cyrilzakka/clinical-trials huggingface dataset:
Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.

OBJECTIVES:

* Provide oxaliplatin for patients with previously treated locally advanced or metastatic colorectal cancer who have exhausted all approved therapies for colorectal cancer.

OUTLINE: This is a multicenter, Treatment Access Program study.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 30 days.

PROJECTED ACCRUAL: Approximately one patient per site per month will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy

  * Locally advanced OR
  * Metastatic disease
* Patients who progressed on a non-oxaliplatin-containing (control) arm in Sanofi-Synthelabo second-line regulatory trials OR
* Patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens
* Documented radiological disease progression after last anticancer treatment

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 75,000/mm3

Hepatic:

* SGOT or SGPT no greater than 6 times upper limit of normal (ULN)
* Bilirubin no greater than 2 mg/dL
* Alkaline phosphatase no greater than 5 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* Adequate organ function and medically stable
* No known concurrent peripheral neuropathy
* Absence of deep tendon reflexes as the sole neurologic abnormality is allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 30 days since prior chemotherapy
* No prior oxaliplatin-based chemotherapy
* No other concurrent investigational chemotherapy agents

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 30 days since prior radiotherapy

Surgery:

* See Disease Characteristics
* At least 30 days since prior major surgical procedure or intervention

Other:

* At least 30 days since other prior anticancer therapy
* No other concurrent anticancer agents
* No concurrent participation in any other investigational studies
Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias

Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis.

Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations \[1\]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias \[2\]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty \&quot; URAGPI\&quot; versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion.

B) Normal appearance of the penis. C) Good functional results.


Eligibility Criteria:
Inclusion Criteria:

* All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al

Exclusion Criteria:

* circumcised patients
* sever degrees of chordae
* previous surgical repair
* meatal stenosis
Effect of Taurolidin on Prevention of Bloodstream Infection

Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.

The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.

Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.


Eligibility Criteria:
Inclusion Criteria:

* Age superior to 18 years
* Home parenteral nutrition on tunnelized central venous catheters
* Bloodstream infection confirmed by differential hemocultures
* Informed consent form signed
* Negative B-HCG test

Exclusion Criteria:

* Subject unable to give his informed consent
* Pregnancy
* Subject who have a two or three-way catheter, or a non-tunnelized central venous catheter
* Hospital related infection
* Central venous catheters placed since less than 15 days
* Neutropenia \< 500 PNN/mm3
* Fungal Infection, polymicrobial who need ablation of the central venous catheters
* No-response to clinical treatment of the Infection
* Septic thrombophlebitis
* Chemotherapy ongoing
* On going malignancy
Effect of Three-Stair-Position on Improvement of Apnea of Prematurity

The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.

Apnea of Prematurity (AOP) is common critical symptoms of preterm infants with great harm for prematurity. Recurrent apnea may lead to brain damage caused by hypoxia, affecting the nervous system, even threatening life (1, 2). Therefore, choosing an intervention which can prevent and reduce occurrence of AOP with fewer side effects is an important issue that should be closely watched by neonatal intensive care unit (NICU) health care.

Prone position is the forefront treatment due to its simple, economic and non-invasive. In clinic, it includes horizontal prone position (HPP), Head elevated tilt 15 ° prone position (HETP) and three-step-prone position (TSP)(3).Many studies have shown that HETP can allow thoracic volume increased and make abdominal movement more coordinated in preterm children, and then it is more favorable than the HPP on improving respiratory function. So HETP has been a routine position in NICU instead of HPP (4, 5). HETP, however, always make the babies slide to the foot of the bed resulting in airway obstruction. Therefore, scholars have proposed TSP which should prevent this phenomenon (6). In the study, the effectiveness of TSP on improvement of AOP will be evaluated trying to find a more suitable position for preterm infants.

Eligibility Criteria:
Inclusion Criteria:

1. preterm, gestational age(GA) \<34weeks determined by obstetric ultra-sonogram and clinical examination
2. steady vital signs
3. Apgar scores were greater than or equal to 3 at 1min and greater than or equal to 5 at 5 minutes.

Exclusion Criteria:

1. infants with congenital malformation，for example Congenital Heart Disease, Diaphragmatic hernia, Hirschsprung,etc
2. Infants who need special position and/or intervention (gastroschisis or umbilical catheterization)
3. weight\<1000g
4. infants who were undertaking conventional invasive mechanical ventilation.
Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)

Based on the collected antibiotic concentration data and individual patient's clinical information, a pharmacokinetic analysis report that can be applied for dose adjustment of the individual patient is provided. The pharmacokinetic/pharmacodynamic index using the minimum inhibition concentration (MIC) of the antibiotic obtained from the patient's clinical isolate is also explored. Utilizing these, we intend to establish a population pharmacokinetic model of antibiotics prescribed in treating Tuberculosis and Nontuberculous mycobacteria (NTM). The developed population pharmacokinetic model can be applied for therapeutic drug monitoring (TDM) based on dose adjustment through the obtained pharmacokinetic parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Tuberculosis.
* Latent tuberculosis, or Nontuberculous mycobacteria (NTM) disease and currently under treatment with antibiotic drugs.
* Patients who understand and voluntarily sign an informed consent form before any study-related procedures are conducted.

Exclusion Criteria:

- Children (minors) for whom the consent of a legal representative is impossible.
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.


Eligibility Criteria:
Inclusion Criteria:

Male and female children and adolescents will be eligible for participation in this study if:

* they are aged 1 year (from the 1st birthday) to \< 16 years (to the last day before the 16th birthday);
* they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
* their parents/legal guardians understand the nature of the study and agree to its provisions;
* written informed consent is available from both parents/legal guardians,
* for Germany/Austria: additional written informed consent is available for children older than 8 years
* they or their parents/legal guardians agree to keep a volunteer diary.

For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria:

- negative pregnancy test at study entry;

Exclusion Criteria:

Children and adolescents will be excluded from participation in this study if they:

* have a history of any TBE vaccination;
* have a history of TBE infection;
* have a history of allergic reactions to one of the components of the vaccine;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
* are known to be HIV positive (a special HIV test is not required for the purpose of the study);
* have received banked blood or immunoglobulins within one month of study entry;
* have a history of vaccination against yellow fever and/or Japanese B-encephalitis;
* suffer from hemorrhagic diathesis;
* are participating simultaneously in another clinical trial;
* if female: are pregnant or breastfeeding.

Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature \> 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.

Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately.

If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.

Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.
Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19

Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years and older
* Admission to the intensive care unit (ICU)
* Pneumonia due to proven or suspected SARS-CoV-2 infection

Exclusion Criteria:

* Refusal to provide consent for the study by the patient or legal guardian
* ICU length of stay less than 24 hours
* Absence of telephone contact
The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life

The purpose of the research is to check the efficiency of practicing the tools of the Grinberg method (GM) in reducing Low-back Pain (LBP), reducing limitations in movement as a result of the pain, and improving the general quality of life.

The hypothesis suggests that by learning to perceive pain differently, the level of pain will reduce and general well-being improved.

The research will include 140 patients, who attended the pain clinic due to chronic LBP. Any change in the pharmacological regimen will be done with consult of the tending doctor and the change will be reported.

Tools and Methods A patient, whom volunteers to take part in the research, will be invited to the Ichilov Pain clinic in order to fill-in questionnaires and sign an informed consent form.

Each participant in the experiment group will participate in a series of 6 sessions lasting 1 hour each, extending between 6 to 8 consecutive weeks, with one of the qualified GM practitioners partaking in the experiment. Each participant will have all their sessions with the same GM practitioner throughout the experiment. Immediately after the last session, the participants will fill-in the same questionnaires given at the beginning of the experiment. The non-GM intervention group will answer the questionnaires after 6-8 weeks of pharmacological treatment only.

Questionnaires:

* General Details and Pain Questionnaire
* SF-MPQ Short Form McGill Pain Questionnaire, Ronald Melzack
* RMDQ - Roland Morris Disability Questionnaire
* SF 36 - The Short Form Health Survey

Eligibility Criteria:
Inclusion Criteria:

* Women and men, age range 18-65; patients of the Ichilov Pain clinic, who suffer from chronic LBP that lasts over 3 months and that appears several times a week.
* LBP which is localized between the 12th rib and the inferior gluteal folds, with or without leg pain. The LBP may be non-specific, mechanical or radicular.

Exclusion Criteria:

* Patients with malignancy and/or other life threatening conditions
* Diabetic patients
* Patients with fibromyalgia
* Pregnancy
* Paralysis
* Patients with obesity
* Patients that underwent organ transplantation
* Severe osteoporosis
* Patients that are scheduled to receive spinal cord injections during the research
* Patients that received less than 4 weeks before the research, other pain interventions than the standard of care treatment such as: alternative medicine (acupuncture, shiatsu, massage, reflexology, homeopathy etc'); physiotherapy, chiropractic, hydrotherapy, bio-feedback, osteopathy and others.
* Patients with severe mental disorders (such as schizophrenia, bipolar disorder, suicidal tendencies etc')
* Pain lasting less than 3 months
Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients

Breathing exercises to improve fatigue and quality of life in hemodialysis patients

Patients receiving haemodialysis have poor physical function, psychological status and quality of life than the general population.Fatigue is a debilitating symptom in haemodialysis patients Exercise training may improve these parameters for haemodialysis patients.

A 3-month randomized control trial with baseline、Week 4、Week 12 measurement periods was conducted. Exercise group was taught to Breathing exercise week and Usual care for three months. The control group received usual routine care.

A total of 86 patients participated in this study, with 43 patients in the Exercise group and 43 patients in the control group Methods: Hemodialysis Fatigue scale 、 WHOQOL-BREF 、 HADS_ Anxiety

、 HRV

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed by end-stage renal disease, regular hemodialysis three times a week and up to six months or more
2. Adults over 20 years of age.
3. Consciousness.
4. can be used to communicate in Taiwanese, accept questionnaire interviews or self-filling questionnaire.
5. no chest pain or shortness of breath symptoms.
6. No lower extremity disability and ability to walk on their own.
7. agree to take respiratory exercise intervention measures, have the intention to participate in this study and signed a consent form.

Exclusion Criteria:

1. unstable vital signs, or serious heart disease: such as the diagnosis of myocardial infarction, unstable angina pectoris, cardiopulmonary disease and other patients.
2. A complication occurs, such as aspiration pneumonia.
3. history of arrhythmia, as well as taking heart rate medication.
4. Physician's advice is not suitable for exercise, such as bone and joint problems.
5. There is a temporary double vena cava catheter placed.
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)

Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.

Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 4-8 years at the time of enrollment
* Have a clinical diagnosis of monosymptomatic primary NE
* Have been dry in the day for \>/= 6 months prior to enrollment
* Have on average no more than 1 dry night per month during the past 6 months at enrollment
* Have an informed consent signed by the their parent(s)/carer(s)

Exclusion Criteria:

* Children in foster/court care
* Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for \> 7 days in the previous 6 months
* Have secondary NE
* Have wetting in the day
* Have faecal soiling
* Have known urinary tract disease
* Have diabetes
* Receive any regular intake of medication
* Have a known developmental/neurological disorder
* Have links to Kimberly-Clark of any kind (including family relations employed by Kimberly-Clark, holding stocks or share in Kimberly-Clark)
Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population

Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.

the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs).

The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen.

At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient.

The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.

Eligibility Criteria:
Drug refractory non-valvular paroxysmal atrial fibrillation patients,

Inclusion Criteria:

1. CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
2. having contraindications to long-term oral anticoagulants (OACs),
3. refuse OAC therapy despite explanation.

Exclusion Criteria:

1. thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
2. oversized LA (LA diameter\>65mm by TTE) or LAA (LAA opening\>35mm) through TEE,
3. pericardial effusion (≥4mm by TTE or TEE),
4. hemodynamic unstable patients,
5. patients with active hemorrhagic diseases,
6. ischemic or hemorrhagic stroke within 30 days.