cyrilzakka/clinical-trials huggingface dataset:
Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy

Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.

Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.

The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.

Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.


Eligibility Criteria:
Inclusion criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Informed consent: a signed and dated written informed consent prior to study participation.
2. Type of subject: inpatient
3. Age: subjects of more than 18 years and less than 85 years.
4. Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy.
5. Central lesion has to be accessible by the biopsy techniques under investigation

Exclusion criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child
2. Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR\>2, thrombocytopenia \<40/nl)
3. Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent.
4. Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
Registry of Patients With Von WilLEbrand Disease Treated With Voncento®

Description of the long-term evolution of patients with von Willebrand disease and treated with Voncento® and of the hemostatic efficacy in the prevention and the treatment of non-surgical bleeding episodes and prevention of surgical bleeding during 2 years after patient inclusion.

Inherited von Willebrand disease (VWD) is considered the most common bleeding disorder. Its prevalence is approximately 1% in the general population but symptomatic patients are rarer (0.01%). It is caused by a partial or total quantitative deficiency (type 1 and type 3) or by a qualitative defect (type 2) of von Willebrand factor (VWF), a large multimeric protein that is required for platelet adhesion and serves as factor VIII (FVIII) carrier. Type 2 VWD is further divided in four subgroups (2A, 2B, 2M, and 2N) that are distinguished according to the nature of the VWF defect. Most patients with type 1 VWD can be treated with the synthetic vasopressin analogue desmopressin (DDAVP; 2-desamino-8-D-arginine vasopressin), whereas patients with type 3 VWD and most patients with type 2 VWD require concentrates containing VWF. Plasma-derived FVIII concentrates, which were initially developed for the treatment of haemophilia, contain large amounts of VWF and are used in patients for whom DDAVP treatment is deemed ineffective or contraindicated. Voncento® (CSL Behring) is a plasma-derived FVIII/VWF concentrate registered in France since 2015 for the treatment and prevention of bleeding events in patients with inherited VWD. OPALE is an observational study describing the use of human coagulation FVIII/VWF concentrate (Voncento®) to treat and prevent bleeding episodes in a French cohort of patients with inherited von Willebrand disease in the real life settings. The aim of the OPALE study is to describe the efficacy and the safety of Voncento® in the prophylaxis and treatment of haemorrhage or surgical bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from constitutional von Willebrand disease for whom Desmopressin treatment is deemed ineffective or contraindicated
* Patients suffering from von Willebrand disease and being treated or having been treated with Voncento® for the treatment of surgical and non-surgical bleeding episodes, the prophylaxis of surgical and non-surgical bleedings
* Patients with no history or suspicion of inhibitors (judged on previous efficacy)

Exclusion Criteria:

* Refusal of the patient or the patient's legal representative to take part in the study;
* Existence of a contraindication to the use of Voncento® treatment
National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.Are eligible women aged between 50 and 80 years old.

Eligibility Criteria:
Inclusion Criteria:

* Between 50 and 80 yrs

Exclusion Criteria:

* Less than 50 and more than 80 yrs
Forward Head Posture Correction Impact on Temporomandibular Dysfunction

The goal of this clinical trial is to test the effect of nerd neck correction on damaged jaw in people who suffers from jaw problems and nerd neck. The main question it aims to answer:

* whether there are different effects of traditional nerd neck correction exercises, device correction method and dental splints on jaw features of pain and function.

Participants will:

* participants will be given the consent to sign first.
* participants will be assessed to check jaw pain and function.
* participants will be divided randomly into 3 groups.
* Each group will be given the treatment sessions for 6 weeks.
* participants will come back after 6 weeks for one last assessment.

Researchers will compare traditional, new and dental treatment groups to see if there is improvement in jaw characteristics.

The relationship between the two conditions of forward head posture (FHP) and temporomandibular joint dysfunction (TMD) have been previously stated with comparing the craniocervical angle (CVA) of TMD patients to the healthy individuals, still a clear relationship couldn't be drawn due to different study limitations such as the lack of subdivision in the TMD patients based on their diagnostic subcategories in addition to, patients posture might have been altered while the photo was captured. Ever since, multiple researchers deliberately investigated the two conditions association and inferred the following: 1. FHP can be a risk factor resulting in TMD where any alteration in the head position produces more tension on the masticatory muscles by changing the mandible position 2. TMD origins from muscular component is more significant than articular component yet the correlation between head posture and TMD is still not clear enough, however, if FHP and myogenic TMD were linked preventive measures can be taken. recently, multiple studies established a relation between the occurrence of FHP in TMD patients which supported the hypothesized relation between them.

Till present, no study has investigated the FHP Denneroll cervical traction orthodontic (DCTO) correction impact alone on TMD and this is where the purpose of this study arises from.

Eligibility Criteria:
Inclusion Criteria:

* The participant experiencing one or more of TMD signs or symptoms and has been diagnosed with TMD beside having forward head posture with craniocervical (CVA) angle \< 50.
* The study will be limited to the patients in the dental clinic of the university of Sharjah.
* Participants experiencing mild to moderate myogenic TMD with symptoms of orofacial pain and limited range of jaw opening.

Exclusion Criteria:

* Previous head, neck or TMJ traumas.
* History of temporomandibular joint surgery.
The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment

Advancing age is associated with an increased risk of developing dementia which can lead to a rapid acceleration in both the healthcare costs and caregiver burden. There is a need to develop non-pharmacological and easily accessible modalities of support for the well-being and enhancing quality of life for individuals with dementia. There is evidence that music listening is associated with stress and anxiety reduction in older adults. Here, the investigators aim to assess the effects of music listening as provided by a novel digital music-based intervention (developed by LUCID) on mood, anxiety, and quality of life in individuals at the early stages of dementia. LUCID uses reinforcement learning machine learning to curate and personalize the musical playlist while incorporating monoaural theta auditory beat stimulation (ABS) into the music. The study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being delivered to caregivers/participants. The study will take place over an 8- week period, with participants completing four 30 mins music or audiobook listening sessions per week. Pre and post-intervention assessments will be done via Zoom with the presence of a research staff member. The control condition consists of a randomized list of short audiobooks. The experimental condition consists of music and monoaural ABS curated by LUCID's AI system. The investigators hypothesize that the LUCID AI music curation system, compared to audiobooks, will be correlated with a greater reduction in measures of anxiety and agitation and an enhancement of mood and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate Cognitive Impairment (mild: MOCA scores (18-25); moderate: MOCA scores (10-17))
* Aged 65-85.

Exclusion Criteria:

* Unmanaged hearing loss (defined as the average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product) - self-report
* Severe Tinnitus
* Hyperacusis
* Current (but not prior) severe psychiatric disorder, an unstable or serious medical condition that may limit participation in the assessments.
Shanghai Children and Adolescent Diabetes Eye Study

To compare the prevalence of eye disease between children and adolescents with diabetes mellitus and healthy people, and to analyze the related factors of eye diseases in diabetic patients.

A cohort study. From January 2018 to 2028, 300 cases of diabetic children in Children's Hospital of Fudan University in Shanghai will be selected as case group, and 300 healthy children without diabetes will be selected as the control group.

The purpose of the study is to guide and regulate eye health screening of children and adolescents with diabetes in Children's Hospital of Fudan University in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance, thus upgrading the level of eye disease prevention and treatment in Shanghai.

Eligibility Criteria:
Inclusion Criteria:

* (1) provision of a written informed consent by a guardian;
* (2) age over 5 years and less than 18 years;
* (3) diagnosis of type 1 or type 2 diabetes based on the WHO diagnostic criteria for cases.

Exclusion Criteria:

* (1) eyelid diseases - eyelid entropion, eyelid ectropion, eyelid, ptosis, and palpebral dyskinesia;
* (2) conjunctival diseases - pterygium and conjunctivitis;
* (3) history of ocular surface chemical injury or use of eye drops with moisturizing artificial tears;
* (4) history of eye surgery within 6 months or history of retinal laser photocoagulation;
* (5) systemic diseases - Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave 's disease, systemic lupus erythematosus, and others.
Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period.

Thirst is defined as the desire to drink water. The perception and satiation of thirst constitute an interconnected network of neuronal, physiological and hormonal mechanisms that act simultaneously. In the oropharyngeal cavity are ionic channels called Transient Receptor Potential Melastatin 8 stimulated by cold temperatures and menthol, which aid in the control and decrease of the thirst intensity for providing refreshment and satiety without, however, the necessity of fluid intake In high amounts.

Thus, the present study aims to: compare the intensity and discomfort of thirst in the use of the menthol popsicle and usual care in patients in the preoperative period. This is a randomized clinical trial, to be performed in a public tertiary hospital. The sample size calculation will be performed after the pilot test is conducted. Two groups will be formed through randomization. The tested intervention consists of the menthol popsicle (experimental group). The thirst intensity (primary outcome) will be measured by means of the Numerical Scale and the discomfort of thirst (secondary outcome) through the Perioperative Seat Discomfort Scale, in two moments: at the end of the first approach of the patient and 20 minutes after the intervention. The results of this research may support the decision-making of health professionals in the implementation of effective and safe actions to manage the seat of the surgical patient in the preoperative period. Another relevant aspect is the production of knowledge about the problem, which is scarce both in the national and international scenario.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years;
* Without the use of pre-anesthetic medication, until the moment of data collection;
* Conscious and alert, who recognizes himself and responds to the stimuli of the environment;
* Oriented in relation to time and space;
* Fasting for more than two hours at the time of data collection;
* Minimum time of three hours prior to the scheduled time for surgery, to approach and collect data;
* Report thirst.

Exclusion Criteria:

* Presenting a contraindication of ingestion or swallowing;
* Present mandibular trauma;
* Being nauseated or vomiting;
* Refer to allergy to mentha;
* In dialysis;
* Report sjogren's syndrome.
Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors

The primary objective is to assess the feasibility, acceptability and explore the impact of a culturally appropriate Latin Dance intervention vs. Usual Care on sleep quality for Hispanic cancer survivors.

Secondary objectives are to examine the preliminary efficacy of a culturally appropriate Latin Dance intervention on secondary cancer- and treatment-related side effects (e.g., Quality of Life, distress, insomnia, fatigue).

In this feasibility Randomized Control Trial (RCT) study, the investigators will assess the feasibility, acceptability, and explore the impact of a Latin dance intervention vs usual care on sleep quality among Hispanic survivors.

Study Aims:

Aim 1: Develop a culturally appropriate Latin dance intervention for Hispanic cancer survivors using a bidirectional community engagement approach. Using iterative qualitative feedback from Hispanic cancer survivors, the investigators will develop a Latin dance intervention for Hispanic cancer survivors.

Aim 2: Assess the feasibility and acceptability of a culturally appropriate Latin Dance intervention for Hispanic cancer survivors.

Aim 3: Provide preliminary evidence of the efficacy potential of a culturally appropriate Latin Dance intervention vs. usual care on subjective and objective sleep quality for Hispanic survivors.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Self-identify as Hispanic and/or Latino(a)
* Have a confirmed diagnosis of a solid tumor or hematologic malignancy
* Must have completed primary cancer treatment 3+ months prior to enrollment (e.g., chemotherapy, surgery, and/or radiation therapy but may be on hormonal therapy and/or immunotherapy or other long-term therapies)
* Have sleep disturbance (indicated by a response of 3 or more on the MD Anderson Symptom Inventory sleep question by using an 11-point scale anchored by 0 \[no sleep disturbance\] and 10 \[worst possible sleep disturbance\]
* Be able to read and understand English and/or Spanish
* Physically Inactive (\<150 minutes of vigorous exercise/week within the past 3 months)

Exclusion Criteria:

* Current regular Latin dancing practice within the past year (2-3 times a week over a period of two months that is not interrupted).
* Inability to speak and read English or Spanish proficiently
* Inability to understand informed consent
* Medical conditions that can cause sleep impairment: sleep apnea, restless leg syndrome, shift work
* Regular use of a walker or wheelchair
* Healing or unhealed fractures
* Heart failure
* Life expectancy \<12 months
* Unwilling to be randomized to study arms and/or commit to 8 weeks of classes and a follow-up assessment
Patient-posture and Ileal-intubation During Colonoscopy

During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.


Eligibility Criteria:
Inclusion Criteria:

* All adult (\> 12y old) patients referred for colonoscopy

Exclusion Criteria:

* Acute fulminant colitis
* Acute Intestinal obstruction
* Suspected intestinal perforation
* Peritonitis
* Pregnancy
* Severe cardio-respiratory disease (ASA grade...)
* Decompensated liver disease
* Recent pelvic or colonic surgery (in last 6 months)
* Large aortic or ileac artery aneurysm
* Human Immunodeficiency Virus Infection
* Uncooperative patients
The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome

The purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome.

Hair thinning and hair loss are highly prevalent conditions affecting both men and women. Various factors can contribute to hair thinning and loss, including nutrition, medications, family history, and more. Overall, hair thinning and loss have a significant impact on quality of life and patients with these concerns have limited options. For example, minoxidil, finasteride, hair transplantations, and platelet rich plasma are effective options but each are paired with their own limitations. Thus, those with hair thinning or loss are increasingly turning to natural therapies shown to improve hair density and self-perceived hair thinning.

Nutrition is closely related to hair health, as evidenced by hair thinning and loss that occur with malnutrition or restrictive diets. Additionally, the hair follicle microbiome has been shown to modulate inflammation that exacerbates inflammatory scalp diseases, and ultimately hair thinning and hair loss.

Thus, an oral supplement that addresses nutrient deficiencies and targets the hair follicle microbiome could support hair health. In this study, we examine the effects of an herbal oral supplement on hair density, shine, and growth.

Eligibility Criteria:
Inclusion Criteria:

- Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Subjects with scarring forms of alopecia.
* Any history of procedures affecting hair growth, such as transplantation
* Any known allergy to any of the ingredients in the study product.
* Any laser treatments for hair growth in the past 3 months
* Use of any over-the-counter or pharmaceutical or dietary products known to affect hair growth
* Subjects unwilling to not alter hair color or style for the duration of the study.
* Subjects taking any hair growth oral supplementation within the past 3 months.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
* Those who have been on an oral antibiotic within 1 month prior enrolling
* Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment
The NEXUS™ Compassionate Use Data Collection Study

A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.

The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.

Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom the Nexus implantation was initiated as part of a compassionate use procedure.
* A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.

Exclusion Criteria:

-There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial

The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions:

1. To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
2. To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?


Eligibility Criteria:
Inclusion Criteria:

* The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia.
* Children with comorbidities will be also included.
* Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ).

Exclusion Criteria:

Children will be excluded from the study if they meet any of the following criteria:

* They receive non-pharmacological interventions for their sleep difficulties.
* They have been previously diagnosed as having an intellectual disability (IQ \< 70).
* They have obstructive sleep apnoea, according to the three items in the CSHQ.