cyrilzakka/clinical-trials huggingface dataset:
Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment

Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.

The purpose of this study is to evaluate the impact of reasoning training on individuals with complaints of changes in memory or thinking in the absence of dementia, when combined with transcranial current stimulation (tDCS). The reasoning training being studied is a strategy based program where individuals are taught strategies designed to engage the frontal lobes. Participants will randomly be placed into one of two groups (1) reasoning training following transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory complaints or lower baseline performance on memory measures. The primary hypothesis is that individuals receiving tDCS prior to brain training will have a stronger response to brain training than those in the sham tDCS group. Response to training will be measured by improved cognitive function and neural changes as measured by neuropsychological testing, MRI, and EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow, structure and function, and to measure changes in brain energy metabolism and electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program will be conducted in small groups at the Center for BrainHealth.

Eligibility Criteria:
Inclusion Criteria:

* Safely have an MRI
* Cognitive complaints in the absence of dementia
* Participate in tasks involving motor abilities such as use of at least one arm and hand
* Read, speak, and comprehend English
* 50-80 years of age
* Comprehend simple instructions, perform tasks, and take part in intervention

Exclusion Criteria:

* Not proficient in reading, comprehending, or speaking English
* Individuals who have any significant health, neurological, or psychiatric illness, or history of substance abuse
* Individuals with any MR contraindications (i.e., non-removable metal within/on the body)
* Individuals taking medications which are contraindicatory for the tDCS procedure
* Individuals who are left-handed
* Not proficient in reading,comprehending, and speaking English
* Females who are not post-menopausal
* Pre-existing cerebral palsy, autism, epilepsy, schizophrenia, pervasive developmental disorder, thyroid diseases, diabetes, claustrophobia, non-correctable vision problems, major depression, psychosis, active behavioral disorder, or uncontrolled epilepsy.
* Women who are pregnant
Medically Assisted Procreation and Choice of the Embryo: How Far Would French People Like to go

In today's context of bioethics laws revision concerning Medically Assisted Procreation, the investigators focus on the opinion of couples resorting to In Vitro Fertilization on a fundamental, much debated issue ; the choice of the embryo.

French lawmakers fear the investigators might be drifting towards embryo selection procedures, but no study allows us to state this is what patients request. This study aims at determining, among the population of patients who resort to Medically Assisted Procreation in France, the ratio of patients who are willing to select the embryo due to its genetic characteristics.


Eligibility Criteria:
Inclusion criteria:

- Male and female IVF patients in the MAP

Exclusion criteria:

- Patient not fluent in French
Iron-Deficiency Anemia in Infants in Two Weekly Programs

This work aims at establishing the effectiveness of weekly doses of ferrous sulfate administered by mothers compared with weekly supplements administered directly by healthcare professionals, to reducing anemia prevalence.

Some studies have shown satisfactory results in reducing the prevalence of iron deficiency using weekly doses of ferrous sulfate, thereby avoiding these side effects. This deficiency is the most common nutritional disorder during childhood and does not only affect individuals from developing countries but also those from industrialized nations.

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency. In this age range the prevalence of anemia is at least 20%. However, studies have shown a low rate of compliance by mothers during the recommended period, which may be caused by a lack of care or, more probably, due to the side effects caused by long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea, staining of teeth and abdominal pain.

This specific study is randomized clinical trial study, achieved in a government healthcare clinic in Sao Jose do Rio Preto, Sao Paulo, Brazil. This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron, either administered in the government healthcare clinic or at the children's home.

The study showed treatment compliance in both groups. Prevalence of anemia for all children was 75% at the beginning of supplementation and 46.3% at the end of the period (p \< 0.0005). Reduction rate for anemic children was 38.3%. Average increases in hemoglobin concentration levels were 0.75 g/dL and 0.65 g/dL, respectively, for home interventions and healthcare clinic administration (p \< 0.00005).

Eligibility Criteria:
Inclusion Criteria:

* Ages ranging between six and 24 months old

Exclusion Criteria:

* Positive results for the Guthrie test
* Use of ferrous sulfate supplements
* Infections process at the time of first consultation
Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI

The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \>18 years of age.
2. Symptoms of STEMI for at least 30 min within previous 12 hours AND

   * ST-segment elevation in at least 2 contiguous leads or new Left Branch Bundle Block (LBBB), OR existing LBBB with positive troponin
   * Residual high grade stenosis and associated abnormalities in regional wall motion.
3. Planned primary PCI in native coronary vessel.

Exclusion Criteria:

1. Confirmed pregnancy
2. Fibrinolytic therapy - Any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours
3. Culprit lesion within SVG or bypass conduit
4. Dependency on renal dialysis
5. Administration of LMWH within 8 hours prior to PCI
6. Administration of abciximab within 7 days prior to PCI
7. Administration of eptifibatide or tirofiban within 12 hours prior to PCI
8. Warfarin MUST BE discontinued prior to procedure, and the INR must be ⎕1.5, or the PT\<15,
9. Heparin. If heparin is administered in the ER as long as it is discontinued at least 30 minutes prior to procedure, OR ACT \<250, a patient may be enrolled. No clotting measurements are required if patient received heparin ⎕30 minutes prior to the initiation of bivalirudin.
10. Allergy to heparin or bivalirudin, or known sensitivity to any component of the products
11. Allergy to aspirin, clopidogrel, or abciximab
12. Contraindication to abciximab
13. Angiomax within 24 hours prior to study drug administration
14. Neurosurgery with three months
15. Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (BP \>180/110 mm Hg)
16. Cardiogenic shock (SBP \<80 for \>30 min or a need for intravenous pressors)
17. Stroke within three months
18. Any hemorrhagic diathesis
19. Life expectancy \<1 year
20. Participation in another clinical trial
Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

The purpose of this registry is to address optimal platelet inhibition during the early management of MI patients prior to coronary angiography or CABG.

The CAMEO registry is a multicenter observational registry that will collect information on 4,000 patients with NSTEMI or STEMI treated with cangrelor or an oral P2Y12 inhibitor into the registry.

Phase 1: Each site will abstract data from the medical record for the first 50 patients meeting the inclusion and exclusion criteria treated at the hospital within 4 months prior to study initiation or during the study period.

Phase 2: After Phase 1, all cangrelor-treated patients meeting the inclusion and exclusion criteria treated at the hospital no later than 1 month from the discharge date will be entered into the registry, and we will begin sampling non-cangrelor patients in a 2:1 cangrelor: non-cangrelor ratio.

Eligibility Criteria:
Phase 1 Inclusion Criteria:

For the first 50 patients at each participating site, consecutive patients are entered in the registry if they are ≥ 18 years of age, underwent coronary angiography for a STEMI or NSTEMI, and received cangrelor at any time during the hospitalization or an oral P2Y12 inhibitor during his/her first 48 hours of the hospitalization for MI.

Phase 2 Inclusion Criteria:

Subsequent patients are eligible to be entered in the registry if they are ≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI and meet at least 1 of the following criteria:

1. The patient was hospitalized for STEMI and met one of the following inclusion criteria:

   * The patient received cangrelor at any time during his/her hospitalization for MI.
   * The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:
   * The patient received a P2Y12 inhibitor and an opiate/opioid within 24 hours prior to or during primary PCI for STEMI presentation.

   OR
   * The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG.
2. The patient was hospitalized for NSTEMI and met one of the following inclusion criteria:

   * The patient received cangrelor during his/her hospitalization for MI.
   * The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:
   * The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG. OR
   * Any 2 of the following criteria without prior PCI or CABG: age\> 60 years, male sex, diabetes, EF \<40% prior heart failure

Exclusion Criteria: If the patient does not meet the inclusion criteria for either Phase.
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.

We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be randomized by means of closed numbered envelopes to operation groups:

1. Two parallel screws (Olmed).
2. Hemiarthroplasty with Charnley/ Hastings prosthesis. A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* Age 60 or above
* Able to walk (any aids allowed)

Exclusion Criteria:

* Anesthesiologically unfit for arthroplasty surgery
* Previous symptomatic hip pathology (i.e. arthritis)
* Pathological fracture
* Delay of more than 96 hours from injury to treatment
* Not living in hospital area
The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists

Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder causing disability with an increasing burden to the patient, his family and to the health services. Treatment of COPD patients depends on the stage of the disease. COPD responds poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis. A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being elucidated, particularly as the molecular basis for the anti-inflammatory effects of corticosteroids is better understood (12). An important mechanism of corticosteroid resistance in COPD, which is also linked to amplification of the inflammatory process, is a reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major changes are at the level of small airways. We will examine the effect of addition of theophylline product to stable COPD patients treated with combined inhaler of inhaled corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up

Exclusion Criteria:

* Heart failure Malignancy Immune suppressed
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study

The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with PTSD and problems with anger after returning from military service in Afghanistan (Operation Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The goal is to determine if a present-centered psychotherapy that teaches skills for emotion regulation and does not require re-telling of traumatic memories is as efficacious as the trauma memory-focused PE psychotherapy.

The study is based on a theoretical and clinical model that involves a series of associated risks that are set in motion by exposure to military-related traumatic stressors in Iraq or Afghanistan. Trauma exposure places personnel at risk for PTSD, which in turn increases their risk of problems with anger and hostility, emotion dysregulation and experiential avoidance, and ultimately with alcohol abuse and aggression. The two types of treatments being compared, TARGET (Trauma Affect Regulation: Guide for Education and Therapy) and PE (Prolonged Exposure), are both designed to directly reduce PTSD severity by reducing emotion dysregulation (TARGET) and experiential avoidance (PE), and therefore are hypothesized to reduce the risk and severity of alcohol abuse and aggression- and thereby to reduce associated legal and societal costs.

Eligibility Criteria:
Inclusion Criteria:

* be a returning OEF/OIF military personnel or veteran
* have experienced PTSD for the past month
* have experienced anger and at least one act of aggression in the last month
* be mentally able to provide a valid consent

Exclusion Criteria:

* currently be danger of suicide
* currently abusing alcohol or other substances
* been in an inpatient psychiatric or addiction treatment program in the past month
Effects of a Face Mask on Oxygenation During Exercise

There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.

There is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. The purpose of the study is to determine the effect of wearing two different types of commonly-worn face masks (diposable and cloth) during exercise on blood and muscle oxygenation. Twelve participants who are experienced with cycling will take part in this randomized cross-over study that will assess blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during a progressive step exercise test to exhaustion. The conditions include no mask, a disposable mask, and a cloth mask. Outcome variables include exercise duration, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.

Eligibility Criteria:
Inclusion Criteria:

* Experienced with cycling

Exclusion Criteria:

* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")
Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer

Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.

Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.

Eligibility Criteria:
Inclusion Criteria:

* Histologically and CT confirmed resectable advanced gastric cancer
* No prior treatment
* No metastases

Exclusion Criteria:

* Having allergic reaction
* Pregnant
* R0 resection is not achieved by gastrectomy with D2 lymphadenectomy according to Japanese gastric cancer treatment guidelines 2010 (ver. 3)
Endolymphatic Sac Tumors in a Population of Patients With Von Hippel-Lindau Disease:The Natural History and Pathobiology, and a Prospective Non-Randomized Clinical Trial of Hearing Preservation Surgery in Patients With Early Stage Endolymphatic Sac Tumors

The von Hippel Lindau (VHL) gene has recently been identified as the genetic defect resulting in a syndrome of multiple neoplasias. Patients with VHL disease develop retinal angiomata, renal cysts and/or carcinomas, CNS hemangioblastomas as well as pancreatic cysts and pheochromocytomas. Investigators have shown the gene to be a tumor suppressor type proto-oncogene located at chromosomal locus 3p26. The gene includes three exons whose gene product targets a cellular transcription factor Elongin SIII. Binding of the VHL proteins to two subunits of this elongation factor inhibits transcription and may play a crucial role in the clinical development of the von Hippel Lindau phenotype.

The von Hippel Lindau (VHL) gene has recently been identified as the genetic defect resulting in a syndrome of multiple neoplasias. Patients with VHL disease develop retinal angiomata, renal cysts and/or carcinomas, CNS hemangioblastomas as well as pancreatic cysts and pheochromocytomas. Investigators have shown the gene to be a tumor suppressor type proto-oncogene located at chromosomal locus 3p26. The gene includes three exons whose gene product targets a cellular transcription factor Elongin SIII. Binding of the VHL proteins to two subunits of this elongation factor inhibits transcription and may play a crucial role in the clinical development of the von Hippel Lindau phenotype.

Eligibility Criteria:
Patients meeting the diagnostic criteria for von Hippel-Lindau (VHL) disease.

No persons who are pregnant or lactating are eligible for the surgical arm of this protocol until the pregnancy and/or nursing period has reached completion.

No patients with disorders associated with multiple abnormalities of the middle ear and inner ear. Specific laboratory abnormalities such as anti-HIV-1, FTA-Abs, serum ANA, and ANCA have been associated with AIDS, Syphilis, Systemic Lupus Erythematosus, and Wegener's Granulomatosis, respectively.

No patients currently undergoing chemotherapeutic regimen with ototoxic agents (e.g., cisplatin). Other agents will be reviewed on a case-by-case basis for their potential to cause ototoxicity and thereby interfere with audiologic data interpretation.

Patients with an ELST in an only hearing ear will be excluded from the protocol for surgical treatment of ELST's (except in cases where other medical indications necessitate intervention for the welfare of the patient).

Patients with only unilateral vestibular function on the side affected by the ELST, as documented by caloric ENG testing, will be excluded from the surgical treatment group in most cases.

No patients with the inability to understand all of the requirements of the study or inability to give informed consent and/or comply with all aspects of the evaluation.
Post-marketing Study Assessing the Long-Term Safety of Abatacept

The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
* Patient is aged 18 years or older on the index date
* Patient was enrolled in the database for at least 180 days before the index date
* Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment
Women With Asymptomatic Endometrial Hyperplasia

The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Exclusion Criteria:

* postmenopausal bleeding