cyrilzakka/clinical-trials huggingface dataset:
Fat Metabolites and Gut Hormones

To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.

Dietary triglycerides are hydrolyzed during digestion to two fatty acids and one 2-monoacyl glycerol. The study will investigate the effects of these different fat components on gut hormone secretion in gastric bypass operated patients and non-operated BMI-matched controls.

Eligibility Criteria:
Gastric bypass operated patients:

Inclusion Criteria:

* Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
* Gall bladder removal

Healthy control subjects:

Exclusion Criteria:

* Bariatric surgery or complicated upper abdominal surgery
* Gall bladder removal
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
* Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation
Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome

To evaluate the platelet function, clinical efficacy, prognosis and safety of Xuesaitong soft capsule in the treatment of acute coronary syndrome, 50 patients with acute coronary syndrome after PCI were treated with Xuesaitong soft capsule (mainly Panax notoginseng saponins) for 4 weeks. The macroscopic and microscopic characterization and biological basis of Xuesaitong soft capsule in the treatment of acute coronary syndrome were explained by multi-group techniques (platelet transcription group, metabolic group, protein group).


Eligibility Criteria:
Inclusion Criteria:

* (1) it accords with the diagnostic criteria of western medicine for acute coronary syndrome.

  (2) within 4 weeks after coronary intervention.

  (3) 18 years old ≤ age ≤ 80 years old, male or female.

  (4) voluntarily participate in this clinical trial, give informed consent and sign an informed consent form

Exclusion Criteria:

* (1) uncontrollable hypertension after drug treatment (systolic blood pressure \&gt; 180mmHg, or diastolic blood pressure \&gt; 110mmHg).

  (2) increased risk of bleeding: previous history of hemorrhagic stroke; intracranial aneurysms; trauma or major surgery within 1 month (including bypass surgery); diseases currently suffering from active bleeding, etc.

  (3) patients with history of digestive tract ulcer and massive gastrointestinal bleeding.

  (4) severe organic heart disease, such as patients with LVEF \&lt; 35% or NYHA/Killip cardiac function grade IV.

  (5) those with a history of malignant arrhythmias (arrhythmias affected by hemodynamics, requiring drug or electrical cardioversion, or cardiopulmonary resuscitation), congenital heart disease or malignant tumor were considered unable to participate in the trial.

  (6) severe hepatic and renal insufficiency: glutamic pyruvic transaminase (ALT) or aspartate oxaloacetic transaminase (AST) ≥ 3 × normal upper limit (ULN) or total bilirubin (TBIL) ≥ 2 × ULN; or creatinine clearance (Ccr \&lt; 30ml/min).

  (7) Women in pregnancy (defined as positive blood pregnancy test) and lactating women.

  (8) those with a history of blood donation or significant blood loss in the last 3 months (≥ 400ml).

  (9) people with a previous history of alcoholism (i.e. men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 25mL spirits or 150mL wine with 40% alcohol content); or screen those who drink regularly in the first 6 months (that is, more than 14 standard units per week).

  (10) those with a history of drug abuse and drug dependence within one year before screening.

  (11) those who have participated in other clinical trials and taken trial drugs in the past 3 months.

  (12) people who are allergic or intolerant to aspirin or P2Y12 receptor inhibitors.

  (13) those who are allergic to the ingredients of the test drugs.

  (14) other situations in which the researchers think it is not appropriate to participate in this experiment.
Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care

Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years. CSs have no clear benefit for overall neonatal outcome and are associated with higher maternal complications and high costs. Dutch guidelines offer clear recommendations on factors that have a direct effect on the decision to perform a CS.

Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS among Dutch gynaecologists.

This study consists of four phases:

1. Development of quality indicators: A set of quality indicators regarding the process, structure and outcome of care will be developed according to the RAND-modified Delphi method. A representative, national expert panel consisting of 12 to 15 obstetricians and midwives will participate.
2. Current care study: The current Dutch care will be studied in 20 hospitals (N=80 gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to the developed quality indicators. To get insight into Dutch practices compared to international data, basic obstetrical data will be extracted from the delivery database.
3. Barrier analysis: A barrier analysis will be carried out based on the results of the current care study. Two groups of hospitals will be identified in the upper and lower extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals with the highest adherence scores. Factors that determine the decision to perform a CS or not (barriers and facilitators) will be analyzed in both groups using semi-structured interviews among 15-20 professionals and 15-20 patients. A questionnaire will be used to study the 'prevalence' of these factors among all obstetric gynaecologists in the Netherlands and among 200 patients.
4. Controlled before- and-after (CBA) study: Based on the outcomes of the current care study and the barrier analysis, a tailor made implementation strategy will be developed in order to increase adherence to the CS quality indicators. Target groups will be selected with focus on women with both a high incidence of the indicator and low indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12 hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs. The sample size will be dependent on the target group and adherence to the quality indicators regarding this target group. These data will be available after performing the current care and the barrier study.


Eligibility Criteria:
Inclusion Criteria:

* A previous caesarean section in a 3-4 month time period.

Exclusion Criteria:

* Major congenital malformality
* Fetal death prior to onset of delivery
* Duration of pregnancy less than 24 weeks of gestation
Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction

Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids

Exclusion Criteria:

* Previous anal surgery or pelvic radiotherapy
* Fecal incontinence or obstructed defecation
* IBD, IBS
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease

The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.

The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after the last study visit.

Beside investigation of the safety and tolerability of locally administered DLX105, the purpose of the study is also to evaluate the response rate and time to response of enterocutaneous fistulas following local injection of DLX105 (secondary objective).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn' Disease
* Single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration.
* TNF-blocker naive patients or patients who are primary or secondary anti-TNF non-responders

Exclusion Criteria:

* CDAI greater than 450
* ongoing treatment with TNF-blockers (duration of wash-out prior to randomization is 8 weeks)
* Active abscess formation within fistula
* Abdominal or anorectal surgery within the last 4 weeks prior to randomization
* Known immunosuppression
* Infections, sepsis
* Positive Test for hepatitis B or C and HIV
* Patients who had life vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
* Active liver disease with ALT and/or AST greater than 3x upper limit of normal
* Any severe, progressive or uncontrolled medical condition that in judgment of investigator prevents the patient from participating in the study.
* History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
* Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive B-hCG laboratory test
Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers

This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.

An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers

Eligibility Criteria:
Inclusion criteria:

* They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
* Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
* Women must be of non-childbearing potential.

Exclusion criteria:

* Bloodwork that meets certain criteria (for example, total cholesterol \> 240 mg/dL)
* Clinically significant hepatic enzyme elevation
* HbA1c less than 6.5 or greater than 10
* Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV
* Any major illness other than diabetes
* Previous use of insulin as treatment for diabetes
* Significant renal disease as defined by screening lab tests
* History of drug or other allergy which in the opinion of the investigator contradicts subject participation
* Smoking or use of nicotine-containing products within the previous 6 months
* History of alcohol or drug abuse
* Unwilling to abstain from alcohol prior to and during the in-patient clinic stays
* Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
* Use of St. John's Wort during the study
* Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study (MIG 2)

The purpose of this research study is to help in the development of safe, effective and reversible male contraception. We are examining the impact of the drug Miglustat on sperm production in normal men.

We want to see if Miglustat will inhibit sperm production in men and act as a reversible male contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of sperm production. We believe Miglustat may have some potential as a safe, reversible male contraceptive.

Glycosphingolipids (GSL) are a main constituent of the sperm cell membrane in mammals. Male mice deficient in enzymes involved in GSL synthesis have severely impaired fertility and knockout mice are infertile. Recently, it was demonstrated that administration to mice of an inhibitor of ceramide-specific glycosyltransferase, the first step in the biosynthetic pathway of GSL formation, resulted in reversible infertility without discernable adverse side effects. This inhibitor was Miglustat, which is an alkylated imino sugar. The impact of Miglustat therapy on human spermatogenesis is unknown. If the effects on sperm morphology and motility are similar to those observed in mice, Miglustat or other GSL inhibitors might have potential utility as non-hormonal male contraceptives.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male, normal lab test

Exclusion Criteria:

* Abnormal lab test, history or evidence of significant chronic or acute medical illness, previous or current ethanol or anabolic steroid abuse.
Gentamicin for Junctional Epidermolysis Bullosa

Herlitz junctional epidermolysis bullosa (H-JEB), an incurable, fatal, inherited skin disease, is caused by loss-of-function mutations in the LAMA3, LAMB3 or LAMC2 genes, resulting in loss of laminin 332 and poor epidermal-dermal adherence. Eighty percent of H-JEB patients have LAMB3 mutations and about 95% of these are nonsense mutations. The investigators recently demonstrated that gentamicin readily induced nonsense mutation readthrough and produced full-length laminin beta3 in several nonsense mutations tested. Importantly, the gentamicin-induced laminin beta3 restored laminin 332 assembly, secretion, and deposition into the dermal-epidermal junction (DEJ). Newly induced laminin 332 reversed abnormal H-JEB cellular phenotypes. Herein, the investigators propose the first clinical trial of gentamicin (by topical and intravenous administration) in JEB patients with nonsense mutations. The milestones will include restored laminin 332 and hemidesmosomes at the DEJ, improved wound closure, and the absence of significant gentamicin side effects.

Three subjects (adults and children of any age) will receive topical gentamicin to be applied to select skin sites.

Three subjects (adults and children of any age) will receive intravenous (IV) gentamicin infusions.

Patients will be assessed for Primary and Secondary endpoints during follow up visits.

Eligibility Criteria:
Inclusion Criteria:

1. JEB patients with nonsense mutations in the LAMB3 gene in either one or two alleles.

Exclusion Criteria:

1. JEB patients who do not have nonsense mutations in the LAMB3 gene in either allele.
2. Pre-existing known auditory impairment.
3. Pre-existing known renal impairment.
4. Pre-existing known allergies to aminoglycosides or sulfate compounds.
5. Pregnancy.
An Intermediate Size Expanded Access Protocol of Elamipretide

Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program. The treating physician must contact StealthBiotherapeutics using the Expanded Access Program Contacts provided. Elamipretide will only be made available after careful review of an individual request submitted by the treating physician. The initiation and conduct of the treatment with elamipretide for an individual patient, and compliance with this treatment guideline, will be under the full and sole responsibility of the treating physician.


Eligibility Criteria:
Key Inclusion Criteria:

1. ≥1 year and ≤ 80 years of age or ≥12 years for Barth Syndrome in SPIES-007
2. Patients with genetically confirmed rare primary mitochondrial diseases including Barth Syndrome

   1. observed cardiomyopathy, renal impairment, neuropathic, or ophthalmic manifestation
   2. where such disease is serious or life-threatening and no comparable or satisfactory alternative therapy options available.
3. Patients without genetic confirmation of a rare disease with known mitochondrial dysfunction but do exhibit serious or life-threatening clinical manifestations of mitochondrial dysfunction.
4. Is self-able or has caregiver willing and able to administer SC injection.
5. Would potentially benefit from treatment with elamipretide and cannot be treated satisfactorily with any approved medicinal product in the opinion of the treating physician.

Key Exclusion Criteria:

1. Known hypersensitivity to elamipretide or any excipients.
2. Women who are pregnant, are planning on becoming pregnant, or are breast-feeding.
3. Patients receiving any other investigational agent within 30 days of dosing.
4. Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.
Open-Label Extension Study of Setmelanotide

This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.


Eligibility Criteria:
Key Inclusion Criteria:

* Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.
* Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
* Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.

Key Exclusion Criteria:

* Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®).
* Any new or worsening depression resulting in suicidal thoughts and/or behaviors.
* Discontinuation from a previous setmelanotide study.
* History or close family history (parents or siblings) of melanoma.
* Pregnant and/or breastfeeding women

Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada

The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada.

This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study.

The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance.


Eligibility Criteria:
Inclusion criteria:

* Participants more than or equal to (\>=) 18 years of age at first dose of teduglutide diagnosed with intestinal failure due to short bowel syndrome as a result of intestinal resection. Note: As "SBS as result of major intestinal resection" is a criterion for teduglutide treatment reimbursement, it is assumed that all participants receiving teduglutide in the PSP have SBS-IF as a result of intestinal resection.
* Stable participants with SBS-IF who were dependent on parenteral support prior to teduglutide treatment initiation, and were treated with teduglutide during the study period with at least 6 months of follow-up data available before the end of the study period.
* Participants who have provided informed consent for secondary use of data for research.

Exclusion criteria:

- Participants with active gastrointestinal malignancy OR a history of gastrointestinal malignancy in the past 5 years before start of treatment.
Incidence and Prevalence of Juvenile Dermatomyositis

This is a descriptive, retrospective, multi-center, cross-sectional and observational epidemiological study of incidence and prevalence of juvenile dermatomyositis in Alsace from 2000 to 2015. Alsace is a French region with a low migratory flow


Eligibility Criteria:
Inclusion Criteria:

* Age under 16 years
* Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

Exclusion Criteria:

* Refusal to participate in the study
Functional Neuroimaging and Genetic Vulnerability to Suicidal Behavior

The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt
* arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide
* arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide

Exclusion Criteria:

* Cons-indications to the use of MRI
* Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture.
Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

Open-heart surgery frequently results in abnormal clotting, which in turn results in excessive blood loss and the need for transfusion of multiple blood products to patients and leads to adverse outcomes. Prompt identification of any clotting abnormalities after cardiac surgery reduces blood loss and blood product transfusion and may improve outcomes. Currently, however, this monitoring is dependent on standard laboratory-based tests of clotting that have a long turnaround time (30-45 min) and do not measure some important aspect of clotting. There are now other monitoring options that are carried out at patients' bedside, providing results more quickly than standard laboratory tests (within 2-5 minutes for some), and measure more aspects of clotting, providing more information on possible causes of any abnormalities. In this study, we will compare the cost-effectiveness of two of these newer monitoring techniques with standard laboratory-based tests by assigning 150 patients who will be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will be assigned by chance to each group). In each group, an explicit algorithm based on the monitoring technique of that group will be used to guide all transfusion decisions. Between-group differences in number of units of blood products transfused (primary outcome), amount of blood loss, rate of adverse events, and cost of monitoring will be measured. The objective of the study is to determine which of the three methods is most cost-effective in terms of these outcomes.


Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years
* no emergent complex cardiac surgery

Exclusion Criteria:

* Isolated CABG
* Single valve surgery
* Pre-existing coagulopathy PTT\>50's, INR\>1.3
* Severe Thrombocytopenia Platelet \<100,000
* Recent Antiplatelet drugs(Plavix within 7 days, Integrilin within 24 hours)