cyrilzakka/clinical-trials huggingface dataset:
Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies

This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.

PRIMARY OBJECTIVES:

I. To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed hematological malignancies.

SECONDARY OBJECTIVES:

I. To determine the complete remission rate and overall response as a result of CLI infusion.

II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.

IV. To determine the disease-free survival, cytopenia rate, relapse incidence after CLI infusion.

OUTLINE: This is a dose-escalation study of ex vivo-expanded T-cells.

Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.

After completion of study treatment, patients are followed up for 100 days.

Eligibility Criteria:
Inclusion Criteria:

* Umbilical cord blood (UCB) recipients with underlying hematological malignancies presenting with post-transplant relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
* UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
* Performance score of at least 80% by Karnofsky or performance status (PS) \< 3 (Eastern Cooperative Oncology Group \[ECOG\]) (age \>= 12 years), or Lansky Play-performance scale of at least 60% or greater (age \< 12 years)
* Negative beta human chorionic gonadotropin (HCG) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study
* Patient or patient's legal representative, parent(s) or guardian able to sign informed consent

Exclusion Criteria:

* Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
* Patients with active (untreated) central nervous system (CNS) disease
* Any active GVHD
* Active invasive infections
* Pregnant or breast-feeding
Meta-analysis of Efficacy of Topotecan

This meta-analysis was conducted to investigate the efficacy of Topotecan and other treatments for recurrent and stage IVB carcinoma of the cervix

Studies included in the meta-analysis were: GOG-0179, GOG-0204 \& GOG-0169

Eligibility Criteria:
Inclusion Criteria:

* Randomised Clinical Trials or systematic reviews or meta-analyses
* Treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease

Exclusion Criteria:

* None
The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome

To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.

The Metamin 3D consists of mixed extractives of nature plants, including soy bean protein, bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of lipid and glucose was reported respectively previously. We design a prospective, double-blinded and placebo-controlled study to evaluate the improvement on metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 75 years
* Fasting plasma glucose \>= 100 mg/dl
* Triglyceride \>= 150 mg/dl
* one of the criteria following

  1. HDL \<40 mg/dl in man or \<50 mg/dl in woman
  2. Blood pressure \>= 135/85 mmHg or anti-hypertension drug treatment
  3. Waist \>90cm in man or 80cm in woman
* Signed the inform consent

Exclusion Criteria:

* Fasting plasma glucose \> 180mg/dl
* Treated by more than two types oral hypoglycemic agents in past 3 months
* Treated continuously by anti-lipid agents for 3 months in past 6 months
* Treated by thiazolidinedione or digitalis at present
* Serum creatine \> 2.5mg/dl
* Liver function (GOT or GPT) more than 3-fold upper limit
* Severe systemic disease by investigator's judgement
* Pregnant or nursing women
* Enrolled in other clinical study in recent 1 month
Motivational Interviewing Effect on Reducing Cardiovascular Disease Risk Factors

Aim: The aim of this study is to examine the effect of motivational interviewing-based training program on reducing cardiovascular disease risk factors in adults.

Methods: In the first stage, individuals' CVD risk levels were determined. In the second stage, a 6-session motivational interview-based training program was applied to the intervention group with a medium CVD risk level (HearthSCORE score between 2 and 5 points). Brochures were distributed to the control group.

The aim of this study is to determine the CVD risks of adult individuals between the ages of 40-70 and to evaluate the effect of a motivational interview-based training program on reducing modifiable risk factors in individuals with moderate CVD risk.

Hypothesis; A 6-session motivational interview-based training program aimed at reducing CVD risk factors reduces the risk level in the intervention group more than the control group.

This study will be carried out in 2 stages. In the first phase, risk prevalence screening will be carried out to determine the CVD risks of individuals between October and November 2023. In the 2nd phase, a randomized controlled study will be conducted to evaluate the intervention program for individuals at medium risk level (HeartScore® between 2 and 5).

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 40 and 70 years,
* Being voluntary to participate in the study,

Exclusion Criteria:

* Having a known and diagnosed CVD
* Not being voluntary to participate in the study.
Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Acute or chronic cardiac dysfunction could be a contributing factor to swimming-induced pulmonary edema (SIPE). Knowledge on cardiac function in SIPE is limited and recommendations for cardiac evaluation of patients with SIPE are lacking. The present study was designed to assess cardiac function in patients with SIPE and in asymptomatic swimmers.

Swimming induced pulmonary edema (SIPE) is an unusual condition occuring during swimming in cold open water. SIPE is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis. Reversible myocardial dysfunction has been described in swimmers with SIPE and divers with immersion pulmonary edema (IPE). Cardiac dysfunction has also been discussed as a contributing factor triggering SIPE. However, prevalence, severity and prognosis of myocardial dysfunction in patients with SIPE is unknown. Official recommendations for cardiac evaluation of patients after an acute episode of SIPE is lacking.

This case-control-study intends to assess cardiac function in patients with SIPE and in asymptomatic swimmers. We study a large cohort of approximately 12 000 swimmers during Vansbrosimningen, Sweden's biggest annual open water event, with a yearly incidence of SIPE of about 0,4%. Cardiac function is evaluated after swimming as well as at rest by echocardiography, 12-lead electrocardiogram and cardiac biomarkers (Troponin I, NT-pro-BNP).

Eligibility Criteria:
Inclusion Criteria:

for patients:

* respiratory symptoms during or after swimming at the Vansbrosimningen open water swimming event
* diagnosis SIPE by signs of pulmonary edema on lung ultrasound
* peripheral oxygen saturation ≤95%

for controls:

* completion of a swimming race of the Vansbrosimningen open water swimming event.
* no respiratory symptoms during or after swimming
* no signs of pulmonary edema on lung ultrasound
* matched to patients with SIPE regarding sex and age

Exclusion criteria:

* declined consent
* hemodynamic instability or decreased consciousness
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2

Exclusion Criteria:

* Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease
* A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
* History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age

Other protocol defined inclusion/exclusion criteria could apply
Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
* Performance status of 0～2 on the ECOG criteria
* Expected survival is above three months
* Adequate hematologic (neutrophil count\>=1.5×109/L, hemoglobin\>=80g/L, platelets\>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =\<upper normal limit(UNL) x2, bilirubin level =\< UNL x 1.5)
* Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

Exclusion Criteria:

* suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
* Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
* Bleeding tendency or coagulation disorders.
* Uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg).
* Urine protein≥++, or urine protein in 24 hours≥2.0g.
* severe uncured wounds, ulcers or fracture.
* Pregnant or breast-feeding.
* Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
* The researcher believe that the Patient is not suitable to participate in the study.
Nutrition and Frailty in Older Persons

The purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.

Nutrition is regarded as an important etiologic factor in the development of frailty in older adults. To date the relation between nutrition and frailty is only poorly described.

Thus, it is the purpose of this study to investigate the association between different nutrition characteristics and frailty in older community-living persons.

206 volunteers aged 75 years or older were included in this cross-sectional study. Nutritional assessment included the Mini-Nutritional Assessment (MNA), a food-frequency questionnaire and a standardised three-day dietary record. Intake of energy and nutrients was calculated using the German nutrient database BLS II.2. Dietary patterns were described by different dietary scores. Frailty was defined according to Fried et al. based on the following criteria: weight loss, exhaustion, grip strength, walking speed and physical activity. In addition several standardised tests were performed to characterise physical performance (Timed Up \& Go, repeated chair stands, balance tests).

The association between nutritional aspects and physical performance is evaluated in an explorative manner.

Eligibility Criteria:
Inclusion Criteria:

* age of 75 years and older
* living independently at home

Exclusion Criteria:

* acute illness
* cognitive impairment (Mini Mental State Examination ≥ 24 out of 30 points)
Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
* Willing to provide proof of identity;
* Without vaccination history of pneumococcal vaccine;
* None-pregnancy or do not plan to pregnancy recently;;
* Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
* Volunteers of 8-17 years old and their guardians who willing sign informed consent;
* Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
* Able and willing comply with the requirements of the protocol

Exclusion Criteria:

* Volunteers whose axillary body temperature was \>37.0# before vaccination
* Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
* Volunteers who has a history of epilepsy, convulsions or psychosis;
* Allergic person;
* Any prior administration of blood products in last 3 month;
* Any prior administration of other research medicines in last 1 month;
* Plans to participate in or is participating in any other drug clinical study;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Had fever before vaccination, Volunteers with temperature \>37.0°C on axillary setting;
* According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial
Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

Investigators will evaluate clinical decision support nudges informed by behavioral science and directed at primary care clinicians. These will be used to reduce commonly misused, and potentially harmful, diagnostic and therapeutic actions that occur in the care of older adults (e.g. overtreatment of type 2 diabetes, misuse of PSA screening, misuse of urine testing in women with nonspecific symptoms or no symptoms.

Diagnostic and therapeutic strategies misapplied to older adults can lead to increased morbidity and mortality. Despite recommendations from the American Geriatrics Society for the Choosing Wisely Initiative, there are clear examples where clinicians do not often follow best practices leading to patient harm. These include: (1) testing and treatment for asymptomatic bacteriuria (ASB) in older women, (2) prostate specific antigen (PSA) screening in older men, and (3) aggressive treatment with insulin or oral hypoglycemics for type 2 diabetes.

Clinical decision support nudges, informed by behavioral economics and social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services. Behavioral economics-informed interventions influence conscious and unconscious drivers of decision making, are low cost, and can be incorporated into existing systems.

This randomized controlled trial will evaluate the effects of three clinical decision support nudges on three clinical quality measures, indicators of patient safety, and clinician attitudes.

Eligibility Criteria:
Inclusion Criteria:

* Northwestern Medicine primary care clinician who sees patients under department code of a randomized clinic

Exclusion Criteria:

* Resident physicians will be excluded
* Clinicians who participated in pilot study of these interventions
* Clinician study investigators
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients

The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of CRYSVITA injection 10, 20, and 30mg, equivalent to in routine clinical settings


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
2. Those (or his/her legal guardian) who have agreed in writing to participate in the survey. Children who have obtained a written consent of his/her legal guardian about participation in this survey. In case of pediatric patient, explain sufficiently what you think the patient can understand. In this case, the legal guardian may provide supplementary explanations of the survey.

Exclusion Criteria:

1. Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
2. Patients who intend to use this drug for other purposes
3. Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
4. Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)
Expectancy as Alternative to Treatment for Cervical Intraepithelial Neoplasia Grade 2 Among Women 25 - 30 Years of Age

In the Swedish organised cervical screening program precursors of cervical cancer are detected and treated. Most precursor lesions detected by screening heal spontaneously. Those who progress do it slowly. There are three levels from light; CIN1, moderate; CIN2 to severe; CIN3. Women with CIN3 are always treated, regardless of age, according to current clinical guidelines. Women with CIN2 who are below the age of 25 years are offered active expectance for up to two years because there is good evidence that they will spontaneously heal their lesions (regression) in 40-70% of the cases during that time.

Method of treatment is today an excisional procedure of the cervix most often by Large loop excision of the transformation zone (LLETZ/LEEP) Treatment increases the risk of premature birth in a future pregnancy. In 2015 about 1800 excisional procedures of the transformation zone of the cervix were performed in the Västra Götalands regionen (VGR) om Sweden. The average age of first-time mothers in Sweden is rising and in 2014 it was 29 years. Postponed childbearing raises the question whether it is possible to refrain from surgery even for the group of women over 25 years old, with proven CIN2. Existing studies suggest that cure of CIN2 in the age group of and above 25 takes place in the same extent as under 25 years of age.There is lack of evidence concerning clinical follow-up.

In a prospective multicenter clinical cohort study (observational study) with careful monitoring, the investigators will examine what proportion of CIN2 changes regress spontaneously within two years in women, 25-30 years old, and if human papillomavirus (HPV) type 16 may can be a marker for poor regression in this group. Instead of LLETZ, active expectance is offered to women this age with CIN2 in five gynecological clinics in VGR. The study protocol includes gynecologist visits every 6 months for two years, including cytology, colposcopy and directed biopsies of the cervix. Power calculation shows 160 women needs to be included, which is expected to occur within one year from the start.

Available in Swedish

Eligibility Criteria:
Inclusion Criteria:

* CIN 2
* Written consent

Exclusion Criteria:

* CIN (any grade) not resolved
* Former treatment of CIN
* Immunomodulating medication
* Pregnancy (at start of study)
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.
Oral Status and Care Needs of People Aged 90 and Over

This study will help describe the state of oral health of very old people (over 90).

In 2011, according to the French National Institute for Statistics and Economic Research, people aged 85 and over accounted for about 3% of the total population. This proportion will increase sharply due to longer life expectancy on the baby boom generation and is expected to reach 7.5% of the total population in 2050.

This very old population has specific health, related to the presence of co-morbidities and co-medications, but also to a frequent state of dependence.

These general health problems and their treatment can create or accentuate oral problems or complicate their management. Thus, very old people are more likely to have some oral diseases although there is no epidemiological data in France. Conversely, oral problems can have repercussions in terms of quality of life, social relations and nutrition, and are factors of risk or aggravating actual or potential systemic disorders.

This very elderly population is therefore likely to present new challenges of dental care that it is important to document.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 90 years old
* Follow-up in 2013-2014 as part of the PAQUID cohort
* Participation Agreement

Exclusion Criteria:

* Inability to give informed consent and refusal of legal guardian.