cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Prophylaxis - Amoxicillin

The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.

A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants.

Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin.

The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthy
* Age 18-45
* Understands the study procedure and speaks Swedish and/or English

Exclusion Criteria:

* Treatment with antibiotics within the previous three months
* Pregnant
* Breast-feeding
* Allergic against penicillin
* Concomitantly participate in another medical product study
* Treatment with any kind of medication, health food preparations or probiotics
Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.

Pre-surgical, window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints. Finasteride has been shown to reduce prostate cancer development in a large phase III trial, and flutamide has a well-known anticancer effect in advanced prostate cancer at the dose of 750 mg/day.

In this randomized, phase IIB, double blind, placebo controlled, multicenter, pre-surgical, window-of-opportunity trial we compared the effects of finasteride (5 mg/day) versus low-dose flutamide (250 mg/day) or placebo on tissue biomarkers in patients with prostate cancer who were candidate to radical surgery. Specifically, the effects of both drugs on the change in epithelial cell nuclear area in prostate cancer tissue between pre- and post-treatment biopsies was evaluated (primary endpoint). Moreover, the changes of the proliferation marker Ki-67 and of karyometric parameters in benign, dysplastic (HG-PIN) and malignant tissues were evaluated (secondary endpoints). Additional endpoints include the changes of serum PSA and testosterone, assessment of toxicity, overall survival, recurrence-free survival and event-free (recurrence + death) survival. Patients with intracapsular biopsy proven prostate cancer were randomized to either flutamide, 250 mg/day, or finasteride, 5 mg/day, or placebo for 4-6 weeks before radical prostatectomy. Blood samples were taken before and after treatment. At surgery, end-of-study ex-vivo biopsies were obtained from the prostatectomy specimens to assess the treatment changes in nuclear area (primary endpoint), Ki-67, topoisomerase-II-α and a 20-feature karyometric discrimant function in normal, high-grade PIN and malignant tissue. After surgery patients were followed up for at least 15 years to assess recurrence and/or mortality. We also plan to follow-up patients by telephone interview to assess their vital status for up to 20 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years
* Patients with a biopsy proven, clinically intracapsular PCa who are candidates to radical retropubic prostatectomy
* ECOG performance status ≤ 2
* Satisfactory hematological and biochemical functions:

  * Platelets ≥100 x 10\^9/L
  * AST and ALT in the normal range
* Able to understand and sign an informed consent

Exclusion Criteria:

* Previous hormone treatment during the 8 weeks before enrollment
* Neurologic and psychiatric diseases precluding patient participation in the study
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with the study procedures.
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer

The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.


Eligibility Criteria:
Inclusion Criteria:

* patients with Colorectal Cancer(CRC);
* subjected to the Fast-Track processing of surgery;
* between 18 and 75 years old.

Exclusion Criteria:

* American Society of Anesthesiologists(ASA) grade \> III;
* BMI \> 30;
* a history of abdominal surgery, endocrine or immune system dysfunction;
* recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
* previous contraindication to epidural anesthesia.
Study of Pemetrexed for Second-Line Pancreas Cancer

This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.

In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.

This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreas
* Prior treatment for distant or locally advanced disease with gemcitabine-based therapy
* Measurable or evaluable disease
* ECOG performance status 0-2
* Adequate hematological parameters
* Adequate baseline liver function
* At least 28 days from any major surgery
* At least 2 weeks from the last radiation treatment
* Must have recovered from reversible toxicities of prior chemotherapy
* Must be able to discontinue any nonsteroidal anti-inflammatory medications
* Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements

Exclusion Criteria:

* Any prior treatment with pemetrexed
* More than one prior chemotherapy regimen
* HIV positive on antiretroviral therapy
* Pregnant or lactating
* Prior organ allograft
* On concurrent antitumor therapy including radiation therapy or other chemotherapies
* Creatinine clearance 45 ml/min or less
* Absolute neutrophil count \< 1500
* Platelets \< 75,000
* Bilirubin \> 1.5 times the upper limit of normal
* Transaminases \> 3 times the upper limit of normal except in known liver metastasis wherein they may be \</= 5 times upper limit of normal
* Clinically significant ascites or pleural effusion that cannot be drained
* Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Studies of States With Resistance to Vitamin D and Parathyroid Hormone

Patients with confirmed or suspected states with resistance to vitamin D or parathyroid hormone (PTH) will be admitted for diagnosis, treatment review with suggestions for modifications to the current or new treatment and for inclusion in other protocols. These states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. Resistance to a factor is manifested by deficient bioeffect despite high levels of the factor in blood. Patients will be tested with multiple indices of mineral metabolism to establish the diagnosis and examine the spectrum of the underlying disorder. The principal therapies will be combinations of calcium, phosphate, and a vitamin D analog. Selected patients will have localization and surgery to remove a tumor that causes renal wasting of phosphate. Patients will also be considered for entry into other research protocols.

Patients with confirmed or suspected states with resistance to vitamin D or parathyroid hormone (PTH) will be admitted for diagnosis, treatment review with suggestions for modifications to the current or new treatment and for inclusion in other protocols. These states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. Resistance to a factor is manifested by deficient bioeffect despite high levels of the factor in blood. Patients will be tested with multiple indices of mineral metabolism to establish the diagnosis and examine the spectrum of the underlying disorder. The principal therapies will be combinations of calcium, phosphate, and a vitamin D analog. Selected patients will have localization and surgery to remove a tumor that causes renal wasting of phosphate. Patients will also be considered for entry into other research protocols.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients, from 2 months to 100 years of age, of either sex M or F, with vitamin D resistance, rickets, osteomalacia, pseudohypoparathyroidism, pseudo-pseudohypoparathyroidism, or suspicion of these or related disorders based upon the appropriateness of their problem to ongoing investigations.

Current investigations are focused principally upon the inclusion of subjects with, or suspected of having, hypocalcemia likely due to a resistance to parathyroid hormone, including subjects who have a diagnosis, or likely diagnosis, of pseudohypoparathyroidism or pseudopseudohypoparathyroidism.
The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment

A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mild Cognitive Impairment
* Carry APOE ε4 gene

Exclusion Criteria:

* Diagnosis of Dementia
* Patients who receive medication for memory or depression
* Patients who do not carry APOE ε4 gene
Triage Survey for Psychiatry Research Eligibility

TRIAGE-Psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
* Participant is at least 18 years old.

Exclusion Criteria:

* Participant is pregnant, breast-feeding, or planning to become pregnant.
* History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
* Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on C-SSRS questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
* Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
* Any condition that in the investigator's opinion makes a participant unsuitable for the study.
* Currently employed by Adams Clinical or a first-degree relative of an employee.
Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies

To study a novel biopsy needle system for performing transperineal prostate biopsy. Prostate biopsy remains the standard approach for prostate cancer detection. While pre-biopsy MRI allows for targeting of visible lesions, systemic or 'off target' samples are recommended due to the well-recognized risk of undegrading and under sampling with current commercially available needles. The SureCore plus single-use biopsy needle produces a more intact tissue core with a same caliber 18g needle with \~21% more tissue per core in pre-clinical studies. This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and characterization of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than age of 18 undergoing prostate biopsy

Exclusion Criteria:

* Unable to consent
* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives
* Prisoners
18793 - Human Photoallergy Test

To evaluate the potential of a test material to produce a photoallergic response.


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive
* be lightly pigmented (Fitzpatrick Skin Type I, II, III)
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form (Health Insurance Portability and Accountability Act) in conformance with 45CFR Parts 160 and 164
* be in general good health as determined by the subject's medical history and in the discretion of the investigator

Exclusion Criteria:

* have a visible sunburn
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
* subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee
GLP1R-imaging in Post-RYGB Hypoglycemia

In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups.

These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent

Patients:

- Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year.

Controls:

* RYGB at least 2 years ago
* Normal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l or HbA1c between 20 and 42 mmol/mol)
* Score ≤ 7 on Sigstad's scoring system (Table 1)
* Hypoglycemia excluded by 14-day continuous glucose monitoring
* Individual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2)

Exclusion Criteria:

* Anti-diabetic medication in the past 6 months
* Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors in the past six months.
* Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment. Normal values of total bilirubin, γ-GT, ASAT and albumin are \<21 μmol, \<40 U/l, \<30 U/l and 35-50 g/l respectively
* Pregnancy or the wish to become pregnant within 6 months
* Breast feeding
* Kidney failure, i.e. calculated creatinine clearance below 40 ml/min
* Age \< 18 years
* No signed informed consent
The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial

The aim of this study is to investigate the use of Edi in patients under the endotracheal tube and tracheostomy, and analysis of cardiopulmonary parameters in adult patients.

Tracheostomy is a utilitarian surgical procedure of access; therefore, it should be discussed in light of the problem it addresses: access to the tracheobronchial tree. The trachea is a conduit between the upper airway and the lungs that delivers moist warm air and expels carbon dioxide and sputum. Failure or blockage at any point along that conduit can be most readily corrected with the provision of access for mechanical ventilators and suction equipment. In the case of upper airway obstruction, tracheostomy provides a path of low resistance for air exchange.

Eligibility Criteria:
Inclusion Criteria:

* Patents under planning tracheostomy will enroll to this study.

Exclusion Criteria:

* Pregnant women, age under 18 and unable to insert nasogastric tube
Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study

Posterior fossa surgery represents on of the most demanding procedure in neurosurgery. Retrosygmoid (RS), key-hole retrosygmoid (KR) and cerebellar hemispheric (CH) are the most common approaches used to access in this area. Despite they are not technically difficult to perform, these approaches can be burdened by postoperative cerebrospinal fluid (CSF) leakage, both at short and long-term follow-up, with an high risk of meningitis. Many techniques were employed to avoid this risk, but it can still be estimated between 2% and 11% according to literature1-4. Spena et al. reported a CSF leakage rate of 6.8% in a previous experience5. As a consequence, newer efforts are necessaries to avoid this potentially lethal complication. By this explorative study, we want to retrospectively analyzed our experience with a newer technique of bone closure, called O'Ring, in patients subdued to posterior fossa surgery by RS, KR and CH approaches, focusing on postoperative CSF leakage (primary objective), wound complications and subcutaneous CSF collections (secondary objectives).


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* availability of pre- and postoperative radiological and clinical data,
* a follow-up period of at least 3 months.

Exclusion Criteria:

* Lacking of clinical, radiological and surgical data
Effect of a Physical Exercise Session Performed During a 24-34 Hour Fasting Period on Energy Metabolism and Cognitive Function in Healthy Adults

This study explores the impact of high-intensity exercise during fasting on energy metabolism and cognitive function in healthy adults. Changes in respiratory exchange ratio, blood substances, and cognitive performance will be measured after 24 and 34 hours of fasting with and without exercise in a randomized crossover design.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old.
* Body mass index: 18.5-30.0 Kg/m2.
* Stable body weight (5kg range within the last 3 months)
* Being able to consume all the food items provided as part of the study.
* Not having change the time zone or have shifted sleeping hours equivalent to more than 3 hours on the previous 2 weeks.

Exclusion Criteria:

* Diagnosed with any chronic condition that, in the research team's opinion or based on the American College of Sports Medicine guidelines, could contraindicate the implementation of 34-hour fasting periods and/or high-intensity exercise.
* Diagnosed with a chronic endocrine, digestive, rheumatic, neurological, cardiac, pulmonary, autoimmune, or infectious condition that affects energy metabolism.
* Presenting any signs or symptoms of illness that, in the research team's opinion or based on the American College of Sports Medicine guidelines, could contraindicate the implementation of 34-hour fasting periods and/or high-intensity exercise.
* Pregnant or breastfeeding.
* Using medications or supplements that may alter energy metabolism.
* Currently undergoing or having undergone any type of nutritional intervention or treatment in the past 3 months.
* Engaging in more than 5 hours per week of habitual moderate-to-vigorous cycling.
* Any other condition that, in the research team's opinion, discourages participation in the study.
Assessing Treatment Response in Breast Cancer With Functional Imaging

Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Newer techniques such as functional MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither modality utilises ionising radiation.

Although MRI is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. Other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a special magnetic resonance (MR) sequence called T2\* to measure the weakly magnetic effect of deoxygenated haemoglobin. The investigators wish to develop and validate T2\* measurements which relate to oxygenation of a tumour. The investigators also want to validate other MR sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues.

Microbubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour Doppler signals obtained from routine ultrasound imaging. Optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. It utilises a light signal input and measures ultrasound signal output.

The investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer due for neoadjuvant chemotherapy

Exclusion Criteria:

* Ferromagnetic implants within body in accordance with standard clinical practice
* claustrophobia
* age \<18 or \>90
A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure

The purpose of this observational study is to assess HRQoL in relapsed and/or refractory multiple myeloma (RRMM) participants who have previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.


Eligibility Criteria:
Inclusion Criteria:

* Must have sufficient command of the Japanese language to understand the study instructions and requirements
* Must be a resident of Japan
* Must have received prior treatment with:

  1. a proteasome inhibitor,
  2. an immunomodulatory agent, and
  3. an anti-CD38 antibody Subjects must be either 2-4 months, 5-7 months, or 8-11 months post triple class therapy exposure at time of consent
* Subject must be diagnosed with multiple myeloma

Exclusion Criteria:

* Participants enrolled in a clinical trial that includes at least one novel/ experimental agent at the point of questionnaire completion

Other protocol-defined inclusion/exclusion criteria apply.