cyrilzakka/clinical-trials huggingface dataset:
Exploratory Investigation on a Novel Catheter

An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.

In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.

Each subject will be followed during approximately one week, depending on the usual time between their TAI.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent.
2. Female and male aged 18-80 years.
3. Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
4. Patients considered suitable to participate by investigator.
5. Able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

1. Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
2. Previous enrolment in the present clinical investigation.
3. Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
4. Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
5. Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
6. Known anal or colorectal stenosis.
7. Active inflammatory bowel disease.
8. Acute diverticulitis.
9. Colorectal cancer.
10. Ischemic colitis.
11. Any anal or colorectal surgery within the previous 3 months.
12. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
13. Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
14. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. This registry will monitor patients undergoing VNS for stroke recovery in the Mount Sinai Health System and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery.

The Vagal Nerve Stimulation device implantation is a common, standardized neurosurgical procedure that has been performed for over two decades for the treatment of epilepsy and depression and has recently been approved for chronic ischemic stroke. The intended purpose of this registry is to monitor the safety, feasibility, and efficacy of vagal nerve stimulation for stroke recovery. This will be accomplished by monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. The secondary objectives of this study focus on the feasibility and efficacy of employing vagal nerve stimulation for ischemic stroke recovery, as well as obtaining qualitative data on the experience associated with stroke rehabilitation paired with VNS. Additional research questions regarding vagal nerve stimulation for stroke recovery may be addressed as well.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program
* Aged 18 or older
* History of ischemic stroke
* Upper extremity weakness
* Planned to undergo VNS implantation

Exclusion Criteria:

* Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.).
* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

This study is a prospective, multicenter, randomized controlled trial and aims to evaluate efficacy and safety of Xuanfei Baidu Granule in the treatment of influenza A.

This study plans to enroll 584 subjects. The subjects will be randomly divided into 4 groups according to the ratio of 1:1:1:1, and they will be treated with Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Xuanfei Baidu Granule combined with Baloxavir Marboxil tablet.1 bag of Xuanfei Baidu Granule and Xuanfei Baidu Granule Placebo in the morning and evening, and take with boiling water for 5 days. Baloxavir Marboxil Tablet was taken orally 2 tablets, once a day for 1 day.

The subjects were visited every day for 7 days after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged ≥18 and \<65, regardless of gender.
* Meet the western medicine diagnostic criteria for influenza in the "2020 Edition of the Diagnosis and Treatment Scheme for Influenza".
* Onset of illness within ≤72 hour.
* Body temperature ≥37.5℃ within 24 hours before treatment.
* Tested positive for influenza A virus by antigen.
* The subject understands and voluntarily signs the informed consent, and is able to follow the visit and related procedures prescribed by the program.

Exclusion Criteria:

* Individuals with known allergies to the test drugs, placebo components, or having allergic constitution.
* Meet the criteria for severe or critical cases as per the "2020 Edition of the Diagnosis and Treatment Scheme for Influenza".
* Patients with acute bacterial sinusitis, allergic rhinitis, tracheitis-bronchitis, pneumonia, herpetic pharyngitis, or similar diseases.
* Individuals with severe primary diseases in cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems.
* Patients with mental illness or those unable or unwilling to cooperate.
* History of epilepsy or febrile convulsions.
* Obesity (BMI \>30).
* Patients with acute and chronic gastroenteritis and unexplained diarrhea within 1 week before administration.
* Liver function test values (ALT, AST) exceed 60U/L;Serum creatinine over 106μmol/L.
* Use of other drugs for the treatment of the disease within 24 hours before administration (including antiviral, hormone and other Chinese and Western drugs and treatment methods).
* Suspected or confirmed history of alcohol or drug abuse, heavy smoker.
* Women who are pregnant or trying to become pregnant, breastfeeding women, those of childbearing age who are unable or unwilling to use adequate contraception during the trial or whose spouse is unwilling to use contraception.
* Immunodeficient, immunosuppressed patients or those who have received steroid therapy or other immunosuppressive therapy in the last 3 months.
* Received influenza vaccine within the last 12 months.
* Participants who have participated in other interventional clinical trials within the last 3 months.
* Participants considered unsuitable for this clinical trial by the investigator.
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
* Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
* Participant is male

Exclusion Criteria:

* Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
* Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
* Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
* Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
* Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
Career Management to Improve Education, Employment and Retention for People With Anxiety and Depression

The aim of the investigation is to evaluate the effectiveness and costeffectiveness of a model of supported employment (the Individual Career Management (ICM) model) designed to help people with common mental illness return to work.

The design of the study is a randomised controlled trial of two groups in a natural setting (intervention group vs control group). The primary outcome is paid employment. Standard care for all participants is a package of psychological therapy (IAPT). The intervention is an additional package of employment support (ICM) delivered alongside standard care.

The intervention group and control group will both receive standard care. The intervention group will receive ICM support in addition to standard care and the control group will be given details of other employment programmes in the local area, in line with current IAPT practice. The control period will last six months. There will be no fewer than 184 participants in the study (92 in each arm).

The study will take place at the Southwark Psychological Therapies Service at the SLaM NHS Foundation Trust. Patients that meet the inclusion criteria will be invited to attend an interview where written informed consent and baseline measures will be obtained. The participant will then be randomly assigned to either the intervention or control group. All participants will be invited to attend a second interview at the end of a six month period where followup measures will be taken. If the intervention is available at this time, control group participants may then be offered the opportunity to receive it.

A randomised controlled trial of supported employment for people with common mental health problems has never been carried out in the UK, therefore this study will be the first of its kind. The results will help to determine if ICM is an effective and costeffective service and will provide the foundations for further research in this area.

Eligibility Criteria:
Inclusion Criteria:

* Must be either unemployed or off sick for at least two weeks if employed at the time of entry to the study
* Must be legally allowed to work in the UK
* Must be between the age of 18-65 for men, and 18-60 for women (based on UK retirement age)
* Must have received an IAPT assessment and been offered psychological therapy
* Must not have been receiving therapy for more than one month
* Must be interested in obtaining competitive employment
* Must have given full written consent to participate in the study

Exclusion criteria:

* People who are employed and attending work or off sick for less than two weeks at the time of entry to the study
* People who do not have the legal right to work in the UK
* People who have not yet received an IAPT assessment
* People who have received an IAPT assessment but not eligible for psychological therapy
* People who have been receiving therapy for more than one month
* People who are not interested in obtaining competitive employment
* People who do not give written consent or who lack mental capacity to give consent at the time of the study
Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.

Primary efficacy endpoint will be assessed during and after 12th IP applications.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria and one of the following:

   1. Immunostaining test: patients who have reduced or no type 7 collagen in staining degree of immunofluorescence. Other antigens (laminin-332, type 17 collagen, plectin, integrin α6β4, type 5 and type 14 keratin, etc.) are normal in immune-staining.
   2. COL7A1 mutational analysis: confirmation of COL7A1 genetic mutation.
2. Subject with skin ulcer lesions of dystrophic epidermolysis bullosa meet the following criteria, on the screening start day (Visit 1) and treatment start day (enrollment day) (Visit 3):

   1. Subject has two skin ulcer lesions judged as comparable to compare the safety and efficacy by investigator during screening period and prior to the IP application (enrollment day).
   2. Two skin ulcer lesions meeting criteria stated in 2a) should be sized 5-20 cm2 (inclusive)
3. Subject who has two comparable target skin ulcer lesions, and each lesions with a change of size equal to or less than ±50% at treatment day (Visit 3) compared to that of screening day (Visit 1)
4. Subject who has no clinical evidence of infection related signs/symptoms, or visible necrosis in the target skin ulcer area (area including ulcer lesion and surrounding area where the IP is to be applied).

Key Exclusion Criteria:

1. Subject who requires antibiotics due to bacterial infection on skin of the target skin ulcer area (area including ulcer lesion and surrounding area where the IP is to be applied).
2. Female subjects: pregnant woman (indicated by serum hCG test result at screening), breast-feeding patient, all sexually active patient, with child bearing potential in case of female\*, who is not willing to contracept\*\* during the clinical trial.
HAND MASSAGE AFTER ACUTE CORONARY SYNDROME

Patients suffering from Acute coronary syndrome may be hospitalized again in a shorter time than expected, and after being discharged, they may live within the limitations imposed by the disease until the end of their lives. This situation causes anxiety in individuals. Today, various methods are used to reduce high levels of anxiety. Massage is the planned and purposeful application of touch and is the most common, most important and oldest complementary treatment used in traditional practices. It is also thought that the comfort levels of individuals experiencing ACS will increase by reducing their anxiety. This study was planned to determine the effect of hand massage applied to patients with ACS on comfort, anxiety level and vital signs.


Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing Acute Coronary Syndrome for the first time,
* Anxiety score of 16 and above (moderate and severe anxiety)
* 18 years and above,
* No psychiatric disease,
* Patients who do not have communication problems and are competent to answer all questions,

Exclusion Criteria:

* Patients with uncontrolled Diabetes mellitus
* Patients who cannot communicate and have confusion,
* Those who have any limb, vascular problem or wound that prevents hand massage,
* Thrombophlebitis, occlusive arterial disease, fever etc. Those for whom massage therapy is inconvenient due to illness,
Mobius® Post-cesarean Pain Randomized Control Trial

The purpose of this study is to investigate whether the use of the Mobius® retractor decreased post-operative pain after cesarean section verses conventional retractor use. Based on clinical experience and a pilot study, we suspect that the retractor will decrease overall pain as well as lateral pain.

This is a prospective, randomized, patient blinded trial of standard surgical retraction versus Mobius® retraction at cesarean delivery. Women will be approached by their provider at their 36 week prenatal visit regarding potential study participation. They will be given a letter describing the study. If a woman is interested, she will be contacted by a study nurse who will obtain informed consent. Ideally, women will be approached prior to the onset of labor or date of scheduled cesarean delivery so as to provide adequate time to review the study and ask questions. Women who undergo antenatal admission will be also approached by their provider regarding possible study participation and given a recruitment letter. If they are interested, then a study nurse will obtain informed consent.

Consenting women will be randomized after the decision to deliver by cesarean section is made. Randomization will be performed in blocks to control for scheduled versus unscheduled cesarean deliveries using a random numbers generator. Assignments will be kept in sequentially number opaque envelopes. Women will not be informed of their assignment until after discharge from the hospital. Efforts will be made in the operating room to avoid disclosing group assignment and the consent forms will not contain the specific name of the retractor under study. The operative team will be aware of group assignment.

Participants will complete a 7 item pain scale each post-operative day until discharge. This pain scale has been used in a pilot study and found to be accurate. The pain scale is a single page and takes less than 5 minutes to complete.

Charts will be reviewed to obtain clinical information which may have an impact on post-operative pain. This includes information about current and past substance abuse. Because of the increased amounts of post-operative pain experienced by women who use methadone during pregnancy, this group of women will be excluded from the study. To protect the information regarding substance abuse, a certificate of confidentiality has been obtained from the NIH.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Potential for having a cesarean section (scheduled or unscheduled) at Dartmouth Hitchcock Medical Center

Exclusion Criteria:

* Less than 18 years old
* Unable to consent due to language barrier or psychiatric illness
* Current methadone use for chronic pain
* Stat cesarean section
Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)

The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.


Eligibility Criteria:
Inclusion Criteria:

* Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP
* Voluntary patient
* patient in the national healthcare insurance system

Exclusion Criteria:

* Patient with central sleep apnea
* Treatment other than CPAP
* Person with liberty privation or under legal protection
Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis

Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease.

Aim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia).

Methodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables.

Expected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.


Eligibility Criteria:
Inclusion Criteria:

* Age range: Over 18 years old
* Patients with confirmed infection by COVID-19 (positive real-time PCR) in ICU with:
* Respiratory failure receiving ventilatory support and high parameters
* Severe pneumonia with rapid progression
* Ability to sign informed consent

Exclusion Criteria:

* Pregnant women
* Contraindication of plasma administration due to history of anaphylaxis during transfusions
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.

This is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the Yale site into treatment. Participants will be screened at various collaborating ob-gyn centers for possible PMS symptoms, and direct referrals from the community will also be accepted. Subject participation length is about 7 months with 6 scheduled study visits.

Methodology: After successfully completing the screening and qualification phase, participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind treatment. Participants will be evaluated monthly during the randomization phase for adverse events, concurrent medication, and primary and secondary efficacy variables.

.

Eligibility Criteria:
Inclusion Criteria:

* Female outpatients between the ages of 18 and 48 who are:

  * Menstruating
  * Meet criteria for moderate to severe PMS
  * Report PMS symptoms for at least 9 our of the 12 months prior to screening; 4) \*Are using an adequate method of birth control.

Exclusion Criteria:

* Any candidate who:

  * Fulfills MINI (DSM-IV) criteria for a serious AXIS 1 disorder
  * Fulfills DSM-IV criteria during the charting phase consistent with a diagnosis of psychotic disorder, bipolar disorder or major depressive disorder
  * Has a severe, co-existing condition that, in the investigator's opinion, renders the patient unsuitable for the study
  * Poses a significant risk of suicide
  * Takes ongoing medication that could treat PMS symptoms
  * Has a history of hypersensitivity or adverse reaction to fluoxetine or calcium
  * Is lactating, pregnant or is planning to become pregnant during the course of the study.