cyrilzakka/clinical-trials huggingface dataset:
Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD

The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0 \~ 12.0 g/dl during the evaluation period

The secondary objective of study is

* No of patients with mean Hb level of +/-1.0g/dl difference from the baseline Hb
* Incidence of RBC transfusion during the titration and evaluation periods
* Mean Hb during the total study period
* Intrapatient Hb variability (mean within-patient standard deviation for Hb)
* Frequency of Micera dose level
* safety

Eligibility Criteria:
Inclusion criteria:

* 1.≥18 yr of age
* 2.peritoneal dialysis for ≥12wk before screening and during baseline period
* 3.weekly Kt/V ≥1.8 for PD patients
* 4.Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1)
* 5.stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1)
* 6.continuous subcutaneous maintenance epoetin or darbepoetin therapy for at least 2 months before screening and during baseline period
* 7.adequate iron status defined as serum ferritin ≥ 100ng/ml or transferrin saturation≥20%(mean of two values deteremined in month -2 and -1)

Exclusion criteria:

* 1.Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod
* 2.RBC transfusions within 2 months before screening or during baseline period
* 3.nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis)
* 4.acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus)
* 5.C-reactive protein\>30mg/dl
* 6.poorly controlled hypertension necessitating interruption of epotien or darbepoetin in the 6 months before screening
* 7.platelets \> 500X109/L
* 8.pure red cell aplasia
* 9.chronic congestive heart failure(New Yorj Heart Association class IV)
* 10.Myocardial infarction,severe or unstable coronary artery disease,stroke,severe liver disease within the 3months before screening or during baseline
* 11.Life expectancy \< 12months
Evaluating Taste and Smell Function and Food and Taste Preferences of Head and Neck Cancer Patients During Radiation Therapy/Chemotherapy

Changes to taste and smell have been reported in head and neck cancer patients who undergo radiation and chemotherapy. This may cause food to be unappealing and can lead to a reduced food intake. Thsi study will increase our understanding of taste and smell changes and how it relates to food and taste preferences.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, hypopharynx, larynx and thyroid
* all histologic types of cancer
* all tumour stages according to American Joint Committee for Cancer (AJCC) Staging
* all forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers
* alert and mentally competent
* English speaking

Exclusion Criteria:

* unable to swallow
* unwilling to participate
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.

A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.

Primary Outcome Measure:

Number of patients who receive a letter and patient navigation services and get screened compared to the control group.

Secondary Outcome Measures:

Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.

Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.

Eligibility Criteria:
Inclusion Criteria:

* Average risk men and women aged 50 - 74
* Unscreened - Defined as no prior CRC screening
* Under-screened - Defined as no FOBT screening within the last two years
* No colonoscopy or barium enema screening within the last five years
* Willing to provide consent to participate in the study.

Exclusion Criteria:

* FOBT within the last two years
* colonoscopy within five years
* barium enema within five years
* flexible sigmoidoscopy within five years
* Bowel cancer.
Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.

The purpose of this randomized clinical trial is to evaluate the effect of acute arterial hypertension maintained during surgery on morphine's requirements in patients undergoing laparoscopic cholecystectomy

The high arterial blood pressure has been correlated with an increase in pain threshold in animal and humans. One of the explanations to this phenomenon is a baroreceptor activity and vasopressin release at the level of spinal cord dorsal horn and hypothalamus.

As far as we know, there is only one study about the effect of chronic hypertension on postoperative pain and none with acute hypertension. We therefore decided to conduct a randomized controlled trial to evaluate the effect of acute hypertension on postoperative morphine's requirements.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology patient classification status(ASA) I-II
* Between 20 and 60 years of age
* Programed for elective laparoscopic cholecystectomy

Exclusion Criteria:

* History of arterial hypertension
* Baseline blood pressure over 139/89
* Use of opioids and any analgesic drug during the last 24 hours before surgery
* Chronic use of nonsteroidal antiinflammatory
* BMI \> 34.9
* History of drug or alcohol abuse
* Use of medications that interfere in the central nervous system
* Adverse reactions to the drugs used in the study
* Pregnancy
Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.


Eligibility Criteria:
Inclusion Criteria:

* Growth hormone deficient by formal testing with two provocative agents.
* Treated with growth hormone for a minimum of 6 months prior to study entry.
* Growth hormone doses must be maintained at 0.2-0.4mg/kg/wk while in protocol.
* Stable organic pathology
* Presence of puberty \[genital Tanner Stage \> II (\>4cc testicular volume)\]
* Bone age (BA) \> or = 11.5 years and \< 15 years

Exclusion Criteria:

* Participation in any other trial involving hormone therapy for at least 6 months prior.
* Chronic illnesses requiring long term medication that impair growth. (Stable patients with occasional asthma, patients on Ritalin or Adderall or patients on topical acne medication may be included).
* Hereditary disease diagnosed clinically.
* Moderate to severe scoliosis.
Enhancing Inhibition With tDCS in Low Back Pain

This cross-over study intends to use consecutive days of active versus sham transcranial direct current stimulation (tDCS) to enhance descending inhibition and look at resulting clinical effects in people with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy men and women
* Aged 18-60 years
* Continuous pain (\>3days pain/week) episode lasting at least 3 months, sufficient to limit daily activities
* Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at the time of recruitment
* Able to speak, read and understand English

Exclusion Criteria:

* Pregnancy
* Low back pain associated with menstruation
* Currently seeking active treatment for low back pain
* Red flags symptoms (i.e. fever, malaise, progressive neurologic deficit, significant trauma, prolonged corticosteroid use or osteoporosis, pain worst at night, urinary or faecal incontinence, or unintended weight loss)
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial
* Current or previous chronic or recurrent pain condition other than low back pain
* Current regular use of analgesic medication or other medication which may affect the trial
* Lack of ability to cooperate
Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .

Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regiment. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. Traditionally, patients experiencing an episode of schizophrenia are first treated with oral medications until they are stabilized, and then injectable long-acting formulations are given. This is an open, multicenter, randomized Phase IV trial in patients after an acute episode of schizophrenia. Patients will be in the trial for 6 months. One treatment group will receive injections starting at baseline (early initiation); the other group will start with treatment as usual at baseline and begin injections at Week 12 (late initiation). Assessment of effectiveness include Positive And Negative Syndrome Scale (PANSS), in order to measure symptoms of schizophrenia; Clinical Global Impression - Severity (CGI-S), measuring overall severity of illness; Global Assessment of Functioning (GAF), assessesing overall psychological, social, and occupational functioning; and Quality of Life Questionnaire SF-12, measuring overall health status. Safety evaluations include the Extrapyramidal Symptoms Rating Scale (ESRS), incidence of adverse events throughout the study, and vital signs (pulse, blood pressure). The study hypothesis is that early initiation of long-acting risperidone injections is not inferior to late initiation as measured by changes in PANSS total score from baseline through endpoint (after 6 months). Risperidone, long-acting formulation for intramuscular injections (25 to 50 mg (maximum)), given every 14 days through 6 months, starting at baseline or Month 3. Treatment as usual for 3 months for late initiation group

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)
* acute episode of schizophrenia within 2 weeks of study entry
* o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
* Positive And Negative Syndrome Scale (PANSS) score \>=80
* Clinical Global Impression - Severity (CGI-S) score \>=5

Exclusion Criteria:

* DSM-IV axis I diagnosis other than schizophrenia
* known hypersensitivity or lack of response to risperidone
* pregnant or nursing females, or those without adequate contraception
* alcohol or drug abuse or dependence diagnosed in the last month prior to entry,
Penile Injection Anxiety

The purpose of this study is to help us understand more about your experience with penile injection therapy. Many men become anxious when thinking about penile injections. We would like to understand more about this anxiety. You will be asked to fill out questionnaires before you start penile injection training, at each training visit, and then at your four month follow-up visit.

The treatment of erectile dysfunction (ED) following radical pelvic surgery has become an increasingly important issue. For many men, oral medications for ED will not be effective immediately postoperatively. These medications enhance the effect of nitric oxide secreted from the cavernous nerves, however these nerves are usually transiently injured intraoperatively diminishing the amount of nitric oxide available. Consequently, oral medications are usually ineffective for up to 18 to 24 months postoperatively while the cavernous nerves are healing. As a result, penile injection therapy is the primary treatment for ED for those men. This treatment delivers intracavernosal vasodilators at the base of the penis with a 29 gauge needle. This direct application produces consistent results and has been found to be effective for 94% of injection users. Despite common sense and clinical experience that indicates men become very anxious about penile injection therapy, anxiety has rarely been assessed in studies of penile injection therapy. We have observed that men who are initially reluctant about penile injection therapy are more likely to try this treatment when they hear that the injection anxiety dissipates quickly, after only a few injections. We unfortunately only have clinical observation to support our claim describing the course of injection anxiety. This study would provide empirical data to support this claim and this data will be used in describing the treatment and encouraging men to try injection therapy.

Eligibility Criteria:
Inclusion Criteria:

* History of a radical pelvic surgery (cystectomy, prostatectomy, low anterior resection)
* Participating in the injection therapy program
* Ability to provide informed consent
* Ability to converse, write and read English

Exclusion Criteria:

* History of or currently receiving radiation therapy,
* History of or currently receiving chemotherapy,
* History of or currently receiving hormone therapy.
External Oblique Intercostal Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Adult Patients Undergoing Open Nephrectomy

The aim of this study is to compare external oblique intercostal plane (EOIP) block and ultrasound guided transversus abdominis plane (TAP) Block for postoperative analgesia in adult patients undergoing open nephrectomy.

Patients undergoing nephrectomy have a high incidence of postoperative pain despite the use of modern laparoscopic surgical techniques. In the postoperative period, these patients are often treated with patient-controlled opioids, epidural analgesia, or both.

Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries, and kidney transplantation, with minimal side effects.

External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for open nephrectomy.

Exclusion Criteria:

* Bleeding disorders.
* Skin lesions or infection at the site of proposed needle insertion.
* Allergy to local anesthetics.
* Neurological disorders.
* Drug abuse.
* BMI \> 30 kg/m2.
* Pregnancy.
* Diabetic neuropathy.
* Severe cardiovascular problems.
Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

Hemoadsorption has been demonstrated to improve clinical and paraclinical results in critically ill patients with sepsis and septic shock. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with sepsis, on organ failure, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.


Eligibility Criteria:
Inclusion Criteria:

* patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines

Exclusion Criteria:

* unsigned informed consent
* duration of therapy under 12 hours
* death before the three consecutive sessions
Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis

This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.

Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.

Eligibility Criteria:
Inclusion Criteria:

1. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent
2. Aged 13 years or older
3. accept at least 4 cycles of chemotherapy
4. ECOG PS 0-2
5. expected survival time ≥ 3 months
6. with -high risk of FN according to researchers

Exclusion Criteria:

1. accepted stem cell or bone marrow transplant
2. undergoing any other clinical trial
3. uncontrolled infection, temperature≥38℃
4. per-week scheme chemotherapy
5. severe and uncontrolled diabetes
6. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
7. Suspected or confirmed drug use, drug abuse, alcoholics
8. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
9. Severe heart, kidney, liver and other important organs chronic diseases
10. Pregnancy or lactation in women or women with gestation detection positive before the first time using drug
11. Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives
12. The investigator believes that the patient's condition is not suitable for this clinical study.
It's Native: Nudging Healthy Ways

Native Americans suffer disproportionately from chronic diseases that may be prevented by achieving a healthy diet, physical activity and weight. For this pilot study, the aim is to examine the effectiveness and feasibility of a standard lifestyle management program implemented in community based settings among Native Americans.

A pilot study will be implemented to establish comparison data for the delivery of a standard lifestyle management program among Southeastern Native Americans. The program addresses the physical and intellectual domains. The ultimate goal will be to use focus group data and this pilot pre-post clinical trial to inform further cultural and social adaptations that could advance the effectiveness of lifestyle management programs in Southeastern Native Americans.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant and more than 6 months postpartum
* Without complicated disease (ie. renal failure, cancer)
* Identify as Native American
* Resident of study area
* Adults 18-50 years

Exclusion Criteria:

* Pregnant or within 6 months postpartum
* Complicated diseases states that are contraindications for the program goals
* Not Native American
* Not permanent resident of study area
* Less than 18 years of age or older than 50 years of age