cyrilzakka/clinical-trials huggingface dataset:
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults

The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.


Eligibility Criteria:
Inclusion Criteria:

1. Between 4 and above at the time of laceration repair.
2. Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
3. Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
4. Subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements.
5. Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
6. Subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the Informed Consent Form.

Exclusion Criteria:

1. Known personal or familial history of scar hypertrophy.
2. Known or suspected allergies or hypersensitivity to non-latex skin adhesives.
3. Atrophic skin deemed clinically prone to blistering.
4. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds").
5. Wounds that require deep dermal closure using sutures.
6. Known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period.
7. Ongoing treatment with cytostatic.
8. Known or suspected diagnosis of severe anorexia.
9. Participating in any other clinical investigation.
10. Known health condition that would affect healing in the opinion of the investigator.
11. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission
* The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
* the diagnosis of ARDS meets the criteria of Berlin definition

Exclusion Criteria:

* chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma
* organic cardiopathy
* pregnancy
ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT

IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.

IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. In the many studies on the treatment of IgAN, both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects, and ACEi/ARB was considered to be the first line therapy. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.

Eligibility Criteria:
Inclusion Criteria:

1. underwent renal biopsy within 1 year before start fo trial;
2. 24 hour urinary protein excretion ranged between 1 to 7 g/d;
3. eGFR, evaluated by MDRD formula, should be higher than 30 ml/min

Exclusion Criteria:

1. crescentic glomerulonephritis;
2. steroid therapy subjected within 1 year before trial;
3. malignant hypertension(DBP\> 130 mmHg and/or SBP\> 220mmHg), resistant to anti-hypertensive agents;
4. urinary protein excretion decrease below 1 g/l after run-in period;
5. Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
6. renovascular disease;
7. diabetes mellitus;
8. Malignancy, severe liver disease, refractory infection;
9. peptic ulcer in active disease phase;
10. pregnancy;
11. other contraindication to the use of ACEi/ ARB or corticosteroid;
12. alcohol abuse or drug addiction
Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. In this randomized controlled cauterization will be compared with ﬁbrin glue for conjunctival autografting in primary pterygium surgery.


Eligibility Criteria:
Inclusion criteria:

* adults (older than 18 years of age)
* both sexes
* primary nasal pterygia ˃4 mm, which tends to increase, including patients with reduced visual acuity, chronic inflammation, cosmetic reasons
* if the patients had a bilateral pterygium, only one eye will be operated

Exclusion criteria:

* connective tissue disease
* prior eye surgery
* chronic use of topical drugs (anti-glaucoma drugs)
Diaphragmatic Breathing Training on Postpartum Anxiety

This is a two-group pretest-posttest, triple-blinded and randomized controlled trial examining the effects of a biofeedback-assisted diaphragmatic breathing training on postpartum anxiety. This study will include full-term postpartum women, aged from 20 to 49, who experienced anxious symptoms with State Anxiety Inventory (A-State) scored 40 or more at the first postpartum day. Participants will be randomly assigned to either an experimental group (n = 64) or a control group (n = 64). The experimental group will undergo the diaphragmatic breathing training assisted with StressEraser to breath slowly 4-6 times per minute and practice 15 minutes twice daily. Participants in the control condition receive postpartum usual care. The outcome measures include anxiety measured by State-Trait Anxiety Inventory (STAI) and the physiological parameters expressed by blood pressure (BP) and heart rate (HR). Measurements will be taken at the first postpartum day and one month postpartum. We except this breathing training design is able to improve women's postpartum anxiety, and in turn improve their physio-psychological health, breastfeeding and baby care skills.

Ditto

Eligibility Criteria:
Inclusion Criteria:

* full-term postpartum women
* aged from 20 to 49
* STAI-S scored 40 or more at the first postpartum day

Exclusion Criteria:

* newborn with severe illness or stillbirth
* maternal suicide or self-harm
* drug use: sedatives, hypnotics or antipsychotic drugs
The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study

Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. The commonly used salvage regimens include:

1. Bismuth based quadruple therapy (combined with ranitidine or proton-pump inhibitor (PPI) plus two antibiotics)
2. Levofloxacin or moxifloxacin or rifabutin based triple therapy.

However, Bismuth is not available in many countries and the administration method is complex. Its usage is limited by the high pill number and low compliance rate. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%.

Aims: Therefore, the investigators aim to assess the efficacy of levofloxacin-based sequential therapy as second line therapy for those who fail from one standard eradication therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients are aged greater than 20 years who have persistent H. pylori infection after one treatment and are willing to receive second line rescue regimens, respectively, are considered eligible for enrollment.

Exclusion Criteria:

* Children and teenagers aged less than 20 years,
* History of gastrectomy,
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (esomeprazole),
* Contraindication to treatment drugs,
* Pregnant or lactating women, OR
* Severe concurrent disease.
Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block for Tooth Extraction

The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled delivery for maxillary teeth extraction.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1
* maxillary incisors canines or premolars indicated for extraction due to periapical pathology, root fracture or orthodontic treatment

Exclusion Criteria:

* allergies to local anesthetic solution ingredients, food and drugs
* alcohol and drugs abuse
* heavy tobacco smoking
Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study

Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

Background: Percutaneous coronary intervention (PCI) is usually proposed to patients with aortic stenosis (AS) before TransAortic Valve Implantation (TAVI) when significant coronary stenosis is detected on preprocedural coronary angiography. However, the benefit of a systematic revascularisation is unknown and may have specific complications in elderly and frail patients.

Aims: The investigators proposed a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

Methods: This prospective open label clinical trial will include 71 consecutive patients with significant coronary artery disease (CAD) defined by one or more significant coronary stenosis in patients admitted for TAVI. Myocardial SPECT imaging will be performed in all patients at 1-month follow-up after the TAVI procedure. Targeted PCI will be performed only in patients with significant related ischemia (\> 10 % myocardial perfusion defect).

The primary outcome criterion is a composite criterion of feasibility and safety including all causes of death, stroke, major bleedings, major vascular complications, per procedural myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6 month follow-up.

Hypothesis: An alternative management of CAD guided by significant myocardial ischemia detection after TAVI could reduce the risk of unnecessary revascularization, the complications and the costs inherent to these procedures and a phase II trial is requiring to the evaluate this innovative and less invasive strategy.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main
* Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision.

Exclusion Criteria:

* Recent acute coronary syndrome (within 30 days before randomization),
* Unprotected left main disease
* Critical stenosis (\>90%) of Left Anterior Descending artery (LAD),
* Significant angina (CCS class more than 2)
* Active bleeding,
* Contraindication for tomographic technetium-99 assessment or dipyridamole injection
* Previous enrollment in a other study
* Impossibly to obtain consent
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density

To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.

High mammographic breast density is a well recognized risk factor for the development of breast cancer and the masking of malignancy within the breast. Previous chemoprevention studies have revealed that only tamoxifen is efficacious in premenopausal women in the reduction of breast cancer. In order for this to occur mammographic density has to be reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are taking up this therapeutic intervention. This trial is trying to establish a combination therapy to reduce mammographic breast density.

This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this combination treatment on mammographic breast density and breast elasticity. Safety and tolerability we also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Pre-menopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, oestrogen) according to the definition of "pre-menopausal range" for the laboratory involved
* Have a Volpara Density volumetric breast density of \>15.5% (combined average both breasts)
* Breast pain in the previous month of equal to or greater than 40mm on a 100mm visual analogue pain scale
* WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L.
* AST/SGOT or ALT/SGPT ≤ 3 times ULN
* eGFR\> 60 ml/min/1.73m2
* Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment;
* For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception during and for at least 6 months after completion of study treatment; OR, a fertile male partner willing and able to use effective non-hormonal means of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least 6 months after completion of study treatment;

Exclusion Criteria:

* Presence of breast cancer
* Diabetes mellitus or glucose intolerance defined as a fasting glucose \>6mmol/l
* Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years (other than skin cancer)
* History of coronary artery disease
* Systemic hormonal contraception
* Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood
* Known hypersensitivity to any component of testosterone
* Unable to comply with study requirements
* Prolonged systemic corticosteroid treatment
* Any investigational drugs
* Systemic hormone replacement therapy
* Pregnant or lactating women
* Known liver disease
* Current warfarin usage
Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.

Evaluation of the clinical results after total knee prosthesis, and correlation with the alignment of the lower limb.

Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire).


Eligibility Criteria:
Inclusion Criteria:

* Patient with osteoarthritis of the knee joint, without severe bone deformation

Exclusion Criteria:

* none
Teriparatide on Maxillary Sinus Floor Osseointegration

The aim of this triple blind randomized controlled trial will be to analyze the effect of a dose of teriparatide combined with a xenograft on bone augmentation of the maxillary sinus, to observe the microarchitecture of the newly formed bone and the primary and late stability of implants placed on these grafts. The sample is composed of 42 participants who have a clinical indication for maxillary sinus floor augmentation with bone grafting due to residual bone height less than or equal to 5mm for the installation of dental implants. Each side will be grafted with Bio-Oss® or Bio-Oss® combined with 1 dose (20 µg) of teriparatide (Forteo®). Three months after grafting, at the time of placement of dental implants, bone biopsies will be obtained using a short 2mm trephine bur. These bone cores will be submitted to histological and histomorphometric analysis. The stability of the implants will be measured, at the time of their installation, through the insertion torque, and through the use of resonance frequency equipment (Ostell®) in three moments: immediately and at 3 and 6 months after the installation of the dental implants.


Eligibility Criteria:
Inclusion Criteria:

* Pneumatization of a maxillary sinus with a residual ridge ≤ 5 mm in height (according to baseline conebeam tomograph).
* Must sign an informed consent to participate in this study.

Exclusion Criteria:

* Residual ridges less than 4 mm in height.
* Uncontrolled systemic disease (ASA 3, 4, 5, and 6)
* Presenting with osteoporosis or any disease of bone metabolism.
* Having received radiotherapy.
* Cancer.
* Any systemic condition that affects calcium absorption.
* Kidney disease.
* Coagulation disorders.
* History of sinusitis.
* Maxillary sinus pathology.
* Heavy smoking (\> 1 pack per day).
* Drug or alcohol users.
* Pregnancy.
* Treatment with drugs that affect bone metabolism.
* Treatment with immunosuppressants.
* Allergies.
* Uncontrolled periodontal pathology.
* Tooth extractions in the last three months.
A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.

The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is present in the blood of study participants at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Efficiency of Mirror Therapy After Carpal Tunnel Surgery

In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery.

PURPOSE: The aim of this study is to investigate the efficacy of mirror therapy (MT).

METHOD: In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery. The SPSS 21.0 statistical program will be used in the data analysis of the study and the level of significance wiil be accepted as p\<0,05.

Eligibility Criteria:
Inclusion Criteria:

* Carpal tunnel diagnosis and open surgery are planned,
* Having the ability to adapt to exercises,
* Voluntarily agree to participate in the work

Exclusion Criteria:

* With the forearm and hand trauma story
* In the last 6 months, local corticosteroid injections to the treatment area have been performed
* Infection in the treatment area
* Having a deformity in hand
* The presence of malignancy
* Being pregnant