cyrilzakka/clinical-trials huggingface dataset:
Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (\> 10 years) with Irritable bowel syndrome (IBS)

The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period . After the screening phase, eligible patients will be randomly assigned to either co-micronised form palmithoylethanolamide/polydatin 200 mg/20 mg, or the equivalent placebo (without the active treatment, replaced by equal amount of microcrystalline cellulose), three times a day, in a 1:1 ratio, for 12 weeks. Study visits were conducted every 4 weeks during the treatment period. All the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size = 4, pre-allocated to centres. Patients and study investigators will be blinded to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock.

After the screening visit and at the end of treatment all subjects will undergo intestinal permeability test and fecal calprotectin assay. Calprotectin assay will be performed using a commercially available enzyme-linked immunosorbent assay test (Calprest Eurospital, Trieste, Italy). According to the manufacturer, calprotectin levels exceeding 100 mg/kg were considered positive. Intestinal permeability will be evaluated using a liquid chromatography/mass spectrometry method previously published .

All subjects will undergo a formal clinical assessment and will be further phenotyped using validated questionnaires. Number of bowel movements per day and/or week and bowel habit characteristics, will be assessed by the Bristol stool scale.

The protocol will be approved by an independent ethics committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice. The trial will be registered in a public registry.

The primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period. Secondary outcome will be modifications of intestinal permeability and fecal caprotectine.

Eligibility Criteria:
Inclusion Criteria:

* positive diagnosis of all IBS subtypes,
* negative fecal calprotectine
* nagative anti-transglutaminasi antibodies

Exclusion Criteria:

* Current use of nonsteroidal anti-infl ammatory drugs, corticosteroids and mast cell stabilisers
* Use of topical or systemic antibiotics in the last month,
* Continuous use of stimulant laxatives,
* Major abdominal surgery, inflammatory bowel disease, infectious diarrhoea, allergic diseases and other organic or psychiatric disorders.
Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients

Among various bariatric procedures, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed procedures worldwide. Though SG provides similar weight loss effect to RYGB in short-term follow-up, its long-term and very long-term weight loss effect was reported to be inferior to RYGB. Weight regain after SG remains the major concern after 2-year follow-up due to gradual loss of appetite suppression and lack of malabsorption function. SG plus procedures have been developed to strengthen the effect of SG on diabetes control. It has been reported that SG plus jejunojejunal bypass (SG - JJB) offered better weight loss than SG and similar weight loss to RYGB. The present study aims to evaluate the efficacy and safety of sleeve gastrectomy plus uncut jejunojejunal bypass (SG - uncut JJB).

Among various bariatric procedures, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed procedures worldwide. Though SG provides similar weight loss effect to RYGB in short-term follow-up, its long-term and very long-term weight loss effect was reported to be inferior to RYGB. Weight regain after SG remains the major concern after 2-year follow-up due to gradual loss of appetite suppression and lack of malabsorption function. SG plus procedures have been developed to strengthen the effect of SG on diabetes control. It has been reported that SG plus jejunojejunal bypass (SG - JJB) offered better weight loss than SG and similar weight loss to RYGB. The present study aims to evaluate the efficacy and safety of sleeve gastrectomy plus uncut jejunojejunal bypass (SG - uncut JJB).

For SG-JJB procedure, after SG was finished, the jejunum was transected 20-cm distal to Treiz ligament. After that, another 200-cm jejunum was measured and side-to-side jejunojejunal anastomosis was made. The anastomotic and mesenteric defects were closed by hand suture.

For SG-uncut JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 32.5 kg/m2 with or without T2DM;
* 27.5 kg/ m2 \< BMI \< 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities;
* Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit
* Waist circumference: male ≥ 90 cm, female ≥ 85 cm
* Age within 16\~65 years old

Exclusion Criteria:

* Pregnancy;
* A history of mental illness and neurological disease;
* The patient refuses surgery;
* Combined with pituitary tumor;
* Long-term use of antidepressant drugs;
* Long-term use of immunosuppressants;
* Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers

This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects


Eligibility Criteria:
Inclusion Criteria:

* non treatment seeking cocaine dependent
* English speaking
* meet DSM IV TR criteria for cocaine dependence
* pulse 50-90bpm
* systolic BP 85-140 mmHg
* diastolic BP 45-90 mmHg
* essentially normal liver and kidney function blood tests
* ECG normal
* sign informed consent
* negative urine pregnancy test at screening and admission

Exclusion Criteria:

* history or evidence of seizure disorder or brain injury
* previous medically adverse reaction to cocaine, including loss of consciousness, chest pain or epileptic seizure
* neurological disorders, organic brain disease, dementia
* psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, major depression
* history of suicide attempts within past 3 months or suicidal ideation/plan
* history of clinically significant heart disease or hypertension
* family history in 1st degree relatives of early cardiovascular morbidity or mortality
* untreated or unstable medical conditions
* positive HIV test
* pregnant or nursing
* have asthma or are currently using alpha, beta agonists or theophylline or other sympathomimetics
* test positive for other drugs of abuse with the exception of cocaine, cocaine metabolites or marijuana
* any other illness, condition or use of psychotropic medications which preclude safe/successful completion of the study
* currently on parole
An Open-label Study of the Safety and Pharmacokinetics of the TGKP

The purpose of the trial is to study the tolerability, safety and pharmacokinetics of the study drug with participation of healthy volunteers after single intravenous administration with dose escalation (0.03 mg/kg, 0.06 mg/kg and 0.12 mg/kg).

Before administration the study drug will be dosed and diluted in 200 ml of isotonic solution of 0.9% sodium chloride, and then will be administered once intravenously via infusion.

During the entire follow-up period, the effect of the study drug on vital signs, instrumental and laboratory data, the development, severity and association of adverse events with the study drug will be monitored, investigated and studied.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to participate in the study;
2. Men and women aged 18 to 45;
3. Healthy volunteers according to the results of a medical examination: no history, as well as according to a screening examination, of pathologies from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which may affect the safety of the volunteer and the assessment of the results of the study (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant abnormalities);
4. Body mass index from 19 to 30;
5. Negative test result for HIV, hepatitis, syphilis;
6. Negative test for the presence of narcotic and psychostimulant drugs in the urine;
7. Negative alcohol test;
8. Negative pregnancy test (for women of childbearing age);
9. Indicators of general and biochemical blood tests at screening within 1.1 x (upper limit of the reference interval) - 0.9 x (lower limit of the reference interval);
10. Consent to the use of barrier contraception methods by the volunteer and his partner during the study period and for 3 months after it.

Exclusion Criteria:

A volunteer may terminate his participation in the study at any stage of its implementation. The principal investigator may remove a volunteer from the study at any time in the following cases:

1. The researcher decided that the volunteer must be excluded in the interests of the volunteer himself.
2. The volunteer is uncooperative or undisciplined.
3. The volunteer was included in violation of the rules of the Protocol.
4. The volunteer needs additional treatment.
Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Single-institutional Cancer Registry

Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china.

This is a single-center continuous enrollment cohort study. The overall survival and disease-free survival of patients with malignant tumors in the target tumor hospital undergoing surgery, radiotherapy, chemotherapy, and immunotherapy were observed. Follow-up methods include medical records review, telephone call interview, and data linkage to the related provincial death certificate registries. This study will provide real world data-sets for researches on long-term survival and prognosis of cancer patients, and expend exploration on the cancer survival determinants both from clinical and social-economic prospective.

Eligibility Criteria:
Inclusion Criteria:

* All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.

Exclusion Criteria:

* Patients who have not been treated during hospitalization;
* Patients with non-malignant tumors.
Clinical Evaluation of Bioactive Restorative vs. RMGI in Class V: A Randomized Control Trial

Clinical performance of bioactive restorative material versus Resin Modifeid Glass Ionoer (RMGI) in class V o will be evaluated over 12 months using United State Public Health Criteria (USHPS) clinical criteria for the evaluation of direct and indirect restorations

Recent developments in the province of material sciences, some novel materials require direct association with oral environment for renewal, recharging or enhancing of the constituents of the restoration to improve marginal integrity to decrease bacterial microleakage. Physical and chemical properties of dental restorations have been progressed such that individual components may exert a bioactive role in the prevention, remineralization, and restoration of active carious lesions.Fluoride containing restorative materials recently gained great attention. Fluoride decreases caries activity by being a bacteriostatic and by decreasing the solubility of enamel and dentin through its integration into tooth tissue to form fluoroapatite. Moreover, it aids to remineralize defected tooth structure after demineralization. conventional GICs and RMGICs are have high fluoride release and could be specified clinically to repair decayed non-biting areas in high caries risk patients.To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified GIs (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment.

Eligibility Criteria:
Inclusion Criteria:

* Cervical Class V carious lesions.
* Age 18-50 years.
* Co-operative patients approving to participate in the study.
* Pulp asymptomatic vital carious posterior teeth.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

* Systemic disease or severe medical complications.
* Allergic history concerning methacrylates
* Rampant caries
* Pregnancy
* Disabilities
* Heavy smoking; xerostomia
* Lack of compliance
* Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure

The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with regards to various flow rates and temperatures.

Bidet is an electronic device spraying stream of the water for cleansing the anus and sometimes to aid defecation. It is widely used in Korea and Japan, with the flow rate (pressure) and temperature of water varying widely among the manufacturers. However, the effects of Bidet on anorectal function have not been studied in detail with regards to these variables.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* anal disease pregnancy any medical disease that is necessary to treat psychosis
Association Between Active Transport and Acute Myocardial Infarction

This study aims to investigate the association between active transport and the incidence of acute myocardial infarction in England.

This is a cross sectional ecological study using aggregated data from the existing Myocardial Ischaemia National Audit Project between 2010 and 2013. Data on active transport according to local authority was obtained from the UK 2001 and 2011 census, whilst important confounders including deprivation levels, prevalence of obesity and population smoking estimates were obtained from Public Health England.

In addition to investigating the association between active transport and AMI, we also studied the extent to which the components of active transport, cycling and walking, were associated with AMI, and investigated whether any associations were contingent on a time lag effect between the dates of exposure to active transport and indecent AMI.

Eligibility Criteria:
Inclusion Criteria:

* All cases of acute myocardial infarction recorded in MINAP between 2003 and 2010

Exclusion Criteria:

* Cases aged \<16 and \>64 years
Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
The Effects of Blood Pressure Reduction on Cerebral Perfusion and Cognition in the Elderly Population

The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 70 years
* Systolic office blood pressure \>= 160 mmHg
* Systolic home blood pressure \>= 155 mmHg

Exclusion Criteria:

* Diabetes Mellitus
* Atrial fibrillation
* Dementia
* Renal failure requiring dialysis
* Life expectancy of less than 1 year
* Disabling stroke
* Contraindication for MRI or anti-hypertensive medication
* Systolic blood pressure \> 220 mmHg
Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract

The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions \>20 mm in the right colon


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* lesions suitable for EMR or ESD
* \> 20 mm
* site in the right colon

Exclusion Criteria:

* Severe cardiovascular pathologies
* Liver and Urinary dysfunctions
* Hematologic diseases
* Pregnancy and breast feeding
* impossible follow-up
* platelet and coagulation disorders (PLT \< 50 x 109/L, INR \> 2)
* Sensitivity or allergy to the drug
Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer

The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.


Eligibility Criteria:
Inclusion Criteria:

* completely resected pathological stage IB or II NSCLC
* adequate haematological, renal and liver function and condition

Exclusion Criteria:

* previous chemo or radiotherapy for NSCLC
* bronchoalveolar cell subtype
* second active primary malignancy or serious concomitant medical disease
* difficulties with adequate follow-up
Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients

This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Moderate or severe ARDS
* Consent to participation obtained from a relative

Exclusion Criteria:

* Protect adult
* Pregnant or breastfeeding woman
* No-affiliation to the social security scheme
* Contra-indication to the placement of an esophageal pressure measuring catheter
* Pneumothorax
* Hemodynamic and / or respiratory instability
* Extra-corporeal membrane oxygenation
Glycemic Index of Pasta From Traditional and Current Wheat Varieties

This randomized, cross-over study compares pasta produced with three different wheat varieties (Senatore Cappelli, Korasan, Claudio). Patients with type 2 diabetes with no pharmacological treatment will be randomized to three different sequences, and asked to eat a standard portion of pasta on three different occasions, four days apart. 3-hour post-prandial interstitial glucose profiles will be recorded using trans-cutaneous sensors.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Body Mass Index (BMI) \> 20 kg/m2
* HbA1c \< 58 mmol/mol

Exclusion Criteria:

* Current pharmacological therapy for diabetes (of any kind)
* Pregnancy or lactation
Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type Transthyretin (ttr) Amyloid Cardiomyopathy.

Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on Day 0, patients will have their entrance criteria reviewed, and medical histories and demographic characteristics obtained.

The physical examination (including weight and vital signs) and the relevant end of study clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than 30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical laboratory assessments must be performed on Day 0.

Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e., first dose) and will return to the clinical unit for study visits every 6 months.

Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated physical examinations (including weight and vital signs) will also be performed at each 6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone call will be made at 3-month intervals between clinic visits to assess safety and use of concomitant medications.

For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ, 6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition, echocardiograms will be performed every 12 months on an annual basis.

An end of study visit including all safety and efficacy assessments will occur upon patient completion of the study, premature withdrawal (for any reason), or in the event of program discontinuation by the Sponsor.


Eligibility Criteria:
Inclusion Criteria:

* Patient successfully completed Protocol Fx1B-201.
* If female; patient is post menopausal. If male, female partner is post-menopausal. If female is of child bearing potential, willing to use acceptable method of birth control up to 3 months after last dose (included female partners of male participants).
* Patient is willing to comply with protocol.

Exclusion Criteria:

* Patient did not successfully complete Fx1B-201.
* Chronic use of NSAIDS.
* Patient has a clinically significant medication condition that increases risk of study participation.
* Patient has received heart or liver transplant.