cyrilzakka/clinical-trials huggingface dataset:
DEMAND - Multifactorial Study to Reduce Dementia in People With Type 2 Diabetes

In the DEMAND pilot study, we will recruit and randomize 80 participants at two study sites (Umeå and Uppsala) for a one-year intervention. The primary objectives are to study the inclusion rate, the adherence rate, and the acceptability of the intervention. The secondary objectives are to examine the effect of the intervention on intermediate outcomes, including metabolic control (i.e., blood glucose and lipids), body weight, blood pressure, physical fitness, and cognitive function. Third, the investigators will perform focus group interviews to explore the participants views on the intervention to assess the acceptability. The interventions include (a) Mediterranean diet (b) an individualized physical training program and (c) pharmacological treatment for type 2 diabetes (T2D) aimed to achieve individualized optimal goals, according to national guidelines, taking into account the risk of hypoglycaemia. This multi-component intervention is more comprehensive than usual care, and it specifically focuses on vascular domains.

To be inserted.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes diagnosed in the last year
* age \>=65 years
* signed consent form
* Mild cognitive impairment

Exclusion Criteria:

* diagnosis type 1 diabetes
* major neurocognitive degeneration
* serious illness with live expectancy less than 3 years
* drug- or alcohol-abuse or other neurological / psychiatric illness which affects the outcome
* depressive syndrome
* predicted inability to conduct the study because of drug abuse, serious illness, language issues
* documented episodes of hypoglycemia where help of a third part was needed
* Allergy to fish or nuts
* Angina pectoris
* Heart failure (NYHA 3-4)
Botanical Supplement Muscle Function and Lean Body Mass

Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength, muscle function, and lean body mass

Participants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. All participants must be healthy recreationally active males between the ages of 18 and 35 years.

Procedures (methods):

Acute phase: Participants will complete three testing visits as part of as part of a cross-over design, during which strength and muscle function will be assessed prior to and following consumption of a supplement. The experimental supplement is a blend of the botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).

Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and metabolic panel, subjective surveys, and strength will be measured prior to and following an 8-week supervised resistance training program, in conjunction with daily supplementation of FULL, HALF, or PLA.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally Active (1- 4 hours of exercise/ sports participation per week and no more than 1 hour of resistance training exercise per week) for the previous 12 weeks.
* BMI \< 30 kg/m²
* Have not smoked in the past year.
* Participant has provided written and dated informed consent to participate in the study
* Participant is willing and able to comply with the protocol
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire
* Participant agrees to abstain from caffeine, tobacco, alcohol, and exercise within 24 hours of testing visits

Exclusion Criteria:

* Participant has not used any dietary supplements within 12 weeks prior to enrollment and will not begin supplementation during the study. Potential supplements include but are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione, DHEA, Whey protein, or a pre-workout supplement.
* Participant has gained or lost 10 lbs in the previous 2 months.
* Participant is currently enrolled in a separate clinical trial.
* Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet.
* Participant has a known allergy or sensitivity to the placebo (maltodextrin) or active ingredients (Rhodiola \& Rhaptonicum)
* Participant consumes more than 8 cups (1 cup = 6 oz) of coffee per day on a regular basis
* Participant consumes more than 3 alcoholic drinks per day.
* Participant uses recreational drugs daily.
* Previous physical symptoms causing a physician to recommend you to refrain from exercise.
AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* female (non-childbearing potential)
* Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer

The purpose of this study is to determine whether ctDNA could help to evaluate whether to use drug adjuvant therapy after SBRT in patients with early lung cancer.

This is a prospective study. The purpose of this study is to determine whether MRD could help to evaluate whether to use drug adjuvant therapy after SBRT in patients with early lung cancer. The ctDNA was detected for early stage lung cancer patients before and after SBRT. If a high level of ctDNA was detected after SBRT, the patients were randomly divided into observation group and adjuvant treatment group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients pathologically diagnosed as non-small cell lung cancer, and was early stage（AJCC 8th）;
2. Patients aged between 18 -80 years; with expected survival time\>3 months.
3. Patients with normal organ function within 30 days prior to treatment, the following criteria are met:

   1. blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;

Exclusion Criteria:

1. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
2. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.) or intravenous medication;
3. Patients with any other severe and/or uncontrolled disease;
4. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
5. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

In this study, patients are randomized into treatment group or delayed treatment group.

\* Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.

1. Experimental: Treatment group (n=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.

   \* oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation.
2. No Intervention: delayed treatment group (n=82) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 19 - 70
2. patients receiving hematopoietic stem cell transplantation
3. HBV serologic test: HBsAg (-), anti-HBc IgG (+)
4. ECOG performence: 0-2
5. patients with informed consent

Exclusion Criteria:

1. HBV DNA (+, ≥10 IU/mL) at the time of screening
2. Receiving hematopoietic stem cell transplantation from donor with HBsAg+
3. Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
4. HIV (+)
5. Previous antiviral therapy history for chronic hepatitis B
6. Other concomitant malignancy
7. combined autoimmune disease (rheumatic arthritis, SLE etc)
8. CTP class B, C
9. Decompensated complications (ascites, hepatic encephalopathy etc.)
10. active tuberculosis
Impact of Cataract Surgery on Keratoplasty Graft Survival

The follow up time after keratoplasty now routinely exceeds multiple decades. It is common for keratoplasty patients to also undergo cataract surgery at a later date in their lives.

Keratoplasties and cataract surgery both result in local inflammation. This may influence the density of endothelial cells, and on average there is a loss of 10% in endothelial cells within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is required to maintain graft transparency. It may be therefore difficult to strike a balance between loss of visual acuity due to the cataract of to the loss of graft transparency over the long term.

The investigators aim to compare graft survival in patients with clear crystalline lens with and without cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing keratoplasty
* Between january 1983 and december 2012
* Age 40 and older at the time of surgery

Exclusion Criteria:

* Cataract surgery prior to the keratoplasty
* Systemic inflammatory disease
* Previous history of uveitis
Spinal Anesthesia Magnesium Infusion

The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate during spinal anesthesia on duration of spinal block and postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II, aged between 18 and 65 female patients undergoing abdominal hysterectomy

Exclusion Criteria:

* severe cardiovascular, renal and hepatic dysfunction, neuromuscular diseases, using calcium channel blockers, and inappropriate for spinal anesthesia.
Sitagliptin in Type I Diabetic Patients

The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood glucose concentrations) and indices of oxidation stress in the plasma of these subjects.

The hypothesis is that Sitagliptin will improve overall blood glucose, fasting blood glucose, and glycemic excursions in patients with Type I Diabetes. In addition, sitagliptin will likely suppress indices of oxidative stress in patients. The study will investigate proposed mechanisms of improved glucose concentrations, including enhanced effect of endogenous GLP-1 and suppression of glucagon.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult, aged 18 to 70 years
2. Type 1 Diabetes Mellitus for 6 months or more, as established by medical history
3. Current treatment with multiple injections of insulin (at least 4) or CSII (continuous subcutaneous insulin infusion or insulin pump) therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month
4. HbA1c ≤ 8.5%
5. Subjects should routinely practice at least 2-4 blood glucose measurements per day
6. BMI ≤ 35 kg/m2
7. Subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for 3 days at the start and 3 days at the end of the study
8. Subjects must be willing to complete study visits per study protocol
9. Able to speak, read, and write English

Exclusion Criteria:

1. Type 1 Diabetes Mellitus for less than 6 months
2. Coronary Event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery, or coronary angioplasty) in the previous 4 weeks
3. Any other life-threatening, non-cardiac disease
4. Pregnant or intends to become pregnant during the course of the study
5. Severe unexplained hypoglycemia that required emergency treatment over the past 3 months
6. History of hemoglobinopathies
7. Post-renal transplantation, currently undergoing dialysis, creatinine of \>1.5mg/dl or a calculated creatinine clearance of \<50 mL/min.
8. Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin
9. Subjects who have an allergy to medication being used
10. Current participation in another study protocol
11. History of autonomic neuropathy or gastroparesis
Benefit of SeptiFast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis

A SpetiFast multiplex PCR kit has recently been placed on the market witch can evidence the DNA of 90% of micro-organisms (bacteria and fungus) implicated in sepsis. However, the clinical impact of being able to detect the DNA of these various agents is unknown. We propose to assess the benefit to patient care of the SeptiFast multiples PCR by answering three questions : 1/in patients with septic immunosuppression, does this kit evidence etiologic agents not revealed by classical methods? 2/Does the use of PCR results permit different diagnostic hypotheses to be considered? 3/Does having the SeptiFast results entail changes to the therapeutic plan?

This study has double purpose :

1. To compare the results obtained from the SeptiFast system with the results from classical microbiological sampling, in particular hemoculture, for immunosuppressed patients presenting sepsis.
2. To perform a blind assessment of the benefit of septiFast care of these patients.

Eligibility Criteria:
Inclusion Criteria:

All patients with onco-hematologic or cancerous pathology, or hematologic disease with chemotherapy and/or radiotherapy and/or some other immunosuppressant treatment in progress presenting an infection requiring hospitalisation and meeting the following criteria:

* Sepsis (at least one of the following signs):

  * Fever \> 38.2°C or hypothermia \< 36°C
  * FO120 min
  * PA\<120 mmHg (or 50 mmHg reduction in base numbers)
  * Respiratory F \> 30/min
  * Confusion
  * Hyperleucocytosis (\>12 G/l) or leucopenia (\<4 G/l)
  * C-Reactive protein \> 40
* With or without organ dysfunction as defined by :

  * Hypoxia (PaO2/FiO2\<300mmHg)
  * Oliguria (urine deficiency\<0.5 ml/kg/h in probed patient)
  * Creatinine \> 200umol/l
  * INR\>1.5 or TCA\>2 X control in the absence of anticoagulant treatment
  * Platelets \< 100 G/l
  * Bilirubin \> 35 umol/l
  * Lactatemia \> 2 mmol/l
  * Arterial hypotension (PAS\<90mmHg, or PAM\<70mmHg or reduction of more than 40 mmHG if known hypertension)

Exclusion Criteria:

* Minor patient
* Pregnancy
* A patient cannot be included again within 15 days of his/her preceding inclusion
Impact of a Community-Based Primary Health Care Project on the Inappropriate Use of Emergency Medical System in Bergamo

The goal of this study is to reduce the inappropriate use of the Emergency Medical System in Bergamo. The main question it aims to answer is: can a Community-Based Primary Health Care Project impact on the use of the Emergency Medical System in Bergamo? Monthly changes in urgent calls to the Emergency Medical System will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Urgent Emergency Medical System call

Exclusion Criteria:

* Non-urgent Emergency Medical System call
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.

Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Recent HIV infection.
* No prior antiretroviral therapy.
* No acute opportunistic infection at study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Intractable diarrhea.
* Bilateral peripheral neuropathy.
* Any other condition that would preclude study therapy.

Concurrent Medication:

Excluded:

* Myelosuppressive, neurotoxic, or hepatotoxic drugs.

Patients with the following prior condition are excluded:

History of bilateral peripheral neuropathy.

Prior Medication:

Excluded:

* Prior antiretroviral therapy.
* Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.
A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

An individual's genetic make-up is known to determine their response to antipsychotic medication. Genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome.

The study is a naturalistic study of routinely prescribed antipsychotics using outcome measures undertaken as part of the routine clinical care of the cohort. These clinical data are linked with genetic information obtained from DNA and RNA from blood samples undertaken as part of the study.

No alteration is made to the subjects treatment regime or medication.

The study is a two stage investigation:

* The first stage involves the collection of a databank of clinical information and blood samples for DNA and RNA extraction from patients treated with antipsychotic medication.
* The second stage is a molecular genetic investigation of treatment-related genetic factors that may contribute to response prediction and predisposition to side effects.

From these genetic studies pharmacogenetic prediction tests will be validated and/or developed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained
* DSM-IV diagnosis must be one of:

  * schizophrenia
  * schizophreniform
  * schizoaffective
  * delusional disorder
  * brief reactive psychosis
  * psychosis not otherwise specified
* Ethnic origin of both parents must be known
* A minimum of 6 weeks continuous treatment completed with the given antipsychotic, prescribed at least at minimum recommended doses
* Prospectively collected outcome data available (pre-treatment and after at least 6 weeks on treatment)

Exclusion criteria:

* Significant psychiatric or medical co-morbidity including history of:

  * head injury with loss of consciousness
  * seizures
  * neurological disorder
  * mental retardation (DSM-IV)
  * drug or alcohol dependence (DSM-IV)
  * serious physical illness e.g. malignancy, hepatic/renal insufficiency
* Concomitant psychotropic medication that may influence ratings
* Concomitant antipsychotics, antidepressants or mood stabilisers prescribed for \>2 weeks during the antipsychotic treatment period rated
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)

The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein.

To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Primary GSV incompetence, defined as reflux \> 0.5 seconds on Duplex ultrasound in a single limb (Note the contralateral limb can have varicosities or SVI if intervention is not required within 3 months i.e. asymptomatic)
* Failed conservative therapy (compression, diet, exercise, leg elevation)
* CEAP Clinical Condition Classification C2 - C6
* Vein diameter 5-10mm, inclusive
* GSV treatable length \> 10cm
* Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4)
* Able to comprehend and sign an informed consent document and complete written study questionnaires
* Willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure)
* Willingness to comply with post-treatment compression protocol

Exclusion Criteria:

* Allergy to polidocanol, xylocaine, or epinephrine
* Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder
* Post thrombotic deep vein disease above the calf veins
* Pregnancy or lactating (within 30 days of randomization)
* Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) \< 0.8
* Previous treatment to targeted incompetent GSV or previous superficial thrombophlebitis in targeted GSV
* Previous venous intervention in affected limb in past 3 months
* Local aneurysmal GSV segments
* Inability to walk unaided
* Inability to wear post-procedure compression bandaging and stockings
* Patients with clinically significant reflux of the small saphenous vein (SSV) or anterior accessory saphenous vein (AASV)
* In the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment
* In the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment
* Patient on therapeutic anticoagulants
* Active malignancy
* Life expectancy \< 2 years
* Documented COVID-19 infection currently or within 2 months prior to randomization
* Enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment