cyrilzakka/clinical-trials huggingface dataset:
Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children

This study is based on the records of the patients treated for labial frenectomy with a dental laser at the Department of Padiatric Dentistry from January 2017 to December 2017. Patients younger than 15 years were included and in total 22 patients who matched the inclusion criteria were investigated in the study. The analyzed data included age, gender, frenelum insertion type, type of dental laser, and postoperative pain perception.

This study is based on the records of the patients who received laser-assisted frenectomy treatment due to mucogingival problems at pediatric dentistry department during two year period. Twenty-two patients treated with either Er,Cr:YSGG laser 2780 nm or 940 nm diode laser were selected who fulfilled the study's inclusion criteria. The analyzed data included age, gender, frenelum insertion type, type of dental laser, postoperative pain perception and wound healing. Post-operative pain was reported with Wong-Baker Faces Pain Rating Scale after 3 hours 1, 7 and 14 days. Wound surface healing was evaluated through photography. Images were uploaded to the software and the changes in the wound area were measured in square millimeters at the day of frenectomy and on days 1, 7, and 14 postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 8-13
* Patients with high frenulum insertion
* Patients without any systemic condition
* Patients treated with either treated Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
* Patients who were followed up after day 1,7 and 14 for wound healing.
* Patients who were followed up after 3 hours, 1,7,14 days for pain perception

Exclusion Criteria:

* Patients with systemic condition
* Patients who were not treated with Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
* Patients whose follow up was not properly completed
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer

This was a single center, proof-of-concept (PoC), Phase II study. Patients with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC) intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and 99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits:

1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1)
2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2)
3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3)
4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal pro B-type natriuretic peptide \[NT-proBNP\]) was performed at each visit.

Overall, it was planned to recruit 30 adults with early stage breast cancer. The first 10 patients were to be enrolled in the PoC phase of the study to assess the potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, uptake and medical relevance. Based on the results of the first 10 patients, the DMC was to decide whether to terminate the study or continue to the Phase II and enroll the next 20 planned patients. The maximum study duration was 26 (±4) weeks per patient (including the screening and follow-up periods).

The sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the AAA development portfolio on oncology theragnostics and not based on safety concerns.

Eligibility Criteria:
Inclusion criteria:

1. Females \>= 18 years of age with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and planned for (neo)adjuvant doxorubicin-based chemotherapy (AC every 2 or 3 weeks x 4 cycles)
2. Eastern Cooperative Oncology Group Status (ECOG) ≤ 2
3. Able and willing to comply with the study procedures

Exclusion criteria:

1. Pregnancy or lactation
2. Moderate or severe valvular stenosis or regurgitation
3. History of atrial fibrillation or flutter
4. History of any disease or relevant physical or psychiatric condition which may interfere with the study objectives at the investigator judgment
5. Know hypersensitivity to the investigational product (IP) or any of its components
6. Prosthetic valve or pacemaker
7. Claustrophobia or inability to lie still in a supine position
8. Contraindication(s) to the CMRI procedure
9. Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration
10. Unwillingness to provide consent
Single-file Pulpectomy in Primary Molars

The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars.

This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Children categorized as class I or II according to American Society of Anesthesiologists (ASA).
* Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.
* History of dull toothache over an extended period of time
* History of spontaneous pain or pain at night
* Swelling adjacent to tooth with or without a sinus tract
* Abnormal tooth mobility
* Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed
* Interruption of lamina dura or thickening of periodontal ligament space
* Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor
* Negative findings of internal root resorption
* External root resorption confined to the apical third and with at least two-thirds of the root length was intact

Exclusion Criteria:

* Uncoperative children or parents/legal guardians
* Sever intellectual, behaviour or emotional problems
* Non-restorable tooth crowns
* Root canal obliteration
* Presence of underlying dentigerous or follicular cysts
Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.

This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

Eligibility Criteria:
Inclusion Criteria:

* Women in their 1st - 4th delivery
* Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
* Vertex presentation
* Singleton pregnancy

Exclusion Criteria:

* Multiple pregnancy
* Previous cesarean section
* Chorioamnionitis on admission
* \>2 symptomatic uterine contractions in 10 minutes
* Prostaglandins hypersensitivity
* Contraindication for vaginal delivery
Health Effects of Occupational Exposure to Combustion Particles - a Study on Volunteers Performing as Train Conductors

Ambient air pollution is a complex mixture of gaseous pollutants and particulate matter (PM). PM has a recognized important role in human health. There is a strong scientific consensus on the independent association of PM and adverse cardiovascular and respiratory effects, as well as cancer. It is reasonable to expect that the smaller particles (ultrafine particles, UFP) may have an enhanced toxicity relative to other PM size fractions, due to physical properties and potential to translocation beyond the lung.

A recent Danish report concluded that train conductors on a working day, and in two specific diesel engine trains, are exposed to higher concentrations of diesel exhaust than by constant stay in a busy street. Indeed, the average exposure for train conductors on such engines was around 100,000-150,000 UFP per cm3 as compared with around 40,000 per cm3 on a busy street in Copenhagen \[1\]. The aim of this study is to investigate if this occupational exposure is associated with vascular and respiratory impairment and DNA damage.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Legally competent subjects

Exclusion Criteria:

* Current smokers
* Pregnancy
* Alcohol and drug abuse
* Prescriptionary use of anti-inflammatory or cardiovascular medication
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and willing to sign an Informed Consent Form (ICF).
* Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent.
* Have a clinical diagnosis of stable, clinically typical, AU or AT.
* Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years.
* Be willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

* Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication.
* Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).
* Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
* Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations.
* The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
Pulmonic Valve REplacement Multi-discIpline EMEA Registry

The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.

Eligibility Criteria:
Inclusion Criteria:

- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.

Exclusion Criteria:

* Angiographic evidence of coronary artery compression.
* RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
* Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
* Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
* Active bacterial endocarditis or other active infections.
* Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
* Presence of any prosthetic valve in the tricuspid position.
* Unstable coronary artery disease-related angina.
* Placement of the SAPIEN THV in pregnant females.
Ozurdex Monotherapy Trial

This study will investigate the efficacy and safety of OZURDEX® (dexamethasone intravitreal implants; DEX, Allergan, Inc. Irvine, CA) as monotherapy for the treatment of non-infectious intermediate-, posterior- or panuveitis. This is a prospective randomized controlled clinical trial taking place at the University of Ottawa Eye Institute, Ottawa, Ontario, Canada, and other possible centers in Canada. Consecutive consenting subjects who meet inclusion/exclusion criteria will be selected to participate in this study. The subjects must have either non-infectious intermediate, posterior, or panuveitis. The subjects will be randomly chosen to be part of one of two groups; one group will receive DEX as monotherapy and the other group will receive oral prednisone. Approximately 84 eyes (42 per arm) will take part in study. The primary outcome will measure the proportion of eyes with a vitreous haze score of 0 six months post initial treatment. Secondary measures will include best corrected visual acuity (BCVA), central retinal thickness (CRT) measured by spectral-domain optical coherence tomography (SD-OCT), time to vitreous haze resolution and time to failure defined at number of months with DEX implant until an adjunct therapy is indicated. Baseline measurements will be recorded within 1 month prior to treatment in both groups, with follow up measurements collected at 0, 1, 2, 4, 6 and 12 months post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of non-infectious intermediate, posterior, or panuveitis in at least one eye
* Active uveitic disease at Screening/Baseline defined by the presence of at least 1 of the following parameters: 1) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 1+ vitreous haze (NEI/SUN criteria)

Exclusion Criteria:

* Presence of isolated anterior uveitis
* Evidence of macular edema due to diabetes, retinal vein occlusion or any other ocular conditions
* Confirmed or suspected active ocular disease or infections
* Intraocular surgery in the past 6 months
* History of glaucoma
* Intraocular pressure (IOP) of \>21 mmHg at Screening/Baseline or confirmed normal-tension glaucoma
* Intravitreal or periocular injection within 6 months prior to screening.
* Unable to tolerate systemic corticosteroids
* Prior topical corticosteroid within 1 month of screening
* Prior non-steroidal anti-inflammatory, systemic steroids, or immunomodulatory therapy (e.g. methotrexate) within 1 month of screening
* For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study
Evaluation of Web-Based CBT for Rape Victims

Rape is unfortunately a common experience among women, affecting between 13 and 20%. In addition, up to 50% of all rape victims experience significant and persistent psychological distress. While cognitive-behavioral interventions have been found to be successful at alleviating distress among victims; the majority do not seek out these services, often because of feelings of stigma and self-blame. One potential method for circumventing these barriers is through online administered treatment. Thus, the current project is designed to conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media, cognitive-behavioral, online intervention tailored specifically for rape victims. The effectiveness of this program at ameliorating distress among college women who have experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated. Reductions in psychological distress was the primary outcome and was assessed at post-intervention and at three and six month follow-up periods. The effectiveness of the intervention was compared to a psycho-educational website.


Eligibility Criteria:
Inclusion Criteria:

* Current rape-related PTSD
* Regular access to a computer
* English language literacy
* Experience of completed rape at age 14 years or older

Exclusion Criteria:

* No current PTSD
* Current psychotherapy
* Lack of stability on psychotropic medication (\< 3 months)
* Lack of literacy in English
* Current substance dependence
* Current elevated suicidality
* Severe acute distress
* No experience of completed rape after age 14
Alendronate Compared to Metformin in Chronic Periodontitis

This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.

ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

Methods:

The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months

Eligibility Criteria:
Inclusion Criteria:

* All the subjects were systemically healthy
* subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
* vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
* subjects with no history of periodontal intervention in the last 6 months.

Exclusion Criteria:

* patients with systemic diseases like cardiovascular disease
* diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
* pregnant/lactating females
* tobacco users
* alcoholics
* patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
* teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
* Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.
Psychological Impact of Tooth Loss

Tooth loss impact on daily living, mood and self-perceived well-being. However, psychological impact of teeth loss has not been evaluated. Present study aims to evaluate the psychological conditions of patients pending complete tooth extraction before and shortly after tooth loss using Hospital Anxiety and Depression scale (HAD) and Geriatric Oral Health Assessment Index (GOHAI).

Patients will be interviewed concerning their psychological conditions (HADS) and their oral health related quality of life (GOHAI) before tooth extraction and one month after complete tooth loss.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate to the study
* dental status identified

Exclusion Criteria:

* uncooperative ou patient not able to complete the questionary
* adult patients under protection
High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results

Eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%.

Eligibility Criteria:
Inclusion Criteria:

* pregnant females
* Of American Society of Anesthesiologists (ASA) physical Status I and II
* For elective cesarean section under general anesthesia

Exclusion Criteria:

* with room air saturation of \<98%
* anticipated difficult airway
* anticipated obstetric risk factor or precious baby
* chronic obstructive pulmonary disease
* thyrotoxicosis
* pheochromocytoma
* hyperkalaemia
* significant cardiac illness
Conventional One-piece Versus Two-piece Magnet-retained Obturators

Evaluation of patients' satisfaction with conventional one-piece obturators versus two pieces magnet -retained obturators in completely edentulous patient maxillectomy cases.

Ten completely edentulous participants with hemimaxillectomy (8 males and 2 females) were selected in an across over study. Participants received conventional obturator one piece and two pieces obturator connecting by magnet attachment in alternate periods (sequences A-B and B-A), and outcomes were assessed after 1 week,3 months, and 6 months Evaluation included Obturator Functioning Scale(OFS) and Oral Health Impact Profile for edentulous people (OHIP-EDENT ). One way ANOVA test and Multivariate analysis of variance with a general linear model with repeated measure was used to test the impact of the group, time, and order on each of the studied scores (α=.05).

Eligibility Criteria:
Inclusion Criteria:

- completely edentulous participants with hemimaxillectomy mouth opening is not less than 25 mm and intact soft palate

Exclusion Criteria:

* exposed to radiotherpy
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine

The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
* Onset of migraine prior to age 50;
* 2-8 moderate to severe migraine headaches per month

Exclusion Criteria:

* Subjects receiving any investigational drug within 30 days before study entry;
* More than 15 headache days per month;
* Known allergy or hypersensitivity to ketorolac and/or excipients;
* Allergy to aspirin or other NSAIDs;
* Currently receiving other NSAIDs or aspirin;
* Medical history that would preclude NSAID use