cyrilzakka/clinical-trials huggingface dataset:
Primary UVB-311nm and Adalimumab in Psoriasis Patients

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \< 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75% and/or 50% between body sites.

Eligibility Criteria:
Inclusion Criteria:

* Psoriasis patients who are scheduled for treatment with adalimumab.

Exclusion Criteria:

* Pregnancy or lactation
* History of skin cancer
* Presence of or history of malignant skin tumors
* Dysplastic melanocytic nevus syndrome
* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
* Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
* Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
* General poor health status
Medication List in and Out of Hospital

30 patients acute hospitalized to medical ward and their medication records are examined. It is to be recorded how the investigators find information about medicine use by the reception when they do not follow the patient. The record of the changes made during hospital stay is examined, whether they are justified in the discharge summaries and whether they are described in the medical list. After a month is to find out if the GP has recorded or possibly rejected changes to medication made in hospital.

Furthermore is to be recorded how the investigators find information about medicine use by the reception when they do not follow the patient and how long it takes to find the right medicine list. The record of the changes made during hospital stay is examined, whether they are justified in the discharge summaries and whether they are described in the medical list. After a month is to find out if the GP has recorded or possibly rejected changes to medication made in hospital.

This shall be recorded in the review of 30 patient with a focus on their medication list and follow them from admission to a month after discharge.

Medicine List in discharge summaries will be compared with medication written in journal during hospital stay and changes described in the text summaries and medication lists should be checked against the same journal.

Medicine list in the municipality one month after discharge shall be compared with discharge summaries and it will be mapped on the GP register, modified and considered if they are valid.

Hypothesis:

Medicine list is missing at admission by \> 50% of patients admitted acutely into hospital.

Medicine List at admission, when available, is often incomplete. When the medication list is not available at admission, its content is often incomplete even after the staff at reception have tried to gather information from different sources.

Changes of regular medication is not always present in the discharge summaries. The changes are not always justified in the discharge summaries. The GP often do not correct the medication list in the journal to the discharge summary.

The GP does not give the patient an updated printout of the list at the first medical consultation after admission.

Eligibility Criteria:
Inclusion Criteria:

* acute hospitalized to medical ward
* using three or more drugs, prescription only

Exclusion Criteria:

* not been able to give consent, if too severely ill or not mentally capable
A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
* Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
* Have been treated with stable doses of metformin for at least 3 months
* Have a body mass index (BMI) ≥25 kilograms per square meter

Exclusion Criteria:

* Have type 1 diabetes (T1D)
* Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
* Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
* Have had chronic or acute pancreatitis any time prior to study entry
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
* Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry
A Study of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)

This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* 1. Understood and signed an informed consent form; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months; 3. Relapsed / refractory MCL; 4. Has received at least one-line and less than four lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment; 5. Has at least one measurable lesion; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.

Exclusion Criteria:

* 1. Has central nervous system violation; 2. Has received other PI3K inhibitors; 3. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 4. Has history of interstitial lung disease; 5. Has a history of immunodeficiency diseases; 6. Has multiple factors affecting oral medication; 7. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 8. Has received systemic steroid treatment within 7 days before the first administration; 9. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 10. Has palliative radiation therapy within 4 weeks before the first administration; 11. Has active infections within 4 weeks before the first administration; 12. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 13. Has a history of autologous hematopoietic stem cell transplant within 6 months or allogeneic hematopoietic stem cell transplant; 14. QTCF \> 480ms, LVEF \< 50%; 15. Urinary protein ≥ 2 +, and urinary protein quantity \>1.0 g in 24 hours within 7 days; 16. Has active hepatitis B or C; 17. Has psychotropic substances abuse or a mental disorder; 18. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

Primary Objective:

To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503.

Secondary Objective:

To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

study duration = 17 to 35 days

Eligibility Criteria:
Inclusion criteria :

* Male or female subjects, between 18 and 75 years of age, inclusive.
* For subjects between ages 75 to 79 with the approval from sponsor's medical monitor.
* Body weight between 50.0 and 115.0 kg, inclusive if male, and between 40.0 and 100.0 kg, inclusive if female, body mass index between 18.0 and 34.9 kg/m2, inclusive.
* Stable chronic renal impairment, as defined by Cockcroft-Gault formula;
* Laboratory parameters within the acceptable range for subjects with renal impairment.
* Using a double contraception method.

Exclusion criteria:

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic,hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness
* Active hepatitis, hepatic insufficiency
* Acute renal failure (de novo or superimposed to preexisting chronic renal impairment), nephrotic syndrome
* History of or current hematuria of urologic origin that limits the subject's participation in the study
* Subjects requiring dialysis during the study.
* Any significant change in chronic treatment medication within 14 days before inclusion.
* Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4, sensitive or narrow therapeutic index substrate of CYP3A4.
* Concomitant treatment with gastric pH modifying agents (proton pump inhibitors and H2-blockers) is not allowed 7 days prior to and 6 hours after study drug treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery

This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal adenocarcinoma
* Elective (or planned) curative surgery
* Laparoscopic surgery
* Midline incision less than 10 cm

Exclusion Criteria:

* Previous laparotomy with midline incision more than 10cm.
* Systemic chemotherapy for any cause within the last 6 months.
A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
* Availability of tissue for analysis
* ECOG Performance Status 0 or 1
* Adequate organ function as defined in the protocol.
* Must be at least 18 years old and able and willing to sign a written informed consent document

Exclusion Criteria:

* Poor venous access requiring an indwelling catheter for study drug administration
* Women who are pregnant or lactating
* Ventricular ejection fraction \< or = to 55% at baseline
* Any uncontrolled intercurrent illness
Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses

Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle is usually responsible for the low yield of tissue samples for histopathological examination. The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can maximize tissue acquisition and sample adequacy, which is important for appropriate diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge needle. This is attributable to the technical difficulty to push the needle out of the endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head region, it is therefore particularly important to improve technical success in these cases. The new 19-gauge biopsy needle "Olympus EZ Shot3 Plus" is more flexible than common biopsy needles such as "EZ Shot2" and should therefore provide improved access to regions like pancreatic head. The aim of this multicenter prospective randomized crossover study is to compare those two needles during EUS-FNB of solid pancreatic masses.

Therefore this study will enroll 40 patients in five German centers with solid pancreatic masses and consecutive indication for EUS-FNB. Both needles will be used in each patient following a predetermined random order.

Primary endpoint is the correct histological diagnosis of the mass assessed by each needle. Technical failure is regarded as a negative histological diagnosis.

Secondary endpoints include a comparison of technical failure using each needle, histological quality, duration of procedure and rate of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* solid pancreatic mass and consecutive indication for EUS-FNB

Exclusion Criteria:

* incapacity to give informed consent
* Haemorrhagic disease, disorder of hemostasis and coagulation (PT \<60%, PTT\> 42 sec. and platelets \<60000/µL)
* oral anticoagulants
* dual antiplatelet therapy with thienopyridines (e.g. clopidogrel)
* Pregnant or lactating
Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer

This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Postmenopausal, hormon receptor positive patients with early breast cancer treated with Arimidex
* Investigators are requested to recruit patients only with at least 1 month prior Arimidex treatment.

Exclusion Criteria:

* Allergy to substance of medication
* Pre-perimenopausal woman
* Woman not eligible for treatment
Cell Phone-supported Cognitive Behavioural Therapy

Definitions

CBT-ubiquitous - Cognitive behavioural therapy (CBT) provided with all-time (ubiquitous) support by cell phone applications CBT-TAU - Cognitive behavioural Therapy provided 'As Usual' CBT-placebo - Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.

Study objectives

1. to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous) against anxiety disorders with CBT-treatment as usual (CBT-TAU);
2. to assess the safety and tolerability of the CBT-ubiquitous as compared with CBT-TAU and CBT provided with access to a placebo technical device (CBT-placebo)..

Study implementation

The investigators hypothesize that all active treatments are superior to placebo given evidence that face-to-face CBT is effective in the treatment of both anxiety and depression. The investigators also predict that patients receiving CBT-ubiquitous will show greater improvement than those given CBT-TAU, and assume that CBT-ubiquitous leads to improved adherence with treatment compared to CBT-TAU and CBT-placebo.

The investigators will use an intention to treat (ITT) approach to fulfill the study aims, by which the investigators mean that clients are analysed as randomized rather than by treatment actually received. The study will be implemented in the central district of Östergötland County Council (pop 145.000). The research group has in two previous projects (VINNOVA 2005-2007, VINNOVA 2008-2009) established cooperation with the 'Unga Vuxna' (Young Adults) service provided in this district. The service supplies CBT to the subpopulation experiencing early stages of mental disorders in the age group 16-25 years (n=20,000) in order to prevent development of significant psychiatric disease and disability. The service employs six therapists with at least one year specific CBT training and is co-located with Primary Healthcare Centres (PHCs) in downtown Linköping, Åtvidaberg and Kisa. Clients staying outside the urban areas can make appointments with therapists at their closest PHC on a weekly basis.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 25; and
* scoring 7 or higher on the anxiety section of the Hospital Anxiety and Depression scale (HADS) at initial evaluation.

Exclusion Criteria:

* at the initial evaluation displays symptoms indicative for referral to a psychiatric specialist, e.g. active suicidal ideas or symptoms of a psychotic disorder, organic mental disorder or alcohol and/or drug dependence; or
* is unable to read, write or speak in the Swedish;
Arabic Translation and Validation of the (Overactive Bladder Symptom Score) OABSS

The English version of the Overactive Bladder Symptom Score (OABSS) questionnaire was translated to Arabic language. The questionnaire was validated by comparing the response to the questionnaire in a patient with Overactive Bladder (OAB) before and after providing treatment with antimuscarinics.


Eligibility Criteria:
Inclusion Criteria:

* More than 20 years
* Had three months history of overactive bladder symptoms (urgency with or without incontinence and associated with frequency and nocturia).

Exclusion Criteria:

* Active urinary tract infection.
* Predominant symptoms of urinary stress incontinence;
* Diabetes mellitus;
* Previous abdominal and pelvic (urological or gynecological gastrointestinal) surgery;
* Previous neurological disease.
Natural Killer(NK) Cell Therapy in r/r AML

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* ≥18 years old
* Diagnosis of r/r AML
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-030a: MFI \<= 2000

Key Exclusion Criteria:

* Allergic to drug used in this study
* Accept other anti-tumor drugs/therapies within certain time of day 0 (first QN-030a dose infusion), time window and drug defined in the protocol.
* received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
* Acute Promyelocytic Leukemia (APL)
* Central nervous system Leukemia.
* Uncontrolled, active clinically significant infection
* Clinically significant cardiovascular disease as defined in the protocol
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* History of central nervous system (CNS) disease such as stroke, epilepsy.
* Females are pregnant or lactating
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to quetiapine or any comparable or similar product.
Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.

Participants will use the Volara System during clinic visit in an attempt to produce sputum.

Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care.

The purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. 2. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.

2. No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771

Exclusion Criteria:

1. \< 18 years old
2. Sputum culture results in last one year
Glypican4 and CTRP5 in Metabolic Syndrome and the Effect of Exercise on These Adipokines

Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we examine the circulating levels of theses adipokines in the subjects with or without metabolic syndrome. Furthermore, we tried to clarify the effect of exercise on the circulating these adipokines.


Eligibility Criteria:
Inclusion Criteria:

* Women between 30 and 60 years of age who had a body mass index (BMI) more than 25 kg/m2
* The subjects of metabolic syndrome and age, gender matched non metabolic syndrome among the participants of Korean SO Study (KSOS) study, which is an ongoing epidemiologic study supported by the Korea Science and Engineering Foundation

Exclusion Criteria:

* participants had a history of cardiovascular disease
* any type of diabetes
* stage 2 hypertension
* malignant disease, severe renal, or hepatic disease
* Subjects taking medications that might affect body weight or body composition