cyrilzakka/clinical-trials huggingface dataset:
A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic parameters of DA-8031 as well as safety profile.


Eligibility Criteria:
Inclusion Criteria:

* 20-45 years healthy male subjects
* Body weight :60-90kg, BMI between 18.5-25

Exclusion Criteria:

* show SBP(Systolic Blood Pressure) =\<100mmHg or \>=140mmHg, or DBP(Diastolic Blood Pressure)=\<60mmHg or \>=90mmHg, or tachycardia (PR(Pulse Rate)\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers
First-in-Human Single and Multiple Dose of GLPG1972

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well.

During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.


Eligibility Criteria:
Inclusion Criteria:

* Males between 18-50 years of age
* Subjects must have a body mass index between 18-30 kg/m²
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile

Exclusion Criteria:

* A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device investigational research study
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Current sexually active (and/or child wish) male; a contraception method should be used
Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection

This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.

Convalescent plasma will be collected by plasmapheresis from patients fully recovered from COVID-19 infection and will be administered in patients with severe COVID-19 infection. The results will be compared with an historical matched control.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL
3. Onset of the disease symptoms no more than 12 days before the inclusion of the patients in the trial
4. Severe COVID-19 infection as determined with one of the following:

   * Respiratory rate 30/min
   * Oxygen Hemoglobin Saturation SAT 93
   * CRP \>1.5 (upper normal limit \<0.5)
   * Ferritin value \>100
   * Ratio of PaO2:FiO2 \<300mmHg
   * Pulmonary infiltrates in Chest X-Ray or Chest CT scan \>50% during 24-48 hours
5. Life threatening infection as determined by one of the following:

   * Respiratory failure
   * Septic Shock
   * Multiple organ failure
6. Signature of informed consent by the patient or legal representative Patients fulfilling criteria 1, 2, 3, 6 and one of criteria 4 or 5 will be eligible for the study.

Exclusion Criteria:

1. Critical illness due to progressive COVID-19 with expected survival time \<48 hours
2. Intubated patients \>72 hours
3. Chronic Heart failure NYHA 3 and/or preexisting left ventricular ejection fraction 30%
4. Cardiovascular failure requiring 0.5μg/Kg/min nor-adrenaline or equivalent or more than 2 types of vasopressor medication
5. Liver Cirrhosis Child C
6. Liver failure with bilirubin \>5X ULN and increase of ALT/AST (at least one \>10X ULN)
7. Previous history of allergic reaction to blood or blood products transfusion
8. Known IgA deficiency
9. Pregnancy
10. Breast feeding women
11. Pulmonary edema
Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis

In ten years, the labor force has grown by 1.4 million people according to French national institute for statistical and economic studies. This increase is partly due to the increased presence of women in the labor market. Thus, the majority of some 800,000 annual births come from working women. However, some women in professional activity may be exposed to occupational risks, which may have effects on the develop-ment of the fetus during pregnancy. France benefits from protective legislative measures against pregnant women. Recommendations already exist.

But with medical desertification, pregnant women may have more difficulty contacting their occupational doctor or treating physician and to access information about the risks to her work-related pregnancy.

It seems to us important to be able to better quantify the information needs of women in this problem.


Eligibility Criteria:
Inclusion Criteria:

* working during their pregnancy (at least 2 months, including the beginning of pregnancy
* having given birth during the period of inclusion
* in a hospital or clinic of Lille metropolis volunteer to participate in the study

Exclusion Criteria:

* minor women
* unemployed
* student
* guardianship
* work abroad
* change of employer during pregnancy
* inability to answer the questionnaire
Reduction of Masticatory Muscle Activity by Restoring Canine Guidance

In this study it is to be evaluated wether a restoration with composite resin fillings to reestablish a canine guidance will reduce masticatory muscle activity in patients with bruxism.

30 patients showing clinical symptoms of bruxism receive treatment within this clinical trial. Typical symptoms like pain or tenseness of the masticatory muscles, headache or abrasions are mandatory preconditions. Exclusion criteria are a present treatment with a biteguard or a sufficient canine guidance.

In the first session a detailed history, a dental status and a clinical functional status are recorded. The baseline situation is documented by taking impressions with alginate of the maxilla and mandible for diagnostic study models. Following this procedure a first measurement of the muscular activity is conducted for seven days with the Grindcare device.

After four weeks without any intervention a second measurement is conducted again for seven days.

In the next session the canine cusps are restored with composite fillings. Finally a sufficient canine guidance should be present. In the same session a second impression of the maxilla is taken. A third measurement is conducted, again followed by four weeks without any intervention.

At last another impression of the maxilla is obtained and a final measurement for seven days is conducted.

At the first examination and after the third measurement of the masticatory muscle activity the patients fill out the questionnaire of the Oral Health Impact Profile in order to allow for the assessment of possible functional restraints and mental interferences.

Eligibility Criteria:
Inclusion Criteria:

* patients show signs of bruxism
* no canine guidance is present
* no prosthodontic restorations of the canine are present

Exclusion Criteria:

* a sufficient canine guidance is present
Outcomes in UK ACS Patients Prescribed Ticagrelor

Cohort study using data from Clinical Practice Research Datalink (CPRD). The study cohort includes all patients who received at least one prescription for ticagrelor for the first time between December 2010 and March 2015, following ACS. Patient baseline characteristics will be described: (Age, Gender, Body Mass Index, Smoking status, Sociodemographic status), type of ACS and interventions, CV history and comorbidities, bleeding and respiratory history.

The following outcomes will be examined: Incidence of vascular events (composite MI, Stroke, vascular death, specific vascular event and all cause death), incidence of bleeding and incidence of dysponea. Time to event for vascular events, bleeding and dyspnoea.


Eligibility Criteria:
Inclusion Criteria:

* First prescription (index date) for ticagrelor between Dec 2010 and Mar 2015
* At least 12 months history in database prior to first ticagrelor prescription
* Linkage to Hospital Episode Statistics (HES)
* Acute Coronary Syndrome (ACS) event in the three months prior to and including the index date

Exclusion Criteria:

Primary care prescription for clopidogrel or prasugrel between the ACS date and the index date
Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80% of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients experienced no resolution of their diabetes despite massive surgical-induced weight loss. There appears to be a variable response to surgery depending on surgical and patient factors. To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication between the digestive system and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.

To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to understand the procedures of the study.
* To agree voluntarily to participate of the study, signing an informed consent.
* Weight variance less than 5% in the last 3 months.
* Operative group with at least 2 year follow-up.

Exclusion Criteria:

* History of hepatic disease like cirrhosis or chronic active hepatitis.
* Kidney dysfunction (creatinine \> 1,4 mg/dl in women and \> 1,5 mg/dl in men).
* Hepatic dysfunction: ALT and/or AST 3x above upper normal limit).
* Recent history of neoplasia (\< 5 years).
* Use of oral or injectable for more than consecutive 14 days in the last three months.
Activity and Quality of Care Indicators' for a Sentinel Network Creation

There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research.

The network will be designed to promote research in women's health and the emergency reception by focusing on:

(i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies.

(ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium).

(v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

Objectives :

* To measure the incidence of the potentially life-threatening gynaecological emergencies (G-PLE) and of the Cases of severe morbidity (SM)
* To analyze the determinants of the SM,
* To validate an objective score of quality

Criterias of evaluation:

* Incidence of the G-PLE and SM cases during one month.
* Reliability and validity of measurements of the indicators of quality of care.

Methodology:

Stage 1: Data acquisition (prospective) within 22 gynaecological emergencies departments.

Stage 2: Sampling and checking of files of patients included at stage 1

Calendar of the research project:

18 months:

* 6 months for the phase of preparation,
* 1 month for the investigation of incidence,
* 5 months for the phase of checking data,
* 6 months of statistical analysis

Statistical Analyzes:

Descriptive statistics of the data. Estimation of the incidence rate of the potentially life-threatening gynaecological emergencies (G-PLE) and of the cases of Severe morbidity (SM) among women consulting for acute pelvic pain.

To construct reliable quality indicators, principal components analysis and Cronbach's α statistics will be performed to determine the underlying dimensions. Construct validity of indicators will be assessed by testing predefined hypotheses about relationship between G-PLE and or SM and quality indicators.

Eligibility Criteria:
Inclusion Criteria:

* French-speaking gynaecological emergencies departments leaned with a public maternity volunteers to take part in the study.
* Sample of files resulting from the principal centers recruiters

Exclusion Criteria:

-
Buprenorphine in Acute Renal Colic Pain Management

The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.

Exclusion Criteria:

* previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
* febrile patients (T \> 38°C);
* hemodynamically unstable patients ( Systolic Blood Pressure \< 90 mmHg);
* pregnant patients;
* patients with abdominal tenderness as a sign of peritoneal inflammation;
* any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection;
* patients with a history of drug addiction or known allergy to opioids;
* patients who had used analgesics 6 hours before arriving.
Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 12 years of age.
2. Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
4. Insulin pump therapy for at least 6 months.
5. HbA1c ≤ 12%.

Exclusion Criteria:

1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc....).
2. Current use of glucocorticoid medication.
3. Use of medication that alters gastrointestinal motility.
4. Planned or ongoing pregnancy.
5. Breastfeeding individuals.
6. Severe hypoglycemic episode within one month of admission.
7. Severe diabetes keto-acidosis episode within one month of admission.
8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
9. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
10. Known hypersensitivity to any of the study drugs or their excipients.
11. Individuals with hypoglycemia unawareness.
12. Individuals with confirmed gastroparesis.
13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Study Discontinuation/Withdrawal

1. Failure to comply with the protocol.
2. Pregnancy.
3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.
Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis

The first objective (LOLA) of this integrated trial is to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis or sigmoidectomy with end-colostomy is the superior approach in patients with perforated diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival. The study is designed as a multicenter and randomised trial.

Patients diagnosed as having perforated diverticulitis with free air on plain abdominal X-ray or CT scan fulfilling the in- and exclusion criteria are randomised during laparoscopy via a central computer. In case of purulent diverticulitis patients are randomised to three arms: (a) laparoscopic lavage, (b) sigmoidectomy with colostomy or (c) sigmoidectomy with anastomosis in ratio of 2:1:1. In case of faecal peritonitis or an overt perforation of the sigmoid, the patient will be randomised 1:1 to sigmoidectomy with colostomy or sigmoidectomy with primary anastomosis.

The first primary outcome parameter consists of a combined endpoint consisting of mortality and major morbidity (LOLA). The second primary endpoint consists of stoma-free survival one year after initial surgery (DIVA). Secondary endpoints are number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. A sample size of 132:66:66 patients per treatment arm will be able to detect a difference in the combined endpoint of serious complications and mortality from 25% in the two sigmoidectomy groups compared to 10% in the lavage group (two-side alpha of 5% and a power of 90%. In the DIVA analysis 2x132 patients are needed to significantly demonstrate a difference of 30% in stoma-free survival between both treatment arms (log rank test two-sided alpha of 5% and power of 90%) in favour of the patients with primary anastomosis. More than 35 hospitals will participate in this study with an estimated total inclusion of 100 patients per year. Patients will be followed for one year.

The study will be executed in concordance with the protocol, the Good Clinical Practice guidelines and regulatory requirements.

After closure of the LOLA-arm due to safety concerns for laparoscopic lavage, the protocol and sample size has for the DIVA-arm been adjusted to 118 patients per study arm (faecal or purulent peritonitis).

Eligibility Criteria:
Inclusion Criteria:

patients suspected of diverticulitis

* age in between 18 and 85 years old
* with written informed consent
* with free air on plain abdominal or thoracic X-ray or CT-scan OR with peritonitis and diffuse gas or fluid on CT-scan

Exclusion Criteria:

* dementia
* prior sigmoidectomy
* steroid treatment \> 20 mg daily
* prior pelvic irradiation
* preoperative shock: requirement of inotropics due to circulatory insufficiency
A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment

The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic impairment.

This is an open-label (all people know the identity of the intervention), single-dose, multi-center (study conducted at multiple sites), non-randomized study to access the pharmacokinetics of PCI-32765 in participants who either have mild, moderate, or severe hepatic impairment or qualify for the control group (normal liver function). The study mainly consists of 3 phases: screening phase (within 21 days prior to the first dose of study medication), treatment phase, and a follow up phase (10 to 12 days after the last dose of study medication). In the treatment phase, participants will receive single oral dose of PCI-32765 on Day 1. Liver impairment will be classified according to the Child-Pugh Classification of Severity of Liver Disease, as: normal, mild, moderate, and severe. Total 30 participants (24 with hepatic impairment \[6 mild, 9 moderate and 9 severe\] at baseline and 6 in the control group according to Child-Pugh criteria) will be enrolled. Participants in the control group will be enrolled after the participants with mild or moderate hepatic impairment have completed the study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The total duration of study for each participant will be approximately for 29 to 33 days.

Eligibility Criteria:
Inclusion Criteria:

* Stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured within 48 hours prior to PCI-32765 administration
* Must be hepatically impaired as defined by the Child-Pugh classification of severity of liver disease
* Control group must have good health with normal liver function
* Participants with controlled hypertension and those with problems directly associated with the primary diagnosis of hepatic impairment
* Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Clinically significant renal laboratory findings including serum creatinine more than 1.5 x the upper limit of normal (ULN) and/or calculated creatinine clearance of less than 60 ml per minute per 1.73 square meter
* Clinically significant abnormal laboratory tests, physical examination, vital signs or electrocardiogram at screening or at admission to the study center
* Antiviral therapy for active hepatitis infection at time of screening
* Use of any anti-coagulation therapy including vitamin K antagonists, low molecular weight heparin, or other anticoagulants