cyrilzakka/clinical-trials huggingface dataset:
Metal-ceramic Fixed Partial Dentures Fabricated With Laser Sintering

The aim of this retrospective clinical study was to evaluate the clinical acceptability of metal-ceramic fixed partial dentures (FPD) manufactured utilizing direct metal laser-sintering technology, taking into account the short-term, medium-term, and long-term outcomes. The Federation Dentaire International (FDI) World Dental Federation criteria were used to evaluate the esthetic, functional, and biological clinical acceptability of the patients who met the inclusion criteria

Objectives: To evaluate the clinical success of laser sintered metal-ceramic restorations throughout several time periods, including the short, medium, and long term.

Materials and methods: Participants who had 3-unit metal-ceramic fixed partial dentures fabricated by laser sintering in the mandibular posterior region between 2014 and 2021 were evaluated. The FDI criteria were used to evaluate the esthetic, functional, and biological clinical acceptability of the patients who met the inclusion criteria. The surface luster was assessed and given a score in the field of esthetic properties. The functional parameters were assessed and rated based on fracture, marginal adaptation, radiographic examination, contact point/food impaction, and patient satisfaction. The biological parameters assessed and rated included tooth vitality, periodontal response, mucosa, and oral health. Following the examinations, each parameter was assigned a score ranging from 1 to 5. (1=Clinically excellent/very good, 2=Clinically good, 3=Clinically satisfactory, 4=Clinically unsatisfactory, 5=Clinically poor) Scoring between 1 and 3 was deemed clinically acceptable, whereas scoring 4 or 5 was deemed clinically unacceptable.

Descriptive statistical analysis was performed for all data.

Eligibility Criteria:
Inclusion Criteria:

* Patients who treated between 2014 and 2021 by prosthodontists at Cukurova University Faculty of Dentistry, Department of Prosthodontics.
* Patients who treated three-unit metal-ceramic fixed partial dentures due to mandibular posterior single tooth deficiency

Exclusion Criteria:

* Patients with any non-vital abutment teeth
* Patients who have severe generalize periodontitis
GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects.

GAMEC-II (GAMEC -S \& GAMEC-A) is an open-labelled, non-randomised clinical trial in patients with relapsed germ cell tumours (GCT) and its objectives are:

1. To establish the response rates to GAMEC-S or GAMEC-A
2. To establish the safety and efficacy of substitution of epirubicin for etoposide (GAMEC-A regimen)
3. To establish the toxicity of GAMEC-A
4. To establish progression free survival (PFS)
5. To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival.

Eligibility Criteria:
Inclusion Criteria:

* Germ Cell Tumour (GCT), relapsed or progressing on or following platinum-based chemotherapy - as evidenced by rising tumour markers or progressive disease on CT scan
* Neutrophil count \>1.0 x109/l
* Platelets \>70 x109/l
* Haemoglobin \>100g/l (may be transfused)
* Creatinine clearance should be \>60ml/min. However, if creatinine clearance \<60 ml/min then an EDTA clearance is MANDATORY. (If EDTA clearance is \<60 ml/min then the patient will be excluded.)
* Males age \>16 ≤35 years \[decision made on physical fitness to participate\]
* ECOG Performance status 0-3
* Full written consent

Exclusion Criteria:

* Other malignancy except basal cell carcinoma
* Evidence of clinically significant cardiac failure, unstable angina or uncontrolled hypertension
* Current participation in any other investigational drug study
Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. History of deep vein thrombosis, or any other thromboembolic event;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
The Ronnie Gardiner Method Effectiveness Study

The investigators want to investigate the feasibility and transdiagnostic effectiveness of the Ronnie Gardiner Method (RGM) in a sample of Flemish psychogeriatric residential patients (≥60 years old) admitted to the Psychiatric Clinic of Alexianen Zorggroep Tienen. No control group will be used in this study, as every patient in the clinic is entitled to receive treatment. The investigators expect to observe significant improvements in the core executive functions (core EFs) by RGM participation. The investigators expect that the more sessions participants follow, the larger the effects will be. Given the strong connection between executive functions and emotion regulation, the investigators anticipate that strengthening the core EFs will in turn contribute to better emotion regulation. More specifically, the mediating role of core EFs in the relationship between the number of RGM sessions attended and improvement in emotion regulation is investigated. Given RGMs previously reported effects on quality of life, the investigators also expect to observe improved well-being. Additionally, the investigators want to examine to what extent positive experiences with RGM and temperament based personality types influence the effectiveness of the RGM training.

The RGM training will be organised twice a week for a period of 12 weeks. The training sessions will be provided by trained RGM-practitioners in the Psychiatric Clinic of the Alexianen Zorggroep Tienen. Each session will last at least 45 minutes. Core EFs, emotion regulation and well-being are evaluated pre-, mid- and post-RGM (at 6-week intervals) using a number of relevant instruments (i.e. questionnaires and neuropsychological tests). At baseline, the information and consent forms will be delivered to the patient and exclusion criteria will be checked using the MMSE and the patient file. Experiences with RGM training will be evaluated midway and post-intervention by means of a brief questionnaire developed by the research team. Personality type questionnaires (The Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scales and the Effortful Control (EC) scale), which allow us to study whether a particular temperament based personality type is predictive of RGMs success, are routinely administered in the psychiatric clinic upon admission.


Eligibility Criteria:
Inclusion Criteria:

* Psychogeriatric inpatients aged 60+

Exclusion Criteria:

* Checking for moderate to severe cognitive impairments (exclusion criterion) using the Mini-Mental State Examination (MMSE; Folstein, Folstein, \& McHugh, 1975; Dutch version: Kok and Verhey, 2002), following exclusion criterion applies: a score of less than 21 on the MMSE (excluding dementia or other moderate to severe cognitive impairment)
* Not fluent in Dutch
* Having undergone surgery and/or chemotherapy in the last three months.
Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.

The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 years of age
* Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure
* Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes
* Could breathe through both nostrils
* Had normal lip, nose, eyelid, and cheek sensations
* Could understand and sign the informed consent document
* Could communicate with the investigator
* Could understand and comply with the requirements of the protocol

Exclusion Criteria:

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma
* Clinically relevant sinus/nasal surgical history
* Baseline Visual Analog Scale value of \> 36 (or greater than weak) at the treatment site
* Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours
* Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)
* Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens
* Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions
* Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications
* History of alcoholism and/or drug abuse
* Had taken a monamine oxidase inhibitor within the past 3 weeks
* Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy)
* Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers

To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. The safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In addition to these a number of exploratory objectives will be investigated with blood sampling.

A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture
* Female volunteers must have a negative pregnancy test at Screening and on admission to the CPU, must not be lactating and must be of non childbearing potential, confirmed at Screening
* Male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the IP
* Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3241
* Orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg decrease in diastolic BP as measured at enrolment and/or randomisation
* History of intolerance or hypersensitivity to mannitol
* Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF)\>450 ms or shortened QTcF\<340 ms or a family history of long QT syndrome
* Abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:Systolic BP\>140 mmHg., Diastolic BP\>90 mmHg., Heart rate\<40 or \>85 beats per minute.
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with UC for at least 12 weeks prior to screening
* Screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years
* Evidence of disease activity at time of screening
* Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC

Exclusion Criteria:

* Diagnosis of Crohn's disease or indeterminate colitis
* History of infection with hepatitis B, human immunodeficiency virus (HIV), active hepatitis C virus (HCV) infection, or other chronic infection
* Active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before Day -1
* History of primary or acquired immunodeficiency
* Abnormal hematologic values
* Abnormal hepatic enzyme or hepatic function values
A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway.

Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.

The new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction

The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Tube Suction will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiology class I and II

Exclusion Criteria:

* Difficult airways
* Cervical pathology
* Full stomach
AI Assisted Detection of Fractures on X-Rays (FRACT-AI)

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). This work aims to evaluate the impact of an Artificial Intelligence (AI)-enhanced algorithm called Boneview on the diagnostic accuracy of clinicians in the detection of fractures on plain XR (X-Ray). The study will create a dataset of 500 plain X-Rays involving standard images of all bones other than the skull and cervical spine, with 50% normal cases and 50% containing fractures. A reference 'ground truth' for each image to confirm the presence or absence of a fracture will be established by a senior radiologist panel. This dataset will then be inferenced by the Gleamer Boneview algorithm to identify fractures. Performance of the algorithm will be compared against the reference standard. The study will then undertake a Multiple-Reader Multiple-Case study in which clinicians interpret all images without AI and then subsequently with access to the output of the AI algorithm. 18 clinicians will be recruited as readers with 3 from each of six distinct clinical groups: Emergency Medicine, Trauma and Orthopedic Surgery, Emergency Nurse Practitioners, Physiotherapy, Radiology and Radiographers, with three levels of seniority in each group. Changes in reporting accuracy (sensitivity, specificity), confidence, and speed of readers in two sessions will be compared. The results will be analyzed in a pooled analysis for all readers as well as for the following subgroups: Clinical role, Level of seniority, Pathological finding, Difficulty of image. The study will demonstrate the impact of an AI interpretation as compared with interpretation by clinicians, and as compared with clinicians using the AI as an adjunct to their interpretation. The study will represent a range of professional backgrounds and levels of experience among the clinical element. The study will use plain film x-rays that will represent a range of anatomical views and pathological presentations, however x-rays will present equal numbers of pathological and non-pathological x-rays, giving equal weight to assessment of specificity and sensitivity. Ethics approval has already been granted, and the study will be disseminated through publication in peer-reviewed journals and presentation at relevant conferences.


Eligibility Criteria:
Inclusion Criteria:

* Emergency medicine doctors, trauma and orthopaedic surgeons, emergency nurse practitioners, physiotherapists, general radiologists and radiographers reviewing X-rays as part of their routine clinical practice.
* Currently working in the National Health Service (NHS).

Exclusion Criteria:

* Non-radiology physicians with previous formal postgraduate XR reporting training.
* Non-radiology physicians with previous career in radiology
Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment

The objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. This study will collect in real-life practice the severity of schizophrenia by Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by documenting spontaneous reports on adverse events as well as change in body weight.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
* Male or female aged between 18 and 65 years
* Patients recruited from both in-patient and out-patient clinics
* Patients who are cooperative, by judgment from investigators, and the use of oral antipsychotic considered adequate

Exclusion Criteria:

* Pregnancy or lactation
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Known intolerance, lack of response, or contraindication to prescribed atypical antipsychotic, as judged by the investigator
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment and patients prescribed with clozapine within 3 months prior to enrolment