cyrilzakka/clinical-trials huggingface dataset:
Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.

To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18 - 55 years of age
* Subjects must be within 18 to 29.9 kilograms/m2 per the BMI
* General good health as determined by medical history and physical examination within 30 days prior to the start of the study
* Blood chemistry, hematology, and urinalysis tests will be performed within 30 days prior to the start of the study
* No participation in an investigational drug study or donation of blood within 30 days prior to the start of the study
* At screening, subjects must have blood pressure and pulse rate within specified ranges
* No grapefruit juice or grapefruit-containing products for at least 72 hours prior to drug administration, each period. Subjects will be queried at check-in each period on consumption of grapefruit juice or grapefruit containing products. Results will be recorded and reported in the final report.
* No alcohol consumption for at least 24 hours prior to drug administration, each period
* No caffeine or xanthine consumption for 48 hours prior prior to drug administration, each period
* No prescription drugs (excluding hormonal contraceptives) within 14 days prior to drug administration, each period
* Subjects should refrain from taking OTC preparations, and/or nutritional supplements within 7 days prior to drug administration, each period. Subjects shall refrain from taking herbal remedies within 14 day prior to drug administration, and throughout the study periods
* Female subjects must not be pregnant or nursing; and must be surgically sterile; one year post-menopausal; or on hormonal contraceptive agents), a diaphragm or condom with spermicidal foam or jelly, or IUD for at least 3 months prior to drug administration and agree to use the same method of contraception for at least 1 month after the last drug administration
* Negative serum pregnancy test at screening and negative urine pregnancy test prior to drug administration, each period
* Negative HIV 1, hepatitis B surface antigen, an urine screen for drugs of abuse within 30 days prior to the start of the study

Exclusion Criteria:

* Disease or condition that could impact interpretation of study results or a condition which treatment would be contraindicated per currently approved product labeling
* Subjects had any of the following conditions:

  * used any prescription or OTC medication within 14 days of study initiation
  * a positive urine test for illicit drugs
  * participated in a clinical investigation within the past 30 days
  * had clinically significant allergies to drugs or foods, ot
  * any condition that might place them at increased risk of complications
Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.


Eligibility Criteria:
Inclusion Criteria:

Patients aged \> 18 years and operation with thoracic epidural

Exclusion Criteria:

Refusal of informed consent
Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort. Originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The study was conducted in Finland as a collaboration between the U.S. National Cancer Institute (NCI) and the National Public Health Institute of Finland. NCI has maintained passive surveillance of the cohort through Finnish national registries, including the cancer registry.

The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. These analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30, 1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other national registries, and epidemiological analyses continue to be conducted.

Eligibility Criteria:
* INCLUSION CRITERIA:

Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.

EXCLUSION CRITERIA:

* Females
* Proven malignancy (except nonmelanoma skin cancer or cancer in situ)
* Severe angina pectoris
* Chronic renal insufficiency
* Cirrhosis of the liver
* Chronic alcoholism
* Anticoagulant therapy
* Use of supplements containing vitamin E greater than 20 mg/day, or vitaming A greater than 20,000 IU/day, or beta-carotene greater than 6 mg/day
Investigation of Embryoscopy in Recurrent Pregnancy Loss

The purpose is to test the value of embryoscopy in women with missed abortions after recurrent miscarriages (at least two previous miscarriages) in the past. This project will assess two functions of embryoscopy:-

1. Whether embryoscopy allows the diagnosis of structural anomalies (disorganized embryos). This is a fetal cause of embryo loss which cannot be diagnosed by other means.
2. Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.

However, it may be that embryoscopy will be found to have no advantage.

In this project, embryoscopy will be evaluated in women with missed abortions (pregnancies which have ceased developing and in which the embryo is dead), after at least two previous (recurrent) miscarriages. The procedure will have two main purposes:- To allow the diagnosis of structural anomalies (disorganized embryos), and to allow an accurate biopsy of embryonic tissue for karyotyping. Hence, this procedure will lead to a more accurate diagnosis of the cause of recurrent miscarriage.

After confirmation of missed abortion by ultrasound, dilatation and curettage (D\&C) is normally performed under general anesthetic to evacuate the uterus in missed abortions. In this project embryoscopy will be added to the standard D\&C. An 8mm hysteroscope with irrigation channel and 300 view will be used with continuous saline flow. The embryo will be visualized, and the findings recorded. Biopsies will be taken for chromosomal analysis from the embryo and the placental villi. Embryoscopy will be performed with a hysteroscope which is in normal clinical use for investigating the uterine cavity, but for a slightly different indication.

The first stage will be a pilot study on 20 patients to judge the value of embryoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent miscarriage, (at least 2 consecutive miscarriages)
* Confirmation of missed abortion by ultrasound
* At least 5 1/2 weeks of gestation
* D \& C is clinically indicated

Exclusion Criteria:

* Sporadic miscarriages
* Less than two consecutive miscarriages.
* If D \& C is not clinically indicated
Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* AJCC/UICC 8th edition N3 nasopharyngeal carcinoma
* Pathology: WHO II/II
* No prior anti-tumor treatment
* Age 18-60
* KPS≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* Pathology: WHO I
* Pregnant
* Combined with other malignant tumor
Comparing Two Types of Sedation to Gynaecological Patients

The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Investigate the difference between two types of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* females
* are having a TCRE, TCRF or TCRP
* speak and understand Danish
* no mental problems

Exclusion Criteria:

* \<18 years old
* don´t speak or understand Danish
* mental problems
* Lung problems
* BMI \>40
* Big fibroma: \>3x3 cm
* abuser
* Allergy towards i Propofol, Remifentanil and/or Citanest
* pregnant
Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients

The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.

In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.

The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Fasting glycemia above 150 mg/dl
* Signed informed consent

Exclusion Criteria:

* Patients with heart failure \> NYHA II
* Uncontrolled hypertension
* Impaired kidney function (creatinine \> 3 mg/dl)
* Acute infection
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with HCM (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with LV wall thickness ≥ 15 mm at time of initial diagnosis or ≥ 13 mm with a positive family history of HCM.
* Age 18-70
* BMI 18-37kg/m2
* Documented LVEF ≥ 55% at the Screening visit as determined by the investigator and the investigational site's echocardiography laboratory.
* Resting LVOT gradient ≥ 30 mg Hg and post-exercise peak LVOT gradient ≥ 50 mm Hg
* NYHA functional class II or higher

Key Exclusion Criteria:

* History of sustained ventricular tachyarrhythmia.
* History of syncope with exercise within past 6 months.
* Active infection.
* Persistent atrial fibrillation or atrial fibrillation at Screening or history of paroxysmal atrial fibrillation with resting rate document \> 100bpm within 1 year of screening.
* Has QTc Fridericia (QTcF) \> 500 ms, or any other ECG abnormality considered by the investigator to pose a risk to subject safety (e.g. second degree atrioventricular block type II).
* Aortic stenosis or fixed subaortic obstruction.
* History of LV systolic dysfunction (LVEF \< 45%) at any time during their clinical course.
* History of obstructive coronary artery disease.
* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or MyoKardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Part A: Ongoing therapy with beta blockers, calcium channel blockers, or disopyramide. Subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the Screening visit.
* Part B: Ongoing therapy with calcium channel blockers or disopyramide. Subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the Screening visit.
* Prior treatment with cardiotoxic agents such as doxorubicin or similar, or current treatment with antiarrhythmic drugs that have negative inotropic activity, e.g. flecainide or propafenone.
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis

To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.

This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis;
2. Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;
3. Subject must have received at least one prior treatment or first use of a biological agent:

Exclusion Criteria:

1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
2. UC lesions were limited to rectum or involved colon \< 15cm;
3. Evidence of toxic hirschsprung's disease was found during screening;
4. History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
Modulating the Vaginal Microbiome After Implantation Failure

Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal supplements.


Eligibility Criteria:
Inclusion Criteria:

* unfavorable vaginal microbiome using ARTPreds test
* non-smoker

Exclusion Criteria:

* use of oral antibiotics oral probiotics between diagnosis and inclusion in the study
* pregnancy at inclusion
* allergy towards study drugs
Proactive Breastfeeding Support in First Time Mothers

In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.


Eligibility Criteria:
Inclusion Criteria:

* expectant women, between 20 and 32 weeks gestation, attending any of 6 pre- determined antenatal clinics
* primigravidae
* singleton pregnancy
* can read and write Croatian
* resides in Croatia or plans to stay in Croatia at least 12 months following the birth

Exclusion Criteria:

* multigravidae
* women expecting twins/multiples
* refuses to participate
* inability to communicate in Croatian by phone
* planning to leave the County of Split Dalmatia within a year of giving birth
* severe maternal psychiatric or medical problems
The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis

This is a anonymised case note study looking at the long term outcomes of patients with Chronic Pancreatitis on micro nutrient antioxidant treatment.

Chronic pancreatitis is the medical term for chronic inflammation of the pancreas. This illness is associated with long-term abdominal pain. In the 1980s it was proposed that chronic pancreatitis was due to a deficiency of protective "antioxidants" in the pancreas and on this basis antioxidant therapy was introduced. This therapy was highly controversial until a large randomised trial of antioxidant therapy in chronic pancreatitis, undertaken in Manchester showed that 6 months intervention with antioxidant therapy was not associated with any change in pain score or improvement in quality of life. Antioxidant therapy is no longer used in modern day pancreatic practice.

However, as with any study, the randomised trial raised some specific questions.

First, does treatment for more than 6 months provide benefit? Second, are there disease sub-types of chronic pancreatitis where antioxidant therapy may benefit?

Given the lack of contemporary use of antioxidant therapy, this question cannot be answered in a prospective study. However, the case records of the Manchester Royal Infirmary contain information on antioxidant treatment in patients who received this therapy over a prolonged period.

Thus the aim of the present study is to review the case notes of patients given a discharge code from the Manchester Royal Infirmary of chronic pancreatitis during the period 1st January 1990 to 1st January 1998 in order to assess whether there is a record of improvement in outcome. Only the case notes will be reviewed and patients will be given an opportunity to opt out.

The study accepts the limitations of assessing pain from clinical notes but also notes that more objective findings such as development of diabetes mellitus (a long term complication of chronic pancreatitis) can be assessed from the notes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Pancreatitis treated with Long term anti-oxidants

Exclusion Criteria:

* Cancer, On trials
Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male Volunteers

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
   * No finding deviating from normal and of clinical relevance
   * No evidence of a clinically relevant concomitant disease
2. Age ≥21 and Age ≤60 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. History of relevant orthostatic hypotension, fainting spells or blackouts
4. Chronic or relevant acute infections
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
6. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
7. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
9. Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
10. Inability to refrain from smoking on trial days
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range of clinical relevance