cyrilzakka/clinical-trials huggingface dataset:
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of \< 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing
* Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age\> 50 years old, b. Stiffness \< 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing
* Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"

Exclusion Criteria:

* Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Who had passed all the screening parameters

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies
* If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening
* The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
* A history of blood dyscrasias
* A history of alcohol or drug abuse within the past year
* Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
* Unable to tolerate vein puncture and multiple blood samplings
* Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss

Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by GSK-3, multifunctional serine/threonin kinase. After phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore, inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been studied yet.


Eligibility Criteria:
Inclusion Criteria:

* age: 19 years \~ 45 years
* subjects with AGA (Hamilton\&Norwood grad III\~IV)
* subjects who are able to be followed for next 24 weeks.

Exclusion Criteria:

* subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease
* subjects with AGA treated with surgical methods (hair TPL)
* subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months.
* subjects who took medicine which can affect the hair growth
* subjects with alopecia other than AGA
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase II dose of the combination; and b) assess the efficacy of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* Expected survival ≥ 6 months.
* Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
* Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
* Adequate organ performance based on laboratory blood tests.
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have received any chemotherapy for the treatment of pancreatic cancer prior to entering the study.
* Previous treatment with any poly ADP-ribose polymerase (PARP) inhibitor.
* Patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (Day 1 visit).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.
* Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks of enrolment (Day 1 visit).
* Patients with known or suspected brain metastasis.
* Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia.
* Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.
* Known active hepatitis B or C infection.
* History of immunodeficiency (including HIV infection) or organ transplantation.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Hypofractionated Stereotactic Radiation Therapy of Brain Metastases: Evaluation of Whole-brain Radiotherapy

The aim is to identify in patients with brain metastases the predictive factors of overall survival, survival without local recurrence and survival with progression-free brain metastases after complementary whole brain radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one to three brain metastases treated in our department with hypofractionated stereotactic radiotherapy (SRT) from March 2008 to February 2013.

Exclusion Criteria:

* A patient record captured after February 2013.
LAL-BR/2001: Study Treatment to Low Risk ALL

The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease

REMISION INDUCTION

Systemic chemotherapy:

Prednisolone (PDN):

* 60 mg/m2 day, i.v. or p.o., days 1 to 27
* 30 mg/m2 day, i.v. or p.o., days 28 to 35

Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.

Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.

Intracranial chemotherapy

Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1)

* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
* MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.
* VP-16: 150 mg/m2 i.v., days 14-15 and 42-43
* ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43
* Intrathecal treatment, days 1, 28 and 56.

REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23)

Dexamethasone (DXM):

* 6 mg/m2 day, p.o., days 1-21
* 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.

MAINTENANCE TREATMENT (M-1)

Continuous treatment

* MP 50 mg/m2/day, p.o.
* MTX 20 mg/m2/week, i.m.

Reinductions

* VCR: 1,5 mg/m2 i.v., day 1.
* PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7
* L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.
* Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended.

Intrathecal treatment: At the start of any reinduction cycle

MAINTENANCE TREATMENT (M-2) (WEEKS 55-108)

* MP 50 mg/m2/day, p.o.
* MTX 20 mg/m2/week, i.m.
* Intrathecal treatment, weeks 54 and 108

At the end of treatment should be done the study of MRD (flux cytometry)

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously

Exclusion Criteria:

* Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t\[8;14\], t\[2;8\], t\[8;22\])
* Mixed forms of ALL
* Acute Leukemia no differentiate
* Patients with coronary disorders, valvular or hypertensive cardiopathy
* Patients with chronic liver disorders
* Chronic pulmonary disorders
* Renal insufficiency
* Neurologic disfunctions
* ECOG 3 and 4
* No signed consent form
Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia

Today, one of the most important challenges of the health system is the attitude towards chronic disorders. That implies changing from a health structure established for the treatment of acute diseases to a continued care system.

In this sense, the approach of chronic pain, of non-oncological origin, supposes an important care challenge, to which this project wishes to respond.

Chronic pain affects one of every Europeans (19%), and has a prevalence of 11% in Spain, being one of the most important causes of medical consultation and is associated with high personal, social and economic costs. For example, in 2017 it was calculated that it has an economic impact of between 1.7 and 2.1% of Spain's GDP.

Referred to the psychological consequences of the disease, it has been found that 42% of people who have chronic pain suffer insomnia, a 40% anxiety, and 24% depressive symptoms. Hence the importance of implementing evidence-based psychological treatments along with their treatment as usual The main objective is comparing the efficacy of mindfulness-based pain management (MBPM), together with the usual medical treatment, in patients diagnosed with chronic pain, with and without comorbid fibromyalgia.

Specific objectives are:

1. To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
2. Define the characteristics of patients who are in the different stages of the disease: stage 1 (less than two years since diagnosis); stage 2 (between 2 and 4 years); stage 3 (between 5 and 8 years), and stage 4 (more than 8 years).
3. Check the effectiveness of psychological therapies MBPM depending on the presence of fibromyalgia.
4. Check the effectiveness of the psychological treatment in function of the stage of the disease.

Method:

A quasi-experimental design of two groups will be used. Patients will be assigned to experimental group: 50 subjects will receive MBPM and control group 40 subjects, 3-months wait list, after which time they will also receive MBPM.

All the participants will be assessed in the baseline; at the end of the treatment; and in the 1, 3, 6 and 12 months follow-ups. Group 2 (waiting list) will be assessed in the baseline, and re-assessed before starting the treatment; at the end of the psychological therapy; and in the 1, 3, 6 and 12 months follow-ups.

The objetive of this research are the study of efficacy in chronic pain and fybromyalgia of mindfulness therapy.

Eligibility Criteria:
Inclusion Criteria:

* Be able to complete the assessment protocol
* Suffer from chronic non-oncological pain, lasting longer than 6 months
* Not being receiving psychological treatment
* Sign the informed consent

Exclusion Criteria:

* Present a cognitive impairment, such as a dementia
* Present a diagnosis of a psychotic disease, bipolar disease or additive disease
BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED

Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).

Dyspneic patients 65 years were enrolled in a randomized, controlled trial; hemodynamically unstable patients were excluded. BNP (Biosite assay) levels were measured prior to physician assessment with randomization in 1:1 ratio to either BNP 1) level reported or 2) level not reported. ED physicians made triage decisions guided by clinical judgment and nomogram to aid in interpretation of BNP level. Primary outcome was mean total hospital cost per subject. Secondary outcomes included admission rate, service assignment, discharge diagnosis and length of stay. Differences between groups were compared by t-test with bootstrap. Costs reflect 2005 constant dollars.

Eligibility Criteria:
Inclusion Criteria:

* Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.

Exclusion Criteria:

* hemodynamically unstability
The Influence of Muscle Contraction on the Cardiac Autonomic System

Population:

16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.

All children aged 6-12 yrs who understand simple commands.

Tools:

1. Polar monitor to record heart rate, attached to chest, in use throughout testing
2. Dynamometer- for assessing muscle strength.
3. Weights

Method:

Each child will be tested once. Both tools will be demonstrated and tried out before actual testing.

With Polar watch attached:

1. 5 min sitting at rest,
2. knee muscle strength assessment with the dynamometer,
3. 15 minutes rest
4. Isometric and isotonic knee muscle contraction at 30% of childs' maximal strength as has assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5 minutes rest in-between All will be perform in both legs.


Eligibility Criteria:
Inclusion Criteria:

* GMFCS I-II
* Unilateral CP

Exclusion Criteria:

* Heart problems
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer

To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.

To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of prostate adenocarcinoma
* Advanced prostate carcinoma.
* Previous treatment with hormones
* Levels of testosterone \< 50 ng/dL
* Good hematological, liver and kidney function
* Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.

Exclusion Criteria:

* Previous chemotherapy (estramustine included).
* Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
* Previous treatment with radiotherapy (isotopes) or previous radiotherapy over \> 25% of the marrow
* Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
* Concomitant serious diseases
* Concomitant treatment with any other neoplassic therapy (exception done to LHRH agonists and/or biphosphonates).
* Contraindication for the treatment with estramustine.
* Previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.
* Previous history of pulmonary spillage or ascitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye

The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.

Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effect on corneal nerves.

Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts.
* Age 18-65 years old.
* Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial.
* At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids.

Exclusion Criteria:

* Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS.
* Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases.
* Those who have a history of previous ocular oprations, eye injuries or contact lenses usage.
* Known hypersensitivity to experimental drugs or any of its ingredients.
* Necessity to modify the systemic treatment of previous diseases during the trial.
* Pregnancy or lactation.
* Severe systemic disease.
Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis

The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.

The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
* Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
* Are normally active, without aid of mobility devices(such as crutch, walker or cane)

Exclusion Criteria:

* Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
* Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
* Have received steroid injections in any joint in last 3 months
* Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of cUTI or AP.
2. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following:

   1. at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
   2. at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine
   3. positive leukocyte esterase (LE) on urinalysis Note: Participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented.
3. Expectation, in the judgment of the Investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study.

Exclusion Criteria:

1. Presence of any known or suspected disease or condition that may confound the assessment of efficacy.
2. Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation.
3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
4. Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula.
5. Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP.
6. Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization.
7. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5×upper limit of normal (ULN) or total bilirubin \>3×ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
8. Pregnant or lactating women.
9. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
10. History of proven or suspected Clostridioides difficile associated diarrhea.
11. History of human immunodeficiency virus (HIV) infection.
12. QT interval corrected using Fridericia's formula (QTcF) \>480 milliseconds (msec) based on screening ECG.
13. History of known genetic metabolism anomaly associated with carnitine deficiency.
14. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.

Note: Other inclusion and exclusion criteria as per protocol may apply.