cyrilzakka/clinical-trials huggingface dataset:
Interventional Study of Videoconferences Between Hospital and Municipality - a Randomized Controlled Trial

The study aims to assess whether the review of discharge planning followed by a cross-sectoral video conference in connection with discharge of medical and geriatric patients at Roskilde and Køge hospitals as well as patients from the Emergency Department at Køge Hospital reduces the proportion of patients who are readmitted within 180 days.

Project nurses at the two hospitals identifies all patients fulfilling the inclusion criteria (above 55 years of age, discharged to their own home), get informed consent and performs the video conferences. Within a few hours after discharge a video conference is held in the patient´s home including the patient,the municipal nurse and the project nurse at the hospital. During the video conference the discharge is reviewed using a structured assessment.

The survey is conducted as an open, randomized intervention study.

The study consists of two parts: First, the project nurse reviews the patients discharge together with the nurse from the hospital ward. Next, the patient is discharged from the hospital and meets the nurse from the municipality at home. Together with the patient the nurse form the municipality reviews:

* Documents from the hospital
* Medicine
* Nutrition
* Mobility
* Assessment of the need for health care services from the municipality

All patients in the project - both patients in the intervention group and patients in the control group - will receive treatment and care equivalent to normally applicable quality standards.

In 2011 4387 patients were discharged Monday to Friday from the Medical and Geriatric Departments at Roskilde and Køge Hospital to one of the seven municipalities. Of these, 1204 persons (27%) were readmitted (in any department) within 180 days. It is expected that the study demonstrates a reduction of ≥ 6 percentage points (from 27% to 21%) with a power of 80% and a significance level of 5%. There will be a need for 792 patients in both control and intervention group, ie 1584 in total.

Eligibility Criteria:
Inclusion Criteria:

* Discharge from the Medical Department and Geriatric Department at Roskilde and Køge hospitals or the Emergency Department at Køge Hospital.

Address in Køge, Greve, Faxe, Solrød, Lejre, Stevns or Roskilde municipalities. Discharges between 8 am and 4 pm Monday-Friday. Acute/subacute admission to the hospital

Exclusion Criteria:

* Patients who cannot give consent to participation. Discharge to a nursing home or relief care home. Patients with planned readmission. Former participant in the study. Patients who are included in the Sub Acute Project. Patients who needs terminal care
Adaptive Cell Phone Support to Promote Medication Adherence

The goal of this pilot clinical trial is to refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question\[s\] it aims to answer are:

* How should the intervention be designed to best fit patients' needs and preferences?
* Is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence Researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.

An initial cohort of adolescents with chronic health conditions will be asked to try the intervention and give feedback to refine the structure and content. Then, a larger cohort will progress through a sequential multiple assignment randomized trial to 1) be randomized to either automated text reminders (active control condition) or computer-delivered Cell Phone Support and then 2) those in the computer-delivered Cell Phone Support condition who do not show a sufficient response will be re-assigned to continued computer-delivered Cell Phone Support only or to Adaptive Cell Phone Support ( computer-delivered Cell Phone Support + responsive human coaching).

Eligibility Criteria:
Inclusion Criteria:

* Children's Hospital Los Angeles patient
* between 15-20 years old
* taking at least one oral medication per day for a chronic health condition
* English speaking
* demonstrating sufficient cognitive capacity to engage in the assent/consent process and study procedures
* has a cell phone

There is no exclusion criteria.
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.


Eligibility Criteria:
Inclusion criteria:

1. Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
2. Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
3. Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
4. Subjects with Performance Status (PS) 0-1.
5. Subjects with adequate organ function.

Exclusion criteria:

1. Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):

   1. Chemotherapy
   2. Biological or immunotherapies
   3. Surgery for primary focus
   4. The radiation therapy for primary focus
2. Subjects with the severe complications or disease history.
3. Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
4. Subjects with simultaneous or metachronous cancers.
5. Subjects who cannot take oral medication.
6. Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.
Pediatric Antibiotic Associated Diarrhea

Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be encountered between two hours to two months after starting of antibiotics. The purpose of the study is to determine incidence,risk factors and severity of pediatric antibiotic associated diarrhea in Turkey.

Antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients either early during treatment or up to two months after the cessation of the treatment. The frequency differs according to the definition of diarrhea, the inciting antimicrobial agent and the host factors such geriatric age, immunosuppression, prolonged hospitalization. Almost all agents, especially the the ones acting on anaerobes may cause diarrhea. Clinical presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. In Turkey still data about antibiotic associated diarrhea is not enough. Incidence and the factors that effect severity are not known.

Eligibility Criteria:
Inclusion Criteria:

* The parents and the child who give consent
* The children who are treated for the acute infections in the outpatient clinics and whole treatment is completed in the outpatient clinics.
* Children who are born mature, for the children who are younger than 1 year of age.

Exclusion Criteria:

* The parents and child who do not give consent
* Children who have primary and secondary immunosuppressive states.
* Children who had abdominal/gastrointestinal tract surgery in the past.
* Children who had used probiotics/prebiotics in the last one month period.
* Children who had used antibiotics in the last one month period.
* Children who has accompanying gastrointestinal symptoms.
* Children who are using anti-acid treatment at the time of involvement.
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Characteristics of opioid use history
* Previously received take-home naloxone
* No life-threatening illness likely to progress clinically during trial
* Able/willing to provide informed consent and locator information, communicate in English, and adhere to visit schedule

Exclusion Criteria:

* Suicidal ideation
* Participating in another interventional study that could possibly impact the study's outcomes of interest
* Planning to leave San Francisco/Boston metro area during study
* Previously exposed to REBOOT counseling intervention
* Any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Reza Band is to be worn when sleeping. The patient will put the Reza Band on at bedtime and take it off upon waking.

This is a prospective, non-randomized, open label, multicenter study designed to assess the safety and effectiveness of the Reza Band. At up to 5 investigational sites, up to 100 subjects will be enrolled.

The primary effectiveness endpoint is to be evaluated by the Reflux Symptom Index (RSI). Success is defined as \>25% reduction in the RSI at the last follow-up, as compared to the baseline RSI. The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45.

All adverse reactions being reported will be evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band. Since some subjects may report the same event several times (e.g., redness), the first occurrence of the worst reported case of the event will be used for the purpose of analysis.

The incidence of site reactions, including laryngospasm, choking, pain, cough and hoarseness will be summarized. Exact 95% confidence intervals for the incidence rate of site reactions will be presented.

Eligibility Criteria:
Inclusion Criteria:

* 18 year of age or older
* The patient must be willing and able to provide informed consent.
* Understands the clinical study requirements and is able to comply with follow-up schedule.
* Clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing)
* Reflux Symptom Index (RSI) \>13

Exclusion Criteria:

* Currently being treated with another investigational medical device and/or drug
* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
* The patient is female and is of child bearing potential and is not using an acceptable method of birth control, or is pregnant or breast feeding.
* Previous head or neck surgery or radiation
* Carotid artery disease, thyroid disease, or history of cerebral vascular disease
* Suspected esophageal cancer
* Has either a pacemaker or implanted cardioverter defibrillator (ICD)
* Nasopharyngeal cancer
* Previously undergone Nissen Fundoplication
EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL

In this study, it was aimed to determine the anxiety levels and comfort levels of the patients using stress ball in patients receiving hemodialysis treatment.

This study was conducted as a randomized controlled trial. The universe of the study consisted of 156 patients receiving HD treatment at a special hemodialysis center. The study was completed with a total of 63 patients, including 31 people in the intervention group and 32 people in the control group, who met the criteria for inclusion in the study between 27.02.2023 and 27.03.2023.

The individual demonstration form was used to collect data, the Visual Analog scale (VAS) for stress level and the hemodialysis comfort scale.

Procedures administered to intervention groups:

Patients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during the 9 (nine) hemodialysis treatment. After the last session, data collection forms will be filled out again.

Use of stress Ball

1) Place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.Squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.

3.Perform this application for a total of 30 minutes before and during hemodialysis treatment.

Procedures administered to control groups:

No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the ninth session.

Eligibility Criteria:
Inclusion Criteria:

* Who is over 18 years old
* Having been on an average of four hours of hemodialysis program, three times a week, for at least 6 months;
* Who can respond in writing or verbally to the scales applied,
* In addition to last-stage kidney disease, there is no physical deficiency,
* Can apply stress ball as shown during hemodialysis work
* Individuals who agree to participate in the research

Exclusion Criteria:

* With fistula on both arms
* People with psychiatric problems
* With nerve, soft tissue and vascular disease in the upper extremity
* Out of town during work
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.

The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.

In order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed.

Eligibility Criteria:
Inclusion Criteria:

* The patients will be limited to those from the Division of Urogynecology to ensure similar surgical techniques. They will be between the ages of 18 and 70 and undergoing major vaginal reconstruction.
* All patients must undergo vaginal reconstructive surgery including: anterior repair, posterior repair, and intraperitoneal vaginal vault suspension. The addition of vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for exclusion.

Exclusion Criteria:

* Any patient who has an allergy to hydromorphone/Dilaudid.
* Any patient already taking chronic opioids, defined as daily use.
* All patients with renal insufficiency or failure.
* All patients with liver failure.
* Any patient who is not having general anesthesia.
* Any patient undergoing abdominal or laparoscopic procedures: sacral colpopexy, laparoscopic hysterectomy or oophorectomy, Burch procedure, or any procedure that enters the abdominal fascia.
Disappearance of Graves' Orbitopathy

There is a general belief among physicians involved with Graves' orbitopathy (GO) that this syndrome is somehow "chronic", namely that the patient's eyes do not return the way they were before GO appeared.

The general impression that comes from the available studies is that the eyes of GO patients do not return to normal even after a very long time since the disease appearance under the physician's point of view, although a discrete proportion of patients feel so. However, no studies are available in which the issue was examined with both objective criteria and self-assessment.

The present study design was to investigated the disappearance of GO, regardless to treatment, in all consecutive patients with a history of GO of at least 10 years who came for a follow-up visit to our GO clinic over a period of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* All GO patients with a GO history of at least 10 years who came for a follow-up visit in our GO clinic over a period of 5 consecutive years

Exclusion Criteria:

* None
Chronic Pelvic Pain Syndrome in Males

The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome.

Volunteers who are between the ages of 20-40, diagnosed with chronic pelvic pain syndrome, and who meet the inclusion criteria will be included in the study and will be randomized into 2 groups: Group I (TENS) and Group II (ESWT).

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 20-40 years old males
2. Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion Criteria:

1. Cancer
2. Surgery related to pelvic floor

2. Receiving drug treatment
Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects. The objective of this study is to evaluate the clinical utility of the da Vinci® SP™ Surgical System, instruments and accessories in TORS benign base of tongue resection procedures for the treatment of moderate to severe OSA. da Vinci® SP™ Surgical System, instruments and accessories are the approved medical device product by MFDS (Ministry of Food and Drug Safety, Republic of Korea).

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 80 years old
* Subject with BMI ≤ 35
* Subject with moderate to severe sleep apnea, defined as 15 or more AHI events/hour
* Subject who has failed or is unable to tolerate CPAP therapy
* Subject diagnosed with OSA due to redundant base of tongue tissue
* Subject must be a suitable candidate for base of tongue resection surgery
* Subject who is willing and able to provide written informed consent
* Subject who is willing and able to comply with the study protocol requirements

Exclusion Criteria:

* Subject with a poor mouth opening or trismus
* Subject with evidence of any primary cancers or metastatic disease, other than skin cancers
* Subject who has had a surgical resection and/or chemoradiation therapy for oropharyngeal cancer
* Subject with congenital malformations in the larynx, throat or tongue
* Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
* Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
* Subject who is mentally handicapped or with a psychological disorder or severe systemic illness, that would preclude compliance with study requirements or ability to provide informed consent
* Subject is pregnant or suspected to be pregnant
Preventing Conduct Disorder in Child Welfare

A mixed methods randomized control trial was conducted to test the effectiveness of Pathways Triple P with child welfare involved families compared to treatment as usual. Outcomes tested included parenting behaviors and attitudes, and child behavior problems. 144 families were recruited into the study. Data was collected at 4 time points (baseline, 4 months, 9 months, and 18 months). Over 70% were retained from baseline to 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Families with open child protective service case following allegation of child physical abuse or neglect
* parent of child between the age of 3 and 12
* Child remained in the home following investigation
* parent spoke English

Exclusion Criteria:

* parent's child could not have chronic medical condition or have a pervasive developmental delay
Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)

PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent;
* 18 years of age and above;
* Documented histopathology or cytopathology of PCa, adenocarcinoma;
* Confirmed as mCRPC;
* Initiated olaparib + abiraterone after site activation

Exclusion Criteria:

* Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation