cyrilzakka/clinical-trials huggingface dataset:
AgION Catheter for Preventing Catheter-Related Bloodstream Infections

The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.

Recently, a silver zeolite-impregnated catheter has been commercialized. This material, namely the patented silver compound AgION™, releases antimicrobially active silver ions which may help prevent catheter-related bloodstream infections CRBSIs which are frequent in preterm infant.

The investigators hypothesized that the use of AgION-impregnated umbilical catheters could decrease the occurrence of CRBSIs in preterm infants. To assess this hypothesis the investigators carried out a randomized controlled study in which preterm infants needing an umbilical vein catheter would received either an AgION catheter or a traditional non-impregnated polyurethane catheter.

Infants with gestational age \< 30 weeks were randomized to receive an AgION- impregnated or non-impregnated polyurethane umbilical venous catheter (UVC) by opening sealed opaque envelopes. The primary end point was the incidence of CRBSIs during the time the UVC was in place.

The investigators studied 86 infants, 41 of whom received the AgION catheter and 45 the non-impregnated catheter. During umbilical venous catheterization 2% of infants in the AgION group developed CRBSI in comparison with 22% of infants in the control group (p=0.005). The incidence density of CRBSIs during the study period was lower in infants who received AgION catheters compared to the control group (2.1/1000 catheter days versus 25.8/1000 catheter days; p\<0.001). The occurrence of UVC colonization was similar in both groups. The Kaplan-Meier estimates of the cumulative likelihood of being free of a CRBSI at each day of UVC placement demonstrate the statistically significant (p=0.004) protective effect of AgION impregnated catheters. Moreover, infants in the AgION group had shorter hospital stay (p=0.04), and a lower case fatality rate due to BSI (p=0.01) than infants in the control group.

AgION catheters were well tolerated and none of patients showed signs attributable to silver toxicity.

Multivariate analysis demonstrated that non-impregnated catheter use (OR 12.5, 95% C.l. 2.06-75.9) and catheter placement for more than 7 days (OR 5.1, 95% C.l. 1.13-23.6) increased the risk of developing a CRBSI in our population.

Conclusions. The AgION-impregnated UVCs were effective in decreasing the development of CRBSIs in preterm infants compared to non-impregnated polyurethane UVCs.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 30 weeks
* Need of an umbilical venous catheter in the first week of life
* Parental informed consent.

Exclusion Criteria:

* Major congenital malformations
* Hydrops fetalis
* Inherited congenital metabolic diseases
* Death during the first week of life
High Precision RT For Soft-Tissue Sarcoma

This research study aims at defining 1) how retroperitoneal sarcomas change over the course of radiotherapy and 2) how radiotherapy affects your well-being. While the investigators know that radiotherapy before surgery is safe and effective, the amount of tumor motion and size change during radiotherapy is unknown. There is also very little information that describes the side-effects of radiotherapy in the treatment of this disease.

Soft-tissue sarcomas (STS) that arise from the retroperitoneum are rare malignancies that are anatomical located deep within the abdominal area and thus pose challenges to surgical and radiotherapeutic management of the patient. As a result, the local control and overall survival for patients with retroperitoneal sarcomas (RPS) are worse than STS from the extremities. Current treatment strategy involves pre-operative radiotherapy followed by surgery. Use of intensity-modulated radiotherapy (IMRT) in RPS had allowed for more conformal treatments with the aim of sparing normal tissues from high doses of irradiation. Yet the accuracy and coverage of IMRT depend highly on target motion, and little is known about the motion of RPS during the course of radiotherapy. As well, RPS are commonly in close proximity to sensitive organs for which the long-term toxicity and effect on quality of life secondary to radiation is unknown. The current study seeks to evaluate the extent of tumor motion during radiotherapy and the impact of radiotherapy to patient toxicity and quality of life. At the conclusion of this study, our results will hopefully identify the optimum PTV, the importance of different normal tissues and their dose-volume constraints, the role of image guidance, and the potential for dose escalation in the treatment of RPS.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically or cytologically) proven diagnosis of sarcoma (except for GIST, Ewing's sarcoma and rhabdomyosarcoma) within the retroperitoneum. These include patients with locally recurrent disease
* Planned to receive pre-operative radiotherapy
* Will undergo a planning CT
* Karnofsky Performance Status of ≥ 70 within 28 days prior to study entry
* No systemic chemotherapy given prior to pre-operative radiotherapy
* Able to provide written, informed consent
* Women of childbearing potential and men who are sexually active must practice adequate contraception.

Exclusion Criteria:

* Tumor pathology of GIST, Ewing's sarcoma or rhabdomyosarcoma
* Metastatic disease to the retroperitoneum from a primary sarcoma not originating from the retroperitoneum
* Systemic chemotherapy given prior to pre-operative radiotherapy.
* Intent on giving chemotherapy ≤ 12 months from the completion of radiotherapy
* Inability to undergo a 4D-CT simulation
* KPS \< 70
* Unable to provide informed consent
* Pregnant women
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.

Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix

.

Eligibility Criteria:
Inclusion Criteria:

* Patient is equal or greater than 18 years old
* Female
* Meets follow-up evaluation time frame
* Understands the nature of the procedure and has provided written informed consent
* Is scheduled to undergo vaginal pelvic reconstructive surgery
* Has \> 2nd degree midline cystocele

Exclusion Criteria:

* Presence of severe mucosal ulceration
* Previous pelvic organ prolapse surgery using an implant that will affect the use of the VCM or affect the outcome of the study
* Allergy to bovine material
* Severe mucosal atrophy
* Shortened vaginal length as determined by Investigator
* Pregnant or intends to become pregnant during study
* Has a UTI
* Has vault prolapse \< 2nd degree cystocele
Validity of Low Physical Activity Questionnaire (LoPAQ)

The goal of this observational study is to assess validity and reliability of Persian Version of Low Physical Activity Questionnaire. The main questions it mains to answer are:

What is the level of physical activity in hemodialysis patients? Is Persian Version of Low Physical Activity Questionnaire, Valid to assess physical activity levels of dialysis patients?

Is Persian Version of Low Physical Activity Questionnaire, reliable?

Participants will answer 3 questionnaires and will do some functional tests.

Currently, between 8 and 16 percent of the world's population is suffering from chronic kidney disease, and this number is increasing day by day, and it is predicted that by 2040, kidney disease will be the fifth cause of death.

End-stage kidney disease patients, especially hemodialysis patients, face various problems, and during the years of dialysis, they suffer from many complications and problems, such as repeated hospitalizations, reduced physical performance, reduced aerobic capacity, low quality of life, and having a sedentary life. suffer, so that the activity level of these patients is between 20 and 50% of healthy people.

The physical activity level of patients undergoing hemodialysis treatment is low and significantly lower than the same inactive control groups. Research has shown that the level of physical activity of hemodialysis patients gradually decreases by approximately 4.5% per month during the entire period of the disease . In addition, the activities related to the work done at home constitute the largest part of the energy consumption of hemodialysis patients, which means that the types of activities of hemodialysis patients are usually limited to the lower category.

Valid instruments for measuring physical activity at the low end of the physical activity range and producing quantitative results are required among dialysis patients who are extremely inactive. This study aimed to translate and adapt a Persian version of the low physical activity questionnaire (LoPAQ) and to examine its reliability and validity among hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* On hemodialysis for ≥3 months
* Able to walk without assistance
* Ability to provide informed consent and complete the questionnaires

Exclusion Criteria:

* Diagnosis of mental or cognitive disorders
* Unstable conditions
* Hospitalization in the previous 3 months
Tissue Engineered Constructs for Alveolar Cleft Repair

Description of the research question

In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?

Objective of the study:

• Research hypothesis

The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.

* The objectives

The primary objective:

Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

The secondary objective:

Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Children with maxillary unilateral alveolar clefts requiring reconstruction
* Children free from any systemic disease that may affect normal healing of bone
* Children in an age range (8-14) year.

Exclusion criteria

* Bilateral alveolar clefts.
* Cleft lip or palate not including the alveolus.
* Immunocompromized patients.
* Children who undergone previous bone grafting procedure for the alveolar cleft
A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer

The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer.

The aims of this study are:

1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
2. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
4. To explore the indication of VATS lobectomy for the lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Early stage NSCLC and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (CT) scan;
* No medical contraindications to lung resection
* Age ≤ 75 years old and ≥18 years old;
* Sign the informed consent form.

Exclusion Criteria:

* Evidence of invasion into neighboring organs;
* Extensive pleura adhesion;
* Central lesion;
* Not suitable for single-lung ventilation;
* Had history of thoracotomy and radiation for thoracic region ;
* Pregnancy or lactation female patients;
* Cannot sign the informed consent form because of psychological, family and society factors;
* Had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate;
* Participants can not accept operation for other uncontrolled factors.
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a hematopoietic stem cell transplantation

Exclusion Criteria:

* Known or suspected allergy to trial product
* Participation in other trials with unapproved drugs or trials with equal or similar objective
Effect of Nurse-Led Intervention Programme Professional Quality of Life and Psychological Distress in Nurses

Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.

In addition, the evidence levels of interventional studies are low.

Aim:The aim of this study is to reduce nurses' psychological distress, burnout and secondary trauma stress.

Design This single-blind randomized controlled trial design was used. Measurements were made before, after and 6 months after Participants and Settings The study was perform at a hospital in Turkey. Intervention program was applied in 4 week. 84 nurses meeting the criteria were invited to the program.48 nurses agreed to participate. Nurses were randomly assigned groups.

Sample Size the sample was calculated with the open epi program. The sample size was calculated as 20 per group.

Intervention The program was created to reduce nurses' psychological distress, and improve the professional quality of life.

The intervention programme were four sessions. The Intervention group was divided into two groups. Intervention were applied in a comfortable room in the hospital. Interventions were based on cognitive behavioral approach.

Outcome measures The outcomes were compassion fatigue, burnout and compassion satisfaction, psychological distress.

These variables were evaluated by the Professional Quality of Life Scale (ProQOL-IV). The GHQ-12 is a scale surveying psychological distress observed within the last few weeks.

Data collection Research data were collected before, immediately after, and six months after intervention.

Validity and reliability Measuring tools showing good psychometric properties were used to ensure validity and reliability. Volunteer participants were randomly assigned to groups, and the intention-to-treat approach was used for data analysis. The study has been reported in accordance with the CONSORT 2010 Statement principles.

Ethical considerations Permission was obtained from the relevant university, and written permission was obtained from the hospital. The participants were informed, all participants gave written consent.

Data analysis Mann Whitney U test, and Friedman analysis was used. All analyses were made on an intention-to-treat approach. Missing data were compensated for using the last observation method carried forward.

Eligibility Criteria:
Inclusion Criteria:

* Nurses who responded to the questionnaires received a score on compassion fatigue higher than the mean score (20 points)
* Nurses who worked at clinics and had at least six months of experience

Exclusion Criteria:

* Nurses who responded to the questionnaires received a score on compassion fatigue lower than the mean score (20 points)
* head nurses
Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers

To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
2. Age ≥60 and ≤85 years
3. BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

1. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Clinically relevant surgery of gastrointestinal tract
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. Any relevant bleeding history
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
8. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
10. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
11. Alcohol abuse (more than 60 g/day for men and more than 40 g/day for women)
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance
16. Inability to comply with dietary regimen of study centre
17. Planned surgeries within four weeks following the end-of study examination
18. Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, coumarin etc. within 10 days prior to administration
19. Male subjects who do not agree to minimise the risk of female partners becoming pregnant from the first dosing day until the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia

This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant or lactating;
* previous treatment with erythropoietin or other erythropoietic substance;
* blood transfusion within the last 3 months;
* need for dialysis expected in the next 6 months;
* administration of another investigational drug within 30 days preceding study start, or during the study.
Effects of Manual IC With and Without SCS on SCM Tightness With FHP

The aim of this study is to compare the effects of Manual Ischemic Compression with and without Strain Counterstrain technique on CVA, ROM, pain and disability among FHP individuals with SCM tightness.

Forward head posture is defined by excessive extension at upper cervical spine(C1-C3) and flexion at lower cervical spine (C4-C7) that increases cranial rotation angle and decreases craniovertebral angle (CVA) because of the altered relative position of the head with respect to the line of gravity. The bubble inclinometer is a gravity-based tool used to measure the cervical range of motion and to assess SCM muscle length. FHP also leads to muscles imbalance and SCM tightness as well. The Numerical Pain Rating Scale (NPRS) are most frequently used to quantify pain intensity and NDI for neck disability.

A RCT study compare the effects of IC and SCS in patients with upper trapezius trigger points. For four weeks, the therapy was given three days a week. As an outcome indicator, the NPRS, NDI, and cervical lateral flexion were used. The outcome measures were evaluated at baseline, after the second week, and after the fourth week: The ischemic compression and strain counterstrain intervention, which lasted for four weeks, significantly improved cervical range of motion, reduced pain intensity, and reduced cervical disability. However, the intergroup comparison revealed that both interventions were equally effective, and none of them outperformed the others.

Most of the studies compared digital ischemic compression as a common treatment with dry needling or other soft tissue mobilizations specially to treat trapezius trigger points but there are few studies specifically investigating comparative effects of Manual Ischemic Compression with and without Strain Counterstrain for management purpose of muscle tightness in individuals with FHP. While various treatment options exist for FHP, limited research directly compares the comparative outcomes of Strain Counterstrain and Ischemic Compression techniques. Due to lack of comparative evidence regarding the efficacy of these specific interventions, there is a need to bridge this gap by investigating and comparing the effectiveness of these interventions by using highly reliable and valid outcome measures in order to provide healthcare professionals and individuals with evidence-based guidance for optimal FHP management and SCM tightness.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain (Numeric Pain Rating Scale \>3)
* Craniovertebral angle (CVA) less than 51
* Shortened SCM muscle

Exclusion Criteria:

* Neck pain with whiplash or headache, neurological disorder
* History of previous head, neck, cervical spine or shoulder surgery
* Infection or inflammatory arthritis in the cervical spine
* History of cervical radiculopathy

  * Diagnosed fibromyalgia and myopathy
  * History of cancer