cyrilzakka/clinical-trials huggingface dataset:
Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are:

* Does MDT lower the possibilities participants have brain damage before the age of one?
* How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN.

Participants will:

* Take MDT or a control method in the management of sNH
* Assess if there's brain damage before discharge and at the year of one
* Record how many times of abnormalities in cranial MRI is detected before the age of one


Eligibility Criteria:
Inclusion Criteria: Inclusion Criteria:

Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams

* Infants with severe neonatal hyperbilirubinemia, including those whose serum total
* bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB \> (threshold - 2) mg/dL).

Exclusion Criteria:

* Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.


Eligibility Criteria:
Inclusion Criteria:

* Should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016).
* Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
* Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Should have adequate hematologic, kidney and liver function as described in the protocol.
* For participants enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol.

Exclusion Criteria:

* Has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
* Has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol.
* Has active central nervous system leukemia.
* Has a history of chronic New York Heart Association (NYHA) class IV heart failure.
* Has a corrected QT interval of \> 450 ms.
* Has a chronic respiratory disease that requires continuous oxygen use.
Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL)

Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old
* ASA I - II
* ACL reconstruction surgery

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurologic deficit in the arm that is going to be operated
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
Prevention of Falls in General Practitioner for Community-dwelling Older Adults [PreFalls]

The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. In addition a reduction of fall-related injuries, reduction of fall-related risk factors and preservation of Quality of Life is to be achieved.

A second goal of this study is the implementation of standardized assessment for fall risk factors as well as building up a network between instructors for fall prevention exercise and general practitioners.

Health related consequences of falls are underestimated. In comparison to different health related risk factors like hypertension etc. falls and their risks are being underestimated by many physicians. Regardless of the high relevance of falls for the elderly as well as the Health Care System, risk of falling is only rarely being assessed. The reasons for this are manifold. Insufficient assessment of risk of falling are one of the reasons. Many registered doctors with their own practice do not use a standardized assessment of risk of falling that is quick and effective. Additionally, patients rarely report occurred falls to their physicians because they don't know the implications or are afraid of subsequently losing their independence.

Physicians already assessing their senior patients' risk of falling lack the possibility to assign them to according ambulatory interventions since these scarcely exist in Bavaria. Chances for improvement are: standardized assessment of risk of falling needed to uncover senior patients' risk of falling quickly, reliably and efficiently at their family physician's. At the same time area-wide programs to effectively reduce falls by targeting individual behavior as well as general conditions must be provided to maintain the independence of individual senior citizens.

Eligibility Criteria:
Inclusion Criteria:

* Target group are community-dwelling senior citizens aged 65 years or above with an increased risk of falling.
* Increased risk of falling are seen by:

  * history of falls
  * fear of falling
  * chair rise \> 10 sec./TUG \> 10 sec./ subjective \& objective balance deficits

Exclusion Criteria:

* Elderly people not living independently or suffering from physical or mental restrictions that do not allow the participation in an exercise program or the assessment of risk of falling
Rural Survivorship Navigation Program

The purpose of this proposed study is to enhance the investigators understanding of the comprehensive psychosocial and medical needs of rural cancer patients and survivors along the cancer continuum, ultimately allowing us to address these gaps by identifying areas of support that can be bolstered by a population health navigator focused on rural populations.

Primary objectives

To enhance understanding of the comprehensive psychosocial and medical needs of cancer survivors and caregivers in rural northwest North Carolina, focusing on their health needs, psychosocial concerns, perceived needs related to cancer and survivorship care, access/barriers to care, and knowledge/perceptions of clinical research using focus groups and semi-structured interviews. This aim is hypothesis-generating.

To document rural cancer patient/survivors' reports of: a) health behaviors; b) psychosocial needs; c) current health-related information and supportive care needs; d) barriers to care; e) symptoms and health-related quality of life using a quantitative survey

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis (other than non-melanoma skin cancer) and \> 6 months post-definitive treatment (e.g., surgery, chemotherapy, and/or radiation); Survivors on ongoing systemic maintenance therapies (e.g., hormonal therapies and immunotherapies) are eligible
* Currently residing in one of the 6 priority counties in northwest North Carolina (Alleghany, Ashe, Avery, Mitchell, Stokes, Surry, Watauga, or Wilkes) or in a rural area in North Carolina as defined by a rural-urban commuting area (RUCA) code of 4-10.
* Ability and willingness to attend a one-time focus group or interview and/or complete a one-time study survey
* Age greater than 18 years.

Providers:

* Healthcare provider (e.g. primary care, oncology or other specialty, allied health) with knowledge of the needs of adult cancer survivors who are currently working in one of the priority counties in Northwest North Carolina (Alleghany, Ashe, Avery, Mitchell, Stokes, Surry, Watauga, or Wilkes)
* Ability and willingness to attend a one-time interview

Exclusion Criteria:

* Those who are unable to read and understand English, as the study interviews/focus groups and survey will be conducted in English
* Unwilling to participate in the study
Colorectal Polyp Clinical Decision Support Device Study

The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.

Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience.

Consecutive consented patients meeting the entrance criteria will undergo standard colonoscopy with the adjunctive use of CDSD. Sensitivity and specificity of CDSD-unaided and CDSD-aided predictions will be compared with the ground truth of histopathology.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Willing and able to provide informed consent
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
* Inflammatory Bowel Disease
* Hereditary Non Polyposis Colorectal Cancer
* Severe coagulopathy
* Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
* No diminutive polyps detected during colonoscopy
Remote Ischemic Conditioning in HSCT

This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. The hypothesis will be tested using a prospective study design. The purpose of the study is to determine tolerability and safety of remote ischemic conditioning in pediatric and adolescent patients undergoing HSCT, with the goal of a larger trial of efficacy to follow. The secondary purpose is to determine if remote ischemic conditioning will reduce subclinical cardiotoxicity as measured by markers of myocardial injury and stress in patients undergoing HSCT. The study will include multiple blood collections and echocardiograms.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients, 10 years of age or above.
2. Able to tolerate upper arm blood pressure inflation.
3. Participating in the BMT Biorepository (2012-1156).

Exclusion Criteria:

1. Systolic blood pressure \>160 mmHg.
2. Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve.
3. Chronic kidney disease as defined as a pre-transplant GFR \<80
4. Central line in both upper extremities.
5. Known peripheral vascular disease or vasculitis.
6. Platelet count less than 30,000.
7. Known clotting disorder or hypercoagulability
8. Non-English speaking patients.
Motivational Interviewing to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1

The purpose of this study is to assess Motivational Interviewing (MI) to improve treatment engagement and outcome in subjects seeking treatment for substance abuse.

Participants seeking treatment at the participating CTPs will be randomly assigned to either "standard" or "MET/MI" treatment, with a 1- and 3-month follow-up. Primary outcome measures will include (1) treatment retention (e.g., number of sessions/weeks completed, the rate of patients completing 3 or more subsequent sessions, and (2) substance use (e.g., urinalyses, days of opioid, cocaine, marijuana, alcohol use, rates of abstinence). Secondary outcomes will include motivation, psychosocial functioning, HIV risk behaviors, treatment utilization, and patient satisfaction. Process assessments will include measures of the working alliance as well as therapist adherence/competence ratings which will evaluate how effectively MET/MI was implemented. Participating CTPs will implement one of two independent protocols, depending on which is the best suited or feasible for the intake procedures at their clinic. Thus, following an invitation to participate, explanation of the study, and provision of informed consent, patients would complete a brief assessment battery followed by either:1) Random assignment to 3 individual sessions of standard treatment (treatment as usual) at the program versus 3 individual sessions of MET; or 2) Random assignment to 1 individual standard assessment/evaluation session.

Eligibility Criteria:
Inclusion Criteria:

Individuals will be eligible for the protocol who: a)Are seeking outpatient treatment for any substance use disorder. b)Are 18 years of age or older. c)Are willing to participate in the protocol (e.g., to be randomized to treatment, be contacted for follow-up assessment, to have their sessions audiotaped). d)Are able to understand and provide written informed consent.

Exclusion Criteria:

Individuals will be excluded who: a)Are not sufficiently medically or psychiatrically stable to participate in outpatient treatment. b)Are seeking detoxification only, methadone maintenance, or residential inpatient treatment.
Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta

Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis

Systemically healthy and non-smoking participants were included in the study. The study groups included a total of 100 participants, 50 of whom were periodontally healthy (healthy group) and 50 with periodontal disease (periodontitis) group). The clinical parameters of plaque index (PI), gingival index (GI), and pocket depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were measured.

The gingival fluid samples were taken in the direction of the paper strip and ELISA method was used for their analysis. A positive, statistically significant relationship was found between IL-1β levels and all clinical parameters (PI, GI, PD, CAL, BOP) (p\<0,01). Likewise, there is a positive and significant relationship between BPI levels and clinical parameters (p\<0,01).

There is a statistically significant positive correlation between GCF volume and clinical parameters PI (r: 0,722), GI (r: 0,740), PD (r: 0,742), CAL (r: 0,751) and BOP (r: 0.752) (p \< 0.01). In the comparison between the groups, it is seen that both IL-1β and BPI levels were statistically significantly higher in the periodontitis group compared to the healthy group (p \< 0,001).

Eligibility Criteria:
Inclusion Criteria:

1. For the periodontitis group, intraoral examination shows inflammation in the gums, supragingival and by observing the formation of subgingival tartar and microbial dental plaque and pockets, Diagnosis of periodontitis means that there is a vertical or detection of horizontal bone loss (Periodontitis group),
2. Failure to observe the presence of periodontal pockets, vertical and horizontal no bone destruction, bleeding score on full-mouth probing below 10 percent (Healthy group),
3. Agreeing to participate in the research and filling out and signing the voluntary consent form.

Exclusion Criteria:

1. Pregnant and lactating individuals,
2. Individuals who smoke,
3. Individuals with any systemic disease,
4. Individuals who have received periodontal treatment in the last 6 months,
5. Individuals who have used antibiotics in the last 6 months
6. Individuals in whom local factors that increase destruction such as fillings and crowns are observed in areas with periodontal pocket formation.
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy

Exclusion Criteria:

* Previous treatment with Class IC or class III AAD
* Previous AF ablation procedure
* Congestive heart failure (NYHA III-IV functional class)
* Left Ventricle ejection fraction less than 35%
* Left atrial diameter \> 55mm
* Unwillingness to participate
Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

The aim of this study is to compare the effects of intrathecal levobupivacaine plus midazolam and levobupivacaine plus fentanyl in patients undergoing caesarean section to get a prolonged postoperative analgesic effect and less side effects


Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anaesthesiologists grades I and II ,

Exclusion Criteria:

* pre-existing neurological or spinal disease
Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands

The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:

1. Disease activity
2. Safety and tolerability of aHSCT
3. Changes in the immune system

Participants will be subjected to frequent visits for five years after treatment with aHSCT. During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed.


Eligibility Criteria:
Inclusion Criteria:

* All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS

Exclusion Criteria:

* Contra-indications for treatment with aHSCT such as known hypersensitivity to the medication used for aHSCT
* Clinically relevant comorbidities preventing safe use of medication used for aHSCT
* Severe clinical depression
* Active addiction to drugs or alcohol
* Active infections such as but not limited to tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, HIV or syphilis.
* Active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix
DxFLEX 10C Clinical Study

A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.


Eligibility Criteria:
Inclusion Criteria: Patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria:

1. Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing.
2. Hematologically abnormal specimens
3. Subjects of any range, ethnicities, and racial backgrounds
4. Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines.

Exclusion Criteria:

There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study:

1. Pre-analytical/Pre-screen exclusion criteria
2. Post-acquisition exclusion criteria.
A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550

In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .

This is a bioequivalence study for CP-690,550.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.

* Evidence or history of any clinically significant infections within the past 3 months.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
ATV/Ritonavir Nevirapine Interaction (USPAC)

Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent form
* For Cohort 1, HIV-infected subjects receiving nevirapine 200 mg twice-daily and 2 to 3 NRTIs for at least 6 weeks
* For Cohort 2, HIV-infected subjects receiving atazanavir 300 mg and ritonavir 100 mg once-daily and 2 to 3 NRTIs for at least 6 weeks
* Have had 2 measurements of plasma HIV RNA of \<400 copies/mL. The first test being 6 to 16 weeks prior and the second being within 3 weeks prior to Day 1
* Have CD4 cell count \>=200 cells/mm3
* Body Mass Index of 18 to 35 kg/m2.
* Men and women, ages 18 to 55.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Presence of a newly diagnosed HIV-related opportunistic infection or CD4 cell count \<200 cell/mm3 within the previous 6 months.
* Any significant acute or chronic medical illness, unless stable or controlled by a non-prohibited medication.
* History of virologic failure on an antiretroviral regimen.