cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain

The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco® 7.5mg/325mg when used for the treatment of moderate to severe post operative pain.

This is a single center, open label, prospective, randomized study on adult post operative subjects who are expected to require oral opioid analgesia for at least 48 hours after surgery. The main study drug of interest in this study is MNK 155. Norco® 7.5mg/325mg is being utilized only as active comparator.

Subjects will be at least 18 years of age and will be scheduled to undergo elective surgery. The following surgical types will be allowed, although the list is not all inclusive:

* Abdominal surgery
* Soft tissue surgery
* Orthopedic surgery
* Spine surgery
* Genitourinary surgery

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who provide written informed consent prior to enrollment.
2. Male or female and 18 years of age or older.
3. Subjects who are scheduled to undergo elective general surgery including, but not limited to the following surgical types:

   * Abdominal surgery
   * Orthopedic surgery
   * Spine surgery
   * Genitourinary surgery
4. Subjects classified as American Society of Anesthesiologists (ASA class I-III).
5. Female subjects are eligible only if all of the following apply:

   * Not pregnant (subjects of child bearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test before surgery);
   * Not lactating;
   * Not planning to become pregnant within the duration of the study;
6. Subjects who are expected to have acute pain requiring oral opioid analgesics for at least 48 hours during the post operative period (either inpatient or outpatient).
7. Subjects who are willing and capable of understanding and cooperating with the requirements of the study.
8. Subjects able to understand and communicate in English.

Exclusion Criteria:

1. Subjects with a medical condition that, in the Investigator's opinion, could adversely impact the subject's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, or any other clinically significant medical condition that may preclude safe study participation.
Reduction of Sweetened Beverages and Intrahepatic Fat

The study will enroll 68 overweight male and female subjects with a high (\> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The following measurements will be performed at the end of the run-in period and at the end of the intervention period

* intrahepatic fat concentration
* visceral fat volume
* changes in day-long metabolic profile from baseline(plasma glucose, insulin, and triglyceride concentrations)
* changes in food intake and daily energy, carbohydrate and sugars intake from baseline


Eligibility Criteria:
Inclusion Criteria:

* gender male or female
* body mass index (BMI) \> 27 kg/m2 consumption of \> 2 3dl-can regular soda/day
* low to moderate physical activity (\< 60 min walking/day; \< 3 exercise session/week

Exclusion Criteria:

* diabetes mellitus
* liver, kidney or heart disease
* any current drug treatment
* contra-indications to MR examination (pacemaker, foreign bodies,etc)
* pregnancy or planned pregnancy
* active weight gain or weight loss (weight change \> 4 kg in the past 12 months)
* consumption of drugs or illicit substances
* consumption of more than 10g alcohol/day
* vegetarians or subjects on special diets
DeBakey Cardiovascular Magnetic Resonance Study

While advancements in cardiac magnetic resonance (CMR) have improved image quality, it is unclear how these improvements are connected to the clinical evaluation of individuals with cardiovascular disease. The aim of this large prospective registry revolves around 4 key principles: 1) utilize CMR to gain additional pathophysiologic insights into cardiovascular disease, 2) understand how CMR compares to alternative cardiovascular diagnostic modalities, 3) determine how CMR affects clinical management decisions, and 4) establish a link between CMR findings and long term prognosis in patients with known or suspected cardiovascular disease. The ultimate aim is to utilize CMR to improve patient outcomes.

CMR techniques to be studies include function, fibrosis, and flow. Focus areas include valvular heart disease, ischemic heart disease, cardiomyopathies, and vascular disease.

Patient Population, Recruitment, and Consent:

Patients presenting to the Houston Methodist DeBakey CMR Laboratory will be enrolled from April 2008 to April 2038. It is expected that up to 100,000 patients may be enrolled during this period.

Subjects will be identified based on their referral to the Houston Methodist DeBakey CMR Laboratory for MRI studies during the proposed study period.

After enrollment, a registered nurse or physician will perform a thorough structured patient interview and/or review of electronic health records to document baseline medical history including cardiac risk factors, symptoms, medication usage, and prior procedure history. A small blood sample will be drawn and stored for future biomarker and/or genetic testing analysis. Annual follow up for clinical status will be performed via review of electronic health records; structured telephone interviews with the patients, relatives, and/or their health care providers; and/or the social security death index database.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.

Exclusion Criteria:

* Unable to provide informed consent
The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program

The purpose of this study is:

* To validate the use of pedometers in assessing the level of physical activity in middle school children.
* To evaluate whether setting a step goal through the use of pedometers could increase physical activity and prevent weight gain in middle school children.


Eligibility Criteria:
Inclusion Criteria:

* All healthy 8th grade students at the Springboard Academy of the Milton Hershey School willing to participate in the study and whose parents give consent.

Exclusion Criteria:

* Any medical condition that prevents the child from walking during the 12 week study period.
* Non-English speaking student.
Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea

Technological advances and non-invasive techniques to modulate brain function have been developed, including transcranial Direct Current Stimulation (tDCS). Basically, electrodes are placed on the brain regions to stimulate or inhibit it. Subsequently, a continuous electrical current (0.4-2 mA) is imposed, for a period of 3-20 minutes, to modify cortical excitability. Few are the research groups that work on the topic of primary dysmenorrhea and the use of tDCS as the focus of study. Preliminary studies associated the use of tDCS with pain reduction, but the outcomes of physical and behavioral function needs further investigation.


Eligibility Criteria:
Inclusion Criteria:

- to have primary dysmenorrhea symptoms for more than 6 months with a mean perception of at least 3 (on a scale of 0 to 10) on the visual analogue scale, to have a regular menstrual cycle from 28 to 32 days.

Exclusion Criteria:

- Participants will be excluded if they have history of genitourinary disease (infectious oncology or infection), neurogenic bladder dysfunction, to have alcohol or drug abuse in the last 6 months, to have severe depression (score greater than 30 on the Beck depression inventory), to have previously neurological disorders diagnosis and to be pregnant.
The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception

The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.

All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.

Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-30 years old,
* in need of emergency contraception (had unprotected intercourse within 120 hours),
* willing to give consent for participation in research,
* willing to comply with study requirements, and
* accessible by telephone.

Participants selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion Criteria:

* Current pregnancy
* Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
* Current behavior suggesting a high risk for pelvic inflammatory disease
* Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
* Abnormalities of the uterus that distort the uterine cavity
* Mucopurulent cervicitis
* A previously placed IUD that has not been removed
* Genital bleeding of an unknown etiology
* Ovarian, cervical, or endometrial cancer
* Small uterine cavity (\< 6cm)
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Under care of physician at least 2 months (for CKD)
* Not on active Vitamin D therapy for at least 4 weeks prior
* If female:

  * Not of childbearing potential, OR
  * Practicing birth control
  * Not breastfeeding
* If taking phosphate binders, on a stable regimen at least 4 weeks prior
* For entry into Pretreatment Phase:

  * iPTH at least 120 pg/mL
  * GFR of 15-60 mL/min and no dialysis expected for at least 6 months
* For entry into Treatment Phase:

  * Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL
  * 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
  * 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL

Exclusion Criteria:

* History of allergic reaction or sensitivity to similar drugs
* Acute Renal Failure within 12 weeks of study
* Chronic gastrointestinal disease
* Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones
* Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
* Current malignancy, or clinically significant liver disease
* Active granulomatous disease (TB, sarcoidosis, etc.)
* History of drug or alcohol abuse within 6 mos. prior
* Evidence of poor compliance with diet or medication
* Received any investigational drug or participated in any device trial within 30 days prior
* Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
* On glucocorticoids for a period of more than 14 days within the last 6 months
* HIV positive
Impact of Swaddle Blanket on Gastroesophageal Reflux

Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.


Eligibility Criteria:
Inclusion Criteria:

- NICU patients who have a 5 channel study requested by the attending neonatologist -

Exclusion Criteria:

-
Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation

The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with intraocular postoperative inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
* Patients showing an anterior chamber cell score of not less than "2" at a day after surgery
* Patients aged 20 years or over, irrespective of genders (it is eligible for enrollment when patients' age attains the criterion on the day of consent obtainment)

Exclusion Criteria:

* Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs;
* Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded)
* Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
* Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
* Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids;
* Patients who underwent sub-conjunctival injection or sub-Tenon capsule injection of corticosteroids;
* Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations;
* Patients who underwent gas tamponade at the surgery;
* Patients with endogenous uveitis;
* Patients having corneal epithelial detachment or corneal ulcer in the target eye;
* Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye;
* Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents;
* Patients showing IOP not less than 25 mmHg a day after surgery;
* Patients who have allergy to corticosteroid drugs;
* Patients who are required to wear contact lens during the study period;
* Patients who are scheduled to undergo surgery of the opposite eye during the study period;
* Patients who are pregnant or may be pregnant or lactating;
* Patients who have participated in other clinical studies within 3 months.
Family Centered Intervention After Traumatic Brain Injury

The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. The intervention will be provided in collaboration with the municipal rehabilitation service. The intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by Oslo University Hospital (OUH).


Eligibility Criteria:
Inclusion Criteria:

Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should:

1. Be out of post traumatic amnesia for at least one month
2. Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
3. Have a Ranchos Los Amigos Scale score of at least 8
4. Mini Mental Status Examination score \>23

   * Family members: individuals related by blood or marriage/cohabitating with the TBI patient.

     1. Belongs to the same household as the individual with TBI and/or in close relation with the patient
     2. are between 18-65 years of age.

Exclusion Criteria:

* TBI survivors or their family members with a history of psychiatric or neurologic illness, active learning disability, or active substance abuse. Inability to speak and read Norwegian. Families in which there are other members requiring care or who have previously been caregivers for other family members.
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Primary Objective:

To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.

Secondary Objective:

Device-related:

* To collect real-use (usability) data assessing the robustness and user interaction of SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in supervised settings.

Pharmacokinetics:

* To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI.
* To evaluate alirocumab PK administered using SYDNEY.

Anti-drug antibodies:

* To evaluate the development of anti-drug (alirocumab) antibodies (ADA).

Efficacy/pharmacodynamics:

* To compare the percent and absolute change in low-density lipoprotein cholesterol (LDL-C) using SYDNEY and AI.
* To evaluate the percent and absolute change in LDL-C using SYDNEY.

Safety:

* To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.

Total study duration per participant was expected to be up to 18 weeks, with up to 2 weeks of screening period and 16 weeks of study treatment period.

Eligibility Criteria:
Inclusion criteria :

* Participants were in either category A or B (below), and were not adequately controlled with a stable daily dose of atorvastatin (20 mg or 40 mg), or rosuvastatin (10 mg or 20 mg) for at least 4 weeks prior to the screening visit (Week -2), with or without other LMT:

  * A. Participants with heterozygous familial hypercholesterolemia (heFH) (diagnosis based on either genotyping or clinical criteria) OR
  * B. Non-FH Participants at high or very high cardiovascular (CV) risk. High and very high cardiovascular risk participants included participants with coronary heart disease (CHD), non-CHD cardiovascular disease (CVD), and other risk factors.
* Participant willing and able to self-inject for the duration of the study.

Exclusion criteria:

* LDL-C \<70 milligrams per deciliter (mg/dL) (\<1.81 millimoles per litre \[mmol/L\]) at the screening visit.
* Currently taking a daily dose of statin that was not atorvastatin 20 mg or 40 mg, or rosuvastatin 10 mg or 20 mg.
* Not on a stable dose of LMT (including statin) for at least 4 weeks, prior to the screening visit and from screening to randomization.
* Having previously used any device for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor administration, or having participated in any clinical trial for a PCSK9 inhibitor.
* Fasting serum Triglyceride (TG) \>400 mg/dL (\>4.52 mmol/L) at the screening visit.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Endothelial Changes in Pseudoexfoliation Syndrome

this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.

Pseudoexfoliation syndrome (PEX) is an age related microfibrillopathy disorder characterized by the deposition of greyish white flaky exfoliative material in ocular and extraocular tissue. It commonly affects patients over 50 years old ((commonly in late 60s and 70s) with prevalence range from 0.5% to \> 30%, Although it occurs in virtually every area of the world, a considerable racial variation exists in its incidence. It is relatively rare among African Americans and Eskimos. Prevalence is high in the Sami people who are indigenous of northern Europe. There is also a high prevalence in Arabic populations. It is also well known that patients with PXF develop cataracts early in their lives. Phacoemulsification is a preferred type of cataract surgery owing to fewer complications than other types. However, it still has significant undesirable hazardous as Posterior capsular rupture, vitreous loss, Retinal detachment, Cystoid macular oedema and Posterior capsule opacification. Also, it can enhance loss of corneal endothelial cells, thickness and density that may result in corneal decompensation and subsequent corneal transplantation. In patients with PXF, small pupils and weak zonular support may enhance Phacoemulsification complications. Non-contact Specular microscope is a non-invasive method for morphological analysis of corneal density of endothelial cells, "size change" (Polymegathism), "hexagonal change" (pleomorphism). Therefore, this technology plays an important role in preoperative evaluation, surgical design and postoperative care.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age is above50 years.
2. Patient with nuclear cataract grade II, III.
3. Clear cornea with no evidence of endothelial disease.
4. Endothelial cell density more than 1000\\mm2.
5. Normal anterior chamber depth and dilatable pupil.
6. No active ocular disease or inflammation.
7. Pseudoexfoliative patients.

Exclusion Criteria:

1. History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
2. Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
3. Pseudoexfoliative glaucoma.
4. Patients age below 50 years.
5. Endothelial cell count less than 1000\\mm2.