cyrilzakka/clinical-trials huggingface dataset:
EValuating the Safety of De-escaLated Head and Neck Irradiation in HPV PositivE Oropharynx Cancer in Non-smokers/minimal Smokers

A prospective, observational study evaluating the durability of local/regional control of previously published de-escalated radiotherapy protocols for patients with P16 positive oropharynx cancers who have minimal nicotine exposure who are not current uses (\< 10 pack year smoking history; \< 10 year history of any nicotine product \[electronic cigarette, chewing tobacco\]). Quality of Life measures will also be collected.

This is a prospective, single-site, observational study in head and neck cancer participants. The purpose of this study is to provide a systematic platform to analyze, interpret, and track radiation dose de-escalation therapy and associated participant outcomes from treatments identified by these results.

Participants will be asked to complete quality of life questionnaires at regular time points before, during, and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologic confirmation of tumor of the oropharynx
* Radiation therapy (de-escalated head and neck irradiation) decision has been made
* Human Papilloma Virus (HPV) associated cancer as determined by positive p16 immunohistochemistry

  * HPV positivity is defined by p16 IHC staining of \> 70% of tumor cells (strong and diffuse nuclear and cytoplasmic staining)
  * For cases that are indeterminate or if p16 testing cannot be accurately performed, HPV positivity can be confirmed by high-risk HPV DNA Testing which covers the following HPV subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
* \< 10 pack year smoking history OR \< 10 year nicotine use history
* No current tobacco/nicotine use (including electronic cigarettes and chewing tobacco)
* T1-T3, N0-N2 (AJCC8) requiring definitive therapy greater than surgery alone
* Ability to provide informed written consent
* Willingness to return to Sanford Cancer Center for follow-up
* Life expectancy \> 12 weeks
* ECOG performance status \< 3 (Appendix B)
* Adequate organ function for chemotherapy and radiotherapy

Exclusion Criteria:

* Any of the following because the inclusion criteria require delivery of radiotherapy and chemotherapy which is known to be genotoxic, and is associated with mutagenic and teratogenic effects: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
* Prior head and neck radiotherapy
* Any factor precluding safe delivery of chemotherapy
Long Term Effect of General Practitioner Education on Antibiotic Prescribing

Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. The aim of this trial was to assess the long-term effect of a continuous education program on general practitioners antibiotic prescribing behaviour. 170 physicians were included in this study. Physicians randomized in the education group attended a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory tract infections. The intervention was limited at physicians level and did not target the patients.


Eligibility Criteria:
Inclusion Criteria:

* General practitioners practicing in three departments of the Parisian area in France
* General practitioners attending a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.

Exclusion Criteria:

* None
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Geographic atrophy in both eyes due to age-related macular degeneration
* Visual acuity between 20/40 to 20/320

Exclusion Criteria:

* Known allergy to brimonidine
* Uncontrolled systemic disease or infection of the eye
* Recent eye surgery or injections in the eye
* Female patients who are pregnant, nursing or planning a pregnancy
OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

* Spasticity in the non-study upper limb that requires treatment
* Presence of fixed contractures in of the study muscles in elbow or shoulder
* Profound atrophy of muscles to be injected
* Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
* Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
* Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
* Condition other than stroke contributing to upper limb spasticity
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis
An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)

This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
* Previously treated with an erythropoietin stimulating agent (ESA)
* Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
* Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL

Exclusion Criteria:

* Current participation in a clinical trial on renal anemia
Human Muscle Gene Expression Profiles in Young and Old Men

To reach the goals of living longer in better medical conditions, many countries reach the same conclusion: new strategies have to be developed to avoid, or at least limit, the effects of age; this requires a better knowledge of the mechanisms of aging. Our project focuses on the loss of muscle mass associated with aging, called sarcopenia. Sarcopenia unavoidably leads to impaired mobility and poor balance, which contributes to loss of functional autonomy and to increased prevalence for severe falls. Skeletal muscle also plays a central role as a reserve for energy and amino acids. Hence, sarcopenia further triggers severe side metabolic effects such as frailty among elderly persons. The precise mechanisms of muscle aging are still mostly unknown, although many theories have been proposed.

The present study aims at better understanding the mechanisms of skeletal muscle loss associated with aging. Using muscle biopsies from young and old subjects, the differential expression profiles of mRNA will be obtained through chips that will evaluate more than 39000 transcripts. On the same samples, proteomic analyses will involve two complementary approaches: (1) bidimensional electrophoresis (2DGE) coupled to mass spectrometry (MALDI-ToF) for dominant proteins; (2) Western-blot (more than 800 antibodies) targeting regulating proteins not detectable using 2DGE. Complementary histological studies (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major biomarkers in the muscle biopsies.

The results of that research will have applications in the medium term and will lead to nutritional interventions to modulate specific metabolic pathways and improve the quality of life in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated or beneficiary of a social security category
* Having signed the inform consent form
* Having signed the genetic consent form

Exclusion Criteria:

* Antiaggregant platelet treatment
* Type 2 diabetes
* Body Mass Index \> 25
* Severe renal disease
* CRP \> 10
* Abnormal clotting test
* Allergies to local anesthetics
Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis

Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in France, mainly in middle-age patients with increased serum ferritin levels associated with normal serum transferrin saturation, and normal serum iron concentration in the absence of other known cause of increased serum ferritin levels.

Treatment includes a combination of dietary measures and physical activity to correct metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high.

This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and diet advices versus lifestyle and diet advices alone on blood glucose level and insulin sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the reduction of risk of diabetes and cardiovascular associated complications.

Non applicable

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Signed written informed consent
* Ferritin ≥ 450 µg/L and ≤ 1500 µg/L
* Hepatic iron overload proved by MRI or histological biochemical measurement (Iron hepatic concentration ≥ 50 μmol/g)
* At least one of the following criteria :

  * Body mass index \> 25 kg/m²
  * Systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg or antihypertensive treatment
  * Abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
  * Fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
  * Fasting HDL cholesterol \< 1.03 mmol/L for men and \< 1.29 mmol/L for women or HDL cholesterol-elevating treatment
  * Fasting blood glycemia ≥ 5.6 mmol/L

Exclusion Criteria:

* Subjects deprived of their liberty by judicial or administrative decision
* Pregnant women
* Other causes of increased serum ferritin levels:

  * Inflammatory syndrome (CRP \>10 mg/L) or inflammatory, immune or malignant diseases
  * Hyper-hemolysis
  * Alcohol consumption more than 210 g for men and 140 g for women per week within the year before inclusion
  * Haemochromatosis established by the C282Y homozygous genotype
  * Chronic hepatic cytolysis due to : viral infection (HBV, HCV), alcohol, hyperthyroid disease, celiac disease, drug or immune hepatitis
  * Increased serum ferritin levels - cataract syndrome (familial cataract or personal history of cataract before 50 years of age)
  * Low ceruloplasmin level
  * Porphyria (cutaneous signs)
* Contraindication of phlebotomy

  * Haemoglobin \<13 g/dL for men and \<12g/dL for women (threshold established by the French Blood Agency)
  * Congestive heart failure or coronary heart disease
  * Hepatic failure (TP\<60%), renal failure (GFR \<50mL/min) or respiratory insufficiency (chronic dyspnea)
  * Poor venous system
* Fasting blood glycemia \> 7 mmol/L or type 1 or type 2 diabetes, treated or not
* Use of drugs known to have anti-steatotic effects : metformin, thiazolidinedione
Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects

The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years of age.
* HCV seropositive.
* HCV RNA \>10,000 IU/mL at screening.
* HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
* Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents).
* Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
* Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP \>50 and \<100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.

Exclusion Criteria:

* Co-infection with either HIV or HBV.
* Evidence of severe or decompensated liver disease.
* Subjects with liver disease unrelated to HCV infection.
* Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Laboratory abnormality at Screening that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Abnormal ECG suggestive of clinically significant cardiac disease or QTc\>450msec.
* History of organ transplant.
* Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers.
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up.
* Pregnant or nursing females.
* Males whose female partner is pregnant.
Digital Follow-up Program for People with Chronic Obstructive Pulmonary Disease in Primary Healthcare

Chronic Obstructive Pulmonary Disease (COPD), characterized by non-reversible airflow obstruction, contributes to high mortality and morbidity rates worldwide, including Norway. Individuals with COPD experience symptoms and complications that impede daily activities and diminish their quality of life. COPD places a growing burden on healthcare systems presently and in the future. Interventions to empower individuals to self-manage their health effectively are needed to help the challenges of living with COPD, and work towards a sustainable healthcare system. As part of the broader healthcare policy agenda, this project aligns with the increasing emphasis on digital homebased primary healthcare. The intervention in this study will combine digital homebased care and guided self-determination follow-ups (GSD) within a general practice setting.

This project consists of 1) explore the feasibility of a COPD specific GSD counselling program delivered within a digital platform in primary care, 2) explore patients' and nurses' experiences applying the program, 3) examine the treatment fidelity of the intervention amongst healthcare professionals.

This project is a pilot cluster-randomized controlled trial (RCT), including individuals diagnosed with COPD, conducted in primary healthcare settings, and assessment of feasibility and uncertainties before conducting a later full-scale cluster-RCT. The intervention draws upon the Medical Research Council's revised guidelines for developing complex intervention studies, focusing on the initial phases of intervention development and pilot testing. Primary care clinics are randomly assigned into either an intervention- or a control group. The intervention consists of the GSD counselling program with follow-up within a digital platform. The control group provide regular care. The project will include both qualitative (individual semi-structured interviews), and quantitative data (questionnaires and clinical data).

In conclusion, this project explores an innovative intervention offering personalized strategies for COPD management in primary care clinic, by containing a digitalized homebased care program and follow-ups. The study aims to improve the daily living for people with COPD, while contributing to the future sustainability of healthcare systems.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD living at home
* Post-bronchodilator forced expiratory volume 1 s (FEV1) to forced vital capacity (FVC) below lower limit of normality

Exclusion Criteria:

* Severe somatic disease
* Severe psychiatric diagnosis
* Not able to provide informed consent
* Do not write, speak or understand Norwegian
Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties.This study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

Research Problem: Laprocopic sleeve gastrectomy is the most common surgical procedure performed for reducing weight in morbidly obese patients. Laparoscopic surgery is considered to be less invasive than open surgery. The treatment of pain in obese patients is a challenge. Administering opioids, can have an increasing effect of respiratory depression in patients already at risk of sleep apnea. The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties. The analgesic effect of gabapentin appears to be related to the surgical procedure undertaken, a more procedure-specific evaluation is needed for different types of surgeries..

Research Significance: This study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

Research Objectives: To evaluate the effect of preoperative administration of gabapentin on postoperative pain, postoperative morphine consumption and preoperative anxiety in patients coming for laparoscopic sleeve gastrectomy.

Research Methodology:

Inclusion criteria: ASA I and II, Age 18-50 years, either sex, Planned Surgical procedure laparoscopic sleeve garstectomy, BMI 30-45 . Exclusion criteria: Patients taking any sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, Methods Patients will be randomly assigned into two groups, Group-Control and , Group- Gabapentin of 25 each. Anesthesia and postoperative course will be standardized. VAS scale will be used for assessment of preoperative anxiety and postoperative pain. Post operatively pain assessment and morphine consumption will be performed for 24 hours in PACU and ward

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and 2
* BMI 35 - 45

Exclusion Criteria:

* Patients taking any sedative or tranquillizers
* Any contraindication to gabapentin.
Effects of a Dance and Walking Program for People With Parkinson's Disease

Parkinson's disease (PD), characterized as progressive and neurodegenerative, is one of the most frequent neurological diseases of the present time. Patients with PD present motor impairment, such as muscle stiffness, rest tremor, slow movements, postural instability, and gait and balance alterations; And non-motor factors, such as cognitive and neuropsychiatric disorders, depressive symptoms, and a consequent decrease in quality of life (QL). Dance can be an important tool for the complementary treatment of these patients, when added to traditional drug therapies and physiotherapies. Thus, the present study aims to verify the effects of a program of dance and walking in gait and QL of 38 adults with PD, divided in two groups, and to compare the aspects of functionality, dynamic stability, kinematics and QL. The data collection instruments will be a personal data sheet of the patients, the Hoehn and Yahr Scale (H\&Y), the Rehabilitation Index (RI), the motor part of the Unified PD Rating Scale (UPDRS III), the Timed Up ang Go test (TUG), the kinematic analysis of walking and the Parkinson's Disease Questionnaire (PDQ-39). Statistical Package for Social Sciences (SPSS) software version 20.0 will be used to analyze the data, using the Wilcoxon test for non-parametric data and the paired t-test for parametric data, in order to compare pre and post intervention data. The significance level adopted for both tests will be p \<0.05. It is expected that a program of 24 sessions of dance classes will be as or more effective than a program of 24 walking sessions for the gait quality and QL for the participants of the study.


Eligibility Criteria:
Inclusion Criteria:

* Both sex;
* Equal to or more than 50 years old;
* Parkinson Disease in regular medical treatment and follow-up;
* Illness diagnosis equal to or more than one year;
* H\&Y scale between one and three;
* Able to walk independently or with a walking stick.

Exclusion Criteria:

* More than six absences in dance class or in the walking training (25%);
* Start a new activity parallel to the project;
* Risk factors: Recent surgeries, Deep brain stimulation surgery (DBS), Other associated neurological diseases or other chronic diseases.