cyrilzakka/clinical-trials huggingface dataset:
PO Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery

Postoperative pain is common, and the pain intensity can be moderate to severe depending on the site of surgery during the first few days after surgery, and an estimated 15% to 45% experience chronic postsurgical pain. When poorly controlled, the pain can have a significant effect on patient recovery. Proper management of postoperative pain is needed to relieve suffering and lead to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. The currently proposed clinical use of Dinalbuphine Sebacate is to administer a single dose of NALDEBAIN® intramuscularly approximately 12 to 24 hours prior to the planned surgery for pain relief. Several clinical studies of NALDEBAIN® have been published, such as the use in laparotomy and laparoscopic cholecystectomy. However, toward the arthroscopic shoulder surgery, no article or report has been available publicly yet. The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN® on patients scheduled to undergo arthroscopic shoulder surgery.

This is a randomized, double-blind, placebo controlled study. Patients scheduled to undergo arthroscopic shoulder surgery will be invited to participate in this study. After obtaining the written informed consent, each subject should be sequentially assigned an individual screening number instead of his/her name, chart number or identification. Subjects will be randomized to two groups, DS group and Control group. Both groups should be treated with both routine analgesic regimen and a dose of investigational product. Random numbers and assignment treatment were generated by computer program before this study initiated. Statistical analyses should be performed on the data to compare the two groups. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo arthroscopic shoulder surgery.
2. American Society of Anesthesiology Physical Class 1-3.
3. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Not willing to adhere to the study visit schedule.
2. With a history of hypersensitivity or allergy to opioids, NSAIDs or sesame oil.
3. With a medical history that may predispose them to abnormal intracranial pressure.
4. Any history of narcotic dependency, addiction, or withdrawal.
5. Any clinically significant condition that may interfere with study assessments.
6. Pregnant or breastfeeding.
7. Nonregular sinus cardiac rhythm or implanted pacemakers.
8. Prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, or antiarrhythmic agents.
Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD

Polycystic kidney disease (ADPKD) is a common genetic disorder, characterized by the formation of cysts in the kidneys, causing gradual renal function-loss. Previous studies have shown that, reduced glomerular filtration rate (GFR) and renal plasma flow (RPF) play a role in the progression of renal disease in ADPKD. Tolvaptan is a vasopressin 2 antagonist, which seems to reduce the growth of total kidney volume (TKV) and the decline in e-GFR in ADPKD. The mechanism is not fully understood and could, at least partly, be caused by stimulation of the renal blood flow. The purpose of this trial is to investigate if tolvaptan´s improve renal blood flow and glomerular filtration in ADPKD, in a randomized, cross-over, double-blind, placebo-controlled study.

The aim is to measure the acute effects of tolvaptan on:

1. Renal hemodynamics (RPF, GFR, filtration fraction ((FF)) and renovascular resistance ((RVR))
2. Blood pressure (central blood pressure ((cBP)) and brachial blood pressure bBP)
3. Several vasoactive hormones (plasma renin ((PRC)), plasma angiotensin II ((p-Ang-II)), plasma aldosterone ((p-Aldo)), plasma vasopressin ((p-AVP))

in patients with ADPKD.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis with ADPKD
* Informed consent
* Contraception for fertile women

Exclusion Criteria:

* Renal transplantation
* Operation in the kidney
* Diabetes mellitus
* Neoplastic conditions
* Pregnancy, nursing
* Unwillingness to participate
* eGFR \> 30
* Intolerance towards tolvaptan
* Alcohol or medical abuse,
* BP \>\>170/110 blood pressure despite regulation
Text Messaging and Cardiovascular Health in Diabetes Mellitus

The purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin \[HbA1C\], systolic blood pressure \[SBP\], and LDL-cholesterol) over 12 months among patients with type 2 diabetes.

Most patients with diabetes have multiple risk factors, such as obesity, hypertension, and dyslipidemia, or with arteriosclerotic cardiovascular disease (ASCVD). The purpose of the study of the proposed randomized trial will examine the effect of health text messages in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin \[HbA1C\], systolic blood pressure \[SBP\], and LDL-cholesterol) over 12 months among patients with type 2 diabetes. This study is a multicenter prospective, randomized, controlled clinical trial. The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care. The messages will target lifestyle recommendation, glucose control, blood pressure control, healthy eating, medication adherence, physical activity and smoking cessation. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. The primary outcome is the combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. The Secondary outcome includes the net change of CVD risk factors (glycated hemoglobin \[HbA1C\], systolic blood pressure \[SBP\], and LDL-cholesterol), and the proportion of participants with HbA1C \<7% (\<7.5% if with clinical CVD), BP\<140/90 mm Hg, and LDL-cholesterol \<100 mg/dL, and net change in estimated 10-year risk of CHD and CVD. The primary outcome and secondary outcome will be measured at month 3, 6, and 12 visits.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years and over
2. Patients with poorly controlled type 2 diabetes who are undergoing routine treatment (defined as HbA1c≥ 7% or HbA1c≥7.5% if combined with clinical cardiovascular disease) have at least one risk factor for other cardiovascular disease (SBP≥140 mmHg and/or DBP≥90 mmHg and/or low density lipoprotein cholesterol≥100mg/dL) or clinical atherosclerotic cardiovascular disease (acute coronary syndrome, ischemic stroke transient ischemic attack or peripheral arterial disease)
3. Participants can provide written informed consent.
4. Participants required access to a smartphone, and be able to receive and read text message.

Exclusion Criteria:

1. Participants were in functional New York Heart Association class III or IV, and were on haemodialysis;
2. Pregnant women or women planning to become pregnant
3. Participants cannot be followed up for 12 months (due to health status or migration)
4. Participants cannot provide written informed consent.
Couples Coping With Alzheimer's Disease

The purpose of this study is to test the efficacy of a new couples counseling intervention for people recently diagnosed with early Alzheimer's disease and their spouses. The study hypothesis is that counseling the couple shortly after the diagnosis, and while the functional impact of the illness is still relatively mild, will have a significant impact on their ability to provide support for each other.

The majority of people with Alzheimer's disease (AD) live at home with their spouses. AD erodes the ability of each member of the couple to support each other. Moreover, couples may be unaccustomed to seeking or accepting emotional and practical support from family members or formal resources. Even though AD can have a major negative impact on each member of the couple and on their relationship, their needs have generally been addressed separately, often without sufficient appreciation for the importance of their ongoing relationship. Previous studies suggest that by improving support for both members of the couple, the intervention will have a positive effect on mental health outcomes such as depression and help keep the person with AD at home rather than in a long-term care facility.

One hundred couples will be randomly assigned either to an immediate treatment group or a wait-list control group which will receive treatment four months after enrollment. Participants will receive a formal baseline assessment, consisting of a structured set of questionnaires to assess dyadic (couple) adjustment, social support, depression and anxiety as well as goals for counseling. There will be two follow-up assessments, 2 and 4 months after baseline using the same instruments. All participants will be able to call a counselor for the duration of the study to obtain resource and referral information or in the event of a crisis. The treatment will consist of 6 sessions of couples counseling within a 2-month period. The focus will be on helping each member of the couple to express feelings, needs and issues that have emerged between them as a result of the diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Couples, in which one partner has been diagnosed with AD and is in the mild stage of the disease
* Ages 21 to 90

Exclusion Criteria:

* Severe psychological or physical illness
* Unwillingness to participate in all aspects of the study
Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia.

Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in children.

This was a pilot randomised controlled trial. Patients were randomised to either receive apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome was the duration of safe apnoea, defined as a composite of the time to first event, either time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2 observed during airway management. Secondary outcomes were number of patients whose SpO2 dropped below 95% and number of patients whose SpO2 dropped below 92%.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included who were scheduled for elective surgery under general anaesthesia.
* Age: one eight years old.
* ASA I and II only.
* Patients with normal cardiorespiratory function.

Exclusion Criteria:

* Children undergoing dental surgeries in which nasal intubation is needed.
* Patients who suffered from quick drops in oxygen saturation more rapidly than healthy children due to different reasons such as: respiratory and pulmonary diseases, active or recent upper respiratory tract infection, syndromes with cardiopulmonary pathologies, cardiac anomalies, anaemia, depressed respiratory effort, ventilation/perfusion imbalance, Obstructive Sleep Apnoea (OSA), and airway obstruction.
* Patients reported with nasal obstruction.
* Patients with grades of laryngoscopic view (Cormack Lahane) greater than II, which indicates upper airway obstruction.
Hyperbaric VO2max Study

This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric environment for exercise performance at altitude. Subjects will complete a short, high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after this training phase, all subjects will be tested for maximum aerobic capacity at a simulated high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of mitochondrial oxidative capacity in a skeletal muscle biopsy.

A group of individuals of similar characteristics completing this training program in a normoxic-normobaric environment will serve as a control.


Eligibility Criteria:
Inclusion Criteria:

* healthy, recreationally active or sedentary individuals

Exclusion Criteria:

* VO2max \< 35 ml/kg/min - male 30 ml/kg/min - female
* chronic cardiovascular or pulmonary diseases
* history of pneumothorax
* active smoker
* pregnant women
* non-english speaking
* not in full mental capacity
* blind
* sickle cell trait or disease
Quality of Life and Sexuality in Women With Gynaecological Cancer

Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment (surgery or radiotherapy) and after completion of treatment in order to estimate the influence of disease and treatment on quality of life indices.

no additional information. see above

Eligibility Criteria:
Inclusion Criteria:

* women with Gynaecological cancer intended to undergo chemotherapy or surgery
Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis

Identify the procoagulant profile in immune thrombocytopenic patients with thrombosis.

Clinical implications of antiphospholipid antibodies in ITP patients with thrombosis.

Diagnostic role of microparticles in ITP patients with thrombosis.

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by isolated thrombocytopenia and an increased risk of bleeding. Paradoxically, ITP is also associated with an increased risk of thrombosis (1).

Recent studies showed that the occurrence of thrombosis in patients with ITP is not purely accidental and can be considered a clinical reality with an important impact on the management of the disease (2).

The pathophysiological mechanism for thrombosis in ITP remains unclear. Sever bleeding episodes are relatively rare in some patients with ITP although having low platelet count, suggests that these patients may have a protective factor against bleeding (3).

Antiphospholipid (aPL) antibodies are a heterogeneous group of autoantibodies with high affinity for phospholipids such lupus anticoagulant (LA), β2glycoprotien І (β2GPІ), and anticardiolipin (anti-CL). They interfere with physiological mechanisms of coagulation and fibrinolysis, leading the haemostatic balance towards coagulation. Moreover, it seems to affect the physiological function of various cells such as platelets and endothelial cells (4).

Microparticles (MPs) are a diverse group of bioactive small-sized vesicles (100-1000nm) that can be found in body fluids and blood after activation, necrosis, or apoptosis of almost all cells. Although most MPs in human blood originate from platelets, MPs are also released from leukocytes, erythrocytes, endothelial cells, smooth muscle cells and cancer cells (5). They participate in intercellular communication and play a major role in homeostasis under physiological conditions and also in diseases (6). The most prominent property of MPs is their procoagulant potential, mainly based on phosphatidylserine exposure and tissue factor expression (7).

Elevated levels of antiphospholipid antibodies and microparticles have been reported as a risk for development of prothrombotic state (8).

Eligibility Criteria:
Patients with confirmed diagnosis of primary chronic ITP with and without thrombosis, male or female above age of 18.Inclusion Criteria:

Exclusion Criteria:

Thrombocytopenic patients due to secondary causes such as pregnant women, patients with uncontrolled hypertension, peripheral or coronary artery disease, abnormal hepatic or renal function tests, bleeding disorder, and thrombopathy well be excluded from the study.

Patients full fill the criteria of antiphospholipid syndrome (APS).
Clinical Predictors of Rehabilitation-induced Arm Recovery After Stroke: Longitudinal Cohort Study

Clinical predictors of rehabilitation-induced arm recovery after stroke are still missing since literature provides evidence mainly on the spontaneous recovery path. This longitudinal cohort study aims to identify neurophysiological and behavioural features able to predict arm recovery and how it can change according to provided rehabilitation.

Rationale: evidence suggests that integrity of the Cortico-Spinal Tract (CST), valid Motor Evoked Potentials (MEPs), age and neurological status are positive prognostic features for better recovery. Concurrently, dosage of rehabilitation therapy is a key factor in promoting functional recovery. However, there are no evidence suggesting whether dose of rehabilitation also influence prediction of UL motor recovery after stroke.

Aims: to define (i) predictive features for rehabilitation-induced UL recovery and (ii) the effect of rehabilitation doses.

Methods: stroke patients will be longitudinally enrolled and assessed with Magnetic Resonance Imaging, Transcranial Magnetic Stimulation (TMS), blood sample and clinical outcome measures at the beginning (T0) of rehabilitation and after 8 weeks (T1).

Eligibility Criteria:
Inclusion Criteria:

* first ever single stroke
* unilateral cortical/subcortical stroke

Exclusion Criteria:

* other neurological disease
* psychiatric disorders
* cerebellar stroke
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery

The aim of the project is to evaluate the effectiveness, on the skin cleanliness of the patient on arrival at the operating room, of an intervention aimed at improving the performance of the preoperative shower, for patients undergoing a planned surgical intervention in an orthopedic surgery department, digestive, gynecological, thoracic, or vascular.

The project will be realized in 2 phases.

- The first phase of the project will consist of a sociological survey conducted with caregivers and patients in the care sectors participating in the study. This component sociological research will be carried out on the basis of in-depth interviews with caregivers (nurses and nursing assistants) from the departments concerned by research and patients. The expected sample, subject to data saturation, is 40 caregivers and 20 patients. These in-depth and non-directive interviews will be carried out by a sociologist and will aim to explore the way in which healthcare professionals see their activity professional, the relationship they maintain with the various members of the healthcare team, their perceptions of the body, privacy and hygiene of patients, but also to explore the representations of caregivers of the preoperative shower and of the relationship with caregivers during phases of explanation, possible help with the shower, and control of cleanliness cutaneous. These interviews will identify the representations of caregivers and patients with the aim of establishing a procedure for caregivers to improve care of the preoperative shower. In view of the statements of patients and caregivers concerning preparing for the preoperative shower and checking skin cleanliness during the Survey exploratory, it appears necessary to improve and formalize the protocol. Investigation will thus establish a base of knowledge necessary to establish a care procedure giving an account of the roles of each person, caregivers and patients.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 and over, and
2. scheduled for surgery (outpatient or full hospitalization) in one of the following specialties: orthopedics, digestive (including bariatric surgery), gynecological, thoracic, vascular, and
3. having read and understood the briefing note and not showing up for research.

Exclusion Criteria:

1. operated on urgently, or
2. operated on for an intervention other than orthopedics, gynecology, digestive surgery, vascular surgery, or
3. having received a toilet in bed, or
4. having expressed their opposition to the research.
Sex Differences in Attentional Bias in Marijuana-dependent Individuals

The purpose of this study is to explore sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures.

Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male controls.

Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in attentional bias and cognitive functioning than marijuana-dependent males.

Ample evidence implicates both environmental cues and negative affective states in maintaining drug use or triggering relapse. However, although 'craving' is believed to drive continued drug use, it is not well understood how cognitive processes influence craving and relapse, nor how they may differ between the sexes. Therefore, the goal of this study protocol is to provide insight into sex differences in the cognitive aspects of drug craving and to assess the impact of stress on attentional bias for drug-related cues as well as on the availability of cognitive resources.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will include subjects between the ages of 18-65 who meet full DSM-IV criteria for marijuana dependence and non-dependent controls.

Exclusion Criteria:

* Exclusion criteria will include medications that may affect cognitive or HPA-axis functioning
* Current depression
* Bipolar disorder
* Attention deficit hyperactivity disorder
* History of psychosis
* Suicidal or homicidal intent
* Significant cognitive deficits
* Dependence on any substance other than marijuana, nicotine, or caffeine.