cyrilzakka/clinical-trials huggingface dataset:
Tezepelumab PRO Study

This study assesses the impact of tezepelumab treatment not only on asthma control but also on cough specific Health-Related Quality of Life (HRQoL). Asthma control can be evaluated using Asthma Control Questionnaire (ACQ). Cough symptom which is one of the symptoms related airway hyperresponsiveness can be assessed via the relevant questionnaire, Leicester Cough Questionnaire (LCQ). There is moderate negative correlation between ACQ and LCQ . Improvements in both asthma control and cough symptom by tezepelumab would clarify effectiveness of Tezepelumab in real-world. Though Tezepelumab is recently approved in Japan, there is no real-world evidence on tezepelumab, particularly on above mentioned symptoms.

Thus, this study aims to estimate effectiveness of tezepelumab on asthma and cough symptoms in real world settings.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years who provide informed consent and who receive new prescription of Tezepelumab as per the physician's decision at baseline according to the package insert saying "Tezepelumab is given to patient with asthma (limited to severe or refractory patient whose asthma symptoms cannot be controlled even with existing treatment)"
2. ACQ-6 ≥1.5 at baseline
3. Patients with persistent cough ≥8 weeks up until the baseline visit according to The Japanese Respiratory Society Guidelines for the Management of Cough and Sputum 2019

Exclusion Criteria:

1. Patients who had asthma exacerbation within one month before study enrollment
2. Patients who had the biologics treatment in following period prior to the enrollment

   * omalizumab in 2 or 4 weeks depending on the body weight and total IgE amount
   * mepolizumab in 4 weeks
   * Benralizumab in 8 weeks
   * Dupilumab in 2 weeks
3. Patients with cough related diseases other than asthma as determined by treating physicians
4. Patients participating in studies that affect this study (study with other interventional treatment to evaluate efficacy/safety of treatment in patients with cough, asthma, or allergic/eosinophilic diseases)
5. Any disorder, including heart failure, malignancy, morbid obesity(BMI≧35) , respiratory infectious disease that is not stable (e.g. patients who need medical treatment) in the opinion of the investigator and could:

   * Affect the safety of the patient throughout the study
   * Impede the patient's ability to complete the entire duration of study
6. Patients with pregnancy or lactation period
Non-contrast DWI for Supplemental Screening

Diffusion-weighted imaging (DWI) is a short (under 5 minutes) non-contrast MRI technique that has shown promise for the detection and characterization of breast cancer. Our preliminary data has shown that DWI holds potential for detecting mammographically and clinically-occult breast cancers. However, current technical limitations reduce the sensitivity of DWI for screening applications.

The identification of a screening tool to complement mammography that is more accurate than ultrasound and faster, less expensive, and safer than conventional contrast-enhanced MRI would have significant clinical impact by improving the early detection of cancer in women with dense breasts. We hypothesize that an optimized DWI approach will enable detection of mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.

Hypothesis: With technical optimizations, non-contrast DWI can detect clinically and mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.

Aim 1: Improve the breast DWI technique to maximize spatial resolution, reduce distortion, and increase lesion contrast.

* Develop novel DWI acquisition to increase spatial resolution and reduce distortion (using reduced field of-view and/or multishot echo planar imaging techniques)
* Identify optimal diffusion sensitization (b-value) to maximize conspicuity of cancers in women with dense breasts

Aim 2: Develop interpretation tools to optimize diagnostic performance for detecting cancer on DWI.

* Determine quantitative DWI thresholds (contrast-to-noise ratio, apparent diffusion coefficient \[ADC\]) that best differentiate benign and malignant lesions (i.e. maximize sensitivity and specificity)
* Develop computer aided assessment tools to facilitate clinical implementation and optimize reader accuracy

Aim 3: Test the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts.

* Conduct a controlled reader study of non-contrast DWI alone for breast cancer detection
* Perform receiver operating characteristic (ROC) analysis and determine the sensitivity and specificity for detection of mammographically occult cancer

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 or older
2. Dense breast identified on mammogram

Exclusion Criteria:

1. Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR\<60, contrast allergy, incompatible metal)
2. Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
3. Women who are pregnant
Multicenter, Prospective, Randomized, Controlled, Double-blind Trial on the Impact of Rosuvastatin on Subclinical Markers of Atherosclerosis in Patients With Primary Necrotizing Vasculitides

The purpose of this study is to assess whether rosuvastatin could reduce the subclinical markers of atherosclerosis and the incidence of major cardiovascular events in patients with primary necrotizing vasculitides.

Previous studies demonstrated the presence of subclinical atherosclerosis in patients with ANCA-associated systemic necrotizing vasculitis. Since statins lower levels of inflammatory proteins and cholesterol, we hypothesized that people with ANCA-associated systemic necrotizing vasculitis but without indication for statin treatment according to recommandations might benefit from statin treatment.

Eligibility Criteria:
Inclusion Criteria:

Patient \> 18 years. ANCA-associated vasculitis: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss syndrome).

Patients will fulfill the Chapel Hill Consensus Criteria and the American College of Rheumatology criteria, in remission of vasculitis.

Patients in remission of vasculitis after induction therapy (for first flare or relapse), including corticosteroids associated or not with immunosuppressive agents according to Good Clinical Practice for the treatment of vasculitis, between 6 months and 10 years after the beginning of induction therapy.

Patients with informed and signed consent

Exclusion Criteria:

Other systemic vasculitis. Secondary vasculitis (paraneoplastic or infectious). Patient with active vasculitis after induction therapy, requiring salvage therapy.

Inability to sign informed consent. Inability to take the experimental treatment. Hypersensitivity to rosuvastatin or to any of the excipients. Pregnancy. Chronic HCV, HBV and/or HIV infection. Patient receiving other statin or other hypolipemic agent. Patient requiring treatment with statin according to Afssaps recommandations published in 2005 as primary or secondary prevention.

Subclinical atherosclerosis that confers a high cardiovascular risk before patient randomization :

* Carotid stenosis greater than 50% in diameter
* Ectasia of the abdominal aorta
* Intima-media thickening greater than 1.2 mm
* Diffuse atherosclerosis lesions
* Heterogeneous or hypoechoic prominent plaques greater than 2 mm

Participation in another interventional study within 3 months before inclusion. Sick patients will not be excluded if they participate simultaneously in a strictlu observational study or a study with only blood samplings.

Any medical or psycatric disease that could prevent from administrating drugs or from following-up the patient according to the protocol, and/or that would expose the patient to an important number of side effects, according to the principal investigator.

Non affiliation to a social security system or any social protection system.
Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease

460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.

Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status") class\> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.

Eligibility Criteria:
Inclusion Criteria:

* surgery treatment for GERD
* laparoscopic surgery

Exclusion Criteria:

* previous surgery for GERD
* ASA classification \>3
* paraesophageal hernias or large hiatal
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years outpatient (regardless of sex)
* Patients diagnosed as non-valvular atrial fibrillation (NVAF)
* One or more following risks of stroke.

Exclusion Criteria:

* Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
* Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
* Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.

This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.

Eligibility Criteria:
1. Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU.
2. Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential).
3. Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
4. Sexually active men had to agree to use a medically accepted form of contraception during the study.
5. Able to reconstitute and self-inject test article or have a designee who can do so.
6. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
7. Able to store injectable test article at 2°C to 8°C.
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir \[ABC\] plus efavirenz \[EFV\] plus didanosine \[ddI\]) with and without hydroxyurea (HU).

Patients are randomized into one of two treatment arms: ABC/EFV/ddI or ABC/EFV/ddI/HU. In the second treatment arm, patients are further randomized to receive HU beginning at Baseline, when ABC/EFV/ddI is started, or at Week 8. Delaying HU may help offset the cytopenic effect of HU, as reflected in a blunted CD4 cell response. Patients are stratified according to their screening plasma HIV-1 RNA level (400 to 10,000 copies/ml and more than 10,000 to 100,000 copies/ml). Participants in the study receive study-related exams, lab tests, and study medications at no cost over the 48-week treatment period. The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count, as well as the side effects caused by the medications. All of the medications are approved by the FDA and are not considered investigational.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are taking lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). Patients may also be taking one or two protease inhibitors (PIs). (Patients will qualify if drug substitutions were made or if the drugs were stopped for up to 2 months under certain conditions.)
* Have a viral load of 400 copies/ml or more (treatment failure) after 16 weeks of this treatment.
* Have a viral load between 400 and 100,000 copies/ml.
* Have a CD4 cell count of 100 cells/mm3 or more.
* Have consent of a parent or guardian (if under 18).
* Agree to use a barrier form of birth control (such as condoms) during the study.
* Are at least 13 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are unable to take medications by mouth.
* Have certain opportunistic (AIDS-related) infections or diseases.
* Have certain serious medical conditions such as diabetes or a disease of the liver, pancreas, or heart.
* Have a history of lymphoma.
* Have had peripheral neuropathy (a painful condition affecting the nervous system) within 2 months of study entry.
* Have been taking anti-HIV drugs for more than 1.5 years without an effect on HIV levels.
* Have ever taken ABC, ddI, or a type of anti-HIV drug called an NNRTI (such as EFV).
* Are unable to complete all 48 weeks of the study or take all of the study drugs.
* Are receiving certain other investigational treatments.
* Are receiving radiation therapy or chemotherapy within 8 weeks of study entry, or plan to receive one of these treatments during the study. (Local treatment for Kaposi's sarcoma is allowed.)
* Are taking certain medications including those that might affect the immune system or HIV levels.
* Have received a vaccine within 8 weeks of study entry or an HIV vaccine within 3 months of study entry.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.
Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery

Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.


Eligibility Criteria:
Inclusion Criteria:

* Parturients of gestational age \> 37 weeks, scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Contraindication to spinal anesthesia
* Any sign of onset of labor
* Emergency cesarean section
* Body weight \< 40 kg or \> 120 kg
* Height \< 140 cm or \> 190 cm
* Severe underlying cardiovascular disease
* Known fetal anomaly
* Preeclampsia
* History of hypersensitivity to fentanyl or morphine
* Chronic opioid use
Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast

RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer.

PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.

OBJECTIVES:

* To improve precision of tumor bed localization and definition of clinical target volume, and to reduce normal tissue irradiation in women undergoing partial breast or breast boost radiotherapy.
* To test whether post-operative MRI improves the precision of tumor bed delineation after wide-local excision in comparison with the current standard CT scan/clip method.
* To determine the impact of tumor position within the excision specimen upon the localization of clinical target volume in relation to the tumor bed.
* To compare theoretical non-target tissue exposure from partial breast irradiation planned in the supine and prone (face-down) positions.

OUTLINE: Patients undergo planned breast-conservation surgery and placement of titanium clips to the four radial, the deep, and superficial margins of the excision cavity (for localization of tumor bed).

Within 2 weeks after surgery, patients undergo supine radiotherapy-planning CT scan as standard analysis. Patients then undergo a radiotherapy-planning CT scan in the prone position. Patients complete a linear analogue questionnaire after both scans designed to assess patient comfort and anxiety in each position. Patients then undergo multifunctional MRI (including dynamic contrast-enhancement MRI and diffusion-weighted MRI) of the ipsilateral breast in the prone position (≥ 3 weeks after surgery). If suspicious lesions ≥ 5 mm are found on MRI, patients are referred for a second-look ultrasound with biopsy (if lesion visible on ultrasound); where suspicious lesions are seen only on MRI, patients undergo MRI-guided biopsy. Lesions \< 5 mm are included in the whole-breast radiotherapy treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planning to undergo breast-conserving surgery (BCS)\* for unifocal ductal carcinoma in situ (DCIS) or grade 1-2 invasive ductal carcinoma (IDC) of the breast NOTE: \*Patients who have underwent BCS and have titanium clips placed according to this protocol are eligible for this study.
* No T4d or multifocal disease (as defined on mammography or ultrasound)
* No G3 disease
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Female
* Menopausal status not specified

Exclusion criteria:

* Cup size DD or greater
* Ferromagnetic implants (exclude participation in MRI)
* Claustrophobia (exclude participation in MRI)
* Gadolinium allergy

PRIOR CONCURRENT THERAPY:

* No prior surgery to ipsilateral breast
* No prior neoadjuvant chemotherapy
68Ga-P3 PET/CT Imaging in Prostate

Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.

\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Eligibility Criteria:
Inclusion Criteria:

patients with confirmed or suspected cancer; Signed written informed consent

Exclusion Criteria:
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.


Eligibility Criteria:
Inclusion Criteria:

* Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:

  * patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
  * patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.

Exclusion Criteria:

* Patient having had pituitary surgery within the previous 3 months
* Patient having received radiotherapy for acromegaly disease within the previous 36 months
* Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
* Patient having received lanreotide autogel at any time before the study
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of vaginal dryness, burning or itching
* Symptom severity at least moderate

Exclusion Criteria:

* Systemic hormonal replacement therapy during the last 12 months
* Local hormonal replacement therapy during the last 4 weeks
* Known allergy to ingredients of the study creams
* Pregnancy
* Breast-feeding