cyrilzakka/clinical-trials huggingface dataset:
Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease

This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.

Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned will be recruited. All the participants of the registry will receive same stent. OCT will be performed to analyze plaque morphology, SB size, SB angle and side branch ostial involvement.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age presenting with stable coronary artery disease.
* Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited

Exclusion Criteria:

* Patient with lesion involving side branch ( \>70 %) by angiogram and need pre-dilation.
* Patients with ostial left main artery lesions or ostial right coronary artery lesions
* Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Known allergy to acetylsalicylic acid or clopidogrel.
* Planned surgery within 12 months.
* History of bleeding diathesis
* Major surgery within 15 days
* Life expectancy \< 12 months.
* Patients with kidney dysfunction (CrCl\<30)
Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement

The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with good systemic health with no contraindication for periodontal surgery.
* No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
* Ability to maintain good oral hygiene as evidenced in recall visits.
* Aged 30 to 55 years.
* Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (\< 2mm bucco- lingual thickness).

Exclusion Criteria:

* Medically compromised patients and systemic conditions precluding periodontal surgery.
* Smokers.
* Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
* Patients subjected to irradiation in the head and neck area.
* Patients treated or under treatment with intravenous amino bisphosphonates.
* Patient affected by active periodontitis or has poor oral hygiene and motivation.
* Uncontrolled diabetes mellitus.
* Pregnant women or planning become pregnant, and nursing mothers.
Sparing in Neuromuscular Blockade in COVID 19 ICU

This is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

The use of NMB agents during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of NMB agents. Large amount of such patient admitted in a short time has led to a shortage of NMB agents, particularly cisatracurium.

The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.

The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* PCR-proven SARS-CoV-2 infection
* Use of VM (mechanical ventilation)
* Use of NMB agents for at least 48 hours

Exclusion Criteria:

* Pregnancy
* extracorporeal membrane oxygenation (ECMO)
Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness

The purpose of this study is to develop, validate, and evaluate the correlation of novel magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and histological data obtained during prostatectomy.

Prostate cancer is one of the most common neoplastic diseases in men. Prostate specific antigen (PSA) has only a limited role in the diagnosis and characterization of prostate cancer. The diagnosis of prostate cancer is still most commonly done by transrectal ultrasonography (TRUS) guided biopsy. However, TRUS guided biopsy carries a risk of increase in complications. There is an increasing interest in developing more accurate non-invasive imaging modalities which could potentially detect prostate cancer aggressiveness.

Diffusion weighted imaging (DWI) and rotating frame relaxation measurements have shown to be particularly promising in prostate cancer detection and characterization. This study which focuses on further development and validation of DWI and rotating frame relaxation measurements will enroll 200 men with histologically diagnosed prostate cancer who will undergo magnetic resonance imaging (MRI) before prostatectomy. Anatomical MRI and novel acquisition methods focusing on DWI and rotating frame relaxation measurements will be performed using surface coils to non-invasively detect and characterize prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age: 35 to 85 years
* Language spoken: Finnish
* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* Diagnosis: Histologically confirmed adenocarcinoma of prostate
* No previous surgical, radiation or endocrine treatment for prostate carcinoma
* Clinical stage T1c-T3aN0 based on transrectal ultrasound, pelvic CT and bone scintigraphy
* Time period between the last biopsy and scheduled radical prostatectomy less than 8 months
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
* symptomatic acute prostatitis
* contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* uncontrolled serious infection
* claustrophobia
The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder

Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to treatments is also a major obstacle in translating efficacy in research settings into effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that a multifaceted intervention will be more effective. The study is aimed to assess the effectiveness of a multifaceted intervention on enhancing medications adherence in patients with bipolar disorders.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years
2. meeting DSM-IV criteria for bipolar I or II disorder
3. concurrently treated with a mood stabilizer
4. not currently in weekly or biweekly psychotherapy
5. Persian speaking.

Exclusion Criteria:

* DSM-IV drug or alcohol misuse disorders (excluding nicotine),
* pregnancy or planning pregnancy in the next year
* requiring changing the drug or the dose of a mood stabilizer
* evidence of severe DSM-IV borderline personality
* Unable or unwilling to give written informed consent.
* An organic cerebral cause for bipolar disorder-for example, multiple sclerosis or stroke.
* intellectual disability
Big Decisions - an Evaluation of a Comprehensive Sexual Health Curriculum Pilot in Ecuador During 2019

The purpose of this study is to assess the efficacy of the "Big Decisions" Adolescent sexual and reproductive health (ASRH) Curriculum via a pilot program with an educational experimental trial design.


Eligibility Criteria:
Inclusion Criteria:

* Student at the Liceo Policial High School in Riobamba, Ecuador(Pilot Site)
* Student at COMIL High school in Riobamba(Control Site)
* Student of 9th or 10th grade.

Exclusion Criteria:

* Not a current student at the Liceo Policial High School in Riobamba, Ecuador(Pilot Site)
* Not a current student at COMIL high school in Riobamba.(Control Site)
* Not a student of 9th or 10th grade.
Home-administered tDCS for Treatment of Depression

This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks.

The Soterix Medical 1X1 mini-CT will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tDCS) in treating unipolar depression. Specifically efficacy will be determined by change in MADRS score from baseline to the 10 week follow-up. Feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed. Self-reported mood scores will be evaluated using the Quick Inventory of Depressive Symptomatology (QIDS-SR) and Quality of Life enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF). All visits will be performed via telephone or video conference. Subjects will be taught to operate the tDCS system and complete a tolerability check. The treatment course will consist of an acute phase of 28 tDCS sessions conducted Monday - Friday over 6 weeks. This is followed by a taper of 4 tDCS sessions spaced 1 week apart. Patients who meet criteria for clinical response (\>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months. Mood assessments will be conducted at baseline, 2 weeks, 4 weeks and 6 weeks in the acute treatment phase. In the taper phase, assessments wil be conducted at 1 month (end of taper), 3 and 6 months following completion of the acute phase. All assessments in the acute treatment phase and the taper phase will have a +/- 1 week collection window.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview.
* Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
* Scored at least 20 on the MADRS at trial entry
* Patient's antidepressant medication is stable for at least 30 days prior to MADRS screening
* Female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential

Exclusion Criteria:

* DSM-V-TR psychotic disorder
* Drug or alcohol abuse or dependence in the preceding 3 months
* Concurrent benzodiazepine medication
* High suicide risk
* History of clinically defined neurological disorder or insult
* Metal in the cranium or skull defects
* Subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator
* Skin lesions on scalp at the proposed electrode sites
* Pregnancy
Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.

This trial is not recruiting patients in the United States.


Eligibility Criteria:
Inclusion criteria:

* Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
* Nodal status negative or positive
* Good Health status 0-2 (Eastern Cooperative Oncology Group)
* Estrogen- and/or progesterone-receptor positive
* Adequate marrow, kidney and liver function

Exclusion criteria:

* Metastatic or inflammatory breast cancer
* Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
* Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery
* Patients with primary overactive parathyroid
* Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma

The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.

The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed sarcoma that is recurrent or refractory to conventional treatment
* Measurable disease by RECIST criteria
* ECOG (Eastern Cooperative Oncology Group) performance status \< 2 (or Lansky/Karnofsky \> 60% for children)
* Life expectancy greater than 3 months
* Adequate organ function
* absolute neutrophil count at least 1,500
* platelets at least 100,000
* bilirubin less than 1.5 x upper limit of normal
* AST (aspartate aminotransferase) and ALT(alanine aminotransferase) less than 2.5 x upper limit of normal
* creatinine less than 1.5 x upper limit of normal OR creatinine clearance at least 60 ml/min/1.73 m2
* fasting serum cholesterol less than 350
* fasting serum triglycerides less than 400
* PT (prothrombin) or INR (international normalized ratio) less than 1.3 x upper limit of normal
* normal urinalysis
* Ability to understand and sign the informed consent document

Exclusion Criteria:

* Prior chemotherapy or radiotherapy within 3 weeks of entering the study (6 weeks for nitrosoureas or mitomycin C)
* Prior treatment with a tyrosine kinase inhibitor within 10 days of entering the study
* History of pulmonary hypertension or pneumonitis
* Patients may not be receiving other investigational agents
* Prior therapy with rapamycin, rapamycin analogues, or tacrolimus
* Uncontrolled brain metastases
* History of grade 3 or 4 hypersensitivity to macrolide antibiotics
* Concurrent treatment with immunosuppressive agents other than a stable (for more than 2 weeks) dose of corticosteroids
* Uncontrolled intercurrent illness
* Pregnancy or breast feeding
* HIV-positive patients on combination antiretroviral therapy
* Grade 3 or 4 proteinuria
Follow-up of Patients Referred to Unscheduled Care Centers by the Emergency Call Center in the Haut-Rhin Department, France

The objective of this study is to determine the follow-up of patients who were referred by the Emergency Call Center of the Haut-Rhin department to an Unscheduled Care Centers (UCC) and to determine whether they actuallly went to a UCC following their call, or if they were taken in charge by another care facility.

Conduct of research:

Patients who contacted the emergency call center and were referred to an unscheduled care center in the Haut-Rhin will be contacted by mail in the first instance. Ten to fifteen days after the call to the emergency call center, the investigator will contact the patient by phone, during which he/she will ask for the patient's oral consent to participate in the research and collect follow-up data using a standardized questionnaire.

If the investigator is unable to reach the patient, further attempts will be made to call the patient up to 30 days after the initial call. If there is no response after this time, patients will not be included the study.

Eligibility Criteria:
Inclusion Criteria:

* Call to the Emergency Call Centre of the Haut-Rhin department by an adult (age ≥ 18 years)
* Referral to the Unscheduled Care Center by the Emergency Call Center

Non-inclusion criteria:

* Patient who does not answer phone within 30 days of call to the Emergency Call Center
* Patient who refuses to participate in the study
* Call for someone other than him or herself (except when a parent calls for his or her minor child)
Contrast Nephropathy in Type 2 Diabetes

To study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria

Study design:

This study will be an observational prospective cohort study.

Study population:

Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors.

Data collection:

Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.

Eligibility Criteria:
Inclusion Criteria:

* Diabetics on DPP 4 inhibitor treatment

Exclusion Criteria:

* Diabetics on insulin
Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation

The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using two different xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor elevation.

A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of autogenous cortical bone (collected by a bone scraper from the access window to the maxillary sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core biopsies will be obtained at the site of implant placement 6 months after the floor elevation. Histological sections will be subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.


Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patients.
* Kennedy class I in the upper jaw.
* Less than 5 mm of residual crestal bone to the maxillary sinus.
* Need for the replacement of teeth with dental implants.

Exclusion Criteria:

* Sinus pathology (sinusitis, mucocele, cysts).
* Smokers.
* Previous long-term (\>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department

Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.

Previous studies in patients undergoing surgical procedures have shown that when IV dexamethasone is given with IV ondansetron to post-operative patients they have less nausea and vomiting than ondansetron alone, and were even found to show decreased post-operative pain associated with nausea. It has also been shown to decrease the need to re-dose antiemetic medication. Although this combination has not been tested in the emergency department it is believed by these investigators that the additional use of dexamethasone may decrease the need to use repeated doses of ondansetron.

The investigators believe this may change the way physicians currently approach the nauseated patient in regards to treatment. That rather than possibly giving multiple doses of one medication over and over to reduce a patient's nausea, physicians can give two medications together at one time. The investigators hope to demonstrate that by giving intravenous dexamethasone and ondansetron together, it may be possible to reduce the number of patients who need additional doses of nausea medication.

Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Chief Complaint of nausea or abdominal pain with nausea
* Inability to tolerate oral nausea medication
* Patients with a negative pregnancy test

Exclusion Criteria:

* Patients younger than 18 years of age
* Patient's chief complaint includes headache, chest pain, or dizziness
* Patients with whom there are contraindications to using the studied medicine (allergies, known adrenal disease)
* Blood sugar greater than 300
* Non-English speaking subjects