cyrilzakka/clinical-trials huggingface dataset:
Standard Follow-up Program (SFP) for Head and Neck Cancer Patients

The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

Specific objectives

* To develop, validate, and improve normal tissue complication probability (NTCP) models for a wide variety of acute and late radiation-induced side effects relevant for head and neck cancer patients (step 1);
* To use the outcome of the NTCP models to better inform patients on the risks on acute and late toxicity;
* To use the outcome of the NTCP models for the definition of dose constraints for radiotherapy treatment planning in current practice;
* To use the outcome of the NTCP models for the development and investigation of the potential benefit of new and emerging radiation delivery technique, such as swallowing sparing intensity modulation radiation therapy (IMRT) and proton radiotherapy.
* To compare the outcome of new radiation delivery techniques that are clinically introduced with the current standard in terms of radiation-induced toxicity, patient-rated symptoms and quality of life and in terms of locoregional tumour control and overall survival

Eligibility Criteria:
Inclusion Criteria:

* All patients planned for curatively intended primary or postoperative radiotherapy will be included. At the first visit, patients are informed about the standard follow up program by the treating physician.

Exclusion Criteria:

* All patients planned for palliative radiotherapy will not be included in the SFP.
Intensive Drug Therapy for Ischemic Stroke Caused by Severe Intracranial Arterial Stenosis

To observe the safety and efficacy of intensive drug therapy for ischemic stroke caused by severe intracranial arterial stenosis.Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%) were enrolled and accept dual antiplatelet therapy (DAPT) (aspirin 100 mg/d and clopidogrel 75 mg/d for 90 days, followed by aspirin 100 mg/d for long term) under the guidance of platelet function analysis (Verifynow) combined with the intensive statin therapy (40 mg/d for 14 days, followed by 20 mg/d for long term).

Patients (35 to 80 years ) with acute ischemic stroke, who can be treated within 72 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomly selected.Patients were treated with dual antiplatelet therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90 days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for 14 days, followed by 20 mg per day long term) after enrollment. Patients with aspirin resistance (aspirin reaction units \[ARU\] ≥550) or clopidogrel resistance (P2Y12 reaction units \[PRU\] ≥208) were excluded on the 7th day of therapy.The primary objective is to observe the safety and efficacy of intensive drug therapy for ischemic stroke patients. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35 and 80 years;
* Onset \<72 hours;
* New-onset ischemic stroke confirmed by skull magnetic resonance diffusion weighted imaging (MR-DWI);
* Severe ICAS (stenosis ≥70%) indicated by time-of-flight magnetic resonance angiography (TOF-MRA).

Exclusion Criteria:

* Ischemic stroke caused by other etiological factors (e.g., cardio-embolism, arterial dissection, vasculitis, etc.);
* Post-infarction hemorrhagic transformation and intraplaque hemorrhage as indicated by imaging examination;
* Contraindications to aspirin, clopidogrel, or atorvastatin;
* Intracranial hemorrhage within 3 months and a recent history of surgery or trauma;
* Severe organ impairment, liver insufficiency, and renal insufficiency;
* Complicated with tumors or hemorrhagic diseases;
* Use of drugs forbidden to use in combination after onset, including other antiplatelet drugs, anticoagulants, thrombolytic drugs, and drugs affecting antiplatelet agents and statin metabolism.
Acthar for Treatment of Post-transplant FSGS

This is an open label safety and feasibility trial using Acthar® in addition to center-specific standard therapy including plasma exchange, for treatment of post transplant recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will receive Acthar® 40 units subcutaneously (SC) twice weekly for two weeks then 80 units SC twice weekly for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Proteinuria \> 1 g/d by urine protein/creatinine ratio (UP/C) or 24 hour urine collection
* If treated with an angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II receptor blockers (ARB), must be on a stable dose for at least 2 weeks prior to enrollment
* Newly diagnosed recurrent focal and segmental glomerulosclerosis (FSGS), or current/previous treatment of recurrent FSGS with no evidence of at least a partial response as defined by one or more of the following:

  1. Recurrent FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), with FSGS as the primary disease confirmed by native renal biopsy prior to transplant
  2. FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant
  3. Patients at any time period post transplant with an established diagnosis of recurrent FSGS in the first 18 months post transplant who did not respond to conventional therapy as defined by persistent proteinuria of \> 3 g/d by UP/C or 24 hour urine collection

Exclusion Criteria:

* Lactation, pregnancy or refusal of birth control in women of childbearing potential
* Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or parvovirus B-19
* Malignancy (with the exception of treated and cured basal cell or squamous cell carcinoma)
* Evidence of diabetic nephropathy, transplant glomerulopathy or other pathologies that could be associated with secondary FSGS on renal transplant biopsy
* Non-renal organ transplant (with the exception of pancreas transplant)
* Contraindication to receiving Acthar®
BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment

Eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and IL-6 as long-term clinical outcomes of omalizumab therapy.

Anti-IgE (omalizumab) has been shown to be an effective add-on therapy for patients with allergic severe asthma. In this observational study patients aged over 18 year with uncontrolled severe persistent asthma are selected for add-on therapy with omalizumab. Patients were on high dose of ICS and had a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with \>15 mg/day prednisone or other medications at similar dose, for at least 3 days). The individual dose and frequency of omalizumab administration is assessed from the dosing table. Lung function tests and asthma questionnaires (ACQ, AQLQ and RQLQ) are used in the aim of assessing clinical improvement after omalizumab treatment. Induced sputum (IS) and exhaled breath condensate (EBC) are used as a simple non-invasive methods for monitoring cellular and biochemical changes in the airways. Total blood eosinophil count, IS cytology, IS and EBC periostin and IL-6 concentrations are measured. Analyses are performed at entry and after 16, 52 and 104,156 weeks of omalizumab treatment.

Eligibility Criteria:
Inclusion Criteria:

1. positive history of atopy
2. serum total IgE level between 30 and 700 IU/ml
3. body weight not more than 150 kg
4. high dose of ICS and LABA
5. a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with \>15 mg/day prednisone or other medications at similar dose, for at least 3 days).

Exclusion Criteria:

1. smoking
2. pregnancy
Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.

This clinical study evaluates the effect of taking a hydrolyzed collagen-based supplement on pain, function and quality of life in a moderately physically active population. Non-pathological knee pain is a common occurrence in many healthy people and can limit the quality of life. Therefore, the resolution of this problem can bring many benefits in terms of quality of life.

Study design

Randomized, double-blind, placebo-controlled clinical trial with 2 parallel study groups (collagen-based formulation and placebo). Participants will take the study products for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who exercise regularly and meet the WHO definition of being moderately active.
* Persistent exercise-associated knee pain lasting at least 2 months prior to study inclusion.
* Knee pain score on the visual analogue pain scale of at least 30 mm, taking into account that the scale has a maximum range of 100 mm.

Exclusion Criteria:

* Individuals with severe illness.
* Subjects who are taking or have been treated within the last 7 days with glucosamine, chondroitin sulphate, collagen or hyaluronic acid injections or any dietary supplement indicated for joint health.
* Subjects with chronic inflammatory diseases affecting the musculoskeletal apparatus.
* Subjects with obesity (BMI ≥ 30 Kg/m2).
* Allergy or known hypersensitivity to any of the ingredients in the investigational product.
* Phenylketonuria.
* Treatment with narcotics, steroidal anti-inflammatory drugs or immunosuppressants. - Symptoms of extreme pain requiring high doses of analgesic therapy for a period of time longer than 2 weeks or intra-articular injection treatment.
* Individuals with diabetes.
* Pregnant women.
* Lactating women.
* Subjects who are participating in a clinical trial.
* Subjects who have participated in a clinical trial for pain in the last month.
Life Enhancing Activities for Family Caregivers

Life Enhancing Activities for Family Caregivers is a six-week program designed to increase positive affect in people who care for a family member with dementia. The intervention consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to teach simple skills that are practiced at home in a study-supplied workbook. The program is preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be conducted at 1-month, 3-months, and 6-months post intervention.

Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate significantly greater improvements in psychological outcomes and will engage in more problem focused and positive appraisal forms of coping compared to the wait-list control condition.

All study activities can be conducted from the participant's home, making participation possible for any qualified caregiver with computer and wifi access, in any U.S. state. The LEAF study will supply the tablet computer, software, and workbook required for participation.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to be defined as the primary care provider for a family member with dementia. (Person with dementia must live with the caregiver or in their own home and not in a care facility.)
* Must speak and read English
* Must have the ability to provide informed consent

Exclusion Criteria:

* Lack of access to a high speed internet connection
* Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients

Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19.

Also the potential variants according with worse outcomes remain to be fully elucidated.

investigators undertook a randomized trial in ESRD patients infected with COVID-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and ICU admission in one weak period and; 2) the potential effective variants in worst outcome. . Paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in June 2021 for registration . The protocol for this trial and supporting CONSORT checklist are available. The SBMU Ethics Board approved the study and all amendments. The study was conducted according to the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients \>3months on hemodialysis admitted for COVID-19

Exclusion Criteria:

* ESRD patients \<3 months on hemodialysis infected with COVID-19
Interest of Daily Physical Activity After Cancer Treatment

Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types.

It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice.

To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry .

Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity.

Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive.

In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.


Eligibility Criteria:
Inclusion Criteria:

* adult (age ≥ 18 years)
* Having been informed of the study orally and in writing and have not expressed opposition to his participation
* Performance status \<2
* Invasive breast adenocarcinoma, histologically documented.
* Patients with a breast cancer and are completing treatment
* Exclusion Criteria:
* Patient with metastatic cancer.
* Patient for which monitoring required by the protocol is impossible.
Clinical Evaluation of Patients With X-linked Retinitis Pigmentosa (XLRP)

The purpose of this study is to evaluate subjects with X-linked retinitis pigmentosa caused by RPGR-ORF15 mutations in a clinical setting to fully characterize their condition, measure testing variability, and estimate rates of progression of clinical parameters.

Males with a clinical diagnosis of X-linked retinitis pigmentosa (XLRP) caused by RPGR-ORF15 mutations will be asked to provide informed consent and will have a single blood or saliva sample obtained for DNA sequence analysis of genes known to cause XLRP, including the RPGR-ORF15 gene. All participants will be informed of the results of testing for these mutations. Those with qualifying mutations in the RPGR-ORF15 gene will be evaluated every 6 months for 3 years using a variety of non-invasive visual function tests to more fully characterize their clinical condition. Testing will include routine ophthalmic examinations and tests of visual acuity, perimetry, OCT, fundus imaging, and completion of quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects with a clinical diagnosis of XLRP and a documented molecular diagnosis from a CLIA-certified laboratory of mutation within the ORF15 exon of the RPGR gene;
* At least 6 years of age;
* Willing and able to perform study procedures;
* Signed informed consent(s) obtained (and child assent where applicable).

Exclusion Criteria:

* Pre-existing eye conditions that would interfere with interpretation of study endpoints (e.g. glaucoma, corneal or lenticular opacities, diabetic retinopathy, history of retinal detachment);
* Participating in an interventional research study of drugs or devices for treatment of XLRP or other retinal diseases;
* Monoocular participants
* Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.

The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have received either Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.
* A male or female infant from the age of 6 weeks at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the infant.

Exclusion Criteria:

• At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
Patient Perception of Visual Distortions

The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.


Eligibility Criteria:
Inclusion Criteria:

* Corneal astigmatism of at least 0.75 diopters
* Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
* At least one month postoperative from second-eye surgery
* Ability to understand, read and write English to give consent and complete study questionnaire
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
* Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
* Patient is pregnant or is lactating
* Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
* Other protocol-defined exclusion criteria may apply
Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora

The purpose of this study is to estimate the effects of caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms.

In recent decades, carbohydrate-centered food pattern has brought worrying negative effects on human health, including increasing incidence of overweight, obesity, and cardiovascular diseases. Animal experiments based on rhesus monkey showed that caloric restriction could prolong their healthy life years, while reports from population-based studies are quite inconclusive. There are some studies reporting that caloric restriction did reduce the risk of cardiovascular disease in those with obesity, while some other cohort studies found that not eating breakfast might increase the risk of coronary heart disease, diabetes and other related diseases. In addition, a number of studies claimed that continuous caloric restriction is associated with the depletion of peripheral immune cells, immune suppression and reduced bone mineral density. In spite of those inconclusive results, on the whole, fasting and caloric restriction in some way do improve the conditions of metabolism, overweight and obesity. Previous studies mostly focused on middle-aged and elderly people, while recent studies in mice show that energy limitation in elderly people could not stop the aging process genetically or metabolically. Therefore, this study aims to estimate the effects of caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms. A pilot study containing around 40 participants will be conducted firstly to assess the feasibility of this intervention plan.

Eligibility Criteria:
Inclusion Criteria:

1. First and second year undergraduate students in Sun Yat-sen University.
2. BMI≥22 kg/m2.
3. Having the time and volunteering to receive the interventions.

Exclusion Criteria:

1. Currently engaged in other weight-lossing studies.
2. With secondary obesity induced by medicine or other diseases.
3. With high blood pressure, diabetes or other cadiovascular diseases.
4. Contraindication to exercise.
Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)

The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Suspension laryngoscopy for diagnostic or therapeutic purposes
* Total intravenous anesthesia using propofol and remifentanil

Exclusion Criteria:

* age \<18 yrs or \>75 yrs
* arrythmia
* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* psychiatric diseases
* autonomic nervous system disorders (epilepsy)