cyrilzakka/clinical-trials huggingface dataset:
Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).

The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.

Eligibility Criteria:
Inclusion Criteria:

• Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.

Exclusion Criteria:

* History of periodontal surgery at the area on the last 12 months
* Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids)
* Pregnant
* Smokers
* Diabetics
* History of head and neck radiotherapy
Bedside Sleep Medicine

The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology intensive care unit. The patients will be submitted to a overnight polysomnography. Those individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the investigators will identify the factors that compromise the sleep and will act to minimize them to improve the sleep quality.

After the interventions, the investigators will evaluate if there are reduced days of hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

At the hospital discharge and after at 1, 3 and 12 months we will evaluate the occurrence of major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction
* Acute decompensated heart failure
* Age \> 18 years-old
* Cardiology intensive care unit admission

Exclusion Criteria:

* Intravenous sedation
* Invasive mechanical ventilation
* hemodynamic instability
* use of intravenous vasoactive drugs
* acute respiratory failure
Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.

Eligibility Criteria:
Inclusion Criteria:

Patients can be included if all of the following criteria are met:

* Written informed consent prior to participation
* Female and male patients ≥40 years of age
* Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D)
* Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.

Exclusion Criteria:

* Patients with contraindications according to Spiolto® Respimat® SmPC
* Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
* Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
* Pregnancy and lactation
* Current participation in any clinical trial or any other non-interventional study of a drug or device.
Dietary Intervention With Shop Model - SHOPUS

The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* abdominal obesity

Exclusion Criteria:

* BMI \> 45, previous weight change
E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference

The study evaluates whether the introduction of e-alcohol therapy (alcohol therapy delivered via video conference) can break with some of the barriers related to alcohol treatment and thereby appeal to people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8). The study aims to evaluate the effect of e-alcohol therapy on initiation, treatment compliance and alcohol intake as compared to treatment as usual .

Background: Only a small proportion of those who have a problematic alcohol use receive treatment and compliance is low among the few that undergo treatment. If treatment more easily can be combined with everyday life and break with some of the barriers related to stigma by having a broader appeal, more people with a problematic alcohol use may seek and complete treatment. Alcohol therapy conducted via video conference may be an attractive treatment option and effective in reducing alcohol intake among people with a problematic alcohol use who do not seek traditional treatment.

Objective: The aim of this trial is to evaluate whether people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8), who enroll in alcohol therapy delivered via video conference to a greater extent initiate as well as comply with treatment and reduce their alcohol intake compared to people allocated to standard alcohol treatment.

Design: Randomized controlled trial

Participants: 375 Danish citizens above 18 years with a problematic alcohol use (Alcohol Use Disorder Test (AUDIT) score \>8).

Intervention: Participants are randomized to one of two groups:

1. Conversational therapy via video conference where participants are contacted by an alcohol therapist for the purpose of initiating a course of treatment where participants are not required to show up at a clinic.
2. Treatment as usual where participants receive contact information on their local alcohol treatment facility for the purpose of contacting the facility to initiate a face-to-face course of treatment at the clinic.

The allocation of participants to the intervention will be 1:1 to the intervention and the control group.

Methods: Data will be collected by questionnaire at baseline, 3 months and 12 months post randomization. Analyses will be intention to treat. Subgroup analysis will be conducted in relation to personal and demographic characteristics.

Process evaluation will be performed using a combination of questionnaires and qualitative interviews with participants, therapists and management at the clinics.

Eligibility Criteria:
Inclusion Criteria:

- Problematic alcohol consumption (Alcohol Use Disorder Test score ≥ 8)

Exclusion Criteria:

* Not legally able and willing to provide informed consent
* No provision of a functional e-mail address
* No provision of municipality of residence and phone number
* No access to a personal computer equipped with functional camera, audio equipment, and Internet access.
Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients

FADOI (Italian Scientific Society of Hospital Internal Medicine) has planned to promote a multicenter cluster-randomized controlled clinical study in order to evaluate the effects of a systematic assessment of patients by using the Padua prediction score and the IMPROVE Bleeding score vs clinical judgement on the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and hemorrhagic events).

The most recent guidelines suggest the use of prophylaxis in patients with a high thromboembolic risk, while taking into account the risk of bleeding.

It is known that patients admitted for acute pathology have an eight-fold higher incidence of thromboembolic events than the general population.

The Padua Prediction Score (PPS) is currently considered the best score available for the evaluation of thromboembolic risk in hospitalized patients, while the IMPROVE score was developed and validated for the assessment of bleeding risk in the same population of hospitalized patients.

In a recent study, data from the real world showed us how many of the patients admitted in Internal Medicine were at high thrombotic risk according to PPS and almost 90% of these were simultaneously at low hemorrhagic risk according to the IMPROVE score: in these patients pharmacological prophylaxis could therefore be prescribed during a safe stay.

Until now only a small prospective monocentric quasi-randomized study has shown that the use of systematic PPS reduces the incidence of thromboembolic events (symptomatic and non-symptomatic) upon discharge, compared to clinical judgment alone.

For these reasons, FADOI Foundation has promoted a multicenter controlled randomized cluster study in a real-life context among patients admitted to medical area departments. The aim of the study will be to analyze the effects of a systematic evaluation of patients (in centers that do not require the use of any score for the evaluation of thromboembolic risk), using the Padua Prediction Score (PPS) and the IMPROVE Bleeding score vs only clinical judgment for the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and haemorrhagic events). The main objective of the study is therefore to evaluate the effectiveness of a systematic evaluation of the thromboembolic and hemorrhagic risk in reducing the number of major complications in patients admitted to Internal Medicine, at a 90-day follow-up after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Hospitalized for any cause in Internal Medicine
3. Signature of informed consent

Exclusion Criteria:

1. Expected hospital stay \< 48 h
2. Any indication for anticoagulant therapy
3. Life expectancy \< 90 days
Stress Management on Nursing Students

In this study, it was aimed to determine the effect of the stress management program on the clinical stress of first year nursing students. This research will be carried out in a randomized controlled experimental design.

The data of the research; The descriptive characteristics form will be collected using the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, and the Stress Coping Behaviors Scale for Nursing Students. students will be assigned as experiment (32) and control (32) by randomization. A four-session stress management program will be applied to the experimental group students. No intervention will be made on the control group.


Eligibility Criteria:
Inclusion Criteria:

The first to enroll in the Nursing Fundamentals course,

Exclusion Criteria:

* Have previously taken nursing fundamentals course
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.


Eligibility Criteria:
Inclusion Criteria:

• Body mass index of 18.0 to 35.0 kg/m2

Exclusion Criteria:

* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
* Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease

Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease

This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Heart Failure with Coronary Artery Disease Subjects

* Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)
* Significant underlying coronary artery disease as evidenced by:
* previous myocardial infarction
* prior coronary artery bypass graft
* 50% coronary stenosis of one or more arteries and/or
* history of percutaneous coronary intervention with or without stenting
* Age 18 years or older at the first screening visit

Group 2: Healthy Subjects

• Age 18 years or older at the first screening visit and within 20% of mean age of Group 1 Subjects

Exclusion Criteria:

Group 1:

* Documented history of "severe" valvular disease
* Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
* Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)

Group 2:

* Known significant cardiovascular or hematological condition
* Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
* Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)
* History of Asthma
* History of peptic ulcers
Oral Health and Pregnancy

The aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them.

Pregnant women will have to complete a questionnaire that brings together their knowledge, practices and social representations of oral health during their current pregnancy.

Eligibility Criteria:
Inclusion criteria:

* pregnant t women over 18 years old
* French language

Exclusion criteria:

- pregnant women under 18 years old
Laser Therapy in Nipples Injured During Breastfeeding

This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in mothers with nipple trauma during breastfeeding, compared to a control group.

The selection was made through the search of women hospitalized in Accommodation beds with nipple trauma, lifting of stipulated criteria, and inclusion of women in the study upon acceptance and signing of the consent form. To collect the data, a group was formed with people trained as evaluators, responsible for election, randomization, filling of First Assessment and Subsequent Assessment forms, recording of photo images and pain evaluation before and after treatment with laser; and applicators, responsible for laser handling and irradiation. Data collection followed the following order: filling of the first instrument, breast image capture, suckling observation, identification of pain during the child's breast sucking, laser irradiation and re-identification of pain during the child's breast sucking after laser treatment. The collection of data of this form occurred continuously every twelve hours until repair of the nipple trauma or patient discharge. A minimum of two and a maximum of six assessments were carried out, from the inclusion of the patient in the study (taken as zero hour) to 60 hours postpartum. Irradiation, in turn, was performed every 24 hours during the same period, including one to three irradiations per patient in each of the breasts.

Eligibility Criteria:
Inclusion Criteria:

Women hospitalized in the Accommodation System with their children, feeding exclusively directly from the breast and presenting unilateral or bilateral nipple trauma.

Exclusion Criteria:

Women who were using any other form of treatment for nipple trauma; use of any topical substance in the nipple-areola region; presence of inverted and pseudo-inverted nipple; presence of mastitis; previous history or presence of malignancies; presence of photosensitivity or any adverse reactions to exposure to sunlight; discharge planned for the first day of data collection; women under unfavorable psycho-affective and cognitive situations which prevented assessment of the analog pain scale, photo image record. and observation of breastfeeding; women who had twins, children with gestational age less than 37 weeks, or birth weight less than 2500 grams.
Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

The prevalence of ascariasis in COPD patients with and without concomitant pulmonary aspergillosis and in controls will be determined. To assess the influence of ascaridosis on the development of pulmonary aspergillosis in COPD patients cytokine status of patients will be studied.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* COPD patients with aspergillosis
* COPD patients with ascariasis
* COPD patients with mix-infection
* Healthy individuals (controls)

Exclusion Criteria:

* COPD patients with other autoimmune diseases
* COPD patients with oncological diseases
* COPD patients with other co-infections
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity

Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA

Secondary Aims of the study include Length of hospital stay , Necessity of further intervention(Whether a Revascularization Procedure or More Debridement sessions) , Incidence of MACE (Major Adverse Cardiovascular Events) in both groups

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included in this study are those suffering from DFUs; and Borderline Ischemia (BLI) / Borderline Vacularity with (Rutherford Grade "I" Categories "2\&3") when they have a borderline ankle systolic pressure

Exclusion Criteria:

* All patients with (CLI) and DFUs as they are indicated for urgent re-vascularization.

Severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage.

Lesions lying within or adjacent to an aneurysm; Non diabetic cases with foot ulcers; Arteritic lesions;(Vasculitic Patients). Patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity
Predictors of Success of IUI in Unexplained Infertility

Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.

Superovulation will conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly. Successful pregnancy after IUI was confirmed by ultrasound as one or more visible gestational sacs in the uterine cavity.

Eligibility Criteria:
Inclusion Criteria:

* These patients had at least 1 tube patent
* there were no significant intrauterine or pelvic abnormalities demonstrated on pelvic-abdominal ultrasonography, hysteroscopy, and/or laparoscopy
* serum follicular stimulating hormone (FSH) level of12 mIU/mL or less

Exclusion Criteria:

* A woman's age of more than 40 years,
* ovarian cyst detected in the ultrasound examination
* uterine lesions such as submucosal leiomyoma, and a previous diagnosis of moderate to severe pelvic endometriosis.
* women with body mass index \> 35 kg/m2,
* PCOS/anovulatory patients
* signs of hyperandrogenemia