cyrilzakka/clinical-trials huggingface dataset:
Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery

OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.

Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients undergoing open bariatric surgery.

DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil. SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly assigned to receive preoperative inspiratory muscle training (IMT group) or usual care (control group).

MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP), lung volumes and diaphragmatic excursion.


Eligibility Criteria:
Inclusion Criteria:

* Female,
* Over 18 years of age,
* No smoking or respiratory disease.

Exclusion Criteria:

* Patients who refused to participate in the steps of the research protocol,
* Patients with a history of prior abdominal surgery,
* Patients who were unable to understand and perform the tests properly
* Patients who refused to sign the Informed Consent Term.
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia

The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia

The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Teeth preparation and impressions, placement and permanent cementation of the final restoration using resin cement, and optical scanning of both the restoration and the opposing tooth. Follow up postoperatively after six and twelve months, and optical scanning of both the restoration and the opposing tooth.

Eligibility Criteria:
Inclusion Criteria:

-

All subjects are required to be:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations.
3. Psychologically and physically able to withstand conventional dental procedures.
4. Patients planned for a single coverage restoration in the posterior area.
5. Patients with a natural (not crowned) opposing antagonist.
6. Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.
Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children

The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish children by collecting and analyzing patient level observational data already available in existing regional and national databases.


Eligibility Criteria:
Inclusion Criteria:

Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)

Exclusion Criteria:

Not Applicable
Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic SCI (\> 12 months since injury) above the level of T11
2. \> 18 years of age
3. a measurable and consistent start and end event is determinable for the bowel routine

   * Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team.
   * Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.
4. Portable smart device with video capabilities and internet access
5. Willingness to access and/or download Zoom (videoconferencing software)

Exclusion Criteria:

1. American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
2. Self-reported bowel management time (BMT) of \<30 minutes
3. Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
4. Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
5. Stoma or colostomy
6. No response to AFES (e.g., lower motor neuron impairment)
7. History of gastrointestinal surgery within the past 3 months
8. Severely obese participants (\>40 BMI)
9. Primary language other than English
10. Previous history of uncontrolled, recurrent episodes of AD
11. Resting systolic blood pressure (BP) reported as \>140 mmHg
Neutrophils in Bone Sarcomas

Hypothesis: Tumor infiltrating neutrophils are present in osteosarcomas and chondrosarcomas and

Experimental design: Exploratory observational research

Population: Adult patients with osteosarcoma or chondrosarcoma

Assessment criteria: Determination of the presence of TANs within tumors and their N1 or N2 profile, the presence of other immune cells, and the PDL-1 status of the tumor.

Investigation plan: Proposal to participate at all eligible patient during the preoperative consultation. If the patient agrees to participate in the study he/she will be included. Participation in the study will not affect its coverage. Patient participation will lead to:

* Taking samples from an operative part,
* The collection of demographic data (age, sex, height, weight, body mass index), family history of cancer, history of bone trauma, sports practice, clinical and anatomopathology reports and data, medical history (Diabetes, Cardiovascular Diseases, Infectious Diseases, Autoimmune Diseases, Bone Metabolism Disorders, Allergies, Menopause, Drug treatments followed, Psychiatric disorders).

Statistical analysis plan: Description in frequency of the presence of TANs, of N1 and N2 profiles, of the presence of other immune cells both qualitatively and quantitatively. Analysis in subgroups on relevant criteria (age, sex, location, type of tumor).


Eligibility Criteria:
Inclusion Criteria:

* Patient of 18 years and more
* Patient of the Orthopedic and Traumatological Surgery Department of the Reims University Hospital or the Godinot Institute
* Patient with osteosarcoma or chondrosarcoma to be operated on regardless of stage.
* Patient agreeing to participate in the study (informed consent form)
* Patient fluent in French
* Patient affiliated with a social security regimen

Exclusion Criteria:

* Patient having a medical history that may compromise the protocol (psychiatric, medical or pharmacological disorders such as the use of anti-inflammatory drugs, or any compound that may alter or modify the inflammatory reaction in the week preceding the protocol).
* Pregnant or breastfeeding women
* Patient with eating disorders (anorexia, bulimia, overeating)
* Patient protected by law (guardianship, curatorship, hospitalized without their consent and not protected by law, deprived of liberty)
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI

The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.

The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years
2. Subject is willing and able to sign the IRB-approved informed consent form (ICF)
3. Subject presents with a Rutherford Classification of 2 to 5
4. Subject has a positive Allen's Test
5. Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion

Index Procedure Inclusion Criteria:

1. Physician obtains successful radial artery access (Note: snuffbox access is allowed)
2. Target lesion appropriate (i.e. location/morphology) for OA treatment via TRA within target area
3. OAS use attempted (defined as ViperWire introduced into the body)

Exclusion Criteria:

1. Subject has no palpable radial artery on the planned access arm
2. Subject has a previous failed radial access attempt on planned access arm
3. Subject has a dialysis fistula on planned access arm
4. Subject has a known subclavian stenosis or occlusion
5. Subject has a previous subclavian stent or previous subclavian intervention
6. Subject has a shunt in the radial artery on the planned access arm
7. Subject has evidence of osteomyelitis
8. Subject is currently participating in an investigational drug or device study
9. Subject is pregnant within the study period

Index Procedure Exclusion Criteria

1. Physician unable to obtain radial artery access
2. Physician determines TRA is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity
3. OAS use not attempted (defined as ViperWire introduced into the body)

   Prior to insertion of ViperWire:
4. Femoral access is obtained
5. Unsuccessful peripheral intervention
6. A reportable adverse event has occurred
Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis

Current standard of care of rheumatoid arthritis (RA) management includes a routine clinical assessment of disease activity to adjust therapy. For the most part, therapy adjustment for therapy non-response and/or suboptimal therapy response leads to therapy switch within the same class of therapy or to a different class of therapy. The lack of objective data to titrate dose of a given therapeutic agent for maximal possible efficacy makes it difficult for providers and payors to titrate dose as needed.

Therapeutic drug monitoring (TDM) provides objective data for a proactive and individualized therapy optimization based on serum drug levels and the presence or absence of anti-drug antibodies. Maintaining optimal trough drug concentration is a proven concept of therapeutics. With respect to adalimumab, this approach helps to maximize therapeutic efficacy and prevent anti-adalimumab antibody development. However, lack of drug and disease state specific published data creates a barrier for a wider adoption of TDM into clinical practice.

The objective of this single site, open label, randomized, parallel group pilot study is to investigate whether proactive therapeutic drug monitoring based adalimumab dose optimization results in higher rate of achieving and/or maintaining therapeutic goal compared to standard of care in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* Starting or already being treated with standard dose adalimumab, 40 mg subcutaneously (SQ) every two weeks
* Good medication adherence rate defined as Proportion of Days Covered (PDC) 80% and above

Exclusion Criteria:

* Detectable anti-adalimumab antibodies
* Overlapping immune mediated diseases
* Steroid therapy for more than 2 months prior to study enrollment
* Poor medication adherence rate (PDC \< 80%)
* History of recurrent infection resulting in therapy pause
* Pregnant or lactating
Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)

One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.

The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.

The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation


Eligibility Criteria:
Inclusion Criteria:

* Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours,
* Patients requiring oxygen therapy,
* Age ≥ 18 years old.

Exclusion Criteria:

* Patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect.,
* Patients who can not be intubated for medical reasons,
* Pregnant women, parturient women or nursing mothers ,
* Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard),
* Adults person who is unable to give consent and who is not subject to a legal protection measure,
* Persons deprived of their liberty by a judicial or administrative decision,
* Persons subject to psychiatric care under duress.
The Asian Pacific TAVR Multicenter Registry

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

Azvudine,(FNC)， new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.


Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old, regardless of gender;
2. Participant must have an positive HIV test;
3. Have not received anti-HIV treatment;
4. HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
5. Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration;
6. The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.

Exclusion Criteria:

1. History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
2. Patients with severe opportunistic infection or tumor;
3. Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
4. Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
5. Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin \> 35%);
6. Glomerular filtration rate \< 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
7. Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
8. History of pancreatitis;
9. Women in pregnancy and breastfeeding;
10. History of drug abuse, alcohol abuse and drug abuse;
11. Participating in clinical trials of other drugs within the first three months of screening;
12. Other factors considered inappropriate by the investigator to be included in the study
Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014

The purpose of undertaking CLN0020, which was a Substudy of the European Coil registry (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in participants undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.

COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application (an "app") with facilitation of rapid personalized clinical recommendations made by the participant's health care provider and communicated to the participant through the application. COPD Co-Pilot AIR™ provides early identification of an increase in a participant's respiratory symptoms relative to the participant's own baseline symptom profile which in turn enables health care providers to rapidly implement modified treatment plans.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has read, understood, and signed a CLN0020 informed consent form prior to enrollment.
2. Participant is appropriate for Coil treatment per the Conformité Européene (European Conformity \[CE\])-Mark Approved RePneu Instructions for Use (IFU).
3. Participant has been enrolled in and scheduled for treatment(s) with the PneumRx Endobronchial Coil procedure in the CLN0014 study.
4. Participant's PneumRx Endobronchial Coil procedure is scheduled to occur no fewer than 14 days from enrollment, providing enough time to establish a baseline of their daily symptoms. Ten days minimum of baseline data are required, which is defined as the Run-in period going forward.
5. Participant is willing and able to use a smart phone.

Exclusion Criteria:

1. Participant has undergone a Coil procedure.
2. Participant has had an acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days prior to CLN0020 enrollment.
3. Participant has a COPD exacerbation or respiratory illness during the Run-in period that in the judgment of the investigator requires medical intervention (for example, treatment with systemic steroids and/or antibiotics and/or hospitalization).
4. Participant is suffering from terminal illness expected to adversely affect survival in the next 12 months.
5. Participant has a history of non-compliance with medical therapies.
Ciprofloxacin BioThrax Co-Administration Study

The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA).

This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45.

The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 45 years of age, at the time of enrollment
* Be in good health as determined by the investigator from medical history and a physical examination.
* If a pre-menopausal female, must be using acceptable methods of birth control.
* Be willing and able to return for all follow-up visits and blood and urine collections for the duration of the trial
* Be willing and able to complete a web-enabled electronic diary and report concomitant medications, adverse events, and BioThrax reactogenicity events during the trial
* Be able to understand and communicate in English.

Exclusion Criteria:

* Prior immunization with anthrax vaccine or known exposure to anthrax organisms
* Intend to enlist in the military during the study.
* Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
* Plan to receive experimental products 30 days prior to study entry or at any time during the study
* Have received a live vaccine in the 30 days before study entry
* Plan to receive a live vaccine at any time during the study.
* Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates
* Have received immunosuppressive therapy (including systemic steroids) within 30 days prior to trial entry
* Have any other condition known to produce or be associated with immunosuppression
* Have received cytotoxic therapy in the previous 5 years
* A chronic condition that, in the opinion of the Investigator, would render vaccination unsafe or would interfere with trial evaluations or completion of the study.