interstitial pneumonias
  * Chronic hypersensitivity pneumonitis
  * Occupational lung disease
* Have been using oxygen therapy by nasal cannula for at least 4 weeks
* 6-Minute Walk Distance (6MWD) ≥ 100 meters and ≤ 450 meters at screening and Baseline/Randomization visits
* World Health Organization (WHO) Functional Class II-IV
* Forced Vital Capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period
* Age between 18 and 85 years (inclusive)

Exclusion Criteria:

* Pregnant or breastfeeding females at Screening
* In the last 6 months prior to screening, evidence of any connective tissue disease with FVC \> 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the local radiologist/Investigator
Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer

• To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece

* To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
* To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
* To record adverse events per line of therapy
* To recording of the causes of treatment discontinuation per line of therapy

Eligibility Criteria:
Inclusion Criteria:

* Women with histological confirmed ER/PR positive, HER2-negative MBC
* Age \>18 years old
* Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC
* Adequate hematologic, renal and hepatic function
* Signed informed consent (ICF)

Exclusion Criteria:

* Active malignancy other than MBC
* Active infection
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair

It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter

Exclusion Criteria:

* defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes
The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy.

Statins are widely prescribed for the patients with hypercholesterolemia.

Though their efficacy in preventing cardiovascular events has been shown by a large number of clinical trials, myotoxic side effects including myopathy or even more severe,rhabdomyolysis are associated with the use of statins.

Because the incidence of myopathy is various among individuals,polymorphism in genes is supposed to be the main factor.

Due to single nucleotide polymorphism in related genes,level of uptake, clearance and metabolism of statins can be seriously different among individuals resulting in various occurrence of myopathy.

Therefore, analytical study in association between SNP of statins-related genes and the incidence of myopathy is such a critical research which can be applied into clinical fields.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Rhabdomyolysis because of prescription with statins

Exclusion Criteria:

* Carnitine palmityl transferase ll deficiency
* McArdle disease
* Myoadenylate deaminase deficiency
Dual-Energy Computed Tomography for Improving Imaging Assessment of Multiple Myeloma

Up to 30% of patients with newly diagnosed/suspected myeloma cannot undergo or do not tolerate whole body MRI (WB-MRI). A number of factors may be contributory. First, WB-MRI protocols can take in excess of 1 hour. Patients must remain still within a narrow bore scanner with multiple MRI coils that can be claustrophobic. Second, there is significant acoustic noise that can be heard despite the use of ear protection. Third, 80% of patients will experience bone pain or fracture at some point during their illness, affecting their comfort within the scanner. Fourth, patients also have higher anxiety. One review reported up to 30% of patients experienced considerable apprehension and up to 10% severe psychological distress when undergoing MRI. Finally, myeloma is predominantly an illness of the elderly and co-morbid conditions decrease patients' ability to tolerate a long scan. When WB-MRI cannot be performed, NICE recommend whole-body computed tomography (WB-CT), which the investigators know offers decreased diagnostic performance in terms of marrow assessment and focal lesion detection. The investigators believe that using a novel CT technique - dual-energy CT (DECT) - may offer better diagnostic performance over standard WB-CT in myeloma patients.

What the investigators seek to do in this study is to evaluate the sensitivity and specificity of DECT in a cohort of untreated patients; and compare the performance of DECT to simulated standard CT (data simulated from the DECT) and also to WB-MRI (reference standard alongside bone marrow biopsy results. The investigators will assess both subjective visual analysis of DECT images as well as CT quantitative values for the bone marrow.

Secondary objectives include assessment of patient experience across both imaging tests and assessment of intra \& inter observer variability in subjective visual analysis


Eligibility Criteria:
Inclusion Criteria:

* Adults with suspected or newly diagnosed myeloma

Exclusion Criteria:

* No previous treatment for myeloma
* No concurrent cancer elsewhere
* No contraindications to CT or MRI scans
* Routine, standard of care cut-off for minimum renal function (eGFR \> 40 ml/min/1.73 m2) in order to receive IV gadolinium-based contrast media.
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Child-Pugh classification A at the time of registration
* Adequate bone marrow, liver, and renal functions within 14 days prior to registration

Exclusion Criteria:

* Prior therapy with a c-Met inhibitor (including ARQ 197)
* Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks
* Local treatment for malignancy within 4 weeks prior to registration
* Major surgical procedure within 4 weeks prior to registration
MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men

The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6 months post-randomization.

The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6 months post-randomization. Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Nurse case managers are trained RNs who support patients with T2DM by coordinating services, supporting self-care and implementing disease management strategies (Welch 2010). MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and skills training; 2) healthcare navigation and 3) basic needs navigation. The NCM will serve as an adjunct to the participant's primary care provider; they will not be embedded within a clinic but instead interact with the participant over the phone after study recruitment from a community setting.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* identify as Black or African American
* identify as male
* formerly incarcerated in a state or federal prison system or county jail
* clinical diagnosis of type 2 diabetes with HbA1c ≥8% at the screening visit
* able to communicate in English.

Exclusion Criteria:

* mental confusion on screening interview suggesting significant dementia
* current participation in other diabetes clinical trials
* active psychosis or acute mental disorder
* life expectancy \&lt;12 months
* awaiting arraignment, trial, sentencing in the criminal legal system
* on active surveillance by the criminal legal system, meaning on house arrest or subject to electronic monitoring
Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches

This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral THA
* Over 18 years of age and below 80
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the approved informed consent form

Exclusion Criteria:

* Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
* Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* Subject is currently incarcerated or has impending incarceration
* Previous hip surgery or infection on ipsilateral hip
Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension

Evaluate the effect of lifestyle modification through the adoption of a DASH diet, with and without physical activity guidance, on blood pressure and insulin sensitivity in elderly patients with type 2 diabetes and hypertension.

Data regarding the effects of physical activity and DASH-type diet on blood pressure control in patients with type 2 diabetes and hypertension are scarce in the literature, whether evaluating these isolated interventions or together. In addition, most studies do not measure BP using ABPM, which has a special importance in the assessment of pressure homeostasis in DM or are short-term studies. Were only two studies have been identified in the literature that evaluated the effect of the DASH diet on patients with type 2 DM; however, in both trials, being elderly was not an inclusion criterion. The first was an Iranian study that demonstrated in 31 non-hypertensive patients a significant reduction in BP after 8 weeks of following a DASH diet. In the second ECR, we demonstrated that in 20 hypertensive type 2 DM patients, all using antihypertensive drugs and with uncontrolled BP, a DASH-type diet for 4 weeks associated with physical activity reduced the systolic BP assessed by ABPM by 12.5 mmHg. However, the adopted design did not allow to separate the effect of diet from the effect of physical activity. On the other hand, the effect of a single session of walking followed by a 24-hour ABPM assessment showed a reduction in BP in hypertensive elderly and non-hypertensive patients, also without DM. So far it is not defined in patients with type 2 DM and hypertension, especially the elderly, whether the DASH diet alone is as beneficial for BP as its association with physical activity, particularly, considering the difficulties of performing exercises in this group of patients. This is valuable information, as it would reinforce the role of diet therapy intervention even if in isolation in this age group. Furthermore, the role of the DASH diet with or without physical activity remains unknown on insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or more
* Diabetes Mellitus
* Hypertension with poor control

Exclusion Criteria:

* Glucocorticoid use
* Unstable angina
* Acute myocardial infarction in the last 6 months
* Heart failure classes III and IV
* history of cirrhosis, alcoholism or use of illicit drugs
* Dementia and malignant disease that compromises survival in 5 years
* Serum creatinine greater than 2, 0mg / dl
* BMI\> 40 kg / m²
* Physical disability that prevents the use of a pedometer
* Participating in another research project involving any type of intervention.
Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.

Determine the best strategy for proteinuria lowering in patients with proteinuria \> 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.


Eligibility Criteria:
Inclusion Criteria:

* proteinuria \> 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
* proteinuria changes \< 50% on 3 separate dosages over 2 months.

Exclusion criteria:

* age \< 18 or \> 80 years systolic BP \< 110 or ≥ 140 mmHg, serum creatinine \> 250 mmole/L
* serum creatinine increase on ramipril + valsartan \> 20%
* intolerance to ACEI or ARB
Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to stimulate the immune system and stop cancer cells from growing. Biological therapy may be an effective treatment for metastatic melanoma and metastatic kidney cancer.

PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in treating patients who have metastatic melanoma or metastatic kidney cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of CD40-ligand when combined with fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer.

OUTLINE: This is a dose-escalation study of CD40-ligand. Patients receive fixed-dose flt3 ligand subcutaneously (SC) daily on days 1-14 and CD40-ligand SC daily on days 12-16. Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3 to 6 patients receive escalating doses of CD40-ligand until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2 (IL-2) standard therapy.

PROJECTED ACCRUAL: A total of 5 patients were accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer or melanoma Measurable disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT less than 2.5 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major active medical illness of the cardiovascular system (e.g., cardiac ischemia, myocardial infarction, or cardiac arrhythmia) Pulmonary: No major active medical illness of the respiratory system (e.g., obstructive or restrictive pulmonary disease) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No history of autoimmune disorders HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No prior systemic flt3 ligand or CD40-ligand Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent systemic steroids Radiotherapy: Prior localized radiotherapy for renal cell cancer or melanoma allowed Surgery: Prior surgery for renal cell cancer or melanoma allowed
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study

The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).


Eligibility Criteria:
Inclusion Criteria:

* Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
* Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
* Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
* Subject was 30 to 65 (inclusive) years of age at time of surgery.

Exclusion Criteria:

* Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
* Subject had a local or systemic infection.
* Subject had previously diagnosed osteoporosis.
* Subject had a femoral neck angle of \>145°.
* Subject had a femoral neck angle of \<125°.
* Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
* Subject had a documented allergy against elements of the implanted device.
* Subject had a neurological disease with changed motor function.
* Subject was pregnant.
* Subject had a Body Mass Index (BMI) \> 30.
* Subject suffered from alcoholism or addictive disorders.
* Subject needed a revision hip arthroplasty.
* Subject had an insufficient command of the language to understand patient information and consent.