cyrilzakka/clinical-trials huggingface dataset:
Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma

The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to \< 12 years of age, managed in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
* Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
* Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
* Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). \[e.g., A and (B or C)\]

A. Fluticasone DPI \> 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)

B. At least one of the following in the preceding 4 weeks prior to the screening visit:

* on average asthma symptoms \> 2 days/week or multiple times in a day on ≤ 2 days/week
* nighttime awakenings ≥ 2 times/month due to asthma symptoms
* use of SABAs \> 2 times/week on average
* some limitation in activity due to asthma
* on spirometric evaluation, FEV1 ≤ 80% of predicted, FEV1/FVC ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best

C. Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit

Exclusion Criteria:

* Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
* Subjects with a history of prior use of omalizumab
* Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
* Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
* Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome

Other protocol-defined inclusion/exclusion criteria may apply
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.

Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis addressed by the MAINTAIN Nephritis Trial is that MMF is superior to AZA.

Eligibility Criteria:
Inclusion Criteria:

* SLE aged ≥ 14 years
* Proteinuria ≥ 500 mg/day
* Biopsy-proven proliferative lupus nephritis

Exclusion Criteria:

* Recent treatment with high-dose glucocorticoids
* Recent treatment with immunosuppressive drugs
* More exclusion criteria in the protocol
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. The effects of methadone dose, with and without the inclusion of additional counseling services, would be measured through MMT retention and illicit opioid use.

Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use.

Eligibility Criteria:
Inclusion Criteria:

* client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study
* 18 years of age or older
* residing in the study areas
Role of the Supraspinal Opioidergic Circuit in Prefrontal TMS-Induced Analgesia

Studies have shown that transcranial magnetic stimulation (TMS), a non-invasive form of brain stimulation, can reduce pain in the laboratory and in the clinic. The purpose of this study is to investigate how TMS relieves pain and affects pain circuitry in the brain. One of the primary study hypotheses is that opioid blockade will significantly reduce the pain relief produced by left prefrontal cortex TMS.

Non-invasive forms of brain stimulation such as transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are currently being investigated as alternative or adjunctive therapies for pain. Clinical interest in these techniques continues to grow because of rising opiate abuse and inadequate pain management strategies. Despite this enthusiasm, studies on the efficacy of repetitive TMS (rTMS) for pain have produced mixed results. Some of the most promising and informative research has focused on rTMS for perioperative pain. In two different postoperative studies, a single session of left dorsolateral prefrontal cortex (DLPFC) rTMS after gastric bypass surgery reduced morphine self-administration by 40% when compared to sham stimulation. These data are particularly fascinating given the role of the DLPFC in top-down pain processing.

Centered at the juncture of Brodmann Areas (BAs) 9 and 46, the DLPFC remains a popular therapeutic target for rTMS given its accessible location and presumed role in high-order cognition and emotional valence. Animal and human studies suggest that cingulofrontal regions like DLPFC may modulate pain perception via recruitment of opioidergic midbrain and brainstem structures like the periaqueductal gray (PAG) and the rostroventromedial medulla (RVM), respectively. These data outline the functional circuitry that might be involved in the analgesic effects of DLPFC rTMS.

While many studies aim to evaluate the clinical efficacy of DLPFC rTMS for pain management, few have examined how it affects pain processing. Imaging the cerebral signature of pain before and after left DLPFC rTMS might reveal information about pain circuitry and help to elucidate the mechanism by which prefrontal rTMS may produce analgesia. Previous studies suggest that opioid blockade abolishes left but not right DLPFC rTMS-induced analgesia. In this study, our a priori hypothesis was that left DLPFC rTMS would attenuate blood oxygenation-level dependent (BOLD) signal response to painful stimuli in pain processing regions. More specifically, we anticipated that midbrain and medulla BOLD signal changes induced by left DLPFC rTMS would be abolished by pretreatment with the μ-opioid antagonist naloxone.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* no history of depression or pain
* no metal in body
* no medications that lower seizure threshold

Exclusion Criteria:

* history of depression or pain
* history of seizures or epilepsy
* metal implants in body
* medications that lower seizure threshold
* psychiatric medications
Use of Ziv Aflibercept in Different Retinal Diseases

A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and OCT(optical coherence tomography) were performed for all patients .Injection was repeated as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.

Eligibility Criteria:
Inclusion Criteria:

* The study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal CNV less than 2 months documented by fundus fluorescein angiography (FFA)and optical coherence tomography (OCT ) , pathological myopia more than 6 D was included .

Exclusion Criteria:

* Previous intraocular surgery .
* Coincident retinal pathology as diabetic retinopathy, retinal vein occlusion .
* CNV due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis.
* Extrafoveal myopic CNV .
* Patients received other lines of treatment for CNV like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti VEGF(vascular endothelial growth factor) agents.
* Known glaucoma , clinical suspicion of glaucoma or IOP(intraocular pressure) more than 20 mmHg.
* Prior ocular inflammation.
* The presence of retinal degeneration.
* Patients who didnot complete 6 months of follow up
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects

This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination \[TC\]) administered for 13 days to healthy male and female subjects


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of non-childbearing potential only.
* Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg.
* Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both ≥80% of their predicted value at screening.

Exclusion Criteria:

* For female subjects: Pregnant or nursing subjects.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* History of hemolysis.
* Total bilirubin level \>2 × ULN at Screening.

Other protocol defined Inclusion/Exclusion criteria applied.
Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective，Open-label, Single-arm Study.

The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in lower-risk MDS patients with thrombocytopenia.

The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in patients with very low, low, or intermediate risk myelodysplastic syndromes(MDS) according to the revised International Prognostic Scoring System (IPSS-R) with thrombocytopenia. The primary endpoint was proportion of patients achieving platelet response at week 24.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older；
* Confirmed diagnosis of MDS based on 2016 WHO (World Health Organization) and classification with very low, low or intermediate (score ≤ 3.5) risk according to the revised International Prognostic Scoring System (IPSS-R).
* Platelets \< 30 x 10\^9/L or platelets \< 50 x 10\^9/L with active bleeding at screening.
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2；
* Ability to understand information material and written informed consent.

Exclusion Criteria:

* Severe active bleeding/infection or any other uncontrolled severe condition;
* History of treatment with thrombopoietin receptor agonists (eltrombopag, avatrombopag, romiplostim, etc.) or recombinant human thrombopoietin with 1 month prior;
* Patients with known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening（If hepatitis B surface antigen or hepatitis B core antibody are positive, HBV-DNA testing are needed. If positive, it suggests a viral replication and subjects will be excluded. If hepatitis C antibody are positive, HCV-RNA testing are needed. If positive, it suggests a viral replication and subjects will be excluded）;
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 x upper limit of normal (ULN), total bilirubin \>2.5 x ULN, creatinine \>1.5 x ULN;
* History of portal hypertension or cirrhosis；
* History of any types of solid tumors within 5 years prior, whether the tumors has been treated, metastasized or relapsed (except basal cell carcinoma);
* History of congestive heart failure requiring medical management, cardiac arrhythmias, peripheral arteriovenous thrombosis within 1 years prior, or myocardial infarction or cerebral infarction within 3 months prior;
* ECOG performance score ≥ 3;
* Female subjects who are pregnant or breastfeeding, or subjects who are planning pregnancy within 6 months;
* Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation;
* Participated in other clinical trials within 3 months prior;
* Any condition which, in the investigator's opinion, deems the subject an unsuitable candidate to receive study drug.
The Effect of Range of Motion (ROM) exercıses on Comfort Level and vıtal sıgns

This experimental study aims to examine the effects of ROM (Range of Motion) exercises on comfort level and vital signs in children diagnosed with cancer.

The sample of the study consisted of a total of 60 oncology patient children, 30 in the experimental group and 30 in the control group, between the ages of 6-12, who were hospitalized in the Pediatric Bone Marrow Transplant Unit and Pediatric Hematology Oncology Service of a state hospital. The data of the study were collected with the "Data Collection Form", "Life Findings Table" and "Comfort Scale in Children". Range of motion exercise applications continued once a day for 5 days a week for approximately 20 minutes. Fever, pulse, respiration, blood pressure, pain and comfort levels of the children were measured before and after the exercise. In the study, it was investigated whether Range of motion exercises have an effect on vital signs and comfort levels of children with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 6 and 12 years of age.
* Patients diagnosed with oncology.
* Patients who agreed to participate in the study and whose consent was obtained from their parents.
* Patients who can communicate and are conscious.

Exclusion Criteria:

* Patients with fractures or orthopedic conditions that may limit exercise.
* Patients with serious cardiac problems that may prevent exercise.
An In-situ Detection for MicroRNA

We designed a new in-site detection method for MicroRNA in the serum of patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria: Healthy without serious diseases

-

Exclusion Criteria:

* situations that may affect the results
Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement

This research study is studying an intervention as a possible treatment for pancreatic cancer.

In this research study, the investigators are researching how well IORT during surgery works in treating pancreatic cancer after 3-6 months of chemotherapy and external radiation therapy. IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy. The investigators believe that the administration of IORT after 3-6 months of chemotherapy will help to stop the cancer cells from growing.

The FDA (the U.S. Food and Drug Administration) has not approved IORT for this specific disease but it has been approved for other uses.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ECOG Performance Status 0-1
* Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)
* Previous completion of either stereotactic-body radiation therapy (SBRT) (minimum 24 Gy) or external beam irradiation (EBRT) (minimum 45 Gy)
* Participation in any investigational drug study within 4 weeks preceding the start of study treatment is PERMITTED.
* Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after IORT.
* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Evidence of disease progression or distant metastases.
* Pregnant or lactating women
* Treatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.
* Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* An active infection requiring systemic therapy
* Other serious medical conditions that the investigator feels might compromise study participation
Pragmatic Set of Interventions Versus Scapular Strengthening Exercises on Scapular Dyskinesia in Adhesive Capsulitis

The aim of this study is to determine the Effects of pragmatic set of interventions versus scapular strengthening exercises on scapular dyskinesia in adhesive capsulitis.

Scapular dyskinesia (SD) is a term that describes a physical impairment in which the scapula's position and motion are altered.Symptoms of SD can be one or a combination of the anterior shoulder pain, Postero-superior scapular pain, superior shoulder pain, proximal lateral arm pain. scapular dyskinesia is commonly found in adhesive capsulitis patients. To determine the scapular dyskinesia with shoulder pain two tests that apply manual assistance to the scapula are lateral scapular slide test and wall push up test.

Pragmatic set of interventions are an important element in rehabilitation, and has improved the treatment of many musculoskeletal and neurological conditions. Scapular strengthening exercises, which aims to improve abnormal scapular movements that commonly occur in people with adhesive capsulitis.

The purpose of this study is to explore the effect of scapular focused exercises on the rehabilitation of adhesive capsulitis, patient with scapular dyskinesia. The importance of scapular rehabilitation in the treatment of scapular dyskinesia and to examine the comparative effect of pragmatic set of intervention with scapular strengthening protocol on scapular dyskinesia.

My study on the effect of a pragmatic set of intervention versus scapular strengthening exercises on scapular dyskinesia in adhesive capsulitis is important because it addresses a gap in the current literature. While both interventions have been shown to improve scapular dyskinesia in patients with adhesive capsulitis, there is a lack of studies comparing the two methods. My study will help determine which intervention is more effective in treating scapular dyskinesia, which will be valuable information for healthcare providers working with patients with adhesive capsulitis

Eligibility Criteria:
Inclusion Criteria:

* Both male and females with age range b/w 25-45
* People with adhesive capsulitis (having pain, stiffness, and decrease movements of - external rotation, forward flexion and abduction)
* Scapular dyskinesia (positive lateral scapular slide with difference of 1.5cm when measurements are compared bilaterally)

Exclusion Criteria:

* History of shoulder surgery or other significant shoulder injury, neurological or musculoskeletal conditions that may affect shoulder function.
* History of significant medical conditions (e.g., heart disease, cancer) that may affect their ability to participate in the study.
* Pregnant or breast feeder, as the exercise program may not be safe or appropriate for them.