cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of IntensiVE Dialysis

This study will assess clinical outcomes of extended weekly hours of haemodialysis (\>= 24 hours per week) compared with standard hours of haemodialysis (\<=18 hours/week) in people with ESKD.

A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.

In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.

The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.

Eligibility Criteria:
Inclusion Criteria:

1. Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
2. Aged 18 years or older
3. Undergoing dialysis for 18 hours per week or less
4. Suitable for either extended or standard dialysis in the view of the treating physician
5. Agreeable to randomisation

Exclusion Criteria:

1. Life expectancy of less than 6 months
2. Definite plans to undergo renal transplantation within 12 months of entry to the study
3. Inability to complete quality of life questionnaire
4. Concomitant major illness that would limit assessments and followup
5. High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
Mobile Application to Improve Nutritional Counseling Provided by Primary Care Physicians for Hypertension.

The purpose of this study is to investigate whether the use of a mobile app could improve knowledge and practice in nutrition counseling performed by primary care physicians in Brazil.

To optimize the nutritional care in the context of the limitations of available time and knowledge in medical practice, the present study proposes to develop a tool of nutritional guidelines for hypertension, easily accessible, based on evidence, and then evaluate its use among primary care physicians registered in a center telehealth. The use of the mobile application tool will aim to improve the nutritional counseling, helping with prevention of other chronic diseases in primary care context.

Eligibility Criteria:
Inclusion Criteria:

* primary care physicians registered in TelessaúdeRS (Center for Telehealth)
* primary care physicians who use smartphone or tablet

Exclusion Criteria:

* not to work in primary care
Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds (CMI)

Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms, mechanical blockages, and recurrent effusions. The treatment of these lesions has progressively evolved from meniscectomy (removal of the damaged meniscal tissue) to the use of meniscal sutures (where possible) to preserve as much meniscus as possible. Numerous studies have demonstrated a correlation between the amount of meniscus removed and the future onset of osteoarthritis.

However, in some cases, especially in the presence of complex and/or chronic lesions, meniscectomy remains the only viable surgical option. Over time, months or years later, a subgroup of patients may develop symptoms such as pain, joint swelling, and mechanical overload of the compartment that underwent meniscectomy, a condition known as post-meniscectomy syndrome..A portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement.

In an attempt to treat this condition, scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery. The goal is to reduce the incidence of long-term osteoarthritis and, consequently, the need for more invasive procedures. To date, no study has definitively demonstrated the real efficacy of these scaffolds (CMI), particularly regarding chondroprotection and the long-term onset of osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years at the time of surgery
* Both male and female patients
* Patients who underwent meniscectomy and/or CMI implantation from January 1, 1998 to December 31, 2010 at the Rizzoli Orthopedic Institute.

Exclusion Criteria:

* Patients who are no longer reachable;
* Patients who do not consent to be included in the study;
* Presence of infection or hematological, rheumatic, or hemostatic disorders at the time of evaluation.
Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer

The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.

Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10 are referred to as intermediate risk, with approximately an 80% chance of cure.

Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a high, localized radiation dose while sparing most the of the bladder and rectum. Brachytherapy is well established for other tumor sites, and has become a standard treatment for prostate cancer.

Establishing that a good quality implant alone is as effective as implant plus beam radiation will allow us to routinely drop the use of beam radiation, a change in policy that will decrease the risk of some complications, will be more convenient for patients, and will lower treatment costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previously untreated prostatic cancer.
* Must have PSA 10-20 ng/ml, Gleason 7 to 9

Exclusion Criteria:

* Patients with proven regional lymph node involvement will be excluded.
Tacrolimus Microsampling

This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age

   1. Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits
   2. Aim 2: outpatient
2. Currently taking tacrolimus

Exclusion Criteria:

1. Non-English-speaking patients
2. Unable to access overnight delivery services (Aim 2 only)
Tissue Biomarker for Pegvisomant Action

Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (\>1.3 X ULN), and inadequate GH suppression (\>0.4 ng/mL) following OGTT
* Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy
* Normal LFTs before treatment
* Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement

Exclusion Criteria:

* Treatment with a long-acting SRL within 12 weeks before enrollment
* Presence of a macroadenoma with visual field defects as a result of chiasmatic compression
* Clinically significant hepatic abnormalities and/or AST or ALT \>3 X ULN on screening
* Known hypersensitivity to any of the test materials or related compounds
* History of, or known current, problems with alcohol or drug abuse
* Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude
Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study

Pioglitazone decreases oxidative load, inflammatory end points and improves vascular reactivity in obese patients in a dose dependent manner and that this effect is independent of its glucose lowering effects.

This is a single center, open labeled study. A total of 24 obese patients will be recruited to participate in this study. The study will have three groups of 8 patients each. Subjects will be enrolled into each group by alternate recruitment. Subjects in group one will receive 15mg of pioglitazone; subjects in group two will receive 30 mg of pioglitazone; subjects in group three will receive placebo. All subjects will receive Pioglitazone or placebo for 6 weeks, followed by a 6-week observation period off Pioglitazone/placebo.

At baseline, and at week 1, week 2, week 4, week 6 and month 3 all patients will have blood drawn for TBARS, ortho and meta-tyrosine, 9-HODE and 13-HODE, NF, Ikb, TNF-a, ICAM-1, VCAM-1, PAI-1, AP-1, EGR-1, MMP-2, MMP-9, TIMP, CRP-1, E-Selectin, P-Selectin, Asymmetric dimethylarginine (ADMA), PAPP-A, SAA, MCP-1, IL-6, ROS generation, insulin levels, and CRP.

Post-ischemic dilation of the brachial artery will be used as an index of endothelium-mediated vasodilation. All subjects will have an oral glucose tolerance test (GTT) with 75gm of glucose at Day 0 and at Day 42. Vascular reactivity will be assessed at 0, 6, and at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* • Obese (BMI\>=30)

  * Age: 20 to 65 years of age inclusive
  * Without established clinical coronary artery disease (documented history or myocardial infarction, typical angina and an exercise ECG positive for ischemia or angiographic evidence of CAD)
  * Good health as evidence by History and Physical exam
  * Female subjects must be:

Postmenopausal for at least one year or Surgically incapable of childbearing (i.e. have had a hysterectomy or tubal ligation) or, if capable of childbearing a subject, must be practicing an acceptable method of contraception.

• Subject will be available for duration of the study and willing to comply with all study requirements.

Exclusion Criteria:

* • Diabetes Mellitus

  * Allergy or sensitivity to Pioglitazone
  * Current use of Insulin therapy.
  * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
  * Hepatic disease (transaminase \> 3 times normal)
  * Renal impairment (Creatinine clearance \< 50 mL/min)
  * History of drug or alcohol abuse
  * COPD
  * Participation in any other concurrent clinical trial
  * Any other life-threatening, non-cardiac disease
  * Use of an investigational agent or therapeutic regimen within 30 days of study
  * Pregnancy or nursing
Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci\&#174; Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.

Eligibility Criteria:
Inclusion Criteria:

* Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
* Written informed consent.

Pre-Operative Exclusion Criteria:

* Unexplained fever and/or untreated, active infection.
* Patient pregnancy.
* Previous head and neck surgery precluding robotic procedures.
* The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.

Intra-Operative Exclusion Criteria:

* It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:
* Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position.
* In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.
Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment

Exclusion Criteria:

* Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such
* Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis
Association of Force Distribution and Bone Resorption

To investigate the residual ridge resorption at anterior and posterior maxillary and posterior mandibular ridges among conventional complete dentures and implant overdenture wearers, and determine its association with the relative occlusal forces distribution, treatment groups and other patient variables.

A total of forty-six edentulous patients participated in this clinical study divided into two groups as following; complete denture group (CD) consists of 23 patients wearing conventional complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical bone area and the reference area in the maxillary and the mandibular ridges. The occlusal contacts percentage of force in maximum intercuspation anteriorly and posteriorly were recorded for both groups by using T-Scan III system.

Oral and written information in English or Malay language, regarding the study, was provided and written consent obtained before enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Patients wearing mandibular IODs opposing conventional maxillary CDs.
* Patients wearing conventional maxillary and mandibular CDs.
* Clearly visible anatomic landmarks of the panoramic radiography image.

Exclusion Criteria:

* Patients with a history of temporomandibular joint dysfunction.
Argentinian Prospective Registry of Patients With Lupus

In Latin America, information about patients with systemic lupus erythematosus (SLE) is limited. Multicenter studies are needed to obtain "real world data '' and to carry out longer follow-ups. The purpose of this project is to design a cohort of Argentinian patients with SLE to describe "our real setting" and to identify possible limitations in access to specialized consultations and treatments.

A longitudinal and multicenter cohort study of patients with systemic lupus erythematosus (SLE) is planned, with a follow-up of for 5 years. The data will be obtained from the clinical history of each patient. The responsible for data collection will always be a physician with experience in the management of patients with SLE and who has received training for data loading.

The data will be collected through the an electronic case report form (eCRF) specially designed for this record and which in turn will facilitate the control of the data and the generation of inquiries to the researchers.

STUDY VARIABLES

Baseline visit:

Sociodemographic data Classification criteria American College of Rheumatology (ACR 1982/1997), Systemic Lupus International Collaborating Clinics (SLICC 2012) and/or European League Against Rheumatism / American College of Rheumatology (EULAR / ACR 2019) History of SLE Access to specialized care Current clinical manifestations Activity and damage Scores Current treatments Patient-Reported Outcomes (PROs): Self-reported quality of life questionnaires EQ-5R; physician global assessment (PGA) and the patient Comorbidities Vaccination Habits Obstetric history Associated antiphospholipid syndrome Hospitalizations for adverse event, infections, or lupus activity

Annual clinical follow-up visits Clinical follow-up of the patient Changes in clinical manifestations Changes in treatments Use of health services; hospitalizations; high cost treatments Activity and damage scores PROs Annual global and SLE-related mortality

STUDY ENDPOINTS

* Number of patients who achieved complete clinical remission or low disease activity status (LDAS)
* Impact on the quality of life and working life measured by PROs and PGA
* Mortality annual and global during the follow up period
* Change in disease activity and damage scores
* Health care resources used reported as number of hospitalizations, emergency visits and need of high cost treatment
* Accessibility to high cost treatment
* Survival of mains drugs reported as time between the first dose and the last dose
* Safety of mains drugs assessed as reason for their discontinuation

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Classified as SLE (according to the 1982/1997 American College of Rheumatology criteria and/or Systemic Lupus International Collaborating Clinics criteria for SLE)
* Less than 5 years from meeting SLE criteria
* Informed consent signature

Exclusion Criteria:

* Diagnosis of other systemic autoimmune diseases or overlap syndromes
* Patients who have been transferred to other centers
Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer

Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.

Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.

Eligibility Criteria:
Inclusion Criteria:

1. age: 18-75 years old
2. PS score: ECOG 0 \~ 2
3. histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum;
4. the time interval between this recurrence and the last chemotherapy was 6-12 months;
5. evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy;
6. expected survival over 3 months;
7. sign the informed consent.

Exclusion Criteria:

1. brain metastasis or the presence of symptoms caused by brain metastasis;
2. serious complications;
3. acute inflammatory reaction;
4. other tumors;
5. a history of allergy to paclitaxel or polyropyridone liposomes;