cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and amifostine following surgery in treating patients who have locally advanced bladder cancer.

OBJECTIVES:

* Determine the toxicity of adjuvant gemcitabine and cisplatin with amifostine cytoprotection in patients with completely resected locally advanced bladder cancer.
* Compare recurrence rate in these patients when treated with this regimen to historical control patients who had a cystectomy performed by the same surgeon.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, and cisplatin IV over 60 minutes and amifostine IV over 15 minutes on day 1. Treatment continues every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Completely resected locally advanced bladder cancer

  * T2-4, N0-2
* Post radical cystectomy with no gross residual disease
* No evidence of metastases by CT of chest, abdomen, and pelvis

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN

Renal:

* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 50 mL/min

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study participation
* No active infection
* No serious concurrent systemic disorders that would preclude study participation
* No metastatic cancer in past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy

Chemotherapy:

* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy except contraceptives and replacement steroids

Radiotherapy:

* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* At least 4 but no more than 8 weeks since radical cystectomy

Other:

* No other concurrent experimental medications
Calcium for Out-of-Hospital Cardiac Arrest

This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of calcium during adult out-of-hospital cardiac arrest. 430 adult patients with out-of-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is sustained return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest
* Age ≥ 18 years
* Received at least one dose of adrenaline

Exclusion Criteria:

* Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction)
* Known or strongly suspected pregnancy
* Prior enrollment in the trial
* Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug
* Clinical indication for calcium administration during the cardiac arrest
Lithium Versus Anticonvulsants and the Risk of Physical Disorders

Nationwide population-based register linkage study covering the entire 5.9 million inhabitants in Denmark systematically investigating the associations between sustained long-term use of lithium versus lamotrigine and valproate, and the risk of a range of physical disorders emulating a randomized trial.

The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium, lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of prior diagnosis of bipolar disorder (N= 156.678).

Main analyses considered a patient exposed to a drug 92 days after a prescription and a 10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60 and 180 days after a prescription, respectively, and with 5- and 15-years follow-up, respectively.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate

Exclusion Criteria:

* None
Human Photoallergy Test

To evaluate the potential of a test material to produce a photoallergic response.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III)
* Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator

Exclusion Criteria:

* Have a visible sunburn
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses
* Have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
* Subjects who are employees of the Contract Research Organization (CRO) and/or Bayer or is a household member of an employee
Assessment of Compliance With Antihypertensive Telmisartan Therapy

The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to asses patients compliance to the therapy with Telmisartan in relation to use of electronic therapy monitoring device.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Untreated or ineffectively treated arterial hypertension

Exclusion Criteria:

* Cholestatic disorders and severe hepatic failure
* Allergy to Telmisartan
* Pregnancy and lactation period
* Unwillingness to participate in the study
* Inability to use the drug reminder device
* Unwillingness to use the drug reminder device
Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families

Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.

this study is composed of three diferents studies:

. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.

* the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
* finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.

* In the first study, case group is composed by patients with IE and their families, both from Madrid and Lérida. The control group is composed by adolescents without mental pathologies, recruited from some high scholls from Madrid and Lérida.
* In the second study, the results will be measured a after the end of treatment and 6 months after the treatment ends.

In the third study, the results will be measured a after the end of treatment and 6 months after the treatment ends.

Eligibility Criteria:
Inclusion Criteria:

* Parents of patients aged 12-17 years whose child is at least 3 criteria of borderline personality disorder ( Diagnostic and Statistical Manual of Mental Disorders 5 ) .
* Talk correctly Spanish correctly.
* Coexistence with son and willingness to participate in the groups.
* Informed consent.

Exclusion Criteria:

* Mental retardation.
* Being involved in some other structured DBT family intervention.
* Parents whose children are not receiving any treatment .
* Participated in Actions for Treatment of Personality in Adolescence (ATRAPA TAI)
Perclose Multi-Access Duplex Ultrasound (DUS) Study

The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
* All the access sites are planned to be treated with Perclose SMC
* Written informed consent is obtained prior to the procedure

Exclusion Criteria:

* Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
* Prior ipsilateral deep vein thrombosis within 6 months
* International Normalization Ratio \>3.5 for patients on warfarin
* Subject who is not able to ambulate pre-procedure
* Women who are pregnant (based on site standard pre-procedure pregnancy test)
* Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children

This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
* A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of, or intercurrent diphtheria, tetanus, pertussis disease.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* Major congenital defects or serious chronic illness.
* History of any seizures or progressive neurological disease.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Child in care.
* Acute disease and/or fever at the time of enrolment.
Effects of Aerobic Training in Patients With Ankylosing Spondylitis

This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.

Ankylosing Spondylitis (AS) is a systemic inflammatory disease that affects mainly the spine and compromises globally the physical capacity of the patients. Despite new advances in pharmacological therapy, physiotherapy and exercise remain essential in the treatment of AS. However, the literature lacks studies showing which types of exercises are more effective in patients with AS.

This is a randomized controlled trial with the objective is to evaluate the effects of aerobic training on functional capacity, mobility, disease activity, cardiopulmonary capacity and cytokine levels (TNF, IL10, IL6 and IL1) in patients with AS.

The duration of the trial is 24 weeks with the first 12 weeks reserved to exercise programs. The participants will be divided in two groups. The intervention group (IG) will perform walking for 50 minutes plus global stretching 3 times a week for 12 weeks. The control group (CG) will do only stretching exercises 3 times a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ankylosing Spondylitis according to New York modified criteria.

  * Stable drug treatment for at least 3 months
  * Sedentary for at least 3 months before randomization
  * Steinbrocker class I/II

Exclusion Criteria:

* Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.

  * Ischemic heart disease
  * Clinically significant diseases
  * Orthopedic surgery, such as hip arthroplasty, in the last year.
  * Inability to walk.
Shoulder Injury Prevention Program in Swimmers

The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder strengthening and stretching program in division I collegiate swimmers. The result of this study may demonstrate the effectiveness of a strengthening and stretching program to positively influence factors that have been associated with pain and injury in division I collegiate swimmers and indicate the need to implement this program for the entire team. Following a 6-week strengthening and stretching program, it is believed that scapular kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be improved compared to control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be included in the study if they meet the following criteria:

  * NCAA division I swimmers
  * Participate in swimming for at least 30 minutes per day for 4 days per week.
  * Participate in all team weight lifting sessions.
  * Complete 15 of the 18 training sessions if the subject is placed in the treatment group.

Exclusion Criteria:

* Subjects will be excluded from the study if:

  * They are currently being treated for shoulder pain
  * They develop shoulder pain during the course of the intervention program
Anal Dilatation for Infants and Children With Constipation

This study is to evaluate the effect of anal dilation in infants and children with constipation.


Eligibility Criteria:
Inclusion Criteria:

1. Infants and Children With Constipation
2. Postoperative infants and children with Hirschsprung's disease
3. Good compliance

Exclusion Criteria:

1. Infants and Children With Constipation
2. Poor compliance
Elastography in Liver Cell Failure

1. evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
2. correlation of degree of spleen stiffness and patient outcome

Portal hypertension (PH) is a major complication of liver cirrhosis, as it predisposes to the development of serious clinical manifestations such as ascites, hepatic encephalopathy and variceal bleeding, aggravating the prognosis of patients.

Liver biopsy and hepatic venous pressure gradient (HVPG) measurements are the current gold standard procedures for determining fibrosis severity and diagnosing PH, respectively; however, both are invasive, limiting their use in clinical practice and larger trials of novel agents. Alternatively, many non-invasive methods have been proposed in order to substitute HVPG. Alterations in the biomechanical properties of the liver or spleen in patients with cirrhosis can be quantified by tissue elastography, which examines the elastic behavior of tissue after a force has been applied Among them, liver stiffness measurement (LSM) has been widely used, as it has been shown to correlate well with HVPG, though this relationship seems to weaken in values of HVPG higher than 12 mmHg, the threshold of serious complications development. Several studies supported the use of spleen stiffness measurement (SSM) instead of LSM, anticipating to a more adequate assessment of this advanced stage of PH. SS measured by ultrasound-based elastography showed good correlation with HVPG, detecting PH with a sensitivity and specificity of 0.88 and 0.92, respectively, and severe PH with a sensitivity and specificity of 0.92 and 0.79, respectively.The aim of this paper is to critically appraise and summarize the literature about the role of SSM as a predictive tool of liver decompensation and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* 1- Age above 18 years. 2-patients with liver cell failure (hepatic encephalopathy, hematemesis, ascites, hepatocellular carcinoma) 3- patient height , Weight

Exclusion Criteria:

* 1- patients who refuse to contribute in this study. 2- Age below 18 years. 3-pregnancy and breastfeeding.
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.


Eligibility Criteria:
Inclusion Criteria:

* Female patient
* Ages 20-90
* All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
* Able to provide verbal consent

Exclusion Criteria:

* Patients who have had prior chest wall or irradiation on the reconstructed side
* Patients not undergoing immediate breast reconstruction at the time of mastectomy
* Any patient with a contraindication to immediate breast reconstruction
Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control

The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.

Myopia constitutes a major threat to vision health globally for its increasing prevalence and irriversible blinding complications. It is crucial to effectively intervene subjects with progressive myopia to reduce risks of myopic pathologies in later life.

Orthokeratology (ortho-k) is the first-line intervention for myopia control, with an efficacy of slowing axial elongation by 43-63%. However, the efficacy decreases over time. Sequential treatment strategy, which switches myopia control interventions at some intervals, has a potential to increase myopia control efficacy regarding the whole treatment period, compared to applying one intervention throughout. However, there lacks evidence supporting the benefit of this treatment strategy.

The purpose of this study is to evaluate the effectiveness of orthokeratology and 0.01% atropine sequential treatment on myopia control in children and adolescents, as compared to continuous treatment with orthokeratology, using a multicenter randomized controlled trial design. Subjects will be randomly assigned into either ortho-k and 0.01% atropine sequential treatment group or ortho-k continuous treatment group. Their axial length will be monitored over two years. Changes in axial length in the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 8-15 years old.
2. Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D.
3. Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
4. Bilateral intra-ocular pressure \< 21mmHg.
5. Normal binocular and stereoscopic visual function.
6. Participants and their guardians' understanding and acceptance of random allocation of grouping.

Exclusion Criteria:

1. Manifest strabismus, except for intermittent tropia.
2. Ocular or systemic diseases which may affect vision or refractive error.
3. Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
4. Other contraindications.