cyrilzakka/clinical-trials huggingface dataset:
PADUA PREDICTION SCORE in Cirrhotic Patients

Primary objective: to evaluate the predictive role of Prediction Score on the risk of developing venous thromboembolism in patients with liver cirrhosis admitted to non-surgical wards.

Secondary objectives:

* To estimate the prevalence and incidence of venous thromboembolism in patients with liver cirrhosis admitted to non-surgical wards
* To calculate the prevalence in the same subset of patients of major bleeding (defined as bleeding resulting in the patient's death, a drop in hemoglobin \> 2g/L, the need to transfuse \> 2 units of packed red blood cells or bleeding into a critical organ/space including the intracranial, retroperitoneal, intraocular, adrenal, spinal, pericardial districts) related to the application or not of thromboprophylaxis measures (pharmacological and mechanical) Study design: The study is single center and it will be divided into two parts, a first retrospective part and a second prospective case control study.

Methods: adult patients with liver cirrhosis admitted in Internal Medicine and Gastroenterology Unit of Policlinico Agostino Gemelli will be enrolled in the prospective study. For the retrospective part of the study, data about cirrhotic patients hospitalized in non-surgical departments of Policlinico Agostino Gemelli will be collected. Exclusion criteria will be hospitalization in surgical wards or intensive care units, patients with active bleeding at the time of admission, patients hospitalized for liver transplantation, anticoagulant therapy at therapeutic dosage at the time of admission for indications other than liver cirrhosis (e.g. personal history of thromboembolic events, atrial fibrillation/flutter or mechanical heart valves), contraindications to anticoagulant prophylaxis (recent or ongoing bleeding, creatinine clearance assessed by EPI-CKD method \< 15 ml/min, platelet count \< 50 x 10\^9/L), patients hospitalized as elective regimen to perform invasive procedures that contraindicate anticoagulant prophylaxis (e.g. liver biopsy, local treatment of liver neoplasms, ligation of oesophageal varices), double antiplatelet therapy, pregnancy


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age more than 18 years old
* diagnosis of liver cirrhosis
* hospitalization in a medical department

Exclusion Criteria:

* pregnancy
* ongoing double anticoagulation or double antiplatelet therapy at the moment of hospitalization
* controindications to anticoagulation therapy
* hospitalization in surgical environnment
Discordant Hormonal Status of Breast Cancer.

The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

Hormonal status between primary breast tumor and axillary lymph node were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.

Exclusion Criteria:

* Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.
Exogenous Reinfection of Tuberculosis in Taiwan

we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

Tuberculosis (TB) remains the most important infectious disease in the world. In Taiwan, the incidence of TB increased in recent years. The failure of control implies the necessity to reevaluate the epidemiology of Mycobacterium tuberculosis. It is widely thought that most cases of TB are caused by reactivation of a latent infection. Treatment programs have therefore focused on cure rates rather than tracking of additional cases. But recent studies showed that exogenous reinfection plays an important role in the development of TB. In addition, it seems that the higher the local incidence, the more important exogenous reinfection is. The question of exogenous reinfection versus endogenous reactivation has an impact on the distribution of resources for the prevention and treatment of TB. Based on these evidences, we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

Eligibility Criteria:
Inclusion Criteria:

* culture-proven tuberculosis with recurrence
Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care

This randomized controlled pilot study will be evaluating an app, MORT-PFPS app (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.

This randomized controlled pilot study will enroll 40 participants, where half will be randomly assigned to the app, MORT-PFPS (n = 20), and half will be assigned to treatment as usual (TAU) (n = 20), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 19 and \<50 years of age
* Patients who have a history of anterior knee pain in one or both knees, persisting for longer than 3months but not longer than 2 years
* Patients who have pain provoked by squatting
* Patients who have pain provoked by 2 or more following activities

  1. long sitting
  2. cycling
  3. running
  4. going up or down stairs
  5. kneeling
  6. compression of the patella
  7. palpation of the patellar facets
* Patients who signed a written informed consent form

Exclusion Criteria:

* Patients with osteoarthritis which scored 2 or higher grade of the Kellgren-Lawrence scale
* Patients who have a history of knee pathologies or injuries (fracture, tendon injury, cartilage injury, or patella dislocation)
* Patients who had previous knee surgeries
* Patients who have patellar tendinopathy
* Patients who have Osgood-Schlatter disease, or other defined pathological conditions of the knee
* Patients who are pregnant or breastfeeding
* Patients who are using anti-inflammatory medication
* Patients with known substance/alcohol use disorders
* Patients with known somatic symptom and related disorders
* Patients who are not able to participate in an exercise or strengthening program
Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination

This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.

The number of visits to the clinic will depend on the clinic's standard practice.


Eligibility Criteria:
Inclusion Criteria:

Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.

Exclusion Criteria:

None
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis

The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed
* Age ≥18 years
* 30% \<FEV1 \<70% predicted
* Presence of bronchial congestion reported by the patient or the investigator

Exclusion Criteria:

* Uncontrolled asthma
* Pneumothorax \<6 weeks
* Recent severe hemoptysis \<6 weeks
* Patient registered on the transplant list
* Exacerbation within 4 weeks (3 months if hospitalization) before screening
* Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
* Patients unable to perform measurements of ROF, spirometry, plethysmography.
* Any contraindication to manual or instrumental physiotherapy.
* Pregnancy, breastfeeding.
* Patient under tutorship or curatorship
* No affiliation to the French social security
* Patient using Simeox at home
* Patient under Trikafta for less than 6 weeks.
* Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion
Radiofrequency Ablation (RFA) in Breast Tumors

To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar.

Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure.

Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Infiltrating ductal carcinoma according the biopsy of the breast,
* Tumor visible by ultrasound, smaller than 2 cm,
* Located \> 1 cm from the chest wall and the skin.

Exclusion Criteria:

* Personal antecedents of breast cancer
* Multifocality or intraductal carcinoma
* Lobular infiltrating carcinoma
* Neoadjuvant therapy
Evaluation of Reactive Oxygen Metabolites in the Value of COPD

This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.

Reactive oxygen metabolites (reactive oxygen metabolites, ROMs) test is a method by measuring the total reactive oxygen metabolites (ROMs) content in blood so as to evaluate the overall level of oxidative stress in the human body .Our previous studies have established the method of detecting ROMs which is suitable for fully automatic biochemical analyser.Our study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD according to GOLD 2013

Exclusion Criteria:

* A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training
TEAMS R34 #1 After-Action Reviews in Child Welfare Services

This project proposes to improve successful mental health service linkage in Child Welfare Services (CWS) by adapting and testing the After Action Review (AAR) team effectiveness intervention to augment the Child Family Team (CFT) services intervention. Despite being both required and a collaborative approach to service planning, CFT meetings are implemented with questionable fidelity and consistency, rarely including children and families as intended. By inclusion of child and family voice, the AAR-enhanced CFT should lead to increased fidelity to the CFT intervention and greater levels of parental satisfaction with the service and shared decision-making, thus resulting in enhanced follow-through with Action Plans and linkage to mental health care for children.

The proposed project will address the following aims:

Aim 1. Conduct a qualitative needs assessment targeting the ongoing implementation of the CFT services intervention in a large, publicly funded, CWS. A qualitative inquiry consisting of interviews and focus groups with key stakeholders will result in the preparation of an action plan to address identified gaps between the current and desired CFT services intervention outcomes.

Aim 2. Adapt and tailor the AAR implementation strategy to address the CFT services intervention needs.

Aim 3. Assess mechanisms of the AAR team effectiveness intervention for CFT implementation.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for CWS leaders and/or caseworkers

1. (For leaders) Employed as one of several CWS leadership positions: CWS Director, CWS Deputy Director, CWS Regional Manager; (For caseworkers) Employed as a caseworker in one of the two participating regions for the proposed study.
2. Plans to remain employed for at least six months beyond study initiation
3. Speaks English or Spanish

Inclusion Criteria for formal and informal CFT members

1. Member of CFT with one of the participating CWS caseworkers. CFT members can include mental health services provider, Court Appointed Special Advocate (CASA), educational representative, and other supports
2. Speaks English or Spanish

Inclusion Criteria for parents/caregivers with active CWS cases

1. Parent/caregiver of child aged 6-17 with an open CWS case
2. Initial CFT meeting for open CWS case has not yet been held (Aim 3)
3. Speaks English or Spanish

Inclusion Criteria for children with active CWS cases (for mental health service linkage data extraction only\*)

1. Child aged 6-17 with an open CWS case
2. Mental health services need/s (identified by the CWS caseworker via CANS screening in advance of the initial CFT meeting, during which consensus is reached regarding the Action Plan and service referral)

Exclusion Criteria:

Individuals who do not meet inclusion criteria are not eligible to participate in this study.
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)

The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

BACKGROUND:

The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the beta-2 adrenergic receptor.

DESIGN NARRATIVE:

Participants were homozygous for arginine or glycine at the 16th amino-acid position of the β-2 adrenergic receptor (B16 Arg/Arg or B16 Gly/Gly). Individuals were matched against their opposite genotype by forced expiratory volume in one second (FEV1) and race. Matched participants entered an 8-week run-in period. This is a 62-week crossover design where subjects receive the following therapies:

* Beclomethasone HFA (240 µg twice a day (BID)) + as-needed (PRN) albuterol: 8-week run-in
* Beclomethasone HFA (240 µg BID) + salmeterol (50 µg BID) + PRN ipratropium bromide + PRN albuterol: 18-week treatment period
* Beclomethasone HFA (240 µg BID) + PRN albuterol: 8-week run-out
* Beclomethasone HFA (240 µg BID) + placebo salmeterol + PRN ipratropium bromide + PRN albuterol: 18-week treatment period
* Beclomethasone HFA (240 µg BID) + PRN albuterol: 10-week run-out

The order of treatments received during the two treatment periods is randomized.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 18 and older
* Clinical history consistent with asthma
* For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
* For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
* Genotype eligibility (determined during screening)

Exclusion Criteria:

* Smoker (total smoking history must be less than 10 pack years)
* Significant unstable medical condition other than asthma
* History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years
* Pregnant or lactating
Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteer aged 18-35,
* Smokers 18-30

Exclusion Criteria:

* Contraindications for using hormonal contraceptives
Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population

The patients who consulted to the geriatric outpatient clinic between 2018 and 2019 were included in the study. The inclusion criterions were being at or over the age of 65 and diagnosed with osteoporosis according to WHO criteria. Exclusion criteria include vertebral fracture due to known accidental traumas, history of drug therapy in the past year (biphosphonate, estrogen replacement therapy, glucocorticoids ), history of co-morbidities as malignancy, radiotherapy or chemotherapy, renal failure, hyperthyroidism, primer hyperparathyroidism, rheumatic disease or adrenal diseases.

Initially, a demographic form including age, sex, comorbidities, weight, height was filled by the participants. Body mass index (BMI, ratio of height and weight, expressed as kg/m2) calculated. Patients waist and hip circumference was measured (cm).

Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan). Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height \[m2\] \[8\]. ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6) \[4\].

Osteoporosis was evaluated by using dual energy x-ray absorptiometry (DXA). According to the T-scores calculated from femur neck (FN) and lumbar spine (LS), subjects divided into 3 groups as following: a) normal: T-score is greater than -1 SD, b) osteopenia: T-score is between -1 and -2.5 SD, c) osteoporosis: T-score is lower than -2.5 SD.

Physical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment \[9\]. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active).

The study protocol was approved by the ethics committee (2018/0478) and all participants gave written informed consent.


Eligibility Criteria:
Inclusion Criteria:

* being at or over the age of 65
* diagnosed with osteoporosis according to WHO criteria

Exclusion Criteria:

* vertebral fracture due to known accidental traumas
* history of drug therapy in the past year (biphosphonate, estrogen replacement therapy, glucocorticoids )
* history of co-morbidities as malignancy, radiotherapy or chemotherapy, renal failure, hyperthyroidism, primer hyperparathyroidism, rheumatic disease or adrenal diseases
Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).

The investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino, or Latina. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.

The investigators will recruit 1,000 individuals (500 English-speaking and 500 Spanish-speaking) to complete the AGPM and previously validated instruments assessing health literacy and numeracy. Results will establish the psychometric properties of the Spanish version of the AGPM.

Eligibility Criteria:
Inclusion Criteria:

* adult (18+ yrs.)
* identifying as Hispanic, Latino, or Latina
* able to provide opt-in electronic informed consent

Exclusion Criteria:

* under age 18 yrs.
* not identifying as Hispanic, Latino, or Latina
* not able to provide opt-in electronic informed consent
Oral Stent Device for Radiation Treatments of Oral Cancers

The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving \>55 Gy by 50%during radiation treatment as assessed duri radiation treatment planning. Patients will have CT scans at three time-points during their standard of care radiation treatment. During these visits patients will receive scans via CT or cone beam CT scan, with both the standard and experimental oral stent devices.

During radiation treatment patients will receive the standard oral stent device.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 year old at the time of informed consent
* Ability to provide written informed consent and HIPAA authorization
* Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively
* Signed consent to study participation
* No history of bleeding disorder
* Platelets within normal limits (150-450 k/cumm)

Exclusion Criteria:

* History of bleeding disorder
* History of allergy to dental grade material