cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Explore the Role of Gut Flora in Acne

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to acne.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages.
3. Diagnosis of acne by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment

Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.


Eligibility Criteria:
Inclusion Criteria:

-

All subjects:

* Signing the informed consent forms.
* 18 years to 65 years (inclusive).
* Body mass index should be between 18 and 30 kg/m2 (inclusive).
* No medication was used before screening#or stable medication for 4 weeks.

Normal liver function:

• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.

Hepatic impaired subjects:

* Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
* Liver damage due to primary liver disease.

Exclusion Criteria:

-

All subjects:

• Subject known or suspected of being sensitive to the study drugs or its ingredient.

Normal liver function:

* Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
* Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.

Hepatic impaired subjects:

* Suspected or diagnosed as liver cancer or with other malignant tumors.
* Drug induced liver injury#acute liver injury#liver transplantation history.
* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps

Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)


Eligibility Criteria:
Inclusion Criteria:

* every patient in the hemato-oncological department who received at least one CVC was included in the study

Exclusion Criteria:

* none
Nasal Provocation Testing in Occupational Rhinitis

In a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a storage mite extract would trigger symptoms and objective signs of rhinitis in bakery workers and a control group.

The investigations include allergy testing with skin prick testing, and measuring of specific Immunoglobulin E (IgE) in sera, answering a questionnaire, and symptom scoring before and after provocations. The participants will be investigated one day with a placebo, and another day with the allergen extract of either Acarus Siro or Lepidoglyphus Destructor. As a measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical scoring of nasal secretion and blockage. Indices of inflammation (ECP and alfa-Macroglobulin) will be monitored in nasal lavage.

Eligibility Criteria:
Inclusion Criteria:

* bakery workers
* \> 18 years
* sensitized to a storage mite (A.Siro or L. Destructor)

Exclusion Criteria:

* pregnant or breast-feeding
* infection in upper or lower airways the last month
* nasal polyposis
Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
* Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
* Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
* Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
* Women able to have children must agree to use 2 forms of contraception during the study

Exclusion Criteria:

* Body Mass Index (BMI) greater than 39
* History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis)
* Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures
* Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year
* Planned surgical procedure during the study
* Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care)
* Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary
* Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
* Patients with significant heart, neurological or psychiatric diseases
* Patients who had cancer other than certain skin cancers within the past 5 years
* Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years
* Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.
Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.

Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the treatment.

For the vast majority of the population, exposure to ICP is perfectly well tolerated. Nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (NIC). NIC is the third cause of an acquired acute renal failure within the hospital.It significantly increases morbidity and mortality and prolongs the hospital stay.

Of all the procedures requiring ICP administration, PCI is associated with the highest rate of NIC.This evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.Age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing NIC.

Nowadays, the use of PCI in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. This is linked to the aging of the population and the increasing incidence of cardiovascular diseases.

ICP-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.These intra-renal mechanisms lead to an acute renal function impairment.NIC is defined as an increase of serum creatinemia ≥ 0.5 mg / dL (or a 25% increase) from the baseline in the 48-72h following PC injection with no other obvious etiology. It reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days.

The prevention of NIC based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). In contrast, there is little data on the relationship between NIC and the PCI volume used. To the investigator's knowledge, the threshold of toxic volume is not well defined. Taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an ICP and the occurrence of a NIC according to the criteria mentioned above.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013
* Access to extensive demographic, clinical and biological data

Exclusion Criteria:

None
Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer

The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels.

Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide


Eligibility Criteria:
Inclusion Criteria:

1. Patients with prostate cancer who have commenced enzalutamide within 3 months
2. Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide)
3. Receiving enzalutamide before or after docetaxel
4. Patients may have hormone-sensitive or castrate resistant disease
5. Patients may have metastatic (M1) or non-metastatic (M0) disease
6. Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide

Exclusion Criteria:

1. Clinical dementia
2. Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines.
3. Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors.
4. Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry.
5. Diagnosed with sleep apnoea
6. Brain metastases, prior seizures, drugs that significantly reduce seizure threshold.
7. Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.
Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis

The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.

Each patient received two successive IV antibiotic courses during a period of pulmonary exacerbation. One of these courses was delivered as thrice daily 30-minute infusions of ceftazidime in 100 ml of 0.9% sodium chloride, and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 0.9% sodium chloride, over 23 hours. The daily dose of ceftazidime was 200 mg/kg, with a maximum dose of 12 g. For ceftazidime continuous infusion, a loading dose of 60 mg/kg (maximum 2 g) was used. All patients also received tobramycin (10 mg/kg), in the form of one 30-minute infusion per day. Portable devices were used: Intermate® SV 200 (Baxter) for the 30-minute short infusions of ceftazidime and tobramycin, Infusor® LV10 (Baxter) for continuous infusion of ceftazidime.

Eligibility Criteria:
Inclusion Criteria:

* patients with cystic fibrosis older than 8 years
* with chronic Pseudomonas aeruginosa infection of the respiratory tract
* with at least 2 courses of IV antibiotic in the year before enrolment
* at the time of a pulmonary exacerbation

Exclusion Criteria:

* allergy to ceftazidime or tobramycin
* bronchial colonization with Burkholderia cepacia
* renal impairment
* history of lung transplantation
Current Practice for Management of Pneumothorax in Egypt

There are standard well-known guidelines for pneumothorax management with minimal difference between societies and associations. We are investigating how much of these guidelines are actually being followed in different healthcare facilites in Egypt. This is a questionnaire that will be sent to all healthcare givers in Egypt acorss different cities and facilities with multiple choice questions presenting different case scenarios and the management options being given to the patient.


Eligibility Criteria:
Inclusion Criteria:

* being health care giver concerned with management of pneumothorax

Exclusion Criteria:

* being not concerned with management of pneumothorax
Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.

Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.

Supratentorial high grade gliomas are for surgical resection in any case according to many factors.

Investigators will compare the outcomes/survival rate and clinical outcome of the different resection types (Total, near total, subtotal/debulking) of supratentorial high grade gliomas according to the clinical condition and comorbidities of the patient, the location and morphology of the lesion, the grading of lesions, and the clinical experience of the neurosurgeon.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo surgical excision of the supratentorial high grade gliomas at the time of study (two years).
* Denovo disease for the first time.
* Any age

Exclusion Criteria:

* Low-grade Gliomas.
* Infratentorial high-grade gliomas.
* Past history of gliomas.
* Patients who are unfit for any neurosurgical interventions.
* Patients who do not receive their adjuvant standard therapy.
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants

The primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (PK) profile of S-309309; and the PK of S-309309 following administration of S-309309 alone and co-administration with itraconazole


Eligibility Criteria:
Key Inclusion Criteria:

* Participants who are considered to be medically healthy as determined by the investigator
* Participants whose body mass index (BMI) is within the range of ≥ 18.5 to ≤ 30.0 kg/m\^2
* Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Participants who understand the study procedures and agree to participate by providing written informed consent
* Participants who are willing and able to comply with all study procedures and restrictions

Key Exclusion Criteria:

* Participants who have a history of clinically significant hypersensitivity or severe side effects induced by a drug.
* Participants who have a history of ventricular dysfunction, congestive heart failure, or pulmonary edema.
* Participants who have a history of gastrointestinal surgery including, but not limited to, cholecystectomy, gastric resection, and/or intestinal resection that may result in a clinically significant abnormality in gastrointestinal function (except for an appendectomy). Participants can be considered by the investigator (or sub-investigator) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations.
* Participants who are considered inappropriate for participation in the study for any reason by the investigator (or sub-investigator).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Improvement of the Etiological Diagnosis of the Pericarditis

Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)


Eligibility Criteria:
Inclusion Criteria:

* Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
* Adult patient (= or \> 18 years old)
* Patient who freely signed the informed consent form.
* Patient affiliated to a health insurance regime

Exclusion Criteria:

* Minor patient ( age \<18 years)
* Pregnant, parturient or breastfeeding woman
* Adult patient incapable or unable to consent
* Patient deprived of liberty under judgment
* Person living in a health or social specialised structure
* Person in vital emergency situation
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy

This pilot phase II trial studies how well vitamin B6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. A nutritional supplement such as vitamin B6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.

PRIMARY OBJECTIVES:

I. To evaluate the effect of Vitamin B6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy \[ADT\]).

OUTLINE:

Participants receive vitamin B6 orally (PO) daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment
* Subjects are experiencing bothersome hot flashes per the study questionnaires
* Subjects are capable of giving informed consent.
* Willing to comply with all study procedures and be available for the duration of the study
* Able to obtain and take an acceptable form of vitamin B6

Exclusion Criteria:

* Subjects without a diagnosis of prostate cancer
* Subjects already receiving other treatment for hot flashes
* Subjects taking selective serotonin reuptake inhibitors (SSRIs)
* Subjects are currently taking vitamin supplementation which includes vitamin B6 at doses \> 10 mg
Mechanisms of Smell Improvement With Dupilumab.

This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP). The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.

Post-marketed administration of dupilumab (FDA approved medication for CRSwNP) in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) will result in significant improvement in objective measures of olfactory cleft inflammation and psychophysical olfaction. The investigators seek to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with CRSwNP. The investigators also want to determine whether change in olfactory cleft inflammation correlates with improvement in olfaction (one of the cardinal symptoms of CRSwNP) at 3 months. The investigators hypothesize that after 3 months of treatment with dupilumab, non-inflammatory factors will explain a significant degree of variation in residual clinical olfaction. Additionally, the investigators want to explore the determinants of ongoing olfactory loss after 3 months of treatment with attention to non-inflammatory factors. The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation. Specifically, the investigators expect to show that reduction in olfactory cleft inflammation is the result of reduction in IL13 levels in olfactory cleft mucus. Finally, the investigators expect to show that most of the variation in post-treatment olfaction can be explained by non-inflammatory measures that are independent of CRSwNP.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Meet criteria for CRSwNP as defined by ICAR-21
* 2 out of 4 cardinal symptoms for ≥12 weeks
* Visible evidence of inflammation on endoscopy or imaging
* Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side)
* Olfaction score ≥1 (0-3 scale)
* Candidate for treatment with dupilumab for CRSwNP
* Elected to proceed with dupilumab for treatment of CRSwNP

Exclusion Criteria:

* Prior use of dupilumab
* Previous treatment with another biologic medication for CRSwNP or asthma within 6 months
* Any nasal or sinus surgery within the last 3 months
* Oral corticosteroid use within the last 1 month
* Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months
* Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection;
* Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis;
* Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome;
* Kartagener syndrome; or dyskinetic cilia syndrome
* Poorly controlled asthma