cyrilzakka/clinical-trials huggingface dataset:
FeNO Observation Study in ICU Patients With ARS

1. Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU.
2. Secondary Purpose:

   1. To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time;
   2. The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;
   3. Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;
2. The expected mechanical ventilation time of tracheal intubation is more than 24 hours;
3. The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2;
4. Agree to participate in this experiment and sign the informed consent.

Exclusion Criteria:

* 1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement; 2. Participating in other clinical research projects; 3. Patients deemed unsuitable by the investigators.
Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer

Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.

IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Histologically confirmed diagnosis of prostate cancer without metastases.
* Patient must have negative bone scan to rule out bone metastases.
* Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
* Eastern Cooperative Oncology Group (ECOG) score of 0 - 2.
* Study medication must be started within 3 months of initiation of ADT.
* Signed written informed consent.

Exclusion Criteria:

* Prior ADT (greater than 3 months).
* History of treatment with calcitriol or bisphosphonates.
* Suppressive doses of thyroxine within the previous year.
* Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
* Evidence of any of the following conditions per subject self-report or chart review:

Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH is within normal reference range).

Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.

Major surgery or significant traumatic injury occurring within 1 month prior to randomization.

* Known hypersensitivity to leuprolide acetate or any of the components found in Eligard
* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
Formulations of Liposomal Local Anesthetics

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery

This prospective randomized controlled study is aimed to determine the advantages of thoracic epidural analgesia for open upper abdominal surgery in combination with multimodal analgesia compared with no thoracic epidural analgesia on postoperative pain control. The primary outcome is total opioid consumption in postoperative 72 hours. Secondary outcomes are the success of continuous epidural analgesia or complications of this technique, pain intensity, morbidity and mortality compare to no continuous epidural analgesia.

Continuous epidural analgesia (CEA) for open upper abdominal surgery has been showed the analgesic analgesia for open abdominal surgery. However the technical difficulty, complications especially hypotension, pruritus of CEA impede the popularity of technique compared to intravenous patient-controlled analgesia (IV PCA) in multimodal analgesia. This study is aimed to study of the role of CEA and multimodal analgesia in open abdominal surgery compare to IV PCA.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* open upper abdominal surgery
* American Society of Anesthesiologists (ASA) grade I-III

Exclusion Criteria:

* contraindications to CEA
* inability communication
* patient's refusal
* emergency surgery
* BMI \> 35
Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs

Tuberculosis is a worldwide common infectious disease and effective first line anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation of anti-TB drugs or changing anti-Tb drug regimen.

Silymarin has been widely studied for the effect on hepatitis and it has been used in hepatology.

Therefore, the investigators hypothesized that prophylactic administration of silymarin with anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB drugs.


Eligibility Criteria:
Inclusion Criteria:

* subjects who are diagnosed with tuberculosis based on microbiological, biomolecular, pathological, or radiographical findings and are expecting to be administered with anti-tuberculosis drugs including INH, RFP, or PZA.
* adults \>=35 years old

Exclusion Criteria:

* basal AST \>40 IU/uL or ALT \>40 IU/uL
* pregnancy
* lactating women
* cases with history of adverse events to silymarin
Comparison of Nasal Steroids After FESS in CRSwNP

The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.

Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1). CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus. Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic sinus surgery.

Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies have shown that nasal steroids are superior to placebo in maintaining improvement in symptom scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal steroids can reduce inflammation locally and can prevent disease relapse without the systemic effects of oral steroids. However, there is no consensus as to which nasal steroid and which delivery method is most effective in treating these patients. Traditional nasal sprays, such as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide is available in a respule form that can be used to instill the medication in the nose. In an attempt to more effectively deliver the medication, changes in patient's head position has been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy over fluticasone nasal spray remains anecdotal as head to head comparisons have not previously been performed.

Practice patterns among rhinologists in the post-operative prescription of nasal steroids vary widely. Determining which medication/delivery method is more effective will help rhinologists better treat their patients and prevent symptoms, for which the surgery was performed, from returning.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have had FESS for CRSwNP within the study period

Exclusion Criteria:

1. Patients who are under the age of 18
2. Concurrent oral corticosteroid use of the equivalent of greater than 10 mg of prednisone use per day
3. The use of medications that accelerate the clearance of systemic cortisol (Dilantin, rifampin, amphetamines, and lithium)
4. The use of medications that inhibit the clearance of systemic cortisol (ketoconazole, amphotericin B, bupropion, fluoroquinolones)
5. Known hypersensitivity to corticosteroids
6. A personal history of Wegener's Granulomatosis or other autoimmune disease with nasal manifestations
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)

Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.

Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter and volume.

Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject or authorized representative has provided informed consent.
* Subject is ≥18 years of age.
* At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter.
* Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation.
* Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
* ≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.

Exclusion Criteria:

* Pre-procedure Exclusion Criteria
* Contraindicated for surgery.
* Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
* Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
* Tumor with pleural contact.
* Tumors located \< 3 cm of staple lines or other metal objects.
* Patients diagnosed with GOLD Stage IV Emphysema.
* Uncontrollable coagulopathy
* Patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure.
* Subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding.
* Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study.
* The investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
* Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).

Intraprocedural Exclusion Criteria

\*Incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.
A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion

The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.

This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic.

The participants were enrolled in two cohorts within this study- Cohort 1: healthy participants received the placebo-embedded IEM tablets, Cohort 2: participants with serious mental illness (SMI) i.e schizophrenia, major depressive disorder, or bipolar I disorder received Abilify MyCite® tablets (aripiprazole-embedded IEM tablets).

This single-center trial was conducted in the United States. The overall time to participate in this study is up to approximately 17 days.

Eligibility Criteria:
Inclusion Criteria for Cohort 1:

* In good general health or medically stable.
* Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
* The participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant.

Inclusion Criteria for Cohort 2:

* In good general health or medically stable.
* Has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar I disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and currently prescribed and taking aripiprazole.
* Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
* Participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant

Exclusion Criteria for Cohort 1 and 2:

* Any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing.
* Hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing.
* Difficulty with or inability to swallow tablets.
* Active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis).
* The investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin).
* Allergy to adhesive bandages/tapes (e.g., Band-Aids®) or latex.
* Positive urine pregnancy test at screening visit (dipstick).
* Participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.
Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement

Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.

Two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.

Eligibility Criteria:
Inclusion Criteria:

* Patient with missing maxillary anteriors or premolars teeth.
* Tooth extraction at the implant sites was performed at least 4 months before the surgery.
* The bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement.
* Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
* With no history of any previous grafting surgeries at the area of interest.

Exclusion Criteria:

* Sever concavity of the alveolar ridge.
* Bad oral hygiene ( Silness-Löe index (score 2-3).
* Heavy smoker (smoke greater than or equal 25 cigarettes per day).
* Presence of acute infections or periapical lesions in adjacent teeth.
* Parafunctional habits.
* Pregnant females.
AHC Ballana Heart Study

This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.

Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations.

Objectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years

Methods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.

Eligibility Criteria:
Inclusion criteria:

* Residents of Ballana from the 1,200 randomly selected households
* Participants must have a valid National ID card
* Written informed consent

Exclusion criteria:

• Residents who are younger than 18 years
Laser Acupuncture for Dry Eye

Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.

Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.

Methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* 20 \< age \< 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.
* Tear film break-up time \< 10 s
* Schirmer's strips with anesthesia \< 5mm/ 5min

Exclusion Criteria:

* presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens
* pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis
* critical illness such as Stevens-Johnson syndrome, etc
* has taken or needs active treatment (including Chinese medicine)
* presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin
* does not meet the physician's assessment for recruitment
* lack of informed consent.
Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients

This is a prospectively randomized and double-blinded clinical study. Cancer patients were suffered from the taxanes-induced joint pain, and would be advised to receive laser acupuncture in specific points to relieve pain. Clinical effects of analgesic changes would be evaluated before and after the intervention. The inflammation associated indices would be further analyzed to reveal the therapeutic mechanism of laser acupuncture. The laser acupuncture was expected to relief taxanes-induced adverse effects in patients and also can improve patients' life quality.

The current clinical study is prospectively randomized and double-blinded, and practice in Chang Gung Memorial Hospital in Linkou, TaoYuan and Taipei branches. All 90 participants suffered from taxanes-induced myalgia and Arthralgia, and will be randomly assigned into the experimental groups (45 participants) and the control group (45 participants). The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment, besides the control group arrange pseudo-laser acupuncture. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients received taxanes treatment and complained with myalgia and Arthralgia in the first taxanes treatment course.
2. Age between 20-70 years old
3. The NRS (numerical rating scale) score of pain increased more than 2 after the treatment.
4. Both 1st and 2nd taxanes treatment with the same dose

Exclusion Criteria:

1. Receiving acupuncture or herbal medicine over past three months
2. Myalgia and arthralgia were not due to taxanes treatment such osteoarthritis or rheumatic arthritis
3. Wounds or skin infections over laser acupuncture points
4. Refuse assign information consent or follow study protocol
Primaquine Enantiomers in G6PD Deficient Human Volunteers

This study is a single center, prospective, cross-over phase 1 trial. Eighteen subjects will be enrolled in the study evaluating the metabolism, pharmacokinetic behavior and tolerability of primaquine enantiomers and placebo over the course of 5 days.

Each subject will receive a 15 mg dose of one enantiomer (SPQ or RPQ or Placebo) daily for up to 5 days, with careful monitoring of hematological parameters before and after each dose. In addition to the general CMP14 safety criteria, any subject who displays a fractional hemoglobin drop of 15% below his/her baseline value, then drug administration will stop (e.g. for baseline Hgb of 14 g/dL, if there is at any point a decrease of 2.1 g/dL). Hematocrit will be similarly monitored, with proportional stop criteria. Elevation in total bilirubin to 2.0 mg/dL or greater will also be used as a stopping criterion. After stopping drug administration (5 days or whenever stop criteria are met), subjects will have a 3-week washout period, and the study repeated with the other enantiomer, and similarly with Placebo.

Eligibility Criteria:
Inclusion Criteria:

* G6PD deficient, otherwise normal healthy adults aged 18 to 65

Exclusion Criteria:

* Known history of liver, kidney or hematological disease (other than G6PD deficiency)
* Known history of cardiac disease, non-sinus rhythm arrhythmia or QT prolongation
* Autoimmune disorders
* Report of an active infection
* Subject is pregnant or breast-feeding, or is expecting to conceive during the study.