cyrilzakka/clinical-trials huggingface dataset:
Extension Study Evaluating Etanercept in Ankylosing Spondylitis

The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.


Eligibility Criteria:
Inclusion criteria:

* Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.

Exclusion criteria:

* Withdrawal from the ASCEND study for safety or any other reason.
Prenatal Cytogenetic Diagnosis by Array-Based Copy Number Analysis

The main objective of the multi-centered collaborative study is to evaluate the accuracy, efficacy and clinical advantages of prenatal diagnosis using microarray analysis as compared with conventional karyotyping.

Specifically, the aims are as follows:

1. Demonstrate the performance of microarray analysis as a clinical method for prenatal cytogenetic diagnosis with regard to:

   1. Accuracy in the detection of the common autosomal and sex chromosomal aneuploid (trisomies, 13,18,21, 45,X, 47,XXY, etc.)
   2. Ability of microarray to diagnose less common, but clinically significant, cytogenetic aneusomies (e.g. DiGeorge, Williams, Smith- Magenis, Prader-Willi syndrome, etc.) currently not detected by conventional karyotype.
   3. Evaluation of the utility of microarray in specific clinical scenarios such as ultrasound detection of congenital anomalies and fetal growth disorders.
2. Evaluate the appropriate construction of prenatal diagnostic microarray devices to allow maximal detection of clinically relevant information with minimal detection of unexpected and difficult to interpret findings which have no clinical significance but might provoke patient anxiety.
3. Evaluate the feasibility and cost-effectiveness of using microarrays as a primary prenatal diagnostic tool.
4. Evaluate approaches to integrate microarray into clinical prenatal cytogenetic diagnostic practice.
5. Develop a prenatal diagnostic tissue repository (TDR) to facilitate the further development of microarray technology. This will be used to investigate the molecular etiologies of specific fetal anomalies and to test newer technologies, such as higher resolution microarrays.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy having either chorionic villus sampling in the first trimester or an amniocentesis procedure at or after 16 weeks of gestation performed for prenatal cytogenetic diagnosis
2. Karyotyping to be performed at Genzyme Genetics Cytogenetics Laboratory
3. Trained study personnel available
4. Presenting at pre-specified sites using Genzyme Genetics for routine prenatal diagnostic services

Exclusion Criteria:

1. Unavailability of one or both biologic parents to provide blood sample (e.g. egg or sperm donor, non-paternity)
2. Patient refusal to allow follow-up through the neonatal period and up to age two if selected
3. Participation in the study in a previous pregnancy
4. Insufficient sample for microarray assay
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants

The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants


Eligibility Criteria:
Inclusion Criteria:

* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic onadotropin) within 24 hours prior to the start of study treatment.
* Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening.

Exclusion Criteria:

* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
* Prisoners or participants who are involuntarily incarcerated
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
Effects of Acute Long-acting Bronchodilation on Oxygenation and Peripheral Ventilation in COPD

The goal of this clinical trial was to compare the action of long-acting ß2-agonists (LABA-olodaterol) and muscarinic antagonists (LAMA-tiotropium) on tissue oxygenation in COPD considering their impact on proximal and peripheral ventilation and, eventually, on lung capillary volume. The hypothesis was that LABA would have a more peripheral effect than LAMA (due to the opposite gradient of their receptors) and better peripheral ventilation would result in a greater oxygenation.

Before and after LABA (visit 1) and LAMA (visit 2) inhalation, COPD participants were asked to perform single-breath washout and forced oscillation tests, double diffusion technique and spirometry, while transcutaneous oxygenation was continuously recorded.

Slopes of He (SHe) and SF6 (SSF6) from single-breath washout test (SBWO) (assessing ventilation heterogeneities at the level of pre- and intra-acinar bronchioles, respectively) (quadruple model, LR6000 Logan-Sinclair, Rochester, UK), respiratory system resistance (R5, R5-R19) and reactance (X5, AX, Fres) from forced oscillation test (FOT) (Resmon Pro, ResTech, Italy), lung capillary volume (Vc) from double diffusion of NO and CO (DLNO/DLCO) (Hyp'Air compact, Medisoft, Dinant, Belgium), and FEV1 from spirometry (Zan®, Oberthulba, Germany) were evaluated before and after LABD administered via a spacer device: during the first visit, before, 30 minutes and 2 hours after inhalation of 4 puffs of 2,5 µg of olodaterol (LABA); during the second visit, before, 40 minutes and 2 hours after the administration of 4 puffs of 2,5 µg of tiotropium (LAMA). Transcutaneous oximetry (Perimed232©, Järfälla, Sweden) was monitored continuously during the 2 hours of each visit.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according to international criteria

Exclusion Criteria:

* inability to perform the tests or to maintain the washout period
* an exacerbation within the previous 6 weeks
* a diagnosis of asthma or another chronic respiratory disease that could influence the results of the study
T Central Memory Cells in Early Localized Non-Segmental Vitiligo

Assessing the level of circulating TCMs (cluster of differentiation (CD) 8+, CD3+,C- chemokine receptor (CCR)7, cluster of differentiation 45 receptor (CD45R) cells) in early localized vitiligo cases prior to treatment and after treatment in comparison to healthy controls. This, in turn, would provide insights regarding the role of TCMs in vitiligo and the role of early treatment in halting disease progression and autoimmune memory formation that accounts for high recurrence rate of vitiligo

Assessing the level of circulating TCMs (CD8+ CD3+ CCR7+ CD45RO+ cells) in early localized vitiligo cases where samples will be processed and stained for CD8, CD3, CCR7, . CCR7, CD45R. Multi-parametric flow cytometry will be used to quantify CD3+ve, CD8+ve, CCR7+ve, CD45RO+ve TCM cells percentage, which will be expressed as a percentage from the total lymphocyte gate. This will be done prior to treatment and after treatment and will be compared to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

- Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration

Exclusion Criteria:

* Patients who received treatment of any type (topical or systemic) within the last 3 months
Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS).

The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary end points.

This is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) in the treatment of chronic rejection in lung transplant recipients with Grade 1 or 2 BOS.

The primary endpoints will include:

* Improvement or stabilization of pulmonary function test (FEV1) from baseline
* Stabilization of histology (no deterioration from baseline)
* Safety of the preparation

The secondary endpoints will include:

* Pharmacokinetics and distribution of CsA in blood -
* Change in cytokine levels from BAL specimens.

Eligibility Criteria:
Inclusion Criteria:

Chronic rejection

1. Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and \> 20% decline from the individual patient's best FEV1 is observed
2. Recipient of a double or single lung transplant
3. Receiving immunosuppressive treatment according to institutional standards

Exclusion criteria:

1. Active invasive bacterial, viral or fungal infection
2. Current mechanical ventilation
3. Pregnant or breast-feeding woman
4. Known hypersensitivity to cyclosporine A
5. Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
6. Receipt of an investigational drug as part of a clinical trial
Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma

Basal cell carcinoma (BCC) is the most prevalent form of cancer among the Caucasian population. There are several subtypes of BCC with different clinical characteristics and treatment strategies. Superficial and nodular BCCs are low-risk BCC subtypes. The diagnosis and subtype of BCC can be confirmed by means of punch biopsy, but non-invasive diagnosis by means of Optical Coherence Tomography (OCT) is proven to be a non-inferior alternative diagnostic instrument. Besides, non-invasive topical treatment is recommended as valuable treatment alternative to surgical excision for low-risk BCC.

Since non-invasive diagnosis and treatment for low-risk BCC is being implemented into daily practice, we want to evaluate the real-world effectiveness of different invasive and non-invasive diagnostic and treatment strategies in the management of low-risk BCC. This real-world evidence will enhance our understanding of these management strategies for low-risk BCC in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Diagnosis of low-risk BCC based on CDE with OCT confirmation or with histopathological verification in case OCT diagnosis is doubtful.
* Tumors meeting the criteria for low-risk BCC
* Patient is able to understand the instruction regarding the study participation and application of IMQ treatment

Exclusion Criteria:

* Tumor location in the H-zone of the face or hairy scalp, anogenital area
* Diagnosis of recurrent BCC or previous skin cancer within 2cm of the treatment area
* Strong suspicion/diagnosis of high-risk BCC subtype or other skin condition on OCT or punch biopsy
* Women who are pregnant or breastfeeding
* Previous allergy or intolerance to IMQ
* No concurrent use any other systemic chemopreventive or immunosuppressive medication during the treatment period, 30 days before start and 3 months after the end of treatment
* Limited understanding of the Dutch language and not being able to give informed consent
Uncontrolled Hypertension Management Among Jordanian Adults

This study will evaluate a newly developed multimodal health intervention including dietary approach to stop hypertension (DASH) diet, exercise (Ex), and medication adherence (MA) using motivational interviewing (MI) counselling (DASH-Ex MAMI) for hypertensive Jordanian adults in primary care settings.

This interventional study specifically aims to:

1. Develop a valid multimodal health intervention that includes DASH, exercise, and medication adherence using MI counselling (DASH-ExMAMI) for hypertensive Jordanian adults in primary care settings.
2. Evaluate the effectiveness of the DASH-ExMAMI intervention on systolic and diastolic blood pressure in adults with uncontrolled hypertension in Jordan.
3. Evaluate the effectiveness of the DASH-ExMAMI intervention on the dietary habits scores in adults with uncontrolled hypertension in Jordan.
4. Evaluate the effectiveness of the DASH-ExMAMI intervention on the physical activity scores in adults with uncontrolled hypertension in Jordan.
5. Evaluate the effectiveness of the DASH-ExMAMI intervention on medication adherence scores in adults with uncontrolled hypertension in Jordan.
6. Evaluate the impact of the DASH-ExMAMI intervention on body mass indices (BMI) and waist circumferences (WC) in adults with uncontrolled hypertension in Jordan

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age between ≥ 18 and 65 years old.
2. Has had diagnosed with hypertension and has started his or her treatment plan.
3. Has uncontrolled hypertension: The average systolic blood pressure reading that is equal to or higher than 130 mmHg and/or diastolic blood pressure that is equal to or higher than 90 mmHg for the last two patients' records available at the health center.
4. Has no other comorbidities that contraindicate exercise or restrict DASH diet.
5. Written medical authorization (documented in patient's medical record) by the attending primary healthcare physician approving the patient's participation.

Exclusion Criteria:

1. Pregnant and postpartum women
2. Has severe hypertension (SBP≥ 200 or DBP ≥110). Resting SBP greater than 200mm Hg or DBP greater than 110mm Hg is a relative contraindication to exercise stress testing.
3. Has history of cardio-pulmonary, renal, or musculoskeletal comorbidities that contraindicate exercise or DASH diet.
4. This research will exclude all clients who are contraindicated to undergo treadmill tests with extra precautions: history of myocardial infarction within six months, angina, cardiac dysrhythmias, symptomatic aortic stenosis, and heart failure, pulmonary embolus, infarction or hypertension, myocarditis or pericarditis, or endocarditis, aortic dissection, history of renal impairment, brittle diabetes mellitus, bronchial asthma, musculoskeletal problems that might worsen by exercise, and mental health problems that interfere with the comprehension of the intervention and its related safety measures. Clients with a history of metabolic disorders and who follow a specific diet restriction will also be excluded such as celiac disease.
Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia

This study was designed to determine whether the success or failure of interscalene brachial plexus block under general anesthesia can be predicted using perfusion index (PI).

The success of peripheral nerve blocks is usually evaluated by assessment of sensory and motor function; however, this method cannot be applied in the patient who has uncheckable mental status, e.g. general anesthesia, or who is uncommunicable, e.g. different language user.

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter, and PI had been proved as a useful tool for evaluation of successful supraclavicular nerve block in awake patients as an objective method.

With the use of ultrasound guidance in skilled hands, it is a reasonable option to perform neuraxial and peripheral regional blocks in sedated or anesthetized patients. However, there has been no evidence of applying PI for predicting the success of nerve block in general anesthetized patients.

Eligibility Criteria:
Inclusion Criteria:

* 20-70 years old,
* BMI 20-35 kg.m-2,
* elective shoulder surgery,
* ASA physical status I-III

Exclusion Criteria:

* refusal of the patient,
* comorbid with serious vascular disease,
* diabetes,
* allergy to local anesthetics,
* patients on regular opioids,
* peripheral neuropathy.
Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* Hepatic Cirrhosis
* Minimal hepatic Encephalopathy

Exclusion Criteria:

* Personal history of surgery in the last 4 weeks
* Use of neuropsychiatric drugs
* Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
* Thyroid disorders without replacement therapy
* Hepatic or renal transplant
* Alcoholism with active ingest of alcohol in the last 6 months
* Pregnancy
* Labour turn-overs
* Spontaneous bacterial Peritonitis
* Personal history of hepatocellular carcinoma
* Placement of transjugular intrahepatic portosystemic shunt
* Use of a probiotic in the last 6 months
The Effect of Hybrid Simulation on Evaluating Neonatal Jaundice

This study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the course
* Had not taken this course before
* Accepted to participate in the research

Exclusion Criteria:

* Have any records of absence
* Taken this course before
* Graduate of health vocational high school
Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving

The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.


Eligibility Criteria:
Inclusion Criteria:

* 20-60 years old
* Smoking \> 15 cigarettes per day
* Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria

Exclusion Criteria:

* Contraindications to noninvasive brain stimulation
* Psychiatric or neurologic condition
Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers

Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers

The objective of this study is to evaluate the clinical and economical effect of introduction of near-infrared spectroscopy (NIRS) in the diagnostic and treatment protocol of patients with lower extremity (LE) ulcers as well as other chronic non-healing ulcers, and to determine a positive and/or negative predictive value or range of values for NIRS correlating to patient progress and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Current patients or patients admitted to Christus Wound Care and Hyperbaric Medicine Departments between July 1, 2024, and December 31, 2024, for the treatment of lower extremity ulcers and other chronic non-healing ulcers.
* Lower extremity ulcers and chronic non-healing ulcers will be included in the study regardless of the wound/ulcer etiology. Patients may become eligible for the study at any point during their course of treatment.

Exclusion Criteria:

* Patients who are being treated at multiple research sites simultaneously.
Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cement

The goal of this clinical trial is to conduct an in vivo study that allows to compare the periapical healing process of 3 different sealing cements through CBCT, as well as implement the evaluation of these lesions through volumetric measurements to provide high-level scientific information and thus have the possibility of being applied in the clinical dental practice, in patients attending UNICOC dental clinics between 2023 and 2024. The main question it aims to answer is:

* Do bioceramic sealer promote faster periapical healing due to their better sealing capacity and high bio-compatibility?
* Are there no differences between endodontic sealers in terms of apical healing? If there is a comparison group: Researchers will compare Bio-C Sealer (Bioceramic sealer) Zinc-oxide eugenol sealer and AH-Plus epoxy resin sealer to evaluate periapical healing after a six months follow-up of conventional endodontic therapy.

Coronal permanent restoration must be performed no later than 15 days after endodontic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 60
* Patients systemically healthy (ASA I)
* Patients that require endodontic therapy for single-rooted teeth with pulp necrosis and apical periodontitis (AP).
* CBCT PAI periapical index score 3 or above, with no symptoms at the time of appointment.

Exclusion Criteria:

* Exclusion criteria included other than ASA-1 classification
* Patients with Perforated cortical plates at cbct analysis
* Premature permanent teeth
* Patients with Endodontic-periodontic lesions, dystrophic calcifications, more than 20° root curvature
* Pregnancy or lactation
* Root fracture cases
* Use of analgesics within 12-24 hours root canal therapy and patients with endodontic abscess.
Collection of Cerebrospinal Fluid in Healthy Children

The purpose of this study is to obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 2 yrs to 8 yrs
* Children already undergoing a lumbar puncture procedure for clinical or diagnostic purposes

Exclusion Criteria:

* Presence of any significant neurological diseases, as judged by the co-investigators
* Presence of any significant medical conditions including cancer
Pilot Study Differential Dissector™ for Blunt Dissection

The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18
* Patient will be undergoing open abdominal surgery
* Patient willing and able to provide his/her own consent

Exclusion Criteria:

* Current alcohol or other substance abuse
* Current incarceration