cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)

A randomized-controlled interventional clinical trial to evaluate the effectiveness of EZC Pak \& EZC Pak+D for the treatment of the common cold and/or a URI.

This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the efficacy of PPC Pharmaceuticals EZC Pak (\& EZC Pak+D) to improve the severity and duration of the common cold or a URI in individuals. It is hypothesized that study participants will experience a positive impact on the duration and severity of their cold/URI while using EZC Pak (\&EZC Pak+D). The second study objective is to examine if patients are accepting the test product as an alternative to antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Seeking OTC remedies to reduce the severity and duration of their common cold symptoms, when they arise
* Must have a thermometer at home
* Must have a blood pressure monitor at home
* Ideally, uses one of the following devices: Apple Watch, Oura Ring, FitBit, other fitness trackers

Exclusion Criteria:

* Unwilling to try the test product for their cold
* Has any of the following medical conditions:

  * ragweed or daisy allergy
  * chronic seasonal allergies
  * liver disease
  * autoimmune or connective tissue disorder (e.g., rheumatoid arthritis, lupus, multiples sclerosis, HIV)
  * alcohol consumption more than 7 drinks per week, or more than 3 drinks per occasion
  * IV drug use
  * renal disease
  * females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration

On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, we want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients
* Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
* Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
* Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
* Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )

Exclusion Criteria:

* Patients having a medical condition that absolutely contraindicates implant placement.
* Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
* Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
* Patients who are having complete lower denture
* Patients who have history of bruxism
Long-term Effects of Bariatric Surgery

The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by:

1. comparing post-surgical outcomes to pre-operative status
2. examining risks and benefits of surgery.

LABS-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status.

Funds are not available to pay for the surgery for patients, only to address research questions.

The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort, approximately 2,400 patients, will be recruited over 3 years. LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic, pathologic and genomic testing of other hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon
* Previous enrollment in LABS-1
* Selected by algorithm to be included in LABS-2

Exclusion Criteria:

* Informed consent not obtained
* Prior bariatric surgery
* Unlikely to comply with follow-up protocol
* Unable to communicate with local study staff
The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

The purpose of this study is to investigate the effect of BMS-986195 in combination with an oral contraceptive in healthy female patients.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive,
* Weight ≥ 50 kg
* Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day 1
* Women of childbearing potential with intact ovarian function, on a stable regimen of combination birth control containing EE without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Cycle 1 Day -1
* Subjects aged 21 years or older must have a normal Pap smear result within 3 years before Cycle 1 Day 1 (a Pap smear may be performed at screening if no result is available); a finding of abnormal squamous cells of unknown significance (ASCUS) is allowed provided it is an initial finding and not a follow up from an initial finding of ASCUS

Exclusion Criteria:

* Exposure to an investigational agent within 12 weeks before Cycle 1 Day 1
* Subjects who are pregnant or breastfeeding
* Any significant acute or chronic medical illness including infection, any active infection, febrile illness within 7 days before Cycle 1, Day 1, or any condition that could predispose the subject to infection
* History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months)
* Any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
* Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc)

Other protocol defined inclusion/exclusion criteria could apply
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
* Subjects with significant liver or kidney disease or significant heart failure.
A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients

The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.

Eligibility Criteria:
Inclusion Criteria:

* An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Secondary hypertension
* Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy
* Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of malignant melanoma
* Previously-treated or untreated unresectable Stage III or Stage IV melanoma
* Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Active brain metastases
* Primary ocular or mucosal melanoma
* History of or current active autoimmune disease
Iron Deficiency in Heart Failure Patients

Heart failure is a common problem with a prevalence of 1-2% in general population and a major cause of mortality,morbidity and impaired quality of life. Anemia is afrequent comorbidity in stable heart failure patients and it increases morbidity in terms of frequent hospital admissions,impaired exercise capacity,poor quality of life ,and increased mortality

Iron deficiency with or without anemia has been commonly associated with heart failure .Although iron deficiency is the commonest nutritional deficiency worldwide ,affecting more than one-third of the population,its association with heart failure with or without anemia is of growing interest .As iron supplementation improves prognosis in patients with heart failure ,iron deficiency is an attractive therapeutic target.

In 2012 ,the European society of cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure recognized iron deficiency as a comorbidity in heart failure for the first time and recommended diagnosis of iron deficiency based on iron parameters in all patients suspected of having heart failure.

Iron deficiency can be classified as absolute or functional. Absolute iron deficiency reflects depleted body stores caused by poor dietary intake, impaired gastrointestinal absorption,and chronic blood loss.

Functional iron deficiency is thought to be caused by increased hepcidin production and subsequent inhibition of the iron exporter ferroportin ,leading to impaired absorption and utilization of iron.

Chronic heart failure patients are susceptible to both forms iron deficiency

Aetiology of iron deficiency in chronic heart failure:

The aetiology is multifactorial and complex

1. reduced dietary intake
2. chronic blood loss
3. chronic heart failure causes an inflammatory state which leads to increased hepcidin levels and subsequent iron deficiency due to reduced iron absorption and enhanced reticuloendothelial block

Eligibility Criteria:
Inclusion Criteria:

.100 males or females patients above age of 18years of age and clinically diagnosed with systolic heart failure,ejection fraction\<50% by echocardiography admitted in Assiut University hospital

Exclusion Criteria:

.Known to be non cardiac condition causing iron deficiency(haemorrhoids,malignancy).

.other conditions causing fluid overload(eg.renal failure on dialysis ). .congenital heart disease.
Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education

Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI).

The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.

Chronic pain (pain that is present for a long period of time) is common among people with spinal cord injury (SCI). The pain is often severe and can affect daily activities. Unfortunately, common treatments such as medications provide incomplete relief from chronic pain. Thus, persons with SCI have to find alternate ways to live a happy, healthy, and productive life, even with some pain.

The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.

Eligibility Criteria:
Inclusion Criteria:

* SCI for at least one year
* Chronic pain for at least three months that is moderate to severe
* Fluent in English
* Not currently starting a new pain treatment or changing a previous pain treatment

Exclusion Criteria:

* Lack of access to a computer with high-speed internet access, at home or another location
* Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect physical or mental functioning
* Significant difficulties with learning or memory
* Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
* Inability to understand English well
* Other conditions not related to SCI that cause pain (such as fibromyalgia)
Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population

The main objective is to study the epigenetic contribution to the pathophysiology of diabetic nephropathy in Qatari population.

Diabetic nephropathy (DN) is a common vascular complication of Type 2 diabetes (T2D) that is associated with increased mortality and poor quality of life.In industrialized countries, DN ranges first among other etiologies of end-stage renal disease (ESRD).Diabetes in Qatar is a serious health issue for the Qatari population since approximately 1/5 of the population has T2D, which is 2-3 times higher than the world average. As observed in other Gulf cooperation council (GCC) countries, obesity and sedentary lifestyle are cornerstones in the development of T2D. Additionally, consanguineous marriages in Qatar contribute to this high prevalence. As a consequence, DN has an enormous burden in terms of management, treatment and especially in renal replacement therapy (RRT) in ESRD in Qatari Population.DN is a glomerular disease defined by increased urinary albumin excretion (UAE), hypertension and decline in the glomerular filtration rate (GFR), all induced by chronic hyperglycemia. However, there are other contributing factors such as genetic predisposition, systemic and intra-renal hemodynamic disturbances, all leading to glomerulosclerosis. All of the known pathways do not explain the complex pathophysiology behind DN. Even different variants of genes described in major GWAS studies have little impact in terms of risk prevention or prognosis of DN. Over the last decade, epigenetics have initiated a new era in Genetic Medicine capable of giving a different approach to human disease.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, at least 18 years old
* Provide informed consent
* Willingness to participate in the study
* In patients with diabetes, no concomitant diseases except for micro and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome ( hypertension, dyslipidemia and obesity)
* Not taking any chronic medications (except of the diabetes and the cardiovascular related drugs)
* Consent to having peripheral blood and urine collection for DNA extraction and micro-RNAs as well as routine laboratory evaluation, including general hematologic studies, general biochemical analyses.

Exclusion Criteria:

* Type I diabetes or other form of diabetes (MODY, secondary diabetes)
* Unable to meet the inclusion criteria
* Pregnancy
* Active infection or acute illness of any kind
* Chronic inflammation (auto-immune diseases) or infections (HIV, chronic viral hepatitis, chronic urinary tract infections ...)
* Evidence of malignancy within the past 5 years
* Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies and pathologies with high red-cell turnover
HPV Education, Early Diagnosis and Knowledge

The aim of this study was to determine the effect of health education given to female teachers on HPV knowledge and screening test. The population of the study consisted of all female teachers belonging to the Bucak Directorate of National Education between September 2021 and March 2022. The sample of the study consisted of 144 healthy female teachers who were registered in the institutions affiliated to the District Directorate of National Education between the specified dates, met the inclusion criteria and volunteered to participate in the study. In this study area, with the assumption that the rate of cervical cancer screening test of 70% of the women in the Healthy Life Centre after the trainings would be considered significant, the effect size d=0.18 was calculated to include at least 98 women in 3 groups at 95% power and 0.05 error level. The calculation was performed with the 'G Power 3.1.9.2' package programme. In this context, the total sample of the study was determined as 156 participants, 52 in each group.


Eligibility Criteria:
Inclusion Criteria:

* to volunteer to participate in the study,
* To be between the ages of 30-65,
* being a woman teacher,
* being married
* to be able to make video calls.

Exclusion Criteria:

* being pregnant or in the postnatal period,
* a history of cervical cancer,
* to have hysterectomy operation.
Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
* Positive therapeutic effect from prior NSAID therapy.
* Worsening of symptoms upon withdrawal of prior treatment.
* With the exception of OA, in otherwise good health

Exclusion Criteria:

* Weight no more than 280 pounds (male or female).
* Recent, sustained use of gastroprotective agents.
* History of arthroscopy of the affected knee within 6 months prior to study entry.
* History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients

Severe burns can decrease pulmonary function and impair aerobic capacity persisting for long times post injury. Low level laser therapy is a new modality used to improve aerobic capacity, enhance exercise performance, increase time until fatigue when used prior to aerobic exercises. This study aimed to evaluate the effects of pre- exercise low level laser therapy on aerobic capacity in burned patients.

Low level laser therapy has a beneficial therapeutic effect on promoting aerobic capacity, improving maximum oxygen consumption and increasing treadmill time when preceding aerobic exercise training.This study was conducted to determine the effects of pre- exercise low level laser therapy on aerobic capacity in burned patients. Low level laser therapy was applied to the study group for 12 weeks before aerobic exercises, three sessions / week, while control group received 12 weeks of aerobic exercises, three times weekly. Patients in both groups were received the traditional physical therapy program as a routine treatment. Aerobic capacity was assessed by measuring maximum oxygen consumption and time to exhaustion at baseline and after twelve weeks of interventions for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Sixty adult burned patients were selected under the following criteria:

  * Patients were both males and females.
  * Their age ranged from (25-40) years.
  * Patients suffered from second degree thermal burns with total body surface area(TBSA) for burns ranged from 20-40%.
  * Patients were participated in this study one month after their hospital discharge.

Exclusion Criteria:

* Cardiopulmonary diseases.
* Any limitation in range of motion (ROM) of joints of the lower limbs which may prevent adequate participation in aerobic exercise program.
* Leg amputation.
* Quadriplegia.
* Psychological illness or severe behavior or cognitive disorders.
* Patients who participated in any rehabilitation program before the study that may affect the results of the study.
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.

Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

Interventional procedure:

1. PTA with Cutting-Balloon (60-120 seconds).
2. PTA with Drug-Coated-Balloon (60 seconds).

Technical success is defined as

1. no recoil \>30%
2. no dissection \>Type B
3. no stenting \>30% of lesion length.

Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).

Eligibility Criteria:
Inclusion Criteria:

* peripheral artery disease (PAD) with femoro-popliteal stenosis \>70% or occlusion (vessel diameter 4-6mm)
* age 18-99
* informed consent

Exclusion Criteria:

* proximal / iliacal stenosis
* stenosis/occlusion of all arteries below the knee