cyrilzakka/clinical-trials huggingface dataset:
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion Criteria:

* Younger than 18 years of age or older than 75
* Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate
The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure

The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.


Eligibility Criteria:
Inclusion Criteria:

* age 25-65 years
* resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg
* BMI 25.0- 29.9

Exclusion Criteria:

* smoking
* regular medication for hypertension, cardiovascular disease, diabetes or asthma
Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery

Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients of age 16-55 years with a clinical \& radiographic diagnosis of through and through periradicular lesion using CBCT
* Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
* Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
* The teeth must have adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria:

* Unrestorable tooth.
* Fractured / perforated tooth.
* Systemic diseases contraindicating surgical procedures or with potential to affect healing.
* Teeth with deep pockets.
* Patient requiring antibiotic premedication.
* Patients with history of antibiotic use in last 3 months.
* Smokers
Cognitive and Speech Disorders in Children With Congenital Heart Defects

The study is aimed to found out expressive speech disorders as a sign of neurocognitive development delay in children with congenital heart defects before and after surgery

The study will investigate the influence of congenital heart disease, operation and other health factors on neurocognitive and speech status of 5-7 years old children

Eligibility Criteria:
Inclusion Criteria:

* children with congenital heart disease that required total correction using cardiopulmonary bypass

Exclusion Criteria:

* patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)
FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute adenoviral conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of suspected acute adenoviral conjunctivitis in at least one eye.

Exclusion Criteria:

* Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle.
Acupuncture for Catheter-Related-Bladder Discomfort After Transurethral Surgery

The purpose of this study is to assess the effectiveness of acupuncture for treating catheter-related-bladder discomfort in adults after bladder outlet obstruction surgery.

This randomized, controlled trial is aimed to assess the effectiveness of acupuncture in the treatment of catheter-related-bladder discomfort (CRBD) in adults after bladder outlet obstruction surgery. Eligible participants will be randomly allocated to acupuncture or sham acupuncture.

To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years old, signed informed consent
* Clinical diagnosis of bladder neck obstruction or benign prostatic obstruction
* Transurethral holmium laser resection of the prostate/transurethral cystoscopy posterior urethral decompression of the bladder neck was planned

Exclusion Criteria:

* Patients undergoing lower urinary tract surgery due to other diseases
* Complicated with urinary tract infection, urinary calculi, urethral stricture, neurogenic bladder, chronic interstitial cystitis
* Receiving treatment for other medical conditions that may affect bladder function
* Patients with severe heart, lung, cerebrovascular, liver, kidney, hematopoietic system and mental diseases
* Patients with contraindications to acupuncture treatment or fear acupuncture treatment
Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design

Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric

Cataract surgery is nowadays considered a safe surgery with a short rehabilitation time for the patients. Two main problems arising post-surgically are the predictability and stability of the implanted intraocular lens (IOL) in the capsular back and the formation of posterior capsule opacification (PCO). The performance of the IOL in the capsular bag influences the anterior chamber depth (ACD), tilt and decentration of the IOL, as well as formation of PCO. The main source of error for calculation of IOL power is an inaccurate prediction of the post-surgical ACD resulting in short- or farsightedness. Furthermore, capsular fibrosis and phimosis can also lead to tilt and decentration of the intraocular lens.

PCO is one of the most frequent long-term complications after cataract surgery, occuring in about 12% after 1 year, in 21% after 3 years, and in 28% after 5 years post-surgically. PCO arises when lens epithelial cells (LECs) migrate and proliferate, growing in between the IOL and the posterior capsule, leading to decreased visual acuity.

Material and design of the IOL may have an effect on the formation of PCO. It is suggested that 360° square edge design and hydrophobic material of the IOL may help in the prevention of PCO.

Hence, the aim of this study is to evaluate the capsular bag performance of monofocal IOLs with different materials but similar design and their influence on PCO formation.

100 eyes of 50 patients will be included into this study. After randomization one eye is implanted with the hydrophilic IOL, whereas the other eye gets the aspherical IOL. Follow-up visits will be 1 - 2 hours and 1 week after the surgery, as well as 6 months, 12 months, and 24 months post-surgically. During this visit a slit lamp examination, measurement of the intraocular pressure, visual acuity assessment, biometrical measurements of the eye, retroillumination photography and analysis of tilt and decentration of the IOL using the purkinjemeter will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age-related bilateral cataract
* Age 21 or older
* Visual acuity \> 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Written informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathologies
* Previous ocular surgery or trauma
* Pregnancy (pregnancy test will be taken in women of reproductive age)
The Individualized Accurate Diagnosis and Treatment of Chronic Objective Pulmonary Disease(COPD) Patients Based on Multidimensional Data

Chronic obstructive pulmonary disease (COPD) is known as progressive lung disease and the fourth leading cause of death worldwide. Despite valuable efforts, there is still no Individualized accurate diagnostic and prognostic tool for COPD. Hence, the investigators' research integrated multi-dimensional data of COPD patients, which may provide an invaluable bioinformatic resource for understanding the underlying molecular alterations that drive disease progression, with the goal of developing individualized accurate diagnostic and therapeutic inventions.

Chronic obstructive pulmonary disease (COPD) is known as progressive lung disease and the fourth leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) is an important event of disease progression worsening in airway function and respiratory symptoms, bringing about respiratory failure, and increasing the rates of mortality. Despite valuable efforts, there is still no Individualized accurate diagnostic and prognostic tool for COPD. In this context, the investigators are to perform comprehensive transcriptomic, proteomic, metabonomic and exosome characterization of COPD patients and healthy controls. Biological samples of COPD participants, including blood, urine, stool, saliva, bronchoalveolar lavage fluid and clinical characteristics are going to be collected from the remaining materials of the routine clinical examination. And samples of healthy controls will be collected from the rest of the healthy examination practice. By integrating the multi-dimensional data, the investigators aim to elucidate the impact of molecular alterations driving phenotypic variation and to delineate the mechanisms of AECOPD for prospective exploration of personalized, precision-based clinical care.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed informed consent.
2. Patients diagnosed with COPD or fully healthy participants.

Exclusion Criteria:

1. Tumor disease.
2. Heart disease.
3. Thyroid disease.
Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy

The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.

Hemiplegic cerebral palsy (HCP) is a form of paralysis that affects motor performance and muscle tone on one side of the body. Spastic hemiplegia CP is the second form of cerebral palsy in premature infants, affecting one side of the body's limbs. Hand and upper limb dysfunction cause problems in half of the children with cerebral palsy. Mirror therapy is a growingly recognized new treatment option for hemiplegic cerebral palsy. While upper extremity involvement in hemiplegic CP and the residual effects are more severe, there is limited evidence of the efficacy of mirror treatment in children with hemiplegic CP

Eligibility Criteria:
Inclusion Criteria:

* Spasticity grade 1 or 1+ based on the modified Ashworth scale
* Able to understand and follow instructions

Exclusion Criteria:

* Cognitive impairment
* Orthopedic dysfunction
* Impairment in visual acuity
* Children who are unable to pay attention during the treatment period
PRP for Glenohumeral Osteoarthritis

The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (\~3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years old
* Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss
* At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy
* MRI of the affected joint
* Transient relief of symptoms after a diagnostic intra-articular injection into the joint
* Email address or network access

Exclusion Criteria:

* Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection
* Prior platelet-rich plasma injection
* Steroid injection within 3 months of the initial injection
* Hyaluronic acid within 6 months of the initial injection
* Involved in workers' compensation or active litigation involving the affected joint
* History of Plavix use
* Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)
* Presence of acute fractures or gross mechanical deformities
* Concurrent "uncontrolled" cervical disorders
Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis

The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria:

1. Subjects who are decompensated cirrhosis of any cause.
2. Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy).
3. Need intermittent plasma albumin and oral diuretics supplement.
4. Serum albumin \<35 g/L, total bilirubin\<170 μmol/L, prothrombin activity \>30% (prothrombin time \<20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥7.
5. Peripheral blood hemoglobin concentration\> 70g/L，platelet count \> 3 × 10\^9/L, hematocrit (HCT) level\>0.25.
6. No gastrointestinal bleeding during the last one month before enrolment.
7. Patient has no conditional to undergo orthotopic liver transplantation (OLT).
8. Willing to sign informed consent.

Exclusion Criteria:

Participants CANNOT meet any of the following criteria:

1. The presence of hepatocellular carcinoma (HCC) or other malignant tumors.
2. Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection.
3. Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease).
4. Pregnant or lactating women.
5. Allergy to G-CSF, contrast agents and anticoagulants.
6. Alcoholism or drug abuse.
Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation

It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure

The study includes the execution of a sample for each time point for the evaluation of inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6, N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or persistent AF;
* Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures;
* Aged between 18 and 85 years;
* Ability to provide informed consent for study participation.

Exclusion Criteria:

* Age \> 85 years or \< 18 years;
* Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram;
* NYHA functional class IV;
* Left ventricular ejection fraction \<30%;
* Myocardial infarction or unstable angina or recent coronary artery bypass graft (\<6 months);
* Significant co-morbidity, such as cancer, severe renal failure requiring dialysis, severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than 12 months;
* Presence of contraindications to the procedure;
* Inability to provide informed consent for study participation.
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥19 and ≤65 years at the time of signing the consent form
2. HBsAg(+) before liver transplantation
3. Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence
4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen, and whole duration of administration of I.V.-Hepabig ing will not be exceeded 1 year while participating this study

Exclusion Criteria:

1. Subject with history of anaphylaxis to any component of the investigational product
2. Pregnant or breast-feeding women
3. Deficiency of Immunoglobulin A
4. Clinically significant renal diseases (serum creatinine \>2.0mg/dL, anuria, renal failure or on dialysis at screening)
5. Hemophilia
6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
8. Subject received estrogen or hormone replacement therapy within 3 months before screening
9. HBsAg or HBeAg or HBV DNA positive at screening
10. Anti HBs titer less than below criteria at screening \<150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation \>500 IU/L for subject whose HBeAg and HBV DNA were positive(+) before liver transplantation
11. Subject with history of drug abuse
12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
13. Subject who are determined disqualified to join clinical trials by investigator
Implementing the Decision-Aid for Lupus (IDEAL Strategy)

The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).

The proposed study will evaluate methods to implement a shared decision making strategy, using an individualized, computerized decision- aid (DA). The investigators will test the effectiveness of this implementation with 3 strategies in 16 clinics. Formative evaluation strategies will be used to assess needs at each clinic, with key clinic informants participating in semi-structured interviews. The study will enroll at least 500 patient participants across all 16 sites, who will review the decision aid and be asked a feasibility and acceptability assessment. At the conclusion of the study, key clinic informants, as well as selected patient participants will participate in semi-structured interviews to assess the effectiveness in implementing the DA in the clinic setting.

Eligibility Criteria:
Clinic Personnel Inclusion Criteria:

* Aim 1: clinic personnel involved in the care of lupus patients
* Aim 2: clinic personnel involved in the care of lupus patients
* Aim 3: clinic personnel involved in the care of lupus patients

Clinic Personnel Exclusion Criteria:

* Aim 1: none
* Aim 2: none
* Aim 3: none

Patient Inclusion Criteria:

* Aim 2: Adults with a diagnosis of lupus
* Aim 3: Adults with a diagnosis of lupus

Patient Exclusion Criteria:

* Aim 2: No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status
* Aim 3: No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status
Aerobic Exercises on Persisted Post Burn Anemia

Fourty patients who have total body surface area ranged from 20% to 35% of burn, anemic and 8th to 16th week post burn will participate in this study, the patients will be randomly divided into two equal groups (20 patients for each group): Group A (Experimental Group) (Aerobic exercise and medical treatment):

Group B ( Control Group) (Medical treatment group):


Eligibility Criteria:
Inclusion Criteria:

The subject selection will be according to the following criteria:

1. Ages of patients will be ranged from 20 to 35 years.
2. All patients underwent severe burn with TBSA ranged from 20% to 35%.
3. 8 th to 16th week post burn.
4. All patients will be referred with persisted anemia by a surgeon before starting the study procedure.
5. All patients will enter the study having their informed consent

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria: 16

1. Patients with persisted pre burn anemia associated with systematic chronic disease such as coronary artery disease or chronic kidney disease.
2. Patients with pre burn persisted anemia associated with autoimmune disease such as Rheumatoid arthritis, Systemic lupus erythematosus ,Vasculitis, Sarcoidosis, Inflammatory bowel disease (IBD).
3. Unevaluated cardiac arrhythmia, Chronic bronchitis, poorly controlled type 1 diabetes, Extreme morbid obesity, Extreme underweight body mass index less than 12, Poorly controlled hypertension, Poorly controlled seizure disorder, Poorly controlled hyperthyroidism, Orthopedic limitation as fracture, .
Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients

The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin will be measured at the proximal part of the carpal tunnel. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin, and ratio of pressure-strain will be measured at the proximal part of the carpal tunnel. In addition, distal latencies in the motor and sensory nerve conductions studies and cross-sectional area of median nerve will be measured. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

Eligibility Criteria:
Inclusion Criteria:

* carpal tunnel syndrome patients and asymptomatic control

Exclusion Criteria:

* Patients were excluded if there was a history of cervical radiculopathy, rheumatoid arthritis, gout, hemodialysis, sarcoidosis, amyloidosis, or traumatic injuries to the arm. Written consent was obtained from all study participants