cyrilzakka/clinical-trials huggingface dataset:
Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®

Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due to their treatment.

70 patients will be randomized in the intervention (Caphosol) or in the standard (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence of pain measured with the NRS-scale (Numeric Rating Scale).

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* Allogeneic stem cell transplantation
* Male and female patients age 18-80
* Signed informed consent after information

Exclusion criteria:

* Contra-indications due to ethical reasons
* Unable to read or write
* Unable to speak or understand the german language
* Low-salt diet
Diastolic Dysfunction in Aortic Regurgitation

Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.

Background

Patients with severe aortic regurgitation show eccentric LV hypertrophy and structural changes of the myocardium. Reversibility of functional and structural changes after successful valve replacement may be limited. Persistent diastolic dysfunction has been observed in the present study late after aortic valve replacement. This finding has been explained by incomplete regression of the extra-cellular matrix 7 years after valve replacement. Interstitial fibrosis remains unchanged compared to the preoperative situation but was increased early after operation due to the reduction in LV muscle mass. Regression of LV hypertrophy was 40% after 2 and 55% after 7 years of valve replacement. Myocardial muscle fibers decreased slightly but remained hypertrophied even late after operation. Interstitital fibrosis was found to be positively correlated to myocardial stiffness and inversely to LV ejection fraction.

Thus, persistent diastolic dysfunction with maintained systolic ejection performance can be observed late after successful valve replacement in patients with severe aortic regurgitation. Altered diastolic function has been associated with increased filling pressures during strenuous exercise with signs of dyspnea.

Objective

Evaluation of myocardial structure and function in patients with chronic volume overload before and after valve replacement(LV-remodeling).

Methods

Pressure-volume measurements and myocardial biopsy samples for assessing myocardial function and structure.

Eligibility Criteria:
Inclusion Criteria:

* Severe aortic regurgitation
* Successful valve replacement
* Informed consent
* Sinus rhythm
* No comorbidities
* No bundle branch block
* No pregnancy

Exclusion Criteria

* Unwillingness to undergo postop. cath
* diabetes mellitus
* arterial hypertension
* bleeding disorder
* pulmonary hypertension
Clinical Study on the Impact of Covid-19 Vaccine on Allogeneic Hematopoietic Stem Cell Transplantation

Aim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation.

Since the first detection of a Corona Virus Disease 2019 (COVID-19) infection in late 2019, the syndrome coronavirus-2 (SARS-CoV-2) has spread rapidly across the globe, threatening the health and safety of an increasing number of people. The development of the SARS-CoV-2 vaccine has been shown to be effective in reducing the chance of COVID-19 infection and the severity of the disease. To control the COVID-19 pandemic, an increasing number of studies are calling for people to receive the SARS-CoV-2 vaccine, and the Chinese government is also advocating universal vaccination. However, the investigators have found in our work that as vaccination has become more widespread, clinicians have become somewhat confused about whether they can choose someone who has been vaccinated against SARS-CoV-2 as a donor for a bone marrow transplant, and what is the optimal time for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in vaccined hematological patients. This study will evaluate the impact of Covid-19 vaccine on safety and efficacy of hematological patients received allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

1. Allogeneic hematopoietic stem cell transplantation is expected to start in the short term.
2. Able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures).

Exclusion Criteria:

1. Patients or donors with a history of previous infection with SARS-Cov-2.
2. Patients or donors are currently infected with SARS-Cov-2.
3. Patients have a history of other malignancies, disease progression, or is currently on systemic therapy.
Study of PLGA-Mg Material in Clinical Orthopedics

The different proportion samples of PLGA-Mg were made in this study. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to fix the fragments. Then, the clinical role for bone will be assessed.

The deposition of calcium could be facilitated by the increase of magnesium, which played an important role in fracture union. However, its degradation may be completed before the fracture line was disappeared. In addition, the hydrogen may be released during degradation. Thus, its clinical popularization was limited.

As a new polymer material, poly lactic-co-glycolic acid (PLGA) has been widely used clinically. The hydrolytic production of PLGA was acidic, which could neutralize the alkalinity of production degraded from magnesium. In addition, it was a long time before the total accomplishment of degradation of PLGA, which may postpone the degradation of magnesium.

The different proportion samples of PLGA-Mg were made in this study. Their physical and chemical properties were analyzed to estimate its safety of implantation. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The osteogenesis and complication of samples are examined to select an appropriate proportion of PLGA-Mg is obtained. Then, the PLGA-Mg material will be used to fix the fracture of human as a fixation. The review of the patients will be conducted to assess its clinical role.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Closed fracture
* Sign the agreement of the experiment

Exclusion Criteria:

* Pathologic fracture
* Open fracture
* Refused to participate
* Follow-up insufficient 12 months
Agentic Self-view as Common Factor in Psychotherapy - Self-efficacy in the Treatment of Inpatients Over the Course of Time

The purpose of this study is to assess the development of self-efficacy over the course of psychotherapeutic inpatient treatment and to examine the interplay of symptom severity with group cohesion and positive self-view, respectively. Moreover, variables that potentially moderate the relationship between positive self-view and treatment outcome will be investigated.

In this study, the aim is to investigate the role of patients' self-efficacy in inpatient psychotherapeutic treatment. More specifically, it will be explored whether patients' positive self-view over the course of psychotherapeutic treatment is linked to symptom severity throughout and at the end of inpatient treatment. Moreover, the interplay between positive self-view and other variables that could potentially influence the psychotherapeutic process such as patients' group cohesion will be investigated. Therefore, it will be examined whether changes in positive self-view and in group cohesion precede and explain symptom change. Furthermore, another objective of the study is to examine whether certain patient characteristics influence the relation between positive self-view and treatment outcome. More precisely, it will be investigated whether patient characteristics such as attachment style and tendency to self-criticism act as potential moderator variables. It is expected that positive self-view as well as stronger group cohesion will lead to subsequent symptom improvement. Additionally, it is expected that reciprocal relations between symptom severity with both positive self-view and group cohesion will be found.

For the above described purposes, data of ca. 1500 adult patients will be used that has been obtained over the course of an (usually) 8-week inpatient psychotherapeutic treatment in the years 2015 to 2021 in Heidelberg University Hospital. Patients filled in pre- as well as post-treatment questionnaires of psychotherapy outcome measures and took part in weekly questionnaire assessments of clinically relevant process variables over the course of treatment. Therefore, data analysis will be performed using the described longitudinal panel data.

To examine the influence of positive self-view on symptom severity as well as the interplay of self-view and group cohesion random-intercept cross-lagged dynamic panel models (RI-CLPM) will be used. To investigate potential moderator variables of the relation between self-efficacy and treatment outcome moderated multilevel regression models will be calculated.

Thus, the general aim of this study is to shed more light on process variables and patient characteristics that might play a role in the psychotherapeutic inpatient treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients of at least 18 years of age
* included in inpatient psychotherapy treatment program in a hospital for psychosomatic medicine
* provided measurements of symptoms, self-view, and group cohesion for at least one measurement occasion

Exclusion Criteria:

* bipolar, acute psychotic or substance abuse disorder
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on hemodialysis therapy for at least 3 months;
* receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers

The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: men and women, 18-55 year old inclusive
3. Body Mass Index: 18.5-30 kgm2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
6. Fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year.

For all female subjects, pregnancy test result had to be negative at screening and Day -1

Exclusion Criteria:

1. ECG 12-leads (supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
6. Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study
7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
8. Blood donation: blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than 1 drink a day for females and more than 2 drinks a day for males, defined according to the USDA Dietary Guidelines 2010), caffeine (more than 5 cups coffee/tea/day) or tobacco abuse (10 cigarettes a day)
10. Abuse drug test: positive result at the drug test at screening or Day-1
11. Alcohol test: positive alcohol breath test at Day -1
12. Diet: abnormal diets (less than1600 or more than 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
13. Pregnancy (females only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
Effect of Applying Paper- Based Versus Electronic Nursing Process on Clinical Competence of Nursing Student

Compare the clinical competence of undergraduate nursing students' of mashhad nursing and midwifery school in two groups applying nursing process (paper- based versus electronic).

The sample consisted of at least 30 nursing students in each of the groups A (paper-based nursing process or PNP) and B (Electronic nursing process or ENP) based on random allocation (lottery sectors) will be divided into two groups. The level of knowledge about nursing process, clinical competency and clinical decision making will evaluate by the knowledge of nursing process, Meretoja competence modified and Lauri clinical decision making questionnaires, by the investigator. Then, for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients and researchers will perform under your guidance will be closely monitored. Clinical competence and clinical decision making will be assessed again at the end of the course with previous method. Satisfaction of the nursing process in each group will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the study
* No Experience working independently (student work, employment, etc.) as a Nurse.
* Participate in the first day of the internship program

Exclusion Criteria:

* Failure to complete course training
A Study Exploring the Use of Challenge Agents in Healthy Volunteers - Intervention Specific Appendix

The purpose of this study is to characterize the disruption of intestinal barrier as a result of indomethacin challenge in healthy volunteers using an orally administered lactulose-mannitol test.


Eligibility Criteria:
Inclusion Criteria:

* healthy on the basis of physical examination, medical history, and vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example, nicotine patch) for 3 months prior to screening
* A woman must be: a) not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (\<1) percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until the end of the intervention cohort. The investigator should evaluate the potential for contraceptive method failure (example, noncompliance, recently initiated) in relationship to the first dose of study intervention
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test prior to study intervention administration on Day -4

Exclusion Criteria:

* history of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* history of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
* has an active, acute or chronic infection
* has a history of inflammatory bowel disease (IBD), celiac disease, or gastrointestinal diseases (GI) surgery, excluding appendectomy and cholecystectomy
* has known allergies, hypersensitivity, or intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
Chronic Obstructive Pulmonary Disease Gene Localization

To localize within the genome a chronic obstructive pulmonary disease susceptibility gene.

BACKGROUND:

Chronic obstructive pulmonary disease (COPD) is a slowly progressive disorder characterized by airways obstruction that lasts for at least several months. The two major causes of COPD are chronic bronchitis and emphysema. Either disorder may occur with or without airways obstruction, but airways obstruction causes impairment of lung function leading to disability and death. COPD is a major health problem in the United States and throughout the world, consistently ranking among the most common causes of death in the United States. Cigarette smoking is the primary environmental factor that increases the risk of COPD, but other environmental factors have also been implicated. However, despite a well-established role, environmental factors alone do not cause COPD. Symptomatic COPD develops in only 10-20 percent of heavy cigarette smokers, probably those with a genetic susceptibility, although common COPD susceptibility genes have yet to be identified.

DESIGN NARRATIVE:

The study applied statistical linkage analysis to family data. Pulmonary measurements had already been collected on 159 members of 16 pedigrees and evidence supporting a COPD susceptibility gene in these pedigrees had been obtained from segregation analysis. Each of 11,995 genetic markers, which had already been genotyped on pedigree members, were tested for evidence of linkage to the inferred COPD susceptibility gene. Evidence of linkage to one or more genetic markers identifed genomic locations of COPD susceptibility genes. The high density of markers allowed fine-mapping of the gene. Successful completion of this gene localization project was the necessary prerequisite for a project to identify and characterize a COPD susceptibility gene. Identifying a gene that when mutated increased the risk of COPD may increase understanding of pulmonary function, as well as allowing gene-carriers to be identified and made aware of their susceptibility.

Eligibility Criteria:
No eligibility criteria
Black Star - Magnetic Stent Removal in Transplant Patients

This is a pilot, single-centre, feasibility study to assess the feasibility issues and collect preliminary clinical data for the design of future randomized controlled trial to evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral stent in transplant patients.

To curtail the pain and discomfort during cystoscopic stent removal and in order to improve patient's quality of life, a newly developed ureteral stent with a small magnet at its distal end and a customized magnetic retrieval catheter is recently used in Europe. The product is Black-Star® with a retrieval device by Urotech (Achenmühle, Germany). The magnetic Blackstar stent is a ureteral stent with a small magnet fixed with a string at the distal loop. The placement of stent is similar as routinely done on a guidewire, the only difference is to include the magnetic piece over the guidewire. To remove the stent a customized catheter with a magnetic Tiemann tip is used. The catheter is inserted after urethral application of a standard lubricant and removed with the stent after coming in contact with the stent's magnet.

The stent comes in various sizes and is currently being used in Europe. The studies have concluded fast and easy retrieval of stent without requirement of cystoscopy and decreased patient discomfort.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years of age and capable of giving informed consent
2. Patients scheduled for deceased donor renal transplant surgery

Exclusion Criteria:

1) Patients undergoing Live donor renal transplant