cyrilzakka/clinical-trials huggingface dataset:
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.

Chemotherapy will be given in accordance with local or regional guidelines but shall include a platinum drug + any topoisomerase inhibitor. Within these limits the study will accept different local variants as long as each centre remains consistent to its declared standard chemotherapy regimen. The recommended regimen is carboplatin or cisplatin plus etoposide q3 weeks for 4 cycles but up to 6 cycles is allowed. Local dosages and dose reduction schedules will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically verified SCLC, all stages
2. WHO performance status 0, 1, 2 or 3
3. Age 18 years or older
4. Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.
5. Platelets \>100 x109 /L
6. Signed informed consent
7. PK (prothrombin complex) INR and APTT within normal ranges.

Exclusion Criteria:

1. Prior systemic chemotherapy for lung cancer.
2. Concomitant anticoagulation treatment, except for ASA or clopidogrel
3. Active overt bleeding of clinical importance or at high risk (e.g. earlier observed haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3 months suffered from intracranial haemorrhage, or surgery in the central nervous system).
4. Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).
5. Pregnancy or breast-feeding
6. Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.
7. Treatment with any other investigational agent, or participation in any other clinical trial.
Iron Supplementation Among Adolescent Girls in India

This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India.


Eligibility Criteria:
Inclusion Criteria:

* Girl 12-19 years of age
* Resides in study area

Exclusion Criteria:

* Does not reside in study area
Retinal Neurodegenerative and Vascular Changes in Diabetic Patients

Using Optical Coherence Tomography and ImageJ software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy.

Relieving the burden of diabetic retinopathy treatment require a prompt and non-invasive assessment of diabetic patients before the occurence of diabetic retinopathy. Since OCT is capable of imaging retina with such a high precision, retinal changes occuring before any clinical signs of retinopathy, such as microaneurysm or haemorrhages, can now be assessed. In the present study the investigators are analyzing the connection between retinal arteries and veins regarding lumen diameter, vessel wall thickness and their correlation with retinal nerve fiber layer and ganglion cell layer thickness. Moreover, using binarization of the choroid the investigators will assess its relationship with outer retina layers, such as retinal pigment epithelium and photoreceptors.

Eligibility Criteria:
Inclusion Criteria:

* history of type 1DM for more than 1 year
* history of type 2 DM for more than 3 months
* diagnosis of no DR or mild Non-proliferative diabetic retinopathy(NPDR)

Exclusion Criteria:

* DR with more than NPDR ,
* Diabetic macular oedema,
* media opacities such as corneal or lens opacities that could preclude appropriate OCT imaging,
* presence of other retinal diseases such as Age-related macular degeneration, Vitreo-macular traction, Macular hole, Epiretinal membrane, Retinal vein occlusion, Macular scars,
* Glaucoma, Optic neuropathies or Neurodegenerative diseases,
* history of ocular trauma,
* Refractive errors of more than ±6 diopters (spherical equivalent),
* previous ocular surgery, focal laser, panretinal photocoagulation or anti-VEGF intravitreal injection
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma

Serum samples of asthmatic patients will be screened for serum biomarkers


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years
* physician-diagnosed asthma

Exclusion Criteria:

* No clear asthma phenotype
* Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
* \> 15 pack years
* No sputum available
* Respiratory infection
* Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)
Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis

Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 19 to 65 years, inclusive
2. Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening
3. Patients who agreed to participate clinical trial and sign on informed consent form

Exclusion Criteria:

1. Patients who are suspicious or diagnosed for pneumonia
2. Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
3. Patients with active infection who needs administration of antibiotics
4. Patients with myocardial infarction, congestive heart failure
5. Patients with renal disorder or liver disorder
6. Patients with hypotension or hypertension
7. Patients with history of epilepsy
8. Patients with hyperthyroidism
9. Patients with gastroduodenal ulcer
10. Patients with sever hypoxemia
11. Patients who are in drug or therapy or planned to have;

    * antibiotics, anti-virus, angiotensin converting enzyme (ACE) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
    * Angiotension II receptor blocker (ARB), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
    * Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
12. Smokers
13. Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
14. Patients with pregnant and/or have breast feeding.
15. Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
16. Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
17. Patients who are identified as inappropriate by other investigators to participate clinical trial
Stretching Techniques of Knee Muscles and Their Effect on Joint Range, Suppleness and Muscle Activity in Elderly

The goal of this clinical trial was to compare the effect of two different types of stretching techniques in elderly population. The main questions it aims to answer are:

1. What is the immediate effect (after a single intervention) of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity?
2. What is the effect of a four week intervention program of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity? There were three groups with ten randomly allocated participants in each group. Intervention group I was given a stretching technique called contract-relax technique and the Intervention group II was given static stretching. The third group was not given any treatment and was taken as a control. The main aim was to find out that whether the two techniques are effective or not and which one of the two is better than the other in terms of improvement in the above mentioned parameters.

The objective of the study was to compare the effects of Proprioceptive Neuromuscular Facilitation - Contract Relax (PNF- CR) and static stretch techniques immediately and post four weeks of intervention on knee range of motion, flexibility and electromyographic activity of knee muscles among older adults. This is an outcome assessor-blinded pre-test post-test randomized controlled trial with two experimental groups (PNF-CR and Static Stretching) and a control group. 30 males aged 55-75 years were randomly assigned into PNF group (n=10), Static Stretch group (n=10) and Control group (n=10). Knee range of motion, electromyographic activity of hamstrings and sit and reach test, were taken for the dominant side thrice: pre-intervention, immediately after stretching and after the training period. Active knee range of motion (ROM) was assessed using a universal goniometer. Surface Electromyography (EMG) was used to record Maximal voluntary isometric contraction (MVIC) of biceps femoris and the Chair Sit-and-Reach Test (CART) was used to assess the hamstring muscle's length flexibility.

Eligibility Criteria:
Inclusion Criteria:

* Male adults aged between 55 and 75 years
* Able to do activities of daily living (ADL) without assistance
* Able to comprehend and follow instructions

Exclusion Criteria:

* Grade III or IV osteoarthritis or any other musculoskeletal condition affecting the muscle length.
* History of any surgery to hip, knee, low back or ankle
* History of any medication (anti-inflammatory, for pain relief, or anti-arthritic) in previous six months
* History of life-threatening disease (neurological disease, cardiovascular disease, severe hypertension)
* Passive full knee extension (popliteal angle 180 degrees)
Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Although no single treatment has shown superiority, short-term pain relief may be offered via a targeted local corticosteroid injection (CSI), used often in combination with local anesthetic (LA), which may reduce plantar fasciitis symptoms for up to 1 month. Moreover, administering a CSI is relatively quick and easy for any Provider to perform, though it is not without potential deleterious side effects and risks, including fibroblast degradation, fat pad atrophy, skin depigmentation, and even plantar fascia rupture.

Research performed in other musculoskeletal disorders (e.g. lateral epicondylitis) suggest that the "method" (i.e peppering vs single bolus deposition) of injection is more favorable than the steroid itself, though evidence for this positive effect in plantar fasciitis is rather scarce.

Injection via peppering is a minimally invasive percutaneous technique which involves repeatedly fenestrating the pathologic site (i.e. plantar fascia) via hypodermic needle insertion at the tender area, then sequentially injecting a substance, withdrawing, redirecting, and reinserting all without emerging from the skin. Though hypothetical, this technique is thought to disrupt the degenerative process of Plantar Fasciitis (PF), encouraging both localized bleeding and fibroblastic proliferation and stimulating a local inflammatory response that would trigger the body's own reparative mechanism, leading to recovery.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age and older
* Patient reported history of plantar heel pain and confirmed clinical tenderness of pain with direct palpation of the medial calcaneal tubercle on baseline exam
* Diagnosis of chronic plantar fasciitis, defined for study purposes as symptoms greater than or equal to 6 weeks in duration

Exclusion Criteria:

* Individuals less than 18 years of age
* Pregnancy
* History of receiving a local heel injection (i.e. corticosteroid injection (CSI) or other injectate) within the last 3 months
* Prior heel trauma or surgery
* Allergy to local corticosteroid or local anesthesia
Omega-3 Fatty Acids to Combat Sarcopenia

The purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 or 65-85 years

Exclusion Criteria:

1. Current use of omega-3 nutritional supplements
2. Fasting plasma glucose ≥126 mg/dL
3. Active coronary artery disease
4. Participation in structured exercise (\>3 times per week for 30 minutes or longer)
5. Smoking
6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
7. Renal failure (serum creatinine \> 1.5mg/dl)
8. Chronic active liver disease (Bilirubin \> 17mmol/L, AST\>144IU/L, or ALT\>165IU/L)
9. Anti-coagulant therapy (warfarin/heparin)
10. INR \>3
11. Use of systemic glucocorticoids
12. Chronic use of NSAIDS or aspirin
13. Pregnancy or breastfeeding
14. Alcohol consumption greater than 2 glasses/day
15. Hypothyroidism
16. Fish or shellfish allergy
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer,advanced endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
2. Subjects with expected survival ≥ 3 months.
3. Cohort A: Subjects with recurrent or metastatic cervical cancer
4. Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
5. Cohort C: Subjects with recurrent ovarian cancer
6. Cohort D: Subjects with metastatic prostate cancer
7. Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
8. Subjects able to provide tumor blocks or slides for biomarker test.
9. Subjects have relatively good organ function and bone marrow function.
10. Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk.
11. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
12. Subject is capable of giving signed informed consent.
13. Cohort E: Subjects with advanced endometrial cancer.

Exclusion Criteria:

1. Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
2. Subjects who suffer from cardiovascular diseases of clinical significance.
3. Subjects with serious and/or uncontrolled concomitant diseases.
4. Subjects diagnosed active hepatitis B or hepatitis C.
5. Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
6. Subjects with known active tuberculosis.
7. Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
8. Subjects with history of allogeneic tissue/solid organ transplant.
9. Subjects previously treated with TROP2 targeted therapy.
10. Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
11. Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
12. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
T790M Mutation Testing in Blood by Different Methodologies

Three laboratories will participate in the study. Each laboratory will analyze the same samples by different methodologies according to the flow indicated in figure 1. This design will allow comparing the agreement performance of different methods available for T790M identification in circulating-free DNA isolated from peripheral blood.

Three blood samples per patient will be collected once at the time of progression, assessed by CT Scans according to RECIST criteria v.1.1 and before the patients start a new treatment The blood samples (5-10 mL each) will be collected in one Cell-Free DNA BCT Streck® and 2 PTT EDTA K2 (BECTON DICKINSON) collection tubes.

All samples will be labeled properly with the patient identification number and date of extraction. These samples will be stored and distributed through the 3 participating laboratories until completion of all the analyses, according to the flowchart in Figure 1. These samples will be registered in the samples collection of the Institute of Health Carlos III Registry. These samples will be kept in each participant laboratory after the completion of the RING study and the patient will be informed of that in the patient information sheet and informed consent.

cfDNA will be extracted using as starting volume 1 ml of plasma with a Maxwell® RSC instrument (Promega), using the Maxwell® RSC cfDNA Plasma Kit (MR), as specified by the manufacturer or with a Qiasymphony instrument (Qiagen company). Additionally, for BEAMing analysis, 3 ml of plasma will be used for cfDNA isolation using the the QIAamp® Circulating Nucleic Acid Kit (Qiagen company), following the manufacturer instructions.

Circulating free DNA from peripheral blood sample is an adequate source for T790M resistance mutation testing. However, comparison across different platforms has been scarcely reported. Discordant results for EGFR biomarker testing could impact patient management.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with EGFR mutant, stage IIIB and IV non small cell lung cancer and who have progressed assessed by CT Scans according to RECIST criteria v.1.1 to first or second generation EGFR tyrosine kinase inhibitors (TKIs) (e.g. gefitinib, erlotinib, afatinib) including patients who received a chemotherapy line before TKI treatment. Samples have to be drawn before the patient starts a new treatment,
* Patients have to sign the informed consent of the study
* Patients aged ≥ 18 years.

Exclusion Criteria:

* Patients progressing to third generation EGFR TKIs (e.g. Osimertinib (TKI))
* No possibility of venipuncture.
Coronary Heart Disease Risk Factors in Blacks Vs Whites

To use data from the Epidemiologic Follow-up Study of the National Health and Nutrition Examination Survey (NHANES) to develop models to predict morbidity and mortality as a function of risk factors for coronary artery disease. Bivariate dependent survival distributions were examined.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)

EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with CP suffering from EPI.

Day of screening: Subjects will undergo screening procedures prior to entry into the study.

Day 0: Subjects will be admitted to the facility. Day 1: Subjects will undergo a first perfusion/aspiration procedure. Day 2: Subjects will rest. Day 3: Subjects will undergo a second perfusion/aspiration procedure. Day 4: Subjects will be discharged.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have the ability to give informed consent
* Female subjects must use a medically acceptable form of birth control and have a negative pregnancy test upon entering the study and not be breast-feeding
* Subjects must have medical condition compatible with exocrine pancreatic insufficiency
* Subjects must be off therapeutic doses of pancreatic enzyme supplementation prior to study entry day
* Subjects must be on omeprazole at least 5 days prior Day 0.

Exclusion Criteria:

* Subjects with a known hypersensitivity and/or contraindication to VIOKASE®16 or to any non-active component of VIOKASE or to any protein of porcine origin
* Subjects with a known hypersensitivity and/or contraindication to omeprazole or to any non-active component of omeprazole
* Subjects on enzyme therapy, H2-receptor antagonists, anticholinergics, antispasmodics prior to study entry
* Female subjects who are pregnant or lactating
* Subjects with acute pancreatitis or acute exacerbations of chronic pancreatic disease
* Subjects with a history of solid organ transplant or significant bowel resection between esophagus and pancreas
* Subjects who have received an investigational new drug within 30 days prior to entry into the study.
* Subjects with a known coagulopathy
* Subjects with any abnormal liver function test
* Subjects known to have a significant medical and/or mental disease that would compromise the subject's welfare or confound the study results
* Subjects who are not on omeprazole at least 5 days prior Day 0
CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension

Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension.

The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.

Obstructive Sleep Apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of CPAP treatment on BP.

But only few studies have raised data about the effect of CPAP treatment on BP in patients with resistant hypertension.

Hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension.

The purpose of this study is to demonstrate that OSA has a major impact in resistant hypertension, whose effects on BP and arterial stiffness can partially be reversible with CPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
* Patient with severe OSA (apnea-hypopnea index \> 30 or \> or equal to 15 with excessive daytime sleepiness), or with mild to moderate OSA without excessive daytime sleepiness, or without OSA.
* Ambulatory patient

Exclusion Criteria:

* Body mass index ≥40 kg/m2
* Other identifiable causes of hypertension
* Contraindication to CPAP treatment or patient already treated with CPAP