cyrilzakka/clinical-trials huggingface dataset:
Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome

The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.

The gut microbiome plays a pivotal role in the intestinal pathophysiology. The mucosal microbiome is in the front face of microbiome-host cross-talk. Confocal laser endomicroscopy (CLE) can provide realtime mucosal images during ongoing endoscopy. We hypothesized that the mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches and participate the evolvement of the mucosal microbiome.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age \< 80 years old
* Scheduled for colonoscopy in Qilu Hospital

Exclusion Criteria:

* antibiotic usage within 2 months
* probiotic or prebiotic usage within 2 months
* ascites
* jaundice
* liver cirrhosis
* impaired renal function
* coagulopathy
* fever
* pregnancy
* breastfeeding
* inability to provide informed consent
* known allergy to fluorescein sodium
Altered Vestibular Perception and Transcranial Magnetic Stimulation

The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences motion sensation. Patients with vestibular disorders frequently have disabling disturbances of perception. Related to these symptoms is that large areas of the cerebral hemispheres and the cerebellum receive information from the vestibular, visual and somatosensory systems that is integrated within a vestibular cortical network into an accurate perception of spatial orientation. Interrupting the pathways that process information about the direction of gravity and angular velocity leads to impairment of the internal estimate of gravity and the perception of body motion. The strategy of this research is to use repetitive transcranial magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss of function within the central vestibular pathways at the very beginning of adaptation. Our underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to affect ocular motor control of vestibular reflexes and perception alike but with a cortical lesion there will be dissociation between ocular motor control and perception. This research helps to understand the mechanisms involved in the perception of vestibular information and the cerebellar influence on processing vestibular input and offers a unique opportunity to make major inroads into the understanding and eventually treatment of the often incapacitating symptoms of patients with vestibular disease


Eligibility Criteria:
Inclusion Criteria:

1. ages 18-70
2. informed consent

Exclusion Criteria:

1. disturbed consciousness
2. other neurological or systemic disorder which can cause dementia or cognitive dysfunction
3. prior history of a major psychiatric disorder
4. history of definite stroke
5. focal lesion on MRI exam
6. use of anxiolytic, antidepressant, neuroleptic or sedative medication
7. has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
8. History of seizure or a family history of epilepsy;
9. increased intracranial pressure, such as after infarctions or trauma
10. pregnancy or possibility of being pregnant unless precluded by a negative pregnancy test
11. history of any significant head trauma.
Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety

Randomized, blind parallel group design. Single intake of 55 g high Epicatechin /Melissa dark chocolate containing 160 mg Epicatechin per 55 g serving or single intake of 55 g low Epicatechin/ oat bran white chocolate containing \< 0,00045 mg Epicatechin per 55 g serving.

A Total of 128 participants, 64 in each group, approx. equal number of male and female. There will be replacement of Drop-Outs until data from 128 participants are completed.

The primary endpoints will be performance in a pictorial memory task and a verbal memory task .

The secondary endpoints will be performance in a working memory test, Saliva cortisol, Visual analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.


Eligibility Criteria:
Inclusion Criteria:

* Healthy by history
* normotensive (BP between 90/60 mmHg and 140/90 mmHg)
* BMI between 18 and \< 30 kg/m2
* male or female
* aged between 18 and 30 years
* native or fluent German-speaking
* Prüfungsangstfragebogen (PAF) total or subscale interference score T value \> 60

Exclusion Criteria:

* Known hypersensitivity or allergy to cocoa, Melissa, oat, vanillin, milk, soja, nuts
* gluten intolerance
* lactose intolerance
* acute or chronic psychiatric disorder including drug or alcohol abuse
* women who are pregnant or breast feeding
* any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc., infections)
* known or suspected non-compliance
* smoking (\> 5 cigarettes per day)
* participation in one of our previous studies using the same memory tests in the past 2 years
* participation in a study with investigational drug within the 30 days preceding and during the present study
* long-term medication within last 3 months (oral contraceptives are disregarded)
A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* HbA1c value between 7.0 and 10.0%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2
* Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
NRS 2002 as a Predictor of Prognosis in COPD With Respiratory Failure

This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to March 2019. The following variables will be prospectively studied: age, sex, height, weight, respiratory function indicators, arterial blood gas analysis results, biochemical data, nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis predictor in COPD patients with respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of COPD at West China Hospital during April 2017 to March 2019
* Partial pressure of O2 (PaO2) \< 60 mmHg and/or partial pressure of CO2 (PaCO2) \>50 mmHg
* Age ≥ 18 years
* Respiratory rates \> 23 bpm

Exclusion Criteria:

* Pregnancy or during lactation
* Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
* Refused to participate in this study
Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute lymphoblastic leukemia Ph negative
* age more than 18 yo

Exclusion Criteria:

* diagnosis of acute lymphoblastic leukemia Ph positive
* acute lymphoblastic leukemia relapsed/refractory
* lymphoblastic lymphoma
fMRI and Visceral Perception Upon Capsaicin Infusion

Brain imaging has shown abnormal brain activations in response to visceral stimulation in patients with the Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD). To investigate the possible role of the Nucleus of the Solitary Tract (NTS), the primary relay station in the brainstem for vagal afferents, its activation in IBS and functional dyspepsia patients will be evaluated. Prior to this, an exploratory study in healthy volunteers will be conducted. This will be the first high magnetic field fMRI study (7T) evaluating the possible role of NTS activation in visceral abdominal pain. Moreover, this will be the first pharmacological fMRI study using duodenal capsaicin infusion as a chemical stimulus, which is more physiological than mechano-stimulation in the upper gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* Of female sex
* Based on medical history and previous examination, no gastrointestinal complaints can be defined.
* Age between 18 and 65 years.
* BMI between 18 and 30 kg/m2
* Women in fertile age (\<55 years old) must use contraception or be postmenopausal for at least two years.
* All subjects should be right-handed.

Exclusion Criteria:

* Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos and/or other metal objects;
* History of major head trauma or head/brain surgery;
* History of claustrophobia;
* History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
* Use of medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study;
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator);
* Pregnancy, lactation, wish to become pregnant;
* High alcohol consumption (\>15 alcoholic consumptions per week);
* Using drugs of abuse;
* Self-admitted HIV-positive state;
* Known allergic reaction to capsaicin;
* High intake of spicy (capsaicin containing) food (meaning an estimated intake of \> than 1.5mg/day), due to possible desensitization of the capsaicin receptor TRPV1 (see further below);
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study;
* Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion.
An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation

The aim of this phase is to examine the feasibility and acceptability of the Augmented Reality (AR)-based and electroencephalography (EEG)-based neglect detection and rehabilitation tool.


Eligibility Criteria:
Inclusion Criteria:

* ages18 and older
* acute stroke
* admitted to inpatient rehabilitation
* presence of neglect (Behavioral Inattention Test total score \<129, or scoring below pre-defined cutoff score in at least one of the six subtests)
* more than 10/% missed targets on the Augmented Reality Screening Test
* intact vibration (positive test on Vibration Sensation Test)
* intact auditory function (positive test on Auditory Sensation Test)
* English speaking

Exclusion Criteria:

* inability to follow one-step directions at least 80% of the time
* current diagnosis of dementia, Parkinson's disease, multiple sclerosis, or space-occupying tumor
* metal in the head that causes interference with the EEG system
* self-report of previous positive photic stimulation test
Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

This study is a phase II, single arm, controlled, open label internal pilot.

This internal pilot will be the first prospective study to assess the feasibility and efficacy of adding metformin in non-diabetic rectal patients who undergo standard of care neoadjuvant chemoradiation therapy (CRT). The translational aim of the study will inform on predictive factors (such as p53) and mechanism of action (hypoxia, proliferation). Metformin has been used for decades in patients with type 2 diabetes and has an extremely safe toxicity profile. With current interest in the use of metformin as a cancer therapeutic in non-diabetics, this study is expected to provide proof-of principle data for a larger study.

Eligibility Criteria:
Inclusion Criteria:

1. Plan for care inclusive of:

   i. standard of care neoadjuvant chemoradiation ii. planned total mesorectal excision (TME)
2. Histologically confirmed adenocarcinoma of the rectum
3. At least one of the following:

   i. T3 or T4 lesions ii. T2 lesions ≤ 1 mm to the mesorectal fascia iii. Node positive rectal tumor
4. ECOG performance status of 0 or 1
5. Provide written informed consent
6. Female participants of childbearing potential agree to use adequate methods of contraception from the start of metformin administration until the start of CRT. Contraception will not be required to be continued during or after CRT as this treatment renders participants infertile. Clinically acceptable methods of birth control for this study include intrauterine devices (IUD), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge.

Exclusion Criteria:

1. Diagnosis of diabetes
2. Current use of metformin
3. Prior pelvic radiation
4. Life expectancy \< 6 months.
5. Active infection
6. Creatinine \> 1.5X ULN, within 1 month prior to baseline
7. AST, ALT \> 2.5X ULN, within 1 month prior to baseline
8. Bilirubin \> 1.5 ULN, within 1 month prior to baseline
9. Pregnant or breastfeeding women
Investigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief

The application of a novel topical formulation for the treatment of muscular pain and stiffness (Egyfil), containing hyaluronic acid, SH-Polypeptide-6 and SH-Oligopeptide-1, is investigated to evaluate efficacy and safety in 26 patients with stiffness and pain. Single-Arm, Pre-Market, interventional study.

26 male and female patients, ranging from 24 to 78 years old, will receive Egyfil Pain Lotion given for the treatment of pain and stiffness over a three-days period. The primary objective of the study is to evaluate the clinical performance of the lotion in providing relief from stiffness, reduced mobility, and muscle tension pain.

Eligibility Criteria:
Inclusion Criteria:

1. signed participants informed consent form (ICF);
2. male or Female, aged \> 18 years at the time of the signature of ICF;
3. 3 to 10 rating according to the Numerical Rating Scale (NRS), applied in participants with muscle tension pain;
4. willing to follow all study procedures;
5. willing to follow indications.

Exclusion Criteria:

1. use of analgesics within the 24 hours prior to V1;
2. damaged skin in the area of treatment;
3. infective or prior inflammatory processes near the area of treatment;
4. ongoing cutaneous allergies;
5. serious and chronical pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy;
6. allergy to lotion components (aqua (water), glycerin, caprylic/capric triglyceride, aloe barbadensis leaf juice powder, simmondsia chinensis seed oil (simmondsia chinensis (jojoba) seed oil), phenoxyethanol, ammonium acryloyldimethyltaurate/vp copolymer, carbomer, tocopheryl acetate, tocopherol, benzoic acid, sodium hydroxide, sodium hyaluronate, dehydroacetic acid, ethylhexylglycerin, butyrospermum parkii butter (butyrospermum parkii (shea butter)), sorbitol, SH-polypeptide 6; SH-oligopeptide-1
7. immune system illnesses;
8. uncontrolled systemic diseases;
9. known drug and/or alcohol abuse;
10. mental incapacity that precludes adequate understanding or cooperation;
11. participation in another investigational study.
Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients

Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. In our study we tried to find if there is any correlation in between Anti-tTG and degree of fibrosis in thyroid tissue (Post-operative specimen).

Most common auto-immune disease associated with Celiac disease is autoimmune thyroiditis. This association in between Celiac disease and aout-immune thyroiditis is related with asymptomatic rise in anti-tTG levels. In our study, we planned to show that if there is any correlation of thyroiditis related fibrosis in thyroid tissue with anti-tTG IgA ( immune-globulin A) and IgG (immune-globulin G).

Eligibility Criteria:
Inclusion Criteria:

* Thyroiditis patients operated for any indication

Exclusion Criteria:

* Patients with known IgA deficiency
Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery

Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid obesity, which is performed under general anesthesia. TAP block is an analgesic strategy covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are located. As far as the investigators know, this analgesic technique has never been studied in LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass surgery, compared to conventional therapy only.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* 18-70 years of age, inclusive
* scheduled for elective laparoscopic gastric-bypass surgery.

Exclusion Criteria:

* contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* pregnancy
* history of alcohol or drug dependence/abuse
* history of long term opioid intake or chronic pain disorder
* history of significant psychiatric conditions that may affect patient assessment
* inability to understand the informed consent and demands of the study
Optimizing Pharmacotherapy for Bipolar Alcoholics

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder

Exclusion Criteria:

* 1) Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
* 2) Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
* 3)Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
* 4) Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
* 5)Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery
* 6)Pregnancy
* 7)Inability or unwillingness to use contraceptive methods
* 8)Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol
Retrieval Practice and Schizophrenia

When people are tested on a previously learned material, they will later remember it better even when compared to a condition where they can re-study it. This phenomenon is called retrieval practice and is supported by an extensive research literature mostly carried out in normal students. This paradigm begins to be used in cognitive remediation programs in patients suffering from memory difficulties.

The objective of this study is to investigate whether retrieval practice is spared in patients with schizophrenia.

If effective, this method could be used in cognitive remediation programs.

Since episodic memory difficulties are supposed to be secondary to deficits in the initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that retrieval practice is spared in schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* French is the native language, or acquired before 5 years old
* People must be able to understand and follow the trial instructions

Specific inclusion criteria (for patients) :

* Diagnostic of schizophrenia, according to the DSM -5, clinically stable
* The treatment must remain unchanged during the trial

Exclusion Criteria:

* Severe or acute cerebral disease
* Other actual psychiatric disorder
* Use of drugs with high anticholinergic effect
* Irregular use of benzodiazepines medication, or high dose of benzodiazepin (more than 2 mg of lorazepam per day or equivalent)
* Inappropriate use of drugs

Specific exclusion criteria (for healthy subjects) :

- Diagnostic of schizophrenia of a relative up to the third degree