cyrilzakka/clinical-trials huggingface dataset:
Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

This goal of this study is to assess whether lavender aromatherapy during gynecologic and urogynecologic outpatient procedures is associated with a decrease in patient anxiety levels. Based on similar interventions in other specialties of medicine, the investigators hypothesize that patients exposed to lavender aromatherapy during their procedure will have less anxiety than those who are not exposed to lavender aromatherapy.

Patients who present to the Loyola Urogynecology office for an outpatient procedure will be invited to participate. Patients who consent to participate will be asked to complete pre-procedure questionnaires including an assessment of their level of procedural anxiety. Subsequently, patients will be randomized to receive either lavender aromatherapy or saline aromatherapy (placebo) during their procedure. Post-procedural levels of anxiety will then be assessed. Changes between pre- and post-procedural anxiety will be compared between the treatment and placebo control groups.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing the following gynecologic/urogynecologic office procedures: colposcopy, loop electrical excision procedure (LEEP), endometrial biopsy, intrauterine device (IUD) insertion, hysteroscopy, Nexplanon removal, cystoscopy, urodynamics, botox intravesical injection, and transurethral bulking injection
* English speaking
* Ability to complete questionnaires

Exclusion Criteria:

* Pregnancy
* Allergy to lavender scent
* Lung disease including asthma or chronic lung disease
* Anosmia or problems related to smell
* Chronic headaches or migraines
* Inability to complete questionnaires
QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
* Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening

Exclusion Criteria:

* Certain medical conditions may exclude patients from participation.
* Should not have participated in another clinical study within 4 weeks of study start
* Smokers are not eligible for participation
* Blood loss of donation of 400 mL or more within 2 months of study start
* Pregnant women or women who are breast feeding
* Past medical history of clinically significant ECG abnormalities
* Connective tissue disorders other than systemic sclerosis.
* Active infection or history of systemic parasitic infection
* History of immunodeficiency diseases, including a positive HIV test result
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety

Other protocol-defined inclusion/exclusion criteria may apply
Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors

To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the "new" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.

This study is a Single-center Phase II, Open, Three-Arm clinical trial. We prospectively enroll patients who undergo ISR for ultra-low rectal tumor in the department of General Surgery, Huashan Hospital, Fudan University. Patients with ileostomy closure are randomly divided into two groups (TMS group and false stimulation group), and healthy volunteers were recruited. The differences of task-state fMRI between healthy volunteers, and ISR patients (both preoperative and postoperative) are compared, combined with rectal function scores (Wexner score, LARS score) and quality of life scale (EORTC QLQ-C30, EORTC QLQ-CR38). Proctoanal manometry are used to find the precise location of the proctoanal motor function area in the cerebral cortex, and to evaluate the effect and value of TMS on postoperative anorectal motor function remodeling in patients with ISR.

Eligibility Criteria:
Inclusion Criteria:

* Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.
* Patient who is willing to participate in the study, and voluntarily sign informed consent.

Exclusion Criteria:

* Anastomotic leakage or other serious complications occur after surgery.
* Advanced tumor, tumor recurrence or metastasis.
* Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.
* Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.
* Combined with organic brain disease and drug abuse history.
* Combined with other mental diseases.
* Pregnant or lactating women.
Validation of DRAGON Versus a Simplified DRAGON/Machine Learning

The CT-DRAGON score can predict long-term functional outcome after acute stroke treated by thrombolysis. However, implementation in clinical practice is hampered by a lack of validation in the broad spectrum of stroke patients undergoing thrombectomy, whether or not in combination with thrombolysis or conservative treatment. Furthermore, the CT-DRAGON score considers multiple items, which are not always readily available in every setting. This study aims to investigate whether either a simplified version of the CT-DRAGON score with only three clinical items or a machine learning technique could be as powerful and more feasible.

The investigators aim to validate the CT-DRAGON score in all ischaemic stroke localisations and for all treatment options, including a conservative treatment policy. The predictability will then be compared with on the one hand simplified prognostic models that include only a selective set of highly predictive parameters that have already been described in the literature, such as patient age, National Institutes of Health Stroke Scale (NIHSS) and pre-stroke modified Rankin Scale (mRS). On the other hand, machine learning techniques, that incorporate a large set of variables and have recently shown some promising results, will also be applied to predict long-term outcome after ischaemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* all patients diagnosed with a stroke

Exclusion Criteria:

-
Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy

Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.

This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive outpatients aged 18 to 75 years old.
2. FD patients defined by the Rome III classification.
3. Willing to choose pCLE and no organic diseases.

Exclusion Criteria:

1. Severe liver, heart, or kidney diseases.
2. Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
3. Pregnant or breastfeeding women.
4. Inability to give informed consent.
5. Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.
Safety and Tolerability of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars

The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.

A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female aged greater than 19 years
2. Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose

Exclusion Criteria:

1. History of cell therapy
2. Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
3. Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
4. Positive for virus infection
5. Use of Anticoagulant therapy or NSAIDs
6. Thrombocytopenia or other coagulation disorder
7. History of keloid scars
8. Infectious disease or other dermatitis in the area of the atrophic scar
9. Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
10. Use of systemic steroid medication
11. History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
12. Use of retinoid medications
Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms

Idiopathic Parkinson's disease is a common neurodegenerative disease, with a prevalence of around 2% in people over 65 years of age in France.

This pathology affects the dopaminergic pathway but also other systems: cholinergic, noradrenergic and serotoninergic.

The symptoms of Parkinson's disease are motor but also non-motor with sleep, smell, cognitive, psychiatric, digestive, urinary, dysautonomic, painful disorders. The discomfort can be such that invasive and expensive solutions have been developed. Invasive or expensive techniques (deep brain stimulation, lesional microsurgery by gamma knife or ultrasound, duodopa or apokinon pumps) brought significant benefits to patients. Opportunities for clinical improvement using less expensive and lighter devices should be sought.

The Remedee endorphin band device is a device that emits millimeter-band electromagnetic waves on the wrist. The device stimulates subcutaneous nerve endings and activates a physiological response leading to the release of endorphins in the brain. Endorphins are involved in several physiological processes, including pain control.

Mu-opioid receptor (MOR) agonists do not only relieve pain, but have effects related to mesolimbic dopaminergic pathways. Indeed, the opioid and dopaminergic systems are closely linked at the cellular level. Endorphins, through inhibition of the release of the neurotransmitter GABA upon binding to the μ receptor, are also linked to an increase in dopamine.

Intervention 1 Name : VERUM

Description :

Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months.

Intervention 2 Name : SHAM

Description:

Control arm (SHAM): delivery of an inactive medical device for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Follow-up for Parkinson's disease for more than 5 years
* Treatment stable for at least 3 months
* Having retained sufficient autonomy to allow participation in the study
* Hoehn and Yahr score in ON DOPA \<4

Exclusion Criteria:

* Genetic forms of the disease
* EVA\> 7 over the previous week
* Moderate to severe cognitive impairment
* Pathology or condition (other than Parkinson's disease) that can generate motor disorders
* Allergy to metals and / or silicone
* Dermatological pathology on the wrists
* Metal object at one of the wrists (implanted metal material, piercing)
* Presence of a tattoo on one of the wrists
* Wrist circumference \<14.5 cm or\> 21 cm i.e. wrist incompatible with the MD template
* Inability of the patient to put on and / or wear the template of the medical device
* Pregnant or breastfeeding woman
The Role of the Vagus Nerve in Tumor-to-Brain Communication in Lung Cancer Patients

the aim of this study is to measure brain metabolism in patients with lung cancer.FDG uptake in the brain in patients with malignant tumors will be compared to the amount of tracer activity found in patients who have benign pulmonary process. if differences between the brain uptake of FDG in the two groups will be found, further assessment will be performed in order to evaluate if such differences could be attributed and specifically localized to the brain regions innervated by the vagus


Eligibility Criteria:
Inclusion Criteria:

* patients with SPN referred for routine whole body FDG-PET imaging
* patients with NSCLC and patients with no evidence of lung cancer on further follow up

Exclusion Criteria:

* patients with a clinical history of vagotomy, abdominal surgery. brain tumor, brain trauma or CVA. or those with a systemic inflammatory disease
Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia

the records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. children were divided into two groups according to the presence of amblyopia and ocular deviations and other parameters were compared between groups.

The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D) astigmatism with or without amblyopia.

The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were noted and compared between the groups. Best corrected visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between amblyopic, fellow and non-amblyopic eyes.

Eligibility Criteria:
Inclusion Criteria:

* astigmatisma ≥1,75 Diopter

Exclusion Criteria:

* systemic diseases additional ocular diseases neurological diseases
Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth

In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.


Eligibility Criteria:
Inclusion Criteria:

* Children will be included that have at least one primary molar with deep cavitated carious lesions in occlusal surface.

Exclusion Criteria:

* Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity. Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Non-institutional (community dwelling) woman of any race
* Between 18-45 years at the first screening visit
* Have regular menstrual cycles
* Diagnosed with invasive breast cancer stage I, II, III within the previous eight months
* Have physician agreement for patient participation

Exclusion Criteria:

* No menstrual bleeding cycles
* Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance
* Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer)
* Stage IV breast malignancy
* Residency outside United States
* No telephone
Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure

Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result.

The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Presenting a situation at risk of acute respiratory failure
* Requiring thorax imaging when they were treated.

Exclusion Criteria:

* Patients with anatomically incomplete thoracic imaging (e.g., technical acquisition error).
Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.

In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily)

Exclusion Criteria:

* Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks
* Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks
* Participants with allergic history to the medications used
* Participants with previous gastric surgery
* The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* Pregnant women.
Screening and Identifying Hepatobiliary Diseases Via Deep Learning Using Ocular Images

Artificial Intelligence may provide insight into exploring the potential covert association behind and reveal some early ocular architecture changes in individuals with hepatobiliary disorders. We conducted a pioneer work to explore the association between the eye and liver via deep learning, to develop and evaluate different deep learning models to predict the hepatobiliary disease by using ocular images.


Eligibility Criteria:
Inclusion Criteria:

* The quality of fundus and slit-lamp images should clinical acceptable.
* More than 90% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate.
* More than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate.

Exclusion Criteria:

* Images with light leakage (\>10% of the area), spots from lens flares or stains, and overexposure were excluded from further analysis.