cyrilzakka/clinical-trials huggingface dataset:
Simultaneous Implant Placement With Autogenous Bone Ring

This study is aiming to evaluate bone gain and secondary stability in autogenous bone ring technique using trephine bur compared to control group of sticky bone.

The main prerequisite of achieving proper implant placement with ideal functional and proper restoration particularly in the posterior maxilla may compromise with violation to Schneiderian membrane especially in pneumatized maxillary Antrum when RBH \< 4 mm, Conventional lateral sinus floor elevation (CLSFE) is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics in severe atrophic maxilla.

The objective of this study was to evaluate sinus elevation with simultaneous implant placement using open technique and bone ring versus sticky bone clinically and radiographically in terms of secondary stability and bone gain around the implant

Eligibility Criteria:
Inclusion Criteria:

* Patients with edentulous vertically deficient posterior maxillary ridge a 4-5 mm. height of alveolar bone.
* Both males as well as females without any active periodontal disease.
* All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
* All selected patients are non-smokers and non-alcoholics.
* Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
* The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
* Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
* General contraindications to implant surgery.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
* Active infection or severe inflammation in the area intended for implant placement.
* Need of bone augmentation procedures at implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Referred only for implant placement or unable to attend a 5-year follow-up.
Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.


Eligibility Criteria:
Inclusion Criteria:

* Participating in the CARDIAC Boot Camp Program
* Between the ages of 4 and 17
* Parental permission
* Ability to provide assent

Exclusion Criteria:

* Inability to comply with saliva collection procedures
* Renal insufficiency or juvenile gout
Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis


Eligibility Criteria:
Inclusion Criteria:

* Esophageal candidiasis confirmed by endoscopy
* Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

* Pregnant or nursing female patient
* Evidence of liver disease
* Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
* Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
* Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
* Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
* Experienced \> 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
* History of anaphylaxis attributed to echinocandin class of antifungals
Use of Consent Language and Mode to Improve Interactive Voice Response Survey in Colombia and Uganda

This study evaluates the effect of one new form of introduction language and three new modes of providing consent on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to control group, in Colombia and Uganda.

Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of five introduction and consent combinations and then have them complete noncommunicable disease risk factor survey with an additional module regarding their understanding of the survey and of its voluntariness. This mobile phone survey will be sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2). This study will be conducted in both Colombia and Uganda.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Colombia, conversant in the Spanish language. In Uganda, conversant in Luo, Luganda, Runyakitara or English languages.

Exclusion Criteria:

* Less than 18 years of age
Efficacy and Safety Study of Elagolix in Women With Endometriosis

The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for the first 8 weeks of the study. Following 8 weeks of dosing, participants continued in the study for an additional 16 weeks in an open-label phase where all participants still enrolled in the study received 150 mg elagolix once daily.

There was no pre-specified primary efficacy end point for this study as there is no single key efficacy outcome measure in this exploratory Phase 2 study. However, the efficacy measures of primary interest included the daily assessment of dysmenorrhea, non-menstrual pelvic pain and dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

Eligibility Criteria:
Inclusion Criteria:

* Be female, aged 18 to 49 years, inclusive.
* Have moderate to severe pelvic pain due to endometriosis.
* Have a history of regular menstrual cycles.
* Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening.
* Have a Body Mass Index (BMI) of 18 to 36 kg/m², inclusive.
* Agree to use two forms of non-hormonal contraception during the study.

Exclusion Criteria:

* Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist other than NBI-56418, or danazol or have received any of these agents within 6 months of the start of screening.
* Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
* Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.
* Have had surgery for endometriosis within the last month.
* Have had a hysterectomy or bilateral oophorectomy.
* Are using systemic steroids on a chronic or regular basis within 3 months.
* Have uterine fibroids ≥ 3 cm in diameter.
* Have pelvic pain that is not caused by endometriosis.
* Have unstable medical condition or chronic disease.
* Have been pregnant within the last six months.
* Currently breast feeding.
Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study

In this study, a retrospective analysis will be performed on collected data of 14 patients with Failed Back Surgery Syndrome, treated with Spinal cord stimulation.

In separate studies, fMRI and EEG recordings were made in resting state conditions on two time points. The fMRI assessments and EEG recordings were performed before the SCS implantation (baseline) and repeated around 3 months after the definitive SCS implantation. During both assessments, patients were asked to fill in a VAS diary for their leg and back pain (scores from 0 to 10).

The aim of the current retrospective study is to correlate the clinical data obtained from the VAS scores, with estimates of effective connectivity (obtained from fMRI and EEG). Effective connectivity will be calculated by using dynamic causal modeling (DCM) on the baseline data and the data obtained 3 months after SCS. The aim is to evaluate whether DCM data of EEG is equally/worse/better correlating with the clinical data as DCM data of fMRI.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old.
2. Diagnosis of FBSS with predominant leg pain (VAS) \> 5) and non-dominant back pain.
3. Cognitive and language functioning enabling coherent communication between the examiner and the subject;
4. Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
5. Stable neurologic function in the past 30 days
6. Subject is included in the previous studies and both EEG and fMRI data are available.

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
2. Subjects currently has an active infection
Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction

Cardiac magnetic resonance imaging (MRI) measures of myocardial interstitial fibrosis (MIF) are elevated in heart failure with preserved ejection fraction (HFpEF) patients and associated with poor prognosis. Extracellular volume (ECV) is the most reproducible and best validated cardiac MRI measure of MIF. Sacubitril/valsartan reduces histological MIF in mice and levels of some extracellular matrix regulatory proteins in humans with HFpEF. However, the effect of sacubitril/valsartan on robust measures of MIF in humans is unknown. Demonstrating reductions in ECV with sacubitril/valsartan would clarify the mechanism of this approved medication. Given the borderline reduction in heart failure hospitalizations with sacubitril/valsartan and the heterogeneity of HFpEF pathophysiology, this result would suggest that neprilysin inhibition may particularly benefit HFpEF patients with greater MIF. The investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition (sacubitril/valsartan vs valsartan alone) on cardiac MRI measures of fibrosis (principally ECV) and circulating protein levels.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 50 years or older
* Able to provide informed consent, as assessed by a physician investigator, and willing to comply with the study
* Clinically confirmed diagnosis of heart failure
* Left ventricular ejection fraction greater than or equal to 45% within 1 year by echocardiogram, cardiac MRI, or nuclear scan

Exclusion Criteria:

* Contraindication to MRI (metal prosthesis, implantable cardiac device, or severe claustrophobia)
* Systolic blood pressure \< 100mm Hg, or \<110 mm Hg for patients not taking an ACE inhibitor or angiotensin receptor blocker
* symptomatic hypotension
* eGFR \< 30 mL/min/1.73m2 within 60 days of enrollment
* Serum potassium \>5.2mmol/L within 60 days of enrollment, or \>5.0 mmol/L for patients not taking an ACE inhibitor or angiotensin receptor blocker
* Myocardial infarction within 6 months of enrollment
* Infiltrative or hypertrophic cardiomyopathy
* History of cirrhosis, biliary cirrhosis, or cholestasis
* History of angioedema
* Pregnancy, planning pregnancy, or breastfeeding
* Active treatment with lithium or a direct renin inhibitor
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery

This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.

Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES) are emerging minimally invasive surgery techniques which can further reduce patient trauma and enhance recovery. However, the wider adoption of these techniques is hampered by the limitation of instrumentation and technical difficulties. Robotic assistance may improve surgical capabilities during single port surgery and NOTES by providing augmented motion precision and manipulation dexterity.

Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.

Design: Prospective, single center, multispecialty study consistent with a stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework.

Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the inclusion and exclusion criteria will be recruited.

Intervention: Single port surgery and transanal/transoral surgery will be performed using the novel single port robotic system.

Study Endpoints: Primary: conversion rate and perioperative complications. Secondary: operative time, blood loss, pain scores, analgesic requirement, and length of stay.

Hypothesis: The prospective study will provide important information on the feasibility, safety, and effectiveness of the novel single port robotic system in performing single port surgery and NOTES in various surgical specialties. A positive study will provide supporting evidence for continuing development of this new technology.

Eligibility Criteria:
GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES

1. Body mass index \<35 kg/m2
2. Suitable for minimally invasive surgery
3. Willingness to participate as demonstrated by giving informed consent

GENERAL EXCLUSION CRITERIA FOR ALL PROCEDURES

1. Contraindication to general anesthesia
2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
3. Untreated active infection
4. Noncorrectable coagulopathy
5. Presence of another malignancy or distant metastasis
6. Emergency surgery
7. Vulnerable population (e.g. mentally disabled, pregnancy)
Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery

The primary purpose of this prospective observational study was to compare these tests used to predict difficult intubation in patients undergoing thyroid surgery. Secondarily; By comparing these tests, we aim to find the test that best predicts difficult intubation and to determine the incidence of difficult intubation in patients who will undergo thyroid surgery.

Patients' demographic information (age, gender, American Society of Anesthesiologists (ASA) classification, STOP-BANG score(snoring, feeling tired, observed apnea, hypertension, obesity, age, neck circumference and gender), body mass index) and thyroid ultrasonographic measurement will be recorded.

At the preoperative visit, patients will be evaluated for El-Ganzouri Risk Index (EGRI) scores (mouth opening, thyromental distance, mallampati score, neck movement limitation, presence of prognathia, body weight and history of difficult intubation) and for airway ultrasonography (skin-epiglottis distance, skin-hyoid bone distance, skin-vocal cord distance, tongue thickness and tongue volume values).

After this information is recorded, patients will be grouped as those expected difficult intubation and those who are not. After the patients are taken to the operating table and monitored, vascular access will be opened, standard anesthesia induction will be applied to the patients by the room specialist, and laryngoscopy and endotracheal intubation will be performed by the trained (\>2 years experienced) anesthesiologist. If Intubation Difficulty Scale (IDS) score will be greater than 5, patient will be considered difficult intubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA scores 1-3
* Patients between 18-65 age
* Patients who undergo thyroid surgery

Exclusion Criteria:

* Patients who do not accept to participate the research
* Patients under age 18 and over age 65
* Pregnant patients
* Patients who undergo surgery due to emergency medical conditions (such as hematoma, thyroid crisis or myxedema coma)
* Patients with airway malformations
* Patients with a high risk of aspiration
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).

The study period per participant was variable depending on the duration of chemotherapy. It included:

* a screening period up to 3 weeks,
* a double-blind treatment period,
* a follow-up period of 1 month.

Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).

Eligibility Criteria:
Inclusion Criteria:

Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy

Exclusion Criteria:

* Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic;
* High risk of bleeding;
* Severe renal impairment (estimated creatinine clearance \<30 mL/min);
* ECOG (Eastern Cooperative Oncology Group) performance status 3 \& 4;
* Major surgery within 4 weeks before randomization;
* Known hypersensitivity to unfractionated heparin \[UFH\] or low molecular weight heparin \[LMWH\].

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Acute Effect of Crocus Sativus on Postprandial Glycemia

This study investigated the effects of two different doses of Crocus Sativus in glucose beverages on glycemic responses.

This study examined the short-term effects of two different doses (15 mg and 30 mg) of Crocus Sativus in glucose beverages on postprandial glycemic responses in healthy young adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoking
* Non-diabetic men and women
* Body Mass Index (BMI) between 18.5 and 24.9 kg/m2
* Normal blood pressure

Exclusion Criteria:

* Severe chronic disease (e.g., coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency
* Allergy in Crocus Sativus
Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease

The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Unprotected left main disease

Exclusion Criteria :

* No exclusion criteria
Prevalence of Delayed Chemotherapy Associated Nausea

This study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics.

Chemotherapies are rated to have a high to minimal emetogenic potential in oncology patients. Their potential to induce delayed nausea is supposed to often be higher than their emetogenic potential. However, data on delayed chemotherapy-related nausea are scarce, which is problematic because nausea (a) has a large impact on patients quality of life and treatment decisions, (b) is often underestimated by health care professionals, (c) is less responsive to commonly used antiemetic medication, and (d) may even be different from rates that have been established in controlled clinical trials.

Therefore, the aim of this study is to assess the prevalence of delayed chemotherappy-induced nausea in adult oncology patients in dayclinics.

Eligibility Criteria:
Inclusion Criteria:

* first day of chemotherapy of a new cycle (any cycle)
* speak and write German
* sign the consent forms

Exclusion Criteria:

* cognitive or linguistic impairments that would significantly impede consent or participation (as assessed by the nurses in charge)
* accompanying radiotherapy;
* pre-existing nausea within three days before the start of the first chemotherapy in this cycle; and
* prior participation in CINrate (each person participates only once)
(-)-Epicatechin and Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe activity limitation and death. There are few treatments for PAH and the available medications are expensive, difficult to administer and have significant toxicities.

(-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and chocolate. Clinical intervention studies using dark chocolate in normal volunteers and subjects at risk for or with established cardiovascular disease have demonstrated improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, glucose tolerance and inflammatory markers.

Our study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 or older
* NYHA Class II-!V
* 6 minute walk distance \< 450 meters
* Outpatients with suspected WHO group I PAH or and established diagnosis of WHO group I PAH undergoing clinically indicated right heart catheterization
* Written informed consent obtained from subject and ability for subject to comply with the requirements of study

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Systolic blood pressure \<100 or \>160
* History of migraine headaches
* Allergy or intolerance to chocolate, tea or wine
* Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason