cyrilzakka/clinical-trials huggingface dataset:
Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis

Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease characterized by rapid loss of attachment and alveolar bone occuring in young individuals. Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy, non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival recession, mobility were recorded at baseline and on day 63. Microbiological samples were obtained fom the sites with PD ≥5 mm at the same time points and evaluated for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia and Treponema denticola using micro-IDent test.


Eligibility Criteria:
Inclusion Criteria:

* systemically healthy,
* non-smoker
* not received any periodontal treatment within the last 6 months
* no antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months
* consent to participate in the study

Exclusion Criteria:

* any systemic disease (i.e. diabetes mellitus, HIV infection) that might influence the prognosis of periodontal disease and outcome of the treatment
* any medical condition that required antibiotic prophylaxis before the treatment
* smoking
* pregnancy and lactation
* ingestion of antibiotics, anti-inflammatory drugs or any other medication during study period
* any physical limitations or restrictions that might preclude normal oral hygiene procedures
A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan

The purpose of this study is to document the extent of on-label and off-label use of Methylphenidate (MPH) (Concerta), MPH (Ritalin), Atomoxetine (ATO), and Guanfacine (GFC) in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Participants have been in the database for greater than or equal to (\>=) 30 days
* Have received, between 1 January, 2013 and 30 September, 2018, a prescription for Concerta, Ritalin, Atomoxetine (ATO) or Guanfacine (GFC)

Exclusion Criteria:

- Participants who received an unspecified Methylphenidate (MPH) formulation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients.

This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before any assessment.
* Male or female patient ≥ 18 years old.
* Up to date vaccination as per local immunization schedules.
* Recipients of a kidney transplant
* Recipients of a primary kidney transplant from a heart-beating deceased, living unrelated or non-HLA identical living related donors.

Exclusion Criteria:

* Multi-organ transplant recipients or prior kidney transplant.
* Recipients of an organ from a non-heart beating donor.
* Recipient of an organ from an HLA identical living related donor.
* ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant
* Recipients of kidneys from donors who are older than 65 years.
* Recipients of kidneys from donors with terminal serum creatinine \> 2 mg/dL.
* Patients at high immunological risk for rejection
* Patient who is anti-HIV positive, HBsAg-positive or anti-HCV positive (without proof of sustained viral response (SVR) after anti-HCV treatment).
* Recipient of a kidney from a donor who tests positive for HIV, HBsAg/HBc positive or HCV.
* A negative Epstein Barr virus (EBV) test.
* Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation.
* Patient with severe systemic infections, current or within the two weeks prior to randomization.
* History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions.
Trends of Renal Biopsy in Pediatric Patients at Tanta University Hospital for 10 Years From 2012 to 2022.

This study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at Tanta University Hospital from 2012 to 2022.

This study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at Tanta University Hospital from 2012 to 2022.

The data will be collected from records:

1. History taking including age and sex.
2. Indications for renal biopsy.
3. Methods of renal biopsy
4. Complications of renal biopsy
5. Adequacy of samples
6. The results obtained by light microscopy
7. The results obtained by electron microscopy, immunofluorescence when indicated

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients less than 18 years' old who underwent renal biopsy.

Exclusion Criteria:

* no exclusions
A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)

This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy, postmenopausal woman at least 40 years of age with onset of menopause within 10 years of screening
* Subject has a normal mammogram at screening
* Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not had a Pap-smear in the last 3 years will have the option to have the test at screening
* Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva flow
* Subject is willing to avoid strenuous exercise during the study
* Subject is willing to avoid use of mouthwash or salt water rinses during the study
* Subject is willing to avoid use of teeth whitening products
* Subject is willing to avoid eating and/or drinking grapefruit products
* Subject is willing to limit alcohol consumption to 2 drinks a day
* Subject is willing to limit caffeine consumption to 3 cups of coffee (or equivalent) per day
* Subject is a non-smoker

Exclusion Criteria:

* Subject has a history of multiple and/or severe allergies to drugs or food
* Subject has a cold or viral infection within 2 weeks of Visit 2
* Subject is taking antibiotics within 2 weeks of Visit 2
* Subject needs dental work or procedures during the study
* Subject has used any estrogen or progesterone preparation or product containing phytoestrogens within 3 months of screening
* Subject is unable to discontinue anti-coagulants
Spinal Hydromorphone Versus Morphine for Post-Cesarean Delivery Analgesia

Morphine is usually used for pain relief after cesarean delivery. However, sometimes it is not available, the patient might be allergic to morphine or intolerant to its side effects. Hydromorphone, another drug from the same class, might be used alternatively, but we need to prove that it is not inferior to morphine.

Spinal or intrathecal (IT) morphine is the most commonly used opioid for post-cesarean delivery analgesia. Factors that contribute to its widespread use include a favorable pharmacokinetic profile with duration of action up to 24 hours, ease of administration (during spinal block for surgical anesthesia) and low cost. Most providers administer 100 to 200 mcg of IT morphine for cesarean delivery analgesia with excellent analgesic results. Nevertheless, subarachnoid use of morphine is not without adverse events. While dose-dependent respiratory depression is the most worrisome complication, other side effects such as pruritus, nausea, vomiting and urinary retention can be bothersome during early puerperium. Furthermore, shortages of preservative free morphine in the United States has led clinicians to seek a reasonable alternative.

For the last 20 years, spinal hydromorphone has been successfully used for chronic pain associated with neoplasms. Its use for post-cesarean analgesia has been successfully reported. However, data regarding its efficacy in the IT space for post-cesarean analgesia is scarce. In the past, doses of 40 to 100 mcg have been reported to provide adequate postoperative pain relief with minimal side effects. In a recent study, the Effective Dose in 90% of patients has been established for both Hydromorphone and Morphine to be 75 mcg and 150 mcg, respectively.

No prospective studies have been conducted to specifically establish non-inferiority of hydromorphone when compared to morphine for post- cesarean analgesia. In addition, while all opioids share the same side effect profile, the frequency of those events are unknown for IT hydromorphone.

The current proposal is a blinded randomized controlled trial of intrathecal hydromorphone versus morphine in term pregnant women undergoing elective cesarean deliveries under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years; American Society of Anesthesiologist's Physical Status (ASA-PS) \< 3; Term pregnancy (\> 37 weeks gestational age); Elective cesarean delivery; Spinal Anesthesia;

Exclusion Criteria:

* Documented allergy or severe intolerance to opioids; Intra-operative conversion to a general anesthetic technique; Chronic pain syndrome with baseline pain levels \>3 on a visual analogue scale (0-10 cm); History of opioid use during this pregnancy; Allergy or intolerance to NSAIDS or acetaminophen; Morbid obesity- Body Mass Index (BMI) \>40.
A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SSc according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and with total disease duration of less than or equal to (\</=) 60 months
* mRSS of 10-35 units, inclusive
* Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential

Exclusion Criteria:

* Pregnant or lactating females
* Major surgery within 8 weeks prior to screening
* Scleroderma limited to the face or areas distal to the elbows or knees
* Rheumatic autoimmune disease other than SSc
* Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline
* Known hypersensitivity to human, humanized, or murine monoclonal antibodies
* Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or gastrointestinal (GI) disease not related to SSc, including diverticulitis or ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to screening
* Active or significant history of infection, including treatment with intravenous (IV) antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening
* Significant history of tuberculosis (TB)
* Primary or secondary immunodeficiency
* Malignant disease, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
* History of drug or alcohol abuse
Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Periodontal Disease

This study investigates the levels of advanced oxidation protein product and monocyte chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included into this study. In each participant, four sites are identified for gingival crevicular fluid samples.

Oxidative stress is the disequilibrium between the formation of free radicals and antioxidant defense mechanisms via damaging cellular macromolecules (DNA, protein, lipid, etc..) which are susceptible to oxidative damage.

Advanced oxidation protein product is identified as a new marker of protein oxidation.

Monocyte chemoattractant protein-1 is a major chemoattractant for lymphocytes, monocytes and macrophages.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic periodontitis and gingivitis

Exclusion Criteria:

* Systemic illnesses
* Any medications known to affect the periodontium
* Pregnancy and lactation
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients with indication for skin or nipple sparing mastectomy
* BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy

Exclusion Criteria:

* prior local radiotherapy
* inflammatory breast cancer
Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients

The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.

Patients' Mallampati score, upper lip bite test, neck mobility, teeth abnormalities were evaluated preoperatively. Mouth opening, sternomental and thyromental distances, neck circumference, thoracic circumference, breast circumference , belly circumference and hip circumference were measured preoperatively.

After anesthesia induciton with propofol and rocuronium, patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.

Laringoscopy was performed with MacIntosh laryngoscop and Cormack Lehane (CL) score was evaluated. CL score III and IV were defined as difficult laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 40
* American Society of Anesthesiologists (ASA) Physical Status I-III
* Patients applied for elective surgery

Exclusion Criteria:

* BMI \< 40
* maxillofacial tumor or fracture
* mass at the neck
* mass in the thorax or mediastina
* scar at the neck area
* previous radiotherapy history to neck area
* history of cervical vertebra operations
* cervical vertebra structure abnormality
Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects

Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.

Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip.

Safety: 24-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions.

Efficacy: 24-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 60 years
* Insulated full thickness cartilage damage of the hip joint after ICRS grade 3
* Received subchondral bone lamella
* received or reconstructed labrum in labrum cartilage defects
* defect size ≥ 1.5 and ≤ 10 cm2
* Intact surrounding cartilage structure around the defect, and the corresponding articular surface
* existence of the written informed consent of the patients after Enlightenment

Exclusion Criteria:

* More than 2 defects or 2 corresponding defects
* defects in both lower extremities simultaneously
* Radiographic signs of osteoarthritis of Kellgren \& Lawrence \> 1
* Profound bony lesion \> 0.5 cm in the defect area
* Presence of rheumatoid, infectious or para-infectious arthritis, as well as state after these diseases
* Skin injury to the limb to be operated on
* cartilage defect of the corresponding articular surface
* Existing medications, drugs or alcohol
* Acute infectious diseases, chronic cardiovascular disease, endocrine or metabolic disorders, autoimmune or neoplastic diseases
* impairment of the upper extremity, which prevents discharge by Crutches
* Known bleeding disorder, such as Hemophilia A / B or thrombophilia
* pregnancy and lactation, which represent the time of treatment is a contraindication
* Known allergy to the ingredients
* inmates in prisons
Superficial Dry Needling for Cervicogenic Headache

It is unknown if applying superficial dry needling to the trigeminal innervation field improves pain and disability for patients with cervicogenic headaches. The aim of this study is to determine if superficial dry needling of the trigeminal innervation field improves pain, neck mobility, and disability in patients with cervicogenic headaches. It will also be examined if psychosocial factors such as stress, anxiety, depression and self efficacy influence improvements in pain, range of motion and neck disability.

Cervicogenic headache (CGH), is defined by the International Classification of Headache Disorders (ICHD) as a "headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain. Prevalence of CGH in the general population is between .4-20%. Although the primary source of pain is generated from the upper cervical spinal levels, there is also neuro-anatomical basis of CGH involving the trigeminal nerve.

Dry needling (DN) is a widely used intervention performed by physical therapists for a wide range of musculoskeletal and neurological conditions. Dry needling has been shown to be beneficial for CGH but DN has only been investigated using trigger point DN to cervical musculature. Superficial DN also reduces pain associated to orthopedic spinal conditions and may be associated with a lower risk of post-treatment soreness.

Non-thrust mobilizations of the cervical spine are an accepted treatment known to reduce pain and disability associated with CGH. Their use has also been recommended in clinical practice guidelines.

This study aims to look investigate whether superficial dry needling targeting the trigeminal innervation sensory field will reduce pain and impairments known to exist in patients with CGH compared to mobilizations of the cervical spine. Mobilizations of the cervical spine are another common treatment that physical therapists employ to treat cervicogenic headaches.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Symptoms: (1)Unilateral pain starting in the neck and radiating to the frontotemporal region or posterior fossa, (2) pain aggravated by neck movement, (3) restricted cervical range of motion, (4) non-throbbing and non-lancinatingnpain, 5) dysfunction/headache pain in at least one of the joints of the upper cervical spine(C0-C4), and (6) headache frequency of at least 1 per week over a period greater than 3 months.

Exclusion Criteria:

* Headache or neck pain \<2/10
* Contraindications to the interventions
* Whiplash associated disorder within 6 weeks
* Pending litigation for neck pain and/or headache.
* Unwilling to cease other care through duration of study
Reducing Anxiety in Children Undergoing Day Surgery

Aim: This study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.

Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data.

This study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.

The study was carried out from April 2023 to January 2024, involving children aged 6-12 years admitted to the pediatric clinic of a teaching and research hospital for day surgery (tonsillectomy, circumcisio, adenotonsillectomy etc.). Notably, the nursing care provided at the hospital does not incorporate distraction techniques aimed at alleviating anxiety in children.

Sample The sample required for the study was calculated using the G\*Power (3.1.9.4) computer program. Based on the Type I error of 5%, Type II error of 99%, SD = 6.20, and Type I error of 5% in the study by Dehghan et al. (2017), the desired effect size for this study was 0.55 and the total required sample size was 64 children (approximately 21 children for each group) (Dehghan et al., 2017). A total of 85 children, comprising 20 children in the control group, 22 in the finger puppet intervention group, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group, was recruited from the pediatric clinic between April 2023 and January 2024, meeting the study's inclusion criteria. Notably, no randomization method was employed in the selection process.

Eligibility Criteria:
Inclusion Criteria:

* children aged 6-12 years
* scheduled for day surgery
* devoid of prior surgical experiences
* willingly consented to participation.

Exclusion Criteria:

* children undergoing major surgeries (e.g., cardiac procedures)
* emergency surgical interventions
* individuals with mental retardation
* as well as those with visual or auditory impairments.