cyrilzakka/clinical-trials huggingface dataset:
Interrelation Between Bronchial Asthma and Smoking

Smoking occurs frequently in patients with asthma. Recent surveys on smoking prevalence report 21-26% current smokers in populations of patients with asthma. Detrimental effects of active smoking in asthma include worse asthma control, an impaired response to corticosteroids and accelerated lung function decline.

The mechanisms by which cigarette smoking contributes to disease severity in asthma are incompletely understood, but it has been suggested that cigarette smoking may change inflammation and airway remodelling in asthma to become more similar to that in COPD (chronic obstructive pulmonary disease).

Any form of tobacco use, especially cigarette smoking, plays an important role in this disease. Asthmatic smokers are prone to several negative outcomes. Cigarette smoking by itself is associated with airway inflammation and features of airway remodelling including increased epithelial proliferation, squamous cell metaplasia, goblet cell hyperplasia, smooth muscle hypertrophy, and increases in bronchial glands mass.

Corticosteroid insensitivity is an important clinical feature of asthma, particularly in patients with severe disease and smokers. The mechanisms of corticosteroid insensitivity in asthmatic patients are poorly understood.

One of the major problems in the treatment of smoking asthma patients is the lack of efficacy data in this group of patients as smokers have almost always been excluded from studies on asthma due to perceived concerns about recruiting patients with COPD. Therefore, there is a lack of specific information about the treatment of asthma in smokers. The asthmatic smoker is a special phenotype with important therapeutic and prognostic clinical implications.

Eligibility Criteria:
Inclusion criteria:

1. Stable asthmatic patients (however smokers, or non-smokers) will be included (stable asthmatic defined as no emergency clinic or hospital visit, oral corticosteroid prescription, or change in asthma treatment in the past month) and (Current smoking was defined as 5 or more cigarettes per day and a smoking history of 5 pack years or greater).
2. Treatment with long-acting b2-agonists, and leukotriene receptor antagonists was allowed.

Exclusion criteria:

1. Acute severe asthma.
2. Causes of airway obstruction other than asthma as COPD patients, bronchiectasis......etc.
3. Age \<18 and \>45 years old.
4. Body mass index \>35.
5. Requirement for treatment with or the presence of conditions likely to be exacerbated by oral corticosteroids
6. The intention to stop smoking. Eligibility for the study required demonstration of reversible airflow obstruction (FEV1 bronchodilator response to b2 agonist of \>12% \[and \>200 mL\]) or a positive methacholine test result. All lung function assessments met relevant international consensus guidelines.
The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma

Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard therapy in patients (\< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation. The probabilities of event-free-survival and overall survival were doubled with a double transplant. The benefits were greatest among patients who had not had a very good partial response to the first transplant.

The aim of this multicenter randomised trial in previously untreated patients with multiple myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection, patients are randomly assigned to receive two autologous PBSC transplants (arm A)or one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders.


Eligibility Criteria:
Inclusion Criteria:

* patients less than 61 years of age
* Durie Salmon stage II or III
* written and informed consent

Exclusion Criteria:

* Prior treatment for myeloma
* ECOG performance score of 4
* Positive HIV test
* Chronic respiratory disease (DLco \< 60%)
* Systolic ejection fraction \< 50%
* Pregnant or nursing women
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following:

  * Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index \[CLASI\] activity score ≥ 10) at screening and Day 1
  * Prior intolerance or inadequate response to at least one of the listed medications for the treatment of CLE
* Stable dose (defined as no change in prescription for at least 28 days prior to Day 1) of antimalarials and/or topical or oral corticosteroids is permitted during the study. Individuals who are not planning to continue these medications during the study must have discontinued them at least 28 days prior to Day 1

Key Exclusion Criteria:

* Use of prohibited concomitant medications per study protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Topical PDT Cream Without Irradiation Source in the Acne Treatment

In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.

Exclusion Criteria:

* known pregnancy
* lactation
* any medical illness that might influence the results of the study
* a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment
* use of topical acne medication within 4 weeks of study enrollment.
Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections

The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison to intrathecal dexmedetomidine.

Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in comparison to patients receiving conventional spinal anesthesia and tap block.

Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size of 126 from the 3 groups is needed to detect a difference of at least 10 using the Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05. The common standard deviation within a group is assumed to be 9. The number of envelopes will be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

II. Statistical analysis Data will be coded and entered using the statistical package SPSS (statistical package for the social science) version 22. Data will be summarized using mean, standard deviation, median, minimum and maximum in quantitative data and using frequency (count) and relative frequency(percentage)for categorical data. Comparisons between quantitative variables will be done using the non parametric Mann-Whitney test. For comparing categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead when the expected frequency is less than 5. P-value less than 0.05 will be considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be full-term pregnant females
* ASA classification I or ll.
* Aged between 18 and 40 years.
* Singleton pregnancy

Exclusion Criteria:

* Refusal of block.
* Bleeding disorders (platelets count \<150,000; INR\>1.5; PC\<60%).
* wounds or infection at the puncture site.
* Known allergy to local anesthetic drugs.
* Contraindications to neuroaxial block.
* Contraindications to TAP block..
Early Detection of Lung Cancer In Patients With Chronic Chest Diseases

* To evaluate the effectiveness of LDCT in detecting early-stage lung cancer in patients with chronic lung conditions compared to standard chest x-rays.
* To improve lung cancer outcomes through optimized use of radiological technologies for early detection in high-risk patients with pre-existing lung conditions.

The early detection of lung cancer is crucial, as it is one of the most common and deadly types of cancer worldwide. Early detection is especially important in patients with chronic chest diseases, as these underlying conditions can make lung cancer more difficult to diagnose at later stages. Radiological imaging techniques play a key role in the early detection of lung cancer in this high-risk patient population.

Recent advances in imaging technologies have improved our ability to detect small lung abnormalities indicative of cancer at earlier stages, even before symptoms appear . Techniques such as low-dose CT scanning have been shown to reduce lung cancer mortality by up to 20% compared to chest radiography alone . Advanced imaging allows clinicians to identify subtle nodules or masses in the lungs that may represent cancer .

Determining the type, size, and extent of lung lesions is important for prognosis and treatment planning . Imaging technologies help characterize lesions as benign or malignant and determine cancer stage . This information guides decisions around surgery, chemotherapy, radiation therapy, or other interventions .

Early detection through radiological screening has been associated with improved survival rates for lung cancer patients with chronic lung diseases . Screening finds a higher portion of early-stage, potentially curable cancers in this high-risk group . Overall, advanced imaging techniques play a vital role in the early detection and management of lung cancer in patients with underlying chronic chest conditions.

Eligibility Criteria:
Inclusion Criteria:

1- Chronic chest diseases Patients .

Exclusion Criteria:

1 - Age: less than 45 years. 2-Patients diagnosed with lung cancer 3-Unstable patients or need for ICU admission
Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE

The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery.

Between January 1993 and September 2006, we enrolled 1400 consecutive patients from the Atherosclerosis Department with known Lp(a) levels and coronary heart disease (CHD) verified by angiography. In accordance with clinical condition and angiography data were assigned them into three parallel treatment arms and followed up to 15 years. This study was conducted according to the principles of the Declaration of Helsinki and the Institutional Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* stable coronary heart disease verified by angiography

Exclusion Criteria:

* acute coronary syndromes,
* acute infections,
* inflammatory disease within 3 months prior to inclusion,
* familial hypercholesterolemia,
* triglycerides\>4.5 mmol/L,
* missing Lp(a) measurements
Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners

Treatment of fractures and dislocations are generally organized in the hospital setting. However, equal care for patients with non-complex fractures or dislocations may be provided in general practices. While substitution of trauma care from the secondary to the primary care setting is stimulated by the government and insurers, it is unknown what the patient satisfaction level is and which determinants affect this patient satisfaction. Therefore, the primary objective of this study is to determine the effect of treatment in a general practice on patient satisfaction compared to treatment in a hospital. The secondary objectives include assessments in quality of life, patient-reported outcomes and cost-effectiveness. Besides, results will be discussed using a small focus group consisting of patients (n=15 per group) and healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

* X-ray confirmed diagnosis of a non-complex fracture or dislocation, which can be treated in the primary care setting according to the treatment protocol.
* Ability of the patient or assigned representative to understand the content of the patient information/informed consent form.
* Signed and dated written informed consent. Parents of patients of age 12-17 must provide a signed and dated written informed consent as well.

Exclusion Criteria:

* Patients of age 11 years and younger.
* Patients presenting outside ordinary business hours.
Study of Pharmacology of 17-OHPC in Pregnancy

We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.

The recently completed trial by the National Institute of Child Health and Human Development (NICHD)-sponsored Maternal-Fetal Medicine Units (MFMU) Network has demonstrated that intramuscular 17-alpha-hydroxyprogesterone caproate (17-OHPC) substantially reduces the rate of preterm birth in women at high risk for preterm delivery because of a prior spontaneous preterm birth. No other strategy or treatment for prevention of preterm birth has proven to be effective. Consequently, the American College of Obstetricians and Gynecologists has cautiously supported this treatment but points out that much more information about this therapy and alternative therapies is required. Although a large body of evidence exists about the safety of this treatment, almost nothing is known about the pharmacology of this agent, especially in pregnancy. The purpose of this study is to define the pharmacology of 17-hydroxyprogesterone caproate in pregnancy. This protocol will focus on pharmacokinetics and placental transport and provide preliminary data on the pharmacoepidemiology of 17-OHPC. The primary research question of this study is: Do the pharmacokinetics of 17-OHPC as represented by area under the concentration vs. time curve after IM injection of 250 mg 17-OHPC differ between the second and third trimesters of pregnancy? We will obtain blood samples prior to and daily for one week after injection of 17-OHPC (8 samples total) for each of two parts of the study, with an optional third part for eligible subjects. Additionally, blood samples will be collected prior to each weekly injection of the study drug and at time of delivery. Approximately 60 subjects (ages 18-45) will be accrued at one of the Obstetrical Fetal Pharmacology Research Units (OPRU) Network sites, with 15 at Magee-Womens Hospital of the University of Pittsburgh Medical Center. Study treatment will be administered until delivery. The total duration of this multi-center study is 2-3 years.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation prior to 20 0/7 weeks gestation
* Planning to receive or receiving 17-OHPC (250 mg IM weekly)
* Previous history of preterm birth
* Able to give consent

Exclusion Criteria:

* Fetal demise, anomaly, or growth restriction
* Hepatic or renal dysfunction
* Placental previa or abruptio placenta
* Polyhydramnios/oligohydramnios
* Short cervix or planned cerclage
* Chronic use of steroids, antiepileptics, antihypertensives, SSRS, street drugs
* Participation in another interventional study that influences gestational age at delivery
* Heparin treatment of known platelet count \<100,000/mm3 (because of contraindication to intra-muscular injections)
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.


Eligibility Criteria:
Primary Inclusion Criteria:

* Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
* Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging \[MRI\]).
* KPS of greater than or equal to 70% at Screening.
* Life expectancy of at least 3 months

Primary Exclusion Criteria:

* Sarcomatous type of mesothelioma
* Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
* Confirmed presence of CNS tumor involvement.
* Evidence of other active malignancy requiring treatment.
Reflexology and Mulligan Mobilization for Knee Osteoarthritis

to investigate the effect of adding Reflexlogy to mulligan mobilization and the conventional treatment for patients with Osteoarthritis knees

Knee osteoarthritis (OA), also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. Treatment by reflexology stimulation increases blood flow to the associated organ or body part. On the other hand, the nerve impulse theory claims that reflexology stimulation boosts nervous connection to the conforming body parts. Regarding to the energy theory; organs and body parts are connected through electromagnetic fields and that these pathways are blocked in states of disease. Finally, lactic acid theory pointed that lactic acid accumulates on the soles of the feet in the form of crystals which promotes free circulation, so reduces regular flow .The effects of foot reflexology on improving physical complains of KOA. Therefore, this study was conducted to evaluate the effectiveness of reflexology foot massage on pain intensity and physical functional abilities among patients with Knee Osteoarthritis.

Mulligan's Mobilization with Movement (MWM) advocates therapist-applied accessory gliding force combined with active movement The goal of MWM is to achieve immediate pain relief possibly by regulation of the non-opioid pain sensory pathways and by correction of micro positional faults. These positional faults may result from changes in the shape of articular surfaces, cartilage thickness, fiber orientation in the capsule-ligamentous complex, and the direction of musculo-tendinous pull, causing altered mechanics in the osteoarthritic knees.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 40 years.
2. Body Mass Index ≤30 kg/m².
3. All participants have Calcium Deficiency
4. Osteoarthritis in mild and moderate stage not in the acute stage
5. The subjects were chosen from both genders

Exclusion Criteria:

1. Deep Vein Thrombosis
2. Fractures
3. Gangrena Patient
4. Osteopenic Patient
5. Lactating or pregnant women
6. Cancer
7. Neurological conditions.
8. Patients with injury including; (lesions, sprain, open wounds, foot ulcer and or burn of the lower extremities), hemorrhage, epilepsy, irregular heartbeat.
9. Vascular (Anticoagulant Therapy, Aortic Aneurysm)
10. Neurological Deficits (multilevel PIVD, Cervical Myelopathy)
11. Psychological Disorders.

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Evaluating In Vivo OCT Imaging for Periocular Basal Cell Carcinoma

Optical coherence tomography (OCT) is an imaging technique which shows the internal structure of living tissue (in vivo). It is safe, quick and painless to perform, and does not damage the tissue in any way. Recent advances in the technology mean that it can now be used to take images of the internal structure of the skin. This is useful because certain conditions, such as skin cancers, alter this structure. At present a suspected skin cancer is identified by taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis. The cancer is then excised including a margin of apparently healthy-looking skin around it to ensure that the entirety of the tumour is removed. The excised tumour is then analysed again under a microscope to confirm that it was indeed completely removed (histology), after which a further operation is required to repair the defect.

The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC with the current 'gold standard' of histology. OCT could potentially improve the investigators ability to define the margins of the tumour before surgery and become a guide for minimally invasive surgery. The preservation of healthy tissue represents a priority, particularly in the area of the skin surrounding the eye.


Eligibility Criteria:
Inclusion Criteria:

* Adults of any age or gender who have capacity to give informed consent, and who have periocular basal cell carcinoma requiring surgical excision

Exclusion Criteria:

* Children, vulnerable adults, inability to give informed consent