cyrilzakka/clinical-trials huggingface dataset:
Detection of Anemizations in Primary Care.

Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia.

Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. The study randomizes 138 patients with chronic anemia. In the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. If a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. Social, demographic and quality of life variables will be collected from all participants.

Hypothesis:

The results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. The improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. Furthermore, the management of the different interventions by the Case Management Nurse (EGC), in this regard, improves the current fragmentation of the different levels of care.


Eligibility Criteria:
Inclusion Criteria:

* People over 40 years old
* Had received 2 or more red blood cell transfusions due to chronic disease, during a year.
* The health provider in Primary Care is the Institut Català de la Salut.

Exclusion Criteria:

* Presenting kidney failure on hemodialysis treatment.
* Being in palliative care situation
* Presenting a moderate-severe cognitive impairment, with a Pfeiffer scale score higher than 5.
* Not having a caregiver able to detect signs of decompensation.
Oxidative Balance in Opioid Therapy

The oxidative - antioxidative balance is the crucial mechanism of opioid-induced immunomodulation. Additionally, impairement of cognitive function during opioid therapy is another important side- effect. This phenomenon was clearly described in opioids abuse. This is interesting to evaluate the importance of this subjects in chronic pain patients. The aim of the study was to investigate the oxidative - antioxidative homeostasis and cognitive functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC) tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain treated with opioids.

The project was approved in Ethical Committee and supported by Medical University of Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. In Study Group anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx, PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.

Eligibility Criteria:
Inclusion Criteria:

* minimally, 6 months opioid therapy in chronic Low- Back Pain

Exclusion Criteria:

* depression, steroids- local or systemic administration
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* Received primary dose of M-M-R II at less than or equal to 12 months of age
* Received primary dose of Varivax at less than or equal to 12 months of age
* Negative history of varicella, zoster, measles, mumps, and rubella

Exclusion Criteria:

* history of receiving more than once dose of M-M-R II or Varivax
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Receipt of immune globulin, or blood product in the past 5 months
Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) AND HEALTH CANADA HAVE APPROVED MDV3100 (ENZALUTAMIDE) FOR SALE TO THE PUBLIC, ENROLLMENT IS CLOSED IN BOTH THE UNITED STATES AND CANADA.

The expanded access treatment protocol is being conducted while marketing approval of enzalutamide is being sought. There is no age requirement.

Subjects will complete visits on Day 1, Week 4, Week 12 and then every subsequent 12 weeks until discontinued from the study.

The study will end if enzalutamide is approved for sale to the public by the country's health authority (commercially available) or if the sponsor otherwise decides or is required to end the study. If a subject would like to receive enzalutamide after the study ends, he and the doctor will decide if he should receive a prescription for enzalutamide, with a goal of avoiding any interruption in treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or orchiectomy
* At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
* Progressive disease as evidenced by prostate specific antigen (PSA) rise or radiographic or clinical worsening of disease
* No known or suspected brain metastasis
* There is no comparable or satisfactory alternative therapy to treat the subject's disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism
* History of loss of consciousness or transient ischemic attack within the last 12 months
* Clinically significant cardiovascular disease
* Following lab values:

  * Absolute neutrophil count is \<1,000/µL
  * Platelet count is \<50,000/µL
  * Hemoglobin is \< 5.6 mmol/L (9 g/dL)
  * Total bilirubin ≥1.5 x upper limit of normal (ULN)
  * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN
  * Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula
* Subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon
* Subject has participated in a previous clinical study of MDV3100 for which the primary endpoint has not yet been reported (e.g., the PREVAIL trial)
Treating Obese PCOS Patients With LSG vs. Met

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.


Eligibility Criteria:
Inclusion Criteria:

* female aged 18- 45;
* meet Rotterdam criteria;
* BMI ≥ 28 kg /m2.

Exclusion Criteria:

* Women who are pregnant or have a pregnancy plan within six months;
* Women who are reluctant to undergo metabolic surgery;
* Congenital adrenocortical hyperplasia;
* Hyperprolactinemia;
* Hyperthyroidism or hypothyroidism;
* Abnormal liver function (≥ 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR\<60ml/min/1.73m2);
* Adrenal or ovarian tumors secreting androgens;
* Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)

The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \>30 seconds duration and in overall arrhythmic load.

Ablation has become a first-line therapy in the rhythm control strategy for atrial fibrillation (AF).

Pulmonary vein electrical isolation (PVI) is the cornerstone of ablation therapy, based on its efficacy profile, safety and lack of alternatives.

Single shot techniques have been increasingly used as the initial approach for PVI, employing cryoablation, i.e. release of cryoenergy into the endocardium via an inflatable catheter, to achieve isolation.

The most commonly used diameter in cryoablation is 28 mm. These generate antral isolation whose profile depends on the distance between veins. When the application is made with larger devices, as has been observed with the cryoballoon with an expandable diameter of 31 mm or ablation devices using pulsed electric fields, the isolation is also antral at the level of the carina, making the result of PVI more similar to that obtained when ablation is performed with a Wide Antral Circumferential Ablation (WACA) strategy using point-to-point radiofrequency (the gold standard for PVI).

The WIDER-PVI study aims to answer the question of whether single-shot ablation with a 31 mm diameter device is superior to conventional ablation with a 28 mm diameter device. The answer to this question is relevant in the context of the development of new, larger devices and concerns about the impact of larger ablation on atrial function.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old.
* Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 years after diagnosis.
* Clinical indication to undergo a pulmonary vein isolation procedure using balloon cryoablation.

Exclusion Criteria:

* Severe left atrial dilatation (indexed volume \>48 ml/m2 or area \>40 cm2 or indexed diameter \>3.0 cm/m2).
* Previous endocardial or surgical ablation of atrial fibrillation.
* Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy less than 1 year.
* Inability to understand or give informed consent.
* Performance of other left atrial ablations in addition to pulmonary veins.
* Need to use another catheter in addition to the cryoablation catheter to complete pulmonary vein isolation.
* Contraindication to anticoagulation or intolerance to heparin.
* Presence of intra-atrial thrombus.
* Reversible cause of atrial fibrillation.
* Severe mitral or aortic valve disease.
* Congenital heart disease.
* Pregnancy or the prospect of pregnancy in the next 12 months.
Study of the Association Between Presbycusis With the Incidence of Frailty

The objective of the project is to establish the association between presbycusis and the incidence of frailty in humans in order to establish hearing loss with age as another index for the diagnosis of frailty; As well as studying the effect of exposure to polyphenols in the diet on presbycusis and frailty. Human study: volunteers between 60 and 99 years old, men and women during a period of 6 months, questions and answers, audiometries, study of fragility, analysis of antioxidants in blood, and samples of urine will be measured Total polyphenols and oxidant capacity.


Eligibility Criteria:
Inclusion Criteria:

* Age

Exclusion Criteria:

* Disease of the hearing system
* Serious illness (e.g. tumor)
* Dementia
* Total dependence
Dietary Methionine and Cysteine Restriction in Healthy Adults

Studies in laboratory models indicate that dietary methionine restriction (MR) enhances longevity and produces short- and long-term metabolic changes that are consistent with a healthy lifespan. The present study was designed to establish levels of dietary methionine or methionine and cysteine that induce physiological changes in healthy adults like those observed in rodent studies .

In this controlled feeding study, subjects will be randomized to one of two experimental. Group A (N=10): will start with control diet (31 mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks followed by a washout for 3-4 weeks, then a 70% MR diet (9.3 mg/kg/day Met; 40.3 mg/kg/day SAA) for 4 weeks, followed by 3-4 weeks washout period and then a 90% MR diet (3.1 mg/kg/day Met; 34.1 mg/kg/day SAA) for 4 weeks. Group B (N=10): will start with control diet (31 mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks followed by a washout for 3-4 weeks then a 50% methionine and cysteine restricted (M/CR) diet (15.5 mg/kg/day Met; 15.5 mg/kg/day Cys; 31 mg/kg/day SAA), followed by 3-4 weeks washout period and then a 65% M/CR diet (10.8 mg/kg/day Met; 10.8 mg/kg/day Cys; 21.6 mg/kg/day SAA) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy English speaking male and female volunteers
* May or may not be students
* Age range 24-65 years
* Subjects will need to be of normal weight or moderately overweight (BMI 18.5-35 kg/m2)
* Subjects will be non-smokers

Exclusion Criteria:

* No use of medications known to impact the biomarkers of interest
* Pregnancy and lactating women
* Persons with documented diabetes
* No use of high dose dietary antioxidant supplements or fish oil/flax seed oil for n-acetylcysteine for at least 1 month prior to the study
* Use of tobacco products over the past 6 months
* Unstable weight
* Individuals with allergies to eggs, wheat, nuts, soy and latex
* Individuals with phenylketonuria (PKU)
The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer

This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.

Breast cancer is the most common malignant tumor among women. Approximately 19% to 30% of patients with breast cancer achieve a pathological complete response (pCR) following neoadjuvant therapy, while about 5% to 20% of patients experience disease progression. Increasing evidence suggests the significant role of psychological factors in influencing cancer treatment outcomes. Cancer patients often experience emotional distress, including fear of relapse, anxiety, depression, and low self-esteem, which may persist for many years. Statistics indicate that the incidence of anxiety and depression among cancer patients is 49.69% and 54.90%, respectively, significantly higher than that of healthy individuals (anxiety: 18.37%, depression: 17.50%) in China. There are indications that emotional issues may be linked to cancer treatment, although the underlying mechanisms remain unclear.

This study aims to investigate the relationship between anxiety and depression and the effectiveness of standard neoadjuvant therapy in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* 1.Age ≥ 18 years; 2.Histological and/or cytological diagnosis of breast cancer; 3.Treatment niave patients; 4.To receive standard neoadjuvant therapy; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ; 7.Informed and agreed to participate in the study;

Exclusion Criteria:

* 1. Breast cancer has not been confirmed through histological or cytological examinations.

  2.Other breast cancer conditions that do not receive neoadjuvant therapy. 3.Combined with other malignant tumors. 4.Concurrent acute or chronic psychiatric disorders, along with having received antidepressant or anti-anxiety therapy within the past month.

  5.Participants must not have engaged in any other clinical trials in the past month, unless those trials are observational or non-interventional in nature.
The Effect of Mood Induction in Body Image Through Virtual Reality

The effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality

The general objective of this study is to analyze the impact of emotional induction (sadness vs. joy) on the two dimensions (perceptive and affective) of body image with the help of virtual reality. Thus, it is hypothesized that a negative emotional induction may partially explain the change in body image measures.

Eligibility Criteria:
Inclusion Criteria for CLINICAL population:

* ED diagnosis: Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified
* BDI-II - depression symptomatology scores \<29 (for ethical reasons)
* Age between 13 and 18

Exclusion Criteria for CLINICAL population:

* suicide risk: the decision of the psychiatrist/psychologist
* present any medical illness or physical incapacity that could impede the experiment
* diagnosis of Binge Eating Disorder
* Body Mass Index \<14 or \> 28
* pregnancy
Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic

This study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. This study was quasi-experimental before and after, with 10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and post test KTK Coordination Body, and the activities were held once a week for six weeks in sessions of forty minutes. It was used for statistical analysis the Student t test dependent and independent (p ≤ 0.05).


Eligibility Criteria:
Inclusion Criteria:

* age 7 to 10 years of age.
* hearing disorders proven by presenting specific examination of Auditory Evoked Potential and Examination of the brainstem (Brainstem Evoked Response - Bera).
* consent of parents / guardians of children to participate in the study by signing Term of Informed Consent (IC).

Exclusion Criteria:
A Cross-sectional Study on COPD Prevalence

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide and hence, estimating its prevalence is important. Since 2007, there are few data on the prevalence of COPD in the general population in Spain. The main objective of this epidemiological observational study is to estimate the prevalence of COPD in residents of Spain among the population over 40 years of age. The subjects will be distributed in two groups depending on the presence and absence of COPD. The study will have a single visit in which a brief interview will take place and subjects will need to complete the medical tests the case report form with a series of questionnaires. No drugs will be administered in this study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 40 years or older selected from the general population.
* Subjects who have provided oral consent to participate in the brief telephone interview; these subjects will need to sign the informed consent to continue participating in the study.

Exclusion Criteria:

* Subjects with any physical or cognitive difficulties which will prevent them from participating in any of the study tests (example, spirometry and questionnaires).
* Subjects who are not located, dead or displaced.
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

Time-to-Progression (TTP)

Determine the time-to-progression (TTP) for subjects with relapsed/refractory acute lymphoblastic leukemia (ALL) receiving single agent lenalidomide 50 mg/day for 28 days/cycle.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute lymphoblastic leukemia (ALL) with \> 10% bone marrow or peripheral blood blasts per WHO-criteria. Refractory define as failure to achieve CR after prior therapy.
* Previously untreated patients \> 60, if not candidates for standard induction
* Age ≥ 18
* Not a candidate for curative treatment regimens
* Unwilling or unable to receive conventional chemotherapy
* ECOG performance status ≤ 2
* Life expectancy \> 2 months
* Registered to in RevAssist restricted distribution program, and willing and able to comply with the program requirement
* Females of childbearing potential (FCBP):

  * Must have a negative serum or urine pregnancy test (sensitivity of at least 50 mIU/mL) 10 to 14 days prior to study enrollment and within 24 hours prior to prescribing lenalidomide
  * Must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control
  * Agree to ongoing pregnancy testing
* Men must agree to use a latex condom during sexual contact with a FCBP
* Able to adhere to the study visit schedule and other protocol requirements
* Willing and able to understand and voluntarily sign a written informed consent

Exclusion Criteria:

* Prior therapy with lenalidomide
* History of intolerance to thalidomide including development of erythema nodosum while taking thalidomide or similar drugs
* Advanced malignant hepatic tumors.
* Concomitant treatment with other anti-neoplastic agents (exception hydroxyurea)
* Anti-neoplastic treatment less than 4 weeks prior to enrollment (exception hydroxyurea)
* Use of any other experimental drug or therapy within 14 days of baseline
* Inability to swallow or absorb drug
* Active opportunistic infection or treatment for opportunistic infection within 4 weeks of first dose of study drug
* New York Heart Association Class III or IV heart failure
* Unstable angina pectoris
* Cardiac arrhythmias with rapid ventricular response (heart rate \> 100 beats/minute)
* Uncontrolled psychiatric illness that would limit compliance with requirements
* Known HIV infection
* Known active hepatitis B virus (HBV) (exception seropositivity due to HBV vaccine not considered active HBV)
* Known hepatitis C virus (HCV) infection
* Pregnant
* Lactating females must agree not to breastfeed while taking lenalidomide
* Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
* Creatinine ≥ 1.5 mg/dL
* Creatinine clearance ≤ 60 mL/min.
* Total bilirubin \> 1.5 x institutional upper limit of normal (ULN) (exception documented Gilbert's syndrome)
* AST and ALT \> 3 x institutional ULN