cyrilzakka/clinical-trials huggingface dataset:
Severe Neutropenia After HIPEC Using Mitomycin-C

Mitomycin-C (MMC) is the most commonly used chemotherapeutic agent for hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) to treat colorectal cancer patients with peritoneal metastases. However, MMC has a side effect of myelosuppression. Particularly, severe neutropenia after CRS with HIPEC can be a life-threatening condition. Despite the postoperative risks of this side effect, the causes and risk factors for severe neutropenia after CRS followed by HIPEC is not identified so far. Therefore, in this study, we aimed to evaluate to evaluate clinical risk factors and pharmacologic properties after CRS with HIPEC using MMC in patients with colorectal cancer or appendiceal mucinous neoplasms with peritoneal metastases.

Evaluation parameters

1. Preoperative period

   * Obtaining informed consent
   * Assessment of baseline clinical characteristics: vital sign, BMI, BSA, ASA classification, ECOG, CBC, CEA level
   * Before 1 day of surgery, assessment of QoR-40 questionnaires
2. Intra-operative period

   * CRS / HIPEC
   * Assessment for peritoneal cancer index, complete cytoreduction score
   * HIPEC procedures: HIPEC was performed using MMC 35 mg/m2 at 41-43℃ for 90 min. Following the HIPEC triple method, MMC 35 mg/m2 was mixed with 3L of Physioneal PD-2 1.5% peritoneal dialysis solution and administered into the intraperitoneal cavity at 50% of the dose at the beginning of HIPEC, 25% of the dose at 30 min, and 25% of the dose at 60 min.
   * Intraoperative samplings of blood and peritoneal fluids during HIPEC :

     * Blood sampling of 5 ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90, 120 min)
     * Peritoneal fluid sampling of 5 ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90 min)
3. Postoperative period : Postoperative assessment until the discharge date or postoperative 14th days.

   * Daily assessment before discharge : vital sign, transfusion, neutropenia occurrence, adverse events, hematologic blood test (CBC, absolute neutrophil count (ANC), postoperative complications, use of G-CSF, ICU admission (If severe neutropenia occurs in the postoperative period, the patient assigns in arm I.)
   * CEA level: postoperative 5th day
   * QoR-40 questionnaires: postoperative 4th and 7th days

Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form
* Patients who diagnosed colorectal cancer or appendiceal mucinous neoplasm with peritoneal metastases
* Patients who undergo CRS/HIPEC using MMC
* ECOG ≤ 1

Exclusion Criteria

* Patients who received synchronous operations for liver or lung metastatic sites during CRS/HIPEC
* Previous histories who underwent CRS/HIPEC
* Patients who received palliative 3rd line chemotherapy
* Patients who received chemotherapy within 1 year to treat other cancers
* Patients who had PCD cathethers for ascites control
* ECOG ≥2
* Infectious status
* Age\<19 years old
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

Drop-out criteria

- Hospital stay \> 30 days
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone the Fontan procedure (regardless of type of Fontan connection or presence or absence of a fenestration)
* Age 8.0 to 35.0 years
* Stable clinical condition over the last 3 months (i.e. No change in medication, treatments, or development of new symptoms)
* Ability to perform exercise testing
* Consent and assent (as appropriate to participate in the study after receiving information concerning procedures, risks, and possible clinical benefits) o Patients will be enrolled without regard to gender, race, and ethnicity. All patients meeting study eligibility will be approached for consent.

Exclusion Criteria:

* Severe heart failure (New York Heart Association functional class III or IV)
* Presence of liver or renal dysfunction based on the latest lab test results
* Presence of hearing or visual deficit
* Transcutaneous arterial blood oxygen saturation (SaO2) \<80% at rest
* History of echocardiographic, MRI, or angiographic evidence of Fontan pathway obstruction
* History of exercise-induced life-threatening arrhythmias or unstable rhythm(i.e. atrial flutter)
* Known or suspected pregnancy. Females in the reproductive age group will be screened for pregnancy using serum beta hCG prior to administering study drug.
* Patients on open label sildenafil or tadalafil
Interleukin 20 and Periodontal Tisuue Destruction

Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction.

In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels


Eligibility Criteria:
Inclusion Criteria:

* The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth

Exclusion Criteria:

* smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months
Body Water Content in Cyanotic Congenital Heart Disease

Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proANP) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. The purpose of this study is to characterize adults with cyanotic congenital heart defects with respect to their body composition (water and fat-free mass) and resting metabolic rates. The study consists of several measures of how much body water, fat and lean tissue a subject has, and measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic congenital heart disease will be recruited along with healthy noncyanotic control subjects matched for age, gender, and body weight.


Eligibility Criteria:
Inclusion Criteria:

* Resting blood pressure below 140/90
Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga Among Older Adults

The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. Participants will be offered weekly visits for 12 weeks to receive combined treatments. Participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. At the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.

This study consists of a single-arm clinical study among 30 older adults taking benzodiazepine receptor antagonists (BRZA) to assess the feasibility of protocol-driven BRZA deprescribing augmented with combined acupuncture and yoga. Adults 65 years or older that are taking BRZA will be recruited. Deprescribing will be provided at weekly visits with a psychiatric nurse practitioner at the Osher Center for Integrative Health at Vanderbilt University Medical Center. Participants will receive acupuncture and yoga from a staff acupuncturist and yoga instruction from a yoga instructor at the Osher Center. Feasibility of study enrollment will occur through the study enrollment period. Feasibility of study treatments will be evaluated during and after study treatment delivery. Feasibility of study outcome assessments will occur at baseline, 4, 8, and 12 weeks. Throughout the research process, investigators will engage a Stakeholder Advisory Panel consisting of patients and clinicians.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month
* English speaking
* Ability to understand study procedures and to comply with them for the length of the study

Exclusion Criteria:

* Cognitive impairment
* Drinking more than 3 alcoholic beverages per day
* Substance abuse disorder
* Uncontrolled psychiatric disorder, such as major depression or psychosis
* Inability or unwillingness of individual or legal guardian.representative to give written informed consent.
Determining Dysphagia Awareness in Caregivers

Genetic, neuromuscular, gastrointestinal, cardiorespiratory diseases and congenital abnormalities can cause dysphagia in children (1, 2). Various symptoms such as coughing during or after feeding, vomiting, recurrent lung infections, inability to gaining weight, difficulty in oromotor control, nasal regurgitation, and prolonged feeding time can be seen in children whose growth and development are affected due to dysphagia (3).

The primary aim of dysphagia rehabilitation is; gaining a child's age-appropriate nutritional experience by ensuring safe swallowing; supporting growth and development (1). Rehabilitation consists of active or passive oral motor exercises, sensory training, thickened fluids, positioning and their combinations (4, 5). The caregiver is one of the most important partners of the rehabilitation program and should apply feding modifications and positioning for safe swallowing during each feeding. In addition, the exercise approaches recommended by the health personnel should be performed in order to improve the swallowing function at certain times of the day (5).

According to a study in patients with neurologenic caregivers' failure to comply with dysphagia strategies; chest infections, aspiration pneumonia, prolongation of hospital stay, and adverse clinical outcomes resulting in death (6). Therefore, the role of caregivers is very important in the perisistence and success of rehabilitation is great. The level of knowledge and awareness of the caregiver directly affects the rehabilitation effectiveness.

The knowledge and awareness of the caregiver directly affects the effectiveness of rehabilitation, as it is the caregiver who is most interested and spends time with the child. The caregiver, who has knowledge about dysphagia, symptoms and management, will give the necessary importance to rehabilitation and will be more aware of the child's existing condition. Thus, communication with health personnel will be strengthened, effectiveness of rehabilitation will increase. The aim of this study; to determine the level of knowledge of the caregiver about dysphagias and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Persons who provided primary care for children younger than 18 years with dysphagia

Exclusion Criteria:

* Doesn't accept to participate to study
The Effects of Acupuncture on Insomnia Among Midlife Women

Aims: To explore the effects of acupuncture on the improvement of insomnia, fatigue, depression and menopausal symptoms among midlife women.

This research is a study with a randomized clinical trial. Participants were 40-60 years old with a sleep disturbance which persists more than one month. Twenty participants were randomly assigned into the experimental and control groups. The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance; the control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance. All participants received pre-test and post-test, including sleep multiple physiological examination (PSG), Pittsburgh sleep quality table, Epworth sleepiness scale, hospital anxiety depression scale, menopausal symptom questionnaire, sleep disturbance comprehensive scale, and wore Actiwatch for three days. Data analysis was performed using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 40-60 years
* Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning
* The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points

Exclusion Criteria:

* History of psychiatric disorders
* History of sleep apnea or nocturnal myoclonus
* Center or neurodegenerative disease
* Cancer
* Melatonin or sleeping pills use in the past month
Effect of Sarcopenia on HCC After Lenvatinib and Anti-PD-1 Treatment

Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with lenvatinib and anti-PD1.

By tracking the short-term and long-term results of HCC patients treated with lenvatinib and anti-PD1,the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after systemic treatment was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.All implementation details are based on the newest EWGSOP definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes, the differences were analyzed and the relationship between sarcopenia and prognosis of systemic treatment was explored.

Eligibility Criteria:
Inclusion Criteria:

Patients with clinical diagnosis of liver cancer

* No cancer other than liver cancer has been diagnosed
* Age ≥18 years

Exclusion Criteria:

* Patients who could not complete the standard tests and questionnaires
* Patients received other therapies
* Patients who had other causes of muscle weakness (injury, fracture, stroke, etc.)
* Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery.

The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days.


Eligibility Criteria:
Inclusion Criteria:

* The patient had no systemic diseases, no taken opioids for a long period, no current infections or acute pericoronitis, no smoke or drink alcohol, no pregnancy, the absence of allergy to penicillin and presence of penicillin allergy.

Exclusion Criteria:

* pericoronitis, no inflammation
Weighted Blankets With Infants With NAS

Infants with neonatal abstinence syndrome (NAS) who are cared for in a Neonatal Intensive Care Unit (NICU) often display symptoms including hyperactivity, irritability, jitteriness, poor feeding, and poor sleep patterns. The recommended first line of treatment to relieve these symptoms involves nonpharmacological interventions. The purpose of the current pilot study is to provide preliminary data to assist in the design of a larger scale study to examine one nonpharmacological intervention, weighted blankets. The pilot study will assess the feasibility of a cross-over randomized controlled design to study the impact of a weighted blanket on infants' symptoms of NAS.

The aims of the study are:

Aim1: To determine the feasibility of recruiting patients for a study evaluating the use of weighted blankets in the care of infants with NAS Aim 2: To determine the feasibility and safety of the study procedures Aim 3: To examine whether there is clinical benefit to using weighted blankets for the treatment of symptoms in infants with NAS.

After informed consent is obtained, infants will be randomized to have either a weighted blanket or a non-weighted blanket placed on them first. A cross-over design will be used so all infants will experience both the non-weighted and weighted blankets. Thirty minutes before each feeding, baseline vital signs and Finnegan score will be obtained. Then, a blanket (weighted or non-weighted) will be placed on the infant for 30 minutes. Infants will be directly monitored and on heart rate/respiratory rate monitors while the blanket is applied. Vital signs and Finnegan scores will be obtained at the end of 30 minutes of blanket placement, infants will be fed, and vital signs and Finnegan scores will be obtained again 30 minutes after the blanket was removed. Descriptive statistics will be used to determine the enrollment rate and feasibility of the protocol. Nonparametric statistics will be used to compare total Finnegan scores for infants with the weighted blanket applied compared to infants with a non-weighted blanket applied. Changes in Finnegan scores will be examined to estimate an effect size to use in a power analysis for a future larger effectiveness study.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the NICU
* Gestational age \> 37 weeks
* Positive maternal drug screen at delivery

Exclusion Criteria:

* Clinical staff does not give permission to enroll the patient
* Had intrauterine growth restriction (IUGR)
* Has any medical diagnosis in addition to NAS diagnosis
* Has a weight below the 10th percentile
ClearWay Rx Readmission Registry

The purpose of this registry is to determine if delivery of weight adjusted, in a large dose with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for primary coronary intervention lowers readmission rate. This is done in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and determine whether or not the patient was readmitted within 30 days, related to the index procedure.

The primary goal of this registry is to prospectively assess if delivery of weight adjusted, bolus only with either abcixmab or eptifibitide through the ClearWay™ RX in patients admitted for primary PCI lowers readmission rate in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.

The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. The ClearWay™ RX creates a low pressure fluid layer that surrounds the balloon, allowing more effective delivery of a prescribed therapeutic agent, without excessive stress and uncontrollable mechanical disruption seen with more traditional elastomeric devices. In addition, the ClearWay™ RX is a low pressure irrigating balloon system and non-compliant balloon that limits the amount of mechanical stress on the vessel wall.

The objective of this prospective registry is to evaluate whether intracoronary (IC) delivery of Glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) during Primary Coronary Intervention (PCI) can reduce the likelihood of 30 day readmissions as a result of the original coronary intervention. Intracoronary delivery of GP IIb/IIa inhibitor Abciximab in ST Elevation Myocardial Infarction has shown to reduce myocardial infarct size, no reflow or slow flow, improve TIMI flow and Myocardial Blush Grade2,3. The ICE trial4 (N=376) compared IC delivery of GP IIb/IIa inhibitor Eptifibitide bolus only administration, bolus with maintenance infusion of Eptifibitide, to standard intravenous (IV) bolus with maintenance infusion. At 24 month follow up, the Major Adverse Coronary Events (MACE) rate was lower in the IC bolus only group (2.5%) versus IC bolus and maintenance infusion (5.8%), and IV bolus with maintenance infusion (10.8%). Further, target lesion revascularization, and readmission rates were significantly lower in the IC bolus only arm, (10.9% versus 16.8% and 28% respectively).

Eligibility Criteria:
Inclusion Criteria:

* Acute Coronary Syndrome (ST elevation myocardial infarction or Non ST elevation myocardial infarction) patients requiring the use of the ClearWay™ Rx local therapeutic infusion catheter for intracoronary delivery of GP IIb/IIIa inhibitor.

Exclusion Criteria:

* Patients not meeting the above inclusion criterion