cyrilzakka/clinical-trials huggingface dataset:
Stability of Biometry in Meibomian Gland Dysfunction

Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. However, some recent studies indicate that preoperative biometry is influenced by dry eye disease (DED). Hence, the investigator's study aims to investigate the effect of the therapy of MGD using the Lipiflow® device on the stability of biometry and selection of IOL.

Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. 31 Patients suffering from DED caused by MGD will be selected and allocated randomly to therapy. Patients with pre-existing DED therapy other than lubricants will be excluded. After completing prestudy-screening and baseline visit, Lipiflow® therapy is applied to the study eye. Follow-up visits will be scheduled two weeks and three months after baseline visit. Each visit includes dry eye investigations and IOL calculation by IOLmaster 700 and CSO MS-39. After each study visit an IOL will be theoretically selected.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Evidence of meibomian gland dysfunction
* Meibomian gland secretion score equal or less than 15 (for 15 glands of the lower eye lid) using the meibomian gland evaluator (see below)

Exclusion Criteria:

* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Usage of systemic antibiotic therapy
* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
* Ocular surgery within prior 3 months
* Ocular injury within prior 3 months
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Eyelid abnormalities that affect lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnancy
Serum Magnesium Level in Type 2 Diabetes Mellitus

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia. It may be due to impaired insulin secretion, resistance to peripheral actions of insulin, or both . Chronic hyperglycemia in synergy with the other metabolic aberrations in patients with diabetes mellitus can cause damage to various organ systems, leading to the development of disabling and life-threatening health complications, most prominent of which are microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications leading to a 2-fold to 4-fold increased risk of cardiovascular diseases Mg2+ deficiency is usually identified by the measurement of serum Mg2+ concentration. Hypomagnesemia is defined by a serum Mg2+ concentration \< 0.75 mmol/L, but a deficiency due to low dietary intake in otherwise healthy people is uncommon. Although overt signs of clinical Mg2+ deficiency are not routinely recognized in the healthy population, relatively low Mg2+ intake and/or Mg2+ status have been shown to be associated with chronic diseases, including cardiovascular disease, T2DM, osteoporosis, pulmonary disease, depression, migraine headaches, inflammation, and cancer


Eligibility Criteria:
Inclusion Criteria:

* • Type 2 Diabetes Mellitus according to WHO criteria.

Exclusion Criteria:

* • Renal failure patients.

  * Type I DM patients.
  * Acute pancreatitis.
  * Hyperthyroidism.
  * Hyperparathyroidism.
  * Malignancies.
  * Patients on loop/thiazide diuretics.
  * Patients on Mg supplement.
  * Patients on Mg containing antacids.
  * Any other conditions causing low Mg levels were excluded from the study.
Influence of Menstrual Cycle Stages on Female Athletes

The influence of the menstrual cycle on women's sports performance is still uncertain. Research on this topic shows methodological biases. The aim of the study will be to determine whether the menstrual cycle affects women's physical fitness, measuring this in 3 differentiated stages of the cycle: the early follicular phase, late follicular phase, and luteal phase. For this purpose, a blood test will be carried out in each phase, with hormone determination (oestradiol and progesterone) and a haemogram to determine the existence of possible anemia. After the extraction and other complementary tests (measurement of vital signs, bioimpedance...) the woman will undergo 3 physical tests to compare the results in the 3 phases. A group of women taking hormonal contraception will also be included, performing the same interventions. To determine whether the woman is ovulating or not, urinary luteinizing hormone (LH) strips will be given to the women and they will have to take them from day 8 of the cycle. In addition, women will wear an accelerometer to monitor their daily activity and to be able to observe if there is an influence on this stage of the menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria natural cycles group:

* Female sex
* Women between 18 and 40 years of age
* Women who are members of a federation and who compete in a sport doing at least 240 minutes of exercise per week.
* Women with regular menstrual cycles (between 23 and 38 days long).
* Women who have not taken hormonal contraceptives (HA) for 6 months or more.

Inclusion criteria artificial cycles group:

* Female sex
* Women between 18-40 years of age
* Women federated and competed in a sport doing at least 240 minutes of exercise per week.
* Long-term users of HA (minimum 6 months).

Exclusion Criteria:

Exclusion criteria group natural cycles:

* Refusal to participate in the study
* Sedentary women
* Women on HA currently or in the 6 months before the study
* Women with irregular menstrual cycles, less than 23 or more than 38 days in length
* Any existing metabolic disease or disorder
* Regular use of medications or dietary supplements that could affect the results
* Pregnancy or breastfeeding

Exclusion criteria artificial cycles group:

* Refusal to participate in the study
* Sedentary women
* Any existing metabolic disease or disorder
* Regular use of medications or dietary supplements that could affect the results
* Inability to manage contraception in a disciplined manner
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as compared to oral nitrofurantoin in the treatment of female adults with cystitis.

Participants were randomized to receive 7 days of treatment of either omadacycline or nitrofurantoin. The End of Treatment visit, Post Therapy Evaluation visit, and Final Follow-up visit was planned within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules.

Eligibility Criteria:
Inclusion Criteria:

* Female participants, age 18 or older who have signed the informed consent form
* Must have a qualifying uncomplicated urinary tract infection
* Participants must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Males
* Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or sexually transmitted infection
* Evidence of significant immunological disease
* Has received an investigational drug within the past 30 days
* Participants who are pregnant or nursing
A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer

The purposes of this study are to determine:

* the safety of pemetrexed and any side effects that might be associated with it
* how much pemetrexed should be given to patients.

It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed.

Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
* Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
* No more than two prior systemic anti-cancer therapies will be allowed.
* Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

* Pregnancy.
* Breast-feeding.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
* Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Motion Perception in Individuals With Type 2 Diabetes

Is the ability to perceive motion altered by diabetes? The investigators are measuring motion perception using a technique called vestibular thresholds. Subjects will undergo 3 hours of testing in which they sit in a chair that makes small movements and report their perception of motion. The investigators are currently looking for individuals who have had type 2 diabetes for at least 10 years.

Previous studies have found that individuals with diabetes fall more frequently, have less stable posture, and have reduced motion and touch sensation in the lower extremities. This study will examine whether vestibular sensation is also affected by diabetes.

This study is observational because measurements will be made without the application of an intervention. The same measurement protocol was applied to a large group of normal subjects, and this published data will serve as normative controls.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 10 years
* Under 250 pounds

Exclusion Criteria:

* Medications not to be used include: Ambien (Zolpidem), Antivert, Bonine (Meclizine), Ativan (Lorazepam), Benadryl (diphenhydramine), Dalmane (Flurazepam), Dramamine, Doral (Quazepam), Fiorinal, Fiorcet (Butalbital), Halcion (Triazolam), Klonopin (Clonazepam), Librium, Librax (Chlordiazepoxide), Nembutal (Pentobarbital), Phenergan (Promethazine), Placidyl (Ethchlorvynol), Prosom (Estazolam), Restoril (Temazepam), Seconal (Secobarbital), Serax (Oxazepam), Transderm Scopes Patch, Vontrol (Diphenidol), Xanax (Alprazolam).
* Individuals meeting the following criteria will be excluded: a) a history of head trauma, b) posterior fossa pathology, c) a well-defined otologic diagnosis (e.g., Benign Paroxysmal Positional Vertigo (BPPV), Meniere's disease, superior canal dehiscence, etc., unilateral or bilateral vestibular hypofunction) d) a recent history of seizures e) any other major neurologic (e.g., Parkinson's, Multiple Sclerosis, dementia, epilepsy, cerebellar ataxia, stroke, recent concussion, etc.) disorder, f) any major psychiatric (e.g., panic disorder, psychosis, etc.) disorder, and g) any other severe health problem (heart disease, pulmonary disease, cancer, etc.).
* Due to nauseogenic nature of some motions and to protect fetus and mother, pregnant women will also be excluded from this study.
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage

This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.

The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.

Patient hospital records are retrospectively reviewed for demographic and clinical data.

The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Upper extremity soft tissue sarcoma locating in between scapula to arm
* No metastasis at the time of diagnosis
* Undergone limb salvage surgery
* A minimum of 6 months follow-up
* Written consent
* Age \> 18

Exclusion Criteria:

* Age \<18
* No limb-salvage surgery due to sarcoma
* Deceased
GR Defect in Sputum Cells in COPD

To investigate a possible mechanism of the GR defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR-GRE binding, expression of inflammatory and anti-inflammatory factors such as IL-6, IL-8, MKP-1, GILZ, SLPI production in sputum cells


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate (stage II, GOLD) COPD or subjects who are healthy smokers or subjects who are non-smokers.
* Written informed consent

Exclusion Criteria:

* Current upper respiratory tract infections
* Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
* Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.

The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I-III classified patients
* Patients undergoing procedure where an endotracheal tube would be normally utilized

Exclusion Criteria:

* Children with expected difficult airways
* Coagulopathy
App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer

The number of new cases of cancer diagnosed in the U.S. was 1.7 million in 2017 and is expected to increase by 35% to 2.3 million in 2030\[1\]. Cancer treatments often create numerous logistic challenges in prioritizing and managing treatment and everyday life priorities and how these challenges affect their everyday lives and well-being (hence "logistic toxicity"). However, there are no established reliable tools to monitor patients' logistic challenges and the associated impacts; and logistic toxicity has been largely unaddressed in cancer care delivery. The objective is to develop the first digital health app for cancer patients to continuously monitor logistic toxicity in their daily lives. The app will combine objective data from mobile sensing with subjective self-reported data to form an app-assisted day reconstruction system that captures activity engagement and well-being information associated with cancer treatment-related activities and trips throughout the day.

The proposed patient monitoring app that captures logistic toxicity information on an ongoing basis will empower patients to advocate for care that better fits their life, give providers new insights into potential reasons for treatment non-adherence and nonresponse, and allow health systems to design more patient-centered care regimens.

A participatory design approach will be used to inform the design of our system, performing in-depth interviews and follow-up surveys with 20 diverse patients undergoing treatment for cancer. Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. Follow-up surveys will ask participants to provide satisfaction ratings towards user interface sketches and app function narratives.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, currently receiving treatment for cancer, able to read/write/speak in English, and able to provide voluntary informed consent.

Exclusion Criteria:

* Those who are currently incarcerated or have opted out of research contact within M Health Fairview system.
Periodontal Disease and Circulatory Microbial Components

The goal of this project is to study the immune activity of certain proteins present in the blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to affect 5-15% of American adults. It begins with an infection of the tissues surrounding the teeth, and leads to a worsening inflammatory response. This study will aid in clarifying the way in which gum disease might affect certain systemic diseases.

This project will have two specific goals: 1. Identify microorganism components in the serum of patients with severe periodontitis; and 2. Characterize the immune regulator activity of periodontitis serum. This proposed feasibility study will then aid in providing the support for an increased sample size and other design requirements for larger, more expanded human clinical trial testing.In this study, forty (40) subjects will be divided into 2 groups: 1) Healthy oral status group and 2) Severe periodontal disease. Patients will be clinically screened using standard periodontal measurements.

Eligibility Criteria:
Inclusion Criteria:

* 35 years or older
* Healthy patients or patients with severe periodontal disease
* Patients with or without Rheumatoid Arthritis
* Patients with at least 20 permanent teeth

Exclusion Criteria:

* Patients undergoing long-term (over 2 weeks) antibiotic-related therapy 3 months prior to study inclusion
* Patients receiving periodontal treatment 12 months prior to study inclusion (INCLUDING CLEANINGS)
* Patients will be excluded if they receive long-term use of medications known to affect periodontal status such as anti-inflammatory drugs, aspirin and ibuprofen
* Patients on immunosuppressive therapies, including glucocorticoids or cyclosporines, are excluded from participation in this study (inhalers are allowed)
* History of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis
* Pregnant women or women attempting to become pregnant
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty

Pneumatic tourniquet is usually used in orthopedic surgeries, as it helps to decrease operative bed bleeding, and thus, maintaining a clean and dry surgical field allowing easy and clear identification of the anatomical structures. Despite that advantage, after its deflation, there is a blood volume shift towards that ischemic area, which may decrease cardiac preload leading to hypotension

Hemodynamic changes after tourniquet deflation include; hypotension, tachycardia and increase in cardiac index. These changes may be insignificant for healthy individuals but, risky for patients with compromised cardiovascular system and geriatric population.

Hypovolemia is a common problem in many clinical situations. The mortality of hypovolemic shock is directly related to the severity and duration of organ hypoperfusion.

Management of hypotension include frequent monitoring of blood pressure, fluid therapy, non-pharmacological methods, and vasopressors. Fluid therapy by crystalloids or colloids has been the traditional approach to restore volume and can be given as preload or co-load .Non pharmacological methods include positioning and leg compression. Trendelenburg position can increase venous return to the heart. Leg compression by flexion of the hip, elastic bandages, or stockings. An efficient method to treat spinal hypotension is administration of vasopressors, either given by infusion or boluses. Vasopressor drugs act by reversing the circulatory effect of sympathetic blockade. They also restore vascular tone and preserve venous return and cardiac filling

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients of both gender
* American Society of Anesthesiologists (ASA) I or II
* scheduled for elective unilateral total knee arthroplasty

Exclusion Criteria

* Patient refusal.
* Major cardiopulmonary disorders
* Uncontrolled systemic hypertension.
* Hepatic or renal disorders.
* Patient with relative contraindication for tourniquet use as peripheral vascular disease, sickle cell anemia, deep venous thrombosis, diabetic neuropathy and crushed injury.
* Cases having American Society of Anesthesiologists \[ASA\] \> II
* Coagulopathy and bleeding tendency.
* Revision knee arthroplasty and bilateral knee arthroplasty
Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population

Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population

Total hip arthroplasty (THA) is one of the most successful surgical procedures in general. Yet, a few problems remain unsolved, and aseptic loosening is probably the most important of them. One of the main reasons for aseptic loosening in THA is the foreign body reaction caused by the wear particles. Since the late 1990s, the orthopedic industry has been developing highly crosslinked polyethylene (HXLPE) materials to capitalize on the increased wear resistance. In 2007, E1® Antioxidant Infused Technology was developed to reduce wear rate, maintain mechanical properties and prevent oxidative degradation.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included in this study if they received Ringloc acetabular system with E1 liner per the approved indications for use by KFDA in Korea. Specifically,

1. Osteoarthritis
2. Avascular necrosis
3. Legg Perthes
4. Rheumatoid Arthritis
5. Diastrophic variant
6. Fracture of the pelvis
7. Fused hip
8. Slipped capital epiphysis
9. Subcapital fractures
10. Traumatic arthritis Patients aged over 20 Patients with limited co-morbidity - ASA I - III

Exclusion Criteria:

Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Ringloc acetabular system with E1 liner. These indications are stated below:

Absolute contraindications include: infection, sepsis, and osteomyelitis

Relative contraindications include:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. osteoporosis,
3. metabolic disorders which may impair bone formation,
4. osteomalacia,
5. distant foci of infections which may spread to the implant site,
6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
8. pregnancy