cyrilzakka/clinical-trials huggingface dataset:
A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis

The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.

This is a prospective, observational, cohort study to collect data on adult participants who have a confirmed diagnosis of psoriatic arthritis (PsA) and are starting either STELARA or a new TNFi as a new therapy in a first, second, or third line of biologic disease-modifying antirheumatic drug (bDMARD) therapy. Approximately 1,400 participants will be enrolled into this study, with 700 participants who are receiving STELARA at study entry and 700 participants who are receiving a new TNFi therapy at study entry. Recruitment into the study will continue for approximately 2 years (with the possibility to extend this period if the patient enrollment target is not reached), with a 3-year follow-up period. For each participant, the follow-up period will continue for 3 years (36 months) after inclusion into the study. Participants will primarily be assessed for parameters of treatment retention, clinical response, effectiveness and safety over an observational period of 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria
* Must be starting either STELARA or any new approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilar) as a new biologic disease-modifying antirheumatic drug (bDMARD) therapy in a first, second or third line of bDMARD therapy for PsA at the time of enrollment into the observational study or within a maximum 2-month window after the baseline visit
* Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

* Participant is starting STELARA or a TNFi therapy as fourth or further line of biologic treatment
* Participant is unwilling or unable to participate in long-term data collection
* Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point
* Participant is currently enrolled in an interventional study
Mycobacterium w in Patients With Severe Sepsis

Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in restoring immunity, thereby improving outcomes in patients with severe sepsis.

In this randomized trial, the investigators propose to evaluate the efficacy of Mw in patients with severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

Patients with severe sepsis within 48 hours of first organ dysfunction

* Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of \>90 and \>65 mm Hg, respectively
* Renal dysfunction: urine output \<0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation
* Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis
* Hematologic dysfunction: platelet count \<100,000/mm3 or decrease by 50% in the three days preceding enrollment
* Unexplained metabolic acidosis: pH ≤7.30

Exclusion Criteria:

* Pregnancy
* Gram-positive culture
* Only fungal infection as source of sepsis
* Patients who received cardiopulmonary resuscitation
* Those on immunosuppressive therapy
* Those unwilling to provide informed consent
Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss

The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).

DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosed with androgenetic alopecia
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in DA-002 or DA-005
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits
Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)

The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks


Eligibility Criteria:
Inclusion Criteria:

Phase 1 (dose escalation)

* patients with histological proven gastrointestinal neoplasms, without standard therapy option
* measurable or evaluable disease
* \>= second-line therapy (metastasized stage) Phase 2 (efficacy)
* patients with proven colorectal neoplasms
* measurable disease, metastasized
* previous chemotherapy with 5-FU/FA ("AIO-regimen")
* age between 18 and 75 years, both male and female
* life expectancy \> 3 months
* WHO-performance status \<= 2
* adequate bone marrow function: hemoglobin \>= 10 mg/dl, neutrophils \>= 2.0 \* 1000000000/l, thrombocytes \>= 150 \* 1000000000/l
* adequate renal and liver function: bilirubin \<= 1.25 \* ULN(\<= 1.5 ULN \* by liver metastases), creatinine \<= 1.25 \* ULN, ASAT and ALAT \<= 3 \* ULN (\<= 5\* ULN by liver metastases; AP \<= 3\* ULN
* written informed consent prior to inclusion into the study

Exclusion Criteria:

* pretreated with mitomycin c
* contraindication concerning 5-FU (e.g. anxiety, myocardial infarction within last 6 months, significant toxicities during previous therapy with 5-FU
* florid infections
* ileus or subileus, morbus crohn or colitis, ulcerative
* actual chronic diarrhea
* other uncontrolled severe concurrent disease excluding cytotoxic intervention
* second malignancy except basal cell carcinoma or cervical carcinoma in situ
* known cns metastases or carcinomatous leptomeningitis
* pregnancy or lactation period
* no effective contraception
* concomitant treatment with another antineoplastic agents
* participation in another clinical trial within the last 4 weeks
* patients being unwilling or unable to undergo trial specific procedures
A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes

It is not fully clear how rheumatoid arthritis originates and develops, but it is understood that multiple genetic and environmental factors interact to trigger its onset. The immune system attacks the joint synovium, which damages the cartilage and bone in the joint by increasing the number of inflammatory cells and forming new blood vessels in the joint space. STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1 cytokine production. A reduction in the Th-1 response has the potential to minimize or eliminate joint damage caused by the immune response in rheumatoid arthritis. This study is designed to assess whether the proposed mechanism of action is associated with a reduction in inflammation in the synovium of patients who have rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older.
* Has a diagnosis of RA in conformance with the American College of Rheumatology (ACR) criteria for at least 6 months.
* Has at least one knee, wrist, or ankle that has active synovitis and is amenable to arthroscopic procedures for the acquisition of synovial tissue via biopsy.
* Must be taking methotrexate for a minimum of 4 months prior to Day 1, with a stable dose regimen for at least 2 months, and
* have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
* If female of childbearing potential, must be neither pregnant nor breast feeding, and
* must have a negative pregnancy test (serum β-hCG) within 1 week of Day 1. Must be willing to use "double-barrier" contraception methods for the duration of the study.

Exclusion Criteria:

* Is taking any disease-modifying anti-rheumatic drug (DMARD) other than MTX concomitantly or within 1 month prior to Day 1.
* A positive (≥10 mm) tuberculin (PPD) skin test, unless the patient has had prior BCG immunization or has received prior suppressive treatment such as 1 year of INH.
* Has received any investigational drug or experimental procedure for the treatment of RA within 3 months of Day 1 for a biologic compound or within 1 month of Day 1 for a non-biologic compound.
* Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma

Although patient-reported adverse events have been promoted as an essential element in clinical trials and daily managements, their efficacy remained unknown. The purpose of this trial was to determine the effect of the patient-reported adverse events during the treatment on the improvements on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
* No evidence of distant metastasis (M0)
* Performance status: PS 0\~2
* Receive standard treatment
* Able to read and understand the questionnaires
* Not exhibiting overt psychopathology
* Willing to give feedback to physicians and written informed consent was obtained

Exclusion Criteria:

* WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Treatment with palliative intent.
* Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
* Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
* Patient is pregnant or lactating
* Severe intercurrent disease
Effect of Mouthwashes on Oral Wound Healing and Microbiome

The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers 18-45 years of age.
2. Good general health.
3. Must sign informed consent form.
4. Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.

Exclusion Criteria

1. Oral pathology, chronic disease, or history of allergy to testing product.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.
4. Five (5) or more decayed untreated dental sites at screening (cavities).
5. Impaired salivary function.
6. Use of medications that can currently affect salivary flow.
7. Use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, antibiotics, antimicrobial, anti-inflammatory medication or daily analgesics within 30 days prior to the start of the study or scheduled to start such intake during the course of the study.
8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
9. Pregnant or nursing women.
10. Participation in any other clinical study within 1 week prior to enrollment into this study.
11. Use of any tobacco products.
12. Subjects who must receive dental treatment during the study dates.
13. Presence of an orthodontic appliance that interferes with required clinical assessments.
14. History of allergy to common dentifrice ingredients.
15. Subjects who wear night guard, denture retainers
16. Not willing to abstain from eating crunchy (eg. Granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period;
17. Not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period
18. Non English-speaking subjects
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in Argentina

The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice.

This study is about collecting data only. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The study will collect data from the participant's medical records.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants (\>=12 years) with investigator confirmed diagnosis of HAE.
* Have received at least one dose of lanadelumab according to approved indications.
* Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria:

- Hypersensitivity to the active substance or to any of the excipients.
Reassessment of Premedication in Surgery

The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.

* one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
* one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
* one receiving placebo before sleep and alprazolam (0.5 mg)at awakening

double blind, randomized controlled study

Eligibility:

* 18 to 65 years old
* elective surgery
* in-hospital preoperative night

Outcome measures:

* anxiety scales
* demographic data

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years old
* elective surgery
* in-hospital night before surgery

Exclusion Criteria:

* myasthenia gravis
* chronic intake of psychotropic drugs
* opiates intake
* severe obstructive sleep apnea
* intracranial hypertension
* morbid obesity
* myasthenia gravis
* acute severe medical disorder
* non health insurance coverage
* protected patients by law
* pregnancy
* non French speaking
Neuronal Mechanisms of Sensory Processing During General Anesthesia

The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.

Up to now there is no fully functional and precise technique for accurate assessment for monitoring the degree of unconsciousness during general anaesthesia. Previous studies and results obtained during the project regarding the effect of anaesthetics on single neurons and small neuronal networks indicate that it would be most promising to use a method directly correlating to the integrity of the relevant functional systems. As one goal of the project it was formulated to develop and test a new system for recording and analysis of mid latency auditory evoked potentials (MLAEP), suitable to be used in the clinical surrounding of an operation theatre. Step by step an investigational system was developed, that after obtaining legal approvement was functional in a broad spectrum of cases. In a multicenter study the including 4 clinical centres and 426 patients the reliability of the system was proved. Even under the hard conditions of the OR the apparatus was able to record the signals with sufficient reliability and precision. A clear correlation of MLAEP parameters with clinically defined states of consciousness could be identified. Differences in the effect of the used combinations of general anaesthetics and opioids were identified. An algorithm for automatic analysis of the signals was developed, to allow users with limited knowledge of interpretation of MLAEP signals to use them for monitoring anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Scheduled for elective urological, gynaecological or general surgery
* ASA status I or II
* Age 18 to 65

Exclusion Criteria:

* ASA status above II
* Operative procedures involving the neurocranium, neck or require other neurophysiologic monitoring
* Inability to communicate freely in the german language
* Major hearing deficit
* Regular centrally acting medication including drug abuse within 3 months prior to the investigation
* Participant of an other clinical investigation
* Lacking or withdrawal of written informed consent
Use of Synvisc® in Knee Osteoarthritis - Survey on Practice

Study of prescription methods in everyday medical practice, tolerance profile and effect of Synvisc® until six months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* not applicable

Exclusion Criteria:

* none
Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
* Able to wear study lenses in the available powers from -1.00D to -6.00D.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury within twelve weeks of enrollment.
* History of corneal or refractive surgery.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
* Monovision correction during the study.
* Other protocol-defined inclusion/exclusion criteria may apply.
Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels

The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI recommended targets in subjects with end stage renal disease (ESRD) receiving hemodialysis, on bio-intact parathyroid hormone, corrected serum calcium, serum phosphorus, and calcium phosphorus product.


Eligibility Criteria:
Inclusion Criteria: - Men and women must agree to use highly effective contraceptive measures throughout the study - Prescribed hemodialysis for at least 3 months before study day 1 - Must be receiving IV vitamin D sterols during the 30 days before day

1 (greater than 2 µg of paricalcitol, greater than 1 µg of doxercalciferol, or greater than 0.5 µg of calcitriol per dialysis treatment) - The mean of 2 biPTH determinations obtained from the central laboratory must be greater than or equal to 80 pg/mL and less than or equal to 160 pg/mL - The mean 2 albumin corrected serum calcium determinations obtained from the central laboratory must be greater than or equal to 8.4 mg/dL - The mean of two Ca x P calculations, based on corrected serum calcium and serum phosphorus determinations obtained from the central laboratory must be greater than 55 mg²/dL Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Pregnant or nursing females - Parathyroidectomy in the 12 weeks before day 1 - Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine and most tricyclic antidepressants). The antidepressant amitriptyline is permitted - Received, within 21 days before day 1, therapy with medications that are potent inhibitors (e.g., ketoconazole, itraconazole and erythromycin) or inducers (e.g., rifampin and St. John's Wort) of the enzyme CYP3A4. Phenytoin, phenobarbital and carbamazepine are also potent inducers of this enzyme. However, subjects on a stable dose of any of these anti-convulsants at baseline, with no evidence of seizure activity in the past 2 months may be eligible for the study - Experienced a myocardial infarction within 12 weeks prior to day 1 - Currently enrolled in, or have not yet completed at least 30 days since ending other investigational device or drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Participated in other studies with cinacalcet HCl - Disorder that would interfere with the understanding and giving of informed consent or compliance with protocol requirements
The Clinical Study of Acute Pancreatitis Treated by TongFuSan

The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.

* Patient who is diagnosed with acute pancreatitis(AP) should be included.
* Patients will be divided into two groups as random number table: control group(A) and experimental group(B).
* Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP.
* Same investigator will write the case report form.
* Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day.
* Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests.
* When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of acute pancreatitis，both mild type and severe type

Exclusion Criteria:

* pregnant or suckling
* cancer in late time
* patient near death