cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Human Heat Perception - Involvement of TRPA1, TRPV1 and TRPM3

Animal studies suggest that the ion channels TRPV1, TRPA1 and TRPM3 are the relevant heat sensors. This study aims to validate these findings in humans.

Surprisingly, it is still not fully understood how humans perceive heat pain. There are several heat-sensitive ion channels whose manipulation in animals resulted in a more or less pronounced phenotype. However, complete blockade of heat sensation in animals has only recently been achieved. In triple knockout mice lacking TRPA1, TRPV1 and TRPM3, it was recently shown that only in the absence of all three receptors heat perception is largely abolished. Although the authors were unable to elucidate the underlying mechanism of this redundancy, the redundancy appears to have evolutionary value for protection against burns. In addition, recent evidence suggests that TRPV1 plays a role as a first-line defense against heat injury, i.e., that it encodes noninjurious heat injury in humans.

The goal of this study is to test whether the redundant functions of TRPV1, TRPA1 and TRPM3 observed in mice with respect to heat perception also apply to humans. More broadly, we want to understand which receptors enable humans to perceive heat pain. The study also aims to test if a chloride channel is involved in heat perception.

Design: Cross-over study with a Williams design group, 16 treatments incl. a placebo control.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Full legal capacity

To ensure an equal number of each sex in the study population, only volunteers of one sex will be included as soon as the number of subjects with the other sex has reached half of the calculated sample size.

Exclusion Criteria:

* Participant of another study, ongoing or within the last 4 weeks
* Medication intake (except contraception) or drug abuse
* Female subjects: Positive pregnancy test or breastfeeding
* Body temperature above 38°C, diagnostically verified
* Known allergic diseases, in particular asthmatic disorders and skin diseases, known allergic reactions to citrus fruits (but excluding food intolerances).
* Sensory deficit, skin disease or hematoma of unknown origin in physical examination of the test site
* Symptoms of a respiratory tract infection (Covid-19 related criterion)
The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting

This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.

Postoperative nausea and vomiting (PONV) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. Gynaecological surgery is considered high risk for PONV.

Ginger is a cheap, widely available and safe natural product in Jamaica and has been found to reduce the incidence of Nausea and vomiting in other clinical situations, such as in pregnancy. It is believed to act via the inhibition of serotonergic receptors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Undergoing elective intra-abdominal, gynaecological surgery

Exclusion Criteria:

* Allergy to ginger, ginger by-products or cornstarch
* Gastroesophageal reflux disease (GERD)
* Allergy to any of the Anaesthesia Agents
* Inability to swallow capsules.
* psychiatric illness which prevents patients giving informed consent.
* Psychological which prevents patients giving informed consent.
Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy

The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.


Eligibility Criteria:
Inclusion Criteria:

* morbid obese patients

Exclusion Criteria:

* contraindication to laparoscopy
Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease

Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo Wii alone or together. After this period the patients will be reassessed to verify the effects of the techniques.

Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the patients will be reassessed to verify the effects of the techniques.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 80 years,
* Stage 1 to 3 on the Hoehn and Yahr scale,
* Absence of visual or auditory impairment,

Exclusion Criteria:

* Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points
* Presence of other neurodegenerative diseases,
* Uncontrolled osteomioarticular or chronic diseases
* Participation in other rehabilitation programs.
Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis

Utility of Multimodal Evoked potentials (mmEP) for monitoring disease course and prediction of progression at different stages of Multiple Sclerosis (MS) is investigated


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with a clinically isolated syndrome (CIS) or MS with a relapsing-remitting (RRMS) or a primary progressive disease course (PPMS):
* CIS: EDSS \<= 5.5 within six months of first clinical event
* early RRMS: EDSS: \<= 3.5 disease course of 5 up to 10 years
* late RRMS: EDSS: 2.0-5.5 inclusive disease course of 5 to 15 years
* PPMS: EDSS: 2.0-6.5 inclusive disease course up to 15 years
* participation in the Swiss Multiple Sclerosis Cohort Study (SMSC)
* mental ability to cooperate
* written informed consent

Exclusion Criteria:

* alcohol or substance abuse
* progressive disease other than Multiple Sclerosis
* psychiatric disorder requiring a treatment by a psychiatrist
* patients with movable metal implants, e.g. pace-maker, stents, deep brain stimulators etc.;(patients with jaw- or bone-fixed metal implants can be included)
Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.

Lumbar radiculopathy is a nerve root disorder which affects quality of life of the patient and it is considered as an important health problem. Therefore, its correct diagnosis is essential. The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.

This is an epidemiological study of randomized consecutive cases which was observational, descriptive, transversal, double blinded and followed the STARD (Standards for Reporting Diagnostic accuracy studies) declaration.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of lumbar or lumbosacral radiculopathy

Exclusion Criteria:

* Healthy subjects or with a radiculopathy already diagnosed
* subjects with Diabetes, alcoholism, HIV+, herpes zoster infection, cancer, multiple sclerosis, hereditary neuropathy or lumbar surgery
* persons with pacemaker or stent
* known pregnancy
* persons that refused to participate in the study or undergo the MRI scan.
Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization

Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.

The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.

Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.

The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.

Eligibility Criteria:
Inclusion Criteria:

* No inflamed sinus
* Minimum alveolar ridge height 5-6 mm
* Medical free
* Both genders males and females.

Exclusion Criteria:

* Remaining alveolar ridge height is less than 5mm
* Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.

  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Patients having history of allergy to any drugs.
  * Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments
  * Untreated periodontitis.
  * Poor oral hygiene and motivation.
  * Uncontrolled diabetes.
  * Pregnant or nursing.
  * Substance abuse.
  * Psychiatric problems or unrealistic expectations.
  * Severe bruxism or clenching.
  * Immunosuppressed or immunocompromised.
  * Treated or under treatment with intravenous amino-bisphosphonates.
Creatine Supplementation and Cognitive and Physical Tests

To assess whether brain creatine availability has an effect on cognition. To do so we will seek to increase brain creatine concentration via a creatine supplementation protocol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological illness including cardiovascular, renal, and endocrine disorder)
* Male/female
* No medication / supplements
* Non-smoker
* Low to moderately active
* Between 18 and 35 years old

Exclusion Criteria:

* Injuries
* Illness
* Use of medication
* Use of creatine in the last 3 months
* History of head trauma or seizure
* Vegetarian diet \[24\]
* Not being able to follow up the restrictions and prohibitions for the subjects (see Restrictions and prohibitions for the subjects)
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients

Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important enzyme that is responsible for eliminating many drugs that cancer patients need to take, including dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on the activity of CYP2D6, and how the human body handles dextromethorphan.

To assess the effect of repeated dosing with 45 mg QD PF-00299804 on the pharmacokinetics of dextromethorphan, a CYP2D6 probe, in cancer patients with advanced malignant solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically or cytologically confirmed advanced malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Patients with performance status 2 could be eligible upon agreement between sponsors and investigators;
* Adequate bone marrow, renal, liver and cardiac functions;

Exclusion Criteria:

* History of Interstitial Lung Disease (ILD).
* Drugs with known CYP2D6 inhibitory effects
* Drugs that are highly dependent on CYP2D6 for metabolism.
* Women who are pregnant or breastfeeding.
Retrospective Study Evaluating The Current Utilization Of Desvenlafaxine Succinate Sustained-Release (Pristiq) Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder

The goal of this observational study is to learn about how Pristiq is currently being used in general practice and how psychiatrists and primary care physicians currently perceive Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for major depressive disorder (MDD).

It is retrospective patient chart study among psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD). Physicians will be asked general medical questions in order to quantify their prescribing behavior and their perception of treatment performance. A retrospective patient chart review will then be performed and patient data will be collected to document patient characteristics and actual treatment outcomes. Upon qualification, specific instructions for chart review will be provided. Once the identified charts are pulled, the physicians are instructed to continue with the on-line survey. In total, there will be approximately 450 psychiatrists and 450 primary care physicians participating in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy.
* Physicians must be either a psychiatrist or a primary care physician, a prescriber of Pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company.

Exclusion Criteria:

* Patients who have not been treated for depression.
Prognostic Markers of Post-Stroke Depression (PROMoSD)

Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke.

Post-stroke depression (PSD) is an important complication after a stroke. Despite significant limitations between studies of PSD risk factors, stroke severity or post-stroke disability, prior depressive episodes, and female sex are arguably the most well-known risk factors for developing PSD, although the predictive value of these factors is limited.

A hypoechogenic brainstem raphe (BR) detected by transcranial sonography (TCS) is associated with depressive symptoms in distinct diseases but is also common with approximately 25% of the non-depressed population in Europe. The primary aim of this study is to investigate the association between BR hypoechogenicity and PSD occurrence in a prospective observational study design.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke with the onset of symptoms within the past 14 days
* Diagnosis of AIS is confirmed by brain imaging, either computer tomography or magnetic resonance imaging

Exclusion Criteria:

* Insufficient transtemporal bone window for transcranial sonography examination
Body Image Therapy in Anorexia Nervosa

The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.

Anorexia nervosa is a severe psychiatric disorder, with high level of mortality and hospitalization is often necessary for the treatment of severe and/or chronic cases.

Anorexic patients often experience a serious disturbance in body and their own shape perception. Body image work should be enhanced in the treatment of anorexia nervosa.

The aim of the study is to test a new body image therapy using the anamorphic Micro software.

Ten sessions of assessment of the patient's own shape and of correction of distorted perceptions of body size with Anamorphic Micro software will be compared to ten sessions of body image therapy as usual.

French 100 anorexia women hospitalized in a specialized Eating Disorder Unit will participate to the study, randomized in 2 arms :

* Body image therapy with Anamorphic Micro software
* Body image therapy as usual

Eligibility Criteria:
Inclusion Criteria:

* woman
* more than 18 years old
* anorexia nervosa
* hospitalized in the CMME (CHSA) TCA Unit
* Body Mass Index ≥ 16
* Informed consent

Exclusion Criteria:

* pregnancy
* severe motor, sensitive or sensorial impairment
* no affiliation of national health service
* dependent of a trusteeship or guardianship
Improvement of Facial Recognition Ability and Multitasking

This study aims to determine the efficacy of training on facial recognition and multitasking. The researchers hypothesize that participants who have undergone facial recognition and multitasking training will demonstrate an improved facial recognition ability and performance in multi-tasking. The researchers also hypothesize that measures of sustained and selective attention will predict performance on multitasking tasks. This work sets the ground work for future research into if and how facial recognition and multitasking ability can be improved.

There has been evidence showing improvements on performance on various cognitive tasks after training, but evidence on multitasking and facial recognition is lacking. Both multi-tasking and facial recognition are crucial for military and law enforcement personnel, and the respective organizations can consider these abilities during their respective recruitment and training processes.

This study will test whether training on multi-tasking and facial recognition tasks can improve an individual's performance. Additionally, it will test whether their performance on other measures of attention and multitasking can predict changes post-training.

Participants will go through 5 testing sessions span over 5 days. For each session, participants will complete a multitasking task and a facial recognition task. Participants are hypothesized to improve in their performance after 5 consecutive days of training on these 2 tasks. Additionally, participants will also complete 2 attention tasks, 1 face memory task, and 1 other multi-tasking task only on the first day. Both multitasking tasks are expected to correlate at baseline, and performance on the attention tasks may predict performance on multitasking tasks as these tasks require sustained and selective attention. A face memory task will also be used to account for each individual's baseline facial recognition ability.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be over 21 if they are not from NUS or Yale-NUS. NUS or Yale-NUS students over 18 can also participate. All participants are expected to be fluent in English.

Exclusion Criteria:

* Participants with a history of perceptual or memory deficit will be excluded.
BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics

The primary objectives of this study are to investigate

* the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions
* the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) : ≥18.5 and ≤30 kg/m\*2

Exclusion Criteria:

* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Febrile illness within 4 weeks before the first study drug administration
* Known hypersensitivity to the study drugs or components of the preparations
* Clinically relevant findings in the physical examination
Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain

Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. However, the criteria leading to initiate a diagnostic procedure during chest pain are imprecise. The fear is, on the one hand, to miss a potentially vital diagnosis and, on the other hand, to expose a large number of patients to unnecessary examinations.

The CARE rule (also known as HEAR score) seems to streamline this first step. It assigns a value of 0 to 2 using 4 items: Characteristic of pain, Age, Risk factors and Electrocardiogram (ECG). The search for an ACS is not justified if the sum of the points is \<2 (negative rule) and, inversely, a troponin determination must be carried out if the sum is \> 1 (positive rule).

The aim of the study is to demonstrate the safety and interest of the CARE rule associated with the HEART score to streamline ACS's diagnostic approach to thoracic pain in emergencies departments.

Data collected in this study are not anticipated to be published in a data repository. However, data will be shared per requested need to researchers, upon presentation of a structured protocol, when approved by the competent ethic committee and approved by the steering committee.

Eligibility Criteria:
Inclusion Criteria:

* Admission to an Emergency Department participating in the study
* Non-traumatic chest pain
* Age greater than or equal to 18 years
* Patient's consent (oral for France, written for Belgium)

Exclusion Criteria:

* 30 days follow-up not possible
* ST-segment Elevation Myocardial Infarction (STEMI) on admittance ECG
* Chest pain formally reported to a diagnosis other than an ACS before inclusion (e.g., pneumothorax, pleurisy, etc.)
* Troponin assay performed prior to inclusion (less than 24 hours old)
* Patient referred by another care structure (excluding primary medicine)
* Patient already included in study still in follow-up period
* Pregnant, breastfeeding or parturient patient,
* Patient deprived of liberty by judicial or administrative decision,
* Patient undergoing psychiatric care under duress,
* Patient subject to a legal protection measure,
* Patient unable to give free and informed consent.