cyrilzakka/clinical-trials huggingface dataset:
Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health. Mild cognitive impairment (MCI) describes problems with brain function such as difficulty with day-to-day memory and concentration. It is at this stage that Mediterranean diet could prove beneficial in terms of prevention.

Previous research by Queens University investigated the opinions of patients with MCI and their care givers to inform the development of Mediterranean diet education material to encourage behaviour change. The study suggested that MCI patients lacked awareness of the link between Mediterranean diet and brain function, although were interested to learn more. Feedback on the developed educational material was positive although there were suggested improvements such as tailoring information to memory loss, a potential staged approach to delivery and adaptations to the material content.

This present study aims to pilot test refined educational material among MCI participants to evaluate the feasibility of encouraging dietary behaviour change among this patient group.

This study aims to evaluate the feasibility of a theory-based, tailored Mediterranean lifestyle education intervention to encourage behaviour change in patients with MCI. The proposed study will be a 6 month RCT with a total of 60 MCI patients who will be randomised to 1 of 3 groups:

1. Group 1 will receive the Mediterranean lifestyle education resource on one occasion at baseline
2. Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
3. Group 3 will receive standard care (control group). Participants will receive the Mediterranean lifestyle education resource after their final 6 month study visit (i.e. delayed intervention).

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of Mild Cognitive Impairment by their physician
* Mediterranean diet score (MDS) less than or equal to 4 (Estruch et al., 2006)
* Willing to make changes to their diet

Exclusion Criteria:

* Diagnosis of dementia
* Patients with visual or English language impairment
* Psychiatric problems
* Significant medical comorbidity
* Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2
* Excessive alcohol consumption
* Taking high dose nutritional supplements
* Dietary restrictions/allergies that would substantially limit ability to complete study requirements
* Inability to provide informed consent
* History of, or comorbid condition which may alter performance on cognitive tests e.g. stroke, head injury, Parkinson's disease, learning disability
Apatinib as First -Line Treatment for Advanced Esophagus Cancer

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:

Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18 to 75 years old, men and women;
* 2. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
* 3. ECOG performance status: 0-2;
* 4. Life expectancy ≥ 12 weeks;
* 5. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;
* 6. Function of the major organs is normal, criteria referred are as follow:

  1. blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;
  2. biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST \<5 ULN; TBIL ≤ 1.5 ULN;
  3. plasma examination Cr ≤ 1.5 ULN;
* 7. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;
* 8. Patients that the investigator believes can benefit.

Exclusion Criteria:

* 1. Those who have had other malignant tumors in the past or at the same time;
* 2. Pregnant or lactating women;
* 3. Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure\>150mmHg, diastolic blood pressure\>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ\~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF \<50%;
* 4. Unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption;
* 5. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months;
* 6.With coagulation abnormalities (PT\>16 s, APTT\>43 s, TT\>21 s, Fbg \<2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy;
* 7. Have a mental illness, or history of abuse of psychotropic substances;
* 8. With anastomotic recurrence and tracheal fistula;
* 9. Patients who participated in other drug clinical trials within 4 weeks;
* 10. Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment;
* 11. Researchers believe that it is not suitable for inclusion.
Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.

In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Eligibility Criteria:
Inclusion Criteria:

* Controlled type 2 diabetes mellitus (HbA1c\<7%)
* Age: 20-65 years
* Body mass index: 18-35 kg/m2
* Serum ALT level: \>60 U/Lit. in males, \>38 U/Lit. in females
* Grade \>=2 fatty liver in liver sonography

Exclusion Criteria:

* Pregnancy
* Acute or chronic liver failure
* Acute or chronic renal failure
* Autoimmune or viral hepatitis
* Wilson's disease
* Alcoholism
* Malignancy
* Hypothyroidism or hyperthyroidism
* Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids.
Physical Activity Recommendation Behaviour in German Psychologists

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychologists working with patients with mental disorders.

Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations.

Clinical psychologists play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German psychologists.

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychologists working with patients with mental disorders.

Eligibility Criteria:
Inclusion Criteria:

* Clinical psychologist
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None
The Effectiveness of the Addition of Dexmedetomidine to Analgesia for Ankle Surgery.

Forefoot surgeries involve a relatively short operation usually completed in 1 - 1½ hours, with patients generally being allowed to go home on the same day. Despite this, post-surgery pain is often severe and a delay in the discharge of patients due to difficulty with pain control after the surgery is common.

Performing nerve blocks in association with sedation is the preferred way to provide pain relief and offers important benefits for foot surgeries. With nerve blocks, the requirement for oral painkillers and their associated side effects is reduced. Increasing the duration of local anesthetic action is helpful as it increases the time of pain relief, allowing for a smoother transition to oral pain medications, earlier discharge, and faster recovery.

Recently, Precedex has been considered for its usefulness in prolonging the pain relief produced by nerve blocks. The identified benefits of this particular use include reducing post-surgical pain medications requirements, reducing the incidence of nausea and vomiting, reducing the incidence of sedation from such medication, and diminishing the incidence of respiratory depression (inadequate breathing). Two small studies have also shown that adding dexmedetomidine to nerve block solution results in prolonging pain relief.

The purpose of the study is to examine several doses of dexmedetomidine combined with local anesthetic drugs and determine the best combination for prolonging pain relief, while minimizing potential side effects.


Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* American Society of Anesthesiologists (ASA) I-III patients
* Ages 18-65
* Body Mass Index (BMI) ≤ 38 kg/m2

Exclusion Criteria:

* Preexisting neurological deficits or peripheral neuropathy in the distribution of the sciatic or femoral nerves
* Known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
* Baseline line heart rate \< 60 Beats Per Minute (BPM) or baseline systolic blood pressure \< 100 mm Hg
* Medications that reduce heart rate
* Known liver or renal dysfunction or existing diseases affecting these organs
* Local infection
* Contraindication to regional anesthesia
* Chronic pain disorders
* History of use of over 30mg oxycodone or equivalent per day
* Contraindication to a component of multi-modal analgesia
* Allergy to local anesthetics or dexmedetomidine
* History of significant psychiatric conditions that may affect patient assessment
* Pregnancy
* Inability to provide informed consent
* Patient refusal
An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses

This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.


Eligibility Criteria:
Inclusion Criteria:a.

* Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document
* 18 years to 75 years (inclusive)
* Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis
* Willing to adhere to standard postoperative care, including ventilator support if required
* Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilization, with appropriate documentation)
* If female subject is capable of child bearing, must use an acceptable method of birth control (hormonal or IUD) for at least 3 months prior to surgery and continue use throughout the study; maintained normal menstrual pattern for the past three months and has a negative urine pregnancy test prior to day of surgical procedure
* Absence of medical history of psychiatric disorders that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations.

Exclusion Criteria:

* Women of childbearing potential who are pregnant at the time of screening or at the time of surgery
* Subject is on treatment with Corticosteroid maintenance therapy (equivalent to \> 10mg/day of Prednisone), immunosuppressive or chemotherapeutic agents within 14 days prior to enrollment; or likely to receive one of these drugs during study period
* Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of \> 3mg/dL
* Subject has liver failure as evidenced by CP category C
* Immunocompromised subjects (hematological malignancies, history of bone marrow transplantation, splenectomized subjects, genetic disorders such as Lupus, severe combined immunodeficiency, etc.) or a positive HIV test result
* Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment
* Any subject that the investigator determines is not likely to be compliant during the study period
* Subjects determined or suspected to engage in substance abuse, or any subject who is currently, or has in the past 6 months, undergone substance abuse therapy
* The investigator feels that the primary anastomosis is not feasible due to local conditions of the bowel or subject has unstable hemodynamic status requiring stoma
* Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.
Therapeutic Effect of Green Seaweed Against Metabloc Syndrome

Metabolic syndrome is a major concern worldwide and in Pakistan as well. Metabolic syndrome is a pathologic condition which includes abdominal obesity, insulin resistance, hypertension and hyperlipidemia. Seafood consumption has been linked to reduced risk of many health conditions including altered blood profile. Green seaweed is known to have a potential in optimizing the blood profile and so, it is helpful in reducing the risk of metabolic syndrome by playing a role in preventing obesity, hyperglycemia, high blood pressure and altered lipid profile. Green seaweed (Ulva Lactuca) powder will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.

Metabolic syndrome is a major concern worldwide and in Pakistan as well. Metabolic syndrome is a pathologic condition which includes abdominal obesity, insulin resistance, hypertension and hyperlipidemia. Seafood consumption has been linked to reduced risk of many health conditions including altered blood profile. Green seaweed is known to have a potential in optimizing the blood profile and so, it is helpful in reducing the risk of metabolic syndrome by playing a role in preventing obesity, hyperglycemia, high blood pressure and altered lipid profile.

Statement of problem: The number of people with high LDL-cholesterol, body mass index and fasting plasma glucose levels has been increasing. These factors are promoting the risk of metabolic syndrome in Pakistan. 26-38% people in Pakistan are reported to be a patient of metabolic syndrome. Seaweed has shown to be protective against the syndrome in previous studies. The goal of this study is to check the role of green seaweed against metabolic syndrome.

Hypothesis: Green seaweed (Ulva Lactuca) has a potential to manage metabolic syndrome.

Objective: To assess the therapeutic effect of green seaweed (Ulva Lactuca) against metabolic syndrome.

Methodology: Green seaweed powder will be procured from Taokaenoi Food and Marketing Public Co., Ltd. (Thailand). The proximate analysis of the product will be performed and then capsules of powder will be prepared to be consumed by the participants. Total 40 subjects (20 in treatment group and 20 in control group) will be selected and green seaweed powder will be added in their diets (200mg twice a day). After a trial of 40 days, the patients will be assessed. Assessment will include anthropometric measurements, blood pressure, lipid profile analysis and total antioxidant capacity (TAC) which will be monitored before and after the trial and final,ly, the data collected will be analyzed by using SPSS 25 by paired sample t test. P value ≤ 0.05 will be considered significant.

Expected outcomes: Green seaweed (Ulva Lactuca) powder will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25kg/m2
* Dyslipidemia
* Altered blood glucose level
* Age 30-55 ( male and female)

Exclusion Criteria:

* Thyroid disorder
* Liver disease
* Kidney disorder
* Cancer etc
A Post-Intervention Surveillance Study Regarding the Acquisition Rate of ESBL-KP, Ecoli

To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres

This is post-interventional study to follow the acquisition rate of ESBP producing E. coli or K. pneumoniae at the sites involved in a previous interventional study.

Eligibility Criteria:
Inclusion

1. All patients admitted or transferred to ICU/burn unit.
2. Patients of either sex, 18 years of age or older. Exclusion

Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours
A Study of Peldesine (BCX-34) in HIV-Infected Patients

The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood.

Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment.
* Plasma viral load by Roche Amplicor HIV Monitor assay greater than or equal to 2,000 RNA copies/ml and less than or equal to 50,000 RNA copies/ml on at least 2 occasions prior to protocol treatment.
* Normal or non-diagnostic electrocardiogram.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Severe opportunistic infection or any other medical condition which in the opinion of the investigators is a contraindication to enrolling in this trial.
* Severe lactose intolerance.

Concurrent Medication:

Excluded:

Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T).

Prior Medication:

Excluded:

* Ongoing dideoxyinosine or other antiretroviral therapy except ZDV, 3TC, ddC, d4T, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study.
* Participation in a study of any systemic experimental drug within the last 2 months.

Required:

- Ongoing (at least 4 weeks) stable dosage of zidovudine (ZDV) and lamivudine (3TC), ZDV and stavudine (d4T), ZDV and zalcitabine (ddC), d4T and 3TC, ZDV alone, or ddC alone, or in combination with saquinavir, ritonavir, indinavir, or nelfinavir.
Impact of Opioids on Heart Rate During Rapid Sequence Intubation

The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained.

Patients will be divided into 3 parallel groups :

* Group A (placebo +remifentanil)
* Group B (sufentanil + placebo)
* Group C (placebo + placebo)

Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output.

To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR.

The MAR injects the drugs according to the standardized study plan (see below):

* T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1
* 3 minute delay
* Patient receives Etomidate 0.3 mg/kg IV over 10 seconds
* 5 second delay
* The patient receives an IV bolus over 30 seconds of molecule n°2
* 5 second delay
* The patient receives Succinylcholine or Rocuronium IV over 5 seconds
* T2: End of induction, oro-tracheal intubation (= T2)

The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13).

Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 65 years old and any possible ASA OR Patient aged 55 to 65 years old with an ASA ≥ 3,
* Patient undergoing surgery (urgent or scheduled), requiring general anesthesia in rapid sequence, because considered to have a "full stomach", i.e. with: gastro-oesophageal pathology or gastroparesis or a history of bariatric surgery or food intake within two hours for liquids and within six hours for solids,
* Patient informed of the study who gave their written consent before starting the study procedures,
* Patient affiliated to a French social security system.

Exclusion Criteria:

* Patient \< 55 years old,
* Patient on beta blockers,
* Atrial fibrillation or other rhythm or conduction disturbances,
* Patient in hemodynamic failure and/or on catecholamines before the start of GA,
* Patient having a history of stroke, hemorrhagic and/or ischemic and/or transient
* Combination with opioid agonists-antagonists or partial opioid antagonists
* Known hypersensitivity to one of the study drugs or to opioids,
* History of difficult intubation,
* Patient under guardianship, curatorship or deprived of liberty,
* Patient participating in another interventional clinical research,
* Patient under AME (State Medical Aid)