cyrilzakka/clinical-trials huggingface dataset:
the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. This prospective randomized controlled study plan to compare the effects of different therapy regimens, including Tibolone and Xiangshao granules, on menopausal sleep disorders.


Eligibility Criteria:
Inclusion Criteria:

* women aged 40-60
* natural menopause for 1-10 years
* PSQI score \>=11 points
* improved K-score\>=14 points
* able to independently sign informed consent forms

Exclusion Criteria:

* Vaginal bleeding of unknown cause
* Known or suspected breast cancer and other sex hormone dependent tumors
* Active venous or arterial thromboembolic disease within past 6 months
* Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month
* Have used anti anxiety, depression drugs or sedative hypnotics within the past month
* Patients with anxiety or depression above moderate level
* Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value
* BMI ≥ 28 kg/m2
* Allergies to research drugs
* Other situations that doctor deems unsuitable to participate in the study
Retrospective Register for Uveal Melanoma

Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. Studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs.

Aim: The proposed project is a register for patients with UM treated at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021.

Patients and Methods: Patients treated for UM at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021 will be included in the register. Information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.


Eligibility Criteria:
Inclusion Criteria

* Patients 18 - 99 years
* Diagnosis of uveal melanoma Exclusion Criteria
* Patients younger than 18 years of age
* Inadequate or missing information on the clinical course in patient charts
The Effect of Low Level Light Therapy on Histamine- and Mucuna Pruriens-induced Pruritus in Healthy Volunteers

This is a prospective, double-blind, randomised, sham-controlled study whose primary aim is to test whether LLLT changes the intensity of itch after histamine application in healthy volunteers compared to sham application.

Rationale and relevance of the study

Low-level light therapy (LLLT) is a method of photobiomodulation that involves the clinical application of light with wavelengths typically in the range of 600 to 1100 nm and with a typical power density of 5 mWcm² to 5 Wcm².

Clinical studies have demonstrated positive effects of LLLT on pain processing, which is attributed to a reduction in neurogenic inflammation and associated neuronal sensitisation. This has been proven by testing for hyperaesthesia or allodynia. In the course of neurogenic inflammation, histamine liberation also occurs, which can be associated with itching. Chronic itching is also frequently associated with somatosensory abnormalities in analogy to chronic pain. Itch-associated dysaesthesias, such as mechanical allocnesia and hyperknesia, can be seen as evidence of neuronal sensitisation in pruritus patients.

Oliviera et al. were able to demonstrate an antipruritic effect of LLLT in a case observation of five burn victims. By irradiating with laser, whose photobiomodulative mechanisms are similar to the mechanisms of LLL therapy, this effect was also investigated in lichen planus patients. The effect of LLL on pruritus can be demonstrated in the case observation of five burn victims.

Itch models can be divided into histamine-induced and non-histamine-induced. To date, there has been no structured investigation of the antipruritic effect of LLL, nor is it clear to what extent the itch-inducing mechanism has an influence on the suspected efficacy of LLL.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the participant
* Healthy test persons aged 18-60
* For female volunteers, negative pregnancy test

Exclusion Criteria:

* known allergy or hypersensitivity to histamine or the Mucuna pruriens
* history of skin diseases
* tattoos in the test area
* neoplasia in the test area
* pacemaker
* pregnancy
* epilepsy
* piercings
* fever
* local acute infection, skin inflammation/rashes
Effectiveness of the Dry Needling Approach in Patients With Tension-Type Headache

Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical, cranial, and facial musculature in patients with frequent and chronic tension-type headache.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of tension headache according to IHS

Exclusion Criteria:

* Documented major trauma through medical history in the cervical area and/or recent surgery.
* Pregnancy.
* Generalized pain.
* Inflammatory, hormonal, or neurological disorders.
* Tendon disorders in the upper extremities.
* Severe psychiatric illnesses.
* Inability to complete the form in Spanish.
* Having a pacemaker (due to the use of equipment with magnetic sensors).
* Specific contraindications to invasive or conservative physiotherapy (infection, fever, hypothyroidism, wounds in the puncture area, metal allergies, cancer, systemic diseases, or belonephobia).
* Having received physiotherapy treatment for the condition in the past month.
Inter-regional Project of the Great Western Exploration Approach for Exome Molecular Causes Severe Intellectual Disability Isolated or Syndromic

Intellectual disability (ID) moderate or severe affects about one child in 250, with 3000 to 4000 new cases each year. Chromosomal or molecular pathology causes are not identified in half of the cases by current techniques. Studies show that de novo mutations are common in many different genes. The "exome" approach by high-throughput sequencing (NGS) has emerged as the technique of choice for identifying and comparing the exome of the child to the parent. We wish to evaluate this approach and its contribution in the diagnostic management of 50 patients with DI seen in genetics in 6 CHU Great West. Genomics platform IBISA / Biogenouest will provide technological and bioinformatics support this project.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe intellectual disability (IQ \<35 ) or moderate (IQ \<50) isolated or syndromic presentation but undiagnosed . The diagnosis is established during genetic counseling of a 6 CHU interregion
* Lack of family history ( parents). We are interested in this project to patients who do not have family history in order to increase the probability of identifying a de novo mutation . We do not however exclude the hypothesis for some patients a mechanism recessive autosomal or X-linked .
* Recruitment in 6 CHU HUGO . Patients are required to have been seen in genetics in a 6 CHU interregion . Molecular analyzes of the Fragile X syndrome and the CGH technique must be negative.
* Indication sequencing exomique adopted by the Scientific Committee. The Scientific Committee HUGODIMS project role to select patients whose DNA will be studied in order to optimize the chances of success for sequencing . This selection must take into account clinical parameters , but also genetic parameters ( potential inbreeding ) . The files will be selected by videoconferencing at the end of the monthly meeting of CLAD . The methodologist of the study will be invited to videoconferencing.
* specific consent obtained for the study.

Exclusion Criteria:

* Parents patient with moderate or severe intellectual disability disagree with the preferred hypothesis of de novo mutation or recessive transmission mechanism.
* Form with known syndromic diagnosis can be targeted molecular studies (clinical signs).
* Cause molecular DI identified by targeted molecular analysis or CGH.
* Explicit refusal to participate in the study of the patient, parents, or one of the two parents.
* Any other indication that intellectual disability.
* The parents of the patient or the patient may be removed.
The Effects of Over-the-Counter Products on the Skin

The primary purpose of this study is to investigate the safety and tolerability of commonly used over-the-counter products and the effects of the products on skin health.

Participant will apply commonly used skin product on skin for a period of time with or without light challenge. The investigators will perform clinical assessments of the skin associated with product application as well as assess these changes with and without light challenge. Skin biopsies will be obtained following standard medical practice and will be used to analyze skin markers related to photoaging, pigmentation, oxidative stress, and other dermatologic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18 years old with healthy skin;
* Participant must be willing and comply with the requirements of the protocol;
* Participant must have the ability to understand and communicate with the investigator;
* Participant must provide informed consent.

Exclusion Criteria:

* Subjects who are unable to provide informed consent;
* Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
* Subjects who self-report that they are pregnant or nursing;
* Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
* Subjects with known bleeding disorders or diathesis;
* Subjects with a history of keloids or excessive scarring;
* Subjects with known allergy to lidocaine, epinephrine, or any of the tested products;
* Subjects who foresee intensive UV exposure during the study (e.g. sunbathing, tanning beds).
Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.

The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients.

Hypothesis:

There is no difference in the relative amount of newly formed bone plus BO between the large (1-2 mm) and small (0.25 - 1 mm) granules.

the use of bovine bone mineral particles (Bio-Oss®)in sinus floor augmentation is well established. bovine bone mineral is an oseoconductive material which serves as a space maintainer and a scaffold for bone augmentation. the commercial product is manufactured in two different particles sizes, "large"1-2 mm, and "small"0.25-1 mm.

Comparison: the histologic characteristics of augmented bone after the use of Bio-Oss® (BO) with particle size of 0.25-1 mm vs. Bio-Oss® (BO)with particle size of 1-2 mm.

Eligibility Criteria:
Inclusion Criteria:

* The patients included in this study are over 18 year old men and women.
* The patient must be a candidate for sinus floor augmentation.
* The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures.
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.

Exclusion Criteria:

* Pregnant women.
* People who smoke more than 10 cigarettes a day.
* Alcohol and drug abusers.
* People suffering from uncontrolled diabetes, severe osteoporosis, rheumatic arthritis, precancer or neoplastic lesions of oral cavity.
* The patient is nursing.
Colonoscopy Using Motorized Spiral Enteroscope

The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy.

Cecal intubation rate represents a key procedural quality parameter in diagnostic colonoscopy. However, even in experienced hands, a significant percentage of colonoscopies (1.6-16.7%) remain incomplete because of a failure to intubate the cecum. The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy. The study aim was to evaluate the feasibility and safety of motorized Spiral enteroscopy for difficult colonoscopies.

Eligibility Criteria:
Inclusion Criteria:

- Indications for Spiral colonoscopy as a rescue procedure because of incomplete antecedent colonoscopy

Exclusion Criteria:

* Age under 18 years
* Known pregnancy
* Poor health status (ASA classification ≥ 4)
* Contraindication for sedation or standard colonoscopy
* Known coagulopathy (INR ≥ 2.0, platelets \< 70 /nl) or anticoagulants other than aspirin
* Medical history of chronic inflammatory bowel disease or suspected bowel obstruction
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
* Signed an informed consent

Exclusion Criteria:

Any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator

* Any history or evidence of clinically significant urinary incontinence, urinary retention, overactive bladder, or other voiding dysfunction
* Known or suspected nerve injuries or paraesthesia in the pelvic area
* Pregnancy within six months before enrolment
* Breastfeeding within three months before enrolment
* Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months
* Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator)
* Any systemic drug use within 2 weeks before the first study day (prescription drugs, over-the-counter drugs, herbal drugs, and/or illicit drugs), except for occasional use of paracetamol (up to 4 g/day), ibuprofen, or antihistamine, hormonal contraceptives and hormone replacement therapy.
Prevalence and Risk Factors of Reventilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason

Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients in the last two categories for whom it significantly prolongs life expectancy. Overall, the treatment is well tolerated, its principal adverse effects being discomfort related to the mask.

In certain patients, morning dyspnoea when the mask is removed has been described. This is disabling as it limits everyday activities for at least 30 minutes, and defines deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work after a night of rest.

The aim of this study is to investigate the prevalence of and factors associated with reventilation syndrome (DS) in a population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU, so as to better understand the mechanisms. Patients with DS will subsequently be invited to participate in a therapeutic trial.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* ventilation for whatever reason
* in the ST mode
* not in life support
* at more than 1 month after the last episode of respiratory decompensation

Exclusion Criteria:

* guardianship
* inability to understand instructions and provide consent
* uncontrolled psychiatric disease
Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat

The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4).
* Centor Score of 0 to 3 points at screening.
* Female and male subjects with 18-75 years of age.

Exclusion Criteria:

* Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS).
* Centor Score of 4 points at screening.
* Presence of exanthema.
* Presence of oral mucosal plaques e.g., soor.
* Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).
Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are:

* Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence?
* Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity?

Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence.

Participants will:

* Complete a baseline electroencephalography (EEG) and self-report questionnaires.
* Complete three one-hour intervention sessions (IMPROVE or control) each one week a part.
* Complete a post-intervention EEG and self-report questionnaires.
* Complete five ecological momentary assessment (EMA) surveys a day for 21 days.
* Complete self-report questionnaires one-month after their last intervention session.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
* Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week \[women/men\] with at least two binge episodes \[4/5+ drinks for women/men in a 2 hour period\] in the past month)
* Elevated psychological distress defined as a total score of \> 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
* 18 years of age or older
* Can read and comprehend English

Exclusion Criteria:

* Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
* Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
* Current comorbid moderate to severe substance use disorder other than alcohol and opioids
* Limited or no access to a smart phone that is compatible with the mobile application
* Participation in Phase One
* Possibility of being pregnant (by self-report)
* Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer
Homeopathic Preparation Plumbum Metallicum for Lead Poisoning

Saturnism, or lead poisoning, is defined by clinical symptoms (affecting primarily the nervous, hematopoietic, gastrointestinal, cardiovascular, musculoskeletal, renal and reproductive systems) compatible with exposure, in the short or long term, to lead or to its compounds, and can manifest as acute or chronic symptoms, pursuant to the intensity and duration of the signs and symptoms. Measuring serum concentration is the primary method for diagnosing and accompanying exposed workers. Presently, elevated lead counts are reversed by using drugs whose effectiveness is contested on various fronts. Experimental studies shows the efficacy of homeopathic preparations in controlling blood lead levels in laboratory animals, creating the need for controlled studies that evaluate the effectiveness and safety of these preparations in humans.The objective of this study was evaluate the effectiveness of the homeopathic preparation Plumbum metallicum in reducing the blood lead level of workers exposed to this metal.


Eligibility Criteria:
Inclusion Criteria:

* had not taken a leave of absence for any reason for a period greater than seven days in the 60 days prior to the intervention;
* where in good medical condition, as analyzed by their medical records and physical exam;
* had an initial blood lead level less than the maximum biological concentration permitted, which is 60µ/dL in Brazil.

Exclusion Criteria:

* workers who, in the last six months, had used medication that interferes/d with the level of lead in the blood, such as EDTA, BAL, penicillinase and DMSA;
* workers who had the right to vacation during the study period;
* workers who did not give their consent to participate in the study.