cyrilzakka/clinical-trials huggingface dataset:
Qol Following Management for Pediatric UI

A comparison of changes between symptoms of incontinence and pediatric quality of life will be used to draw conclusions about whether differences in quality of life are noted with changes in symptoms of incontinence.

Although positive physiological results are associated with successful treatment for bowel and bladder dysfunction and daytime incontinence (BD-UI), there are few studies examining the effects of treatment on quality of life (QoL) for children. The purpose of our study is to determine whether successful physical therapy treatment improves QoL for children with BD-UI.

Consent will be obtained from parents and assent from children. Children will be asked to complete a global, age appropriate quality of life assessment and a quality of life instrument specific to incontinence. Information will be provided by the parent through completion of a parent report instrument matched to the child's global quality of life tool as well as completion of an instrument depicting child symptoms. Clinicians will report general information about related physiological changes and progress with established outcomes individualized to the child. A repeated measures MANOVA will be used to analyze the results.

Eligibility Criteria:
Inclusion Criteria:

* Children between ages 5-18 who were currently receiving conservative treatment for daytime UI with or without constipation or encopresis met inclusion criteria.

Exclusion Criteria:

* Exclusion criteria included children who only had nocturnal enuresis or children with neurogenic bladders.
An Educational Video to Improve Patient Comprehension of Midurethral Sling

The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.


Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

Exclusion Criteria:

* \< 18 years of age
* Non-English speaking or requiring interpreter assistance
* Presence of cognitive dysfunction
* Women receiving a repeat midurethral sling (not primary)
* Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
* Pregnant women
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written consent, fluent in English;
* Healthy subjects with no medical, psychiatric or current sleep disorders;
* Men or women between 18-75 years;
* Body Mass Index of ≥ 18 and ≤ 30 kg/m2.

Exclusion Criteria:

* Major surgery, trauma, illness or immobile for 3 or more days within the past month;
* Pregnancy or recent pregnancy (within 6 weeks);
* A positive test for drugs of abuse at the screening or evaluation visit.
Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation

To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients.

This study is a clinical randomized controlled study, applying index of microcirculatory resistance (IMR) to evaluate the myocardial protection of ischemic postconditioning (IPC) in patients receiving direct PCI treatment for acute myocardial infarction.IMR is a quantitative evaluation index of microcirculation status. IPC has been reported to reduce ischemia-reperfusion injury and has a myocardial protective effect.The research plan divides patients into IPC and non-IPC groups at random. After the infarction-related artery is successfully implanted with a stent, the pressure guide wire is used to measure IMR and CFR in the state of maximal expansion of the microcirculation induced by intravenous ATP infusion.And analyze whether there are differences in indicators between the two groups and the relationship between these indicators and the patient's myocardial level reperfusion, cardiac function and prognosis.The purpose is to evaluate the myocardial protection of IPC and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients. It is expected that the target IPC can improve the IMR value, and IMR can predict the degree of myocardial reperfusion and cardiac function and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, no gender limit;
* First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned;
* Agree and cooperate to participate in this research.

Exclusion Criteria:

* Old myocardial infarction;
* Killip grade of cardiac function ≥ grade III or cardiogenic shock;
* Systolic blood pressure ≤100mmHg;
* Bradycardia, HR\<60pbm, or AVB above II degree;
* Past history of asthma or severe COPD;
* Severe liver and kidney dysfunction.
ANXA5 M2 Haplotyping in IVF Patients and Embryos

This study aims to characterize the association between history of pregnancy complications and M2 carrier status in IVF patients and the utility of M2 haplotype preimplantation genetic testing (PGT) in embryos produced by carrier couples. Participants in this study will be screened for the M2 variant. History of pregnancy complications and miscarriages will be studied in order to determine potential associations with M2 carrier-ship.

Patients consenting to participation in the study will receive a saliva collection kit for M2 testing. Genomic Prediction Clinical Laboratory will perform testing and issue a report per routine clinical procedures. Upon completion of issuing a report, the patients' medical records will be obtained from the IVF Center providing care to the patient. Information obtained may include: history of miscarriage, embryo transfer outcomes, preeclampsia, small for gestation age baby, or thrombophilia disorders.

In addition to obtaining records related to history of pregnancy complications, carrier couples will be offered the use of preimplantation genetic testing for M2 carrier status (PGT-M2) in their embryos. Patients electing to perform PGT-M2 will receive PGT-A according to standard clinical practice, along with M2 carrier status.

A total of 500 patients will complete the study and may be recruited from any IVF clinic in the United States. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by each clinic.

Eligibility Criteria:
Inclusion Criteria:

* All couples above the age of 18

Exclusion Criteria:

* Any case where biological parental DNA is unavailable.
Virtual Reality, Ice Application and Self-injection and Self-test Fair, Pain and State Anxiety

AİM:The aim of this study is to control the fears and anxieties of Type 2 diabetics in insulin injection and blood glucose measurement with motivational videos and Ice applications to be applied with virtual reality glasses.

Material and Methods: The research is designed as a semi-experimental model with pretest-posttest control groups. The research will be carried out in the endocrine services located in Turgut Özal Medical Center in Malatya province. The universe of the research will be 2113 Type 2 diabetes patients who are being treated in the hospital specified on the specified dates, who are injecting insulin and following blood sugar. According to the analysis of the power, the sample of the research is composed of an experiment effect of 0.5% with bilateral significance level, 95% confidence interval determined with 5% error level, the experiment group to be applied with 80% Reality with 80% representation power, and the control group with 80 ice application. will create a total of 240 Type 2 diabetes patients.In the collection of the data, the Participant Presentation Form developed by the researcher, Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ, State Anxiety Scale and VAS will be used.

VR is a relatively new human-computer interaction tool in which a person becomes an active participant in a virtual world. Sensory cues of VR, especially the precise control of auditory, tactile and olfactory systems, enhances the reality of the virtual environment. As a result, users feel that they can look around and enter the simulated environment. The virtual environment provides sensory information such as visual, auditory, movement, virtual or artificial, and makes the individual feel similar to real life.

Ice application has been used as a topical pain reliever for centuries. It works through a variety of mechanisms, such as slowing the transmission of peripheral nerve fibers, promoting sensory competition, and reducing the release of inflammatory and nociceptive mediators. Ice application is cheap, easily accessible and reaches its purpose relatively quickly to skin anesthesia. Apart from these effects, it also reduces pain by activating the Door-Control mechanism, stimulating the touch receptors and increasing the release of endogenous opioids.

Eligibility Criteria:
Inclusion Criteria:

* Being literate,
* Injecting insulin at least twice a day,
* Following blood sugar at least twice a day,

Exclusion Criteria:

* Having any psychiatric diagnosis,

  * communication barriers
  * The patient has any diagnosis, such as epilepsy, that will trigger seizures.
  * Any diagnosis, such as vertigo, that causes dizziness in the patient.
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review
* No prior treatment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* Grade 3b follicular lymphoma
* Transformation to high-grade lymphoma secondary to follicular lymphoma
* Types of Non-Hodgkin's lymphoma other than follicular lymphoma
* Presence or history of central nervous system (CNS) disease
* Corticoid therapy during the last 4 weeks, except prednisone treatment less than (\<) 20 milligrams per day (mg per day)
* Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
Mechanisms Regulating Wound Vascularization

This pilot study is designed to assess the impact of ischemia/ diminished wound vascularization and stress on wound healing by comparing patterns of gene expression in specific cell types critical to wound healing biology, e.g. macrophages or endothelial cells.

Chronic wounds affect approximately 2% of the U.S. population at any given time. Animal models can not simulate the complex set of pre-existing conditions in each individual that results in failed wound healing. Therefore, human subjects must be used to obtain valid data. Adequate wound vascularization that permits blood vessels to deliver oxygen to the wound is a requirement for wound healing to occur. This protocol will attempt to gain greater understanding of the mechanisms of chronic wounds through 3 specific aims: 1) identify the angiogenic mechanisms in wound site macrophages, which are required for healing, 2) determine the impact of stress and glucocorticoid resistance on endothelial cell and macrophage biology and ultimately wound healing outcomes, 3) identify patterns of gene expression in wound endothelial cells that are found in healing versus non-healing wounds. This data will be correlated with the wound oxygenation status to determine the impact of wound vascularization on the observed biological responses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-69 years
* ischemic wound group
* non-ischemic wound group
* diabetes with good glycemic control
* lower extremity wound

Exclusion Criteria:

* Age greater ≥ 70 years
* End stage renal disease
* Unable to provide informed consent
* Pregnant women
* Therapeutically anticoagulated
* Prisoners
* Periwound TcOM \< 25mmHg
* Spinal cord injury
* Taking immunosuppressive medications
* Individuals with current diagnosis of a major psychiatric illness (e.g.schizophrenia,psychosis)
* Severe protein malnutrition- pre-albumin \< 10 mg/dl or albumin \< 2 g/dl
* Diabetes with poor glucose control-defined as hgb A1c \> 8.4%
Effects of Volatile and Intravenous Anesthetics on Pupillary Function

To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children

The investigator will measure the pupillary function with pupillometry during general anesthesia with volatile or intravenous anesthetics in children.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing general anesthesia

Exclusion Criteria:

* If injection of any agents that can change pupil size or index
* Any severe side effects, adverse drug reaction
Safety and Efficacy Evaluation of Insight GS Growing System

Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.

The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).

Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.

Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* TCLE signed by parents
* Ages 3 to 10 years, or Risser 0, or Sanders 1,2,3 and 4
* Cobb angle bigger than 30°
* Thoracic spine height T1-T12 less than 22 centimeters
* Risk of thoracic insufficiency syndrome (TIS).

Exclusion Criteria:

* Need for fixation at occipital or cervical levels
* Risser sign greater than or equal to 1
* Sanders bigger than 4
* Previous spine surgery
* Medullary abnormalities
* Existence of malignant processes
* Local or systemic inflammations and infections, acute or chronic
* Allergy or intolerance to materials
* Non-reducible scoliosis
* Morbid obesity
* Insufficiency or absence of skin coverage
Residual Tubal Tissue on the Ovarian Surface Following Salpingectomy With Laparoscopy and Laparotomy

Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included. Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded. Laparoscopy and laparotomy groups will be compared in terms of fibril tissue remnants on the ovarian surface.

Histopathologic data have revealed that up to 70% of ovarian cancers may actually arise from the fallopian tube. Thus, opportunistic bilateral salpingectomy is now promoted for women at the time of hysterectomy for a benign disease. In turn, the potential surgical risks and ovarian cancer prevention of this emerging practice have generated multiple studies, some of which reported microscopic fimbriae were left behind adherent to the ovary. Although it is thought that there is no direct connection between the ovary and its adjacent fallopian tube, the investigators often find remnants of the fimbria adherent to the ovary at the time of surgery. If this tubo-ovarian interface is not separate, then practices such as salpingectomy and radical fimbriectomy may be incomplete, and the effectiveness of this technique as a prophylactic strategy may need reconsideration. In this study, the investigators aim to assess the presence of residual fimbrial/tubal tissue on ovarian surfaces following salpingectomy and to discuss the efficacy of this procedure on the reduction of epithelial ovarian cancer. Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included. Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded. Salpingectomy with or without hysterectomy, as indicated, will be performed initially. This will be followed by bilateral oophorectomy as a second step within the same procedure. The ovaries and tubes removed will be sent in separately labelled containers: right tube, left tube, right ovary and left ovary. Histological assessment will be performed by gynecological pathologists. The fallopian tubes will be sectioned serially and ovaries will also be serially sectioned and examined for presence of any remnant tubal tissue.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included.

Exclusion Criteria:

* Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded.
Amino Acid Loss During Continuous Renal Replacement Therapy

The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are:

What amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy?

Amino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.

In order to quantify the amount of amino acids lost via the continuous renal replacement (CRRT) machine, it is warranted to measure amino acid concentrations in the blood and effluent over the entire treatment period.

To this end, 20 intensive care patients will be examined throughout the entire duration of CRRT as part of this exploratory non-interventional study. Additionally, 10 intensive care patients without renal replacement therapy will be enrolled. In the CRRT-group amino acid loss through the effluent will be measured at different time points. Amino acid plasma concentrations will be determined in both groups. Amino acid urine concentration, nitrogen balance, as well as blood urea nitrogen, creatinine and albumin in the plasma will be measured as secondary outcome parameters. Additionally, observations regarding nutritional status and mobility (indirect calorimetry, bioimpedance analysis, ultrasound muscle and adipose tissue thickness, strength and mobility scoring) will be analyzed as exploratory secondary outcomes.

Duration of CRRT, length of intensive care and hospital stay as well as mortality will be monitored.

High-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine.

To answer the primary research question, change in amino acid plasma concentrations and effluent loss between treatment start and day 4 of continuous renal replacement therapy will be analysed using a two-sided Wilcoxon signed rank test.

Eligibility Criteria:
Inclusion criteria:

* Postoperative ICU patients
* Age ≥ 18 years
* Patients on enteral or/and parenteral nutrition given according to internal standard operating procedure

A) CRRT group:

- CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))

B)Non-CRRT group:

* no current or previous (\<30 days) continuous or intermittent RRT
* no chronic kidney disease stage G3-G5

Exclusion criteria:

* Preoperative intensive care patients
* Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification
* Patients with acute liver failure