cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.

A phase 3, 52-week, open-label study to evaluate the long-term safety and tolerability of SEP-363856 in patients with schizophrenia in Japan. Participants will take flexible dose of SEP-363856 (50 mg/day and 75 mg/day) every night at bedtime for 52 weeks in an open-label manner.

Eligibility Criteria:
Inclusion Criteria:

1. Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.
2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
4. Must have a PANSS total score \>=60 at Screening and Baseline.
5. Must have a CGI-S score \>=3 at Screening and Baseline
6. Judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Baseline and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening
7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination, vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).

Exclusion Criteria:

1. Have a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder or substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of \>= 10 years during the subject's lifetime, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment
2. At significant risk of harming self, others, or objects based on Investigator's judgment.
3. Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
4. Female subjects who are pregnant or lactating.
5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.
Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury

In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.

In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.

Eligibility Criteria:
Inclusion Criteria:

* spinal cord injury with or without OH
* aged 19 or older
* ASIA Impairment Scale (AIS) A to D
* neurological level of injury above T6.

Exclusion Criteria:

* Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
* Those who are taking medications affecting BP that cannot be stopped
Pregnancy/Implantation Rates Using a Day 3 Score Versus Graduated Embryo Score Plus a Biochemical Marker (sHLA-G)

Objective: To compare pregnancy rates and implantation rates when embryos are selected based on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.

Comparing pregnancy rates and implantation rates when embryos are selected using the most common criteria for embryo selection on day 3 - the morphology-(number of blastomere, their shape and size and the percentage of fragmentation)vs a graduated embryo score accumulated over 72 hours and the expression of sHLA-G at 44-46 hours post fertilization.

Eligibility Criteria:
Inclusion Criteria:

* Self paying ART patients

Exclusion Criteria:

* Abnormal uterus
* Specific Immunologic factors
Use of a Microbial Sealant to Reduce Surgical Site Infections.

Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean contaminated colorectal procedures (Class 2).


Eligibility Criteria:
Inclusion Criteria:

1. Nonemergent colon and/or rectal abdominal surgical procedures
2. Women of child-bearing potential must have a negative serum HCG assay prior to surgery
3. Ages ≥18 years.

Exclusion Criteria:

1. Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
2. Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.
3. Undergoing a significant concomitant surgical procedure (e.g., Whipple \& organ transplant surgery).

   The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy.
4. History of prior laparotomy within the last 60 days of this planned procedure.
5. Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
6. Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7
7. Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.
8. Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
9. Receiving antibiotic therapy within the 1 week prior to the date of surgery.
10. Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
11. Preoperative serum creatinine \> 3 mg/dL or renal failure requiring dialysis.
12. History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
13. History of major organ transplantation, including bone marrow transplantation.
14. Taking systemic steroids \>10 mg prednisone daily or remicade within 2 weeks prior to surgery or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count \< 200.
15. Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
16. Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
Factors for Impairment of Renal Graft Function in Intensive Care

hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed.

the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization.

Optimization of renal graft management in the ICU and management by nephrologists after the ICU


Eligibility Criteria:
Inclusion Criteria:

* kidney graft
* \> 18 years
* first hospitalization in ICU

Exclusion Criteria:

* chronic hemodialysis before ICU
* transfer to intensive care immediately after transplant within 24 hours
ESTIMATION OF BALANCE STATUS IN HEMIPARETICS

Although Balance Evaluation Systems Test(BESTest) is an important balance assessment tool to differentiate balance deficits, it is time consuming and tiring for hemiparetic patients. Using artificial neural networks(ANNs) to estimate balance status can be a practical and useful tool for clinicians. The aim of this study was to compare manual BESTest results and ANNs predictive results and to determine the highest contributions of BESTest sections by using ANNs predictive results of BESTest sections. 66 hemiparetic individuals were included in the study. Balance status was evaluated using the BESTest. 70%(n=46), of the dataset was used for learning, 15%(n=10) for evaluation, and 15%(n=10) for testing purposes in order to model ANNs. Multiple linear regression model(MLR) was used to compare with ANNs.

The demographics and clinical information of the participants' were recorded. Clinical information consists of some basic medical data for the patients. Hodkinson Mental Test was used to assess the cognitive status of the participants if they met inclusion criteria. Balance Evaluation Systems Test was used to assess balance status of the participants.

Feed-forward back-propagation ANNs was used in this study by employing Levenberg-Marquardt training algorithm. Tangent hyperbolic transfer functions were used in the hidden layer. Matlab (Version R2017b, Mathworks Inc, USA) was used in ANNs modeling. 70% (n=46), 15% (n=10) and 15% (n=10) of the data obtained from the participants were used for training, validation and test in the study, respectively. Multiple linear regression (MLR) models also were used to compare with ANNs.

Firstly, the ANNs were modeled for the first aim of the study. We used the data of the five traditional balance tests in the BESTest that did not use the real values (the timing or distance), but just the classified values (0-3 points in the BESTest) to train ANNs. Five balance tests were functional reach test (cm), one leg standing test for right and left side (sec), 6-metre timed walk test (sec) and timed up and go test (sec). Then, we compare the manual total BESTest scores with the predicted scores by the ANNs.

Secondly, we removed 6 sections of the BESTest one by one and modeled with the remaining 5 sections of the test to estimate the total BESTest score. After this modeling, we removed each item one by one in the first section and estimated the first section total score. We repeated the process for all the sections of the BESTest.

Statistical Analysis

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 35-65 years,
* Able to walk independently or with a walking aid,
* Able to stand at least 1 minute independently,
* Having single hemiparesis,
* Getting at least 8 points from Hodkinson Mental Test.

Exclusion Criteria:

* Having comorbidities affecting their balance,
* Having communication problems.
* Patients who cannot comprehend the directions given to them were excluded from the study.
Trial of Impact of Crime Group Intervention for Jail Inmates

This pilot study is designed to evaluate the efficacy of the Impact of Crime (IOC) group intervention for jail inmates. The hypothesis is that participants in IOC will show decreases in criminogenic thinking, decreases in shame, increases in guilt, and increases in empathy, which in turn will be reflected in reduced recidivism (official records and self report), relative to those randomly assigned to a treatment as usual group.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must be male
* Must be currently incarcerated jail inmate
* Must be sentenced
* Must speak, read, and write in English with sufficient proficiency to use workbook and participate in group sessions
* Must be assigned to the jail's "general population"

Exclusion Criteria:

* Actively psychotic
* Assigned "keep separate" from other group members
Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)

The purpose of this study is to evaluate the safety of 2.0 mg/kg and 4.0 mg/kg sugammadex given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium in cardiac patients


Eligibility Criteria:
Inclusion Criteria:

* Cardiac patients of NYHA Class II to III
* ASA class maximally 4
* Age at least 18
* Scheduled for elective, non-cardiac surgery under general anesthesia with propofol in the supine position, with planned muscle relaxation using rocuronium and allowing for 12-lead ECG assessment during surgery;
* Given written informed consent.

Exclusion Criteria:

* Disorders interfering with the reliability of the assessments (e.g. ECG measurements), such as paroxysmal atrial fibrillation or the presence of a pacemaker
* Known or suspected neuromuscular disorders impairing NMB
* Known or suspected significant renal dysfunction
* Known or suspected (family) history of malignant hyperthermia
* Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
* Intended) use of medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and/or the time of administration (such as antibiotics, anticonvulsants and Mg2+ )
* Pregnancy (pregnancy to be excluded for women both from medical history and by an hCG test within 24 h before surgery, except for women who were not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
* Childbearing potential without using any method of birth control or using only hormonal contraception as birth control (subjects were allowed to participate if they were willing to use a condom, or a diaphragm with spermicide, or IUD, or have a vasectomized partner (\>6 months) or abstinence, for one month after participation in the trial)
* Breast -feeding
* Prior participation in any trial with Org 25969
* Participation in another clinical trial not pre -approved by Organon, within 30 days of entering into trial 19.4.309
Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin

The purpose of the study is to show that the intake of L-arginine and metformin improves muscle function and delays disease progression in patients with Duchenne's muscular dystrophy.

This is an investigator-initiated, open-label, single-center, proof-of-concept-study. The study medication consists of L-arginine and metformin. The duration of the study is 16 weeks and comprehends one screening and four study visits.

Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of DMD
* Patients 7 - 10 years of age at time of screening
* Ambulant

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in another therapeutic trial
* Use of L-arginine, L-citrulline or metformin within the last 3 months
* Known individual hypersensitivity to L-citrulline or metformin
* Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of the investigator
An Epidemiological Investigation on Correct Wearing of Mask by Hood Test

The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

1. Overall design：This study uses the methods of cross-sectional survey and chance sampling.
2. Sign the Informed Consent Form.
3. Investigation on the basic situation of personnel: The gender, age and education level of the subjects were analyzed as the factors influencing whether the mask was worn correctly or not.
4. Investigation on the types of wearing masks： 1) The types of masks worn by the subjects were recorded as the basis of stratified statistics.

2) Mask suitability testing：

1. Visual inspection whether the mask is close to the face with obvious gaps.
2. Breathing test Are there any obvious gaps or whether the cotton around the mask is blown when the subject taking a deep breath.
3. Spray test The FT-30 qualitative fitness test system of 3M company was used to test the suitability and correctness of wearing mask.

In the spray test, all subjects underwent a sensitivity test to prove their ability to smell the bitterness of the reagent, and then sensitive subjects can participate in the hood test..

In order to objectively reflect the overall situation of the subjects, it is necessary to cover many ages and educational levels of men and women.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, Persons under the age of 18 need to obtain the consent of their legal guardians；
2. The subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects；
3. People who volunteered to take part in the study；
4. There was no respiratory infection in nearly one month.

Exclusion Criteria:

1. People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
2. People with any history of drug allergy；
3. People who have participated in the experiment are not allowed to participate in this study for the second time;
4. Pregnant women；
5. The healer after COVID-19 's infection；
6. After questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test；
7. Those who are participating in clinical trials of other drugs / devices；
8. Subjects with poor compliance or unwilling to cooperate with the operation as required；
9. The researchers believe that any other situation that may affect the evaluation of the study.
NET-PD LS-1 Creatine in Parkinson's Disease

The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.

Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.

This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.

In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent and willing to commit to long-term follow-up
* PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis
* Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years.

Exclusion Criteria:

* Use of creatine 14 days prior to baseline or during the study
* History of known hypersensitivity or intolerability to creatine
* Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up
* Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.
Reablement Intervention for Older Adults Conducted by a Multi Professional Home Rehabilitation Team

Background: People live increasingly longer and are expected to function independently in their own homes to a greater extent than before. This puts great demands on the support given to older persons living at home, to be efficient and provide good conditions for them to manage on their own and experience good health. Short time goal directed reablement delivered by a multidisciplinary team is expected to strengthen the functional capacity and quality of life, while home care-hours and thus municipal expenditures decline. Theoretical focus of this project is related to international classification of functionality and disability (ICF) in which participation are understood as engagement in life situations and related to the environment as well as the person. Reablement is expected to extend the time of independent and autonomous life for older persons while also reducing municipal costs of elder care.

Aim: This research project measures the effects of reablement in terms of bio-psycho-social health among older people (65+). In addition, the project highlights older person's experiences of the intervention and the professional team´s experiences of working with reablement.

Methods: This is a randomized controlled study of the intervention reablement performed by the multiprofessional team with controls receiving usual home care. The effects are measured by self-reported health and quality of life, physical capacity, and home care hours. Data are collected at inclusion (applying for home care), after the three months intervention and at six months. Interviews with users are performed after the intervention, and staff experiences through written narratives.

Impact of results: This project will contribute with collecting possible evidence of reablement, and contribute with knowledge development of older persons' bio-psycho-social health and experiences.


Eligibility Criteria:
Inclusion Criteria:

* older adults, over 65 years
* residing in the central areas of Eskilstuna municipality
* applying for social care and services delivered by the municipality of Eskilstuna

Exclusion Criteria:

* life-threatening disease
* severe mental illness
* severe cognitive dysfunction
* other conditions that prevent the participants from expressing their will or desires