cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis

This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.

The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age (inclusive), male or female
* Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
* History of pollen-induced seasonal allergic rhinitis but otherwise healthy
* Positive skin prick test for timothy and/or birch allergen
* Sufficient reaction to nasally administered allergen at screening
* Signed informed consent obtained

Exclusion Criteria:

* Expected symptoms of seasonal allergic rhinitis during the study period
* Asthma
* Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
* Anti-allergy immunotherapy in the previous two years
* Extensive use of nasal sprays
* Any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional OTC analgesics
* Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John's-wort) that may effect the enzyme CYP3A4
* Smoking within 3 months of first treatment period
* Clinically significant laboratory findings
* Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control
* Known hypersensitivity to any constituent of the study medication or placebo
* Participation in any other investigational study in the last three months
* Subject anticipated not being able to adhere to study plan according to investigator judgement
Virtual Coronary Intervention and Non-invasive Fractional Flow Reserve (FFR)

The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Significant stenosis at CT angiography
* Normal ejection fraction on echocardiography
* Informed consented patient

Exclusion Criteria:

* Total occlusion and collateral flow to target vessel
* AV conduction abnormality
* Left ventricular hypertrophy
* Significant valvular heart or primary myocardial disease
Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD).

The study will last for 57 days.

OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
* Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
* Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
* Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (\<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

Exclusion Criteria:

* Females who are pregnant or breastfeeding.
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
* History of liver problems that have required previous investigations
* Evidence of tuberculosis infection
* Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.
StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.

This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.

Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-65 years, inclusive
2. Written informed consent
3. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
4. Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting

   * Total skin defect may consist of more than one wound area
5. Full-thickness complex skin defects requiring excision and autografting
6. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
7. For thermal burns only, first excision and grafting of treatment sites

Exclusion Criteria:

1. Pregnant women and prisoners
2. Subjects receiving systemic immunosuppressive therapy
3. Subjects with a known history of malignancy
4. Preadmission insulin-dependent diabetic subjects
5. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
6. Expected survival of less than three months
7. Participation in the treatment group of an interventional study within the 90 days prior to enrollment
8. Chronic wounds
9. The face, head, neck, hands, feet, buttocks, perineum, and area over joints
10. Treatment sites with exposed tendon or bony prominences
11. Chemical and electrical burns
12. Treatment sites adjacent to unexcised eschar
13. Clinical suspicion of infection at the anticipated treatment sites
Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60

The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients older than 60 years.

This is a phase 3, open Label, single arm, multi-center study in elderly newly diagnosed AML patients. The patients will receive DAC combined with HAAG in the induction treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
2. 60-79 years old.
3. ECOG score: 0-3.
4. No history of previous chemotherapy or target therapy.
5. Provide informed consent.

Exclusion Criteria:

1. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
2. Patients with another malignant disease.
3. Patients with uncontrolled active infection.
4. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
6. Patients with creatinine clearance rate \< 50ml/min.
7. Patients with active hepatitis B or hepatitis C infection.
8. Patients with HIV infection.
9. Patients with other commodities that the investigators considered not suitable for the enrollment.
Systematic Screening for COPD in Tabacology Consultation

COPD is a very common disease, an estimated 3 million people are affected in France. Unfortunately, this pathology is under-diagnosed. Several reasons can be mentioned: the banality of the symptoms or the several comorbidities.

Screening faces a major difficulty: the realization of a spirometry. Various studies have shown the complexity of the implementation of mass screening in cities by mini-spirometry.

The COPD World Health Days allow this mass screening but without visibility on the actual entry into a care pathway.

The objective of this study is to assess the impact of systematic screening for COPD during a tabacology consultation


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 45 years old, followed in Tabacology unit at CHRU of BREST - No COPD patient or COPD patients not followed for more than 3 years (considered out of care)
* No opposition filed

Exclusion Criteria:

* Patients already followed for COPD
* Contraindication to spirometry
* Refusal to participate
Concealed Penis in Pediatric Age Group

Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by phallopexy only, group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by both phallopexy and dartos excision.

Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by anchoring the penile skin dermis to Buck's fascia at the penile base at 3 \& 9 o'clock points using PDS 5/0 (phallopexy), group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by phallopexy as in group A after complete dissection and excision of dartos fascia. Follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.

Eligibility Criteria:
Inclusion Criteria:

* patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature

Exclusion Criteria:

* Patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.
Gambling and Brief Interventions

This study will compare four different combinations and durations of motivational enhancement therapy, cognitive behavioral therapy, and brief advice treatments for gambling versus a non-intervention condition to determine which is most effective in reducing problem gambling.

Gambling, if done compulsively, can cause psychological, physical, social, and vocational problems. Problem gambling, or compulsive gambling, is a progressive addiction characterized by a preoccupation with gambling, a need to bet more money more frequently, restlessness or irritability when attempting to stop, and gambling more to make up for losses. This study will compare four different combinations and durations of motivational enhancement therapy (MET), cognitive behavioral therapy (CBT), and brief advice treatments for gambling versus a non-intervention condition to determine which is most effective in reducing problem gambling.

This open-label study will last a total of 9 months. Participants will be randomly assigned to one of four groups. Group 1 will have no intervention and will be instructed to call if they experience any gambling problems. Group 2 will receive 5 minutes of education on the hazards of heavy gambling. In addition, they will receive a 1-page brochure on problem gambling and its consequences. Group 3 will receive a 1-hour session of MET focused on increasing commitment to change by raising awareness of personal consequences of gambling. Group 4 will receive the same MET session as Group 3, as well as three 1-hour sessions of CBT focused on identifying specific social and mood cues associated with gambling. Treatment will end at Week 4. Participants will have two follow-up sessions held over the phone at Week 6 and again 9 months after enrollment. Gambling behavior, employment status, alcohol and drug use, psychiatric problems, and family problems will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for problem gambling
* Two or more gambling episodes per month for 2 months prior to enrollment
* Has spent at least $50 per month on gambling for 2 months prior to enrollment

Exclusion Criteria:

* Any uncontrolled psychiatric conditions
* Severe cognitive impairment
* Currently receiving treatment for gambling
Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis

An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.

1. Informed consent will be obtained from all patients prior to enrollment.
2. The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements.
3. This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI.
4. All patients will undergo AFP and US if they do not have results within the past three months.
5. If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC.
6. For all patients, a case report form will be completed.
7. All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded.
8. If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test.
9. All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence.
10. If available, all additional MRI/CT/US results will be recorded within the patient's CRF.

Eligibility Criteria:
Inclusion Criteria:

1. Any patients with chronic liver disease at risk for HCC.
2. Age ≥ 18 years.
3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.

Exclusion Criteria:

1. Any patients with chronic liver disease at risk for HCC.
2. Age ≥ 18 years.
3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
5. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
6. Women who are pregnant or breast feeding.
7. Patient taking drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
8. Patient, based on the opinion of the investigator, should not be enrolled into this study.
9. Patient unable or unwilling to sign informed consent.
10. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
TOPS for African American Breast Cancer Survivors

For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study.

To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change.

Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).

Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial).


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Exclusion Criteria:

* Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.
Evaluation of Labor Related Pelvic Floor Changes: A 3D Transperineal Ultrasound Study

The aim of the study was the define changes LAM morphology, biometric measurements of the LAM and genital hiatus at immediate evaluation of pelvic floor and at 3 month after delivery was evaluated. We also sought to define the optimal time for evaluation of pelvic floor after childbirth

Sixty four of 72 primiparous women who vaginally delivered singleton babies that eligible for trial were examined within 36 h of delivery and at 3rd months after delivery.Parameters such as age, episiotomy, mode of delivery, duration of labor, birthweight and antenatal biparietal diameter (BPD) measures were obtained from the clinical files. The length of the first stage of labor was calculated from the beginning of regular and at least three strong uterine contractions in 30 min according to the women's statements, tocography and palpations to full dilatation. All static ultrasound volume acquisitions were performed by the same experienced sonographer trained in pelvic floor ultrasound within 36 h of delivery. Same patients invited for second evaluation.Two 3-D volumes (one at rest, one on Valsalva maneuver) were recorded in the supine position after voiding.The effectiveness of valsalva was ascertained by observing 2-D ultrasounds before acquiring volumes.. LAM thickness is determined at the plane of minimal hiatal dimensions rather than 1-1.5 cm above the actual LAM hiatus where LAM thickness is maximal as described by Dietz et al.(15). The following parameters were assessed for this study: maximum diameters of the LAM hiatus (anteroposterior and transverse) at rest and on Valsalva maneuver; area of the LAM hiatus at rest and on Valsalva; and pubovisceral muscle thickness (left and right of the rectum), difference in anteroposterior and transverse diameter of hiatus and LAM hiatus area between rest and Valsalva

Eligibility Criteria:
Inclusion Criteria:

* primiparous women who vaginally delivered singleton babies that eligible for trial were examined within 36 h of delivery

Exclusion Criteria:

* operative deliveries (forceps or vacuum assisted), multifetal pregnancy, cesarean delivery, handicap in lithotomy position, refused consent and uncooperative patient for effective Valsalva maneuver.
The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP).

CML-MBP has dismal outcome. Currently, there is no standardized induction treatment approach in CML-MBP. The European LeukemiaNet (ELN) recommendations and NCCN guideline recommended the combination of TKI and chemotherapy in CML-MBP. The previous study revealed that TKI combined with hypomethylating agents had promising efficacy. However, imatinib and second generation TKI are the most widely applied in combination treatment, there is limited data in third generation TKI.

Currently, venetoclax in combination with hypomethylating agents such as azacitidine is standard treatment for patients with AML unsuitable for intensive induction chemotherapy. Maiti et al. reported that TKI combined with venetoclax and detectable had promising efficacy in CML-MBP. Therefore, the investigator conducted a study to explore the efficacy and safety of a third generation TKI in combination with azacitidine and Bcl-2 inhibitor in CML-MBP and multi-omics exploratory analysis was performed to identify potential biomarkers correlated with the outcome.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old;
2. philadelphia chromosome (Ph)-positive or BCR::ABL-positive;
3. serum creatinine ≤ 1.5 × upper limit of normal (ULN) or 24h creatinine clearance ≥ 50 mL/min when serum creatinine was \&gt; 1.5 × ULN;
4. serum total bilirubin ≤ 1.5 × ULN;
5. aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN;
6. amylase ≤ 1.5 × ULN; (7) lipase ≤ 1.5 × ULN;
7. ejection fraction \&gt; 50%; corrected QT interval on electrocardiographic evaluation was ≤ 450 ms in men or ≤ 470 ms in women.

Exclusion Criteria:

1. concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI;
2. diagnosis of other primary malignancies;
3. history of allogeneic HSCT;
4. extramedullary disease only.