cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study of Vinpocetine in Healthy Volunteers

The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.

The planned study seeks to provide preliminary data to assess the benefits and safety for vinpocetine to address cognitive problems in two groups of patients. One group are patients with epilepsy in whom cognitive problems are common, but there is currently no specific treatment available. Vinpocetine has been shown to improve memory in animals and also has anticonvulsant activity. The other group are people who suffer cognitive/behavioral problems from fetal exposure to alcohol or anticonvulsant drugs. In animals, vinpocetine has been shown to mitigate these deficits. We propose to extend our prior preliminary studies by conducting a Phase I study in healthy volunteers, a Phase I study in adolescents with cognitive impairments from fetal alcohol exposure, then Phase II studies in patients with epilepsy and in adolescents/adults with cognitive impairments from fetal alcohol or antiseizure medication (e.g., valproate) exposure. The proposed investigations are guided by prior PK and PD studies in animals and humans. They are designed to provide data on the dosages needed to provide levels comparable to effective animal studies and provide data on the potential efficacy and safety of vinpocetine in improving cognition in order to direct more definitive randomized trials in the future.

Specific Aim: To determine the maximum tolerated oral dose of vinpocetine in healthy adult volunteers and develop data on pharmacokinetic response curve for vinpocetine effects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 18-40 years old.
2. Proficient English.
3. Use of appropriate contraception if woman of childbearing potential.

Exclusion Criteria:

1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
2. Those who score \>18 overall on the BDI-II or \>0 for item #9 (suicidal thoughts) at screening.
3. Use of centrally active medications.
4. History of allergy to vinpocetine.
5. IQ\<80.
6. BMI≥30.
7. Pregnancy or lactation.
Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol

Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).

Higher brain centers responsible for bladder function may be related to the presence of incontinence.

The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.

Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.

Higher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.

The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* lower or upper urinary tract dysfunction
Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture

This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear.


Eligibility Criteria:
Inclusion Criteria:

* Arthroscopy confirmed small to medium full rotator cuff tear
* Unilateral rotator cuff injury
* Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
* Young and middle-aged patients aged 20 to 60

Exclusion Criteria:

* Previous shoulder surgery (incision or arthroscopy)
* Combined with diseases of other parts of the same limb
* Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
* Bilateral onset
* Unable or unwilling to receive clinical follow-up
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia

This study aims to explore the effect of narrative enhancement and cognitive therapy in improving self-stigma, self-esteem, depression and hope of patients with chronic schizophrenia.

86 participants with chronic schizophrenia in two different hospitals in northern Taiwan were recruited in this study. All participants were randomized into experimental and control groups through block randomization. After randomization, the participants in control group received routine care and the others in experimental group received Narrative Enhancement and Cognitive Therapy(NECT) which contains 20 times group meetings. The research tools include demographic data, the Internalized Stigma of Mental Illness Scale (ISMIS), the Discrimination and Stigma Scale (DISC), Rosenberg self-Esteem scale (RSES), Beck Depression Inventory (BDI-II) and Herth Hope Index (HHI). The questionnaires were collected for three times, including before the intervention, 12 weeks after intervention, and after the end of intervention. The collected data were analyzed by IBM SPSS 24.0 statistical software. The descriptive statistics include mean, standard deviation, minimum, maximum, frequency distribution, and percentages; the Generalized estimating equations (GEE) were used to explore the effect of Narrative Enhancement and Cognitive Therapy on self-stigma, self-esteem, depressive symptoms and hope in patients with schizophrenia after controlling demographic data.

Eligibility Criteria:
Inclusion Criteria:

* People with Schizophrenia for more than two years.
* The age is between 20(included) and 64(included).
* Can communicate with Mandarin or Taiwanese.
* The score of the Mini-Mental State Examination (MMSE) is above 24(included).
* The score of the Positive and Negative Syndrome Scale(PANSS) is below 60(included).
* People are willing to participate in this study, can read and know the consent and can sign on the consent by their own.

Exclusion Criteria:

* Exclude people with a personality disorder, brain injury, cognitive impairment, Intellectual Developmental Disorder or substance use disorder.
* people who are not willing to sign the consent.
* people can not read.
* people can not communicate with Mandarin or Taiwanese.
Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma

The goal of this observational pilot study is to explore whether we can identify biomarkers predictive for the diagnosis of adrenocortical carcinoma in blood. Five participants who are suspected to have adrenocortical carcinoma will undergo an adrenal vein sampling in order to obtain a blood sample from the adrenal vein. This blood sample will be analyzed and compared to blood samples taken from the adrenal vein of 20 control patients, which are patients who do not have adrenocortical carcinoma. The blood samples of the control patients will be drawn during routine medical care.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in the study group, a subject must meet all of the following criteria:

* Patient age ≥18 years
* High clinical suspicion of adrenocortical carcinoma, based on clinical signs (due to hormonal overproduction), steroid hormone profile and radiological features (e.g. tumor size ≥4cm, inhomogenous aspect and tumor attenuation of HU ≥10)
* Able to provide signed informed consent

In order to be eligible to participate in the control group, a subject must meet all of the following criteria:

* Patient age ≥18 years
* Routine diagnostic process includes AVS
* No suspicion of malignancy
* Able to provide signed informed consent

Exclusion Criteria:

Patients are not able to participate if:

* They have a known allergy to (iodinated) contrast fluid
* They use vitamin K antagonizing anticoagulants or DOAC's, except for when on the day of the adrenal vein sampling the anticoagulants are already stopped for the following adrenal surgery, and in case of using vitamin K antagonizing anticoagulants the INR is \<3
* The platelet count is below 20
* Anatomy of the adrenal vein is not suitable for performing the AVS procedure, based on the judgement of an experienced interventional radiologist
* Contraindications for use of Synacthen
* They have a known hypersensitivity to any of the substances of Synacthen
* They are pregnant
SoftHand Comparison Study

A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.

This study will measure improvements in outcomes obtained from laboratory testing of the SHP and i-Limb from baseline to after 8 weeks of daily use. A secondary analysis will incorporate the subjects' existing prosthetic hands. Finally, surveys and usage data collected through the SHP and i-Limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.

Eligibility Criteria:
Inclusion Criteria:

1. the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis);
2. the individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable;
3. the individual is a user of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic.

Exclusion Criteria:

1. individuals who have had transradial amputation for less than 6 months;
2. individuals who have been fit and trained to use a prosthesis but chose not to use one;
3. individuals who use the i-Limb Quantum myoelectric prosthesis;
4. clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy;
5. orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed);
6. visual problems that would interfere with the grasping;
7. co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history;
8. limited range of motion as assessed through range of motion testing;
9. inability to follow study instructions;
10. use of medications that might affect sensory and/or motor functions.
Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and protein biomarkers will also be investigated.

Treatment will be prescribed by HCPs in accordance with their clinical judgement and the prescribing information for Edaravone. The decision to prescribe Edaravone to the participants should be made separately from the decision to enroll then in the study. There will be no randomized assignments to treatment and no restrictions on the use of commercially available medications (but those participating in an experimental study, even if taking Edaravone, will be excluded). No experimental treatment is evaluated in this study. The intervention is limited to the collection of blood and urine samples for biomarker testing.

During the estimated study period, eligible patients who are prescribed Edaravone within the approved indication will be invited to participate in the study. An initial screening/baseline visit will be scheduled for participants who are considered for study participation.

Participants in this study will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles \[each cycle consisting of 28 days\], corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation. Throughout the study period, the investigators will record participant baseline and follow-up information and perform clinical and biomarker assessments.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 years or older at enrollment
* Sporadic or familial ALS diagnosed as possible, probable, probable-laboratory supported or definite as defined by the World Federation of Neurology revised El Escorial criteria
* Decision made to prescribe Edaravone prior to screening
* Participant will likely be able to obtain commercial Edaravone and likely to complete 6 cycles of treatment, per site investigator estimation
* Participant either naïve to Edaravone or who did not receive any Edaravone does within 1 month prior to screening
* Signed informed consent by the subject, or a witness if a subject cannot read or write or is physically unable to talk or write, obtained before any study-related activities are undertaken

Exclusion Criteria:

* Participant with a contraindication to Edaravone
* Participant is participating in an interventional clinical trial
A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.

By using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments. And exploring the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.

Monoclonal gammopathy (MG) is an asymptomatic pre-cancerous clonal proliferation of plasma cells. The onset of this disease is concealed, usually discovered by chance by patients who undergo protein electrophoresis to detect monoclonal gamma globulin (M protein) due to various clinical symptoms and disease evaluations. Due to the insidious onset of monoclonal immunoglobulin, involving multiple organs, and the non-specific clinical symptoms, it is more prone to misdiagnosis. This study hypothesized that among patients who first came to the hospital for treatment, some patients had elevated serum monoclonal immunoglobulin levels but were not initially diagnosed with hematology department, but instead sought medical attention from other departments due to other symptoms. In this study，by using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments，and to explore the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital;
* Age: over 18 years old;
* There are sufficient remaining serum samples and extensive informed consent has been signed.

Exclusion Criteria:

* Early diagnosis of hematological diseases such as plasma cell or other B lymphocyte proliferative diseases；
* Improper storage or repeated freeze-thaw of remaining serum samples.
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast

The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in fat content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.

Participants will be asked to report to the lab for their first main trial, having not eaten for 12 hours, and refrained from caffeine and alcohol intake and strenuous exercise for 24 hours. Both trials will take place at the same time of day.

Upon arrival height and body mass will be recorded and a cannula will be inserted into a vein in the back of the hand and a 10 ml blood sample will be taken.A visual analogue scale (VAS) will then be used to subjectively measure the participant's appetite pre-breakfast.

Participants will then be provided with one of the two breakfast meals that are being tested in a randomised order. The two breakfasts consist of a high fat breakfast or high fat plus additional whey protein. A drink of water shall also be consumed, the volume of which depends on the trial being carried out. The high fat breakfast will consist of scrambled egg yolks made with single cream and butter (Tesco, Hertfordshire, UK). The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total). For the whey protein trial, 23.9g whey protein isolate (Lacprodan DI-9224, Arla Foods, Denmark) shall be added to water and incorporated into each meal as a drink on the side, in order to provide 20g whey protein.

A timer shall be set when the participant takes their first mouthful of breakfast, and they will be required to rest for the following 3 hours. At 15, 30, 45, 60, 90, 120, 150 and 180 minutes post-breakfast 10 ml blood samples shall be collected. Every 30 minutes during this period the appetite VAS will also be completed. After this participants will be provided with a standardised lunch meal which shall consist of pasta with a tomato and basil sauce, olive oil and cheddar cheese, along with a 350 ml drink of water. The macronutrient distribution of the lunch is 13% protein, 49% carbohydrate, 38% fat. Following this, the post-breakfast procedure shall be repeated for another period of 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years old (male)
* Recreationally active (\>30 minutes of structured exercise, 5 times/week)

Exclusion Criteria:

* Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)
* Taking any prescribed medication
* Regular breakfast skipper
* Food allergies or intolerances
* Eating disorders
* Smoker
Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior.

Severe injurious behaviors in children with autism spectrum disorder are challenging. First line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths.

Therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial.

The present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.

Packing therapy has never been assessed, namely in children with severe injurious behavior and autism spectrum disorder.

The aim of the present study is to evaluate the beneficial effect of wet versus dry therapeutic body wraps through an exploratory randomized controlled open label blinded outcome assessment approach.

The primary objective is the comparison of change in ABC irritability scores from baseline to 3 months between the two groups. According to the potential recruitment, we plan to recruit 30 subjects in each group. This sample size could allow us to detect a minimum effect size of 0.74 between the 2 groups (considered large in literature) with a power of 80% (two-sided test and type I error of 5%).

As described elsewhere, wet or dry session will be organized through twice-a-week sessions for a 3-month duration.

Comparison in primary outcome (ABC irritability score) between the 2 groups will be performed using Analysis of Covariance (ANCOVA) adjusted for the baseline value. The standardized difference (effect size) will be computed taking into account the adjustment for baseline and its 95% confidence interval will be estimated using a bootstrap resampling. The validity of the ANCOVA model will be checked by examining the model residuals.

The same methodology will be used for the secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* a current diagnosis of autism, Asperger syndrome, atypical autism according ICD-10 criteria confirmed by specialized clinical assessment;
* presenting severe behavioural disturbances such as hetero and self-injurious behaviours, automutilation, severe motor hyperactivity, severe stereotypies.
* having a systematically consultation by a neuro pediatric.

Exclusion Criteria:

* children with known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.
* patients with stabilized seizure condition, antiepileptic medication should be stable for at least 4 weeks.