cyrilzakka/clinical-trials huggingface dataset:
Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

This pilot study is designed to determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone refractory prostate cancer.

The information obtained from this trial will help determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in this patient population. If the data from this phase I trial are encouraging, a phase II trial will be conducted to further assess the efficacy of this dosing schedule.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 65 years;
* histologically confirmed adenocarcinoma of the prostate;
* metastatic disease;
* unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in PSA at least 1 week apart;
* patients must have serum testosterone levels \< 50 ng/mL at time of study entry. For patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression;
* prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. No evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;
* chemotherapy naïve;
* full recovery from the effects of any prior surgery or radiation therapy. At least 4 weeks since any radiation therapy;
* ECOG performance status 0-2;
* adequate kidney, liver, and bone marrow functions;
* signed study-specific informed consent form.

Exclusion Criteria:

* Concurrent chemotherapy or immunotherapy;
* Patients who have received an investigational drug within 4 weeks of registration;
* Prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years;
* Serious medical or psychiatric illness which would prevent informed consent;
* Life expectancy \< 3 months;
* Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled;
* Known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

Fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. However, no pharmacokinetic study has thus far been conducted in pediatric patients. Fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. Pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients.

Through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics.

Through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free survival).

Eligibility Criteria:
Inclusion Criteria:

1. Conditioning regimen including fludarabine
2. Age: \< 19 years old
3. Functional class: ECOG 0-2
4. No loss of function of major organs. Criteria may be individualized.

   * Heart: shortening fraction \> 30%, ejection fraction \> 45%.
   * Liver: total bilirubin \< 2 ⅹ upper limit of normal; ALT \< 3 ⅹ upper limit of normal.
   * Kidney: creatinine \< 2 ⅹ normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
5. No active viral or fungal infection
6. Appropriate hematopoietic stem cell donor
7. Informed consent from patients' parents

Exclusion Criteria:

1. Pregnant or breast feeding
2. Disease progression due to clinical test
3. Psychiatric disease may interfere with clinical test
4. Whether attending physician consider the patient inappropriate for study enrollment
Asthma Control-A "Patient Follow up Programme" Maintenance and Reliever Therapy in a Single Inhaler

To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.


Eligibility Criteria:
Inclusion Criteria:

* Asthma patients from both sexes, age 18 or older
* Have already been on Symbicort SMART treatment
* Willing to give written informed consents to participate in the program.

Exclusion Criteria:

* Patients who are not willing to give written informed consent
* Patients in emergency care for asthma at ICUs or COPD patients are excluded from the program.
Tolerance and Acceptability Evaluation of MONACO

To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Patients (\>18 years) who are able to communicate clearly.
* Patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement.
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement
* Informed assent/consent obtained.

Exclusion Criteria:

* Patients with cow's milk protein allergy requiring a milk free diet
* Patients with inherited metabolic conditions.
* Patients requiring enteral tube feeding or parenteral nutrition.
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list)
* Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
* Patients with dysphagia requiring stage 1, 2 or 3 thickened fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
African-American Heart Failure Trial

A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.

The overall objective is confirmation of BiDil's Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.

Eligibility Criteria:
* African American male or female 18 years or older.
* NYHA Class 3 \& 4.
* Have either a resting LVEF less than or equal to 35% (by any method) or a resting LVIDD greater than 2.9 cm/m2 BSA (or greater than 6.5 cm) with LVEF less than 45% (by echocardiogram).
Linagliptin in Post-renal Transplantation

Post-renal transplanted patients frequently present hyperglycemia immediately after the procedure.

This was a retrospective comparative study performed in post-renal transplanted patients in a single high speciality center with the goal of compare the effect of linagliptin + insulin in post-renal transplanted patients with hyperglycemia Interventions were linagliptin 5mg daily plus insulin vs insulin alone during 5 days after renal transplantation with hyperglycemia, and the main outcome were glucose levels, insulin dose and severity of hypoglycemia

This was a retrospective comparative study performed in a single center between 2016 and 2018, included the data collected from 28 hospitalized post-renal transplanted patients that presented hyperglycemia (\>140 mg/dl or or 7.77 mmol/l) immediately after renal transplantation (RT); 14 patients were treated with linagliptin 5mg daily plus a basal bolus insulin scheme prescribed by the Endocrinology group at the hospital, and 14 patients treated only with basal bolus insulin scheme were randomly selected from a list of patients treated during the same period of time and by the same Endocrinology group. Linagliptin dose was 5mg daily and the basal bolus insulin regimen was started and adjusted according to the international guidelines; in general, patients received a starting insulin dose of around 0.5 U/kg/day, given half as basal insulin (NPH or Glargine) once or twice daily and half as insulin lispro divided into three equal doses before meals. Insulin dose was adjusted daily to achieve the goal of fasting glucose between 80-140 mg/dl (4.44-7.77 mmol/l) or random glucose levels below 180 mg/dl (9.99 mmol/l). Correctional insulin dose was used before each meal, depending on the glucose measurements, starting at 1 unit for each 40mg above 140 mg/dl (7.77 mmol/l) of glucose. Glucose levels were monitored at fasting and before each meal, as well as at bedtime according to standard clinical practice. Data regarding fasting and preprandial glucose levels, hypoglycemia, renal function, and immunosuppression therapy were recorded from the patient´s file during the first 5 days after RT; fasting glucose and renal function were also recorded at 1, 6 and 12 months after RT. Patients were included if they were between 18-65 years of age and presented fasting hyperglycemia (\>140 mg/dl or 7.77 mmol/l) immediately after RT.

Ethical and Research committee (CEI) at the Hospital approved the study protocol with the number CEI-49-18.

Eligibility Criteria:
Inclusion Criteria:

* Hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation

Exclusion Criteria:

* Incomplete records on the patients file
* Acute complications such as liver failure
Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting

This study will investigate the hypothesis that preoperative erector spinae plane (ESP) block will reduce the incidence of postoperative nausea and vomiting (PONV) in patients undergoing elective lumbar disc herniation (LDH) surgery. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.

The study will include patients aged 18 years and older, with (American Society of Anesthesiologists) ASA physical status I and II, and scheduled for single-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.), Apfel score, postoperative nausea and vomiting (PONV) status, intraoperative opioid use requirement, surgical duration, postoperative pain status, rescue analgesic and emetic requirement will be recorded. The primary outcome parameter will be the PONV incidence within the postoperative 24 hours. PONV severity during this period will be assessed using a Likert scale from 0 to 10. PONV will be defined as vomiting, marked nausea (numerical rating scale \[NRS\] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using the Likert scale. Nausea and its severity, vomiting attacks, need for intraoperative opioid use, pain and its severity, need for additional analgesics, and administration of antiemetic rescue medication will be evaluated as secondary outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* ASA physical status I to II
* One lumbar disc herniation surgery under general anesthesia

Exclusion Criteria:

* body mass index \>35 kg/m²)
* history of drug use
* nausea and vomiting before surgery
* psychiatric disorders
* use of antipsychotic or antiemetic drugs
* severe heart disease
* central nervous system diseases
* vertebrobasilar artery insufficiency
* cytostatic therapy
* vestibular diseases
* renal and/or hepatic dysfunction
* pregnant patients
* presence of bleeding diathesis
* patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)
* patient's refusal to accept the block procedure
* allergy to local anesthetics
* injection site infection
Association Between Low Back Pain and Quality of Sleep

A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.


Eligibility Criteria:
Inclusion Criteria:

* patients with non-specific low back pain of more than 14 days duration
* seen in health centers participating in the study
* who accept to participate and sign the consent form
* without age limits and regardless of gender

Exclusion Criteria:

* inability to complete the questionnaires (illiteracy, dementia)
* inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years
Resveratrol as a Preventive Treatment of OHSS

Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving hemoconcentration and symptomathology of this condition

Eligibility Criteria:
Inclusion Criteria:

* Number of follicles greater than 12 mm after ovarian stimulation
* Number of retrieved oocytes greater than 21

Exclusion Criteria:

* \>35 years-old
* PCOS
* Endometriosis
* Systemic pathology
* Positive serologies for HBV, HBC and HIV
* Abnormal karyotype
Nutrition Intervention for Chronic Pain Patients

The primary objective of the study is to determine the effectiveness of nutrition education (individual and group) on the intensity of pain in patients suffering from chronic pain. The secondary goal is to determine whether there is a change in the status of the patient's nutrition, their quality of life, quality of life, and other indicators of the psychophysical condition of the patient.

The underlying hypothesis of the study is that patients with chronic pain that go through a series of nutrition education (individual and group) specifically tailored to fit their needs (based on our preliminary findings), they increase the consumption of foods that have antiinflammatory properties, which will result in lower levels of inflammatory cytokines in the body (high sensitivity C-reactive protein (hs-CRP ), interleukin (IL) -2, IL-4 and IL-6), and consequently reduce the intensity of pain. Also, weight loss in obese patients is expected, and it will have an contributing effect of the intervention. Patient's quality of life and indicators of their psychophysical condition (eg, depression level) are also expected to improve.

Chronic pain patients who either attend Daily clinic (Control Arm) or the 4-week multidisciplinary programme at the Department of Anesthesiology, Resuscitation and Intensive Care (Intervention Arm) will be recruited. They will be followed for total of 8 weeks (4 week intervention + 4 week follow-up).

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* chronic low back pain with or without radiculopathy patients; non-cancer pain
* BMI within the range \>18 and \<35 kg/m2
* Croatian-speaking
* referred to a multidisciplinary pain management center
* able to report on their health and pain status (neurologically stable)
* pain intensity on 0-10 visual analog scale ≥ 5 prior to treatment
* magnetic resonance imaging (MRI) of the lumbar spine and electromyography (EMNG) studies completed confirming clinical symptoms of low back pain with or without radiculopathy

Exclusion Criteria:

* younger than 18 or older than 80
* cancer pain
* pregnancy
* disability (unable to walk)
* inability to fill in questionnaires in Croatian
* cognitive impairment
* significant, symptomatic uncontrolled psychosis
* psychiatric disorder
* pain intensity on 0-10 visual analog scale \< 5 prior to treatment
* severe somatic disorder (oncological disease, type 1 diabetes, hepatological or nephrological)
* undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder
* acute low back pain, or shorter than 6 months
* clotting disorders
* BMI \<18 or over 35 kg/m2
* nutritional deficiency (e.g. iron deficiency anaemia, osteoporosis)
* current or history of eating disorder (anorexia, bulimia or EDNOS)
* current use of weight loss interventions (drugs; exercise interventions)
* regular use of supplemental omega-3 fatty acids, gamma-linolenic acid or vitamin D
Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients

Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis.

This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed pediatric patients with mild-moderate UC.

The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation, in newly diagnosed pediatric patients with mild-moderate UC.

All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed (\>9 months) with mild to moderate ulcerative colitis as per colonic biopsy and clinical disease activity (SCCAI 5-12).
* Patients not started on immune-suppressive or anti-inflammatory medications (Mesalamine is allowed).
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
* Ability to understand and the willingness to sign a written document, including the willingness to accept risk of unrelated donor stool.
* Ability of parents or other legal guardian to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
* Ability to swallow oral medications.

Exclusion Criteria:

* Severe, uncontrolled ulcerative colitis.
* At time of enrollment, immune-suppressive or anti-inflammatory medications, except Mesalamine.
* Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
* Delayed gastric emptying syndrome
* Known chronic aspiration
* Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
* Pregnant and breast-feeding women
* Participants who are unable to swallow pills.
Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis

The goal of this project is to investigate the extent and role of mesothelial - mesenchymal transition (MMT) and cancer associated fibroblasts (CAFs) in the pathogenesis of colorectal peritoneal carcinomatosis (PC).


Eligibility Criteria:
Inclusion Criteria:

• Patients presenting with colorectal peritoneal carcinomatosis

Exclusion Criteria:

* Pregnancy or breast feeding
* Psychiatric pathology capable of affecting comprehension and judgment faculty
* HIPEC (hyperthermic intraperitoneal chemotherapy) or PIPAC (pressurized intraperitoneal aerosol chemotherapy) in the past
* Abdominal radiation treatment
Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study

This study intends to carry out a prospective, multi-center cohort study based on MRI to explore the incidence of structural and functional damage of central, brain and kidney in patiant with SSc and its clinical relevance, and to search for the characteristics of serological markers of structural and functional damage of heart, brain and kidney.

Systemic sclerosis (SSc) is a autoimmune disease of unknown etiology with an estimated global incidence of 0.1‰. SSc characterized by abnormal immune activation, neovascularization, vascular remodeling in pathology, and eventually leads to fibrosis of tissues, skin, and organs \[2\]. In addition to skin sclerosis, SSc often involved multiple organ involvement, such as finger ulcer, gastroesophageal reflux, interstitial lung disease, pulmonary hypertension, cardiomyopathy, kidney damage, etc. Neuropsychiatric manifestations such as anxiety and depression may also occur in SSc patients. A long-term follow-up study indicated that cardiomyopathy (14%), cardiovascular disease (12%), and kidney injury (4%) were important causes of death in SSc patients. Therefore, early diagnosis and early intervention for multi-organ complications of SSc can significantly prolong the survival time of SSc patients.Magnetic resonance imaging (MRI) is a non-invasive, radiation-free imaging examination method with excellent soft tissue contrast, which can achieve one-stop multi-parameter imaging. At present, MRI has been widely used to accurately diagnose and evaluate the structure and function of organs such as heart, brain and kidney. Previous literature has shown that cardiac MRI can identify cardiac injury in patients with SSc earlier than echocardiography even in the early stage. Meanwhile it can find the abnormalities before clinical symptoms. Therefore, MRI is an effective noninvasive imaging method to evaluate the structural and functional damage of heart, brain and kidney in SSc patients.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

Complicated with other immune disease Claustrophobia Contraindications for MR examination Heart or respiratory failure Diseases that affect MR findings (e.g. rapid atrial fibrillation) Complicated with heart, brain and kidney diseases not caused by SSc（such as diabetic nephropathy and congenital heart disease） Pregnant Disturbance of consciousness