cyrilzakka/clinical-trials huggingface dataset:
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle

The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.

The safety of the needles will also be studied.

As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign a separate consent for the bronchoscopy.

If participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If participant is in Group 1, participant will have the EBUS-TBNA performed by first using a 25-gauge needle, followed by a 22-gauge needle.
* If participant is in Group 2, participant will have the EBUS-TBNA performed by first using a 22-gauge needle, followed by a 25-gauge needle.

To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide the needle into the area.

Length of Study:

Participation on the study will be over after the bronchoscopy and EBUS-TBNA.

This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The study doctor can explain how the needles are designed to work.

Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.

Exclusion Criteria:

1. Patients who are pregnant or lactating
2. Inability to give informed consent
3. Patients in which only one lymph node station is expected to be sampled by the performing clinician.
Shoulder Disorders in Patients With Parkinson's Disease

Parkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly recognized in our ageing population. It is characterized by cardinal clinical features including bradykinesia, tremor, rigidity, and postural instability. For most people with PD, the most serious concern is with the motor system: stiffness, slowness of movement, impaired handwriting and coordination, poor mobility and balance. However, more than half of all people with PD have experienced painful symptoms. Most people experience aching, stiffness, numbness and tingling at some point in the course of the illness. Defazio et al reported that pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5 Aching muscles and joints are especially common in PD. Rigidity, lack of spontaneous movement, abnormalities of posture and awkward mechanical stresses all contribute to musculoskeletal pain in PD.

One of the most common musculoskeletal complaints is shoulder pain or shoulder disorders, including frozen shoulder, bursitis, and rotator cuff lesions. Actually, shoulder pain or shoulder disorder can be the first sign of PD. The prevalence and severity of shoulder disorders in Parkinson's disease are not totally clear. In a retrospective study, Stamey found shoulder pain was present in 11% of patients with PD.

Over the past ten years ultrasound (US) has become popular in the evaluation of shoulder disorders. It allows for the detailed assessment of a wide range of changes involving different anatomic structures of the shoulder joint, including rotator cuffs, biceps tendon, and subdeltoid bursa. Koh et al found among 33 PD patients, 22 patients had abnormal US findings on the dominant side, and all 22 patients with abnormal US finding had a tendon tear and 9 patients had frozen shoulder. However, there were no control group in Koh' s study, and diagnosis of frozen shoulder with US findings is still controversial.

The purposes of this study are to evaluate patients with PD with a combination of physical examination and US study of the shoulder, and to compare the frequency and type of shoulder lesion in US between patients with PD and normal subjects. The investigators also plan to test the correlation between shoulder disorders or US abnormality and the severity of PD.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilled the diagnosis of PD, as described by the United Kingdom Parkinson's Disease Society Brain Bank,
* Aged 50 to 80 years old.

Exclusion Criteria:

* Fracture or dislocation of the shoulder,
* Previous shoulder joint surgery,
* Severe medical comorbidities,
* Cognitive impairment (Mini-Mental Status Examination \< 24).
Frequency of Hymenoptera-stings in Patients Under Allergen-Specific Immunotherapy (SIT)

In Switzerland, 3.5% of the population are suffering from hymenoptera venom allergy. The only causal treatment of hymenoptera alelrty is venom specific immunotherapy. There are however several reasons, which question the relatively broad application of this expensive treatment. That's why we aim at investigating the actual risk for hymenoptera stings in patients undergoing allergen specific immunotherapy against hymenoptera sting allergy


Eligibility Criteria:
Inclusion criteria:

* Bee and/or Wasp allergic patients treated by SIT

Exclusion criteria:

* None
Correlation Between Targeted HbA1c Values and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After PCI

Diabetes is a leading social and economic burden in the world. It is the main reason of macrovascular disease incidence and mortality. Prospective studies have demonstrated that high glycosylated hemoglobin (HbA1C) levels are associated with an increased risk of cardiovascular events in a population of diabetic patients without a history of coronary artery disease. Further, the predictive value of high preprocedural glycemia levels has been reported in diabetic patients undergoing percutaneous coronary intervention (PCI). The aim of the present study was to assess the predictive value of preprocedural HbA1C levels for cardiovascular complications in a large population of diabetic patients undergoing PCI with stent implantation. Glycosylated hemoglobin (HbA1c) reflects the average blood sugar level in the past 2-3 months. As glycosylated hemoglobin has been clinically tested and standardized internationally, increasing evidence is recommended for routine monitoring in diabetes care. The American Diabetes Association (ADA) suggested that in the treatment of diabetes, blood sugar control should control HbA1c level below 6.5%. Although，there is evidence that controlling blood glucose can reduce the incidence of microvascular complications, in the past three trials, intensive glycemic control did not significantly reduce adverse CV events in patients with onger duration of diabetes.Therefore, most primary and secondary prevention guidelines recommend HbA1c below 6.5% or 7% to prevent adverse cardiovascular outcomes in patients with diabetes mellitus. The optimal target level of glycosylated hemoglobin is still hotly debated. In addition, there is still lack of evidence for the level of HbA1c in patients with major vascular disease history in secondary prevention of recurrence cardiovascular events.

Therefore, to explore and determine the optimal level of blood glucose control is the focus of controversy in preventing recurrence cardiovascular events in diabetic patients. Investigator will combine epidemiology and metabolomics to study the effect of glycosylated hemoglobin on secondary cardiovascular events, and further determine whether to strengthen hypoglycemic treatment after PCI.

This is a longitudinal cohort study including retrospective study, prospective study and nested case-control study.The first cross-sectional survey was conducted in 2021.

Eligibility Criteria:
Inclusion Criteria:

- 1. Age ≥ 18, male or female;

2. all patients with diabetes combined with PCI operation;

Exclusion Criteria:

* 1. Less than 18 years old

  2. Pregnancy

  3. Patients with preoperative glycosylated hemoglobin index deficiency

  4. Chronic maintenance hemodialysis patients
Stepping Stones and Creating Futures Intervention Pilot

This is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce gender inequality.


Eligibility Criteria:
Inclusion Criteria:

* Over 18
* Mentally competent
* Able to communicate in English, Zulu, or Xhosa
* Normally resident in the informal settlement

Exclusion Criteria:

* Over 30
* Unable to do informed consent
Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality

People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. The effectiveness of non-invasive ventilation (NIV) has been demonstrated during the management of PAO and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. On the other hand, the impact of NIV on mortality in cardiogenic PAO seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population.

The objective of this study is to determine whether the use of NIV in cardiogenic PAO in elderly subjects admitted to the emergency room of Strasbourg University Hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject (\> 75 years old)
* Admission to the NHC emergency room between January 1, 2021 and October 31, 2021
* Diagnosis of cardiogenic PAO
* Indication of NIV according to current recommendations
* Subject not opposing the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed his opposition to the reuse of his data for scientific research purposes.
* Presence of an absolute contraindication to NIV
* Respiratory distress due to pneumonia or other diagnosis
* RT-PCR Sars Cov 2 positive in emergency
Persistence of Hepatitis A Antibody in Healthy Adults ~32 Years Post Vaccination.

The goal of this clinical trial is to evaluate the persistence of Hepatitis A antibody \~32 years post vaccination in healthy adults. The questions this study will answer are: 1) how long antibody persists and 2) The immune response to an additional dose of vaccine among those with no detectable antibody. Participants will be asked to provide a blood specimen.

Those with no detectable antibody will be offered an additional dose of vaccine.

The kinetics of antibody response in this population will be summarized.


Eligibility Criteria:
Inclusion Criteria:

* Consent obtained
* Participated in original hepatitis A study in 1991
* No detectable hepatitis A antibody \~32 years after study start

Exclusion Criteria:

* Receipt of any dose of hepatitis A vaccine other than the hepatitis A vaccine used in the initial studies
* History of hepatitis A
* Receipt of blood transfusion or blood products, including immunoglobulins, within the past 6 months.
* Receipt of any vaccine within the 14 days before receipt of the additional dose of hepatitis A vaccine or scheduled to receive any vaccine within 30 days after receipt of a booster dose of vaccine.
Complete Occlusion of Coilable Aneurysms

To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms


Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 75 years, inclusive
* Patient has a single target IA that:

  1. is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
  2. is saccular
  3. has a parent vessel with diameter 2.5-5.0 mm
* If target IA has a neck \>4 mm, at least 2 of 3 members of an independent expert committee (IEC) have confirmed that coil embolization with optional adjunctive techniques\*\* has a very high likelihood of procedural success (i.e., coil placement and retention)
* Subject has provided written informed consent using the IRB-approved consent form
* Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements

  * \*\* Adjunctive techniques include intravascular balloons \["balloon remodeling"\], 3D coils, dual catheter techniques.

Exclusion Criteria:

* Target IA has BOTH neck \>4 mm AND size (maximum fundus diameter) \>10 mm
* More than one IA requires treatment in the next 6 months
* Subarachnoid hemorrhage in the past 60 days
* Any intracranial hemorrhage in the last 42 days
* Major surgery in the last 42 days
* Coils in place in the target IA
* Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
* Known irreversible bleeding disorder
* Platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction
* Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
* Prior stent placement at target site
* Contraindication to CT scan AND MRI
* Known allergy to contrast used in angiography that cannot be medically controlled
* Known severe allergy to platinum or cobalt/chromium alloys
* Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
* Woman of child-bearing potential who cannot provide a negative pregnancy test
* Evidence of active infection at the time of treatment
* Other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
* Current use of cocaine or other illicit substance
* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
* Extracranial stenosis greater than 50% in the carotid artery
* Intracranial stenosis greater than 50% in the treated vessel
Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation

Sinusoidal obstruction syndrome (SOS) or hepatic veno-occlusive disease (VOD) is a serious complication that occurs, most often occurring in patients undergoing hematopoietic stem cell transplantation (HSCT), especially in its first thirty days. The morbidity and mortality in this syndrome are considerable, since severe SOS is associated with a mortality of more than 90% in the first hundred days of HSCT.

Some risk factors are modifiable, especially those related to transplantation, but when non-alterable factors are present, preventive measures are needed that can reduce the incidence and / or severity of SOS.

This is a single-center, randomized, placebo-controlled study to evaluate the efficacy and safety of N-acetylcysteine as prophylaxis of sinusoidal obstruction syndrome in patients undergoing hematopoietic stem cell transplantation Up to date, no approved medications are available for prophylactic treatment of sinusoidal obstruction syndrome in patients undergoing hematopoietic stem cell transplantation. N-acetylcysteine is a drug that has been long used as a mucolytic. And placebo responses contribute to help assess the appropriateness of randomized clinical trials in determining the size of drug effect.

The study will enroll patients undergoing hematopoietic stem cell transplantation to receive sequentially one of two treatment: N-acetylcysteine or Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Age ≥ 18 years
* A proven diagnosis of one of the hematological malignancies: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia, Chronic Lymphoid Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
* Patients must be scheduled to undergo of Allogeneic hematopoietic transplantation or HLA (Human Leukocyte Antigen) haploidentical related or Unrelated or HLA-matched related or autologous stem cell transplant
* Patients must be able to understand and sign a written informed consent

Exclusion Criteria:

* Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study
* Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
* Known hypersensitivity to N-acetylcysteine
* Contraindications to perform any procedure provided for in this study
* Patients who have already undergone a previous transplant
Validation of Modified AST

The objective of the study is the validate and to assess the reliability of a modified version of the Athetic Shoulder Test. The activity of peri-scapular muscles during the realization of the test will be assessed too.

The study will be divided into two sessions. A time of 7-10 days will be provided between the two sessions of tests to limit the influence of sport and training on the results.

Session 1:

* Warm-up
* Realization of the Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)
* Realization of the modified Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)

Session 2:

* Warm-up
* Realization of the Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)
* Realization of the modified Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)

Eligibility Criteria:
Inclusion Criteria:

* to practice an overhead sport at least 5 hours a week

Exclusion Criteria:

* no shoulder pain
* no history of shoulder pain
* no history of shoulder surgery
* no scoliosis or lower limb lengths differences
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fed study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis

Exclusion Criteria:

* Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)
* Other exclusion criteria were the following: major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; acute superimposed liver injury;patients with metabolic disorders such as diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; any additional precipitating factors such as high protein intake (additional high-protein meals), constipation; illiteracy.
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder

Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).

This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed ADHD-diagnosis
* speaking a Scandinavian language

Exclusion Criteria:

* Unable to give informed consent
* Psychosis
* Severe learning difficulties