cyrilzakka/clinical-trials huggingface dataset:
Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness

This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English or French
* Legally authorized surrogate available to provide informed consent
* History of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection.
* Has been followed clinically on the CRS-R for a minimum two weeks and has undergone a minimum of 4 assessments with the CRS-R.
* Serial CRS-R scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record).
* CRS-R screening examination completed by research staff confirms the absence of a behavioral sign of consciousness on a least one CRS-R subscale.
* Medically stable (i.e., no systemic illness or disease) and capable of independent ventilation

Exclusion Criteria:

* History of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment.
* Evidence or surrogate report of uncontrolled seizure disorder
* Metallic brain implant or implanted electronic brain medical devices or pacemaker
* Subjects with craniectomy
* History of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed
* Pregnancy
BREAST ADM Trial for Alloplastic Breast Reconstruction

This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
* Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.

Exclusion Criteria:

* Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
* Patients with a history of previous breast reconstruction procedures.
* Patients with prior radiation treatment to the breast or with prior mantle radiation
* Any patient with a contraindication to breast reconstruction
* Patients undergoing an axillary node dissection with clearance
* Patients with an allergy to Polysporin or any of its ingredients.
* Patients with contraindications to any of the acellular dermal matrices:

  • DermACELL: Allergy to Gentamicin, Vancomycin\[12\]
* The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.
Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal barrier dysfunction and increased intestinal permeability was associated with bacterial translocation which is believed to prompted these infections.The purpose of this clinical trail is to observe the potential capability of FMT in reduce the bacterial translocation and alleviate infectious complications by the reconstruction of a gut functional state.

Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus minimizing bacterial translocation and alleviating infectious complications. The investigators will further examine the effect of FMT on the incidence of infectious complications，duration of clinical course and mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of severe acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus
2. Onset of pancreatitis more than 2 weeks
3. Intestinal bacterium screening tips gut dysbacteriosis
4. Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients.

Exclusion Criteria:

1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
2. Pregnancy and lactation women
3. Not signed the informed consent
Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C

The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.

Panels A and B of the PLUS study were designed to assess the safety and tolerability, pharmacokinetics, and viral kinetics over four weeks of two doses of Locteron™ (230 ug and 640 ug) given every two weeks in comparison with PegIntron® given weekly in treatment-experienced subjects with chronic hepatitis C of any genotype who were co-administered weight-based oral ribavirin. The two cohorts of 16 subjects each in Panels A and B consisted of subjects who had failed prior interferon therapy. In Panel A, 8 subjects were randomized to and completed 4 weeks of treatment with 320 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. In Panel B, 8 subjects were randomized to and completed 4 weeks of treatment with 640 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. When the results of Panel A and Panel B were known, conduct of Panel C for 12 weeks in treatment-naive patients with chronic genotype-1 HCV was considered unnecessary and cancelled, and an entirely new study was begun instead.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of chronic hepatitis C
* Positive HCV RNA test with a level \>= 1 x 104 IU/mL (by RT-PCR)

Exclusion Criteria:

* Decompensated Liver Disease
* Positive test for serum antibodies to the human immunodeficiency virus (HIV), hepatitis A (HAV-IgM), o hepatitis B (HBV- +Hepatitis B surface antigen)
* A history of severe psychiatric disease, including major depression
* A history of immunologically-mediated disease, COPD, severe asthma, severe cardiac disease, active cancer or cancer within last 5 years, seizures within the past 5 years or epilepsy, solid organ or bone marrow transplant, uncontrolled thyroid disease, or clinically significant retinopathy
* Pregnant or lactating females
Mobile Individual Atrial Fibrillation Management Program

The aim of the study is to develop a mobile individual atrial fibrillation management (m-BAFY) program and to evaluate the effects of the program on symptom severity, medication compliance, self-care agency and quality of life. The main questions that the study aims to answer are as follows;

* Is the m-BAFY program effective in symptom control?
* Is the m-BAFY program effective in increasing medication compliance?
* Is the m-BAFY program effective in improving self-care agency?
* Is the m-BAFY program effective in improving quality of life? In order to measure whether m-BAFY is effective, the researchers will download this application to one group's phones, and the other group will not download the application.

Participants;

* Use this application for 3 months
* Patients in the intervention group use the application at least once every two weeks.
* Fill in the symptom diary in the application.
* Clinical interviews are called for the first interview, at the end of the 1st month and at the end of the 3rd month.

The research sample was divided into two groups, the intervention and control groups, using the simple randomization method. The m-BAFY program prepared for the intervention group will be downloaded to their phones and asked to use it for three months. A unique username and password will be created for each patient. Patients' records and navigation between tabs will be tracked via the Firebase system. Motivational messages and feedback will be given to patients. Patients will be informed that they will be provided with consultancy services within the scope of the program content throughout the research.

The standard program of the clinic will be applied to the patients in the control group. No intervention will be made by the researcher. Follow-up data will be collected by the researcher at the end of the 1st and 3rd months using the tools in the data collection form.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years old and above
* Having an AF diagnosis
* Being literate
* Being able to understand and speak Turkish
* Being able to use a smartphone
* Being willing to participate in the study

Exclusion Criteria:

* Hearing and speech problems
* Cardiac surgery \< 3 months before the interview date
* Presence of psychiatric disease
* No data entry for at least 2 weeks
Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia.

Participating physicians will identify potential participants based on their medical judgment for a new prescription of QUVIVIQ® (daridorexant) 50 mg. Physicians will discuss with the potential participant in person to briefly describe the study (purpose, confidentiality, questionnaires, as well as compensation). Potential participants interested in participating in the study will be asked to give their authorization to share with the PROxy Network their contact information by signing an authorization form. A designated PROxy team member will then contact the potential participant to explain the study in more details and to assess the eligibility. If the potential participant agrees to participate and provides verbal consent, he/she will be invited to visit the Participant Portal on the PROxy website to sign the ICF and complete the online baseline questionnaires.

Five days prior to each study timepoint (1 month, 2 months and 3 months following baseline questionnaire completion), participants will receive an email inviting them to fill their study questionnaires. This e-mail will be sent every other day to the participant who have not completed the questionnaires. In the case where a participant has not completed the questionnaires within a period of 5 days after the first email was sent, a call will be made by a designated PROxy team member to remind the patient to complete the questionnaire. Participants who don't complete the questionnaires in the 5 days following the call will be excluded from this timepoint analysis.

Eligibility Criteria:
Inclusion Criteria:

* Signed ICF prior to any study-mandated procedure.
* Has received a first prescription of daridorexant 50 mg to treat insomnia, treatment start has not exceeded 7 days prior to enrollment.
* Ability to read and understand French or English.

Exclusion Criteria:

* Patients participating in a clinical trial.
* History of daridorexant use in the past (i.e., samples provided by the physician before prescription).
* Taking a concomitant medication to treat insomnia.
* Already started daridorexant more than 7 days prior to enrollment.The 7-day period is necessary to allow flexibility between the time of prescription and PROxy first contact to participant. Beyond this 7-day period, patients may already have experienced benefits from daridorexant. To minimize bias in baseline results, these patients will be excluded.
Treatment of Adolescent Suicide Attempters (TASA)

The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide.

Suicide is the third leading cause of death in adolescents and is a major public health problem. Depression is the most common diagnosis for adolescent suicide attempts. Little is known about what treatment is best for these adolescents since they are usually excluded from participation in research studies.

Participants in this study will be randomly assigned to receive carefully monitored antidepressant medication with routine support and management, cognitive behavioral therapy (CBT), or a combination of antidepressant medication plus CBT.

Eligibility Criteria:
Inclusion Criteria:

* At least one suicide attempt or interrupted attempt within the past 45 days
* Continuously reside with a primary caretaker (parent, legal guardian, foster parent) for at least 6 months that can provide legal consent
Transcranial Magnetic Stimulation in Substance Use Disorder Patients

To determine the effect of substance use disorder on cortical excitability using transcranial magnetic stimulation (TMS) , it's a scientific study

The numbers for substance use disorders are large, and we need to pay attention to them. Data from the 2018 National Survey on Drug Use and Health suggest that, over the preceding year, 20.3 million people age 12 or older had substance use disorders, and 14.8 million of these cases were attributed to alcohol. When considering other substances, the report estimated that 4.4 million individuals had a marijuana use disorder and that 2 million people suffered from an opiate use disorder. It is well known that stress is associated with an increase in the use of alcohol and other substances, and this is particularly relevant today in relation to the chronic uncertainty and distress associated with the COVID-19 pandemic along with the traumatic effects of racism and social injustice,Trans-cranial magnetic stimulation (TMS) is a safe and painless technique for evoking activity in neurons in the human brain through the intact scalp and skull). Since its introduction in the mid-1980s is used to evaluate the cortico-spinal tract, cortical motor areas,, map motor and cognitive functions, study neural networks, and modulate brain function with a potential therapeutic aim, On one hand, the development of specific stimulation protocols, such as the cortical silent period (CSP) and paired-pulse paradigms, as well as the emerging concept that motor cortical output is affected by non-primary motor areas, including the ventral and dorsal premotor cortex, supplementary motor area, and cingulate cortex, has allowed the use of TMS to explore inhibitory and excitatory interactions within motor cortical regions in several neuropsychiatric disorders. Different TMS protocols can be used to study different components of cortical excitability and provide insight in to the regulation of different neurotransmitter systems.

Eligibility Criteria:
Inclusion Criteria:

1. Age:above18yearsold
2. males only
3. Patients fulfilling diagnostic criteria of substance use disorder according to DSM-5

Exclusion Criteria:

* 1. patients with other comorbid psychatric disorders. 2-patients with medical disease. 3.patients wirh epilepsy or family history of epilepsy. 4-cardiac pacemaker 5-metal implants in head as participant will be applied to magnetic field of the TMS 6-age yonnger than 18
Clinical and Histological Evaluation of Hesperidin as a Direct Pulp Capping Material

Direct pulp capping technique is one of the oldest known treatments for exposed pulp tissue, and there is a continuous requirement for the most efficient materials to be used in this approach. Successful pulp capping is the usual way to preserve the vitality of tooth and avoid root canal treatment or surgical tooth extraction.


Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene,
* Sound wisdom teeth with closed apices with normal pulp vitality response
* No periodontal disease or periapical lesions on periapical radiograph
* Cooperative patients approving to participate in the study

Exclusion Criteria:

* Medically compromised participants
* Evidence of parafunctional habits
* Heavy smokers
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis
* Severe periodontal problems or pathological periapical changes
* Teeth with open apex or pulp calcification
Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia

The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.


Eligibility Criteria:
Inclusion criteria:

* patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements
* having signed a consent for study participation

No Inclusion Criteria:

Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...)

* Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months
* Ongoing neuroleptic treatment
* Pregnancy or breastfeeding
* Lack of insurance coverage

For patients, are added the following no inclusion criteria are added:

* Trembling cervical dystonia
* Injection of botulinum toxin in the past three months
Influence of Tumor Associated Immunity on the Number of Lymph Node Retrieved After Colorectal Cancer Surgery (Preliminary Study)

Hypothesis of this study is that increased immunity of primary tumor affects the increased number of lymph node retrieved. This study investigates whether immunity-related cytokine expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph node retrieved in colorectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically confirmed colorectal cancer 2. Non-metastatic cancer (cTNM I, II, or III) 3. Over 20 years of age 4. Curative resection (R0)

Exclusion Criteria:

* 1. Patient with distant metastasis 2. History of chemotherapy or radiation therapy for malignancy 3. Patient receiving immunosuppressive or anti-inflammatory treatment 4. Hereditory colorectal cancer 5. Preoperative chemoradiation therapy for colorectal cancer 6. Pregnancy 7. Emergency
Atrial Fibrillation Screening with MobiCARE in Subjects with Health Care Examination

This study aimed to detect and diagnose atrial fibrillation early by conducting a screening test for atrial fibrillation using a continuous electrocardiography monitoring device for those who have undergone a health screening examination.

Early detection through atrial fibrillation screening tests in high-risk patients with stroke is intended to prevent stroke by starting stroke prevention treatment early. It is intended to detect asymptomatic atrial fibrillation patients early through examination and ultimately improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 65 years or older who have at least one stroke risk factor\*
2. Subjects aged 19 years to \<65 years who have two or more stroke risk factors.
3. Subjects aged 75 years or older

   * Stroke risk factors: heart failure, hypertension, diabetes, vascular disease, women, stroke/systemic embolism/transient ischemic attack (although stroke/systemic embolism/transient ischemic attack among stroke risk factors is considered to have two risk factors)
   * Heart failure: a history of heart failure diagnosis or a history of current heart failure treatment.
   * Hypertension, Diabetes: Diagnostic History
   * Vascular diseases: Significant coronal atherosclerosis (when 70% or more of the computed tomography or coronary angiography is present or coronary intervention is performed), 50% or more of the carotid artery disease, peripheral vascular disease, history of myocardial infarction, and aortic plaques

Exclusion Criteria:

1. Subjects diagnosed with atrial fibrillation in the past
2. Subjects aged under 19 years and other vulnerable research subjects
3. Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin rash/hives that are difficult to apply patches continuously
4. Subjects who have a structural abnormality in the thorax and is difficult to attach the device.
5. Subjects who have cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized therapy-pacemaker or defibrillator)
6. Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization due to arrhythmia that can be life-threatening
7. Subjects who are deemed inappropriate to participate in the research as judged by the researcher for other reasons.