cyrilzakka/clinical-trials huggingface dataset:
Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema

Periorbital edema and ecchymosis are common morbidities in the post-operative period after rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large contributing factors to the degree of bruising and edema. This is due to injury to the angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling and bruising, it can cause difficulty with visual acuity in the early post-operative period. Most importantly, this can be quite distressing to the patient and impact the time required to return to normal social activities. Numerous studies have examined various interventions to reduce periorbital swelling and ecchymosis. These include peri-operative steroids, lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to minimize post-operative edema and ecchymosis without the risk profile of steroids would be ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group received compression with a cold saline soaked gauze to the nasal dorsum during the surgery and the control group received compression with a dry gauze. Both groups received a pre-operative dose of intravenous steroids. The study group had significantly less periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study unfortunately did not examine the role of compression alone and the study was performed in the presence of steroids, which is not routinely utilized by all surgeons. As such, the proposed study will provide evidence for the use of direct compression intra-operatively after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings of this study may provide a simple, effective and non-costly technique to minimize the morbidity of rhinoplasty.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy

Exclusion Criteria:

* Patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.
PUER ("Previously Unrecognized Emerging Risks") Life Clinical Study (PUER) in Ages 6 Through 18

The goal of this observational study is to learn about changes in health in children that develop over time that may impact overall health and a healthy lifespan. The main questions it aims to answer are:

* What are the changes in health that impact overall health and lifespan in children; and
* What test(s) are best at finding changes in health in children?

The two parts of the PUER Research study include (1) Baseline health assessment and (2) blood tests including genetic, molecular, and laboratory profiling. The Baseline assessment will consist of a health history questionnaire interview. Genetic assessment will be conducted using peripheral blood samples. Molecular and laboratory assessments will be conducted using peripheral blood samples and, potentially, urine, stool, and/or saliva samples.

The study will result in cross-sectional and longitudinal real world data collection to inform if any tests used can inform of health changes for individuals and may predict long-term health outcomes. Researchers at study sites will not be blinded to the data being collected during this study.

Eligibility Criteria:
Inclusion Criteria:

To participate in the study, patients must meet the following criteria:

1. Male or non-pregnant female; age 6 to less than 18.
2. Females of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at all visits.
3. Presence of

   1. At least one pathogenic genetic variant in a biological parent, which is annotated as pathogenic in at least one public database, such as dbSNP, ClinVar, VEP (variant effect predictor), etc.; OR
   2. Presence of unexplained disease, illness, trait, or phenotype.
4. Approval is at the sole discretion of the sponsor.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study participation:

1. Unwillingness or inability to participate in the study.
2. Unwillingness or inability to provide assent as per inclusion criterion #1, including those who lack the capacity to provide assent and will obtain 18 years of age prior to completion of the study.
3. WOCBP a with positive pregnancy test at enrollment or at any visit.
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.

Patients currently on either AZT or ddI receive ganciclovir therapy.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Concomitant AZT or ddI.

Allowed:

* Probenecid.
* Aerosolized pentamidine.

Patients must have:

* Asymptomatic HIV infection.
* CMV seropositivity or CMV culture positivity at present or at any time in the past.
* No history of CMV disease (e.g., retinitis, colitis) or any other AIDS-defining illness.
* Treatment with AZT or ddI for at least 1 month prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Uncontrolled diarrhea (three or more loose stools/day).
* Clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
* AZT patients only:
* Deficiency in glucose-6-phosphate dehydrogenase.
* ddI patients only:
* Grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

* Combination antiretroviral therapy.
* G-CSF or GM-CSF.
* Acyclovir.
* Amphotericin B.
* Amikacin.
* Captopril.
* Carbamazepine.
* Cimetidine.
* Cyclosporine.
* Glutethimide.
* Gentamicin.
* Griseofulvin.
* Ibuprofen.
* Imipenem-Cilastatin.
* Lithium.
* Methicillin.
* Methotrexate.
* Naproxen.
* Pentamidine (Pentam 300) (Aerosolized drug permitted).
* Phenacetin.
* Phenobarbital.
* Phenytoin.
* Piroxicam.
* Ribavirin.
* Rifampin.
* Tobramycin.
* Vidarabine.
* Zalcitabine.
* Other investigational drugs.

Patients with the following prior conditions are excluded:

* History of hypersensitivity to acyclovir or ganciclovir.
* AZT patients only:
* History of gout, uric acid, kidney stones, peptic ulcer or porphyria.
* ddI patients only:
* History of pancreatitis or alcoholism, or seizures within 6 months prior to study entry or prior need for anticonvulsant therapy.

Prior Medication:

Excluded:

* Combination antiretroviral therapy within 1 month prior to study entry.

Required:

* AZT at 500 mg/day for at least 1 month prior to study entry (with 100 mg administered five times per day for at least 1 week prior to study entry). OR
* ddI at recommended dose for at least 1 month prior to study entry (with 250 mg administered every 12 hours for at least 1 week prior to study entry).

History of alcoholism (in ddI patients).
Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy

Cancer survivors are at a high risk to develop second primary malignancy (SPM) which constitutes a serious threat for them. Radiotherapy is the cornerstone for the management of many cancers as a locoregional treatment modality. Due to the low liver tolerance, cirrhotic patients are at a high risk of developing radiation-induced liver toxicities despite the modern safe radiation delivery techniques. Radiation damages cells through direct energy deposition and reactive free radical generation. Recent studies demonstrated a potential risk of SPMs following radiotherapy with further investigations for strategies to decrease radiation-induced SPMs. However, it is insufficiently addressed if developing liver SPMs is a serious adverse event following radiotherapy for cirrhotic patients. The aim of this study was to quantitatively assess the risk of gastrointestinal (GI) and liver SPMs following radiotherapy in patients with chronic liver disease.

The SEER.stat software version 8.4.3 was used to obtain and analyze the data of patients with chronic liver disease diagnosed from 2010 to 2021. Using Ishak fibrosis score: F0-4 no to moderate fibrosis and F5-6 advanced or severe cirrhosis. patients were subgrouped according to the history of receiving radiotherapy for prior cancer treatment in two groups and excluded patients with unknown radiotherapy administration history. An MP-SIR session was used to calculate the Standardized Incidence Ratio (SIR) as Observed/Expected (O/E) with 95% confidence interval (CI). Significance was achieved at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients were classified according to fibrosis severity using the Ishak fibrosis score: F0-F4 (no to moderate fibrosis) and F5-F6 (advanced or severe cirrhosis) from 2010 to 2021.

Exclusion Criteria:

* Patients with unknown radiotherapy history or unknown fibrosis score or missing age data
Multidisciplinary Evaluation of Patients With Hemophilia

Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are:

* Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis.
* Descriptive study of the alterations of periarticular muscle strength as a result of acute processes or the development of chronic articular sequelae.
* Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia.
* Descriptive study of the joint space, regarding hemarthrosis and synovitis, intraarticular by ultrasonography.
* Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.

Observational study that will allow us:

Analyze and evaluate the skeletal muscle of patients with hemophilia involvement.

Describe the periarticular muscular deficit, depending on the degree of injury, age, presence of inhibitors and the development of physical activity.

Identify the relationship between the functional deficit by clinical assessment performed with the use of validated scales measure force production with patients.

Observe the presence of joint bleeds in children with hemophilia and synovial hypertrophy developing therein.

Detect biomechanical abnormalities of the lower limbs and their impact on gait in patients with hemophilia.

Assess the factors that influence the perception of illness and quality of life of patients with hemophilia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A and B.
* Patients of all ages (pediatric, adolescents, youth and adults).
* With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint loading.
* Patients with or without inhibitors.

Exclusion Criteria:

* Patients without prior walking capacity.
* Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
* Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
Project UPLIFT for Psychogenic Non-Epileptic Seizures

Developed by researchers from the Centers for Disease Control and Prevention (CDC), Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a group telephone program designed to improve depression for people with epilepsy. Project UPLIFT uses evidence-based approaches of cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy to help people manage and prevent symptoms of depression.

For people with psychogenic non-epileptic seizures, there are few treatment options for depression that address the relationship between mood and seizures. There is evidence that mindfulness-based therapy and cognitive therapy are both effective for people with non-epileptic seizures, both in treating depression and reducing seizure frequency. In this study, Project UPLIFT will be offered to patients with psychogenic non-epileptic seizures.

Project UPLIFT is facilitated by a trained clinician to groups of 4-8 patients over the telephone. The group will meet at a regular time, once a week, for 8 consecutive weeks. Participants will be assigned to one of two groups: an immediate-treatment or a waitlist control group which will begin Project UPLIFT 3 months after enrolling in the study.

Upon enrollment in the study, participants will be randomly assigned to one of two groups: an immediate-treatment group, or a 3-month waitlist control group. Both groups will be given surveys to complete online, and a seizure calendar to keep track of auras, seizures, and events. The immediate-treatment group will be scheduled to start Project UPLIFT with their trained facilitator. Each of the eight weekly sessions will take place at the same day of the week and at the same time, and will last approximately one hour. Participants will have the option of using a fake-name during the telephone calls to conceal their identity during the group telephone calls.

After the 8 weekly sessions, both groups will be given a second set of online surveys to complete individually. At this time, the waitlist control group will be scheduled to start Project UPLIFT with the trained facilitator. After the waitlist group completes the final session of Project UPLIFT, both groups will complete a third and final set of online surveys, thus concluding all study procedures.

Eligibility Criteria:
Inclusion Criteria:

* History of psychogenic non-epileptic seizures, confirmed by study investigator.
* Literate
* Reliable telephone access

Exclusion Criteria:

* Dual diagnosis of PNES with epilepsy.
* Presence of serious mental illness that will impair ability to participate.
* Presence of active suicidal ideation at baseline with intention to act.
* Severe mental disability or estimated intelligent quotient (IQ) less than 70.
* No reliable telephone access.
Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia

Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia

Multi-center, Randomized, Double-blind, Phase III clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Over 19 years
* Type II DM with Dyslipidemia
* 6.5% ≤ HbA1c \< 11%
* Triglyceride \< 350mg/dL
* 100mg/dL ≤ LDL-C ≤ 250mg/dL
* FPG ≤ 270mg/dL

Exclusion Criteria:

* Type I DM
* Unstable angina, MI, Stroke, CABG with 6 month from screening
* SBP ≥ 180mmHg, DBP ≥ 110mmHg
* TSH \> UNL
* Heart failure (NYHA class III/IV)
* Serum Creatinine \> UNL or CLCr \< 60 mL/min
* CK ≥ 2x UNL
* HIV positive
* BMI \> 40 kg/m\^2
Prediction Model for TOF

This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing neurosurgery
* scheduled for intra-operative neurophysiological monitoring
* American Society of Anesthesiologists physical class I, II, III

Exclusion Criteria:

* unable to monitor train-of-four
* decline to participate in the study
Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group

Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17


Eligibility Criteria:
Inclusion Criteria:

* endoscopic confirmed diagnosis

Exclusion Criteria:

* corticosteroid or immunosuppressive therapy
Effects of a Diaphragmatic Breathing Training Program in Chronic Obstructive Pulmonary Disease (COPD) Patients

Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.

Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.


Eligibility Criteria:
Inclusion Criteria: (1) age between 50 and 80 years; (2) a post-bronchodilator forced expiratory volume in one second (FEV1) \< 80% of the predicted value and a FEV1/ forced vital capacity (CVF) ratio \< 0,7; (3) stable respiratory/clinical condition without changes in medication and symptoms (dyspnea, volume or color of sputum) for at least 4 weeks before admission to the study; and (4) receiving regular treatment with inhaled bronchodilators and steroids.

Exclusion Criteria: (1) presence of other pulmonary, cardiovascular or musculoskeletal diseases; (2) previously participation in any exercise-training program in the last 2 years before participating in this study; and (3) current smokers.
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study

This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals

Exclusion Criteria:

* None
CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma

This is a randomized, parallel arm, multicenter, double-blind trial.

Patients with POAG will be randomized 1:1 ratio to receive:

* Prostaglandin analogue (PGA) monotherapy + CoQun® (Arm A)
* Prostaglandin analogue (PGA) monotherapy + Vehicle (Arm B)

CoQun® 10 ml is a medical device marked by the European Community as class IIb. This device has a system of dispensation that permits it to be preservative free (OSD - Ophthalmic Squeeze Dispenser). Investigators and patients will be masked to the study treatment. In order to mask the treatment, identical kit boxes, identical packaging (bottles and labels) will be used for vehicle and active product. The bottles will be dispensed sealed to the patient.

One or two drops of the solution (CoQun® or Vehicle) will be instilled in the conjunctival sac of both eyes, twice daily from 8 to 10 AM and from 8 to 10 PM. Hypotensive therapy should be administered in the evening one hour after the CoQun® or Vehicle administration.

At baseline, ocular hypotensive treatment, as per inclusion criteria has to be a PGA monotherapy. During the follow-up, in case the IOP exceeds 28 mmHg, any additional hypotensive therapy will be allowed to obtain IOP control.

Dose modifications/reductions of CoQun® /Vehicle are not permitted.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of POAG (monolateral or bilateral) with an IOP ranging from 17 to 21 mm Hg (at the last performed visit and confirmed at the baseline study visit) on treatment with a topical prostaglandin analogue (PGA) monotherapy.
2. VF examination at randomization: VF Mean Defect (MD) at baseline within -4 decibel (dB) and -10dB and VF Pattern Standard Deviation (PSD) within 4 dB and 10dB (stage 2-3 per the Enhanced Glaucoma Staging System 2 (GSS) determined by Humphrey Field Analyzer II-i, program 30-2 SITA standard.
3. In order to determine patient's reliability to perform VF examination: before baseline VF, at least two reliable VF examinations during the last year had to be performed. Visual fields are considered reliable if false-positive responses are fewer than 15% and a clear blind spot could be seen in the VF printouts, threshold value \<10 dB.
4. Age \>40 years
5. Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

1. Secondary glaucoma (exofoliative glaucoma, pigmentary glaucoma, neovascular glaucoma).
2. Abnormalities of the anterior segment of the eye that could affect IOP assessment.
3. Cornea abnormalities with entities that could affect IOP evaluation.
4. Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage).
5. BCVA) \< 0.5 Snellen decimal fraction
6. Any previous ocular surgery except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (argon laser trabeculoplasty and/or selective laser trabeculoplasty).
7. Pregnancy or breast-feeding.