cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Function and CT Scan Finding in CKD Patients After COVID-19 Infection

COVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) on dialysis. CKD requires particular emphasis during the pandemic due to concern for increased susceptibility to infection from greater use of health facilities in people undergoing maintenance hemodialysis. COVID-19 due to SARS-CoV-2 involves multiple organs and lung injury is one of the most clinical manifestations. The binding of SARS-CoV-2 to the ACE2 receptors at target cells ,including type II pneumocytes ,and alveolar macrophages in the lung could arise into acute systemic inflammatory responses and cytokine storm.The consequentially leading to lung-resident dentritic cells (rDCs) activation, T lymphocytes production and release antiviral cytokines into the alveolar septa and interstitial compartments resulting in diffuse alveolar epithelium destruction,hyaline membrane formation, alveolar septal fibrous proliferation and pulmonary fibrosis.Although it has been reported that subgroups of COVID-19 survivors developed persistent lung parenchymal injury that persisted at least after 6 months 5-6 ,the data in CKD patients has not been reported yet.In addition, a study of pulmonary function test after COVID-19 is needed to be investigated.Thus,we plan to assess pulmonary sequalae of COVID-19 in hemodialysis (HD) patients and pulmonary function test after recovered of infection at least 3 months.

This is the prospective,observational cohort study including CKD stage 5 on hemodialysis who survived acute COVID-19 and presented for clinical follow-up after either mild/moderate or severe COVID-19.The study was conducted at Faculty of Medicine ,Vajira Hospital ,Navamindradhiraj University from June 2022 -September 2022.We adhered to the Declaration of Helsinki,and all patients provided written informed consent before inclusion.Ethics approval was obtained from Institutional Review Board (IRB) prior to start of the study (COA No 302/64 E).

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 5 requiring HD or continuous peritoneal dialysis (CAPD ) for more than 3 months
* Age 18-80 years
* Diagnosis of COVID-19 confirmed by real time polymerase chain reaction (RT-PCR) and recovered for more than3 months previously

Exclusion Criteria:

* patients with history of chronic lung diseases i.e chronic obstructive pulmonary disease (COPD) and restrictive lung disease.
Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
* Currently treated with a NPH insulin for at least 3 months prior to screening
* Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to screening
* HbA1c between 7.0% and 10.0% (both inclusive). (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* Able and willing to eat at least 2 main meals each day during the trial
* Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol
* Experience in performing self-measured plasma glucose (SMPG)

Exclusion Criteria:

* Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to screening
* Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
* Impaired kidney function with serum creatinine above or equal to 133 µmol/L (1.5 mg/dL) for males and above or equal to 124 µmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
* Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment
Getting INFORMED and Living Well Among Asian Americans in California

The project is to facilitate pandemic recovery by promoting emotional wellness among Asian Californians. The intervention includes a 6-week program in which participants may choose to receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian Americans residing in California who speak/read English, Chinese, Korean, Hmong, or Vietnamese.

Investigators will conduct a non-randomized intervention trial (preference trial). Research participants involved in the trial will include 20 lay health workers (LHWs) and 600 trial participants with intervention delivered via SMS text messaging (for all participants), and the intervention group will receive educational intervention outreach from an LHW via Zoom or mutually agreed video conferencing online venues, and by telephone or instant messaging. Participants will choose which group they are in, SMS text messaging only or SMS text messaging plus educational outreach from an LHW.

Eligibility Criteria:
Inclusion Criteria:

i) age 18 and older

ii) speak Chinese, English, Hmong, Korean, or Vietnamese

iii) self-identify as Asian American

iv) have access to a mobile phone to receive SMS text messages

Exclusion Criteria:

* unwilling to receive SMS text messages from the project
Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position

This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective shoulder surgery

Exclusion Criteria:

* untreated hypertension
* no pulse in a. dorsalis pedis or a.tibialis posterior
* leg ulcers
* failed scalenous blockade
A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study

CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema.

CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Visual acuity impairment
* Diabetic macular edema in at least one eye
* Type 1 or type 2 diabetes mellitus
* Medication for the diabetes treatment must be stable for the last 3 months

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases
* Laser photocoagulation in the study eye for the last 3 months
* Any history of any intraocular surgery in the study eye within the past 3 months
* Blood pressure \> 160/100 mmHg

Extension Inclusion Criteria:

-Completion of the Core Study
The Study of Inflammation on Blood Glucose Levels in Obese People

Chronic subaccute inflammation may underlie the development of diabetes cardiovascular disease and other components of the metabolic syndrome. Rodent studies suggest diet induced obesity is associated with activation of the IKK/NF-kB pathway and this pathway can be inhibited by salicylates. This study seeks to determine the effect of salicylates in overweight persons.


Eligibility Criteria:
Inclusion Criteria:

* obesity (\> 85th% for age,BMI \> 30); HbA1c \<6%; hemoglobin and/or hematocrit within 2 standard deviations of normal range, without high risk of bleeding, without donation of blood in the previous 2 months; without involvement in any study evaluating an investigational drug or device for the previous 2 months; normal clotting studies; if female using barrier or oral contraception and with a negative pregnancy test.

Exclusion Criteria:

* Pregnant or lactating women; Patients with abnormal liver function defined as elevation of bilirubin, alkaline phosphatase, ALT, AST, or GGTP more than 1.5 times the upper limit of normal; Patients with kidney disease (serum creatinine \> 1.5 mg/dL) macroalbuminuria (1+ protein on a standard urine dip-stick, or \> 300 mg urinary albumin/day); (patients with microalbuminuria will be enrolled); Patients with any significant diseases or conditions, including emotional or psychiatric disorders and substance abuse, including history of binge drinking, that, in the opinion of the investigator, are likely to alter the patient's ability to complete the study ; Patients with metabolic acidosis (abnormal anion gap); History of gastric ulcer, dyspepsia, or upper or lower GI bleed; History of allergy to aspirin, or bleeding diathesis or currently on oral anticoagulants including warfarin, heparin, aspirin or other NSAIDs; Patients with major vascular event within 6 months of screening for the study (e.g., MI, stroke, CABG, angioplasty, PV surgery); Patients with chronic heart disease, or a history of myocardial infarction or stroke. Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA; classification as Functional Class III or IV; Patients who smoke more than one pack of cigarettes daily; Patients taking treatment medications known to affect insulin sensitivity (e.g. diuretics, beta-blockers); Patients with inadequately controlled serum lipid levels (total cholesterol ≥ 275 mg/dL and fasting triglycerides ≥ 450 mg/dL); Patients with history of cancer within 5 years prior to screening for the study other than basal cell carcinoma; active alcohol or other substance abuse.
Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

The purpose of this study is to observe the efficacy and safety of ozonated autohemotherapy in patients of post-ischemic stroke insomnia and to explore its mechanism of action.


Eligibility Criteria:
Inclusion Criteria:

* meet the diagnostic criteria for ischemic stroke; Insomnia quality index (ISI) score \> 7 points

Exclusion Criteria:

* acute ischemic stroke; associated with failure of important organs or malignant tumor; patients with worsening condition, new cerebral infarction or secondary cerebral hemorrhage; with comprehension or cognitive impairment, unable to fully understand the scale and unable to cooperate with treatment
CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

Giant cell arteritis (GCA) is the most common vasculitis in the elderly. Accurate diagnosis is of utmost importance in order to then initiate the necessary immunosuppressive therapy. For large-vessel GCA (LV-GCA) involving the aorta and its branches, FDG-PET/CT is the standard in imaging for diagnosis and is recommended by the guidelines. However, this only indirectly visualizes inflammation through vessel wall uptake of glucose. A new PET tracer, 68Ga-pentixafor, is used to visualize the chemokine receptor CXCR4. This receptor is expressed by cells of the immune system. In the context of inflammatory processes, upregulation of CXCL12, the ligand of CXCR4, occurs in affected tissues. The chemotactic effect of this ligand leads to the immigration of CXCR4-positive inflammatory cells into the inflamed area, which can be visualized by PET using the CXCR4-specific tracer 68Ga-Pentixafor. The value of CXCR4-PET should therefore be tested in the context of LV-GCA. This study tests the benefit of CXCR4 in therapy-naïve patients with suspected LV-GCA. For this purpose, patients will receive a FDG-PET and a CXCR4-PET for direct comparison. This is an imaging-only study. Therapy will not be affected by the study. The study is single-arm and not blinded.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of GCA within 5 days of diagnosis or initiation or intensification of therapy.
* Evidence of inflammatory activity based on clinical parameters, elevated serologic markers of inflammation (CRP \> 1.0 mg/dl), or a positive imaging finding on vasculitis MRI, CCDS, or FDG-PET/CT
* Ability of the patient to provide information
* Exclusion of contraindications for the performance of a PET/CT examination (see below)

Exclusion Criteria:

* Contraindications for the performance of a PET CT examination
* Pregnancy
* Allergies
* Lack of capacity of the patient to give informed consent
Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS

The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol), sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different times points after initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking are measured at 6 and 12 months. To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to document any changes in fatigue related medication.


Eligibility Criteria:
Key Inclusion Criteria:

* Tysabri prescribed according to national guidelines but not yet started treatment
* Signed informed consent form
* FSMC sum score above \> 43 at baseline (mild fatigue)

Key Exclusion Criteria:

* FSMC sum score below 43 at baseline
* History of treatment with Tysabri
* EDSS \> 6 at baseline
* Amphetamine as medication
* Major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI initially, at 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
2. No anticipated changes in chelation regimen for the next 12 months
3. Completed and signed Informed Consent

Exclusion Criteria:

1. Pregnancy
2. Advanced class III/IV heart failure or LVEF \< 0.35% (by MRI)
3. Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
4. Advanced heart AV block
Compatibility of Different Injury Prevention Exercises in Athletes

This investigation is aimed to examine the effects of two different exercise-oriented protocols on the knee torque-angle relationship of the knee flexors.

Thirty two young soccer players were be randomly assigned to three groups: hamstring-eccentric (ECC, n=11), unstable-squatting (UNS, n=11) or control (C, n=10). The ECC and UNS groups performed eighteen sessions over 6 weeks of an injury prevention protocol, using only 3 hamstring-eccentric or unstable-squatting exercises. The angle-torque relationship was measured before and after the training intervention. Voluntary isometric torque was recorded at six test angles, with participants prone (35º-100º; 0º on full extension).

This study utilized a three parallel-groups randomized controlled design, where 3 between-participant conditions, ECC, UNS and C, were tested. Once considered eligible for the study, all participants were familiarized with the testing procedures. Participants attended the laboratory for a pre-training test session, where body mass, height and muscle functional parameters were recorded. Two days after their pre-test, participants including in ECC or UNS started a 6 weeks (18 sessions) training program while the control group did not perform any type of resistance training.

Nevertheless, during the 6 weeks intervention period all three groups continued with their normal recreationally physical activity consisting in 2 to 3 sessions per week of soccer training or friendly matches. Two days after the end of the intervention period muscle function was re-tested.

Eligibility Criteria:
Inclusion Criteria:

* males, recreationally trained football players
* Read and sign the informed consent

Exclusion Criteria:

* Participants that has undertaken a lower body resistance-training program in the preceding 6 months,
* Reported a previous lower limb injury
The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.

This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.

The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.

The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment

Eligibility Criteria:
Inclusion Criteria:

* • 20 year old ≤ Male or female \< 80 year old

  * Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test.
  * Subject who fully understands conditions of clinical trial
  * Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

* Known hypersensitivity to experimental and concomitant drugs
* Subjects who are taking contraindicated medications for experimental and concomitant drug.
* Subjects with abnormal levels in the laboratory tests

  * Total Bilirubin, Creatinine\> 1.5 times upper limit of normal
  * AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal
* Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study.
* Pregnant and/or lactating women
* Reproductive aged women not using contraception
* Uncontrolled diabetics
* Uncontrolled hypertension
* Uncontrolled liver dysfunction
* Alcoholics
* Subjects with a history or possibility of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy
* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
* Subjects participating in a clinical trial before another trial within 30 days
* Inconsistence judged subject by researcher
Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold

The objective of this clinical test is to verify the safety and efficacy of MINTLIFT®, used for the purpose of improving the appearance of the nasolabial fold on both sides of the face.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) at the time of the screening and at the baseline time point
* Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this clinical test

Exclusion Criteria:

* Subjects who have a scar or hypertrophic scar or a history of keloid conditions that may affect the determination of effect
* Subjects allergic to local anesthetics or sleep anesthetics
* Subjects whose ALT/AST ratio is 2.5 times or more greater than the normal upper limit
* Subjects who have been administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening, or who require an anticoagulant during the period of the clinical test
* Subjects who have been administered systemic corticosteroids or anabolic steroids within two weeks of the date of the screening or who require their administration during the period of the clinical test (note, however, that the administration of inhaled corticosteroids in a standardized dosage is permissible)
* Subjects who have been administered Vitamin E or non-steroidal anti-inflammatory drugs within 1 week of the date of the screening
* Subjects who have used Topical liniments in the facial area (steroids, retinoids: only medical drugs are included in this criteria, with the exclusion of cosmetic products) within 4 weeks of the date of the screening or who plan on continuing usage during the period of the clinical test
* Subjects who have received wrinkle reduction treatment using CaHA within 1 year of the date of the screening
* Subjects who have received wrinkle reduction treatment using collagen or HA filler within 6 months of the date of the screening, or who have received acne treatment, skin regeneration procedures, or cosmetic surgical procedures (including Botox injections) in the facial area
* Subjects who have a permanent skin expanding implant such as Softform or silicon inserted in the facial area
* Subjects who have scars in the facial area requiring treatment that has not healed for a period of 1 year or longer, or who have a scar or trace in the area on which the clinical test device will applied.
* Subjects who have a chronic or recurrent infection or a history of inflammatory disease that may affect this clinical test
* Subjects who have experienced severe allergies such as symptoms of anaphylaxis