cyrilzakka/clinical-trials huggingface dataset:
WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

The current pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs in this patient group.

The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities.

This pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (≥18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion.

Exclusion Criteria:

* Allergy to plaster, plastic, or silicone.
* A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
* If the patient was deemed not able to open the front door when visited by the investigator.
* Inability to give informed consent.
Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?

This is a retrospective study performed on medical records, in order to compare the number of venous thromboses, the surgery duration, the complications rate and the duration of anastomosis in breast reconstructive surgeries by the DIEP (Deep Inferior Epigastric Perforator Flap) technique, with or without the use of a venous coupler.

Breast cancer is the most common and deadliest cancer among women in Belgium. Women with invasive cancer may be offered a total mastectomy with or without adjuvant/neoadjuvant therapy, and with or without breast reconstruction. It is obvious that the loss of a breast can impact the self-image, hence the importance of informing the patient about the possibilities of breast reconstruction. Between 14 and 20% of women choose to resort to reconstruction.

Different types of breast reconstruction exist: prosthetic reconstruction, lipolifting and flap reconstruction (of large dorsal, gluteus maximus, rectus abdominis muscle and "DIEP").

DIEP (Deep Inferior Epigastric Perforator Flap) presents numerous advantages. It consists in the use of a free cutaneo-greasy flap taken from the abdomen, without muscle removed. The abdominal skin has a similar appearance to the breast skin and, thanks to the presence of fat, the missing volume is replaced by a living tissue. Weakness of the abdominal wall is also avoided. However, it remains a surgical procedure with possible complications.

There are several steps in this surgery. The first is to dissect the abdominal flap by talking the skin and subcutaneous fat and isolating one or two branches of the lower epigastric artery and one or two veins. The donor area is then closed. The second step is to prepare the recipient area, ie dissect the artery that will be anastomosed with the lower deep epigastric artery.This artery can be the intern mammary artery, the thoraco-dorsal artery or more rarely the axillary artery. The third step consists of performing arterial and venous anastomoses and checking the quality of these.

Two microanastomoses must thus be performed: arterial and venous. The classic technique, the most used, is to suture the 2 veins. Alternatively, a coupler device can be used to perform the venous anastomosis.

It is therefore interesting to compare the classical method and the venous coupler method in terms of surgery duration, venous thrombosis and complications. If the coupler is proved effective, it could replace the manual suture.

Venous thrombosis is the main cause of flap failure. But surgery duration has also an impact on the complication rate, and the anastomosis duration corresponds to the time during which the flap is not perfused. It is thus necessary to keep it to a minimum in order to reduce the risk of flap loss.

Eligibility Criteria:
Inclusion Criteria:

* Total mastectomy with mammary reconstruction by the DIEP technique
* Patients treated within the CHU Brugmann Hospital
* Patients treated between 01/01/2017 and 01/09/2017

Exclusion Criteria:

/
Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure
* hypoxemia with PaO2/FiO2 ratio \< 300 mmHg
* aged of 18 years or more

Exclusion Criteria:

* Need of immediate intubation
* Need of vasopressor drugs
* coma with Glasgow scale \< 8
* Acute respiratory failure linked to cardiogenic pulmonary oedema
* Chronic respiratory insufficiency
* Peripheral or central nervous system pathology
* Known psychiatric pathology or agitation
* Patient with decision of no intubation
* Patient refusal
* Pregnant or breastfeeding women
* Patient under legal guardianship or protection
* Patients with no health insurance coverage
Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey

A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously or currently diagnosed with bipolar disorder
* Patients (or any of their relatives) who give a written informed consent.

Exclusion Criteria:

* Patients who were previously included in this study.
Adalimumab in the Treatment of Chronic Pouchitis

This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis.

The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.

Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity.

It is a double-blinded randomized placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Operated with proctocolectomy and construction of an IPAA
* Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria.
* Diagnosed with chronic pouchitis as defined above
* PDAI ≥ 7, with the clinically part of PDAI \>2 and the endoscopic part of PDAI \>3
* Age \>18 years
* Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites
* Serology negative for chronic hepatitis B
* Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test)
* Signed informed consent

Exclusion Criteria:

* Treatment with glucocorticoids within the last 4 weeks
* Diagnosed with Crohn's disease
* Need of an interpreter or if patients do not understand oral or written information.
* Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch
* Abuse of medicine, alcohol or drugs
* Ongoing treatment with NSAID (non steroid anti inflammatory drug)
* Pregnancy or nursing
* A diverting stoma
* Malignancy or other severe chronic disease or expected longevity less than one year
* Patients diagnosed with immune deficiency
* Ongoing infectious disease
* Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
Periodontal Dressing After Surgical Crown Lengthening

Background: There is controversy regarding the postoperative effects of periodontal dressing on the periodontium, pain and discomfort. The aim of the present study was to compare postoperative pain following surgical crown lengthening with and without the use of periodontal dressing.

Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients. Following surgical crown lengthening, the individuals were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative infection, stability of the gingival margin and type of healing were also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* need for surgical crown lengthening on only one tooth with need for proximal osteotomy;
* aged 18 years or older;
* absence of systemic disease;
* absence of periodontal disease at the site of surgical crown lengthening;
* no restrictions regarding the procedure;
* no need for antimicrobial prophylaxis.

Exclusion Criteria:

* failure to return for the postoperative evaluations;
* failure to fill out the charts correctly;
* occurrence of pulp alteration in the operated tooth following the procedure;
* occurrence of partial or total loss of the periodontal dressing;
* allergic reaction to periodontal dressing.
A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen Allergy

This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tree pollen allergy.

The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks like a treatment but does not contain any real medicine.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).


Eligibility Criteria:
Key Inclusion Criteria:

1. Documented or participant-reported history of moderate to severe birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season
2. Positive SPT to birch allergen extract, as described in the protocol
3. Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7 kUa/L) at screening visit 1
4. Must be able to complete birch screening CACs and meet the criteria, as described in the protocol

Key Exclusion Criteria:

1. Participation in a prior clinical study and received either REGN5713-5714-5715, REGN5713-5715, or REGN5715 antibodies, as described in the protocol
2. Inability to complete or termination of the screening or confirmatory CACs due to a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement
3. Significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study CAC assessments, as assessed by the investigator, as described in the protocol
4. Persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1, as described in the protocol
5. The presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply.
Endophenotype Characterization of a Family Psychiatric Disorder

Bipolar disorder is a chronic and frequent mood pathology, that impacts on emotional and socio-professional life of sick subjects, and also increase mortality by suicide. Suicide is considered as a bipolar disorder result.

The main goal of this study is the endophenotype characterization from a clinical and cognitive point of view, of a bipolar spectrum's disorder present in a family, and then highlight a mutation of one of the genes involved is this disorder.

Heritability of bipolar disorder is now well established, but seems to be multifactorial in most of the cases.

The use of an endophenotype characterized in a family presenting numerous bipolar sufferers enable to reflect the expression of simpler genetic variants than those involved in the disease, and might enable the identification of genes involved in the etiopathogenesis of this endophenotype.

Eligibility Criteria:
Inclusion Criteria:

* Members of a family adult (more than 18 years)
* Signed informed consents
* Registered to a French social security or possesor of the European Health Insurance Card

Exclusion Criteria:

Clinical part :

* Refusal to sign the participation study consent.
* Organic affection likely to affect cognitive abilities and brain structures or acute decompensation of a bipolar disorder.

Genetic part :

* Refusal to sign the genetic sample consent.
Covid 19 Pandemic. Emerging Legal and Ehical Disputes Over Patient Confidentiality

Many critical ethical questions arise in pandemic covid 19planning, preparedness and response. These include: Who will get priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources? In the face of a pandemic, what obligations do health-care workers have to work not withstanding risks to their own health and the health of their families? How can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? What obligations do countries have to one another with respect to pandemic covid 19 planning and response efforts?


Eligibility Criteria:
Inclusion Criteria:

* adult aged 18 years to 60 years
* medical personel graduated from egyptian faculty of medicine.
* non medical personel live in egypt

Exclusion Criteria:

* personel less than 18 years old .
* medical personel not graduated from egyptian faculty of medicine.
* non medical personel live outside egypt
Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training

Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Simulation-based training can improve surgical skills, but little is known on how to optimally structure a training program to acquire camera navigation skills. The objective of this trial is to examine if simulation-based laparoscopic camera navigation skills transfer to the operating room after practicing one of two fundamentally different laparoscopic tasks on a simulator. The first group practice a procedure on a virtual reality simulator, the second group practice camera navigation on a virtual reality simulator and the third group receive no training. All participants are tested as camera navigators and assistants during a procedure in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* Medical students on the 4th, 5th or 6th semester, enrolled at The Faculty of Health Science, University of Copenhagen
* Signed informed consent

Exclusion Criteria:

* Previous participation in trials involving simulated laparoscopic training.
* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon or as a surgical assistant).
* No informed consent.
* Does not speak Danish on a conversational level.
Collaborate and Leverage Evidence in African American Rural Network

The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.

The research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy under NCT02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern North Carolina counties and implemented by community-based facilitators.

This study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from NCT02707432. Propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. The research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched NCT02707432 controls.

Eligibility Criteria:
Inclusion Criteria:

* Identify as Black or African American
* Reside in rural, eastern North Carolina
* Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease

Exclusion Criteria:

* Evidence of active or unstable cardiovascular disease
* Cognitive impairment that limits informed consent
Association of Haptoglobin 2-2 With Postoperative Delirium

Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)
* No psychological and psychiatric history and presentation before surgery
* No major organ dysfunction or failure

Exclusion Criteria:

* Anemia (hemoglobin \< 100 g/l) preoperatively.
* Requires \> 4 units of allogeneic red blood cell transfusion during the surgery
* Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion.
* Can not cooperate with the study
* History of bleeding
* BMI \< 18 or \> 30
* History of hemoglobin metabolism disorder
HRQoL and Financial Toxicity in Patients with VEXAS Syndrome

This multicenter cross-sectional observational study aims to describe health-related quality of life (HRQoL) and symptom profiles of patients with VEXAS syndrome.

Moreover, the study will investigate financial toxicity and treatment tolerability. To contextualize the results the data of VEXAS patients will be compared with a cohort of matched MDS patients.

The overall aim of the study is to establish benchmark HRQoL data to be used in future prospective studies and clinical trial design.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old) with a confirmed diagnosis of VEXAS syndrome (UBA1 pathogenic mutation detected)
* Written informed consent

Exclusion Criteria:

* - Having any kind of psychiatric disorder or major cognitive dysfunction.
* Not able to read and understand local language
Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of SBP
2. Age \> 18 years
3. Consent to participate in the trial

Exclusion Criteria:

1. Secondary peritonitis
2. Malignancies including HCC
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.

Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.

Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).

Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.


Eligibility Criteria:
Inclusion Criteria:

Healthy women with menopausal status (\>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.

Exclusion Criteria:

* Acute or recurrent urogenital infections
* Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
* Hormonal replacement therapy within the last 6 months before study entry
* Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
* Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
* Any condition that could interfere with study compliance
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years of age
* Constipated according to ROME I criteria
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
* Subjects who are pregnant or lactating, or intending to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any BLI-801 component.
* Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days