cyrilzakka/clinical-trials huggingface dataset:
PMCF Study of Preloaded Trifocal IOL

This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.

This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
* Desire for high post-operative spectacle independence
* Willingness to cooperate with and complete all post-operative visits
* Calculated lens power within +5.0 D and +34.0 D
* Planned cataract removal by phacoemulsification
* Clear intraocular media other that cataracts in both eyes
* Potential post-operative visual acuity of 20/25 or better
* Ability to comprehend and sign an informed consent
* Signed informed consent

Exclusion Criteria:

* More than 1.0 D of pre-operative corneal astigmatism
* Expected post-operative astigmatism of more than 0.75 D
* Mature/dense cataract which makes the pre-operative fundus examination difficult
* Previous ocular surgery or trauma
* Clinically significant irregular astigmatism
* Choroidal hemorrhage
* Microphthalmos
* Severe corneal dystrophy
* Medically controlled or uncontrolled glaucoma
* Clinically significant macular/RPE changes
* Concomitant severe eye disease
* Severe optic nerve atrophy
* Diabetic retinopathy, proliferative or macular edema
* Amblyopia
* Extremely shallow anterior chamber
* Chronic sever uveitis
* Pregnant or lactating
* Previous retinal detachment
* Previous corneal transplant
* Concurrent participation in another drug or device investigation
* May be expected to require other ocular surgery during the study
Effect of GIP After a Meal in Patients With Type 2 Diabetes

The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes
* HbA1c \< 75 mmol/mol
* BMI \> 27 kg/m2
* Stable weight (+/- 5%) during the last 3 months

Exclusion Criteria:

* Treatment with medicine or dietary supplements that cannot the paused for 12 hours
* More than 14 units of alcohol weekly or abuse of drugs
* Liver disease, estimated at plasma ALAT levels \> 3 x normal value or INR outside normal range
* Reduced kidney function (estimated at eGFR \< 60 ml/min/1,73 m2)
* Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)
* Low red blood cell count (hemoglobin \< 8.3 mmol/l
* Special diet or planned weight change during the trial period
* Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age;
* stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
* myelosuppressive chemotherapy scheduled for at least 9 weeks;
* anemia at screening visit.

Exclusion Criteria:

* transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
* iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
* prior treatment with Mircera.
Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section

The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than 34 weeks' gestation born by cesarean section

Exclusion Criteria:

* Inability to obtain informed consent from the mother state
* Monochorionic-monoamniotic twin gestation
* Placenta abruption
* Uterine rupture
* Transplacental cesarean
* Hydrops fetalis
The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.

Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus. Different pharmaceutical types of metformin are available. As a clinical trial, we compared the efficacy and complications of metformin produced by "Pars Mino pharmaceutical company, Iran" with "Apotex pharmaceutical company, Canada", in type 2 diabetic patients.

Method: 18 eligible women with type 2 diabetes were given metformin "Pars Mino" or "Apotex" (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study. These two groups randomly under treatment with generic metformin (manufactured by Pars Mino company) or non-generic (manufactured by Apotex Canada). After 2 weeks washout period another 6 weeks period with another Brand of metformin was prescribed. FBS, HbA1C, lipid profile (Cholesterol, TG, HDL, and LDL), weight, and BMI were assessed before and after each treatment phase. The results were compared with each other by paired sample T-test, Independent sample T-test.


Eligibility Criteria:
Inclusion Criteria:

* Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes

Exclusion Criteria:

* Creatinine more than 1.5, severe organ damage
TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure

Increased intracranial pressure is a cause of disease progression in patients with brain disease, a common cause of poor prognosis. Intracranial pressure monitoring is the observation of the disease, treatment, evaluation and important way to improve the prognosis. Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage, brain trauma, encephalitis and other patients. Ophthalmic artery originated from the internal carotid artery, the optic canal into the orbit, the entire process can be divided into intracranial optic tube segment and orbital segment. investigators' preliminary experiments show that when intracranial pressure, intracranial ophthalmic artery segment velocity increases with increasing velocity difference orbital segment. Accordingly, the investigators speculate, may be judged by the level of intracranial pressure intracranial and orbital velocity difference between the ophthalmic artery segment, and accordingly calculate the specific values of intracranial pressure. The investigators will collect brain trauma surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility index, the invasive intracranial pressure and comparing the measured values to calculate the the critical value of the ophthalmic artery segment intraorbital and intracranial velocity difference when intracranial pressure, thus fitting Based on projections of mathematical formulas intracranial pressure. This study will provide a non-invasive intracranial pressure monitor new approach.

2014/08/28

Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years of age (including 18 and 75 years), gender, ethnic limitation;
2. have been carried out invasive intracranial pressure monitoring;
3. the patient or his agent informed consent. -

Exclusion Criteria:

1. the patient does not fit, measured by TCD can not be completed;
2. TCD failed to detect the satisfaction of the ophthalmic artery flow signals were;
3. patients with ocular trauma or a history of intraocular pressure -
Resolution of Primary Immune Defect in 22q11.2 Deletion Syndrome

* Evaluate about age of resolution in immune defect in 22q11.2 Deletion Syndrome
* Incidence of immunodeficiencies in 22q11.2 Deletion Syndrome

22q11.2 Deletion Syndrome is the most common for microdeletion syndrome. The incidence is about 1:4000 of live birth. Clinical features in this syndrome are vary which consist of conotruncal cardiac anomalies, developmental disabilities, palatal anomalies, speech delay, hypocalcemia, characteristic facial features and immunodeficiencies. The most common type of immunodeficiencies is T cell defect that associated with thymic hypoplasia. In the present time, the investigators don't know about the resolution of immune defect in this syndrome.

Eligibility Criteria:
Inclusion Criteria:

* 22q11.2 deletion syndrome patients in allergy and immunology clinic, genetic clinic, cardio clinic, genetic clinic and development clinic

Exclusion Criteria:

* loss follow up in 22q11.2 deletion syndrome patients or incomplete medical record
Spineology Clinical Outcomes Trial: An IDE Investigation

This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation was conducted at 10 centers with 102 subjects being enrolled and treated.

Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment duration, some subjects were remotely assessed through self-administered surveys at 36- and/or 48-months.

The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature;
* Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
* Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
* Minimum Oswestry Disability Index (ODI) score of 40;
* Received at least 6-months of conservative care; and
* Willing and able to comply with protocol evaluations and provide informed consent.

Exclusion Criteria:

* Previous fusion or total disc replacement at the index level;
* Greater than Grade I spondylolisthesis;
* Has symptomatic multi-level lumbar DDD;
* Active systemic infection or infection at the local surgical site;
* Active or suspected malignancy;
* Body Mass Index of greater than or equal to 40;
* Significant metabolic bone disease;
* Taking medication known to interfere with bone healing;
* Has a current substance abuse disorder;
* Has a somatoform, dissociative, eating or psychotic disorder;
* Waddell Signs of inorganic behavior;
* Current tobacco user;
* Is a prisoner;
* If female, pregnant or contemplating pregnancy during follow-up period; or
* Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation
Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants

The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398 using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.

This is a 2-part, single center, double-blind study (neither physician nor participant knows the treatment that the participant receives). Part 1 is designed to evaluate the safety, tolerability, and pharmacokinetics (level of drug in the blood) of a dosing regimen of an investigational drug (JNJ-26528398) prior to its use in Part 2. In Part 1, participants will be assigned by chance to receive either 3 mg/day JNJ-26528398 (6 participants) or placebo (3 participants) for 7 consecutive days while staying in the clinic for 10 days. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. Part 2 is designed to evaluate the anti-inflammatory properties of JNJ-26528398 by measuring markers of inflammation in the blood after intravenous (IV) administration of a substance (endotoxin) which activates the immune system and temporarily causes flu-like symptoms. In Part 2, participants will be assigned by chance to receive up to 3 mg/day JNJ-26528398 (6 participants) or placebo (4 participants) for up to 7 consecutive days while staying in the clinic for 10 days. Endotoxin will be given on the last day of study drug administration. Participants will remain in bed for at least 6 hours after endotoxin administration and will be closely monitored by study personnel.

Eligibility Criteria:
Inclusion Criteria:

* Nonsmoker
* Be in good health on the basis of physical examination, medical history, and electrocardiogram (ECG)
* Must have good exercise tolerance
* Have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive
* Have a history of consistent dental hygiene and dental care
* Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
* Must agree to not donate sperm during the study and for 3 months after study

Exclusion Criteria:

* Is currently enrolled in an investigational study, has recently received an investigational drug (including investigational vaccines), or has donated blood within 3 months
* Has had a vaccination within past 3 months
* Has history of significant drug or alcohol abuse within past 2 years or has a positive drug screen
* Blood donation within past 3 months
* Part 2 only: Has received endotoxin within past 3 months, or has a known allergy or history of significant adverse reaction to endotoxin or its excipients lactose and polyethylene glycol 6000
Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control

This study aims to examine

1. the feasibility
2. immediately
3. long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.

This study is based on the guideline of falls management exercise programs (FaME) designed exercise from Skelton and Dinan.

The FAME program is structured so that four biocybernetic pillars are embedded in the three successive stages of training.

The biocybernetic pillars:

1. improving the balance
2. improvement in functional capacity
3. improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety).

The training phase should reach the following goals:

1. Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
2. Training Gain: with the aim to improve functional abilities.
3. Maintaining the Gains: with the goal of muscle mass and bone density and introduce them to build complex multi-sensory exercises.

We started the FaME program with assistance from the pilot study, "Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Trial Registry: NCT01045746). It was found that a whole-body vibration with stochastic resonance (SR-WBV) enables that strength, coordination, and balance training while standing, in the exercise training gain phase is possible.

For this reason, this study will examine the feasibility and the immediately and long term effects of SR-WBV with 6 Hz, Noise 4 on postural control and strength in frail elderly.

Eligibility Criteria:
Inclusion Criteria:

* RAI (Resident Assessment Instrument) \>0
* live in canton Bern
* in terms of training load be resistant.

Exclusion Criteria:

* acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute surgical scars
* seniors with prosthesis.
* alcoholic
* acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
* acute inflammation or infection tumors
* fresh surgical wounds
* severe migraine
* epilepsy
* acute severe pain
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors

Exclusion Criteria:

* Other squamous cell carcinomas in the past history
* More than 2 transplantations
* Patients not under calcineurin inhibitors
* Unstable graft function
* Non controlled hyperlipidemia (cholesterol \> 7.8 mmol/l or triglycerides \> 3.95 mmol/l)
* Leucopenia \< 3000/mm3
* Thrombocytopenia \< 100,000/mm3
* Liver dysfunction
* Pregnancy
* Allergy to macrolides
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY

The goal of this study is to test an intervention to prevent high blood pressure among rural, Black adults living in Alabama. Black adults in this region have one of the highest rates of high blood pressure in the US. Eating fruits and vegetables and exercising daily lowers the chance of getting high blood pressure. Many problems get in the way of eating a healthy diet and exercising like a lack of grocery stores with fresh foods, few gyms, little money, lack of transportation, and limited support for keeping healthy habits. One place where many Black adults in rural Alabama meet weekly and feel supported is their church. The investigators will connect with 30 churches in rural Alabama. The investigators plan to hold health fairs to find 12 Black adults from each church with blood pressure that is higher than normal but not high enough to need blood pressure lowering medications. The investigators will randomly select 15 churches to get group health education and tablets to access online cooking shows and exercise classes. Adults in the other 15 churches will get support from a health coach over the telephone to help set and meet diet and physical activity goals as well as the group health education and tablets to access online cooking shows and exercise classes. In this study, the investigators will ask church members to sign up to be a health coach. These 15 churches will also get money to help bring healthy foods and/or physical activity opportunities to their communities. The investigative team will train 2 to 3 of their church members to learn how to coach others to eat more healthy food and be more physically active. This study answers two questions. 1) Will this intervention designed to reduce barriers to a healthy lifestyle lower blood pressure among rural, Black adults? 2) Can churches and participants complete the whole two-year study, and can the intervention be used in other communities in a cost-effective way to improve blood pressure? This project will add to the health equity mission of the American Heart Association by finding out if an intervention using health coaches lowers blood pressure among rural Black adults.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Black/African American
* Mean systolic blood pressure 120-139mmHg OR diastolic blood pressure 80-89mmHg

Exclusion Criteria:

1. Mean systolic blood pressure greater than or equal to140 mm Hg, or mean diastolic blood pressure greater than or equal to 90 mm Hg
2. Currently taking antihypertensive medication
3. Self-reported history of hypertension outside of pregnancy
4. Known pregnancy
5. Self-reported history of cardiovascular disease
6. Age ≥65 years or self-reported history of chronic kidney disease, or diabetes, if systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80
7. Planning to move out of the county within the next 18 months
8. Not having a cellular phone or landline
9. Inability to speak English
Six Months Clinical and Echocardiographic Outcome of ARNI LCZ696 Therapy in HFrEF Patients

To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality and rehospitalisation rate.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 year old.
2. Functional class using New York Heart Association (NYHA) classification class II, III or IV %).
3. Left ventricular systolic dysfunction using transthoracic echocardiography with EF ≤ 40%.
4. Who was already taking ACE inhibitors or ARBs.

Exclusion Criteria:

1. Symptomatic hypotension.
2. Systolic blood pressure \<100 mm Hg.
3. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
4. History of angioedema.
5. Hisotry of unacceptable side effects while on while on treatment with an ACE-inhibitor or ARBs.