cyrilzakka/clinical-trials huggingface dataset:
Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

The surgery for the extraction of the third molars is a procedure in Dentistry that generates a large picture of anxiety in the patient. One of the ways to try to soften this picture, are the professionals to use sedation. Thus, the objective of this study was to evaluate three sedation protocols, and to compare them with vital signs values, in order to obtain the sedation method with greater patients stability.

The surgery for the extraction of third molars is one of the procedures in Dentistry that generates a great picture of anxiety in the patients, due to the expectation of pain and discomfort in the postoperative period, but mainly in the trans-operative period. One of the ways to try to minimize this situation is to use sedation, which is a relatively safe procedure performed by trained professionals and with an accurate indication for anxious patients. There are several protocols in the literature, but few comparative studies. Thus, the objective of this study was to evaluate three sedation protocols. For this purpose, 120 patients who required surgical treatment for extraction of third molars, aged between 18 and 30 years, and whose anxiety was moderate to severe according to the Corah Anxiety Scale from the School of Dentistry of São José Dos Campos (UNESP). These patients were randomly divided into three Groups: Group I - oral sedation with diazempam 5 mg; Group II - oral sedation with midazolam 7.5 mg and Group III - inhalation sedation with 40% of nitrous oxide . Prior to sedation, anxiety was quantified through the Corah Anxiety Scale. Vital signs (blood pressure, heart rate and oxygen saturation) were measured before sedation, after sedation, in the trans-operative period and 15 minutes after the end of sedation. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients (ASA1), without surgical contra indications, requiring avulsion of the included third and / or semi-molar third molars,
* Between the ages of 18 and 30,
* Patients who agreed to voluntarily participate in the research, after knowing the risks and benefits, and signing the Informed Consent Form (TCLE).
* Patients who presented moderate to high anxiety level in the questionnaire proposed by Corah in 1969.

Exclusion Criteria:

* Patients with any systemic or local change that contra indicated the procedure,
* Use of anti-inflammatories in the last 15 days,
* Pericoronitis,
* Patients who did not accept the Informed Consent Form (TCLE)
Tissue-resident Memory T Cells Expression in Melasma

The treatment of melasma and the maintenance of depigmentation represent a challenge due to its frequent recurrences. Pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. Tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites but they have not been described in melasma. This a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least 1-year duration, lesional and perilesional skin biopsies were taken for PCR and DIF. The objective is to determine the transcription factors of Trm cells in malar melasma.

Melasma is a common, acquired pigmentary disorder characterized by chronic and relapsing hypermelanosis on sun-exposed areas that causes significant emotional and psychosocial impact in patients mainly in women with Fitzpatrick III-V phototypes. The treatment of melasma and the maintenance of depigmentation represents a challenge due to its frequent recurrences.

Different pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. In pathologies such as vitiligo and psoriasis, tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites. These cells have a specific profile of transcription factors (Runx3+, Notch+, Blimp1+) and CD69 + CD103 + markers. These cells have not been described in melasma.

Objective: to determine the transcription factors of Trm cells in malar melasma. This is a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least1 year duration, and no treatment in the last 4 weeks, were included. Lesional and perilesional skin biopsies were taken for PCR and DIF. The presence of trm cells has not been described or studied in melasma where there is recurrence of the dermatosis in the same site, it is essential to understand its pathogenesis in order to address directed future therapies targeting these cells that may related to the disease.

Eligibility Criteria:
Inclusion Criteria:

female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score

Exclusion Criteria:

* Exclusion criteria were pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exer- cise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year
UNiD 3D VBR Register

Multicenter study allowing to include the first sixty patients implanted with a custom-made corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients implanted in thoracolumbar region.

The main objective is to confirm feasibilty and safety of patient-specific implants for one or multi-level corpectomy and fusion.

This study was approved in March 2016 allowing to include retrospectivley all patients since the first implantation in January 2015 and prospectively all patients after the approval.

Anterior cervical corpectomy with fusion (ACCF) has been demonstrated as a good alternative to anterior cervical discectomy and fusion (ACDF) to treat cervical spondylotic myelopathy (CSM). However, the use of vertebral body replacement (VBR) cages is technically demanding, especially to adjust the size of the cage to the defect without compromising the endplate integrity increasing the risk of subsidence. Beside recent studies advocating the interest of the shape, size and design of an implant to achieve fusion and stability in cervical spinal diseases indications, 3D printing offering rapid and patient-specific manufacturing has emerged over the past years. Several materials and technologies can be used and clinical and radiological data are still sparse.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent a single or multilevel cervical or thoracolumbar coprectomy and implanted with a patient specific implant (UNiD 3D VBR) for the following indications:

   * Cervical region

     * Fracture / Trauma
     * Tumors
     * Cervical spondylotic myelopathy
     * Infection (Ex: Osteomyelitis)
     * Spinal instability
     * Symptomatic degenerative spinal disease
     * Inflammatory rheumatism.
     * Pseudarthrosis
   * Thoracolumbar region

     * Fracture / Trauma
     * Tumors
     * Infection (Ex: Osteomyelitis)
     * Spinal instability
     * Symptomatic degenerative spinal disease
     * Pseudarthrosis
2. Patients \> 18 years
3. Patients who signed an Informed Consent Form

Exclusion Criteria:

1. Patients who can't or doesn't want to sign an ICF
2. Patients unable to fill HRQOL questionnaires
3. Non-compliant paitents regarding follow-up or protocol
4. Pregnant patient or intended to be pregnant within the next 2 years
5. Sytemic or local infection
6. Allergy known or suspected to a componant
7. Patients presenting a contraindication as indicated in the instruction for use
Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients.

This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.

Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.

Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.

Inclusion Criteria:

* Ability to provide written informed consent and comply with study
* Age 65-90 years
* Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept

Exclusion Criteria:

* Previous intraocular inflammation
* Treatment with systemic anti-inflammatory agents
* Known systemic autoimmune diseases
* Treatment with intraocular steroids in the past 3 months
* History of intraocular surgery in the past 3 months
* Age greater than 90 years
* Patients who were switched between either therapies in the past 3 months

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age 65-90 years
* Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept

Exclusion Criteria:

* Previous intraocular inflammation
* Treatment with systemic anti-inflammatory agents
* Known systemic autoimmune diseases
* Treatment with intraocular steroids in the past 3 months
* History of intraocular surgery in the past 3 months
* Age greater than 90 years
* Patients who were switched between either therapies in the past 3 months
Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease

A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's disease.

* administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged
* follow-up after administration of IV amantadine for 4 weeks
* allocation ratio of amantadine:normal saline is 2:1

Intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in patients with Parkinson's disease. The study investigators experienced several open label cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and freezing of gait as well. In addition, there is a pilot open label trial in parkinsonian patients with refractory freezing of gait which showed marked benefit in patients with Parkinson's disease, but not in patients with parkinson-plus syndromes.

This study was aimed to evaluate the efficacy of intravenous amantadine in both levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of Parkinson's disease according to the United Kingdom Parkinson's Disease Brain Bank criteria
* presence of freezing of gait and the scores of Freezing of Gait Questionnaire 7 or more
* having been treated with oral dopamine replacement therapy for 6 months or more
* score of Korean version of mini-mental status examination is 20 or more

Exclusion Criteria:

* presence of significant cognitive dysfunction, behavioral or psychiatric disorders
* presence of severe cardiac disease
* presence of renal failure, seizure, peptic ulcer disease, liver disease, pheochromocytoma, chronic exhaustive disease, or malignancy
* participation to other clinical trial within 4 weeks
* pregnancy or lactating women
* hypersensitivity to study drugs
* history of intoxication to heavy metals
Wound Infiltration With Sodium Diclofenac vs Bupivacaine for Postoperative Pain Following Appendectomy

The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way.

Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies.

Method: Comparative, double blind, American Society Anesthesiologist classification I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3 (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiologist I- II
* aged 18 and 65
* both sexes
* patients diagnosed with acute appendicitis operated under general anesthesia

Exclusion Criteria:

* Patients known to any allergy of the drugs used in the study
* Different incision approach Mc Burney
* Some intraoperative surgical complications
* Pregnant patients
Predictors Of Mortality After Pelvic Fractures: A Retrospective Cohort Study From A Level-1 Trauma Center In Upper Egypt

A retrospective cohort study was carried out for all pelvic fracture patients admitted to Assiut University Trauma Unit (AUTU), a level-1 trauma center. (AUTU) is located in Upper Egypt and provides healthcare to over 30,000 patients per year.

In 2010, a Pelvic Injury Registry was developed to document treatment and outcomes in a standardized manner. All patients admitted to AUTU sign an informed consent to permit using their data for research purposes. Patients' data are prospectively collected and stored in a local database specifically designed for this purpose.

Data collected included age, gender, mechanism of injury, fracture classification, associated injuries, and admission to ICU, the length of hospital stay and presence of abdominopelvic collection as diagnosed by Focused Assessment with Sonography for Trauma (FAST) at admission. The primary outcome measure was in-hospital mortality. Predictors of in-hospital mortality were identified by comparing characters of survivors and non-survivors. Secondary objectives were to analyse the differences between adults and children and to analyse the causes and timing of death.

Eligibility Criteria:
Inclusion Criteria:

* first-time admissions and patients whose treatment was completed at our hospital
* all pelvic fracture patients admitted to our Trauma Unit.

Exclusion Criteria:

* penetrating injuries
* isolated acetabular fractures
* Patients who were discharged on their own will against the medical advice or whose treatment was continued at another hospital
* re-admitted patients
* Firearm injuries
Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients

The investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥75 years old
2. Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
3. Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
4. Speaks English
5. Have not attended a dialysis education class or met with the dialysis education coordinator.
6. Have not made a dialysis decision

Exclusion Criteria:

1. Patient has already been seen by a palliative care clinician or is enrolled in hospice
2. Is already on dialysis
3. Hospitalized at the time of recruitment
Effectiveness and Safety of Yiqitongluo Granule for Stroke

The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.


Eligibility Criteria:
Inclusion Criteria:

* mild and moderate ischemic stroke patient with 4-25 NIHSS score
* stable patients within 1 week to 3 months
* sign informed consent before study

Exclusion Criteria:

* CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
* severe disturbance of consciousness
* dysphagia
* TIA
* hemorrhagic diathesis
* patient with malignant tumor whose expected lifetime is less than 3 months
* allergic constitution
* gestation period, lactation period, woman with the possibility or plan of pregnancy
* those who participated in other clinical trials within 3 months or taking part in other clinical trials
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
* Moderately to severely active Crohn's disease, as defined by a CDAI score \>250 and \< 450 at baseline
* Evidence of active inflammation

Exclusion Criteria:

* Short bowel syndrome
* Stricture with obstructive symptoms within 3 months
* Bowel surgery within 3 months
* Ileostomy and/or colostomy
* Any gastric or intestinal pouch
* Ulcerative colitis
* Evidence of an infected abscess
* Bowel perforation or evidence of noninflammatory obstruction during the 6 months
* Stool positive for C. Difficile toxin at screening
* Presence of active infection requiring treatment
* Serious infection within 8 weeks
* Significant concurrent medical conditions
* Pregnant or breast feeding
* Significant Laboratory abnormalities
* Any anti-tumor necrosis factor (TNF) agent within 2 months
* Steroid enemas within 2 weeks
* Tysabri (natalizumab) within 1 year
* Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
* Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months
Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants with EGFR Alterations or Fusions

This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma. BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be given safely to people who have tumors that can be dependent on that growth signal because of changes in a protein called EGFR. These gene changes are called amplifications, mutations, fusions or alterations and are found only in the tumors.

Eligible participants will enroll in the Phase 0 study and receive BDTX-1535 prior to a planned resection. During surgery, blood, tumor, and CSF samples will be collected to measure the amount of drug that is present in the samples. Participants with tumors demonstrating PK response will continue with once-daily BDTX-1535 treatment, continuously in 28-day cycles after surgery. Participants will continue to receive BDTX-1535 until the progression of disease, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have had a prior resection of diagnosed HGG (2021 WHO grade 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy.
* Adequate archival or biopsy tissue available for testing of EGFR alterations.
* Participants must have measurable disease preoperatively.
* Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Ability to swallow oral medications.
* Participant has adequate bone marrow and organ function

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Known allergic reactions to components of the BDTX-1535.
* Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
* Known active systemic bacterial infection, fungal infection, or detectable viral infection .
* Significant cardiovascular disease.
* Symptomatic or radiographic leptomeningeal disease.
* Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study .
* Concurrent use of prohibited medications.
Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).

The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.


Eligibility Criteria:
Inclusion Criteria:

* A recorded Ankylosing Spondylitis diagnosis in the database
* A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
* At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
* Complete information on gender and birth year
Preconception Women's Health in Pediatric Practice Intervention

The aims of the intervention are:

1. Assess the feasibility and effectiveness of preconception health care initiated by pediatric clinicians on outcomes including women's access to primary care and contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy interval; and women's immunization rate, control of chronic illnesses, nutritional status, smoking and substance use, mental health and violence exposure; child and family health.
2. Assess the cost-effectiveness of preconception health care initiated in pediatric practices.

The investigators will evaluate these outcomes with a clinic based trial comparing usual care to preconception care intervention.


Eligibility Criteria:
Inclusion Criteria:

Mothers with children ages 0 to 12 months presenting with their child for care at a participating pediatric office.

Exclusion Criteria:

-