cyrilzakka/clinical-trials huggingface dataset:
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Combination of oral antibiotics and mechanical bowel preparation was reported with lower SSIs and LOS in some retrospecitve data analysis, however a prospective randmized controlled trial was absent. Herein, the current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.

Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Colonic bacterial flora is the major cause of SSIs after elective colorectal procedures. For more than century, preoperative mechanical bowel preparation (MBP) has been utilized as it could theoretically decrease bacterial load within the surgical field, thus reduce risk of SSIs. Later afterwards with widely application of antibiotics, combination of oral antibiotics (OA) and MBP was conducted by surgeons to further decrease rates of SSIs. But SSIs still occurs despite of forehead mentioned methods, the best bowel preparation mode remains controversial. Since 2005, several RCTs and meta-analysises demonstrated MBP alone was not associated with reduced SSIs compared with no bowel preparation, while postoperative ileus, anastomotic leakage and other complications incidence increased paradoxically. Nevertheless, function of preoperative oral antibiotics remains debated. Recently, combination of oral antibiotics and MBP has been evaluated in several retrospective studies and demonstrated a significant decrease in the rate of SSIs. However, bias existence in these trials may affect result as information was exacted from national database without detailed matching. Herein, current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old，
* Undergoing laparoscopic colorectal surgery due to malignancy.

Exclusion Criteria:

* No elective surgery
* Intra-abdominal infection
* Combination of other infectious surgery such as appendectomy, cholecystomy
* Sever comobidity such as uncontrolled hypertention and diabetes mellitus
* Peritoneal implantation and matastasis
* Radiotherapy history.
* Colorectal surgery due to benign lesions
* Allergic to antibiotics or PEG
* Preoperative dermatosis may interfere wound healing
* Long time application of corticosteroid
* Autoimmune disease may affect wound healing
* Patients refuse to enroll
Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer

The purpose of this project is to develop and test an integrated mHealth learning program (L-mHealth program) for gynecological cancer that integrates effective educational strategies and mobile health application to meet the learning needs of Taiwanese Women with Gynecological Cancer (WGC) through the process of co-creation, with the active input of WGC and experts' directly impacting content and design. This project was to develop the L-mHealth system and prototype of a smartphone app for WGC through the process of co-creation, with the active input of WGC and experts' directly impacting content and design.

The second year research purpose is to establish the L-mHealth program's framework, which according to the needs assessment and health education strategies of the first year. The L-mHealth system will be then developed according to the course framework use TTM theory and self-efficacy theory as the basis. A single-blinded, randomized controlled parallel-group clinical trial with repeated- measures research will be conducted in the third year. A total of 120 ovarian cancer women will be recruited from a medical center in northern Taiwan and then assigned to one of two groups (the experiment and control groups) by stratified randomization. Women were randomized either to the intervention group (n=60) receiving the L-mHealth program plus care as usual or the control group (n=60) receiving care as usual alone. Data will be collected at baseline (T0), 1 months (T1) and 3 months (T2) after the intervention. Co-creation is a user-involved process that can create a useful and customized product for the WGC target population. As such, this process is a beneficial process to tilize when addressing the specific needs of WGC. Through the study of the L-mHealth program, it is expected to improve women's use of ICT and demonstrate its potential as an effective and easily accessible intervention to promote women's symptom interference and quality of life for WGC.

Eligibility Criteria:
Inclusion Criteria:

1. Women definitively or suspected to be diagnosed with ovarian cancer, with the cancer staged at Stage 3 or below.
2. Women receiving surgery, chemotherapy, or immunotherapy at the recruiting hospital.

3.20 to 70 years old. 4.Possesses and is able to use an internet-enabled mobile device (such as a smartphone or tablet).

5.Able to clearly communicate and read/write in Mandarin or Taiwanese. 6.Agrees to participate in the study and signs the informed consent form.

Exclusion Criteria:

1. History of other malignant tumors.
2. Intellectual disability or mental disorders.
Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.

Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group.

Primary Outcome

* Peyronie's Disease Questionnaire (PDQ)
* Visual Analogue Scale score (VAS)
* International Index of Erectile Function 5 (IEFF-5)
* Penile curve measurements (gold standard) on pictures before and after treatment
* Plaque size

Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months.

A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization.

All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.


Eligibility Criteria:
Inclusion Criteria:

* PD for more than 6 months
* Penile curve greater than 30 degrees and less than 90 degrees
* Age 18-80
* No previous penile surgery
* Informed consent
* Able to speak and understand Danish

Exclusion Criteria:

* Penile curve greater than 90 degrees
* Previous surgery for PD
* Patients undergoing other interventions for PD
Maximal Effort-dependent Respiratory Flow Rates

The general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.

1. Reproducibility and reference values in normal subjects: the investigators will propose a method for measurement of the maximal inspiratory flow rates (MIFR) and establish their reproducibility in normal subjects. The variability of these inspiratory flow rates will be compared with the variability of effort dependent and non-effort dependent expiratory flow rates.

   Also, reference equations will be drawn up and compared to the only existing set of reference values (2) (needing a revision).
2. Reproducibility in disease: the investigators will evaluate the reproducibility of the MIFR in patients with neuromuscular diseases (Steinert muscular dystrophy, amyotrophic lateral sclerosis) and with upper airway obstruction (tracheal stenosis, thyroid enlargement) and compare to the reproducibility of expiratory flow rates in this population.
3. Monitoring of diseases: In the neuromuscular patients MIFR will be correlated to the existing parameters used for monitoring of these diseases (respiratory muscle strength, forced vital capacity), with a longitudinal follow-up.

In the patients with upper airway obstruction the MIFR (quantitative measurement) will be compared to the visual inspection (qualitative interpretation) of the maximal flow-volume loop and also the evolution after a therapeutic intervention (airway stenting, thyroidectomy) will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* healthy hospital workers or visitors

Exclusion Criteria:

* current smokers or ex-smokers with a history of \> 80 PY
* Presence or history of serious illness or thorax deformity (questionnaire)
* recent respiratory tract infection (1 week)
Cognitive-Behavior Therapy for Insomnia

Insomnia is a prevalent public health problem affecting large segments of the population on an occasional, recurrent, or chronic basis. Persistent insomnia is associated with impairments in daytime functioning, reduced quality of life, and increased health-care costs. Despite evidence that cognitive-behavior therapy (CBT) is an effective and well accepted treatment for insomnia, a significant proportion of individuals do not respond adequately to this treatment. Hence, there is a need to identify the active therapy components and mechanisms of change in order to develop more effective therapeutic approaches and optimize outcomes. The specific aims of the proposed study are to (a) evaluate the effects of behavioral versus cognitive therapies for insomnia and associated daytime impairment, (b) investigate the mechanisms of change and, (c) examine the impact of insomnia therapies on psychiatric conditions commonly associated with insomnia (anxiety disorders and depression). A sample of 186 adults with chronic insomnia will be recruited from two sites (Laval University and University of California, Berkeley). Participants will be randomly assigned to one of three groups: (a) behavior therapy (BT; n = 62), (b) cognitive therapy (CT; n = 62), or (c) cognitive-behavior therapy (CBT; n = 62). Measures of outcome (sleep/insomnia, daytime functioning) will be administered at baseline, end of treatment, and at 6- and 12-month follow up. Measures of mechanisms of change (maladaptive sleep habits, unhelpful beliefs, sleep-related worry) will be administered at baseline, after the 4th and 8th therapy sessions, and at the end of treatment. It is expected that (1) BT and CBT will be more effective for improving sleep, relative to CT, (2) CT and CBT will be more effective for reducing daytime functional impairment, relative to BT and (3)CT will be more effective than BT in reducing comorbid psychiatric disorders. The public health significance of the proposed study is that it will provide useful information to improve our understanding of insomnia and to enhance efficacy and efficiency of therapeutic approaches for a prevalent and costly health problem. The long-term objective is to contribute to the development and dissemination of evidence-based treatments for chronic insomnia and its common comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Aged 25 years old or older
* Chronic insomnia(\> 6 months)
* 3 nights or more per week with difficulties falling or staying asleep

Exclusion Criteria:

* Progressive or unstable medical condition directly interfering with sleep
* History of psychosis or bipolar disorder
* Alcohol/substance abuse within the past 12 months
* Use of medications interfering with sleep
* Presence of another sleep disorder (e.g., sleep apnea, restless legs syndrome/periodic limb movements)
* Irregular sleep-wake schedule
Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

In general, the percentage of complete remissions is 85 - 90 % for acute lymphoid leukemia (ALL). In developing countries, percentages are lower secondary to higher sepsis-related mortality. Although the effect of statins on inflammatory response associated with sepsis has been demonstrated, including an effect on bacterial proliferation in patients with a state of immunosuppression, their effect has not been demonstrated so far in patients with hemato-oncological cancer.

Death associated with sepsis is one of the principal complications related to chemotherapy treatment; there are currently no strategies to prevent its development besides the use of prophylactic antibiotics or granulocyte colony stimulants to reduce the period of febrile neutropenia. Most of the trials on the use of statins are retrospective with controversial results and include patients with different clinical situations that conditioned the septic study.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute leukemia under treatment of a chemotherapy regimen
* Stable performance status (ECOG: 0 or Karnofsky scale greater than 80%) at time of analysis and under chemotherapy regimen
* Life expectancy greater than 48 hours after diagnosis
* Oral route available
* Have signed informed consent at the time of the study
* Patients whose chemotherapy regimen is administered in a hospital rather than an outpatient manner

Exclusion Criteria:

* Patients with acute leukemias over 55 years of age and with impaired functional status at the time of diagnosis
* Elevation of liver enzymes 3 times higher than the range established by the central laboratory
* Persistent kidney involvement despite having adequate hydration
* Pregnant patients
* Patients with peripheral neuropathy considered severe or disabling grade
* Patients with a history of psychiatric disorders or psychotic attacks
* Individuals who do not have the oral route available, who are maintained with a nasogastric tube, or who require support for the diagnosis through parenteral nutrition
* Patients undergoing peritoneal dialysis or hemodialysis treatment
* Patients with leukemia associated with Down syndrome
* Patients under low-intensity chemotherapy regimen or palliative regimen
* Previous allergy to any statin component
* Patients with a history of liver failure (Child-Pugh Stage B or C)
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer

The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
* Adequate organ function (section 3.1.10).
* ECOG performance status 0-2.
* Life expectancy of \>=12 weeks.
* Systemic chemotherapy washout period \>=7 days.

Exclusion Criteria:

Patients who have previously been treated with whole brain irradiation, pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent.
Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing

Three patients were recruited for assessment of ICG fluorescence in burns.

The early determination of healing potential in indeterminate thickness burns may be difficult to establish by visual inspection alone, even for experienced burn practitioners. This case series explores the use of indocyanine green (ICG) fluorescence using portable bedside assessment as a potential tool for early determination of burn depth. Three subjects with indeterminate thickness burns had daily perfusion assessment using ICG fluorescence assessment using the SPY machine (SPY®, Lifecell Corp., NJ, USA) in addition to standard burn care. The fluorescence was quantified as a percentage of the perfusion of intact skin, and areas of hypo and hyper-perfusion were indicated. The burn surgeon, blinded to the ICG results, made a clinical determination of the need for skin grafting or discharge. The perfusion in areas of differing depth of burn were compared over the entire study period to determine both the magnitude of difference, and the point in the time course of healing when these changes became evident.

Eligibility Criteria:
Inclusion Criteria:

* patients with burn less than 15% TBSA

Exclusion Criteria:

* none
CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been proven to be effective in the prevention and treatment of breast cancer.

Studies showed the CYP2D6 gene has more than 100 variants; some of which are linked with reduced drug activity, while others do not have any pathological implications. The metabolizer profile of these variants is generally grouped into Ultra-rapid, Normal, Intermediate, and Poor Metabolizers (UM, NM, IM, and PM, respectively). In our previous study (NCT04312347), the investigators recruited 150 breast cancer patients who were taking adjusted dose of tamoxifen daily based on their CYP2D6 phenotype. Although the investigators have measured the endoxifen level of the patients with adjusted treatment, the clinical outcomes of the study are not yet conclusive.


Eligibility Criteria:
Inclusion Criteria:

1. female
2. diagnosed with ER+ breast cancer
3. have been genotyped and classified as PM and IM in the previous study
4. are recommended by doctor to take tamoxifen 40 mg according to their metabolizer profile
5. have finished the definitive therapy course (surgery, chemotherapy, or radiotherapy).

Exclusion Criteria:

1. have other primary cancer aside from breast cancer.
2. those with residual tumor cells/have experienced second primary breast tumor.
3. patients who are recommended by doctor to switch to aromatase inhibitors (AI)
Decoding the Genetic Landscape of Skeletal Diseases

This 5-year project aims to (1) search for genetic causes for yet unsolved congenital skeletal disorders (GSDs); (2) study consequences of the newly identified pathogenic variants in cells and in transgenic mice, (3) summarize data on natural course and complications for different GSD groups. For patients with unsolved GSD, the investigators search for molecular causes of GSDs using whole genome sequencing (WGS) and total ribonucleic acid (RNA) sequencing. Candidate gene variants are selected using genome or transcriptome sequencing data, clinical findings and screening of omics databases. Causality of the new variants is studied in cells and in transgenic mice models. Molecular and clinical findings are summarized for different GSD groups.

Genetic skeletal disorders (GSDs) are a large group of rare diseases caused by abnormalities in genes regulating skeletal development. This 5-year project aims to (1) search for genetic causes for yet unsolved congenital skeletal disorders; (2) study consequences of the newly identified pathogenic variants in cells and in transgenic mice, (3) summarize data on natural course and complications for different GSD groups. The project is a collaboration between the Dept of Clinical Genetics, Karolinska University Hospital, Lab of Clinical Genetics and Lab of Bone and Cartilage Physiology, Karolinska Institutet and Sahlgrenska Academy. In a well-characterized group of 300 GSD participants whose DNA samples were analyzed using whole genome sequencing (WGS), there are 120 study participants with unsolved diagnoses. For those participants, we search for molecular causes of GSDs using WGS and total RNA sequencing. Candidate gene variants are selected using genome or transcriptome sequencing data, clinical findings and screening of omics databases. Causality of the new variants is studied in cells and in transgenic mice models. Molecular and clinical findings are summarized for different GSD groups. Our results improve diagnostics for GSDs, advance knowledge on pathogenesis and help establishing new individual follow-up and treatment strategies for patients with GSDs. This project increases understanding of skeletal pathophysiology and will contribute to the development of novel treatment methods for skeletal diseases.

Eligibility Criteria:
Inclusion Criteria:

Clinically suspected skeletal dysplasia based on previous investigations

Abnormal height

Radiographic abnormalities of the skeleton in addition to other syndromic features

Healthy relatives of the affected study participants

Exclusion Criteria:

No radiographic data available from clinical investigations

Suspected environmental or multifactorial causes
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patients, 18-60 years of age
* Diabetic for \>2 years
* Treated with CSII for \>=6 months
* HbA1c \<8.5%

Exclusion Criteria:

* Treatment with daily insulin injections
* Inability to handle pump therapy
* Untreated retinopathy