cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses

The aim of the study is to compare the concordance between chest computerized tomography-scan (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen in Allergic BronchoPulmonary Aspergillosis (ABPA).

The ABPA is responsible for pulmonary exacerbations in chronic bronchial diseases. The treatment of ABPA consists in systemic corticosteroids and anti fungal therapy, which can have severe side effects. The diagnosis is difficult, based on several but non-specific characteristics. One of the radiologic abnormalities on CTscan could be more specific : high attenuation in impacted mucus, but this sign is found in about 30% of cases. Recent articles and investigators experience seem to demonstrate that MRI could provide an interesting tool for ABPA diagnosis, studying the signal of bronchial impactions. The aim of the study is to describe the MRI characteristics of patients with ABPA and compare the results with those obtained by CTscan, and in order to determine if there is a specific signal of impaction in ABPA.

Eligibility Criteria:
Inclusion Criteria:

* study patients have a diagnosis of ABPA
* control patients have severe asthma
* All the patients are ≥ 18 years old, have social security care, signature of consent form

Exclusion Criteria:

* cystic fibrosis
* other type of aspergilloses
* contraindication for MRI
* woman without effective contraception
Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial

The purpose of this study is to compare intrapartum glycemic control using insulin pump versus intravenous (IV) insulin administration.

Intrapartum maternal glycemic control in women suffering from pregestational diabetes mellitus type 1 will be evaluated and compared in the 3 study groups. Maternal and neonatal capillary blood glucose will be measured. All women suffering from diabetes mellitus and all neonates to hyperglycemic mothers are being tested for their blood glucose in our institute. Measurements' data will be collected. The primary outcome of the study is the number of neonatal hypoglycemic events (neonatal blood glucose \< 40mg/dL). All women participating in the study will be treated according to the standard accepted protocol for "the treatment of pregestational diabetes during labor" in our institute. The research will not include new treatments or equipment.

The study is a cohort prospective and retrospective observational study in the tertiary center - Sheba medical center.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women suffering from pregestational diabetes mellitus type-1,
* Women are being treated for a minimum of 3 months in the high risk pregnancy clinic in Sheba medical center
* Women are being treated with either insulin pump or SC insulin (basal-bolus)

Exclusion Criteria:

* Women not compliant to treatment
* Women not planning their delivery in our institute
The Characteristic of Airway Microbiome Profiling of COPD-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation

The overlap between chronic obstructive pulmonary disease (COPD) and bronchiectasis is a neglected area of research, and it is not covered by guidelines for clinical practice.

COPD and bronchiectasis share common symptoms of cough with sputum production and susceptibility to recurrent exacerbations driven by new or persistent infection.

Physiological criteria for the diagnosis of COPD and structural criteria for the diagnosis of bronchiectasis create the possibility for individual patients to fulfil both, resulting conceptually in either co-diagnosis or an overlap syndrome between the two conditions. The prevalence of this overlap will vary depending on the respective prevalence of COPD and bronchiectasis in the population under consideration.

A recent study of 201 COPD patients with airway wall abnormalities typical of bronchiectasis confirmed an association with exacerbations and was predictive of mortality over 48 months. A further, single-centre study demonstrated a near three-fold increased mortality rate, with patients with bronchiectasis and associated COPD having a 5-year mortality of 55%, compared with 20% in those with bronchiectasis without COPD. Airflow obstruction is perhaps best considered one marker of disease severity in bronchiectasis.

Disease-associated exacerbations have a major effect on patient healthcare costs as well as quality of life due to increased lung damage and mortality risk. Microorganisms such as Pseudomonas aeruginosa and, to a lesser extent, other Gram-negative and Gram-positive microorganisms identified in culture, have been linked to disease progression, poor clinical outcomes in bronchiectasis and driving airway neutrophil-mediated inflammation. The microbiome has the potential to provide valuable information regarding disease phenotype/endotype, treatment responses and targets for future therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as COPD, bronchiectasis or overlap based on HRCT and lung function test.
* Aged between 18 and 80 years.

Exclusion Criteria:

* Patients with active tuberculosis, traction bronchiectasis, malignancy, and severe systemic diseases.
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction

The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.

The total number of study subjects is 100, with 50 people recruited prospectively into the test group and 50 people retrospectively into the control group.

The test group will consist of 50 patients aged 20 to 80 who have undergone total mastectomy for breast cancer and are scheduled to undergo immediate breast reconstruction using implants. These subjects will receive SC Derm (ADM processed by DOF Inc.) during the implant-based breast reconstruction surgery.

The control group will consist of 50 patients who will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between June 1, 2021, and November 9, 2021.

Patients who fall into the following categories cannot participate in this clinical study because they meet the exclusion criteria:

1. Patients who have received an organ transplant and are taking any immunosuppressants.
2. Patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse.
3. Individuals who are unable to complete the survey conducted in this clinical study.
4. Patients who participated in other clinical trials within the previous 120 days at the time of screening.
5. Patients for whom the investigator determines participation in the study is not appropriate.

Among breast cancer patients who decide to undergo implant-based breast reconstruction after total mastectomy at our hospital, the investigator will fully explain the study to these patients during outpatient visits and recruit those who voluntarily express their willingness to participate.

Before any screening or enrollment, all subjects must confirm their willingness to participate by signing the informed consent form.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy

Exclusion Criteria:

Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.

1. Patients who have received an organ transplant and are taking any immunosuppressant.
2. Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
3. People who are unable to complete the survey conducted in this clinical study.
4. Patients who participated in other clinical trials within the previous 120 days at the time of screening.
5. If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
Effects of Environmental Factors on Opiate Drug Choice in Opioid Dependent Individuals.

The purpose is to study how certain factors, including money, the amount of drug available and the amount of work effort, affect opiate drug choice.

A drug dependent person chooses to take drug more often (and suffer its long-term bad consequences) than choosing to engage in healthy activities (which have better long-term consequences). The present research will be conducted in a controlled laboratory setting with heroin abusers who are not seeking treatment to understand what factors guide their choices.

This research focuses on environmental (i.e. non-medication) factors that affect choosing a drug versus money. Findings from this research are likely to be important in developing a theoretical and practical basis for behavioral interventions as part of drug abuse treatment. HYD is a drug that is currently used as a cough suppressant and to relieve pain.

Participants in this observational study will take part in multiple trials in which they have the opportunity to choose HYD or money. On the first two experimental days, prior to choice sessions, participants will receive a sample of the drug doses that can be chosen. During test sessions, participants will have 12 opportunities to choose either drug or money. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Self-report questionnaires will be completed at different times during the study.

Participants will be maintained on buprenorphine throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Opioid dependent, as determined by structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
* Positive urine test for opiates
* Willing to use an adequate form of contraception for the duration of the study.
* Reads and writes English

Exclusion Criteria:

* Psychiatric illness, as determined by the DSM-IV criteria
* History of or current neurological disease, including structural abnormalities, seizures, infection, peripheral neuropathy, and head traumas
* History of cardiovascular disease, myocardial infarction, chest pain, or edema
* Systolic blood pressure greater than 160mm HG or less than 95 mm HG: PR diastolic blood pressure greater than 95 mm HG.
* Pulmonary disease, including obstructive pulmonary disease, Cor pulmonale, tuberculosis, and asthma
* Systemic disease (e.g. endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, autoimmune disease)
* Current alcohol or sedative drug dependence
* Pregnant or breast feeding
* Currently receiving treatment for opioid dependence
* Known phobia of injections
Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy

The main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance exercise model

Specific aims

1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
2. To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
3. To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy.

We hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with CP, when compared with conventional weight-stack technology. Importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance.

Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients will perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (Fig. 1).


Eligibility Criteria:
Inclusion Criteria:

* Teenagers and young adults between 16-25 years of age
* Unilateral or bilateral spastic cerebral palsy
* Gross Motor Function Classification System (GMFCS) of level I, II or III.

Exclusion Criteria

* Surgical treatments of the knee extensor apparatus within the last 12 months
* Botulinum toxin treatment within the last six months
* Ongoing intrathecal baclofen treatment
Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study

Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. A score to assess the severity of illness may be associated with acts to develop an activity indicator easy to use. The investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not been validated. The correlation between the severity of children and the associated diagnoses and acts has not been studied. The main objective of this study is to validate these 2 scores. The secondary objective is to determine a simplified activity indicator.


Eligibility Criteria:
Inclusion Criteria:

* All children admitted to the paediatric inpatient unit

Exclusion Criteria:

* parental refusal
Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation

The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.

Patients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Known aortic regurgitation of any grade
* Scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned.

Exclusion Criteria:

* Non sinus rhythm
* Mitral regurgitation more than mild.
* Pre-operative critical state (according to the definition of the EuroSCORE II)
* Presence of a prosthetic aortic valve
* Contra-indication to trans-esophageal echo
Palliative Care for Patients With Liver Cirrhosis

Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment.

Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services.

Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services.

Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status.

Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention.

Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.


Eligibility Criteria:
Inclusion Criteria:

1. Liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness
2. 2 or more items checked on the Supportive and Palliative Care Indicators Tool (SPICT™, appendix)
3. Expressed desire for palliative support from the patient and relatives
4. Ability to give informed consent

Exclusion Criteria:

1. Inability to give informed consent
2. Age \< 18 years
3. Ongoing contact with specialized palliative care teams or hospice
4. Other chronic life-threatening illness than liver cirrhosis is more likely to become the cause of death within 1-2 years.
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. All patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (C0168T37 ,C0168T46, C0168T72) are eligible to participate in this long-term safety follow-up study (C0168T62). Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years. No study agent will be administered. Information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. In addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. All adverse events, including non-serious adverse events, will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
* Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion Criteria:

- Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation
Individual Dosing of Levothyroxine After Thyroidectomy

Recently, Zaborek et al. raised a Poisson regression model for levothyroxine(LT4) dosing scheme to predict individual dose of LT4 after thyroidectomy: daily LT4 dose=e\[2.02+0.01(W)-0.0037(A )-0.098(F)-0.01(B)+0.007(T)+0.108(I)-0.014(M), where W is the weight of the patient (Kg), A is the age of the patient (years), and F is the gender (for women 1, male is 0), B represents the patient's body mass index (BMI), T represents the preoperative TSH level, I represents whether the patient takes iron preparations (1, if not 0), M represents whether the patient takes multivitamins/minerals (1, if not 0). We demonstrated its value with our retrospective data in our center. Therefore, we intend to carry out this randomized controlled trial in order to further evaluate the model. The clinical significance of this method can provide a basis for the future use in clinical optimization of individualized dosing.

Patients who underwent total/near-total thyroidectomy or completion thyroidectomy and require levothyroxine replacement therapy will be enrolled in this study. They will be randomized distributed into two groups. In one group, patients will be dosing LT4 according to weight-based algorithm, namely 1.6 μg /kg/d. In the other group, patients will be dosing LT4 according to the Poisson regression model algorithm. They will be followed up 3-6 weeks after surgery for the first time. During the follow up, thyroid hormone will be tested and LT4 dosing will be adjusted accordingly. Then, we compare patients in which group will achieve euthyroidism more quickly.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent total/near-total thyroidectomy or completion thyroidectomy; patients with benign disease, or low-risk differentiated thyroid cancer, or medullary thyroid cancer who don't need TSH suppressive therapy;

Exclusion Criteria:

* patients with heart disease or severe liver/kidney insufficiency; patients taking liothyronine in addition to levothyroxine;