cyrilzakka/clinical-trials huggingface dataset:
Satisfaction, QoL,Health Status & Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology

The aim of this study is to measure the impact of musculoskeletal (MSK) complaints on the quality of life and general health of MSK Patients attending MSK triage clinics. The investigators will also record the proposed management options for patients' complaints. This will be achieved by asking patients to complete questionnaires (MSK HQ) at musculoskeletal triage clinic appointment, by undertaking a clinical assessment, by recording the proposed management plan and assessing if patients have follow up appointments for the same complaint in the following year. The investigators will also measure patient satisfaction using VSQ 9 Questionnaire. After a year the investigators will repeat the MSK HQ to assess the longterm impact of MSK Triage appointment on the MSK complaint.

At present there is no data available to describe the impact of musculoskeletal (MSK) disease on the Quality of life and General Health for patients attending Rheumatology MSK triage clinics in SUH and OHLM or in similar service around Ireland. A new questionnaire (MSK HQ) has been developed which has been validated in use with this population. This will be completed by the patient on the day of the appointment and again a year later. Their number of visits to secondary care in the year after their visit will also be captured and analysed. This information will inform the health service of the outcomes of these patients and the impact of their MSK disease on the health service. It will also help with resource allocation and planning for future services, which will ensure the best service for these patients in the future.

Alongside this, Patient satisfaction and feedback is vital to ensuring service quality and quality improvement. The VSQ 9 will be used to measure Patient Satisfaction in this study to evaluate if patients are satisfied with the service they have received on the day. The repeated MSK HQ will help identify if their triage clinic appointment was beneficial to their Quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* Patients who attend the musculoskeletal Triage Clinic in Rheumatology.
* Patients who can answer the study questionnaires independently.

Exclusion Criteria:

* Under 18 years
* Patients who present with red flag conditions, inflammatory disease or non-musculoskeletal conditions.
* Patients who cannot answer the study questionnaires independently.
Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

In patients that require dental implants , does performing the surgery in clean sterile field compared to aseptic field, produces more post-operatory complications, implant morbidity or patient discomfort ?

The investigators intend to compare two types of operatory room preparation (aseptic versus clean), used world wide, for placing dental implants.

The investigators want to see if it has impact on post-operatory healing, osseointegration and success rate of dental implants.

Before Study begins the investigators will perform inter-observer agreement in surgical preparation of the surgical suite, implant placements and operatory-room behavior.

Eligibility Criteria:
Inclusion Criteria:

* All surgeries schedule for implant placement

Exclusion Criteria:

* Surgeries not made with local anesthesia
Functional Neuroimaging of Pain Using EEG and fMRI

The purpose of this research is to use non-invasive imaging technologies to study how the human brain processes pain. The investigators will use contact heat to induce pain and record data scalp EEG and functional magnetic resonance imaging (fMRI). What the investigators learn from this study will help us gain insights in pain management with broad socioeconomic impacts

Functional imaging of brain networks associated with pain processing is of vital importance to aid developing new pain-relief therapy and to better understand the mechanisms of brain function. The pain response in the brain is a complex process, which involves multiple cortical brain regions, such as primary and secondary somatosensory cortices, anterior cingulate cortex, and insular cortex . Recent advancement in neuroimaging techniques suggests the possibility to map the brain structure and networks that involve pain processing. Electroencephalography (EEG) is a noninvasive monitoring technique, which is widely used to probe neurological disorders with high temporal resolution. Few attempts have been made to use EEG to map the active brain regions in pain patients. Functional MRI (fMRI) measures the hemodynamic brain response and could image the active brain regions with high spatial resolution. Studies have shown that fMRI is a useful tool to delineate the brain regions associated with pain processing. Recent studies from simultaneous EEG and fMRI recording have suggested that the EEG response to the pain may be correlated with the fMRI response, and both EEG and fMRI could be used to image the brain pain processing regions, such as the primary somatosensory cortex and anterior cingulate cortex.

The aim of this research is to develop and evaluate a functional neuroimaging approach using EEG, fMRI and EEG-fMRI, in pain study. EEG, fMRI, or simultaneous EEG-fMRI will be collected in healthy subjects who receive external thermal stimulation inducing pain. The painful stimuli will be delivered at different intensity levels and the subject pain rating will be collected. The imaging technique combines the EEG signal with high temporal resolution and the fMRI signal with high spatial resolution to obtain a spatiotemporal imaging of the brain electrophysiological and hemodynamic activity in response to different levels of pain. Cross validation between this method and subject pain score will be used to quantitatively and qualitatively evaluate the technique. The successful completion of the current protocol will help establish an important imaging technology accessing pain level in an objective way.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no known neurological disorders
* Sickle cell patients with no metal implants

Exclusion Criteria:

* Age over 65 in either group
Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy

The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (NPT) and positive skin prick test (SPT, wheal ≥ 3mm larger than diluent) to grass pollen extract
* Female participants must meet one of the following criteria:

No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be \>40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)

* Written informed consent
* Patient is willing and able to comply with all trial requirements

Exclusion Criteria:

* Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period
* Contraindication to Allergen Preparation
* Contraindication for Nasal Provocation Test
* Contraindication for Skin Prick Test
* Actual significant obstructive pulmonary disorder (FEV1\< 70%)
* Pharmacological treatment that could affect allergic sensitivity during the trial
* Presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator
* Serum test positive for HIV, HBV, or HCV
* Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
* Pregnancy or lactation
* Blood donation within 30 days before enrolment
* History of abuse of alcohol or other recreational drugs
* Specific immunotherapy against pollen allergy within the last two years
* Intake of an investigational drug within three month before enrolment
* Intake of contraindicated medicaments for SIT as Betablockers, ACE/ATII Inhibitors
The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic

This is a single institution, prospective study to evaluate the prognostic significance of renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the spontaneous stone passage rate of ureteral stones.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and older at the time of consent
* willing and able to sign consent
* CT diagnosis of ureteral stone with a stone burden less than or equal to 10mm

Exclusion Criteria:

* obstructed solitary kidney
* obstructed transplant kidney
* bilateral obstructed kidneys
* any condition or reason that, in the opinion of the treating physician, interferes with the patient's ability to participate or places the patient at undue risk.
Study With an Innovative Equipment to Monitor and Control SALT During Cooking

In this study, the researchers will evaluate the efficacy of an intervention using the SALT CONTROL H instrument (an innovative equipment to monitor and control salt) in workers at the University of Porto to reduce dietary salt intake. This is a randomized clinical trial with intervention conducted according to good clinical practice guidelines.

The researchers will randomize 260 workers who meet the eligibility criteria and are enrolled in occupational health appointments. Prior to the intervention, the informed consent of the participants will be obtained and those who agree to participate will be allocated randomly in one of the two arms of the study (control or intervention), with balance of baseline characteristics (sex and hypertension).

The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content, will be used an illustrative video and recipes with an adequate salt content; use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!".

Control Group: No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants.

Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention analysis will cover the following domains: urinary sodium excretion corresponding to a 24 hour urine collection as a proxy for salt intake; 24-hour urinary potassium excretion, sodium:potassium ratio, systolic and diastolic blood pressure, and anthropometric measurements. Urine samples will be collected according to standardized procedures and analyzed by a certified laboratory. Secondary data such as satisfaction questionnaire, daily use of equipment, iodine analysis of salt used and excreted in urine 24h, hydration status, analysis of quality of life and quality of diet will also be analyzed, as well as intestinal microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years)
* Eat frequently cooked meals at home (\> 4 days a week, of which at least 3 Sundays / month)
* Have an occupational health appoitments at São João Hospital
* Reported motivation to control salt consumption

Exclusion Criteria:

* Pregnant
* Subjects with kidney disease,
* Subjects with active infection with an impact on renal function,
* Subjects with urinary incontinence,
* Subjects with acute coronary syndrome,
* Subjects with severe liver disease;
* Subjects with heart failure;
* Subjects who do not use salt for cooking;
* Subjects with hypotension;
* Subjects that work at Faculty that are the Sponsor of the study
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.

Bio-equivalence between two formulations of sildenafil citrate

Eligibility Criteria:
Inclusion Criteria:

* Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2.
* Good health conditions or without significant disease, at medical discretion, according to the rules defined in the Protocol, and evaluations undergone: clinical history, pulse and blood pressure measurements, physical and psychological examination, ECG and complementary laboratory examination.
* Able to understand the study nature and objective, including the risks and adverse effects and willing to cooperate with the investigator and act according to all the trial requirements, which is confirmed by signing the Informed Consent Form.

Exclusion Criteria:

* Hypersensitivity to the study drug or to the chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
* History or presence of hepatic or gastrointestinal diseases, or other condition that affects the drug absorption, distribution, excretion or metabolism
* History of hepatic, renal, lung, gastrointestinal, epileptic, hematological or psychiatric disease; hypo or hypertension of whatever etiology which demands treatment with drugs; history or occurrence of myocardial infarction, angina and/or cardiac failure;
Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.

Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo

Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.

The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on:

* Weight
* Eating Disorder Inventory (EDI) scale
* Motor and inner restlessness (estimated by accelerometry)
* Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients under treatment for AN.
* Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
* Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period.
* Age over 18.
* Duration of the disease over 5 years.

Exclusion Criteria:

* Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
* Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study.
* Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest).
* Patients not attending to the weekly controls.
* If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
* Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.
* Patients with known allergy to dronabinol or sesame oil.
* Fertile, menstruating women not using safe contraception.
* Pregnancy.
Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

Post-craniotomy pain remains a major challenge in patient care following neurosurgery.Flurbiprofen axetil (FA), as an injectable nonselective cyclooxygenase inhibitor, is a widely prescribed NSAID for postoperative pain. As FA is highly lipophilic by merging into emulsified lipid microspheres, it has a high affinity to the surgical incision and inflammatory tissues to achieve targeted drug therapy and prolonged duration of action, thus providing a basis for its local use to achieve efficacy and safety comparable to or greater than systemic administration. In this study, we attempt to evaluate the clinical effects of FA as an adjunct to ropivacaine in pre-emptive scalp infiltration to prevent or reduce pain after craniotomy.


Eligibility Criteria:
Inclusion Criteria:

1. Age minimum 18 years;
2. ASA physical status of I - II;
3. Body mass index (BMI) of 15 - 30;
4. Scheduled for supratentorial craniotomy under general anesthesia;
5. Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy.

Exclusion Criteria:

1. Glasgow Coma Scale \<15;
2. Unable to use the PCIA device or comprehend the pain NRS;
3. History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery;
4. History of craniotomy or scalp infection;
5. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease;
6. History of allergy to any drug used in the study;
7. Pregnancy and breastfeeding.
Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients

The aim of this research will be to investigate in stroke patients whether upper limb motor function can be maximized in response to sensory stimulation by comparing protocols for the application of Transcranial Magnetic Stimulation (rTMS) in the cortical region of S1 and Sensory Therapy in the upper limb paretic. Patients will be randomly and randomly allocated into four groups, Group 1 (G1) composed of individuals who will receive the protocol for the application of rTMS in the ipsilateral S1 cortex and fictitious sensory therapy in the paretic upper limb; Group 2 (G2) subjects will receive protocol of Sensory Therapy in the upper limb ethical and application of fictitious rTMS in the ipsilesional S1 cortex; Group 3 (G3): application of the protocol of application of rTMS in the ipsilateral S1 cortex associated with Sensory Therapy in the upper limb paretic and, G4 (GSHAM) control group in which fictitious rTMS will be performed and fictitious Sensory Therapy in the paretic upper limb).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging,
* absence of cognitive deficits (evaluated by Mini Mental State Examination, score ≥ 20 - FOLSTEIN 1975);
* partially preserved motor functions (evaluated by the Fugl-Meyer Scale, score between 14 and 60, due to the necessary movements to be performed during the intervention);
* partially preserved sensorial (evaluated by the Fugl-Meyer Scale, score between 2 and 10 in the sensorial item , Indicating subjects with sensorial alterations but without extinction of the sensation) (MAKI, QUAGLIATO, CACHO, et al., 2006);
* patients who, through exposure to electric current by TENS, perceive the electrical stimulation in the palm, back of the hand and ventral forearm will be included.

Exclusion Criteria:

* clinical evidence of multiple brain lesions or other associated neurological diseases;
* peripheral neuropathies;
* leprosy;
* fibromyalgia;
* rheumatoid arthritis;
* other upper and lower motor neuron pathologies;
* sensitizing skin diseases;
* history of psychiatric illnesses including drug and alcohol abuse;
* traumato-orthopedic deformities installed in upper limbs;
* those who are performing some rehabilitation treatment during the collection (Physiotherapy and / or Occupational Therapy) will not participate in the research.

In addition, for the application of rTMS:

* patients with intracranial metal implants will be excluded;
* pregnancy;
* history of seizures and / or epilepsy;
* use of medication that interferes with cortical excitability.
A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer

This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (LDD) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with chest wall recurrences of breast cancer.

A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
* ECOG performance status \< 3.
* Patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
* Patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
* Skin of target site and control site must be grade 0 or 1 by Common Terminology
* Patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver CLIPT (10 x 10 cm, or 3 x 3).
* If located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.
* Absolute neutrophil count \> 1000.
* Adequate coagulation status as indicated by platelet count \> 50,000, PT and PTT \< 1.5 time the upper limit of normal.
* Patients must sign informed consent.

Exclusion Criteria:

* Male patients not considered for this study.
* Patients must have a target lesion in a location other than the hands, feet, genitals, or face. Lesions in those locations will be excluded.
* Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
* Pregnant and nursing patients will be excluded. Women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
* Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, St. John's wort and amiodarone) will be excluded.
* Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT \> five times upper limit of normal) will be excluded.