cyrilzakka/clinical-trials huggingface dataset:
Verticalization Robotic Exoskeleton DoC

Mobilization, specifically verticalization, has been shown to play a role in enhancing consciousness. Vestibular stimulation has the potential to influence the neural substrate of consciousness, but this modality has not been thoroughly explored. The primary aim of this study is to compare the influence of verticalization with and without vestibular input on level of consciousness in patients experiencing disorders of consciousness (DoC).


Eligibility Criteria:
Inclusion Criteria:

1. unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) following traumatic brain injury (TBI), intracerebral bleeding, ischemic infarction, or hypoxic brain injury
2. Medical clearance by a physician
3. 18-75 years old
4. Mobilization into standing for at least 10 minutes without signs of orthostasis

Exclusion Criteria:

1. Time since injury less than 4 weeks or more than 6 months
2. Mobilization into standing lasts more than 30 minutes
3. Severe osteoporosis
4. Muscle tone that prevents joint motion (Modified Ashworth Scale (MAS) 4)
5. Unstable fractures
6. Decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum)
7. Inability to fit device requirements\*

   * Height 4'8"-6'4", Weight 88-222 lbs., Hip Flexion 0-90˚, Knee Flexion 0-90˚, Plantigrade
Upper Limb Tremor Reduction in Essential Tremor Patients

This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor.

A prospective, randomized, blinded clinical trial. Subjects meeting all inclusion criteria will have five days of treatment with each of the three arms, received in a randomized order. Subjects will complete two rounds of assessments each day.

Arm 1: Inactive stim Arm 2: Stim therapy utilizing a specific dermatome Arm 3: Stim therapy utilizing a tailored frequency

Eligibility Criteria:
Inclusion/Exclusion:

Inclusion Criteria:

1. Between the ages of 22 and 80 years of age
2. A diagnosis of essential tremor (definite or probable based on TRIG criteria)
3. At least one hand exhibiting tremor \> 2 as assessed by the Essential Tremor Rating
4. Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
5. Stable tremor medications for at least 30 days prior to enrollment and the ability to maintain stable medications through the duration of the study

Randomization Inclusion Criteria

1. During the Baseline evaluation period, a median tremor score of \> 2 on at least one hand as assessed by the TETRAS finger to nose task, the duck wing task, OR the Archimedes Spiral AND
2. During the Baseline evaluation period, a median score of \> 3 on any one of the subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL)

Exclusion Criteria:

1. Previous surgical interventions for tremor reduction on the upper limb being used for inclusion in this study (eg, thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, or focused ultrasound)
2. Use of botulinum toxin for treatment to hand tremor within six months of enrollment
3. Suspected or diagnosed epilepsy or other seizure disorder
4. Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia
5. Pregnant
6. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
7. Numbness, tingling or pain affecting the tested upper extremity (eg, suspected or confirmed peripheral neuropathy, carpal tunnel syndrome)
8. Known allergy to silicone
9. Subjects are unable or unwilling to comply with the protocol requirements
10. Subject is part of a vulnerable population who is unable to give Informed Consent for reasons of incapacity, dementia, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
11. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Epidural vs. Wound Catheter Following Liver Resection

Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described.

This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia


Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled to undergo an open liver resection at this hospital will be eligible to participate.

Exclusion Criteria:

* Patients with a contraindication to either epidural or wound catheter
* Inability to give written, informed consent
* Aged less than 18 years old
* Liver resection combined with a secondary surgical procedure
* Body mass index of \<18 or \>40
* Pregnancy or lactation
* A history of chronic pain requiring regular opioid analgesia
* Prisoners
Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema

This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Having had mastectomy or breast conserving surgery
* Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm

Exclusion Criteria:

* The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users

To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four weekly intervention sessions with a time-and-attention-matched control condition.

This research study will test the effects of CHRP, a community-friendly risk reduction intervention, which is based on the Information-Motivation-Behavioral Skills model of health behavior change (IMB; Fisher \& Fisher, 1992), and, thus, is designed to enhance knowledge, motivation, and behavior skills for reducing drug- and sex-related HIV risk behaviors. Outcomes assessed will include urine toxicology screens, self-reported HIV drug- and sex-related HIV risk behavior, HIV/AIDS knowledge, risk reduction motivation, and risk reduction behavioral skills.

To measure the effects of CHRP, the investigators are proposing a two-condition (standard of care plus the CHRP intervention vs. standard of care plus a time-and-attention matched control condition) randomized design, balancing for participant gender. The investigators will assess participants at baseline, immediately post-intervention (i.e., at 4 weeks), and at 3-, 6-, and 12-month measurement points following the intervention. This assessment approach will allow the investigators to examine the trajectory of HIV risk reduction change including the decay or emergence of intervention effects.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Opioid-dependent and seeking methadone maintenance treatment
* Report drug- or sex-related HIV risk behavior in previous 6 months
* Able to read and understand the questionnaires, Audio Computer Assisted Self Interview (ACASI), and consent form
* Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., jail term)
* Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a licensed clinical psychologist

Exclusion Criteria:
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD

Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person (the host) who has received cells or organs (graft) from another person because the graft attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes (a type of white blood cells) are likely to play a role in the development of chronic GVHD. Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a new therapeutic approach to treat chroninc GVHD.

The main objective of this study is to assess the effectiveness and safety of several doses of ponesimod in subjects with chronic GVHD who did not respond to standard available treatments.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic immunosuppressant (IS) therapy
* Women of child bearing potential must have a negative pregnancy test and use reliable methods of contraception

Exclusion Criteria:

* Clinically significant medical conditions including active or uncontrolled infections, new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and uncontrolled diabetes.
* Karnofsky Performance Score \< 60.
* Immunosuppressant therapies other than allowed background therapy
* Anti-arrhythmic and heart rate lowering drugs.
* Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue

The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a promising method with a satisfactory resorption volume and patient and surgeon satisfaction. However, this technique allows for small to moderate breast augmentation and is therefore not suitable for patients wanting a significant increase.

Breast prostheses allow a significant increase. Numerous studies have shown an improvement in patient satisfaction and quality of life assessed using the BREAST-Q questionnaire.

On the other hand, very few studies have objectively evaluated the satisfaction of patients who have benefited from an autograft of adipose tissue as part of aesthetic breast augmentation. No study has yet compared the satisfaction of patients who have benefited from breast implants or lipofilling.

The aim of this study is to compare the satisfaction of patients who have benefited from breast augmentation by prosthesis or by lipofilling using a remote satisfaction interview.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (age ≥ 18 years)
* having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022
* not opposing the reuse of its data for scientific research purposes.

Exclusion Criteria:

* Woman who expressed her opposition to the reuse of her data for scientific research purposes
* Woman with a breast malformation: tuberous breasts or breast asymmetry of more than one cup
* Woman with comprehension difficulties
* Woman under guardianship or curatorship
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions

Background: In type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. Therapeutic patient education (TPE) is the key to successful management of the disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the Mediterranean region in France, and the care teams implementing them wish to promote joint reflection with sick teenagers and families to identify needs and expectations of everyone on priority skills to develop, to promote better management of the disease and improved quality of life.

Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions, to promote self-management of their disease and their treatment.

Method: Four audio-recorded focus groups will be organized in all 10 clinical settings (adolescents, parents and health professionals). Thematic analysis will be carried out from the transcript of the focus groups.

Expected results: The results will allow a joint reflection involving the participation of young patients, families, health professionals and the research team to build and implement new educational sessions that meet the identified needs. This action resulting from the research is expected to pool resources in different health facilities providing therapeutic education programs and to harmonize practices.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 11 and 16 years inclusive
* Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria
* Monitoring in the institutions participating in the research
* Speaking the French language (elementary level)
* Consent signed by the holders of the exercise of parental authority and the participant

Exclusion Criteria:

* Pregnant women, parturient women or breastfeeding mothers
* Persons deprived of liberty by a judicial or administrative decision
* Those hospitalized without consent under articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8
* Persons admitted in a health or social institution for purposes other than research (art. L.1121-6 health public code)
The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder

Participants with chronic orofacial pain caused by masticatory and neck muscles will be distributed in two groups, both followed with the same occlusal and self-care treatment. The experimental group will receive 5 sessions of physiotherapy applying a specific pressure on the trigger points while the control group will receive placebo through a simulation of the same technique. Orofacial perceived pain, pain pressure thresholds, catastrophizing, kinesiophobia, cervical disability, depression and anxiety will be evaluated at baseline, immediately after treatment and 3 months later.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years.
* Patients diagnosed of myofascial TMD with at least one TrP with referred pain.
* TMD patients with a current complaint of myofascial pain with more than 6 months of evolution.
* Patients with myofascial TMD initially treated with splint currently used, that has not been modified in the last 6 months, without improvement.

Exclusion Criteria:

* Patients treated with occlusal splint recently modified.
* Patients with acute TMJ diseases.
* Patients with systemic disease, neurological and muscular diseases.
* Patients with psychiatric or psychological disorders.
* Patients with cervical disc hernia and acute whiplash injury.
* Changes in the painkillers intake during the experiment.
Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia

The study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects

The objective of this study is to evaluate the feasibility of the LensAR Laser System to surgically intervene within the crystalline lens to improve vision by increasing amplitude of accommodation in patients having elected to undergo lens extraction and IOL implantation

Eligibility Criteria:
Inclusion Criteria:

* Subjects must sign and be given a copy of the written informed consent form.
* Subjects must have elected to undergo lens extraction and IOL implantation to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
* Cataract should not exceed LOCS III Grade 2.
* Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
* Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
* Subjects must be willing and able to return for scheduled follow up examinations for 6 months after cataract surgery or up to 3 years (at 6 month intervals) if no cataract surgery is performed.
* Subject must have central 7 mm of clear cornea without vascularization

Exclusion Criteria:

* Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
* Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
* Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
* Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
* Subjects with macular degenerative pathology.
* Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
* Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
* Subjects who cannot attain ocular dilation adequate to allow laser treatment within the minimum range based on the laser procedure to be applied.
* Subjects with known sensitivity to planned study concomitant medications.
* Subjects using systemic medication that is known to reduce the amplitude of accommodation (such as medication for motion sickness containing hyoscine or other antimuscarinic drugs, anticholinergic drugs, anti-psychotic drugs, tricyclic antidepressants and other drugs acting on the central nervous system).
* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Levels of Neuregulin-4 and Its Receptor ErbB4 in Periodontitis Patients With and Without Diabetes Type 2

The aim of this study is to assess the levels of neuregulin-4 and its receptor ErbB4 in the GCF and saliva in stage III and IV periodontitis patients with and without type 2 diabetes mellitus.

The aim of this study is to measure the levels of Nrg4 and ErbB4 in the GCF and saliva of periodontitis stage III and IV patients with and without type 2 diabetes mellitus and to correlate their levels with the periodontal clinical parameters and the blood glucose levels including the fasting plasma glucose level (FPG) and glycated hemoglobin (HbA1c).

This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.

Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.

Eligibility Criteria:
Inclusion Criteria:

* For periodontitis stage III and IV patients according to (Papapanou et al., 2018 and Tonetti et al., 2018)

  1. Bleeding on probing (BOP) ≥ 30%.
  2. At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD ≥ 6 mm in one or more sites.
  3. Tooth loss due to periodontitis ≥ 5 teeth.
  4. Presence of a minimum of 15 natural teeth. For diabetes and non-diabetic patients according to ("Diagnosis and Classification of Diabetes Mellitus," 2014)
  5. Patients with type 2 diabetes mellitus will be diagnosed as having type 2 diabetes mellitus ≥ 5 years before the study and treated with stable doses of oral hypoglycaemic agents and/or insulin under the supervision of an endocrinologist with their glycated haemoglobin level (HBA1c) \> 6%.
  6. Non diabetic Patients in the control and stage III and IV periodontitis groups will be selected as having Fasting plasma glucose (FPG) \<126 mg/dL.

Exclusion Criteria:

1. Individuals with any known systemic disease other than type 2 diabetes.
2. Pregnant and lactating women.
3. Individuals that received periodontal treatment within the last 6 months.
4. Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
5. Former or current smokers.
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
* Undergoing upfront AIs adjuvant treatment within 7 days.

Exclusion Criteria:

* Patients who disagree to participate this study
* Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements.
* The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.