cyrilzakka/clinical-trials huggingface dataset:
The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 and older
* Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population.
* Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms.
* Willing to participate and understand the informed consent document.
* Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.

Exclusion Criteria:

* Those currently taking any tricyclic antidepressants (TCAs)
* Those currently taking any selective serotonin reuptake inhibitor (SSRI)
* Those with porphyria
* Large tattoos in the treated areas
* Pregnancy or nursing
* Taking any oral or topical medications that could interfere with the PDT (Appendix A)
* Active rashes in the area
Respiratory Quotient and Food Liking, Food Wanting and Food Consumption

The purpose of this study is to observe the influence of carbohydrate-to-fat balance on liking, wanting and food consumption in humans.

16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study. The sessions differed by the composition of the breakfast which was rich in carbohydrates (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4 foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast) were evaluated.

In accordance with the carbohydrate-based models of feeding, one may expect that food choices as well as "liking" and "wanting" (the two components of the reward system) could be influenced by glycogen stores and the carbohydrate-to-fat balance. More precisely, one may expect that a high fat oxidation rate could increase liking and wanting carbohydrates to replenish glycogen stores and conversely, that a high carbohydrate oxidation rate could produce the reverse. In order to validate this hypothesis, the present study has been conducted to investigate in humans the influence of the carbohydrate-to-fat oxidation ratio on carbohydrate-to-fat selection and the food reward system.

Eligibility Criteria:
Inclusion Criteria:

* Good health
* Absence of medication
* Moderate physical activity (irregular and less than 5 h/wk)
* Low-smoking habit (less than 5 cigarettes/d)
* Normal body mass index (20\< BMI \<25)

Exclusion Criteria:

* Eating disorders
* Dieting or fasting
* Aversions for the foods offered and elevated 'cognitive restriction of eating' (score ≥ 7) according to the Three Factor Eating Questionnaire
Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.

Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.

Eligibility Criteria:
Inclusion Criteria:

* REM sleep behavior disorder according to ICSD-3 criteria
* No cognitive deficit or symptom of Parkinsonism
* Those with written consent.

Exclusion Criteria:

* who took medication (ex. clonazepam) for REM sleep behavior disorder
* with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.)
* who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor)
* who is unable to answer questionnaires
* who have hypersensitive reaction to medications
* Pregnant women or breastfeeding
* who are diagnosed with other parasomnia disorder
* with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)
AVODART(Dutasteride) Post-marketing Surveillance(PMS)

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information


Eligibility Criteria:
Inclusion Criteria:

* The Korean BPH Patients administrated dutasteride according to the prescribing information

Exclusion Criteria:

* women and children and adolescents.
* patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis

Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).


Eligibility Criteria:
Inclusion criteria

* All patients in age of 18 to 80, non-smokers
* With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.
* Peri-implantitis defined according to the EFP/AAP consensus meeting
* Combined defect configuration

Exclusion criteria:

* Pregnancy or lactation
* History of or current smokers
* Uncontrolled medical conditions,
* Cement-retained restoration
* Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico

Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever.

In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.


Eligibility Criteria:
Inclusion Criteria:

* Participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis
* Participants allowing to use the data for research and marketing purposes as well as talking to authorities
* Participants allowing us to use the pseudo-randomized individual data for further data analysis
* Able to read and understand the language of the online questionnaire

Exclusion Criteria:

- None
BXCL501 for Agitation in Schizophrenia

Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent.
2. Male or female between 18 and 65 years of age, inclusive
3. According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.

Exclusion Criteria:

1. Current significant medical condition or other comorbidities
2. Current substance dependence
3. Women who are pregnant or breastfeeding
Resilience in Persons Following Spinal Cord Injury

This study aims to quantify resilience in survivors of a spinal cord injury. The study will consist of structured interviews and self-reported surveys. We will look for common themes between participants at different stages of injury (1-5 years, 5-15 years, \>15 Years).

The goal of this project is to broaden the understanding of the lived experience of aging with a disability, from the perspectives of individuals with physical disabilities resulting from spinal cord injury (SCI). The specific objectives of this project are to:

1. Learn how people with SCI attain and maintain optimal quality of life as they age.
2. Understand how people with SCI develop resilience as they grow older.
3. Understand how individual quality of life is related to the degree and mechanism of resilience among people with SCI.
4. Learn which resources and practices have been most helpful and useful to people with SCI as they age with their disability.
5. Assess personal, behavioral, and environmental factors that contribute to resilience and quality of life among people aging with SCI.
6. Refine and confirm a holistic model for the relationships among the concepts of resilience, quality of life, and person-centered factors (resources, behaviors).

Through in-depth interviews and detailed surveys, we will explore how people with SCI attain and maintain optimal quality of life as they age, and how their quality of life relates to resiliency as they traverse the path of aging with SCI. We will explore with participants the resources and practices that have been most helpful and useful to them as they age with their disability.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* History of Traumatic Spinal Cord Injury at least 1 year prior
* Ability to self-report on factors affecting health and well being Exclusion Criteria
* Progressive Spinal Cord Injury
Neurofilament Light Chain as a Potential Marker in Behcet's Disease

To determine the role of neurofilament light chain in Behçet's disease with or without neurological affection and its relation to neurological manifestation (either peripheral or central ).

Behçet disease is a multisystemic autoinflammatory disorder characterized by recurrent oral and genital ulcer, eye affection, thrombosis and many systems can be affected with the most serious being the nervous system affection which is commonly called neuro-Behçet's disease (NBD) In Ghita et al, the prevalence of Behcet disease in Egypt was estimated to be 3.6/100,000 with CNS affection occurred in about 13.1% of the patients , while in other study performed in Egypt the peripheral neuropathy affection reached 53.3% of the patients with insignificant difference between both upper and lower limb but sensory affection was manifested more than motor affection in those patients.

Neurofilament light chain (NFL) is a neuronal cytoplasmic protein, which was assumed to have a role as a prognostic biomarker in several neuroimmunological and neurodegenerative diseases. It was documented in peripheral nerve affection of patients with diabetes mellitus and GuillainBarré syndrome. Recently, some studies documented the presence of high level of NFL chain in serum of neurolupus and primary sjogren's diseases , more over in 2022, Karaaslan et al. measured NFL in the cerebrospinal fluid (CSF) and found it high in neurobehcet patients and assumed that it can predict the prospective cognitive and somatic disability in NBD patients.

So, the investigators aim at our study to assess the role of NFL chain in serum of behcet disease in those with and without peripheral and central nervous system affection and its relation to neurological manifestation.

Eligibility Criteria:
Inclusion Criteria:

* any adult patient satisfied International study group criteria of Behcet's disease

Exclusion Criteria:

* Patients with definite diagnosis for any other causes affecting central and peripheral nervous system eg....

  1. Infection (Viral, Bacterial, Fungal)
  2. Toxic
  3. Drug induced
  4. Other diseases (Multiple sclerosis, Neuromyelitis Optica)
  5. Trauma
  6. other autoimmune diseases
  7. Diabetic patients
  8. purely degenerative diseases
  9. Tumours
Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese

This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance. Both treatments will be test by all of the participants and they will make the polysomnography exam to have the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥40 kg/m² and ≤ 49,9 kg/m²
* Female and male patients (Both of gender patients) with ages between 20 to 65 years old
* Obstructive Sleep Apnea (OSA) diagnosis by polysomnography

Exclusion Criteria:

* sedative drugs users
* Oxygen-dependent or decompensated lung disease
* Decompensated congestive heart failure
* Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)
* craniofacial deformities carriers
* previous OSAS Diagnosis and treatment
* Active Oncological diseases in the last ten years
* Patients with less than 8 teeth per arcade;
* Patients with advanced periodontitis;
Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY

This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.


Eligibility Criteria:
Inclusion Criteria:

* Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged \>8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses.
* The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form.
* The registrant must sign the Release of Medical Records in the event of an adverse event in the study.
* The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses).
* Current participant in an unrelated research study.
* Employee or family member of Recruiting Practitioner or Johnson \& Johnson.
What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study

Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand and walk.

GENERAL:

Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy early after stroke. For example, training has led to substantial recovery if initiated 5 or 14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this early period is characterized by heightened levels of plasticity and that training can exploit this leading to improved outcome. The typically observed non-linear recovery pattern in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the human brain, however clinical research on this is disappointingly sparse.

In two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (Phase I) and the specific effects of robot-assisted training (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the same characteristics as observed in animal models. To initiate gait training at an early stage, when patients usually present severe weakness and balance deficits, a mobile exoskeleton is used which is developed to provide intensive walking practice.

OBJECTIVES:

(I.a) Is there a distinct time window of behavioral restitution (i.e., returning towards pre-stroke movement patterns) underlying early walking recovery?

(I.b) Are improvements in standing and walking throughout the first 6 months post-stroke explained by behavioral restitution or learning to use compensation strategies?

Eligibility Criteria:
Inclusion Criteria:

* First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
* Age: 18 - 90 years
* Baseline assessments within the first 14 days after stroke onset
* Weakness of the lower limb (NIHSS item \>0 at 72 hours post-stroke)
* Pre-morbid independence in activities of daily living (mRS \</=2) and gait (FAC \>3)
* Able to communicate and comprehend
* Sufficient motivation to participate
* Provided a written informed consent

Exclusion Criteria:

* No other neurological condition affecting motor functions of the lower limbs
* Pre-existing musculoskeletal impairment severely affecting the gait pattern
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome

This study will learn more about how the body uses energy. Usually, the body uses sugars as energy first and then fats are used when the sugar stores are gone. Some people have trouble using fats as energy. This can lead to feeling tired, difficulty exercising, and storing too much fat where it does not belong (like in the muscle). It is believed that some boys and men with Klinefelter Syndrome may not be able to use fats as energy normally, and that a medication called fenofibrate could help this.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Ages 15 to 40 years
* Total testosterone concentration within the normal range for age and pubertal stage
* For the KS group only: genetic testing results confirming KS

Exclusion Criteria:

* Liver disease (ALT or AST \> 3x upper limit of normal)
* Renal impairment (estimated creatinine clearance \<80 ml/min)
* Diabetes mellitus (A1c \> 6.4%)
* Untreated hypogonadism
* Treatment with a PPAR agonist (including fish oil) or statin within the past month
* Unstable medications with any medication added or removed within the past 2 weeks or plan for medication changes during the study period
* Inability to tolerate study procedures, including any medical conditions that make exercise unsafe at the discretion of the study physician
* For the KS group only: known allergy to fibrates, inability to swallow tablets
Sympathetic Neural Outflow During Xenon Anesthesia in Humans

The purpose of this study is to test the hypothesis that sympathetic neural outflow to muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in Healthy Volunteers.

Objectives for this study :

* Main Objective : Influence of Xenon anesthesia on Sympathetic Nervous Activity
* Secondary Objectives : Security under LENOXe™ (xénon 100 % v/v) anesthesia

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers \> 18 years and \< 65 years of age
* ASA physical status I
* Legal competence
* for whom the consent form has been signed

Exclusion Criteria:

* Healthy volunteers \< 18 years and \> 65 years of age
* Pregnancy, lactation period or missing secure anticonvulsive therapy
* Missing legal competence
* Participation in other clinical trials
* Contraindications as mentioned on §4.3 of the SPCs of LENOXe™ (xénon 100 % v/v)
* Any medication especially of Sildenafil (Viagra®) or other potency remedy
* Existing relationship of dependency to the sponsor or the investigator
Turkish Version of Occupational Balance-Questionnaire (OB-Quest)

The objective of this study was to translate and culturally adapt the Occupational Balance Questionnaire (OB-Quest) and evaluate the psychometric properties of the translated version by validity and reliability testing.

This study consists of two parts; in the first part, the translation and cross-cultural adaptation were undertaken, and in the second part, analyses of psychometric properties of OB-Quest Turkish were performed.

Part I: Translation and cross-cultural adaptation

The developers of the original questionnaire were contacted to seek their permission to translate the OB-Quest into Turkish and permission was obtained by the researchers via email. The five-stage translation-back translation method proposed by Beaton et al were used in the cross-cultural adaptation of the questionnaire (Beaton et al., 2000).

The first stage included translation procedures, and two therapists translated the questionnaires' English form into Turkish. In the second stage, two translations were compared to avoid any discrepancy and converted a single text by the research team. Generally, OB-Quest has a simple and understandable sentence structure. Therefore, it did not require any cultural adaptation, simple arrangement was enough to provide clarity. Researchers arranged on the last two items. These items consisting of a single sentence were divided into two as 'example and question', to overcome the complexity of the questions and maintain the integrity of the meaning. After the corrections, researchers had an agreement on the Turkish version of OB-Quest. In the third stage, the back translation of the final text from Turkish to English was made by two native English speakers whose Turkish very well. In the fourth step, the researchers compared the original text with the last English form and produced the final version. The final stage covered the pilot study to get understanding items. After the translation process was completed, a pilot study was conducted with a group of 30 people. Participants approved the final version was appropriate and understandable. The participants in the pilot study did not include in the sample group.

Part II Analysis of the psychometric properties of OB-Quest

Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* native speakers of Turkish
* literate of Turkish
* healthy
* volunteered to participate in the study

Exclusion Criteria:

* diagnosed with acute/chronic disease