cyrilzakka/clinical-trials huggingface dataset:
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction

A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be conducted.

Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 45 days after ACL reconstruction. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.


Eligibility Criteria:
Inclusion Criteria:

* Young adults aged between 18 and 40 years;
* Recreational athletes;
* Unilateral ACL injury;
* Presence of total or partial rupture of unilateral ACL within 90 days after injury;
* Male subjects;
* Classification of body mass index up to pre-obese (25.0 - 29.9 kg / m2);
* Not undergoing any strength training program for the lower limbs in the six months prior to the study.
* Acceptance of individuals in participating in the procedures proposed by the research.

Exclusion Criteria:

* Recidivism in ligament injuries;
* Associated ligament and / or meniscal lesions;
* Previous history (\<6 months) of musculoskeletal lesions in the thigh;
* Patellar tendinopathy;
* Patellofemoral pain syndrome;
* Respiratory or cardiovascular conditions that limit the performance of exercises;
* Users of dietary supplements or anabolic steroids
23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.

The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation. Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal preference.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written consent and comply with study assessments for the full duration of the study.
* Presence of retinal detachment with history of cataract surgery.
* Vision of hand motion or better.

Exclusion Criteria:

* Presence of a very large tear or type of retinal detachment usually a result of trauma.
* Prior eye surgery except for cataract surgery.
* Presence of significant scar tissue.
* Presence of retinal detachment due to hole in the macula.
DOAC ADRs Retrospective Study on Genetic Variations

The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots from forming in the blood vessels.

Genes can have variants or mutations that can increase the participant's risk for bleeding when receiving a direct oral anticoagulant (DOACs). The investigators will be studying participants on DOACs who have had bleeding and also participants who are on DOACs who did not have bleeding (control group). The goal of the study is to determine the accuracy of Cipherome's Drug Safety Score (DSS) in it's ability to predict adverse drug reactions (ADRs). A DSS score ranges from 0 to 1, with scores less than 0.3 correlated with a higher risk of ADRs and scores more than 0.7 correlated with a lower risk of ADRs. The participant's DSS score will be compared with the actual clinical outcome using a statistical test to determine the accuracy of the DSS.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient 18 years and older, who experienced major bleeding, clinically relevant non major bleeding or treatment failure while taking a DOAC during the study time frame and is able to provide informed consent. Control patients will be recruited from all adult patients who are on DOAC therapy.

Exclusion Criteria:

* Failure to provide informed consent
The Optimum Time for Preoxygenation Based on Body Mass Index

The purpose of this study is to evaluate the relationship between the time needed to raise the oxygen concentration in patient's blood to 90% and his/or her body mass index. The prevalence of obesity in our society continues to rise. No studies have shown the time required for preoxygenation (oxygen given) in relation to body mass index (body weight in kg/height in meter2).

100% oxygen given to patient before induction of anesthesia (asleep) is the standard clinical care. However, studies using various methods have shown differences in terms of the optimal time, technique and number of breaths needed for efficient oxygenation. The only difference to the standard pre-anesthesia care is that we will record the time to raise patient oxygen to 90%. Age is recorded to ensure that the subjects fall within our inclusion criteria. The weight (W) in kilograms and height (H) in meters will be used to calculate the body mass index (BMI): BMI = W/H2. Alveolar oxygen uptake is dependent on respiratory rate, heart rate, blood pressure, temperature and hemoglobin level. These parameters are measured in order to identify factors that may affect the accuracy of the study. We will record the pulse oximetry value to note the initial oxygen saturation on room air and after the oxygenation.

Facial hair and mask fit are recorded to assess possible failure of an optimal facemask seal. End-tidal carbon dioxide (FE'CO2) is also measured to ensure an adequate facemask seal. Anxiety can increase the respiratory rate, heart rate and affect patient compliance with a fitted facemask. All of the aforementioned values are recorded to assess reasons for possible failure of the preoxygenation technique and inaccurate results.

Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 18-50 years with no limitations as to gender or race
* Participants classified as ASA 1 or 2
* Participants capable of understanding and signing an informed consent

Exclusion Criteria:

* Conditions which would affect their oxygenation such as heart disease, lung disease, anemia (Hemoglobin less than 12 g/dL)
* History of smoking (smoking can affect pulmonary function and oxygen carrying capacity)
* Acute substance abuse (substance abuse can affect respiratory function).
* Maxillofacial abnormalities which would interfere with proper face mask seal.
Body Mass Index and Audiology Function

Obesity may directly or indirectly lead to hearing loss

Obesity is measured by Body Mass Index.it is calculated by dividing a person's weight in kilograms by the square of height in meters. For children and adolescent. Overweight is defined as Body Mass Index is \<85th percentile \<95th percentile but obesity is defined as body mass index at or above the 95th percentile for children and teens of the same age and sex the increasing in body mass index mass may affect auditory function Directly as adipose tissue secretes hormones and cytokines, proinflammatory cytokines lead to release of obesity-induced inflammation which may directly contribute to end-organ damage Also, Adiponectin, which is thought to have anti-inflammatory and antiatherogenic effects, and associated with favorable lipoprotein profile, independent of BMI and insulin resistance, low plasma concentrations of adiponectin have been associated with obesity in children. In adults, low level of adiponectin has been associated with elevated high-frequency thresholds.

Indirectly, by obesity comorbidities including Hypertension, Type 2 diabetes mellitus, Dyslipidemia , Metabolic Syndrome and Cardiovascular Diseases

Eligibility Criteria:
Inclusion Criteria:

It will include 50 subjects whose:

* Age ranges from 10 to 40 years old.
* Body Mass Index more than the 85th percentile.
* male and female will be included

Exclusion Criteria:

* External or middle ear disease that causes conductive hearing loss such as otitis media, otomycosis, perforated drum, tumors, dislocation of the ossicles.
* High environmental noise exposure which causes acoustic trauma such as exploration, fire shots and noise in industries.
* ototoxic drug intake such as Aspirin, Aminoglycosides, Erythromycin, Vancomycin Streptomycin, Kanamycin, Neomycin, Gentamycin, Tobramycin, Lasix, Cisplatin, Nitrogen Mustard, and Vincristine, and Quinine.
* Major neurological or psychiatric diseases brain tumor, vestibular Schwannoma, stroke, acoustic neuroma, encephalitis, meningitis, and depression.
A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not yet been studied. This study is designed to estimate quizartinib bioavailability of quizartinib following oral and intravenous (IV) administration.

Quizartinib bioavailability based on the dose-adjusted exposure of quizartinib following oral and IV administration will be assessed in healthy male subjects. The primary objective of this study is to determine the absolute oral bioavailability of quizartinib. Secondary objectives will include characterizing the plasma PK of quizartinib, radiolabeled quizartinib, and the major circulating metabolite after a single oral dose and IV administration. Safety and tolerability of quizartinib will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18 years to 55 years of age (inclusive) at the time of signing informed consent
* Body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2 (inclusive) at screening

Exclusion Criteria:

* History or presence of:

  * Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, as judged by the Investigator.
  * Any other condition, including laboratory abnormality, that in the opinion of the Investigator, would jeopardize the safety of the subject, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
* History of a clinically significant illness, in the opinion of the Investigator, within 4 weeks prior to administration of quizartinib.
* History, or presence in the average of triplicate ECGs at screening and admission (Day -1), of any of the following cardiac conduction abnormalities:

  * QT interval corrected with Fridericia's formula (QTcF) \> 450 milliseconds (ms).
  * Evidence of second- or third-degree atrioventricular block.
  * Evidence of complete left or right bundle branch block.
  * QRS or T wave morphology that could, in the Investigator's opinion, render QT interval assessment unreliable (confirmed with triplicate ECG).
* Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range, if considered clinically significant by the Investigator at screening or admission (Day -1).
* Estimated creatinine clearance (CrCl) \<90 mL/min (calculated using Cockcroft-Gault Equation) at screening.
* Use of drugs with a risk of QT interval prolongation or Torsades de Pointes (TdP) within 14 days of admission (Day -1) (or 5 drug half-lives, if 5 drug half-lives are expected to exceed 14 days).
Cardinality Matching Study of Early v.s. Delayed VV ECMO in Severe Respiratory Failure

Clinical reasoning and recent data suggest that early use of venovenous extracorporeal membrane oxygenation in refractory respiratory failure may confer a survival advantage.

This retrospective matched study will assess whether patients who received VV ECMO at less severe hypoxaemia had differing outcomes to those who received ECMO with very severe hypoxaemia.

VV ECMO is increasingly used in refractory respiratory failure. Despite advances in lung protective ventilation strategies, patients who have severe respiratory failure often develop complications from mechanical ventilation, including volutrauma and barotrauma. ECMO allows gas exchange to occur extracorporeally and may reduce the potential burden of iatrogenic lung injury by allowing a reduction of volume and pressure support - a 'lung rest' strategy. It is theorised that earlier intitiation of ECMO may allow for better outcomes, as there will have been less time for iatrogenic lung injury to occur.

The UK ECMO registry has been collected of patients treated under the NHS England commissioned respiratory ECMO service since 2011. This study has been previously registered and publication is intended shortly.

Patients will be extracted from this registry if they received VV ECMO. Propensity matching scores will be created and patients will be stratified into groups of 'early' vs 'delayed' ECMO, based on their probability of being in either group.

Patients will be divided into cohorts based on the median PaO2/FiO2 ratio at decision to cannulate ('less severe hypoxaemia') and ('very severe hypoxaemia'). Matched cohorts will be created correcting for key confounding factors (age, primary diagnosis, duration of pre-ECMO ventilation and PaCO2), using cardinality matching (a novel technique described by Zubizaretta et al. in 2014) and traditional propensity-score-based methods.

The technique with greater balance and statistical power (as defined by sample size) will be selected for the primary analysis.

Further analyses will assess the relationship between hypoxaemia at decision-to-cannulate and confounding factors as above.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the UK ECMO registry (see previous registration; NCT number awaited; protocol ECMO-001)
* Patients with VV ECMO

Exclusion Criteria:

* Patients with inadequate or missing data for creation of propensity score models.
Phthalate Esters and Childhood Obesity

Phthalate esters have been considered closely related with childhood obesity, but the existing studies revealed inconsistent results. This study was desigened to investigate the association between phthalate esters and childhood obesity in China.

The physical activity, dietary intake and the levels of urine phthalate metabolites of children were detected, and the associations between these 3 factors and childhood obesity were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Children who were classified as normal, overweight and obesity based on age, gender and BMI.

Exclusion Criteria:

* The participants who were with endocrine disorders.
Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty

Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort.

Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy is still controversy.

No studies to date have investigated the best administration route of dexmedetomidine to dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the least grade.

This prospective, randomized, double blinded study was designed to investigate the best administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and secondly as adjunctive analgesic.

The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the analgesic duration, the first postoperative day analgesic consumption, the sedation score and early ambulation ability were the secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* both genders
* American Society of Anesthesiologists physical status I and II
* scheduled for unilateral primary TKA under spinal anesthesia

Exclusion Criteria:

* chronic opioid use
* known allergy to the used drugs
* any contraindications to regional anesthesia like; patient refusal, coagulopathy, neuropathy or infection at the injection site
Blood Flow Restriction and Recovery in Soccer Players

The objective is to evaluate the effects of blood flow restriction training on the post-competition recovery of professional and semi-professional soccer players. Randomized crossover clinical trial, with two intervention groups: Experimental group I will carry out a recovery training based on the use of the blood flow restriction (BFR) on day 1 post-competition. On the other hand, the Experimental II group will perform the same recovery training without the use of BFR. After 1 month the groups will cross their intervention and make the recovery with the opposite method to the initial one. The study will be carried out during the 2021-2022 season, from first regional to third division of Spanish soccer, with soccer teams from the Mallorca Island. Before the competition, the countermovement jump (CMJ) will be evaluated and repeated at 0, 24, and 72 h after the competition. The levels of muscle soreness (DOMS) will be evaluated pre-post-competition 0, 24, 48 and 72h later. The same procedure will be carried out to evaluate muscle fatigue, sleep quality, and stress through a questionnaire that athletes will fill out pre, 0, 24, 48 and 72h after the game. Sociodemographic and anthropometric data will be collected before starting the study.

W-UP:

The warm-up will consist of 5 minutes running slow, 5 minutes mobility, and 5 minutes of running exercises. In addition, the warm-up will contain a familiarization with the jump test.

Eligibility Criteria:
Inclusion Criteria:

* 50 Minutes or more playing during the last match.

Exclusion Criteria:

* No injuries players.
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study:

* The frequency of treatment related adverse events.
* The frequency of efficacy assessment.
* Treatment related unlisted adverse events in Japanese Package Insert.
* Risk factors likely to affect the frequency of treatment related adverse event.

All the patients whom an investigator prescribes the first gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* All the pediatric subjects (aged 3-15 years) whom an investigator prescribes the first gabapentin (tablets, syrup, and switch to syrup from tablet) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Exclusion Criteria:

* Patients who have been enrolled in the drug use investigation of Gabapen tablets in adults (protocol No. A9451163).
* Patients who receive Gabapen tablets or syrup before, except for switched from tablets to syrup.
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.

This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.


Eligibility Criteria:
Abbreviated Inclusion Criteria:

1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy \> 12 weeks
4. ECOG performance status of 0-1

Abbreviated Exclusion Criteria:

1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
4. History of severe autoimmune disease
5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating patients who have advanced cancer.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II. Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients.

OUTLINE: This is a multicenter, dose escalation study of gemcitabine. Patients receive oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with a fixed dose of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable malignancy for which standard therapy does not exist or is no longer effective No greater than 3 prior treatment regimens No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No allergy to platinum compounds or antiemetics No uncontrolled active infection or other illness

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to at least 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents No other concurrent anticancer therapy No HIV positive patients receiving antiretroviral therapy (HAART)