cyrilzakka/clinical-trials huggingface dataset:
Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

This study evaluates structural and functional repercussions of pulmonary tuberculosis sequelae by chest imaging (computed tomography and radiograph), functional respiratory tests (spirometry and six minute walking test) in patients with cured pulmonary tuberculosis.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary tuberculosis with completed treatment (patients that received at least six months of treatment and with confirmed cure by negative culture and/or sputum smear, or clinical and radiological improvement after well succeed treatment);
* Treatment finalized at least one year before.

Exclusion Criteria:

* Physically impaired to perform the functional tests;
* Coexisting lung pathology (history of previous respiratory disease or clinical or radiological evidence of lung disease other than tuberculosis);
* Pregnants.
Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope

The aim of this study is to determine if the insertion of the linear endobronchial ultrasound bronchoscope is more comfortable for patients when done through the nose compared to its insertion through the mouth. Our hypothesis is that nasal insertion is more comfortable.

Linear endobronchial ultrasound (EBUS) now plays a crucial role in the diagnosis, staging, and treatment planning of lung cancer. Most centers perform linear EBUS via the oral route given the larger diameter of the bronchoscope used. However, the feasibility and the diagnostic accuracy of linear EBUS performed through the nose have not been reported. Furthermore, the two routes of insertion have never been compared in terms of patient satisfaction and comfort.

In order to compare the two routes of insertion, consecutive patients referred for a linear endobronchial ultrasound will be recruited. Participants will be randomized to either oral or nasal insertion. All participants will be sedated and will receive local anesthetics in a similar manner. After the procedure, patients will fill a questionnaire regarding their comfort and satisfaction with the procedure.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years of age
* patients referred for a first linear endobronchial ultrasound

Exclusion Criteria:

* Patients who previously underwent an EBUS
* Patients intubated with an endotracheal tube
* Patients under the age of 18
* Patients unable to provide informed consent
* Patients currently taking anticoagulants (therapeutic doses of intravenous or subcutaneous heparin, low-molecular weight heparins, direct thrombin inhibitors or other agents)
* Patients taking anti-platelet therapy other than aspirin (clopidogrel, ticagrelor, prasugrel). A period of 7 days off medication is required before participation.
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.

Inclusive criteria are:

* 18-75 years of age
* ASA physical status I-III
* BMI \< 35 kg/m2

Exclusion Criteria:

* all open shoulder procedures
* patient having difficulty understanding the instruction on using the anesthetic infusion pump
* contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy)
* significant neurologic disorders of the upper extremity
* psychiatric or cognitive disorders
* history of substance abuse or chronic opioid use
Novel Dietary Interventions for Treating Insulin Resistance

Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI): 30.0-40.9 kg/m\^2
* Metabolic Syndrome

Exclusion Criteria:

* Diabetes
* Inflammatory diseases
* Eating disorders
* Pregnancy
* Known kidney, coronary, gastrointestinal or peripheral artery disease
* Smoking
* Recent fish oil (\>500mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/day) or polyphenol supplement use
* Recent weight change
* Strenuous exercise
* Fish/food allergies
* Current diabetic, lipid-lowering (fibrates, statins), anti-inflammatory, immune-suppressant, and/or anti-inflammatory hypertension medication use
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Diagnostic Group 1, with pulmonary vascular resistance \> 800 dyne\*sec\*cm\^-5,
* On stable doses of bosentan and sildenafil

Exclusion Criteria:

* Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as congenital large or small unrepaired systemic to pulmonary shunts, portal hypertension, Human Immunodeficiency Virus (HIV) infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic teleangiectasia, hemoglobinopathies, myeloproliferative disorders, veno-occlusive pulmonary disease
* Significant lung diseases not related to PAH
* Significant cardiovascular system disorders, hematological system disorders, liver insufficiency
* Significant diseases in other organ system.

Other protocol-defined inclusion/exclusion criteria may apply
Effect of a Secure Message Reminder on Hypertension Follow-up at an Integrated Health Care System

This study will assess whether adding a secure message reminder to routine care improves the percentage of patients who complete a follow-up appointment with a new, documented blood pressure reading.

Hypertension is one of the leading risk factors for cardiovascular disease. Optimizing blood pressure management can help prevent adverse cardiovascular outcomes. The National Committee for Quality Assurance (NCQA) defines blood pressure control as less than 140/90 mmHg. Per this definition, less than half of Americans with hypertension are considered controlled. Literature has been published describing several ways of improving blood pressure management, but results have been variable.

Eligibility Criteria:
Inclusion Criteria:

* Member of Kaiser Permanente Georgia Pharmacy Cardiac Risk Service (PCRS)
* 18-75 years of age
* Enrolled in http://kp.org
* Most recent documented blood pressure is greater than or equal to 140/90 mmHg

Exclusion Criteria:

* Most recent documented blood pressure is greater than or equal to 180/110 mmHg
Reflective Mindfulness and Emotional Regulation Training to Enhance Nursing Students' Self-Awareness, Understanding, and Regulation

This study assessed the impact of a six-week Reflective Mindfulness and Emotional Regulation Training (RMERT) program on fourth-year nursing students. Using a randomized controlled trial with 40 participants, the intervention group (n=20) received RMERT, while the control group (n=20) continued standard coursework.

This study evaluated the effectiveness of Reflective Mindfulness and Emotional Regulation Training (RMERT) in enhancing nursing students' self-awareness, emotional understanding, and regulation. Nursing students frequently face significant academic and psychological challenges, particularly in mental health nursing courses, which can lead to stress, anxiety, and compromised well-being. RMERT was designed as a psychoeducational intervention integrating mindfulness and emotional regulation techniques to help students develop critical skills for managing these challenges.

Study Design The randomized controlled trial employed a mixed-methods approach and involved 40 fourth-year undergraduate nursing students at Benha University. Participants were randomly allocated into an intervention group (n=20) and a control group (n=20). The intervention group attended a six-week RMERT program, while the control group continued their standard academic activities without additional interventions. Both groups underwent pre- and post-intervention assessments using validated instruments: the Emotion Regulation Questionnaire (ERQ) and the Mindful Attention Awareness Scale (MAAS). Qualitative data, collected exclusively from the intervention group, were analysed thematically.

Intervention The RMERT program consisted of six weekly 90-minute sessions facilitated by researchers trained in cognitive behavioural therapy (CBT) and transactional analysis (TA). The training employed the ABC model of CBT (activating events, beliefs, and consequences) to address maladaptive cognitive patterns, along with TA techniques such as empathic inquiry and reflection. Relaxation strategies, including diaphragmatic breathing and progressive muscle relaxation, were also integrated. The sessions focused on enabling students to reflect on their mental and emotional states, process their feelings, and apply cognitive reappraisal-a healthy emotional regulation strategy-instead of relying on expressive suppression, which is maladaptive.

Eligibility Criteria:
Inclusion Criteria:

* Students enroled in the psychiatric/mental health nursing course for the first time, i.e., did not enrol in or join similar or the same course before.
* for example, joined the faculty from the secondary school, not through other paths or bridging educational programs that would include psychiatric/mental health courses/modules as part of their programs
* did not fail the course before or attended it for more time.

Exclusion Criteria:

no
Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)

Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will be monitored. Safety and efficacy will be observed in the study.

This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be immunized i.d. and i.v. biweekly with DC cellular vaccines. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria, progression-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed glioblastoma grade IV
* Patients at the age of 18-65.
* Patients must have undergone maximal surgical resection of the tumor.
* Patients with Karnofsky scores \> or =70
* Patients with normal range of hematologic and metabolic test results.
* Patients must have no corticosteroids treatment at least one week before vaccination.
* Patients capable of understanding the study and signed informed consent.

Exclusion Criteria:

* Breast feeding females.
* Pregnant women.
* Infectious diseases HIV, HBV, HCV
* Documented immunodeficiency
* Documented autoimmune disease
* Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
* Patient inability to participate as determined by PI discretion.
The Effectiveness of the Adapted Bridge's Self-management Programme

The effectiveness of the adapted Bridge's self-management programme in South African community-dwelling stroke survivors: A randomized controlled trial with two arms will be used, with the intervention group receiving self-management sessions delivered by experienced therapists and usual care and control group will only receive usual care which includes a information booklet.

This study aim to determine the effectiveness of the Adapted bridges self-management intervention on South African stroke patients' functional activity, self-efficacy, and participation. Method: This experimental study will make use of a randomized controlled design (RCT), consisting of one hundred and sixty eight stroke survivors recruited from different health care facilities within the Cape Metropolitan area. The study participants will be divided randomly into two groups, with one receiving the intervention - the experimental group - and the other receiving an educational booklet - the control group. Participants will be assessed at baseline, immediately post-intervention (six weeks), three and sixth-month post intervention, using standardized outcome measures (both subjective outcome measures and objective clinical tools). Ethical clearance and permission to conduct the study will be obtained and patient information will be kept confidential. Analyses will be conducted using descriptive statistics of frequencies and percentages for categorical variables and mean and standard deviation for continuous variables. Given the assumptions of equal variance, a two-way full factorial ANOVA will be computed in order to assess interaction between groups and intervention type.

Eligibility Criteria:
Inclusion Criteria:

* having a first ever stroke, by a physician, based on the WHO (1988) definition of stroke which is "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin"; ≥18 years of age; of sufficient cognition to participate: having a score of ≥24 points on mini-mental state examination (placing participants at matched mental status) ; are medically stable and; and are within the sub-acute to chronic phase of their rehabilitation (10 weeks to 6-months post stroke).

Exclusion Criteria:

* Participants will be excluded if they have serious medical conditions such as HIV/AIDS or TB, which could additionally affect the outcomes evaluated in this study. Participants with depression, having recurrent stroke, still receiving in inpatient rehabilitation, with cognitive or receptive language difficulties and are unable to comprehend the intervention will be excluded.
Effects of Increased Maternal Choline Intake on Child Cognitive Development

The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.

Choline, an essential nutrient, plays numerous important roles in fetal development. However \>90% of pregnant women in the U.S. consume less than the recommended amount, and choline is typically absent from most prenatal vitamins. Moreover, current choline recommendations for pregnant women may be inadequate for optimal fetal development and lifelong health. Animal studies clearly show that maternal choline supplementation (MCS) improves offspring memory, attention, and emotion regulation. The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during the second and third trimesters of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Singleton pregnancy (carrying one baby)
* 21-40 years old
* Between 12-18 weeks pregnant at the time of screening
* Self-reported BMI \<35.0 in the three months prior to pregnancy (estimated or known)
* Willingness to comply with all study procedures for the duration of the study
* Intending to live in Ithaca, NY or the surrounding area for the duration of the study
* Intending to deliver at Cayuga Medical Center

Exclusion Criteria:

* Self-reported history of health conditions associated with metabolic or gastrointestinal function or adverse child outcomes
* Current use of medications known to affect liver or kidney function or child outcomes
* High omega-3 fatty acid intakes from diet (as determined by a licensed registered dietitian) at screening
* Choline supplementation that exceeds 50 mg/day at screening
* Use of alcohol, tobacco products, or recreational drugs during pregnancy or during the Prenatal Phase of the study
* Use of non-study approved or provided supplements during the Prenatal Phase of the study
* Development of pregnancy-related complications during the study (i.e. gestational diabetes, gestational hypertension, preeclampsia, genetic abnormalities, or miscarriage)
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)

The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).

This was a multicentre, open-label, randomized phase II proof-of-concept study.

The efficacy and safety of poractant alfa was evaluated in terms of ventilatory free days during the 21 days after randomization, in adult patients diagnosed with ARDS due to SARS-COV-19 infection.

Each patient randomized to the study treatment received 3 administrations of Curosurf ® with a 24 hours dosing interval. The assessment collection was up to Day 28, when the evaluation occurred at the Intensive Care Unit (ICU), or by phone call if the patient has already been discharged.

Seventy patients were planned to be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm). The control arm population received Standard of Care (SoC). This study was conducted in United Kingdom (UK), United States of America (US), and Italy.

Overall, 13 patients (Curosurf ® group) and 8 patients (control group) were randomised in the study. Due to low recruitment rate the study was terminated early for non-safety reasons.

Curosurf® is a pulmonary surfactant of natural origin which, when delivered endotracheally (ET). Curosurf® is currently approved for marketing as treatment of premature neonates with RDS or at risk of Respiratory Distress Syndrome (RDS). Chiesi Farmaceutici S.p.A (Chiesi) conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to evaluate the efficacy and safety in ventilated adult patients who were critically unwell in intensive care with SARS-COV-19 ARDS.

Eligibility Criteria:
Inclusion Criteria:

Participants were eligible to be included in the study if the following criteria apply:

1. Male or female ≥18 and ≤ 80 years of age
2. Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure)
3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before randomisation
4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio \< 150 mmHg
5. Lung compliance ≤45 ml/cmH20
6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration

Exclusion Criteria:

Participants were excluded from the study if any of the following criteria apply:

1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax)
2. Weight \< 40kg
3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) \< 30)
4. Pregnancy
5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration
6. Extracorporeal membrane oxygenation (ECMO)
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and mid-range ejection fraction.

Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).

Exclusion Criteria:

-