cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics

This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system (EQ-5D-5L).


Eligibility Criteria:
Inclusion Criteria:

* Patient willing and able to complete the questionnaires
* Diagnosis of OAB
* Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:

  * number of micturitions \> 8/24 h or
  * decrease in urgency urinary incontinence (UUI) or incontinence episodes / 24 h less than 50% or
  * decrease in urgency episodes / 24 h less than 50% or
  * decrease in number of micturitions / 24 h less than 20% or
  * not acceptable tolerability
* Eligible to start Vesicare™ 5 or 10 mg according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* History of stress incontinence
* Active urinary tract infection (confirmed by positive urine analysis)
* Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Peak urinary flow rate (Qmax) \< 10ml/sc and/or Postvoid residual urine volume (PVR) \> 150 ml
* Uncontrolled Diabetes Mellitus
* History of drug and/or alcohol abuse at the time of enrolment
* History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk for these conditions.
* Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor
* Previous treatment with solifenacin
* Likely to participate in another study during study period of 12 months from study entry
Capillary and Venous Lactate in Emergency Department Patients

The objective of the present project is to study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample.

Background:

Increase in lactate levels (hyperlactataemia) is common in critically ill patients and it is a sensitive marker in early identification of patients who are critically ill. Blood lactate is also a predictor of clinical outcomes. High level of lactate is associated with high mortality as well as increased morbidity. Capillary blood sample is easy to collect, less painful, and its measurement using handheld device which may allow more rapid determination of test results in ED. This rapid lactate measurement could aid early recognition of patients at high risk of mortality and morbidity. However, the accuracy of this rapid capillary lactate measurement using handheld devices has not been well studied in ED patients.

Objective:

To study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample.

Study design:

This is a prospective observational study of patients presenting to ED of Prince of Wales Hospital (PWH). Patients aged 18 or above who are triage category 3 presenting to ED will be recruited. Capillary and venous blood samples will be collected. Venous lactate levels will be measured by blood gas analyzer (Siemens Automatic QC RAPID Systems RAPID Point@500) and two hand-held lactate analyzers (StatStrip Xpress Lactate Meter and Lactate Scout + ). Venous lactate levels measured by blood gas analyzer will be served as "reference method". Capillary lactate levels will be analyzed by handheld lactate analyzer. We are aimed to recruited 240 patients.

Outcomes:

The primary outcome is the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g. venepuncture blood gas analyzer sample. The secondary outcomes are: (1) compare the difference in values of venous lactate using blood gas analyzer and hand-held lactate analyzers, (2) compare values of capillary and venous lactate using hand-held lactate analyzers, (3) compare the reporting times of handheld and blood gas analyzer, and (4) Compare values of capillary lactate using between the two hand-held lactate analyzers.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above who are triage category 3 in emergency department
* Presenting to emergency department between 9am and 4pm, Monday to Friday

Exclusion Criteria:

* Aged below 18 years
* Pregnant
Aortic Stenosis and Cardiac Amyloidosis

The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is \<50 patients. It is the aim of the present international, multi-center registry to collect \~300 patients with AS-CA creating a big enough cohort to allow

1. thorough characterization of this condition
2. assessment of log-term clinical outcomes of AS-CA
3. assessment of effectiveness of amyloid-specific treatment on top of valve replacement

Calcific aortic stenosis (AS) and transthyretin (ATTR) cardiac amyloidosis are both conditions commonly affecting the elderly. Bone scintigraphy using amyloid-avid tracers (99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid, DPD; 99mTc-pyrophosphate; or 99mTc-hydroxymethylene diphosphonate) represents the key imaging modality for non-invasive ATTR diagnosis. Recent studies have used this technology to screen AS patients and demonstrated that AS and ATTR may coexist in 8 to 16%. This is substantially higher than in non-cardiac referrals for bone scintigraphy (range 1-3% in individuals \>80 years), which is considered the most accurate approach to estimate the ATTR prevalence in the general population. While the dual burden of AS and ATTR might suggest adverse prognostic implications, it has been shown that AS-ATTR and lone AS patients benefit equally from transcatheter aortic valve replacement (TAVR) with comparable 1- and 2-year survival rates. Yet, data on long-term outcomes are still missing.

With increased recognition and valvular treatment of AS-ATTR, the disease course after TAVR becomes a key issue. Our data suggest significantly different remodeling between lone AS and AS-ATTR, with the latter being transformed into a "lone-ATTR" cardiomyopathy phenotype at one-year post-TAVR. Novel ATTR-specific treatments are now available, with the potential to further improve prognosis in AS-ATTR on top of valvular replacement. However, patients with significant AS were not included in the ATTR-ACT trial, and treatment effectiveness in this patient population therefore remains unclear. Also, despite increased ATTR screening globally, the case numbers for dual AS-ATTR of individual centers are still low.

The present international multi-center study is therefore designed to provide detailed characterization of dual AS-ATTR, inform about long-term clinical outcomes and assess the effect of ATTR specific treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant AS and a concomitant diagnosis of cardiac amyloidosis who are eligible for inclusion as per local permissions

Exclusion Criteria:

* Patients without significant AS (less than moderate AS)
* Patients with other subtypes of cardiac amyloidosis (e.g., light chain)
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.


Eligibility Criteria:
Randomized, Double Blind Treatment Period:

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
* Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
* No prior treatment with cytotoxic chemotherapy
* Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease
* History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Open-Label Treatment Period:

The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.

Eligible patients must meet all inclusion criteria.

* Received randomized double-blind treatment in PREVAIL;
* Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
* Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:

* Has taken commercially available enzalutamide (Xtandi);
* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease
Effectiveness of Glove Changing in Reducing Wound-related Complications

This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.

In Vietnam, the rate of Cesarean section (CS) is very high, ranging from 40-50%. Despite that, there are very limited publications concerning the risk factors, complications, and management of surgical site infection (SSI) following CS. Our study is the first to investigate the effectiveness of glove changing in reducing the incidence of post-operative infections in Vietnam. Specifically, the aims of this study are 1) to evaluate whether changing gloves during CS reduces complications and SSI, and 2) to identify other factors that are associated with complications and SSI.

Eligibility Criteria:
Inclusion criteria

* pregnant women were 18 years old or higher;
* pregnant women had cesarean surgery performed at Hung Vuong hospital;
* pregnant women lived close to Ho Chi Minh city and agreed to return for postpartum care one-month post-surgery.

Exclusion criteria

* pregnant women had fever during labor;
* pregnant women had systemic infectious conditions;
* pregnant women had surgical site infection SSI or sexually infectious conditions;
* pregnant women had ongoing internal conditions such as pre-eclampsia, severe anemia, American Society of Anesthesiologists (ASA) ≥ 3, New York Heart Association (NYHA) class 3 or above, pulmonary edema, or severe asthma.
Blended Care for the Discontinuation of Benzodiazepine Use

This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and older capable of giving informed consent,
* Having his/her Global Medical File managed by one of the participating general practitioners
* Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis
* Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems

Exclusion Criteria:

* Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal
* Presence of terminal illness
* Any cases where stopping of (z-)BZDs might be harmful
* Unwillingness or inability to provide informed consent
* Not having e-literacy (being familiar with email and internet use)
* Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.
The Effect of Atorvastatin 80 Mg on Hs-CRP/Albumin Ratio in Reducing Thrombus Burden in PCI-STEMI Patients

40 STEMI patients who underwent primary PCI were subsequently allocated into two groups via a double-blind randomization method: An Atorvastatin 80 mg group and the control group.

Levels of hs-CRP and albumin were assessed for both groups upon presentation at the emergency department before to initial PCI and were re-evaluated 24 hours after primary PCI. Thrombus burden was assessed using angiography with the TIMI Thrombus grade.

This study encompasses 40 STEMI patients who underwent primary PCI at Dr. Moewardi General Hospital in Central Java, Indonesia, between September and October. This study employed an experimental design with a pre-and-post technique, with participants recruited through sequential sampling. Patients were subsequently allocated into two groups via a double-blind randomization method. A treatment group was administered a loading dose of high-intensity statin (80 mg atorvastatin) upon initial presentation at the emergency department (ED), whereas the control group received no such intervention. Both cohorts received therapy in accordance with established guidelines prior to performing primary PCI.

Levels of hs-CRP and albumin were assessed for both groups upon presentation at the emergency department before to initial PCI. In the treatment group, a second 80 mg dose of atorvastatin was provided 24 hours after the original dose. Both hs-CRP and albumin levels were re-evaluated 24 hours after primary PCI in both the control and treatment cohorts.

Thrombus burden was assessed using angiography with the TIMI Thrombus grade

Eligibility Criteria:
Inclusion Criteria:

* STEMI with onset less than 24 hour and undergo a Primary PCI

Exclusion Criteria:

* STEMI beyond 24 hours from the onset of chest pain
* Prior statin therapy within the preceding 24 hours
* Hypersensitivity to statins, pregnancy, lactation, severe inflammatory conditions including active liver dysfunction, chronic kidney disease (eGFR \<30 mL/min), autoimmune disorders, malignancy, severe malnutrition, and
* Contraindications to statin administration.
Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne

Acne patients were included in this randomized controlled trial. Each patient received four treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were applied to the one side of the face while 25% trichloroacetic acid was applied to the other side. Evaluation was done by counting number of non-inflammatory and inflammatory lesions before, after two and after four treatment sessions. The dermoscope was used in evaluating the degree of improvement of erythema.

This study included 34 patients with mild and moderate acne vulgaris. The patients were recruited from the dermatology outpatient clinic of Kasr AlAiny hospital.

This study was approved by the Ethical committee of the Faculty of Medicine Cairo University and the Ethical committee of the Dermatology department Cairo University.

After signing an informed consent, patients were subjected to history taking, clinical examination and grading of their acne by global acne grading score, photography, dermoscopic examination and chemical peeling.

Photography:

Patient was photographed from front, lateral and side view before each session and two weeks after the 4th session. All photographs were taken using a digital camera (Nikon AW1, Indonesia) with identical lightening and patient positions.

Dermoscopy:

The cheek was split as four quadrants and photography of dermoscopic figures was taken before every session and two weeks after the 4th session (Using Dermalite DL3N Gen, USA).

Chemical peeling:

Skin degreasing was performed before every session using acetone. Trichloroacetic acid 25% was applied on one side of the face and azaleic acid 20% with salicylic acid 20% to the other side of the face randomly. Randomization was done through a computer-generated random sequence prepared by a statistician; Allocation was concealed in sequentially numbered, sealed, opaque envelopes, and kept by a nurse not involved in the study.

A gauze was used to apply the peel. The gauze was soaked with the peel. The peel was applied uniformly starting from medial to lateral. The peel was left on each side for around 60 seconds. The patients were asked to wash their faces using tape water for neutralization of the peel until the burning sensation is eliminated.

Patients received 4 sessions 2 weeks apart. As a post procedure care, the patients were asked to apply sun screens immediately after the procedure until their next session.

No other topical or systemic treatment was used during sessions. Patients will receive 4 peeling sessions 2 weeks apart.

Eligibility Criteria:
Inclusion Criteria:

* any patients with active acne

Exclusion Criteria:

1. Pregnancy.
2. History of oral herpes simplex virus.
3. History of keloid formation.
4. Associated autoimmune disease (e.g vitiligo, systemic lupus erythematosus).
5. History of past medications in the last six months.
6. Patient unable to perform necessary postoperative care
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.

The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.

Eligibility Criteria:
Inclusion Criteria:

* All patients with functioning filtering blebs will be evaluated prospectively for inclusion

Exclusion Criteria:

* Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria:

  * Ongoing ocular inflammatory disease
  * Bleb leakage - determined by Seidel test
  * Suspected infection
  * Known contraindications to use of any of these study medications.
  * Pregnancy
An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)

This prospective, non-interventional time and motion study will evaluate the costs of healthcare resource utilization associated with the administration of trastuzumab (Herceptin) SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical study MO22982 (NCT01401166/PrefHer).


Eligibility Criteria:
Inclusion Criteria:

* Participants from the MO22982 (PrefHer) clinical trial who consent to the presence of an observer to record data for the study during administration of trastuzumab
* Members of the care team responsible for management of participants from the MO22982 (PrefHer) clinical trial who also consent to the presence of an observer during administration of trastuzumab

Exclusion Criteria:

* None specified
Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)

This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).


Eligibility Criteria:
Inclusion Criteria:

* advanced idiopathic Parkinson's disease (Brain Bank criteria)
* optimal clinical response to dopaminergic medication (\>30% UPDRS-III improvement)
* presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb

Exclusion Criteria:

* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
* other main neuropsychiatric co-morbidity
Virtual Reality in Children With Hemiparesis

children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance

Twenty volunteer children diagnosed with hemiparetic cerebral palsy will be recruited from national institute of neuromotor system. they will be randomly assigned to intervention and control group.

Eligibility Criteria:
Inclusion Criteria:

* - Age between 7 and 11 years
* spasticity grade of 1+ or 2 on MAS
* level I and II on GMFCS
* level II and III on MACS
* Being able to cooperate and being motivated

Exclusion Criteria:

* visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
* Structural or fixed soft tissue deformities in the affected upper extremity
A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients

There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).

The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed smear positive pulmonary tuberculosis.
2. Age between 18 to 75 years
3. No pre-existing liver or renal disease
4. Available for return visits as outlined in the trial protocol
5. A Firm home address

Exclusion Criteria:

1. Extra-pulmonary or smear negative tuberculosis
2. Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
3. Pregnant or lactating women
4. Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
5. Baseline Hypercalcemia \>10.5 mg/dl