cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants

Existing measures to prevent intraventricular hemorrhage in preterm infants include preventing premature delivery, pre-natal administration of corticosteroid, active treatment of chorioamnionitis, and improvement of postnatal resuscitation and transfer process. Many overseas studies show that nursing care can reduce the risk of intraventricular hemorrhage and death, but there is no such study in Taiwan.

Objective: to explore the effect of bundle nursing care on prevention of IVH in premature infants.

A quasi-experimental study design was employed and a total of 230 preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks will be recruited at the neonatal intensive care unit of National Taiwan University Hospital. The infants will be divided into 200 in the control group and 30 in the experimental group. Enrollment began after approval was granted by the Institutional Review Board. Eligible hospitalized preterm infants that met the inclusion criteria from January 2017 to December 2029 were selected for the control group by retrospective cohort and matched by the gestational age, birth weight and delivery method with the experimental group. The experimental group received bundle nursing care within 3 days after birth in addition to routine nursing care after consent was given and the informed consent form was signed. The study tools include 1. Intervention Tools: small towel or head positioning pillow (Tortle Midliner) and timer; 2. Data collection: Self-created questionnaire on awareness and behavior for preventing intraventricular hemorrhage in preterm infants in nurses, medical record and bundle care implementation record. The data were analyzed by descriptive statistics, t-test, Chi-square test and Logistic regression using SPSS 26 statistical software. The expected results are reduction in the incidence of intraventricular hemorrhage, the length of stay in the intensive care unit and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Inborn Preterm infants
* Preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks

Exclusion Criteria:

* Preterm infants with congenital malformations
* Genetic syndromes
* Congenital infections of the TORCHS group(syphilis, rubella, herpes, toxoplasmosis, and cytomegalovirus)
* Resuscitation and Pneumothorax at birth.
A Pilot Exercise Study for PTSD in Women Veterans

The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans.

Specific aims of the study are to;

1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise
2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.
3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Women veterans ages 18 and older
2. Premenopausal women of childbearing potential with a negative pregnancy test
3. DSM IV-TR confirmed PTSD related to any traumatic event as measured by Clinician Administered PTSD Scale (CAPS) with a CAPS score of at least 45
4. Relatively low sedentary life style
5. Existing psychotropic medications are allowed if on a stable dose
6. Evidence-based psychotherapy (e.g. Cognitive Processing Therapy or Prolonged Exposure) is not allowed to start of the study. However supportive or educational groups that are not PTSD-focused are allowed.

Exclusion Criteria:

1. Other psychiatric diagnoses including bipolar disorder, schizophrenia, schizoaffective disorder, active substance dependence/abuse (use in the past 1 month), obsessive-compulsive disorder, and eating disorders.Comorbid major depressive disorder, dysthymia and generalized anxiety disorders are not excluded.
2. Serious psychopathology
3. Actively suicidal or homicidal
4. Psychiatric hospitalization within the past 30 days
5. Active medical conditions that preclude the use of aerobic exercise such as uncontrolled hypertension, active musculoskeletal degenerative conditions, and symptomatic cardiovascular or respiratory conditions.
Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. Aim of the study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD and impaired glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* either impaired glucose tolerance (2-h plasma glucose concentration \>7.8 and \<11.1 mmol/L during an oral glucose tolerance test) or impaired fasting glucose (fasting glucose concentration \>6.0 and \<7.0 mmol/L)
* coronary artery disease determined by coronary angiography
* BMI \> 25
* male patients aged 35-75 years

Exclusion Criteria:

* diabetes mellitus type 1
* diabetes mellitus type 2 in combination with glycosylates hemoglobin \>6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/L
* unstable angina pectoris
* indication for coronary artery bypass graft operation
* myocardial infarction within the last 3 months
* reduced left-ventricular systolic function \< 40 %
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for elective hip replacement surgery

Exclusion Criteria:

* Subject has active bleeding or any condition associated with increased risk of bleeding
* Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
* Subject has had an MI or stroke within 3 months before planned hip replacement surgery
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence

The purpose of this study is to study whether a herbal-based medication is superior to placebo for prevention of acute otitis media in pre-school children with upper respiratory tract infection.

This is a prospective, controlled parallel-group comparison for superiority of Otovowen®.

Patient will be identified by screening of patient cards. Patients with recurrent AOM aged 12 to 59 months will be randomly assigned either to Otovowen® or placebo. Randomization will be stratified by age at enrolment (12-35 versus 36-59 months).

The observation period per subject will be 6 months. Data collection and documentation will be performed weekly via online diary by the parents/legal representative(s) and by the investigator via eCRF.

Patients will be seen by the doctor at baseline and at end of study. Unscheduled visits in case of AOM or severe URI or any other disease are initiated by the parents/legal representative(s).

Study medication will be sent to the patient/parents/legal representative(s) after randomization. and will be administered at first signs or symptoms of URI (e. g. elevated temperature, common cold, influenza, coughing, sore throat, hoarse voice, frequent sneezing, running or stuffy nose, sinusitis, fever, headache, etc.) until resolved (maximally 8 weeks of continuous application).

AOM will be diagnosed during unscheduled visits according to the criteria detailed in the study protocol. An AOM will be considered as resolved through confirmation by the investigator only.

Compliance will be assessed by weighing contents of bottles of IMPs.

Eligibility Criteria:
Inclusion Criteria:

* Children with at least 3 episodes of acute otitis media (AOM) within 12 months prior to study inclusion as documented in their medical records. Diagnosis criteria for AOM see study protocol
* parental written consent

Exclusion Criteria:

* Ongoing acute otitis media or URI
* Current prophylaxis/treatment for URI or AOM
* Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties
* Use of tympanostomy tubes
* Chronic tympanic membrane perforation (TMP)
* Palatine cleft
* Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis
* History of hypersensitivity to the investigational drug or to its ingredients.
* Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator's opinion, would contraindicate study participation or compliance with protocol mandated procedures.
* Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.
One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding

To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Good health according to the investigator
* Willingness and ability to adhere to the study regimen
* Able to give informed consent

Exclusion Criteria:

* Known or suspected previous vaccination against rabies
* Known or suspected allergy against any of the vaccine components
* History of unusual or severe reactions to any previous vaccination
* Immunocompromized state due to illness or medication
* Administration of plasma or blood products three months prior to inclusion in the study
* (hydroxy)chloroquine or mefloquine use
* History of any neurological disorder including epilepsy or febrile seizures
* Pregnancy or breastfeeding
* Any current infectious disease other than seasonal cold
* Bleeding disorders or use of anticoagulants
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
* Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
* Adequate cardiovascular, hematological, hepatic and renal function
* Willingness to abide by contraceptive measures for the duration of the study
* Participants must have known PD-L1 status

Exclusion Criteria:

* Pregnancy, lactation, or breastfeeding
* Known hypersensitivity to any of the components of RO7247669
* Participants must not have ocular melanoma
* Symptomatic central nervous system (CNS) metastases
* Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to randomization
* Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
* Active or history of autoimmune disease or immune deficiency with some exceptions
* Prior systemic anticancer therapy for unresectable or metastatic melanoma
* Prior anticancer therapy with any-immunomodulatory agents including CPIs (such as anti-programmed death-ligand 1\[PD-L1\]/PD-1 and anti-cytotoxic T lymphocyte-associated antigen \[CTLA-4\]) with some exceptions if used as prior adjuvant or neoadjuvant melanoma therapies
* Prior treatment with anti-LAG3 therapy
Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies

This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* females age 18-65yr,
* American Society of Anesthesiologists (ASA)I-II,
* Body Mass Index(BMI) 18-25kg/m2.

Exclusion Criteria:

* a history of severe cardiac, pulmonary, hepatic, renal disease, chronic drug or alcohol abuse;
* the presence of preoperative shoulder pain or any chronic pain syndrome, long-term use of analgesics; allergy or contraindications to nonsteroidal anti-inflammatory drugs (allergy, peptic ulcer disease, gastroesophageal reflux disease, renal insufficiency, coagulopathy) and any other drugs used in the study;
* patient's pain evaluation is judged unreliable;
* patients with conversion to a laparotomy;
* refuse to coordinate with the follow-up tests.
Telerehabilitation for TMD

This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Referred to PT with ≥1 TMD subtype diagnosis
* PI has no previous knowledge of the participant's diagnosis
* Email access
* Possession of any device that can be positioned for hands-free TR visits (TR group only)
* Willingness and ability to comply with all study requirements and PT program
* Able to provide informed consent

Exclusion Criteria:

* Non-English speakers
* Permanent residence outside of the state of Minnesota (TR group only)
* Women in the last trimester of pregnancy
* Referred for post-surgical rehabilitation
* Severe chronic pain as identified by level 4 classification on the GCPS
* Current diagnosis or existence of the following conditions that can limit response to PT and participation in study activities:

  1. Neuropathic pain
  2. Fibromyalgia and/or generalized widespread pain on both sides of the body in ≥3 areas above and below the waist
  3. Rheumatoid arthritis or juvenile idiopathic arthritis
  4. Dystonia or other movement disorder
  5. Fractures and/or recent jaw or facial trauma
  6. Malignancies
  7. Current substance abuse
Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients

The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.


Eligibility Criteria:
Inclusion Criteria:

* cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems

Exclusion Criteria:

* mucositis more than grade 1
* cannot perform oral intake of gel-based artificial saliva eg. aspirate
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older

Exclusion Criteria:

* Women of childbearing potential
* Gastrointestinal disorders
* Bleeding disorders
* Peptic ulcer disease
* Abnormal ECG
* Abnormal Clinical laboratory tests
* Abnormal Thyroid
* Congestive heart failure
* Cholecystectomy
* Asthma
* Hypertension
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)

This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.

Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes mellitus
* Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
Patient Controlled Administration of Liquid Acetaminophen

This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.

The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers. Investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen, with more than 50% patient enrollment rate and less than 20% withdrawal rate from the study group to the traditional nurse-administered acetaminophen pills.

The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration.

If the medication is spilled or otherwise not dispensed correctly, the patients will be instructed to report this instantly to the nurse. The nurse will document and provide a replacement.

All study participants have the option to call the nurse for assistance with break through pain. In addition, there is a call button to call for help with any other needs or discomfort.

All other medications, such as NSAIDs or oral opioids, will be administered as prescribed.

Participants will have to fill out a paper questionnaire and keep a pain diary, and nurses will have to fill out a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

Participants

* Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty

Nurses

* The nurse who will administer acetaminophen to a study patient.

Exclusion Criteria:

Participants

* Pregnant patient
* Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)
* Emergency surgery
* Chronic pain
* On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.
* Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder
* History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction
* Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)
* Liver dysfunction limiting amount of safe oral acetaminophen
* baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)
* patients unable to take PO
* Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.

Nurses

* any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the PCA pump.