cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward

To explore the possible benefit of a patient hotel, a study was undertaken to test the hypothesis that perioperative care at a patient hotel would be valued better than care in a general ward. The study focuses solely on the patients' perspective and satisfaction of the care provided.

The study was designed as a prospective randomised controlled trial, carried out at a single centre (Danderyds University Hospital). The protocol was approved by the Ethical committee for human studies.

With a primary outcome that perioperative care at the hotel would be valued 15-20% higher than care in a general ward, a power analysis, two-sided with α = 0.05, indicated that a sample size of 150 was needed to attain a power of 80%.

The patients were randomised to receive pre- and postoperative care either in a general surgical ward or at a patient hotel by using a sealed envelope method.

To evaluate the patients' experiences of the care provided at the ward and the hotel, respectively, the Swedish validated version of the adult inpatient survey of 2005 (IN2005-E) was used.

Adjacent to the discharge from the ward or hotel, the patient was provided with the IN2005-E questionnaire, which was filled out before the patient left the facility. The filled out form was sealed in an envelope by the patient herself and thereafter sent to a separate institute (Indikator) for further analysis. Indikator is responsible for the majority of the statistical analysis of patient surveys in Sweden.

Patient characteristics were compared using a confidence interval of 95%. The SF-36 was analyzed with a two-sample t-test. The IN2005E was analyzed by a cross-tabulation of the data using the χ² test in SPSS 17.0. The significance level was set to \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

Women with a breast tumour, who were to undergo surgical treatment in order to remove a known cancer or to exclude cancerous changes in a diagnosed tumour

Exclusion Criteria:

* Insulin dependent diabetes
* Severe impairment of mobility
* A known coagulopathy
* Cancer surgery with a coherent primary reconstruction
* Severe cardiac illness
* An inability to understand Swedish
* Mental incapacity.
Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis

The purpose of this study is to determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients

Low back pain is a significant morbidity in chronic hemodialysis patients affecting about 1/3 of them. Among the physiotherapeutic interventions, the McKenzie Method (Spine 1983;8:141-4), has shown to be an effective approach to manage patients with low back pain. More specifically, it consists on standardized repetitive flexion and extension exercises of the lumbar spine. Thus far, there has been no randomized intervention testing the effectiveness of physiotherapeutic interventions in chronic renal failure patients on hemodialysis. In this study we selected four of their main proposed exercises (flexion in standing, extension in standing, flexion in lying, and extension in lying position) to apply three times a week for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic low back pain
* Chronic renal failure
* Hemodialysis therapy for more than 3 months

Exclusion Criteria:

* Fractures of the spine
* Psychiatric diseases
* Alcohol of other drugs use
* Planned living donor transplantation
* Clinically unstable patients
* Chronic neurologic diseases
The Study to Compare SMART Nitinol Stent and Balloon Angioplasty

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.

The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. At least one calf vessel must be patent. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm.

Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty.

Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.

This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months;
2. One de-novo or restenotic SFA with an occluded length \> 5 to \< 22 cm;
3. Patent popliteal artery on the index side (without \> 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without \> 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.

Exclusion Criteria:

1. Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
2. Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;
3. Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
An Examination of a Weight Loss Formula on Health

The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 25 and 34.9

Exclusion Criteria:

* Recent history of weight change (+/- 10 lbs. within the past 3 months)
* Uncontrolled metabolic disorders
* Uncontrolled cardiovascular disorders
* Currently taking prescription medications (birth control is allowed)
* Currently taking dietary supplements for weight loss
* Pregnant or plan to become pregnant
* Have an intolerance to caffeine or other natural stimulants
T1 Mapping in HIV Patients With High and Low CD4+ Cell Counts

HIV-infection is associated with an increased risk for cardiovascular disease. Especially patients with low CD4+ counts have a higher incidence of structural heart disease. Myocardial T1 relaxation time, as well as T1-derived extracellular volume fraction are relatively new methods for non-invasive myocardial tissue characterization, including diffuse myocardial fibrosis.

In our study HIV-patients with high and low CD4+ counts are examined on a 3T MRI scanner (Ingenia 3T, Philips Medical, Best, Netherlands). Scanning protocol includes common SSFP sequences, STIR imaging and LGE \[Late gadolinium enhancement\]. All HIV patients are treated in the HIV outpatient clinic of the hospital's Internal Medicine department and have an unremarkable history of cardiac disease. Patients are recruited from all over Germany. In order to obtain reference values, a subgroup of healthy, age-matched controls is included in this study.

Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups. In addition, we also want to create cut-off values for healthy and affected myocardium in asymptomatic HIV-infected patients. This study could show whether myocardial T1 mapping is a potential screening parameter for beginning heart disease as part of an HIV-infection, and whether an application in routine diagnostic is reasonable.


Eligibility Criteria:
Inclusion Criteria:

* chronic HIV infection
* no known cardiac disease
* no cardiovascular risk factors

Exclusion Criteria:

* contraindications to MRI (e.g. metal implants)
* chronic kidney disease
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age above or equal to 18 years at the time of signing informed consent
* BMI greather than or equal to 27.0 kg/m\^2
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
* Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
* HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Exclusion Criteria:

* Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
* Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear

This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff tears. This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

Eligibility Criteria:
Inclusion Criteria:

* Patient after an arthroscopic rotator cuff repair
* 1 to 4 years postoperative
* Presence of pre-operative radiography of the shoulder

Exclusion Criteria:

* Massive irreparable cuff tear
* Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic repair
* Absence of pre-operative radiography in neutral rotation
Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.

Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3 mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass grafting patients

Exclusion Criteria:

* Psychiatric disorders, sleep apnea, cardiac insufficiency
Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study

This study assesses perceived usefulness of a web-based virtual prostate cancer genetics board for providers across academic, community, and veteran affairs settings to discuss prostate cancer genetics cases, precision treatment, and screening recommendation. Information gained from interviews and surveys of participants taking part in the virtual genetics board may lend insights into perceived usefulness, perceived ease of use, acceptability, self-efficacy, genetics knowledge, and barriers/facilitators to implementation to refine the process.

PRIMARY OBJECTIVE:

I. To assess perceived usefulness of a virtual genetics board.

SECONDARY OBJECTIVE:

I. To assess acceptability/feasibility, perceived ease of use, self-efficacy for recommendations, genetics knowledge.

OUTLINE:

Participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. Participants may also complete a semi-structured interview after virtual genetics board.

Eligibility Criteria:
Inclusion Criteria:

• Non-genetic providers who perform PCA genetic testing for men in their practices (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers)

Exclusion Criteria:

• Non-medical providers
Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia

On the basis of the database established in the previous stage, a cohort analysis was conducted on patients with BDDH complicated by hip arthroscopy for minimally invasive treatment of glenoid and lip injury, according to which the indications of minimally invasive surgery for BDDH patients were optimized and surgical measures were improved. Achieve accurate and rapid repair, rehabilitation and functional recovery, serve national fitness, and treat people's injuries

Based on the work of the previous research group, we prospective constructed a bidirectional cohort of patients with critical hip dysplasia, and summarized the influencing factors for the surgical prognosis of patients with BDDH, so as to continuously optimize patient selection. On this basis, the cohort size was extended to analyze the difference in efficacy between arthroscopic glenolabial repair and glenolabial repair combined with soft tissue enhancement, and further improve the minimally invasive surgery to promote the efficacy of minimally invasive surgery in BDDH patients

Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of borderline hip dysplasia with glenolabial injury.

Exclusion Criteria:

-
Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI)

This is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will receive either VITIS CPC Protect® mouthwash (Mouthwash with cetylpyridinium chloride (CPC) as an anti-plaque antiseptic at a concentration of 0.07%) or mouthwash without cetylpyridinium chloride, as control group Subjects included in the study will be followed for 90 days. Symptoms associated with vURTIs (viral upper respiratory tract infections) should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract.

Symptoms and adverse effects will be recorded when the episode occurs. The assignment as VURIs will be made by the investigator once the diaries have been completed, or during the symptoms if possible.

This is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will be included. Allocation ratio (1:1). The trial will be offered to subjects who live in a nursing home and who can perform mouthwashes themselves or to whom healthcare professionals can apply the product.

Subjects included in the study will be followed for 90 days. Symptoms associated with vURTI should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract. If such an infection exists (when three of the following symptoms are present: fever over 37º, non-productive cough, sore throat, runny nose, nasal congestion or malaise) the degree of severity will be determined and recorded.

Symptoms and adverse effects will be recorded when the episode occurs. The assignment as vURTI will be made by the investigator once the diaries have been completed, or during the symptoms if possible. Follow-up visits will be conducted fortnightly

Eligibility Criteria:
Inclusion Criteria:

* Subjects admitted to nursing home
* Subjects who have had a washing period of 2 months since the last use with mouthwashes.
* \> age 65
* Subjects who are able to do mouthwashes or receive oral hygiene by caregivers
* Delivery of the Participant Information Sheet (HIP) and signing of the Informed Consent (IC) to subjects or legal guardians of the subjects who agree to participate.

Exclusion Criteria:

* Subjects who are suffering from an upper or lower airway infection at the time of recruitment
* Subjects who are physically or psychologically unable to perform mouthwashes or receive oral hygiene with gauze or cotton soaked in antiseptic
* Subjects who have used oral antiseptics continuously in the past month
* Use of oral hygiene measures outside the study conditions
* Subjects who frequent residences, but are not admitted (e.g. day centre) Subjects or legal guardians of subjects who do not provide their IC to participate Subjects who have a registered allergy to the product or to the excipients of the product.
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy

The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.

Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) status \< 3

Exclusion Criteria:

* acute cholecystitis
* conversion to open cholecystectomy
* history of epilepsia, psychiatric disorders and cognitive impairment
* Pregnancy and breastfeeding
* allergy to pregabalin and/or gabapentin
* Chronic pain
* Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory drugs
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder

Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Patients in different groups will be treated by psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12 weeks of treatment.

Patients meeting the inclusion criteria undergo an examination that included a diagnostic interview, vision test, and psychophysiological measures. Participants then undergo the baseline fMRI scan within 48 hours, after that, they will receive psychotherapy or SSRI treatment.and returned the scan once they completed the therapy.

Eligibility Criteria:
Inclusion Criteria:

* meet SCID -Ⅰ/P major depressive disorder diagnosis;
* Right handedness;
* good visual acuity.

Exclusion Criteria:

* neurological disease ;
* serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
* with other mental disorder;
* psychotic symptoms
* personality disorders;
* pregnancy;
* suicidal risk;
* treatment by antidepressants or other psychotropic medications within 6 months prior to the start of the trial;
* with contraindication for MRI
Use of Google Translate to Enhance Patient Pain and Nausea Assessment and Satisfaction After General Anesthesia

This study investigates the use of Google Translate "Conversation Mode" translation service to improve communication about pain and nausea with Spanish-speaking patients who are recovering after surgery. The Google Translate "Conversation Mode" translation application is designed to provide translation from one language to another and used to allow the nurse or study doctor to communicate with patients in Spanish by asking pre-prepared questions through an electronic device such as an iPad or iPhone. Google Translate "Conversation Mode" may facilitate assessment of pain and nausea after surgery in Spanish speaking patients.

PRIMARY OBJECTIVE:

I. To determine the feasibility of Google Translate "Conversation Mode" use to assess postoperative surgical pain presence, location and intensity, and nausea presence and intensity in Spanish speaking patients in the post-anesthesia care unit (PACU).

SECONDARY OBJECTIVES:

I. To evaluate the length of stay in PACU. II. To assess patient satisfaction with regards to pain/nausea experienced in PACU.

III. To determine nursing satisfaction with regards to the use of Google Translate "Conversation Mode".

OUTLINE:

Patients use Google Translate "Conversation Mode" translation application before and after surgery. Patients also complete survey over 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Patients between 18-80 years of age whose primary language is Spanish and will require translation services as part of standard care
* American Society of Anesthesiologists physical status (ASA) 1-3
* Are scheduled surgery under general anesthesia
* Ability to understand and complete all study questionnaires

Exclusion Criteria:

* Emergency surgery
* ASA \>= 4
* Patients who do not require official translation services for consent purposes
* Patients who have chronic pain and/or are taking opioids chronically (daily intake for more than a month before surgery)
* Patients who undergo craniotomy
* Patients with a hearing impairment that prevents the ability to hear the recorded statements; and/or a cognitive impairment that would prevent them from completing post-op assessments