cyrilzakka/clinical-trials huggingface dataset:
A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients

Stroke is the leading cause of premature death and disability, and early recognition and treatment of dysphagia is fundamental to stroke management. Early and full tube feeding in the acute phase of stroke helps to address nutritional problems resulting from dysphagia and impaired consciousness and helps to reduce morbidity and mortality and poor outcomes. Current guidelines for acute stroke management do not address the goal of tube feeding of enteral nutrition for energy and protein. In the treatment of acute stroke, there is a strong global focus on pharmacological thrombolysis or mechanical thrombolysis, with nutritional interventions being a less explored topic. Real-world evidence on large samples, feeding attainment and outcomes, and nutrition in the acute phase of stroke is lacking in China . The aim of this study was to understand the current status of nutritional therapy in stroke hospitalization in neurology and its impact on prognosis nationwide, and to improve the standardized management process of enteral nutrition therapy in the acute phase of stroke.

Malnutrition is a common geriatric syndrome with a disproportionate incidence in geriatric and neurology inpatients. In recent years, national nutritional surveys of geriatric inpatients have shown that about 2/3 of geriatric inpatients have nutritional problems; only half of neurology inpatients at high risk receive nutritional support, and inadequate nutrition exacerbates primary disease, increases complications, makes hospital stays longer, and ultimately affects patient survival outcomes.

To increase comprehensive and up-to-date research on the current status of nutritional therapy in geriatric and neurology inpatients, and to lay the foundation for future standardized treatment and standardized management, we conducted a nationwide survey on the current status of nutritional risk screening and treatment in geriatric and neurology inpatients. The aim is to raise the level of clinicians' awareness of malnutrition and nutritional risk in hospitalized patients, standardize clinical practice, and properly implement nutritional support to improve patients' clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Newly admitted stroke patients admitted to neurology, age ≥18 years, within 7 days of onset, expected survival \>3 months (i.e., not end-stage), expected neurology stay 7-10 days；
* At risk of malnutrition (MUST ≥ 2 points) or at nutritional risk (NRS2002 ≥ 3 points), sign an informed notice.

Exclusion Criteria:

* Transferred during treatment, contraindications to nutritional therapy (e.g., hemodynamic instability, gastrointestinal bleeding (bleeding \>100 ml), other nutritional studies, pregnancy.
Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed consent;
2. Aged 18 to 75 years old , sex is not limited;
3. Pancreatic cancer or primary liver cancer,must have undergone radical resection;
4. Availability of at least 0.5 g tumor sample;
5. Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation;
6. Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment；
7. ECOG ≤1；life expectancy of at least 12 weeks
8. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] and bilirubin (total) \<1.5 times IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs); 9. Agree to Surgical indications of Heart \& lung and without the coagulation system disease;

10.Negative pregnancy test for female patients of childbearing potential; 11.Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration.

Exclusion Criteria:

1. Unable to get the informed consent ;
2. Patient not suitable for radical resection;
3. Patients with active liver disease；
4. Did not get enough tumor tissue ;
5. Progression prior to vaccination as determined by the Principal Investigator;
6. Rreceiving other anti-cancer therapy at the same time;
7. Patient with allergic constitution;
8. Unstable or severe intercurrent medical conditions;
9. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection;
10. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids;
11. Any other cilical trials within 30 days pre-vaccination;
12. Female patients who are pregnant or breastfeeding.
Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.

PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.

OBJECTIVES:

* Examine the effects of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum.
* Investigate cytologic patterns of epithelial breast cells obtained from NAF as a measure of proliferation in relation to soy intake.
* Explore the effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites.
* Compare estrogen levels in NAF and serum measured at the same time during the luteal phase.

OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 intervention arms.

* Arm I: Participants partake in a high soy diet consisting of 2 daily soy servings (approximately 50mg isoflavones). The choice of soy foods will include ½ cup of tofu, ¾ cup of soy milk, or ¼ cup of soy nuts. Replacement of currently consumed foods with soy foods will be encouraged.
* Arm II: Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling.

In both arms, intervention continues for 6 months. After 6 months, participants undergo a 1-month washout period and then cross-over to the other intervention arm.

Nipple aspirate fluid, urine, and blood samples are collected periodically to measure laboratory endpoints.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy participant

  * No diagnosis of cancer

PATIENT CHARACTERISTICS:

* Premenopausal
* Regular menstrual cycles

PRIOR CONCURRENT THERAPY:

* Not taking birth control pills or other hormones
Survivor Health and Resilience Education

An intervention to assist pediatric cancer survivors to behaviorally manage late effects.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric cancer survivor

Exclusion Criteria:

-
Biomarker Profiling in Individuals at Risk for Prion Disease

We are doing this research to identify biomarkers in individuals who are at-risk for familial prion disease. We hope to use these biomarkers to predict timing of disease onset in pre-symptomatic individuals and to guide the direction of future clinical trials.

This study aims to measure biomarkers longitudinally in individuals at risk of developing genetic prion disease to identify clinical assays and molecular markers that: can inform our understanding of pre-clinical pathology, predict timing of disease onset in pre-symptomatic individuals, and enable development and evaluation of novel treatment efficacy in pre-symptomatic or early symptomatic individuals.

Participation in the study involves annual visits to the clinic site in Charlestown, MA. Study visits include: a medical exam, blood draws, cognitive tests and questionnaires, spinal fluid collection, and (optional) MRI.

Travel support and stipend is provided for interested individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 - 85,
2. One of the following:

   1. Known carrier of pathogenic PRNP mutation
   2. History of probable or definite prion disease in biological parent and other family members
3. Medically safe to undergo blood draw, lumbar puncture and cognitive testing,
4. Adequate visual and auditory acuity to complete cognitive testing,
5. Fluent in English,
6. At least 5 years of education,
7. Capable of providing informed consent and following study procedures.

Exclusion Criteria:

1. Any CNS disease other than asymptomatic or early prion disease, such as clinical stroke, brain tumor, multiple sclerosis, significant head trauma with persistent neurological or neurocognitive deficits, Alzheimer's disease, Parkinson's disease, frontotemporal lobar degeneration or other known neurodegenerative disease,
2. History of alcohol or other substance abuse or dependence within the past two years,
3. Any significant systemic illness or unstable medical condition or pregnancy that could represent safety risk or affect participation in the study,
4. Coagulopathy or anti-coagulant therapy (such as Coumadin) increasing the risk for phlebotomy or lumbar puncture resulting in PT/PTT and INR within 1.5 standard deviation over the upper normal limit.
Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 years.
2. Scheduled for an elective cesarean section.
3. Uncomplicated pregnancy.
4. Planned for spinal anesthesia.
5. ASA I or ASA II.

Exclusion Criteria:

1. History of diabetes.
2. History of gastro-intestinal reflux (GERD).
3. Unable or unwilling to sign an informed consent.
4. Contraindications to spinal anesthesia.
5. Contraindication to Oral carbohydrate formula.
Incretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)

The incretin hormones are secreted from the gastrointestinal tract in response to nutrient ingestion, and are responsible for 70 % of insulin secretion in response to glucose. The incretin response is attenuated in subjects with type 2 diabetes and other conditions associated with insulin resistance. Polycystic ovary syndrome (PCOS) is characterised by irregular periods and increased androgen levels. It is the most common endocrine disorder amongst young women at fertile age, and the most common cause of female infertility. Insulin resistance plays an important role in the development of the disease, and women with PCOS are at increased risk of developing tyoe 2 diabetes. the incretin hormones have not previously been investigated in women with PCOS, and the purpose of the present study was to investigate the secretion of the two most important incretin hormones Glucose-like peptide-1 (GLP-1) and Glucose dependent insulinotropic peptide (GIP) during a three hour oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who fulfill the Rotterdam criteria for PCOS. Age 18-38

Exclusion Criteria:

* Other endocrine diseases or diseases known to influence glucose/insulin/fat metabolism
* Oral contraceptive administration within three months of study start
Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules

The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.


Eligibility Criteria:
Inclusion Criteria:

* 2-15 months of age

Exclusion Criteria:

* previously recorded allergy to PCV
* intravenous immunoglobulin (IVIG) given within the previous 6 months
* primary or secondary immunodeficiency
* any chronic medical condition
Immunogenicity and Safety of Pentaxim™ in an Indian Population

The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.

Safety:

This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).


Eligibility Criteria:
Inclusion Criteria:

* Aged 42 to 56 days inclusive on the day of inclusion
* Born at full term pregnancy (\> 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the past.
* Any vaccination preceding the trial vaccination (except BCG and hepatitis B)
* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Evaluation of B+ Surface on Early Loading

The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.


Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 and ≤75 years old
* One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).

Exclusion Criteria:

* One-stage bone augmentation
* Heavy smokers (\>10 cigarettes/day)
* Uncontrolled type 1 or 2 diabetes (HgA1c\>8)
* Known auto-immune or inflammatory disease
* Severe hematologic disorders, such as hemophilia or leukemia
* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
* Liver or kidney dysfunction/failure
* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
* Long-term history of oral bisphosphonates use (i.e., 10 years or more)
* History of intravenous bisphosphonates
* Long-term (\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system
* Severe osseous diseases (e.g., Paget disease of bone)
* Pregnant women or nursing mothers
* Not able or not willing to follow instructions related to the study procedures
The Effect of Progressive Relaxation Exercises on Sleep Quality

This study; In order to investigate the effect of progressive relaxation exercises on sleep quality, serotonin and melatonin levels in cardiac patients with sleep problems, a pretest/posttest experimental design study will be conducted with a control group.

The data of this study will be collected between May 2022 and December 2022. The research will be carried out with a total of 60 (experimental group=30, control group=30) patients treated for heart failure, myocardial infarction and angina pectoris in the cardiology clinic of a university hospital.

The data of the study will be collected using the Richard's Campbell Sleep Scale and the Commercial ELISA kit.

Progressive relaxation exercises will be applied to the patients included in the experimental group for 3 consecutive days.

Before relaxation exercises, urine melatonin, serotonin level \[5-hydroxyindolacetic acid (5-HIAA) and 6-sulphatoxymelatonin(6-HMS)\] measurement and sleep quality will be measured according to the kit procedure.

In the analysis of the data, significance p \<0.05 will be accepted. Institutional permission, ethics committee approval, and written consent from the participants were obtained before the study.

The data of this study will be collected between May 2022 and December 2022. The research will be carried out with a total of 60 (experimental group=30, control group=30) patients treated for heart failure, myocardial infarction and angina pectoris in the cardiology clinic of a university hospital.

The study was planned as a randomized controlled experiment. Patients meeting the research criteria will be randomly assigned to 30 experimental-30 control groups by randomization method.

Information Form, Richard's Campbell Sleep Scale and commercial ELISA kit will be used as data collection tools in the research.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years of age,
* who reported sleep problems
* scored 25 or less on the Richard's Campbell Sleep Scale,
* were scheduled to be hospitalized for at least 4 days,
* had no pain, were able to give urine samples,
* were lying in a single or double room,
* had serotonin-containing or decreased serotonin secretion.
* do not take any medication that provides medical treatment,
* can do PGE,
* do not have a hearing problem or a communication disability will be admitted.

Exclusion Criteria:

* who were discharged early,
* had an unexpected change in their condition,
* started to experience pain,
* could not adapt to the working principles,
* gave up volunteering will be excluded from the study.
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis of ED by using IIEF-EF domain with score of â‰¤ 25.
* Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.

Exclusion Criteria:

* Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
* Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD) versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic drug-refractory AF (with history of failure of ≥ 2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
* PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
* History of significant hypertension (defined as SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg), receiving treatment with at least one antihypertensive medication
* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

* Previous atrial fibrillation ablation
* Type 1 of diabetes mellitus
* Structural heart disease
* Secondary cause of atrial hypertension
* Severe renal artery stenosis or renal arteries abnormalities
* Previous operations on renal arteries
* Pregnancy
* Previous heart, kidney, liver, or lung transplantation
* Unwillingness of participant