cyrilzakka/clinical-trials huggingface dataset:
Lymphocyte Immunophenotyping in Common Variable Immunodeficiency

The purpose of this study is to discover if differences in the surface markers of B-cells (antibody producing cells of the immune system) in Common Variable Immune Deficiency (CVID) are related to CVID or its complications/treatment (e.g. bronchiectasis, granulomatous disease, immunoglobulin treatment).

The study hypothesis is that the altered B-cell surface markers are related to CVID, and not to the complications or treatment of CVID.

Common Variable Immune Deficiency (CVID) is a syndrome containing a spectrum of disorders which results in weakened immunity and recurrent infections. The ESID (European Society for Immunodeficiencies) CVID definition includes patients with marked decrease of IgG (at least 2 standard deviations below the mean for age). Patients must also have disease onset at an age over 2 years, absent isohaemagglutinins and/or response to vaccines and other defined causes of hypogammaglobulinaemia must be excluded. The Euroclass system of classifying CVID is the result of a European multicentre trial attempting to develop a consensus of two existing classification schemes of B-cell immunophenotyping. In this paper it was shown that B-cell immunophenotype correlated with coincidence of clinical sequelae and it suggested implementing this to further classify CVID to give prognostic and therapeutic information. However, it has not yet been shown that these alterations in B-cell immunophenotype are the result of CVID itself and not caused by the treatment or complications of CVID (e.g. immunoglobulin replacement therapy, granulomatous disease, bronchiectasis). The aim of this study is to show that alterations in B-cell immunophenotype are caused by CVID itself and not by its complications or treatment. The study will therefore compare CVID patients to suitable control patients with granulomatous disease, bronchiectasis and on long-term immunoglobulin therapy. A control group of normal people will also be included to ensure the assay can detect normality and to show differences between normal people and patients with CVID.

Eligibility Criteria:
Inclusion Criteria:

* 18 or over
* Competent to consent
* Have diagnosis of Common Variable Immunodeficiency, granulomatous disease, on long term immunoglobulin or bronchiectasis.

Exclusion Criteria:

* Under 18
* Unable to consent.
* Medical problem that could alter B-cell immunophenotype (except for the diagnoses in the inclusion criteria)/
Breathing Exercise for Rib Fracture

Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. In our study, patients with rib fractures will be divided into two groups. In the control group, standard treatment consisting of routine analgesic treatments will be applied. In the other group, respiratory physiotherapy will be applied with triflu for 8 hours a day. At the end of the study, pulmonary complications in both groups will be compared.

Patients between the ages of 18 and 100 who will apply to our hospital due to rib fractures between April 2024 and April 2025 will be evaluated. Patients who meet the inclusion criteria will be included in the study. Patients will be divided into two groups using randomization blocks. Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. In the other group of patients, in addition to conservative treatment, triflow breathing exercise will be applied for 8 hours a day. Respiratory function test pain scores and pulmonary complications of patients in the two groups will be compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* Isolated thoracic injury within 24 hours
* Age between 18-100

Exclusion Criteria:

* Pneumothorax and hemothorax requiring intervention at admission
* Injury severity index \>16
* COPD, Atshma
* Extrathoracic trauma
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients

The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.


Eligibility Criteria:
Inclusion Criteria:Subjects should meet all of the following criteria to participate in the trial.

* Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy
* Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.
* Aged 18 years or older.
* ECOG performance status of ≤ 2.
* Anticipated life expectancy of ≥ 3 months.
* Clinically acceptable function of bone marrow, kidney and liver function as below.

  1. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
  2. Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
  3. Serum creatinine ≤ 1.5 mg/dL or CLcr \> 60 ml/min
* Subjects whose written informed consent can be obtained prior to their participation in the trial.

Exclusion Criteria: Subjects who meet any of the following criteria should not be included in the trial.

* Pregnant or breast feeding women
* Serious concurrent complication, severe active infection.
* Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis
* Subjects with epilepsia or severe psychiatric disorders.
* Subjects who are regarded to be unsuitable for this trial by the investigator.
* Subjects who are participating in other clinical trials
* Subjects who have received prior chemotherapy including irinotecan.
Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy

Despite careful monitoring of patients with diabetes, it is so far difficult to predict the occurrence of cardiac events in the evolution. As shown by various studies conducted in patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or systolic functions using non-invasive investigations such as echocardiography. For 4 years, the evaluation technique of myocardial deformations by two-dimensional speckle tracking strain by echocardiography is the subject of high hopes in the earlier detection of still asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this technique would improve the detection of myocardial contraction abnormalities in patients with insulin-dependent diabetes mellitus (IDDM), and would establish their association with micro-angiopathy, frequently encountered in these patients.

This is a single center case-control study based on routine care, designed to recruit patients with type 1 diabetes mellitus free from any other myocardiopathy. The inclusion will take place over a period of 24 months. No monitoring of patients (no follow-up) is provided under this protocol. The analysis will focus on the combination of the left ventricle myocardial deformations alteration revealed by the echocardiographic 2D strain analysis (\< 18% in absolute value), with the existence of micro-angiopathy in type 1 diabetes mellitus patients with preserved left ventricular ejection fraction ( ≥ 60%).

Two hundred subjects with type 1 diabetes mellitus will be recruited: 100 subjects with impaired left ventricular myocardial deformation by 2D strain analysis (\< 18% in absolute value), constituting the 'cases' group and 100 subjects without alteration in myocardial deformation (global strain ≥ 18%).

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 45 years
* with diagnosed Type 1 diabetes mellitus (with or without complications or peripheric vascular micro-angiopathy)
* having a negative myocardial ischemic test (exercise echocardiography) in the previous month inclusion

Exclusion Criteria:

* Known or suspected coronary artery disease
* atrial fibrillation
* hypertension
* moderate to severe valvular disease
* sequelae of myocardial infarction
* secondary or primary cardiomyopathy
* myocardial conduction abnormalities
* pregnancy or breastfeeding.
Effectiveness of a Four-level Chinese Emergency Triage Scale in Mainland China

Inter-rater reliability between experts and triage nurses was assessed in 484 emergency patients. The criterion-related validity was evaluated in other 30687 emergency patients, based on emergency department (ED) mortality, the length of stay in ED, the number of discharge, and hospitalization (intensive care/general ward).


Eligibility Criteria:
Inclusion Criteria:

* Patients, older than 14 years and admitted to the ED, were eligible for this study.

Exclusion Criteria:

* Gynecologic and obstetric emergencies
* Patients, who left against medical advice or hadn't been aided by a doctor
Health Literacy 3D Kidney Model Patient Education Trial

High blood pressure has a different rate effect on many minoritized individuals. African Americans, as a result of high blood pressure, are six times more likely to go through kidney failure compared to white counterparts. Hispanic communities are also disproportionately affected by high blood pressure and, unfortunately, generally have lower knowledge about the effects on the kidneys as well. Unfortunately, many minoritized and underserved communities are affected by the weight of the social determinants of health, i.e., housing, education, food, health care, etc., that contribute to large disparities in health outcomes. These factors lead to poor care management, less ability to manage care effectively, and disengagement from care. Health education is vital to recognizing and communicating with minoritized patients with hypertension-induced chronic renal disease. As the patient's knowledge of the condition grows, this can significantly influence the trust between clinicians and patients. Effective and patient-centered education can inspire patients to be proactive in their prevention strategies with clinicians. This study's overall goal is to assess the utility of a novel patient education tool (3D-printed healthy kidney and diseased kidney models) in optimizing patient education for underserved populations who have hypertension with a potential lead to hypertension-induced chronic renal disease.

The overall Aims of the study are to:

Aim 1: Examine the feasibility of creating a high-quality life-size 3D reconstruction of a healthy kidney model and diseased kidney model through collaboration with NIH 3D print exchange and the University of Kentucky College of Engineering.

Aim 2: Assess the acceptability and preliminary efficacy of 3D print model-supported patient education in improving the patients' medical understanding, motivation for self-care, intention to adhere to the clinician's instructions, and better trust between clinician and patient.

Aim 3: Continuously implement of 3D-printed models for patients in new or current care education so that it can be sustainable after the research project is concluded.

To achieve Aim 2, up to 100 patients with hypertension-induced chronic renal disease will be enrolled and randomized to receive either standard clinician-led patient education (TAU) or patient education employing the 3D kidney model. A brief pre-post structured survey will be implemented to measure changes in patients' understanding of their condition, as well as acceptability of the 3D model for those assigned to the experimental education condition.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* Seeking medical care in study location
* Current diagnosis of hypertension and renal disease

Exclusion Criteria:

-
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper

Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. When patients need to or want to come off their opioid pain medications, there is little to guide physicians as to how to best help them do so, and it is not known how patients do after coming off opioid medications. The goals of this study are (1) to evaluate two medications in assisting patients in coming off their opioid pain medications and (2) determining outcomes after discontinuing opioids.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 70 years of age
* Ability to speak and read in English
* Currently taking chronic opioid therapy for pain for at least 6 months
* On opioid dose of \>60mg and \<200mg oral morphine equivalents/day
* Voluntarily seeking opioid discontinuation
* Willing to attempt buprenorphine-assisted opioid discontinuation
* Willing to be randomized to gabapentin or placebo
* Have current physician who is actively prescribing opioids and who will be notified by the research team of the patient's entry into the study.

Exclusion Criteria:

* Previous intolerance or allergy to buprenorphine or gabapentin
* Diagnostic \& Statistical Manual -V criteria for substance use disorder currently or in the past (other than nicotine)
* Unstable medical or psychiatric condition that would preclude safe or meaningful participation (e.g. traumatic brain injury; severe mental illness; severe cardiac, renal, pulmonary, or liver disease)
* Current use of illicit drugs
* Maintenance on fentanyl or methadone
* Current treatment with gabapentin
Liothyronine (T3) for Bipolar Depression

This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with bipolar disorder. In this study patients will be randomized to receive T3 or placebo.

Bipolar affective disorder is a debilitating illness, and is characterized by depression episodes that dominates the longitudinal course and are most difficult to treat. Controlled trials with monotherapy mood stabilizers such as lithium and valproate show little to no efficacy and antidepressants may offer no additional efficacy. Recently there has been a growing interest in the use of quetiapine in bipolar depression. However, a successful treatment may take up to 8 weeks, and full remission is achieved in only 50% of patients. Thyroid hormone augmentation strategies have been used in unipolar depression with good results, but there is a paucity of its efficacy in bipolar depression (BD). To our knowledge there are no controlled studies regarding the efficacy of thyroid augmentation in BD. The present study proposes to evaluate the efficacy of T3 as an augmentation to treatment as usual in the treatment of BD. We plan to enroll patients with bipolar disorder I or II who are currently presenting with depressive symptoms. Patients will be randomized to 2 groups - liothyronine or placebo Results will provide information on the possible role of thyroid hormone augmentation in the treatment of patients with bipolar depression, and may contribute to alleviate the burden of this disabling condition.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65;
2. DSM-IV diagnosis of BP I or BP II as per SCID;
3. Currently presenting with at least moderate levels of depression (HAM-D \> 15;
4. Patient has to be on stable dose of at least one mood stabilizer (lithium, valproate, carbamazepine, lamotrigine, second generation antipsychotics) for at least 4 weeks as per history;
5. Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks;

Exclusion Criteria:

1. Evidence of acute mania or hypomania (as measured by CARS-M \> 7);
2. Abnormal (outside of lab normal range) thyroid function tests;
3. Current thyroid hormone treatment;
4. Any medical condition considered a contraindication for treatment with T3 (i.e. history of myocardial infarction, cardiac arrhythmia, severe cardiac insufficiency, Autoimmune Thyroid Disease /Hashimoto's Thyroiditis as determined by anti-thyroid antibody testing, previous or current thyroid adenoma, hyperthyroidism);
5. EKG showing rhythm other than sinus or repolarization phase abnormalities;
6. Current alcohol or substance abuse or dependence in past month as per SCID;
7. Score of 3 or more on the suicide item of the HAM-D;
8. Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.
A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation

The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be undergoing their first cardiac allograft transplant
* Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation
* Women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy
* Participants and/or their guardians must be willing and be capable of understanding risks and comply with the purpose of the study

Exclusion Criteria:

* Previous organ transplants
* Participants receiving multiple organs
* Participants requiring ventricular assist device (VAD) upon completion of transplantation surgery
* Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study
* History of a psychological illness or condition which would interfere with the participant's ability to understand the requirements of the study
* White blood count =\<2500/mm\^3, platelets =\<50,000/mm\^3 or hemoglobin =\<6 g/dL
* HIV-1, the presence of positive HBsAg, or chronic active hepatitis C
* Active peptic ulcer disease
* Severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication
* Malignancies within the past 5 years, excluding skin carcinoma that have been adequately treated
* Participants who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study
* Inability to start microemulsion form of cyclosporine within 72 hours
Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.

Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Large volume of pleural effusion (1 liter and more), required evacuation
* Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor)
* Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)

Exclusion Criteria:

* Autoimmune disorders
* Previous treatment for
rTMS for the Treatment of Freezing of Gait in Parkinson's Disease

This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The investigators hypothesize that treatment with rTMS on supplemental motor area will improve gait quality and decrease the frequency of FOG in PD patients.

Freezing of gait (FOG) is a common and debilitating symptom in patients with Parkinson's disease (PD), characterized by sudden and brief episodes of inability to produce effective forward stepping. FOG is a major risk factor for falls, and greatly contributes to reduced mobility and quality of daily life. Treatment of FOG has been perceived as a very challenging task. Although various treatment approaches exist, including pharmacological and surgical options, evidence is inconclusive for many approaches and no clear treatment protocols are available until now.

Repetitive transcranial magnetic stimulation (rTMS), a noninvasive neural modulation technique, has been closely applied as a treatment for various neurologic and psychiatric disorders. A recent meta-analysis demonstrated that rTMS could improve motor symptoms for PD patients with a moderate effect size. To date, however, only few rTMS studies have focused on its efficacy on FOG in patients with parkinsonism, and most of them targeted the primary motor cortex or dorsolateral prefrontal cortex . Even though some evidence indicates the involvement of the SMA in FOG, no report has described the SMA rTMS in PD patients with FOG.

Moreover, few studies combined functional magnetic resonance imaging (fMRI) and rTMS to unravel the mechanism of its beneficial effects. To address these issues, the investigators conducted a randomized, double-blind, sham-controlled study to explore the efficiency of SMA-rTMS on FOG in PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD patients.
* Presenting with FOG.
* The mini-mental state examination questionnaire score above 24 points.

Exclusion Criteria:

* Other neurological or psychiatric disorders.
* History of epilepsy, seizures or convulsions.
* Metal implantation.
* History of exposure to rTMS in the past (to minimizing risk of unblinding sham condition).
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have participated in the 331-14-213 study.
* Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.

Exclusion Criteria:

* Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.