cyrilzakka/clinical-trials huggingface dataset:
Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study

In this study, bilateral simultaneous high tibial osteotomy (HTO) was compared with staged bilateral HTO in terms of complications. We did not use any grafts to support the osteotomy line and the patients were mobilized immediately with a full load on a postoperative day 1. And our hypothesis is that bilateral simultaneous applications are safe in comparison to the staged ones in terms of complications.

Knee osteoarthritis is the most common orthopedic chronic disease, and varus knee abnormalities can often be related. The load from the medial tibiofemoral joint increases significantly in varus alignment disorder and it plays an important role in the structural progression of knee osteoarthritis. Varus malalignment and patients with medial tibiofemoral disease comprise a common patient subset. The probability of progressing to severe disease is 3 to 4 times higher in these patients compared to those with a neutral knee alignment. Although the long-term results of high tibial osteotomy are well documented, but data on bilateral simultaneous HTO are insufficient. In general, staged surgery is preferred in bilateral cases due to the difficult rehabilitation, healing of the osteotomy line, and complications related to surgery. Advances in post-surgical rehabilitation have been made due to increased confidence in stability due to improvements in the technology of plates.The advantages of an bilateral simulatneous HTO is single administration of anesthesia, total shortening of the hospitalization periof and reduced costs.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral primary genu varus gonarthrosis

Exclusion Criteria:

* Secondary gonarthrosis
Pharmacokinetics and Safety Following Administration of DWP16001

To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers aged ≥ 19 years at screening
* Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
* Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
* Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion Criteria:

* Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
* Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
* Clinical laboratory test values are outside the accepted normal range at screening
* Other exclusive inclusion criteria, as defined in the protocol
Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

The primary aim of this study is to introduce a new effective and efficient 3D printed design of an intra-oral space maintainer.

The secondary aim of the study is to:

Evaluate the clinical performance of 3D printed space maintainer versus conventional metal band and loop over a period of 6 months regarding their functional , biological aspects and patient satisfaction.

And will be conducted as follows:

* In-Vivo evaluation of the clinical performance of 3D printed space maintainer versus metal band and loop concerning oral hygiene, retention and patient satisfaction.
* A total of thirty healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University. They will be divided using simple randomization in two groups:

Group 1: Children with 3D printed space maintainer (n=15) Group 2: Children with conventional band and loop(n=15)

Eligibility Criteria:
Inclusion Criteria:

* Aged 6-9years' old
* Premature loss of primary molar or molars in one or more quadrant.
* Absence of abnormal dental conditions such as cross bite.
* Sound and healthy buccal and lingual surfaces of abutment teeth.

Exclusion Criteria:

* Bad oral hygiene
* Medically Compromised patients.
* Presence of periapical pathology radiographically.
* Carious buccal and lingual surfaces of abutment teeth.
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations

Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.

Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.

Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.

Eligibility Criteria:
Inclusion Criteria:

* children between ages 6 weeks to 24 months
* first episode of wheezing
* diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score

Exclusion Criteria:

* Children with mild bronchiolitis (Wang score \< 5)
* Children with pre-existent cardiac disease
* Children with clinically significant chronic respiratory disease
* Immunocompromised children
* Children with a gestational age at birth less than 34 weeks
* Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
* Children who received corticosteroid in any form in the preceding 2 weeks before presentation
* Children who received bronchodilators within 24 hours before presentation
* Children with critical illness at presentation requiring immediate admission to intensive care unit
Bioequivalence Study Between "DA-5215 Tab" and "DA-5215-R Tab"

An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers

1. Study design: An open-Label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study
2. Administration method:

   The subject should maintain a minimum of 10 hours of fasting status before administration, and give an oral dose of 1 tablet (DA-5215 or DA-5215-R) with 150 mL of water at around 8 a.m. on 1D of each period. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the subjects is about one minute apart, considering the blood collection time.
3. Wash out period: at least 7 days
4. Blood collection time: Before the administration,15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 hours after the administration (total 16 times)

Eligibility Criteria:
Inclusion Criteria:

1. A person who aged 19 or older at the time of screening
2. BMI of 18 to 30 (BMI calculation: kg/m2)

   - Males weighing 50kg or more, Females weighing 45kg or more
3. No congenital or chronic diseases or pathological symptoms
4. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
5. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
6. A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature

Exclusion Criteria:

1. A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP
2. A person who has participated in other clinical trials within six months prior to the first administration of the IP
3. A person who has had whole blood transfusion within 8 weeks or the apheresis within 2 weeks before the first administration of IP
4. A person who has medical history of gastric resection that can affect the drug absorption
5. A person with a history of regular alcohol intake within a month prior to the first administration of the IP:

   * Male: More than 21 cups/week
   * Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits)
6. A person who is hypersensitive to any of the IP components
7. A person who has medical history of mental disease
8. A person who is judged not to be suitable for the study by the investigator
9. Lactating or possibly pregnant women
Efficacy of Selective Laser Trabeculoplasty in Patients Under Treatment With Topical Prostaglandines

Retrospective analysis of efficacy of selective laser trabeculoplasty in patients under treatment with topical prostaglandins compared to patients without topical prostaglandins is performed.

Inclusion criterion are patients with glaucoma or ocular hypertension, who underwent treatment with selective laser trabeculoplasty due to insufficient control of intraocular pressure during their routine treatment at the University Hospital Zurich / Division of Ophthalmology.


Eligibility Criteria:
Inclusion criteria:

* Patients with ocular hypertension or glaucoma who underwent selective laser trabeculoplasty due to insufficient control of intraocular pressure despite maximum tolerated topical treatment.

Exclusion criteria:

* Optic neuropathy other than glaucoma
Auditory Steady State Response vsAuditory Brainstem Response

All children with hearing loss should have access to resources necessary to reach their maximum potential. The following principles provide the foundation for effective EHDI\[Early Hearing Detection \& Intervention\] systems and have been updated and expanded since the 2000 JCIH \[ joint Committee on Infant Hearing \] position statement .

1. All infants should have access to hearing screening using a physiologic measure at no later than 1 month of age.
2. All infants who do not pass the initial hearing screening and the subsequent rescreening should have appropriate audiological and medical evaluations to confirm the presence of hearing loss at no later than 3 months of age.
3. All infants with confirmed permanent hearing loss should receive early intervention services as soon as possible after diagnosis but at no later than 6 months of age. A simplified, single point of entry into an intervention system that is appropriate for children with hearing loss is optimal.

The importance of early identification and habilitation of hearing loss for improved access to auditory stimuli and for positive prognosis of speech and language is well established in the literature . Auditory brain stem response (ABR) is the most commonlly used test in clinical practice to estimate the degree of hearing loss, but the auditory brainstem response (ABR) cannot differentiate between severe and profound SNHL \[5\], whereas the ASSR can provide threshold information in a frequency-specific manner at intensity levels of 120 dB and higher. This intensity stimulation advantage uniquely qualifies the ASSR for investigation of residual hearing in young and difficult-to-test cochlear implant candidates.

Eligibility Criteria:
Inclusion Criteria:

* Absent ABR \[Auditory Breanstem Response\] waves .
* normal middle ear function

Exclusion Criteria:

* Ears with otitis media with effusion,
* Preserved otoacuastic emission ,
* Preserved ABR waves .
The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.

To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years；
2. Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
4. The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
5. BMI(Body Mass Index)\<30 kg/m2；
6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
10. Sufficient vital organ functions；
11. Signed informed consent.

Exclusion Criteria:

1. Preoperative examination indicates disease stage cStage II or above；
2. Women during pregnancy or lactation；
3. Suffer from other malignant tumors within 5 years；
4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
5. Severe mental illness；
6. Severe respiratory disease；
7. Severe liver and kidney dysfunction；
8. History of unstable angina or myocardial infarction within 6 months；
9. History of cerebral infarction or cerebral hemorrhage within 6 months；
10. Continuous application of glucocorticoid within 1 month (except for topical application)；
11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
12. The patient has participated in or is participating in other clinical studies (within 6 months).
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.


Eligibility Criteria:
Key Inclusion Criteria:

* New onset moderate or severe cGVHD as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project Criteria
* Need for systemic treatment with corticosteroids for cGVHD
* No previous systemic treatment for cGVHD (including extracorporeal photopheresis \[ECP\])
* Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d
* Age ≥12 years old
* Karnofsky or Lansky (subjects \<16 years) performance status ≥60

Key Exclusion Criteria:

* Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form.
* Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD
* Any uncontrolled infection or active infection requiring ongoing systemic treatment
* Progressive underlying malignant disease or any post-transplant lymphoproliferative disease
* Known bleeding disorders
* Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity

The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)


Eligibility Criteria:
Inclusion Criteria:

* Males and females 20-80 years old
* Who had suffered more than twice Upper respiratory infection\* disorder or common cold causing URI
* Able to give informed consent

Exclusion Criteria:

* WBC concentration below 3000 ㎕
* Subjects vaccinated against influenza within the last 6 months prior to the study
* Subjects with Upper respiratory infection at screening visit
* Subjects with BMI \< 18.5 kg/m2 at screening visit
* Allergic or hypersensitive to any of the ingredients in the test products
* Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents

Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.

This study will evaluate the intracellular PK of TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents with and without TB coinfection. As the clinical effects of TDF and FTC are related to the intracellular concentrations of the phosphate anabolites, called TFV-DP and FTC-TP, there is a need to understand the cellular pharmacology of TDF interactions in African HIV-infected adolescents with and without TB, as the study team cannot extrapolate from US patients not on antituberculosis (anti-TB) drugs. This study will enroll HIV-infected adolescents aged 10 to 18 years old with and without TB coinfection who are already established on ART. The study team hypothesize that younger age, adenosine triphosphate (ATP)-binding cassette subfamily C (ABCC) single nucleotide polymorphisms (SNPs) and anti-TB therapy may influence the intracellular TFV-DP and FTC-TP concentrations in adolescents.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected adolescents aged 10 to 19 years old who are stable on antiretroviral regimen containing TDF/FTC (300/200 mg daily) for at least 8 weeks.

Exclusion Criteria:

* Unable to obtain informed signed consent from parent(s) or legal guardian.
* Pregnant or breast feeding.
* Require therapy for other opportunistic infections other than tuberculosis (TB).
Characterization of Bio-psychosocial Pain Profiles in the Perioperative Period

This is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain

This is a two institution (Naval Medical Center San Diego and Walter Reed National Military Medical Center) prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain.

A total goal of 1500 subjects (750 subjects at Walter Reed National Military Medical Center and 750 subjects at Naval Medical Center San Diego) will be queried regarding their postoperative pain experience following mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery. Descriptive multidimensional tools (the Defense and Veterans Pain Rating Scale (DVPRS) and the electronic Pain Assessment Screening Tool and Outcomes Registry (PASTOR) will be used preoperatively, as an inpatient, and up to 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 80 and having any of the following surgical procedures: mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery.

DEERS eligible

Exclusion Criteria:

* Total Hip/Total Knee arthroplasty revision Younger than 18 years old Refuse participation Cannot understand English Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)
Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor

The aim of the study is to investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in mild cognitive impairment (MCI) and Alzheimer's disease (AD) patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia.

Alzheimer's disease (AD) is an aging-related disease and is considered to be a type 3 diabetes. Brain-derived neurotrophic factor (BDNF) is a potential therapeutic biomarker for AD. Studies have found that antioxidant supplementation could elevate the level of BDNF. Coenzyme Q10 is an antioxidant nutrient that participates in energy synthesis in mitochondria. Studies have shown that coenzyme Q10 has the potential to regulate blood glucose. However, there are few clinical studies to examine the effects of coenzyme Q10 supplementation on glucose and muscular metabolism and BDNF status in AD. This study will conduct an intervention study to understand the effect of coenzyme Q10 on BDNF and metabolic conditions (hyperglycemia and pre-sarcopenia) in patients with mild cognitive impairment (MCI) and AD. The study will be designed as a randomized, double-blind, cross-over, placebo-controlled study. To investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in MCI and AD patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia. During the study, demographic data, mini-mental state examination, anthropometric measurements, dietary records, nutritional and muscle function assessment, quality of life, and depression assessment will be collected. Blood specimens will be also collected before and after the intervention; then the levels of coenzyme Q10, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial function will be analyzed. The study hopes to clarify the cause effects of coenzyme Q10 supplementation on the regulation of glucose and muscle metabolism, and cognitive function in this prospective clinical study. The results of this study will provide a reference for aging nutrition and health care.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment (MCI).
* Clinical diagnosis of Alzheimer's Disease.
* MCI and AD patients with hyperglycemia ( Fasting glucose \>=100 mg/dL).
* MCI and AD patients with pre-sarcopenia (low calf circumference, low hand grip, or low muscle endurance).
* Must be able to swallow tablets.

Exclusion Criteria:

* Cancer patients.
* Severe heart, lung, liver, and kidney diseases.
* Severe disability or aphasia.
* Malnutrition (body weight changes \> 5% within one month).
* Using coenzyme Q10 supplements.
* Warfarin therapy.