cyrilzakka/clinical-trials huggingface dataset:
Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment.

Background:

Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have indicated that WM can be improved trough computer based training.

Objectives:

The objective of the study is to evaluate if working memory training is effective in improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and progression to dementia will also be investigated.

Patients and Methods:

The proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either training or a placebo version. The intervention is computerized working memory training performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI will be performed before, 6 and 12 months after training.

Relevance:

Currently there is no known treatment available for mild memory impairment/MCI, and few studies on specific cognitive training in MCI-patients have been performed. The proposed study has received funding from a Norwegian Health Region. If computer based training results in positive changes to memory functions in MCI patients this may represent a new, cost-effective treatment. Secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in MCI patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the Peterson diagnostic criteria of MCI:

  1. memory complaints (preferably confirmed by an informant).
  2. memory impairment according to age and education.
  3. preserved general cognitive function.
  4. intact activities of daily living, absence of dementia.

Exclusion Criteria:

* head trauma with post-traumatic loss of conscience for 30 minutes during lifespan.
* loss of senses (blindness, deafness).
* photo-sensitive epilepsy.
* unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia.
* drug and/or alcohol abuse.
Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.

The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.

Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).

Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.

Eligibility Criteria:
Inclusion Criteria:

* Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

* herpetic endotelial disorders
Iron Bioavailability From Cubes

Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem, especially in developing countries. There are several strategies to correct iron deficiency in populations: besides supplementation with tablets, one of the most sustainable and effective strategies on medium term has been iron fortification, the addition of iron to regularly consumed foods. In fortification, the chemical nature of the compound to be added plays an important role: depending on the compound sensory qualities of the fortified foods can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to bouillon, as was recently suggested by in vitro experiments in the laboratory.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 40 years at screening;
* Body weight \<65 kg;
* Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
* With low iron stores (serum ferritin \<15µg/L);
* Reported intense sporting activities ≤10h/w;
* Reported alcohol consumption ≤14 units/w;
* Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
* Willing and able to participate in the study;
* Having given a written informed consent.

Exclusion Criteria:

* Being an employee of Unilever or the Laboratory of Human Nutrition of the ETH Zürich;
* Blood donation or significant blood loss over the past 6 months;
* Reported use of any medically- or self-prescribed diet;
* Use of medication (except oral contraceptives)
* Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
* Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
* Is pregnant or will be planning pregnancy during the study period;
* Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
* Known gastrointestinal or metabolic disorders;
* Moderate or severe anemia defined as Hb \< 90 g/L.
* Participation in another clinical trial during the last 30 days prior to the beginning of the study.
DUAL Antithrombotic Therapy in Patients With AF and ACS

The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

Eligibility Criteria:
Inclusion Criteria:

1. Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome
2. Planned use of antiplatelet agents for at least 12 months
3. Males and Females ≥ 18 years of age
4. Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

1. Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
2. Severe renal insufficiency (serum creatinine \> 2.5 mg/dL or a calculated creatinine clearance \< 30 mL/min
3. Patients with a history of intracranial hemorrhage
4. Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
5. Patients with known ongoing bleeding and patients with known coagulopathies
6. Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists
7. Have a history of stroke or Transient Ischemic Attack (TIA)
8. Have known significant liver disease or liver function test (LFT) abnormalities
9. Have any severe condition that would limit life expectancy to less than 12 months
Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction.

In this study, patients with locally advanced adenocarcinoma of gastroesophageal junction will be enrolled to explore the safety and efficacy of preoperative radiotherapy and chemotherapy combined with Toripalimab (PD-1). Around 45 patients will be recruited in this one-arm cohort. All patients in this cohort will be treated with preoperative radiotherapy and chemotherapy plus PD-1 for two times, then another two times of PD-1 before operation. After surgery, postoperative chemotherapy plus PD-1 will be carried out for four times. This study focuses on the safety of chemoradiotherapy combined with immunotherapy, and whether the TRG grade, LC, DFS have been improved.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age 18-75, male and female.

  2) ECOG score was 0-1.

  3) Diagnosis of adenocarcinoma in the gastroesophageal junction.

  4) Initial treatment of locally advanced patients (cT3-4 or N+, and M0).

  5) The estimated survival time will be more than 12 months.

  6) Adequate organ reserve function.

  7) agree to join the group, willing to cooperate with clinical research, and sign the informed consent.

Exclusion Criteria:

* 1) Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.

  2) Immunosuppressive drugs were used within 4 weeks before admission.

  3) Active infection, acute myocardial infarction in recent 6 months, severe arrhythmia requiring long-term drug intervention, severe stroke, uncontrolled epilepsy or other serious medical complications.

  4) In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).

Patients who meet all of the inclusion criteria and none of the exclusion criteria are randomized 1:1:1 to receive subcutaneous injections of adalimumab at either 160/80 mg at Week 0/2 and 40 mg every other week (eow) starting at Week 4 to Week 50, 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or placebo eow starting at Week 0 to Week 50 under the double-blind condition. At or after Week 8, participants who have inadequate response during the double-blind period can switch to the rescue arm, where participants from the placebo group initially receive adalimumab 160 mg and 80 mg 2 weeks later and those from the adalimumab group receive adalimumab 40 mg initially and 2 weeks later under double-blind conditions. All participants in the rescue arm then receive 40 mg adalimumab eow until Week 50. Participants who complete the 52-week double-blind period receive open-label adalimumab 40 mg eow starting at Week 52 and continuing until the end of the study. Participants who have an inadequate response or disease flare can dose escalate to 80 mg eow at or after Week 60. Participants who dose escalate to 80 mg eow and continue to have an inadequate response or disease flare are withdrawn from the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
* Active ulcerative colitis with a Mayo Score of 6-12 points at Baseline and endoscopy subscore of 2-3 during the Screening Period, despite concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):
* Stable oral corticosteroid dose (prednisolone dose of ≥ 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisolone of 5 to less than 20 mg/day) for at least 40 days prior to Baseline. And/or
* At least a consecutive 90-day course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline, with a dose of azathioprine ≥ 50 mg/day or 6-MP ≥ 30 mg/day, or a dose that was the highest tolerated by the patient.

Exclusion Criteria:

* History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or was planning bowel surgery.
* Patients with disease limited to the rectum.
* Indeterminate colitis and/or Crohn's disease.
* Received any biological therapy (including infliximab) in the past.
* History of tuberculosis or malignancy.
* Pregnant women.
* Patients with positive C. difficile stool assay at Screening.
* Current diagnosis of fulminant colitis and/or toxic megacolon.
Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study

The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.

A two-year cluster-randomised prospective study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling (5-6 years of age) in schools in the city of Granollers. The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test.

Eligibility Criteria:
Inclusion Criteria:

* Children born in 2000 who attended schools in Granollers City

Exclusion Criteria:

* Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued
Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors

Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. Actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487 once every six weeks for three cycles. An amino acid infusion will be administered along with each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival will be assessed every six months.


Eligibility Criteria:
Inclusion Criteria:

1. Life expectancy \> 6 months.
2. Subjects must have distant metastases.
3. Subjects must be able to discontinue Sandostatin LAR treatment for at least 1 month prior to Day 1/Cycle 1; last dose of Sandostatin LAR must be 60 days or more prior to the first OctreoTher™ dose. For subcutaneous Sandostatin discontinuation should be 12 hours. Subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval.
4. Upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the SWOG response criteria.
5. Subjects must state or agree with the statement that "I have symptoms from my cancer that bother me." Subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician.

Exclusion Criteria:

1. Chemotherapy, biologic therapy or other investigational therapy within 4 weeks of Day 1.
2. Surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of Day 1.
3. Subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start.
4. Subjects who received high dose OctreoScan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. MIBG) for treatment of metastatic carcinoid.
A Pilot Study of Acupoint Injection for Primary Dysmenorrhea

Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K into an acupuncture point has been used as treatment for dysmenorrhea at the Obstetrics \& Gynecology Hospital in Shanghai, China since at least 1985. More research is needed on the effectiveness of this treatment and its acceptability to different women. The objective of this study is to examine the feasibility and effectiveness of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the United States. Twenty participants will be randomized to receive either 1) vitamin K1 injection into an acupuncture point at the start of their menstrual cycle followed by a saline injection in a non-acupuncture point two months later or 2) saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months later. The primary outcome measure will be change in pain intensity measured before and after each treatment. Data on other menstrual symptoms will be collected by telephone or a web-based survey. Three additional participants will be recruited to receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and after injection to determine absorption of vitamin K1. The aims of the study are to collect preliminary data on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S. women; and test the blood absorption of vitamin K1 following acupoint injection treatment.

The investigators hypothesize that:

1. Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.
2. Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection does.
3. The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.
4. Vitamin K1 is absorbed into the blood thru acupoint injection.


Eligibility Criteria:
Inclusion Criteria:

* Young women age 18-25
* Severe primary dysmenorrhea (defined as severe, recurrent painful periods for 6 months or more, that are not due to any other diagnosis, and that have not been relieved, or have been only partially relieved by any other treatment)
* Nulliparous
* English speaking
* No acute or chronic conditions diagnosed or suspected
* Not on hormonal contraceptives
* Regular menstrual cycles for at least 6 months
* Has a working phone or pager

Exclusion Criteria:

* Use of hormonal contraceptives, or intra-uterine device
* Pregnancy
* Dysmenorrhea due to any other suspected or recognized causes
* History of abdominal surgery
* Participation in other concomitant therapy for acute or chronic pain
* Current treatment with anti-coagulant drugs for any reason
* Previous treatment with vitamin K acupoint injection
* Plans to be out of area during next 5 months
* Under age 18
* Known allergy to Vitamin K.
Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial

Background: Several risk score models are now available to assist clinicians estimate outcomes after an acute ischemic stroke. Limited information is available on the predictive value of these scores compared to real outcomes and clinical judgment.

Objectives: To compare clinician judgment with the use of a validated stroke risk score (iScore) and patients' outcomes.

A convenience sample of 111 practicing clinicians (general and vascular neurologists, internists, and ER physicians) predicted the outcomes of 5 stroke patients based on case summaries. Cases were randomly selected as being representative of the 10 most common clinical scenarios (n=1,415) from a pool of over 12,000 patients admitted to stroke centers in Ontario, Canada. Stroke cases had known clinical presentation, comorbidities, stroke severity, and outcomes.

All participants are active practicing physicians caring for patients with acute stroke. Conditions were standardized to mimic clinical practice.

Main outcomes of interest included 30-day mortality and death or disability at discharge.

Secondary outcome: death or institutionalization at discharge

Eligibility Criteria:
Inclusion Criteria:

* Practicing and active physicians managing patients with stroke

Exclusion Criteria:

* retired physicians
* physicians not exposed to care for stroke patients