cyrilzakka/clinical-trials huggingface dataset:
Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
* A diagnosis of probable AD \[according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria\] of moderate severity \[Mini-Mental State Examination score between 15 and 20, inclusive\]
* On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

Exclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
* Previous imaging results not consistent with the diagnosis of AD
* Modified Hachinski Ischemia Score greater than 4
* Evidence of other neurologic disorders
* Inability to participate in MRI testing
* No clinically significant systemic disease
* A known or suspected history of alcohol or drug abuse in the past 10 years
* Taking excluded medication
* Previous treatment with commercial memantine
Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project

Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or over
* diagnosis of hypertension with most recent blood pressure \>140/90 mmHg or blood pressure \>130/80 mmHg if patients also had diabetes mellitus
* treated with at least one anti-hypertensive medication
* continuous active patient (at least one visit) of the clinic for at least the past 6 months (1/1/2010-6/31/2010)
* English speaking
* Able to complete questionnaires in English.

Exclusion Criteria:

-do not meet provisions of the clinical collaborative agreement protocol in the judgment of the patient's physician or the clinical pharmacist
A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina

The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
* Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra).
* Have received at least one dose of atezolizumab as per local label and clinical practice.

Exclusion Criteria:

* Contraindicated atezolizumab therapy
COVID-19 Contact Study by Antigen Detection Test

Stopping the SARS-CoV2 spread is essential to control the pandemic cause by this virus.

A great effort is being made to carry out surveillance, case detection and contact control protocols in order to detect and isolate those contagious subjects.

Since both symptomatic and asymptomatic subjects can be contagious, a surveillance system based on the presence of symptoms is not enough, requiring to perform diagnostic tests in a large number of subjects, such as asymptomatic contacts or high-prevalence populations, and repeatedly. Moreover, the speed in obtaining results is crucial in order not to delay the isolations of positive subjects.

The polymerase chain reaction (PCR) is an expensive test which requires specialized equipment and personnel with a delay in results of 24-48 hours. In addition, its high sensitivity can mean that subjects without infective capacity have a positive result.

In contrast, antigen detection tests (ADTs) are cheap and easy to perform, having a result in few minutes. They have shown high sensitivity and specificity in symptomatic subjects, specially in the first week of symptoms when the viral load is high. This could be very useful for the study of asymptomatic contacts to detect those with potential contagiousness quick, easily and cheaply. However, there is no evidence to support the use of ADTs in this group of subjects.

For this reason, the investigators propose to carry out a study to compare the diagnostic efficacy of ADTs versus PCR in the group of subjects considered to be close contacts of SARS-Cov2 positive patients in the health area of Cáceres.


Eligibility Criteria:
Inclusion Criteria:

* Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health of Spain at the time of inclusion.

Exclusion Criteria:

* Subjects who do not obtain their informed consent for the study.
* Symptomatic subject at the time of inclusion.
Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography

CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. There are several shortcomings of commonly used isotonic mannitol as an oral contrast agent, such as incident adverse reactions and gases in the gut. However, polyethylene glycol can avoid these drawbacks with a good performance in some pilot experiments.


Eligibility Criteria:
Inclusion Criteria:

* patients aged from 18 to 75
* patients undergoing CT enterography

Exclusion Criteria:

* patients with a history of colorectal surgery
* patients with severe colonic stricture or obstructing tumor
* patients with significant gastroparesis or gastric outlet obstruction
* patients with known or suspected bowel obstruction or perforation
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with severe inflammatory bowel disease or megacolon
* patients with documented allergy to intravascular contrast agent
* patients with dehydration
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients with dysphagia
* patients with severe constipation.
* patients unable to give informed consent.
Peer-Based Skills Training to Enhance Teen Weight Loss

To evaluate the efficacy of peer-based skills training to enhance weight control and improve psychosocial functioning in overweight adolescents.

BACKGROUND:

The prevalence of obesity in children, adolescents, and adults has increased significantly over the last two decades. Adolescents who are obese are at great risk for remaining obese into adulthood. Given the difficulty of treating adult obesity, intervening with adolescents before they reach adulthood is critical. Decreasing obesity during adolescence provides an opportunity to prevent the continuance of pediatric onset obesity into adulthood. There are well-established weight control interventions for children between 8 and 12 years of age. However, treatment findings with overweight adolescents are not as robust and are difficult to replicate. One potential limitation of existing weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment.

The study was in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

A total of 119 adolescents between the ages of 13 and 16 years and between 20 and 80% overweight were randomized to one of three treatment conditions: (1) cognitive-behavioral treatment (CBT); (2) cognitive-behavioral treatment with the addition of peer-based skills training (CBT + PBST); or 3) standard care (SC). The cognitive-behavioral intervention consisted of 16 weekly sessions followed by four monthly maintenance sessions. Adolescents randomized to CBT + PBST received the cognitive-behavioral treatment as well as an intensive 32 session peer-based intervention. The peer-based intervention combined problem-solving therapy with principles from Outward Bound to address self-reliance, social competence and physical self-worth. One way analyses of variance was conducted at the end of treatment and at 6-months after the end of treatment to compare the three groups on initial reduction in percent overweight and maintenance of decreases in percent overweight at follow-up. Analysis of variance was also used to compare the three groups on measures of social functioning, self-esteem, physical activity level, and physical self-worth.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial

The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.

The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease. Investigators will recruit 70 albuminuric CKD patients and randomly assign participants to combination therapy with sodium nitrite and isoquercetin or placebo for three months.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 21-74 years old with any race/ethnicity background
* CKD as defined by an eGFR \<60 ml/min/1.73 m2 or urinary albumin to creatinine ratio ≥ 30 mg/g or protein to creatinine ratio ≥150 mg/g.
* Systolic BP≥120 and \<180 mmHg and/or diastolic BP≥70 and \<110 mmHg

Exclusion Criteria:

* Allergic to organic nitrite, isoquercetin, niacin, or vitamin C
* Institutionalized (e.g., prisoner, nursing home or skilled nursing facility resident)
* Unable or unwilling to give consent
* Known HIV infection and/or AIDS
* Pregnant or lactating women
* Currently on dialysis
* Previous or current organ or bone marrow transplant
* Receiving immunosuppressive treatment or other immunotherapy
* Receiving chemotherapy or alkylating agents for systemic cancer
* Recent acute myocardial infarction, cerebrovascular accidence or transient ischemic attack, or hospitalization in 3 months
* Acute kidney injury within the previous 3 months
* Currently taking a phosphodiesterase-5 enzyme inhibitor, such as Viagra
* History of chronic headaches
* Chronically receiving fluoroguinolones, cyclosporin (neural, sandimmune), nitrate drug, NSAIDS ( except aspirin ≤ 81 mg daily), allopurinol or uloric, meperidine and related central nervous system (CNS) depressants, oral glucocorticoids, and not willing or able to stop during study period.
* Active infection (i.e. systemic or osteomyelitis)
* Class III or IV heart failure
* History of hemolytic anemia including sickle cell disease
* Hemoglobin \<10
* History of chronic obstructive pulmonary disease (COPD)
* Have a positive screen for glucose-6-phosphate dehydrogenase (G6PD) deficiency at screening
* Involvement in other clinical trials
* Current alcohol or other substance abuse
* Current smokers
* Unwillingness to stop flavonoid supplementation
* Unwillingness to stop nitrate and/or nitrite supplementation
UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma

To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.

Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy.

Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study.

Exclusion Criteria:

* Previous history of venous thromboembolism, myocardial infarction, stroke, TIA
* Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome.
* Von Willebrand disease, inherited platelet abnormalities.
* Familiar history of hypercoagulable state.
* Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks.
* Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.
Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft

The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 20
* 2. elective off-pump coronary artery bypass graft

Exclusion Criteria:

* 1. arrhythmia
* 2.EF \<40%
* 3.valvular heart dz
* 4.pul HTN
* 5.PAOD
* 6.lung dz
* 7.NYHA IV
* 8.ESRD
Impact of Anterior Cross Bite Treatment on Children's Speech Performance

The goal of this prospective, single-arm clinical trial is to evaluate the speech performance of children with anterior dental crossbite before and after correction. Also, to assess the impact of early interceptive orthodontic treatment in the mixed dentition stage to correct the anterior dental crossbite on the quality of life of children.

Fifty children of both sexes aged from 8 to 10 years were enrolled and evaluated using the study's inclusion \& exclusion criteria. before beginning interceptive orthodontic treatment, each child underwent full mouth treatment. then, using a removable anterior expansion screw along with posterior bite planes to treat the anterior crossbite. All children were subjected to the Protocol of speech evaluation before appliance insertion and after complete correction of anterior crossbite. Also, the Child Perceptions Questionnaire (CPQ 8-10) in the Brazilian version was used to gauge how the anterior crossbite affected the children's oral health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* healthy cooperative children aged 8-10 years
* have at least one or more maxillary permanent incisors in a crossbite relationship
* fully erupted four first permanent molars
* Angle Class I molar relationship and Class I skeletal relationship
* the mother language of all the subjects was Arabic.

Exclusion Criteria:

* Children with systemic illness or previous history of speech therapy
* children who are ill-habituated or unable to follow up
* children with previous orthodontic treatment
* uncooperative children
* Anterior skeletal or functional crossbite
* presence of sucking habits
The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract

To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.

Prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. A health education module consisting of a lecture and workshop was incorporated into a health-care course. A non-validated survey assessed knowledge. Parental stress was assessed using self-questionnaires before and after training .At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.

Eligibility Criteria:
Inclusion Criteria:

* children with regulated cataract surgery

Exclusion Criteria:

* difficulty in understanding the language
* uncompleted questionnaires or badly filled in by two different people
Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2\*ULN, but ≤5\*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

* 1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. The researchers think inappropriate.
A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole

To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.

Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
* Life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Underlying clinical condition that would preclude completion of study or place subject at significant risk.
* Judged unreliable with respect to physician's directives.

Concurrent Medication:

Excluded:

* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
* Systemic antifungals.

Patients with the following prior conditions are excluded:

* Previously documented disseminated candidiasis.
* Previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition.
* History of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry.

Prior Medication:

Excluded:

* Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.
Fresolimumab In Systemic Sclerosis

The purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Meet ACR criteria for diffuse systemic sclerosis
* \< 24 months since onset of first SSc manifestation other than Raynaud's phenomenon
* Modified Rodnan Skin Score ≥ 15
* Male or female adult ( ≥ 18 years of age)
* Able and willing to give written informed consent and comply with study protocol

Exclusion Criteria:

* Moderate or severe pulmonary disease w/ FVC \< 80% or DLCO \< 70% or ground glass and fibrosis \> 20% of lung fields by HRCT
* Treatment with investigational drug within 4 weeks of screening
* Ongoing use of high dose steroids (\> 10mg/day) or unstable steroid dose in past 4 weeks
* Treatment with immunosuppressive, cytotoxic, or antifibrotic drug within 4 weeks of screening
* Positive for HIV, HBV, and/or HCV
* Known active infection (bacterial, viral, fungal, mycobacterial, or other); not including fungal infection of nail beds or any major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening
* Patients w/ history of malignancy or premalignant lesion
* History of keratoacanthoma or squamous cell carcinoma
* Moderate to severe hepatic impairment
* SSc renal crisis within 6 months or creatinine \> 2.0
* Lack of IV access for medication administration
* Moderate or severe cardiac disease with significant arrhythmia, heart failure, or unstable angina
* Anemia (Hb \< 8.5 gm/dL)
* Thrombocytopenia or blood clotting disorder
* Patients with organ transplant (including allogeneic bone marrow transplant)