cyrilzakka/clinical-trials huggingface dataset:
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)

Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. In the past an operation (mediastinoscopy) was required to diagnose the glands. Endobronchial ultrasound (EBUS) is a new procedure that may be able to diagnose these glands without the need for mediastinoscopy. The REMEDY trial aims to examine whether EBUS can reduce the number of mediastinoscopies and healthcare costs in patients with enlarged glands in the chest.

Although the literature is replete with data on the utility of Endobronchial Ultrasound for lung cancer, there are very few data available on its role in the diagnosis of isolated mediastinal lymphadenopathy due to other causes such as sarcoid, tuberculosis or lymphoma. The REMEDY trial aims to evaluate the accuracy of EBUS in this setting and assess any reduction in the number of mediastinoscopies and healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with undiagnosed mediastinal lymphadenopathy (\>1cm in short axis) on CT or PET-CT scan for whom pathological evaluation is clinically indicated.

Exclusion Criteria:

* Patients without informed consent, those with anterior mediastinal lesions or with contra-indications to EBUS or mediastinoscopy will be excluded.
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.

All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.

Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
* Decision taken to start an induction regimen with rituximab
* Informed and having signed the study consent form
* If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop
* no-breast-feeding during RTX treatment and in the 12 months following RTX treatment stop

Exclusion Criteria:

* Other primary or secondary systemic vasculitis
* Incapacity or refusal to sign the informed consent form
* Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
* Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
* severe active infection
* Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease Pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks
* Patients with active hepatitis B
* Any live vaccine within four weeks prior to the first infusion of RTX
A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects

The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, both sexes, age between 18 to 55 years old
* Weight with normal range according to accepted normal values for BMI (18-25 kg/m2)
* Give a written informed consent
* Acceptable medical history and physical examination
* Normal hematology values including hemoglobin, hematocrit, WBC, platelets, WBC differential
* Normal laboratory test including : Blood urea nitrogen, sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, fasting glucose, albumin and creatinine
* Normal urinalysis results including: specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and casts
* Acceptable electrocardiogram (ECG) result
* Negative result for serological tests of Hepatitis B, Hepatitis C and HIV
* Negative result for pregnancy test

Exclusion Criteria:

* Smoker or alcoholism
* Pregnant woman or nursing mother
* Have history of hepatic, cardiovascular, gastrointestinal or renal disease
* Potentially sensitive to azithromycin or other related drugs
* Received any investigation drug within four weeks
* Donation or loss more than 450 mL of blood within 3 months prior to the screening
Prevalence and Burden of Bronchiectasis in Tuberculous Patients

Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree

Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree.

The prevalence of bronchiectasis is age-related and occurs in every age group and in the pre-antibiotic era . it most often began in childhood. Recent evidence shows that bronchiectasis disproportionately affects women and older individuals and will be contributing to increase in healthcare burden.\[3\] International data show an increase in the prevalence of bronchiectasis over recent years.

Eligibility Criteria:
Inclusion Criteria:

* 1-patients were diagnosed to have tuberculosis by sputum culture and gene x pert.

  2-patients were diagnosed to have bronchiectasis after lab and radiological examination as well as clinical score.

  3- patients diagnosed as bronchiectasis after history of tuberculosis or anti Tuberculosis treatment with positive or negative tuberculous culture in the time of research.

Exclusion Criteria:

* 1-patients presented with other Pulmonary diseases. 2-Chronic liver and renal disease . 3- Lung cancer and tumors. 4- patients were previously diagnosed as bronchiectasis .
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)

The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).

At least 600 subjects with a similar medical condition will take part in this study.

Objectives:

To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.

Eligibility Criteria:
Inclusion Criteria:

* Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
* If the patient is currently taking a lipid modifying medication other than Zocor \& he/she is willing to discontinue this medication
* LDL-C levels and/or non HDL-C levels above normal.
* Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

Exclusion Criteria:

* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
* HbA1c ≥ 9% in diabetic patients
Urdu Translation and Validation of MLHFQ

* To translate the Minnesota Living with Heart Failure Questionnaire (MLHFQ) questionnaire into Urdu language of Pakistan.
* To determine the validity and reliability of cross cultural adapted and Urdu translated MLHFQ questionnaire version among HF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic heart failure who sought treatment at the outpatient cardiology clinic.
* Who could read and write in Urdu and English language and are willing to participate in the study.

Exclusion Criteria:

* Decline consent
* Communication barriers or cognitive disorder as well as those with exacerbated condition and those who were not available for re-test were excluded from the study.
The Effect of Acute Concurrent Exercise on Inhibitory Control: An Event-related Potential Study

The present study aimed to determine the effects of acute concurrent exercise on inhibitory control via behavioral and event-related potential approaches and to examine its potential mediational role on lactate among younger adults. The main questions it aims to answer are: (1) Does acute concurrent exercise improve inhibitory control via behavioral and event-related potential approaches? (2) Does lactate play a potential mediational role in the effect of acute concurrent exercise on inhibitory control?

The present study aimed to determine the effects of acute concurrent exercise (CE) on inhibitory control via behavioral and event-related potential approaches and to examine its potential mediational role on lactate. Participants were randomly assigned to either a CE, aerobic exercise (AE), or control (CON) group. Participants in the CE group engaged in 12-minutes of AE (40%-59% of heart rate reserve \[HRR\]) coupled with 13-minutes of resistance exercise (1 set, with 75% of 10-repetition maximum, and 12 repetitions of 8 movements). The AE group participated in 25 minutes of AE (40%-59% HRR). Prior to and following exercise onset, participants in both the CE and AE groups completed a 5-minute warm-up and cool-down. Participants in the CON group read books for 35 minutes. Lactate concentrations were measured at timepoint of 0-, 17-, and 30-minutes relative to the treatment onset. Response time (RT) and accuracy in the Stroop test, as well as P3 amplitudes, were assessed before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 30 years
* able to exercise without undue risk (i.e., the first seven questions of the Physical Activity Readiness Questionnaire for Everyone \[PAR-Q+\] were answered "No")
* right-handed dominance
* typical or corrected-to-typical eyesight
* limited physical activity in the previous month (i.e., \< 150 minutes/week of moderate-intensity physical activity)

Exclusion Criteria:

* psychiatric or neurological ailments
* cardiorespiratory or neuromuscular conditions
* obese status (body mass index \[BMI\] \> 27 kg/m2)
Utility of the History and Physical Exam in the Emergency Department

The study is trying to prove that the history and physical exam (H\&P) in the emergency department is the most important tool in exam of patients. The investigator is attempting to correlate the time of the H\&P of residents and attendings to the accuracy of diagnosis.

The purpose of the study is to examine the utility of the history and physical exam in the emergency room towards obtaining a diagnosis. The goal of this observational study is to correlate physician level of experience and time spent on history and physical exam, to the correct diagnosis.

The aim of this study is:

1. To draw a connection between time and accuracy of the history and physical exam.
2. To draw a connection between time and level of experience as a physician based on post-graduate level.
3. To assess the number of laboratory and radiographic studies and the post-graduate level.
4. To assess the relevance of the labs and radiographs ordered. (Relevance is defined as something that changes plan of care.)

Time is a critical component of the ED physician. Our study will analyse if modern medicine has created a more laboratory/image based need to ascertain a diagnosis or if history and physical examination alone can predict the ultimate diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Anyone over the age of 18 with a generalized complaints able to provide consent

Exclusion Criteria:

* Anyone under 18 yrs and anyone with a very specific, system based complaint.
Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy

The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.

Renal ischemia reperfusion injury (IRI) is an inevitable event in patients undergoing laparoscopic partial nephrectomy (LPN), which can obviously affect the post-operational renal function. Pneumoperitoneum preconditioning (PP) is a promising strategy to render a protective effect on kidney, which has been already confirmed in some clinical settings. This study is designed as a randomized, prospective, double-blind and parallel controlled clinical trial to assess the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy, and observe its effect on the other abdominal organs. Patients with renal tunours and willing to accept elective LPN will be screened as eligible participants. The investigators aim to enroll 86 subjects. Patients randomized to the treatment arm will receive PP consisted of three cycles of 5 min insufﬂation and 5 min desufﬂation before PLN, while the control arm receive a sham operation.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years and older;
* Patients with renal tumours (whether benign or malignant) and accept laparoscopic partial nephrectomy as the surgical method;
* The renal tumor must be stage T1a (assessed by MRI/CT), and tumor≤4cm in diameter;
* Unilateral renal tumour, and another contralateral renal function reveal normal (renal function \>40% as determined by radionuclide scintigraphy);
* Patients volunteer for this study and provided written informed consent.

Exclusion Criteria:

* Large tumour (tumor\>4cm in diameter);
* Severe renal insufficiency (glomerular filtration rate, GFR\<30 ml/min/1.73m2) or needing preoperative dialysis (hemodialysis or peritoneal dialysis);
* Patients severe cardiopulmonary dysfunction;
* Pregnancy Women;
* Patients with other malignant tumours;
* Patients who have had a renal transplantation;
* Patients with a history of other abdominal viscera operations within one year (open or under laparoscope);
* American Society of Anesthesiologists (ASA)\>Ⅲ.
Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain

The aim of this study is to develop an evaluative questionnaire, to evaluate patients with hip and groin disability, and a strength measurement for the hip, for patients with hip and groin disability.

Both measurement instrument are aimed for evaluating the natural course and different treatment modalities in patients with hip and groin disability.


Eligibility Criteria:
Inclusion Criteria:

* Hip and/groin pain more than 6 weeks
* Physically active

Exclusion Criteria:

* Systemic diseases
* Physically inactive
Miltefosine for Mucosal Leishmaniasis

This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Treat bolivian mucosal leishmaniasis with miltefosine.

Eligibility Criteria:
Inclusion Criteria:

* Mucosal leishmaniasis

Exclusion Criteria:

* Abnormal liver function tests (LFT)
* Abnormal kidney function test
* Concomitant diseases
Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022

In Helsinki Birth Cohort 2018-2022 a large, longitudinal and well-phenotyped birth cohort of infants and their parents will be established. Mothers, fathers/spouses and their children in Helsinki and Uusimaa Hospital District are recruited in the study and newborn composition of the children born in Helsinki Women's Hospital will be measured. Data on maternal and paternal diet quality, physical activity and depression during and after pregnancy will be collected and data from the hospital and national registers will be collected. Health of offspring and parents will be followed during their later life.

Helsinki Birth Cohort 2018-2022 (HeBiCo) study is designed to find evidence between various intrauterine exposures and offspring adiposity and later health. It will be examined how different maternal (e.g. chronic diseases, ethnicity, BMI), and obstetric factors (e.g. gestational weight gain, diagnoses during pregnancy) as well as parental lifestyle and psychological aspects (e.g. diet quality, physical activity, depression and anxiety) are associated with newborn body composition and later health (e.g. obesity and neurocognitive health).

In the first phase of the study the participants are recruited on postnatal ward after delivery. The umbilical cord blood sample will be collected of all the neonates. After a consent the participants fill in the digital background, food frequency, depression and physical activity questionnaires. If the parents do not give their consent, the umbilical cord blood sample will be destroyed. Body composition of offspring will be assessed within 72 hours after birth. Registry data will be collected.

The second phase of the HeBiCo study is based on the HUS WomensHub treatment path and/or Apotti platform. The second phase of the HeBiCo constitutes of the mother-child pairs (and fathers/spouses) whose pregnancy can be followed from the early pregnancy to the end of the pregnancy through treatment path. Body composition of offspring born in Helsinki Women's Hospital will be assessed within 72 hours after birth.

The future studies will include 1) the intervention studies with digital service concept through WomensHub platform, and 2) the follow-up studies of offspring and parents in later life (to establish e.g. growth trajectories and later metabolic health of offspring).

The first phase of the HeBiCo study was registered 3/2018.

The second phase will be registered now.

Eligibility Criteria:
Inclusion Criteria:

Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.

Exclusion Criteria:

Inability to communicate in Finnish language
Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients

This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.

The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation.

Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.

PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.

In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).

The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Female patient 18 to 40 years of age seeking their first IVF treatment.
* Cycle day 3 FSH less than 10.0 IU/l.
* 8 to 15 antral follicles observed on ultrasound.

Exclusion Criteria:

* Failure to follow the protocol.
* Embryo biopsy.
* Any prior IVF cycle(s).
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)

Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.

Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses.

ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes.

To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA.

The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.

Eligibility Criteria:
Inclusion Criteria:

Patients ≥ 18 years of age referred for EUS

Lesions requiring histologic diagnosis:

* Mesenchymal tumors
* Autoimmune pancreatitis
* Granulomatous disease
* Indeterminate hepatitis
* Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor)
* Lymphoma
* Solid tumors
* Previously non-diagnostic FNA

Exclusion Criteria:

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Uncooperative patients
* Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
* Refusal to consent form
* Cystic lesions
* Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)