cyrilzakka/clinical-trials huggingface dataset:
Drug-drug Interaction Study in Healthy Male Volunteers Following the Administration of Pantoprazole and Rosuvastatin

This is a single-center, randomized, 2-period, 2-sequence, cross-over study.

Background:

Notions used to describe drug disposition are being reviewed as the roles of drug membrane transporters are being discovered. In the near past, simple biophysical principles - lipophilicity and passive diffusion - were used to explain drug absorption, distribution and elimination. Today, with more than 367 genes known in humans, membrane transporters occupy a much central role.

Rational:

Drug influx/efflux transporters are expressed in various organs with variable activities and their presence increases (influx) or decreases (efflux) the intracellular concentration of a drug in a specific organ. Therefore, intersubject variability in the activity of these transporters due to genetic polymorphisms or concomitant drug treatments can explain intersubject variability in drug actions.

Rosuvastatin is an HMG-CoA reductase inhibitor and a substrate of OATPs and BCRP. There is not much information on the transporter-mediated disposition of rosuvastatin. Literature suggests that rosuvastatin is a transporter substrate of the influx OATP1B1, 1B3 and 2B1 as well as the efflux BCRP. The efflux of rosuvastatin by BCRP would be of major importance in the hepatocytes. BCRP would be responsible of the excretion of 30% of the unchanged drug in the bile. To confirm this hypothesis and identify patients at risk of toxicity with rosuvastatin, we want to perform a drug-drug interactions study with an inhibitor of BCRP namely, pantoprazole. With this approach, we will confirm if rosuvastatin is a real substrate of BCRP as suggested in the literature.

Methodology:

To determine changes induced by the administration of pantoprazole on the pharmacokinetics of rosuvastatin in healthy volunteers 16 healthy volunteers will be administered a single dose of rosuvastatin with and without (placebo) pantoprazole.

Urine and plasma analysis will be performed by LC-MSMS. Pharmacokinetics analysis will be performed. Plasma and urine concentrations of rosuvastatin will be analysed using a noncompartmental method. Pharmacokinetic parameters calculated in this study will be Cmax, Tmax, AUC0-72, AUC0-∞, Kel, T1/2β, CL/F, CLr, and Ae.

Eligibility Criteria:
Inclusion Criteria:

* Vital Signs, EKG and Clinical Laboratory Values within the normal range
* Body mass index (BMI) \[20-29kg/m2\]
* Caucasian male
* Age between \[18-55\]
* Healthy by physical exam
* Non or ex-smoker

Exclusion Criteria:

* Presence or history of intolerance or hypersensibility to proton pump inhibitors or HMG-CoA reductase inhibitors.
* Significant illness. History of cardiovascular, kidney, liver or gastrointestinal disease. Presence of cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
* consumption of an investigational product or donation of blood in the previous 28 days preceding the study.
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations.

Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations.

This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 18 years
* Planned laparoscopic or robotic-assisted sacral colpopexy

Exclusion Criteria:

* History of ulcerative colitis or Crohn's disease
* Prior large or small bowel resection
* Known diagnosis of gastroparesis
* Prior pelvic radiation
* History of abdominal or pelvic malignancy
* Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair
* Pregnancy
* Known allergic reactions to components of the study products
* Known renal insufficiency
* Non-English speaking as the primary study questionnaires are all currently in English only
Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme


Eligibility Criteria:
Inclusion Criteria:

* Have histologically proven malignant Glioblastoma Multiforme in first or second relapse
* Have failed prior Fractionated External Beam Cranial Irradiation or IMRT
* Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy
* Have a Karnofsky performance status of ≥ 60
* Have adequate bone marrow function, liver function, and renal function before starting therapy

Exclusion Criteria:

* Have had more than two relapses
* Have had radiosurgery
* Have a cardiac ejection fraction \< 50% by MUGA or ECHO
* Have Troponin-I elevated above the normal range
* Have an increasing steroid requirement
* Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage
* Have active stroke and/or transient ischemic attack not optimally managed
* Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension)
* Be pregnant or breast feeding
* Have had prior hypersensitivity reaction to Cremophor EL
* Be HIV positive
A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

This is a multicenter, randomized, observer-blind, and parallel-controlled clinical study to evaluate the immune responses and safety profiles in adults (≥ 18 years) receiving investigational products (intramuscular injection or nebulized inhalation) ≥ 180 days after the immunization of 2 doses of BNT162b2 vaccines plus one dose of booster AZD1222 vaccine. This study will enroll about 30% participants aged 60 years and above.

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 18 years and above at the time of screening.
2. Received the 1st booster vaccination at least 180 days earlier.
3. Agree to attend all visits and sign the written informed consent form.

Exclusion Criteria:

1. Have a history of seizures, epilepsy, encephalopathy, psychosis.
2. History of severe anaphylaxis or allergy to any vaccine component.
3. Positive urine pregnancy test result, pregnant, lactating women.
4. Medical history of Guillain-Barré syndrome.
5. Have had asthma attacks within 2 years.
6. Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
7. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
8. Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
9. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
10. Current diagnosis or receiving treatment for tuberculosis or cancer.
11. History of SARS-CoV-2 infection for less than 3 months.
12. Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
13. Have an axillary temperature of \> 37.0℃.
14. Any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
AVL200 IOL for Treatment of Cataract and Presbyopia

This study is to evaluate the performance of the AVL200 IOL in terms of visual function improvement over a range of focal points. Participants meeting eligibility criteria will undergo cataract surgery with implantation of the AVL200 intraocular lens (IOL), then be followed through 1 year postoperatively. Postoperative assessments include safety and visual function.


Eligibility Criteria:
Inclusion Criteria:

* Visually significant cataract
* Best corrected distance visual acuity between 20/40 and 20/200
* Potential distance visual acuity of 20/32 or better
* Corneal astigmatism ≤ 1.5 diopters

Exclusion Criteria:

* Use of medication that could affect accommodation
* Previous corneal surgery or significant corneal abnormalities
* Ocular pathology or degenerative disorder having potential to impair visual acuity
* Pupil abnormality
* Intraoperative cataract surgery complications that could affect IOL implantation or positioning
Long Term Extension Trial of Setmelanotide

This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

The primary objectives of this extension trial are to explore the long-term safety and tolerability of setmelanotide for up to 5 years or until drug is otherwise available through authorized use. Patients can enter this protocol immediately upon completion of their index protocol such that dosing of setmelanotide continues without gaps in therapy.

Eligibility Criteria:
Key Inclusion Criteria:

1. Patients aged 2 or older (or aged \>2 years as per local regulations) who have completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)
2. Patient and/or parent or guardian is able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements
3. Agree to use a highly effective form of contraception throughout the trial

Key Exclusion Criteria:

1. Pregnant and/or breastfeeding women
2. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
3. Current, clinically significant disease
4. Documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
5. Suicidal ideation, attempt or behavior
6. History of significant liver disease
7. Moderate to severe renal dysfunction as defined by a glomerular filtration rate (GFR) \<30 mL/min.
8. History or close family history of melanoma or patient history of oculocutaneous albinism

Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair

From September 2014 to March 2015, 57 consecutive patients with hypospadias who are candidate for surgery will be enrolled in this randomized clinical trial.

Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of the study and all parents will sign a written informed consent.

Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity. Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated.

All selected patients will randomly allocate to one of the two groups: group A will receive caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive general anesthesia before surgery and CEB afterwards. The surgical procedures will be performed by a single pediatric urologist (FA). The surgical technique will be tubularized incised plate in all cases.

Intraoperative blood loss will be determined by weighing all surgical gauzes used during procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to minimize the effect of water vaporization on gauzes weights.

In addition to blood loss, operation time, dose of fentanyl used during procedure and length of the urethral plate defect will be recorded for each patient by trained nurses.

Demographics and disease characteristics as well as operation details will be compared in the two studied groups.


Eligibility Criteria:
Inclusion Criteria:

age between 6 months to 15 years and hypospadias with any severity

Exclusion Criteria:

coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety

Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.

Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Many children with anxiety disorders, especially those on the autism spectrum, do not receive evidence based treatment, which has fueled the development and evaluation of cognitive-behavioral therapy (CBT). Accordingly, we are proposing a randomized controlled trial to examine the efficacy of exposure based CBT that heavily incorporates parents (EF-CBT) relative to a TAU condition (TAU) in 50 youth ages 6-12 years with ASD and comorbid anxiety disorder(s).

Eligibility Criteria:
Inclusion Criteria:

* Outpatient children with an autism spectrum disorder between the ages 6-12 years.
* Meets criteria for a diagnosis of one of the following anxiety disorders: generalized anxiety disorder, separation anxiety disorder, social phobia, specific phobia, panic disorder or obsessive-compulsive disorder.
* Minimum score of 12 on the Pediatric Anxiety Rating Scale - Severity Scale.
* Child has a Full Scale and Verbal Comprehension IQ \> 80.

Exclusion Criteria:

* Current clinically significant suicidality or engagement in suicidal behaviors within the last 6 months.
* Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment).
* Any lifetime diagnosis (meeting DSM-IV criteria) of bipolar disorder, schizophrenia or schizoaffective disorder; or Substance abuse in the past 6 months.
* Initiation of an antidepressant medication within 10 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 6 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects). If the child is on a medication, she or he can remain on it at its current dose. While in their treatment arm, children randomized to the EF-CBT condition will not be able to continue or initiate psychosocial interventions targeting anxiety(psychotherapy, certain types of social skills training, applied behavior analysis targeting anxiety). Those in the TAU arm will be able to seek out psychiatric/psychological services at their discretion.
Prospective Randomized Non-Inferiority Study Comparing Natural Cycle Frozen Embryo Transfer (NC-FET) to a New Type of Endometrial Preparation for FET: Natural Proliferative Phase (NPP-FET)

Frozen embryo replacement cycle :Two methods traditionally used: the spontaneous cycle and the artificial cycle.Now, Emergence of new protocols: NPP-FET or "Natural proliferative phase - frozen embryo transfer" Demonstrate non-inferiority between the NPP-FET and the spontaneous cycle, and superiority in terms of planning.

The protocol Natural proliferative phase/Natural Programmed by Progesterone, Patients with regular cycles, candidates for replacement of embryos frozen in a spontaneous cycle. The monitoring of the cycle is carried out by taking blood and follicular ultrasound between the 10th and 13th day of the cycle. Support luteal phase by intravaginal progesterone (utrogestan 200 mg) 1 tablet, 2 times per day, is initiated once the following criteria are met:

* Thickness of the endometrium \> 7 mm on ultrasound
* Ovarian follicle \> 14 mm
* Estradiol( E2) \> 120 pg/mL Embryo transfer is scheduled on the 6th day of progesterone exposure exogenous. A progesterone dosage on the day of transfer will be systematically realized

Eligibility Criteria:
Inclusion Criteria:

* Single transfer Blastocyste

Exclusion Criteria:

* PGT (Preimplantation genetic diagnosis)
* Testicular Sperm
* Donor oocytes
Circulating Tumor DNA in Patients at High Risk for Lung Cancer

Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the early detection of lung cancer.

Specific somatic (i.e. acquired and not inherited) mutations have been found in many cancers. Some of these cancers shed this DNA into the patient's blood stream and is called circulating tumor DNA (ctDNA). Pathway Genomics has developed a new molecular assay that uses blood plasma as the source of DNA fragments. The ctDNA is isolated, amplified and analyzed for the presence of one or more of 96 known mutations that are found in 9 cancer driver genes. This technique of using a "liquid biopsy" to screen for and monitor cancer has been documented in a number of recent medical publications. However, the majority of published studies are on subjects who have already been diagnosed with cancer. Therefore, the investigators wish to look at a population of patients who are scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy without a know history of cancer (other than basal cell carcinomas of the skin). The blood will be drawn at the time of or a few weeks before the procedure. The analysis of the blood sample will take placed in the Pathway Genomics clinical laboratory which is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified.

Following an informed consent process, the patients will fill out a health questionnaire and will have the blood drawn prior to the surgical procedure. Up to 30 ml of blood (approximately 2 tablespoons) will be drawn at any one time. The patient will be asked to agree to being contacted by the investigators yearly for up to 5 years to provide follow-up medical information. No patient will be identified in presentations or publications resulting from this work and all data will be reported from analysis of combined information from participants in this study.

Individuals may participate in this study if they are 18 years of age or older, have not had a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic surgical procedure for a cancer that was diagnosed within the prior month), and are undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed).

Exclusion Criteria:

* Prior history of cancer.
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.

The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.

Most patients with colorectal neoplasm have iron deficiency, which can be triggered in the pre-operative period by a decrease of iron intake and the bleeding in the site of neoplasm.

In the postoperative period, iron deficiency can be aggravated by surgical bleeding.

Iron plays a leading rol in haemoglobin production, cell mitosis and immune system. Animal experimentation has shown that induced iron deficiency and mild anemia lead to postoperative mortality and lactacidemia in a model of peritonitis.

Moreover, anemia is the main risk factor to require intra and postoperative blood transfusions, and iron deficiency and anemia are associated to a larger number of postoperative complications (infections and longer hospital stay).

Oral iron therapy is the standard treatment in patients with preoperative iron deficiency, but iron levels inside red cells may not reach normality in time before surgery, and it can not be resumed until the patient can start again oral feeding.

In these patients, any increase in preoperative haemoglobin decreases the risk to need a blood transfusion during or after surgery.

This trial will compare standard oral iron and intravenous iron.

Eligibility Criteria:
Inclusion Criteria:

* Non-recurrent colorectal neoplasm, surgically resectable
* Anemia

Exclusion Criteria:

* Severe renal impairment
* High anesthetic risk