cyrilzakka/clinical-trials huggingface dataset:
Hernia Repair With or Without Sutures

This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.

This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.

Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.

Eligibility Criteria:
Inclusion Criteria:

Demographics:

* Age ≥ 18 years old
* If female, negative pregnancy test

Pre-Operative Findings:

* Presence of an abdominal hernia associated with previous surgical incision
* Midline ventral\\incisional hernia demonstrated either on physical examination by investigators or radiologic imaging tests.
* CT scan, MRI, Ultrasound
* No evidence of incarceration, strangulation
* Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)
* Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter

Exclusion Criteria:

Pre-Operative History:

* Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.
* History of the following:

  * Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
  * Chronic use (defined as greater than 3 months) of narcotic analgesic for pain other than from the hernia that is intended to be repaired
* Allergy to products used in hernia repair including surgical mesh
* Any abdominal ventral incisional hernia previously repaired with permanent synthetic mesh placed inside the peritoneal cavity
* Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of the abdominal musculature and fascia)
* Presence of simultaneous intra-abdominal infection
* Simultaneous presence of a bowel obstruction
* History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.

Intra-operative Findings:

* Simultaneous performance of another surgical procedure during hernia repair other than acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)
* Intra-operative identification of full thickness injury to intestine (i.e. enterotomy), liver, bladder, etc.
Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection

Staphylococcus aureus is a bacteria that causes serious, often life threatening infections including pneumonia, wound, and bloodstream infections. Persons with AIDS are at high risk for S. aureus infections. They are also at high risk for nasal carriage of S. aureus. In fact, nasal carriage is a known risk factor for subsequent S. aureus infection. Topical mupirocin, an antibiotic when applied to the anterior nares, is a safe, effective way to eliminate S. aureus colonization. Some studies have shown that mupirocin can also decrease the risk of S. aureus infection, but many of those studies utilized historical controls and none were rigorously tested among AIDS patients over an extended period of time.

The main purpose of this randomized, double-blinded, placebo controlled study is to determine if mupirocin can eliminate S. aureus nasal colonization in residents at PSI (inpatient, drug rehabilitation facility for AIDS patients in the Bronx.) PSI residents currently have a high incidence of S. aureus nasal colonization and infection. Nasal cultures followed by twice daily application of mupirocin vs. placebo for five days will be performed on a monthly basis for 8 months. the study will examine whether mupirocin decreases the incidence of S. aureus infections and prevents S. aureus nasal colonization. The study is important because it may show that mupirocin is an effective way to eliminate nasal colonization and prevent S. aureus infections in AIDS patients, among those at highest risk for serious S. aureus infection.

Hypothesis: Monthly application of mupirocin will reduce nasal colonization with S.aureus

This was a randomized double-blinded placebo controlled trial. Subjects were treated with intranasal mupirocin or placebo on a monthly basis and tested for nasal colonization a month after each treatment. This was performed up to 8 months.

Eligibility Criteria:
Inclusion Criteria:

* Resident at Project Samaritan Inc. (PSI)

Exclusion Criteria:

* Past hypersensitivity to mupirocin or glycerol
* Pregnancy
* Lactation
* Expected discharge from PSI in the following month
* Treatment with intranasal mupirocin within the preceding two months
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire

The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.

\> 100 lower extremity prosthetic users with major lower extremity amputation are recruited for the present study. The aim is to assess the reliability and validity of the Finnish version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Major lower extremity amputation Prothetization

Exclusion Criteria:

* Other amputation besides major lower extremity
* No prothesis in use
The Validity and Reliability of the Four Square Step Test

This study will evaluate concurrent and discriminative validity, reliability and level of agreement between the Timed Up \& Go test and the four square step test in typically developed children.

Participants will be assessed by two physiotherapists on two separate days. Prior to the trial, testing instructions to be delivered to participants will be translated and adapted into Turkish. In order to maximize potential agreement and to improve rating accuracy, reliability, and validity, assessment skills of the raters will be refreshed through training.

Administration of the tests will be performed in a corridor of the school. Assessments will be performed in a quiet and adequately lighted environment to minimize the distraction. Participants will be tested with their regular footwear. The demographic information of participants will be recorded. The dynamic balance performances on the four square step test (FSST) and the Timed up \& Go test (TUG) will be assessed by Rater A and B independently and these assessments repeated 24-h later. The participants will be allowed to rest up to five minutes between sessions. A stopwatch will be used to measure time to complete the FSST and TUG test.

Evaluations of concurrent and discriminative validity will be based on mean scores from the first measurement of rater A. Pearson's correlation coefficient (r) will be used to assess the concurrent validity of the FSST and TUG tests. Between-groups discriminative validity of the FSST will be evaluated by the one-way analysis of variance (ANOVA) with Bonferroni post-hoc test. Both intra- and inter-rater reliability will be assessed using intraclass correlation coefficients (ICC). ICC2,1 and ICC2,2 estimates and their 95% confidence intervals will be calculated based on absolute-agreement. Bland \& Altman plots will be constructed to demonstrate agreement between TUG and FSST, and between assessments of rater A and B.

Eligibility Criteria:
Inclusion Criteria:

* aged 5 to 10 years,

Exclusion Criteria:

* have musculoskeletal or neurological disorders,
* have history of surgeries of the spine or orthopedic,
* have uncorrected visual acuity.
MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 or grade 4 according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \< IOP \< 35 mmHg in the study eye at baseline visit.

Exclusion Criteria:

* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
* Neovascular glaucoma in the study eye.
* Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
* Prior glaucoma surgery in the study eye.
Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.

The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.

Eligibility Criteria:
Inclusion Criteria:

* Acute flank with visual analog pain scale score equal or more than 5
* and most possible diagnosis after initial clinical exam is acute renal colic

Exclusion Criteria:

* Pregnant or lactating women
* Patients whose use of any of the study drugs is contraindicated
* Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses
* Recent episode of acute myocardial infarction or patients with significant heart failure
* Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses
* Patients with bleeding tendency
* Patients who have history of any seizure
* Patients with documented organic brain injury
* Patients taking warfarin
* Patients whose primary diagnosis is not renal colic
A Gene Delivery Study to Evaluate the Safety and Expression of Delandistrogene Moxeparvovec in Participants Under the Age of Four With Duchenne Muscular Dystrophy (DMD)

This open-label, single-arm study will evaluate the safety and expression of delandistrogene moxeparvovec in participants with DMD. Participants will be in the study for approximately 264 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Cohort A: \>=3 years of age to \<4 years of age
* Cohort B: \>=2 years of age to \<3 years of age
* Cohort C: \>6 months to \<2 years of age
* Cohort D: \<=6 months of age
* Has a definitive diagnosis of DMD prior to screening based on documentation of clinical findings and prior confirmatory genetic testing using a clinical diagnostic genetic test
* Able to cooperate with age-appropriate motor assessment testing
* A pathogenic frameshift mutation or premature stop codon contained between exons 18 and 79 (inclusive)

Exclusion Criteria:

* Exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression, within protocol-specified time limits
* Recombinant Adeno-Associated Virus Serotype rh74 (rAArh74) antibody titers are elevated, as per protocol-specified criteria
* Receiving regular oral corticosteroids as a treatment for DMD or planning to receive oral corticosteroids as a treatment for DMD within 1 year of baseline
* Presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risk for gene transfer
* Medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the participant's ability to comply with the protocol required testing or procedures, or compromise the participant's well-being or safety, or clinical interpretability

Other inclusion or exclusion criteria could apply
Terbutaline Concentrations in Blood and Urine

The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.

To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline.

To investigate the above mentioned in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma with positive reversibility or challenge test.
* Informed consent.
* Age between 18 - 45 years.
* Sex: male.
* Asthma classified as mild to moderate according to GINA guidelines.
* Used beta-2-agonist in minimum 12 months.

Exclusion Criteria:

* Smokers or ex-smokers with a smoking history of 10 pack years or more.
* Respiratory tract infections within the last 2 weeks prior to visit 1 and 2.
* Subjects with other chronic diseases than asthma and allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 6 days prior to study day.
A Study of TL-925 for the Treatment of Allergic Conjunctivitis

In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
* Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
* Calculated best-corrected visual activity of 0.7 LogMAR or better
* Positive bilateral CAC reaction

Exclusion Criteria:

* Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
* Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
* Any ongoing ocular infection (bacterial, viral or fungal)
Study Comparing Mini-Incision Versus 2-Incision Approach for Total Hip Replacement

The purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). It is unclear which of these techniques is associated with a faster recovery and lower risk of complications.

Recently, surgical techniques and surgical instruments have been developed to limit the dissection required to perform a total hip arthroplasty. Proponents of these procedures feel that it is associated with less perioperative blood loss, less pain and an accelerated recovery while critics have raised concerns that the more limited exposure may negatively impact component position and increase the risk of perioperative complications. Among less invasive surgical techniques, two of the different approaches utilized include a "mini-incision" posterior approach which aims to limit the amount of dissection associated with a standard posterior approach to the hip and a 2-incision technique which seeks to further limit soft tissue disruption by taking advantage of intermuscular planes and the use of fluoroscopic guidance.

While the mini-posterior approach utilizes an abbreviated exposure which is familiar to most surgeons, the 2-incision approach is a more novel approach and critics of this approach feel that its technically demanding nature may be associated with a higher risk of complications and component malposition. Proponents of the 2-incision approach feel that this approach is less invasive, more muscle sparing and leads to substantial improvements in patient rehabilitation and recovery with potential longer-term benefits in terms of improved function. The goal of this project is to compare the use of a mini-incision posterior approach and the 2-incision approach in primary total hip arthroplasty via a prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of hip osteoarthritis
* age greater than 18 years
* willingness to undergo a neuraxial anesthetic for the procedure
* female patient greater than one year postmenopausal, surgically sterile or using an accepted form of contraception

Exclusion Criteria:

* use of any medication that may impact platelet aggregation within 10 days of surgery
* chronic use of coumadin for anticoagulation
* the use of low molecular weight heparin postoperatively
* clinically significant systemic disease or laboratory abnormalities
* a primary hematologic disorder
* recent gastrointestinal or intracranial bleeding
* any contraindication to anticoagulant use
* history of previous ipsilateral hip surgery
* a body mass index of greater than 30
* significant hip deformity that precludes the use of standard implants
* use of ONLY general anesthetic during surgery
Dry Needling & Trigger Point Compression Release in Neck Pain

This randomized control trial was conducted to investigate the efficacy of trigger point dry needling which is a modern treatment intervention compared with ischemic compression release in the patients having neck pain due to myofascial trigger points.

Many treatment protocols have been used in the clinical arena for the improvement of neck pain but un-availability of follow-up studies and lack of evidence of modern treatment interventions are few shortcomings a researcher faces. Thus, a need stands up to address these perspectives for newer treatment strategies. This randomized control trial is conducted to investigate the efficacy of trigger point dry needling which is a modern treatment intervention compared with ischemic compression release in the patients having neck pain due to myofascial trigger points. Findings of this research will assist in creating awareness about better treatment intervention for trigger point release among medical community.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age group of 20 to 40 years.
* Both Male and female patients.
* Patients presenting with neck pain due to MTrP's.
* The presence of a palpable taut band in the neck region.
* Patients reporting typically referred pain pattern of the MTrP in response to compression.

Exclusion Criteria:

* Patients with any associated comorbidities such as hypertension and diabetes.
* Patients with known history of fibromyalgia syndrome, whiplash injury, cervical spine surgery fracture and cervical radiculopathy.
* Patients with any systemic disease such as rheumatism and tuberculosis or cervical myelopathy and multiple sclerosis.
* Patients with history of myofascial trigger point therapy one month prior to enrollment.
* Patients with non-cooperative attitude, fear or any contraindications to needling.
Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite

This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).

Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity. It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 1, open-label study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-positive healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). The vaccine will be given to each study subject three times at 4 week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Must have positive Montenegro skin test (reaction \>5 mm)
* Must be in good general health with normal lab values
* Negative for HIV, hepatitis B and C

Exclusion Criteria:

* History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE.
* Pregnant or nursing female