cyrilzakka/clinical-trials huggingface dataset:
Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic cancer
* Glucose 6 phosphate dehydrogenase status normal
* ECOG performance status 0-2
* Normal creatinine and transaminase
* Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria:

* Concurrent chemotherapy or radiotherapy
* Significant co-morbid disorders
* Significant psychiatric symptoms
* Prior treatment with gemcitabine
* Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
* Regular use of nonsteroidal anti-inflammatory agents
* Smoking more than 1 pack per day
* Excessive alcohol or drug use
* Enrollment in other experimental therapy
* Active infection
* Patients experiencing ongoing response to recent treatments
Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

This is cross-over, randomized clinical trial, with objective to evaluate the effects of low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms

Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment

The investigators hypothesis is that a different genotypes in the receptor estrogen gene and FTO may have an influences on treatment response in metabolic markers and cardiovascular risk


Eligibility Criteria:
Inclusion criteria:

* last menstrual period between 6 months and 3 years before the beginning of the study plus FSH levels higher than 35 IU/L;
* age between 42 and 58 years;
* no use of any medication known to interfere with hormonal, glucose, or lipoprotein levels in the past 3 months;
* no use of steroidal or no steroidal anti-inflammatory drugs in the last 15 days.

Exclusion criteria:

* patients with diabetes,
* previous hysterectomy,
* endometrial thickness \>0.5cm,
* history of cancer,
* thromboembolism, or
* established cardiovascular disease
TAPB Combined With RSB Versus ESPB for Postoperative Analgesia After Laparoscopic Liver Resection

Postoperative pain after laparoscopic hepatectomy is composed of multiple factors, and the peak pain of postoperative pain mainly occurs within the first 24 hours, so it is particularly important to find an appropriate analgesic method. Transversus abdominis plane block (TAPB) and Rectus sheath blocks (RSB) are widely used in abdominal surgery, but too deep a needle tip during RSB may puncture abdominal organs. TAPB and RSB can only provide somatic analgesia, but lack visceral analgesia. Recently, Erector spinae plane block (ESPB) has been used in some studies for analgesia after abdominal surgery. The purpose of this study is to compare the analgesic effect and postoperative recovery effect of erector spinae plane block and transverse abdominis plane block combined with rectus sheath block in patients undergoing laparoscopic hepatectomy. Therefore, this study has important clinical implications.

In a double-blind randomized controlled study, researchers randomized 60 patients undergoing laparoscopic hepatectomy to TAPB combined with RSB or ESPB, with both groups receiving additional standardized treatment, including multimodal analgesia. The main outcome was the consumption of morphine within 24 hours after surgery. Secondary outcomes included the number of rescue analgesia at 1h, 2h, 4h, 8h and 24 hours after surgery, VAS scores in resting and coughing at 1h, 2h, 4h, 8h and 24h after surgery, CVP values at 5, 10, 15 and 30min after nerve block, QoR-15 patient questionnaire scores before and 24h after surgery, and postoperative liver function (the percentage increase of AST and ALT compare with preoperative), postoperative complications and discharge time.

Eligibility Criteria:
Inclusion Criteria:

1. ASA grades I-II;
2. Age 18\~70 years old;
3. BMI 19～28kg/m2;
4. Patients undergoing elective laparoscopic partial liver resection;

Exclusion Criteria:

1. The nerve block cannot be performed, such as skin infection at the puncture site;
2. Daily using the opioid analgesics or have a history of opioid abuse;
3. Allergy or a history of drug allergy to any of the drugs used in the study;
4. Patients have cognitive impairment, mental or neurological diseases, motor or sensory deficits;
5. Coagulation disorders;
6. Severe lung, heart, liver, or kidney dysfunction;
7. Participating in other clinical trials within 3 months before being included in this study;
Prevalence of Hyperventilation Syndrome in Difficult Asthma

Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) \< 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.

There is only one visit. During this visit, each patient will complete self-questionnaires like Nijmegen, Hospital Anxiety and Depression Scale(HAD), Short-Form 36(SF36), and Asthma Quality of Life Questionnaire (AQLQ), The participants will have baseline spirometry and fractional exhaled nitric oxide measured at expiratory flow of 50 mL/s (FENO50), blood gases at rest, an hyperventilation challenge and Cardiopulmonary Exercise Testing(CPET) to determine accurately the presence or not of chronic hyperventilation syndrome. The diagnosis is confirmed by two positive tests (Nijmegen, Hyperventilation challenge and blood gases) and the final decision of a medical committee. The first step is to determine the prevalence oh this syndrome in this specific population. The second step is to assess the sensitivity, the specificity, the false positive rate and the false negative rate of the different parameters measured during the tests.

Eligibility Criteria:
Inclusion Criteria:

* men and women,
* aged more than 18,
* non smokers for two years or longer, less than 10 pack/years smoking history,
* physician-diagnosed asthma,
* uncontrolled asthma with Asthma control test (ACT) \< 18,
* historical of FEV1 reversibility,
* daily inhaled steroids treatment by at least 2000microg eq beclomethasone,
* Forced expiratory volume in 1 second (FEV1) \> 50% predicted value

Exclusion Criteria:

* other chronic pulmonary disease,
* vocal cord dysfunction,
* pregnancy,
* Participation in another interventional research trial,
* unable to provide consent,
* asthma exacerbation within the last 4 weeks
Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy

This is an investigator-initiated prospective, randomized, controlled study. Hypothesis/Objective: The study will evaluate the rates of wound healing among patients with lower extremity diabetic wounds comparing two groups of patients. Group 1, the control group, will be treated with the standard of care treatment of moist wound therapy. Group 2 will be treated with ConvaTec Engenex® NPWT. Both groups will be treated in the inpatient and outpatient setting. It is expected that the NPWT device will be an effective therapy that expedites time to closure and demonstrates a significant decrease in the size and depth of the wound over the course of the 12 week therapy as compared to the standard of care.

After determining if you meet the criteria to be included in the study, your wound will be debrided (cleansed of any dead tissue or infection). You will then be randomly placed into one of two treatment groups. Group 1 will be the control group and a moist wound therapy will be applied to the wound. Either you or home nursing will then change the dressing twice a week. Group 2 will have a negative pressure wound therapy (NPWT) dressing applied. The NPWT dressing will be changed twice a week by home nursing. You will return to clinic every 2 weeks for a total of 12 weeks for observation and assessment of the diabetic foot ulcer. If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older
2. Subjects with chronic lower extremity diabetic wounds, with or without a previous history of partial foot amputation.
3. Subject has Diabetes Mellitus (type 1 or type 2)
4. University of Texas Classification 1A-3A or 1B-3B
5. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Subjects \< 18 years of age
2. Subject is non-diabetic
3. Subjects who present with wounds of etiology other than diabetes
4. Subject demonstrates increased signs of clinical infection
5. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
6. University of Texas Classification 1C-3C
7. Subjects participating in any other trials in regards to the diabetic foot ulcer.
Effectiveness of Trauma Treatment in the Specialist Health Care Services

Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients.

The main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.

Participants will be recruited from Asker DPS, Bærum DPS, Drammen DPS, and Ringerike DPS. They were referred to DPS for PTSD treatment, either by general practitioners, other primary health care services in their municipality, or psychiatric hospitals. This study is a longitudinal multi-assessment 2-arm RCT and does not include a treatment as usual group. The standard treatment protocol includes up to 24 weekly sessions. Conversely, if no discernible improvement is seen after 10 sessions, it is recommended to terminate treatment. The clinical assessment consists of self-administered questionnaires collected through CheckWare, which is a digital platform developed for healthcare services. They will be asked to report symptoms of PTSD, depression, anxiety, psychosis, alcohol/drug use, functional outcomes, working alliance. Before treatment starts, patients will complete baseline assessments. Throughout the treatment phase, all patients will be requested to fill out self-administered questionnaires after each session.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* meeting criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score ≥23

Exclusion Criteria:

* insufficient mastery of the Norwegian language
* severe intellectual impairment (estimated IQ of 70 or less)
* comorbid psychiatric illnesses in an acute phase where other types of treatment need to be prioritized (e.g. hospitalization)
* history of EMDR or CT-PTSD treatment
Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care

Eprotirome is a liver selective thyroid hormone that can reduce several independent risk factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic tissue.

The purpose of this Phase III study is to assess the long-term efficacy and safety of Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed HeFH and 18 years of age at screening
* Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL)
* Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL)
* On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation

Exclusion Criteria:

* Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation

Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell transplantation is one of the meaningful issues in aspect of patient's recovery and survival. in recent years, the understanding of the pathology of GVHD is much important to prevent or treat aGVHD. additionally, (oral) mucositis is one of the problems in patients with high dose chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as proinflamtory cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if it was released to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for promoter of inflammation and cancers. at this point, there are no reported articles about correlation of HMGB1 and aGVHD in human. recently, we have seen excessive secretion of serum HMGB1 in mouse model, then base on this results, we will check correlation of HMGB1 and aGVHD/ oral mucositis in human.

1. materials 1) inclusion criteria

   1. over 18-year-old
   2. patients with myeloablative conditioning regimen
   3. autologous transplant
   4. patients with confirmation of acute GVHD as over grade II
   5. patients with salvage chemotherapy

      2) exclusion criteria

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   1. old age ( over 60-year-old)
   2. patients with reduced intensity stem cell transplantation
2. method 1) check the serum level of HMGB1, TNF-a, IL-1b, IL-6, Th1, Th2, Th17, FoxP3 on 7-day before transplant day(D-7), transplant day(D0), 7-day after transplant(D+7), D+14, D+21. 2) check the immunohistochemistry level of tissue in diagnosed aGVHD ( performed sigmoidoscopy and random biopsy of gut is routine process in our center) 3) check the oral mucositis grades (using WHO grading system, NCI -CTC ver.3 scoring system)
3. analysis 1) student t-test , chi-square test 2) survival analysis

Eligibility Criteria:
1. Inclusion Criteria:

   1. over 18-year-old
   2. patients with myeloablative conditioning regimen
   3. autologous transplant
   4. patients with confirmation of acute GVHD as over grade II
   5. patients with salvage chemotherapy
2. Exclusion Criteria:

   1. very old age ( over 75-year-old)
   2. patients with reduced intensity stem cell transplantation
HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. This loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn.

Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise.

24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. During these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. Throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.


Eligibility Criteria:
Inclusion Criteria:

* T1D diagnosis more than 6 months ago (to ensure participants are out of the honeymoon period),
* Using a basal bolus insulin regime or insulin pump therapy
* BMI ≤ 32 kg.m-2

Exclusion Criteria:

* Pregnancy (or planning pregnancy)
* Disability preventing participation in an exercise regime
* Angina
* Autonomic neuropathy
* Medication that affects heart rate (this will affect estimation of fitness)
* Major surgery planned within 6 weeks of study
* Uncontrolled blood pressure
* Significant history of hyperglycaemia
* History of severe hypoglycaemia requiring third party assistance within the last 3 months
* Severe non-proliferative and unstable proliferative retinopathy
Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)

This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.

Objectives:

The primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). A secondary objective is to examine potential mechanisms of action that might account for improvements in pain or PTSD. Third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. It is hypothesized that 1) participants receiving the intensive treatment (PT) will report significantly greater decreases in symptoms of pain and PTSD from pre-treatment to post-treatment when compared to participants randomized to a standard care (SC) condition, and 2) participants receiving PT will show greater maintenance of change on measures of pain and PTSD at 3 months following the completion of treatment when compared to participants randomized to the SC condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology.
* Patients must also meet diagnostic criteria for PTSD.

Exclusion Criteria:

* Patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.
Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases

The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in the routine in any laboratory is difficult. it will be useful to standardize them detection to control the emergence.

The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy because CARBA are often the alone antibiotics available to cure severe infections due to extended-spectrum β-lactamase (ESBL)-producing isolates. Two mechanisms of resistance to CARBA have been identified: membrane impermeability associated with ESBL or cephalosporinase production and carbapenemase (CARBase) production. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital in order to avoid the dissemination of the CARBase-producing strain and insure patient safety. Prevalence rate of non-susceptible (NS) isolates to CARB, the proportion of the two types of mechanisms of resistance to CARB and the factors associated with CARB- NS isolates are still unknown in France. Moreover, detecting CARBase in the routine in any laboratory is difficult. Providing data regarding all of these points will be useful for any hospital and will permit to optimize the management of the patients suspected or proved to harbor a CARBase-producing Enterobacteriaceae isolate.

Eligibility Criteria:
Inclusion Criteria:

* Case: Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae
* Control 1: Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case
* Control 2: Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case, hospitalised in any type of ward in the hospital

Exclusion Criteria:

* the patient with digestive ER-CARB