cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli

The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a moderate to high clinical suspicion for PE.


Eligibility Criteria:
Inclusion Criteria:

1. Written consent by the subject to participate in the study.
2. Moderate to high pre-test probability of acute pulmonary embolism.
3. Positive D-dimer.
4. Onset of PE symptoms occurring within the last seven days.
5. Aged 18 years or older.
6. Women of childbearing potential must have a negative serum pregnancy test (β-hCG) result at the time of enrollment into the study. Both male and female participants must agree to use effective contraception for the first 30 days after administration of 99mTc ThromboView®.

Exclusion Criteria:

1. The subject is unwilling or unable to provide written informed consent.
2. Allergy or other contraindication to intravenous iodinated contrast media.
3. Prior exposure to murine, chimeric or humanized antibodies.
4. Illicit intravenous drug use in the past 12 months.
5. Administration of therapeutic radioiodine in the past 6 months.
6. Life expectancy less than 90 days.
7. Previous participation in the current study.
8. Current enrollment in a clinical trial involving any other investigational agent.
9. Subject is unsuitable for SPECT scanning at the study Investigator's discretion (e.g. residual detectable radioactivity within the lungs due to prior imaging studies or treatment, preceding planned administration of 99mTc ThromboView®).
10. Inability to perform CTPA or 99mTc ThromboView imaging, for any reason.
11. Renal dysfunction: calculated creatinine clearance \< 30 mL/min.
12. Hepatic dysfunction: serum transaminases ≥ 3 x upper limit of normal range.
13. Hepatic dysfunction: subject has history of chronic or currently active liver disease.
14. Current pregnancy or lactation or conception intended within three months of enrollment.
15. Subject is unsuitable for the study at the study Investigator's discretion. -
CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma

Single-center, interventional, open-label, randomized phase II study aimed at describing the changes in airway inflammation at the onset of asthma symptoms that lead to the use of rapid acting bronchodilator (RABD) as a rescue medication in a mild to moderate asthma population. The study will assess whether there are differences in the airway inflammation profile in patients using a reliever medication containing ICS (anti-inflammatory rescue strategy) compared to a reliever medication containing only a bronchodilator for symptom relief (Non anti-inflammatory rescue strategy).

The study is structured into two distinct and separate phases, an observational and an interventional.

- Phase 1: Observational Phase The observational component of the study aims to describe the variations in airway inflammation at the onset of asthma symptoms when patients (n=50) are under the appropriate anti-asthma therapy (Standard Of Care, SOC), which includes a rapid-onset bronchodilator (RABD) as needed. The RABD used may be either salbutamol or formoterol, depending on the therapeutic strategy employed by the patient and the GINA Track followed.

Before and after taking the SOC rescue medication, the patient will measure markers of airway inflammation and clinical impact (FeNO, FEV1, PEF, VAS scale) using the "PEFESP kit" provided to each enrolled patient. They will record these values in the "patient diary" for the subsequent 48 hours.

- Phase 2: Interventional Phase In a crossover design according to the AB/BA scheme, it will be assessed whether there are differences in the airway inflammation profile in patients (n=30) using a reliever medication containing ICS compared to a reliever medication containing only a bronchodilator.

The interventional phase consists of two open-label monitoring phases, each lasting a maximum of 3 weeks, separated by a washout period of 3 to 7 days and for a maximum of 3 symptom episodes. As in the observational part, patients will be asked to record the markers of airway inflammation and the clinical impact of symptoms at the onset of the change from stable condition and in the 48 hours following the administration of the reliever medication.

Patient with mild asthma will be the first group of severity enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients already followed for asthma according to ERS/ATS criteria
* Mild and moderate asthma (GINA steps 1-3), with the exclusion of patients with severe asthma (GINA steps 4-5).

Exclusion Criteria:

Severe asthma (Gina steps 4 and 5)

* Inability to give informed consent
* Diagnosis of other clinically significant respiratory diseases
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* History of smoking: \> 10 pack/year or stop for less than 3 months
* Oral steroid therapy in the 2 months prior to enrollment
* Number of asthma exacerbations per year ≥ 2
* Pregnancy
* Evidence of clinically significant pathologies other than in respiratory system (i.e., cardiovascular, hepatic, renal, nervous, endocrinological, oncological, dermatological systems)
Precision Medicine of Diabetes Program in China

The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diabetes according to WHO 1999 criteria

Exclusion Criteria:

* with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data
US-Guided Superficial Cervical Plexus Block

This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block

Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery of the shoulder and clavicle
* Urgent or planned surgery

Exclusion Criteria:

* Refused to sign informed consent
* Pregnant women
* Allergic to the local anesthetic
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)

REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT to improve recovery after Intensive Care Unit (ICU) discharge in patients with COVID-19 (REMM-HIIT-ICU-COVID) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, Mhealth-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years
2. ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for \> 48 hours with an ICU length of stay of ≥ 4 days.
3. Ability to ambulate with or without a gait aid prior to hospital discharge
4. Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)

Exclusion Criteria:

1. Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
2. Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
3. Unable or unwilling to follow coaching via mobile-health iPhone interaction
4. Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:

   1. Recent (\< 5 days) acute primary cardiac event
   2. Unstable Angina
   3. Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
   4. Symptomatic aortic stenosis
   5. Uncontrolled symptomatic heart failure
   6. Acute myocarditis or pericarditis
   7. Suspected or known dissecting aneurysm
The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.

The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.

Eligibility Criteria:
Inclusion Criteria:

i. male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test

Exclusion Criteria:

i. patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy
Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)

Prospective randomised clinical trial planned. Older than 18 years old perianal benign diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal fistula) cases without malign tumour, cronic colorectal disases, and routine used of vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases were exclused of the study.

Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases Group-5 (n:50): Uncomplicated, simple perianal fistula cases

Eligibility Criteria:
Inclusion Criteria:

* Grade 1 and 2 hemorroidal disease
* Cronic anal fissura
* Uncomplicated simple perianal fistula

Exclusion Criteria:

* Any malign tumour
* Cronic colorectal disases
* Routine used of vasoactive medication
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL \>7μg/mL: interval prolongation allowed; (C) TL \<3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL \<3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target \* Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients.

The patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.


Eligibility Criteria:
Inclusion Criteria:

* all adult IBD patients treated for at least 14 weeks with infliximab were included

Exclusion Criteria:

* induction treatment with infliximab (\<14 weeks)
* treatment with other biological for IBD
Cigarette Smoking Decision Study

The Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Although the FDA has restricted use of descriptors such as "natural" and "additive-free," research shows that the tobacco industry quickly pivoted to increase use of alternative, unregulated tactics. Greenwashing is one increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. The investigators' preliminary research indicates that greenwashing tactics may inaccurately convey modified product risk to consumers. The overarching objective of this project is to test the effect of greenwashing methods used by cigarette companies to market products on actual smoking behavior in a controlled laboratory study. The investigators' proposed research focuses on young adults (age 18-29), because this is a key age for smoking initiation and escalation, and research has found that young adults may be more susceptible than older adults to greenwashing in cigarette ads. This study will test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study. These data will clearly connect tobacco advertising features to product risk perceptions and actual smoking behavior. This work will provide FDA with an integrated set of evidence that identifies misleading greenwashing tactics that inaccurately convey modified product risk which can be used to inform regulatory action regarding restrictions of this type of advertising.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 29 years of age
* Smoke at least five cigarettes per day
* Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter

Exclusion Criteria:

* The intention to quit smoking in the next 30 days
* Report "roll your own" cigarettes as an exclusive form of smoking
* A serious medical or psychiatric disorder or unstable condition
* Any positive toxicological screening for illicit drugs other than cannabis will be excluded
* Women who are pregnant, plan to become pregnant or are breast-feeding
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
* No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
* Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

* Participants with HER2 positive status
* Participants with known untreated central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy

Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.

Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Eligibility Criteria:
Inclusion Criteria:

* adult female patients
* American Society Of Anesthesiologists (ASA) class I or II
* scheduled for elective unilateral modified radical mastectomy

Exclusion Criteria

* patient refusal
* bilateral breast surgery
* coagulation disorders
* body mass index\> 35
* allergy to local anaesthetics or magnesium sulphate
* severe respiratory or cardiac disorders
* pre-existing neurological deficits
* liver or renal insufficiency
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed Consent of the patient;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can

  ´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* Decongestants dependent patients or patients receiving allergen specific immunotherapy;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* History of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.
Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction

The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.

This will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.

This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MGD
* Minimum age 18 years

Exclusion Criteria:

* History of ocular disease, trauma, surgery (other than refractive), orbital cancer
* 3 month history of ocular infection and/or ocular inflammation not associated with dry eye
* 3 month history of any active physician administered or prescription dry eye treatment
* Pregnant, potentially pregnant or nursing
Treatment of the Osgood Schlatter

The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases there is persistent residual pain in adulthood.

The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who continued his sports without restriction.

The possible consequences are numerous including the presence of a free bone fragment at the insertion of the tendon originally described by Osgood the establishment of a genu recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying sport.

The main two treatments are complete rest from sport activity or cast immobilization.

The main objective is to compare these two technics according to the proportion of full sporting recovering at 12 months


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls
* From 9 to 15 years old
* Coming to consult in the Sports' medicine ward
* Patients diagnosed with Osgood-Schlatter disease defined by a swelling of the anterior tibial tuberosity (ATT) , pain on palpation of the ATT , pain with passive knee flexion , pain thwarted knee extension and soft rays in profile knee radiography according to the classification of Woolfrey and Chandler (types A -C
* Unilateral or bilateral
* Previously treated or not
* Agreed to participate
* Agreement of the parents to participate
* Affiliation to national security

Exclusion Criteria:

* Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
* Local infection
* Hypothermia \<32°C
* Need for implementation of arterial catheter only
* Need for implementation of venous catheter only