cyrilzakka/clinical-trials huggingface dataset:
Active Choice Intervention About Physical Activity for Physically Inactive Adults

This web-based experimental study aims to ascertain whether promoting an active (i.e. conscious and autonomous) choice process about physical activity results in better behavioural outcomes (e.g. physical activity) and psychological outcomes (e.g. physical activity intention) compared to promoting a passive choice process in physically inactive adults.

In this web-based experimental study, the investigators will use a pre-test post-test four-arm parallel design to compare the effect of promoting an active choice process versus a passive choice process about physical activity on behavioural outcomes (e.g. physical activity behaviour, perceived increase in physical activity) and psychological outcomes (e.g. physical activity intention, commitment) among physically inactive adults.

Participants will be randomized to one of four groups. Participants in group GA+ will be encouraged to make a very active choice by weighing advantages and disadvantages of physical activity, considering personal values, identifying barriers and engaging in action and coping planning. The intervention for group GA is similar, but lacks the action and coping planning exercises. In the other two groups, a passive choice process will be promoted by only providing information: Group G will read the national physical activity guideline and group GI will read the guideline and information about possible advantages and disadvantages and barriers to physical activity. Behavioural and psychological outcomes will be assessed at the first measurement and follow-up measurement. Regression analyses will be performed to examine intergroup differences. In addition, sensitivity analyses and a process evaluation will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Low levels of physical activity (i.e. physically active for at least 30 minutes on \<5 days a week and engaging in \<150 minutes of physical activity in total throughout an average week)

Exclusion Criteria:

* Pregnancy
* Wheelchair user
* Not being able to walk a minimum of 100 meters
The Value of 68Ga-FAPI PET/CT in the Efficacy Evaluation of Advanced Unresectable Hepatocellular Carcinoma Patients Undergoing Systemic Antitumor Therapy

This study aims to investigate the value of 68Ga-FAPI PET/CT in the efficacy evaluation of advanced unresectable hepatocellular carcinoma patients undergoing systemic antitumor therapy.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT before treatment and after 3-month treatment. The imaging response measurements will be compared with the histopathological results as gold standard.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological and clinical diagnosis of advanced unresectable hepatocellular carcinoma patients.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 18-75 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person
Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method

The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.

Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be a major cause of disability for children, as well as an emotional stress for parents. The Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. It has traditionally been described using plaster of Paris (POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast) has grown in popularity. There are currently no randomized controlled trials to prove its efficacy with respect to POP.

Eligibility Criteria:
Inclusion Criteria:

* congenital idiopathic clubfoot

Exclusion Criteria:

* positional equinovarus
* teratologic etiologies of clubfoot
* treatment started at another center
* refuse randomization
* do not understand English
Improving Sleep Quality During Pregnancy Using an Oral Appliance

Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. It may also impact fetal outcomes negatively. The purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. Sleep quality is evaluated objectively using an un-intrusive home sleep test system.

As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time points: T0 - Baseline prior to OA use for two consecutive nights; T1- first two consecutive nights wearing the OA; T2 - for two consecutive nights after 4 weeks of appliance use. In addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. All participants will be given the opportunity to use their OAs after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. Participants will get to keep and use their OAs after the study.

Pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. Those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant adults who snore
* At least 8 teeth per arch
* Mallampati score from I to II
* Palatine tonsils grade 0,1 or 2
* Capable of giving verbal and written informed consent
* Able to apply the sleep recorder and the oral appliance.

Exclusion Criteria:

* Pregnant \> 32 weeks
* Uncontrolled serious health issues
* Cardiovascular or cardiac rhythm disorders
* Pharmacological dependency
* Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
* Ongoing temporomandibular joint disorders
* Loose teeth or periodontal disease
* History of uvulopalatopharyngoplasty (UPPP)
Cardioband With Transfemoral Delivery System

To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Moderate to severe functional Mitral Regurgitation (MR)
* Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.
* Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm
* Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site)
* Transseptal catheterization and femoral vein access is determined to be feasible
* Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria:

* Active bacterial endocarditis
* Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
* Heavily calcified annulus or leaflets
* Subjects in whom transesophageal echocardiography is contraindicated
* Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
* CRT implant within 3 months prior to procedure
* Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (\>70% by Ultra sound)
* Renal insufficiency requiring dialysis
* Life expectancy of less than twelve months
* Subject is participating in concomitant research studies of investigational products
* Mitral valve anatomy which may preclude proper device treatment
* Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation
Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam

Women age \>18 scheduled for a diagnostic ultrasound examination had both a hand held ultrasound and an automated breast volume scan. Exams were performed by different technologists. Images were blinded and blinded read for diagnostic accuracy of the two examinations

Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study. If the patient had both a palpable mass and a mammogram that had an abnormality the indication was listed as a palpable abnormality. Exclusion criteria included inability to give informed consent and abnormality of the breast that is larger than one quadrant. No patients were excluded from the study.

All patients received both a Hand Held (HH) and Automated Breast Volume Scanner (ABVS) ultrasound. Patients were initially randomized to have either a HH or an ABVS. The HH ultrasound was performed by one of 4 sonographers that had a minimum of 10 years experience in breast ultrasound. A different sonographer than the one performing the HH or mammography technician performed ABVS. All technologists performing ABVS participated in a training course on ABVS and performed at least 10 patients satisfactorily before beginning the study. The choice of a mammography technician or sonography to perform the ABVS was randomized. Both the sonographer performing the HH and the sonographer or mammography technologist performing the ABVS were provided the patient's history and results of the mammogram if performed for placement of the ABVS and region of interest for the HH. However the results of the HH or ABVS were not available to the person performing the second examination.

Final diagnosis was performed either by a 12 gauge core biopsy (Celero, Hologic, Marlborough, MA ) or confirmation of a benign lesion by no significant change over 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.

Exclusion Criteria:

* Unable to give informed consent
* breast abnormality greater than one quadrant
Neutrophil/Lymphocyte Ratio in Acute Pancreatitis

Acute pancreatitis (AP) is a disease characterized by dysfunction of pancreatic acinar cells, improper activation of trypsin, and subsequent destruction of pancreatic self-defense mechanisms, further exacerbating injury and damage of pancreatic cells. It is a rapidly developing inflammatory process of the pancreas, and the most common reasons are alcohol and gallstones.

As one of the most common gastrointestinal diseases in hospitalized patients, the incidence of AP has gradually increased and is 4.9 to 73.4 cases per 100,000 people worldwide in the past few decades, imposing a heavy burden on the health system and leading to long-term hospitalization, most medical costs, and significant mortality.

Up to 10% to 20% of AP patients will develop SAP, and the leading cause of poor prognosis in patients with AP is a vital organ (cardiovascular organs, lung, and kidney) failure and pancreatic necrosis . In clinical practice, varieties of scoring systems are available and have been gradually confirmed, such as the Ranson score, Glasgow score, Acute Physiology and Chronic Health Evaluation (APACHE II), BISAP, and computed tomography severity index (CTSI) . These systems are cumbersome and take a long time to operate, requiring a lot of parameters that are not routinely collected in the early stages of the disease. For example, the BISAP score is characterized by high specificity, but its sensitivity to SAP is not satisfied. Therefore, their early prediction power is not good.

In AP, inflammation first activates a series of inflammatory cytokines, proteolytic enzymes, and anaerobic radioactive nucleic acids to destroy the tissue. The degree of neutrophils decrease is related to the improvement of prognosis of AP, while the degree of lymphocyte increase is related to the severity of the disease. The neutrophil-lymphocyte ratio (NLR) is a more comprehensive biomarker that used neutrophil and lymphocyte counts to respond rapidly to the extent of inflammatory progression and serves as a useful predictive marker to identify the severity of AP. It is well known that AP is a fast-onset inflammation of the pancreas, and an effective prediction of the severity of AP can guide AP patients to receive adequate treatment earlier, contributing to a better prognosis.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute pancreatitis

Exclusion Criteria:

* Patients with acute abdomen with diagnosis other than AP
* Patients with AP who are under age of 18 years old
* Patient's refusal
Clinical Precision and In-use Analyte Stability Study for 19 Parameters in Adult Arterial Whole Blood for PICO70 and SafePICO

The purpose is to characterize the precision and in use stability of 19 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, cUrea/BUN, cCrea, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF \& ctBil) in arterial blood drawn and stored in self-filling syringes (PICO70 and safePICO) across different lots of samplers measured on ABL90 FLEX PLUS analyzer.

The study aims to determine the total (within Lot and Lot-to-Lot) precision for the PICO70/safePICO in arterial whole blood. Furthermore, the study aims to determine the stability for up to 45 min. at room temperature (18-25 °C) for arterial blood sample analysis in the PICO70/safePICO for all 19 parameters.

The study is a Post-Market Clinical Follow-up (PMCF) randomized unblinded study, expected to be conducted at two sites in Denmark using arterial whole blood samples collected from adult patients to determine the precision and stability for the PICO70/safePICO syringes when measuring 19 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, cUrea/BUN, cCrea, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF \& ctBil) using the RMED ABL90 FLEX PLUS analyzer. The 19 parameters will be analysed for each syringe in the syringe series on the ABL90 FLEX PLUS analyzer. For PICO70: Approximately 40+4 (4 contrived sample series) completed series of arterial blood samples consisting of 6 syringes: The syringes will be from three different lots (A,B,C) and analyzed at four different time points, T0, T15, T30 and T45. For safePICO: Approximately 40+4 (4 contrived sample series) completed series of arterial blood samples consisting of 6 syringes: The syringes will be from three different lots (A,B,C) and analyzed at four different time points, T0, T15, T30 and T45. According to guidelines (CLSI GP34) samples should be distributed throughout the analytical measurement range of measurands evaluated. To ensure coverage of the full range for each parameter, it may be necessary to contrive some sample series.

Eligibility Criteria:
Inclusion Criteria:

Subject must be 18 years of age or older. Subject must have an arterial catheter line established as part of the standard of care.

Subject must be suitable for the study according to the protocol evaluated by the principal investigator or designee.

Exclusion Criteria:

Subject is unconscious or otherwise incapable of understanding and signing the informed consent form.

Subject must not have been previously enrolled into this study. Subject must not be known with pregnancy or breastfeeding.

Subject must not be taking the following medications within 72 hours prior to the sample collection:

Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day. Acetylcysteine drug used against paracetamol intoxication. Fluorescein dye (used for the diagnosis of ocular disease). Patent Blue dye (used to mark the lymphatic vessels, arterial territories, and lymph nodes prior to a biopsy).
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

Exclusion Criteria:

1. Detectable major (or severe) congenital malformation identified before randomization.
2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
3. Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
Assessment of Teleconsulting in Nursing Homes

The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents requiring emergent or elective care.


Eligibility Criteria:
Inclusion Criteria:

* All residents of selected nursing homes

Exclusion Criteria:

* None
Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer

This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To determine if eliminating placement of a pelvic drain in patients during robotic assisted laparoscopic prostatectomy (RALP) increases incidence of early postoperative adverse events occurring within 90 days from prostatectomy, compared to patients who have a pelvic drain placed during RALP.

SECONDARY OBJECTIVES:

I. To determine the incidence of early postoperative adverse events in patients with and without a pelvic drain when adjustments to confounders associated with these events are made (confounders: demographic, surgical and pathologic; age, body mass index \[BMI\], pathologic stage, Gleason sum, extent of lymph node dissection).

II. To report peri-operative and postoperative outcomes, including but not limited to, length of hospital stay, re-admissions, continence, potency and incidence of medical interventions for patients with and without pelvic drain.

III. To compare early postoperative adverse event rates between patients with and without a pelvic drain in patients who had extended pelvic lymph node dissection during RALP.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo RALP.

ARM II: Patients undergo RALP and placement of pelvic drain.

After completion of treatment, patients are followed up at 1 week and then 1, 3, 6, 9, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center
* Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
* Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria

Exclusion Criteria:

* Non-compliance
* Prior radiotherapy to the pelvis or prostate
* Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon
* Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
* Intra-operative injuries (for example: rectal injury)
* Inadequate hemostasis