cyrilzakka/clinical-trials huggingface dataset:
Preprocedural Fasting and Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment of Children

Nitrous oxide analgesia is used routinely for the dental treatment of anxious or uncooperative pediatric patients. In many instances it is used alone without any supplemental oral premedication. A controversy exists among pediatric dentists and pediatric dental departments regarding the need to apply pre-procedural fasting (PF) or other limitations on children undergoing dental treatment with nitrous oxide alone.The purpose of this study is to investigate the association between PF and the frequency of vomiting in pediatric patients receiving dental treatment with nitrous oxide analgesia.

Materials and methods The experimental protocol will be submitted for approved by the Institutional Human Subjects Ethics committee of Hadassah-Hebrew University School of Dental l Medicine. Informed consent will be obtained from all parents or legal guardians of participating subjects.

Subjects All pediatric patients attending the graduate student pediatric dental clinic of the Department of Pediatric Dentistry at Hadassah Clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. All participants must be in good health (ASA I). Prior to one session subjects will be restricted and have a preprocedural fasting as per the following guidelines: All subjects will be without solids (including milk) for at least 4 hours prior to nitrous oxide administration and without clear liquids 2 hours before treatment. On the alternative session subjects will have no restrictions on their food or liquid intake.

Evaluation

A survey will be given to parents prior to treatment and information regarding the following will be gathered:

Age, previous nitrous oxide experience, history of vomiting or nausea (motion sickness, foods etc), last mea: what and when? The resident administering treatment will record the following: Duration of inhalation administration, percentage of nitrous oxide and flow rate, steady or fluctuating, occurrence of vomiting during or immediately following treatment.

Statistical analysis of data will determine the incidence of vomiting and if any significant differences between the two sessions exist.

Eligibility Criteria:
Inclusion Criteria:

- All pediatric patients attending the graduate student pediatric dental clinic of the Department of Pediatric Dentistry at Hadassah Clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. All participants must be in good health (ASA I).

Exclusion Criteria:

-
Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures

The purpose of this study to to determine whether a single incision technique or a double incision technique is more effective in the surgical treatment of distal bicep tendon ruptures. Patients will be randomized to one of the two techniques upon consenting to the study. Prior to surgery patients will have their elbow flexion, extension, pronation, and supination strength measured. Elbow Range of motion will also be measured in each of these four movements. A number of subjective questionnaires will also be administered to the patient prior to surgery. The identical objective tests and subjective questionnaires will be completed by the patient at intervals of three months, six months, one year, and two years following their surgery. Additional information from patients clinical visits may also be collected throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Complete rupture of the Distal Bicep tendon
* Acute bicep tendon rupture (\< 10 days since rupture)
* 18 years of age and older

Exclusion Criteria:

* Partial rupture of the Distal Bicep tendon
* Chronic bicep tendon Ruptures (\>10 days since rupture)
* Under 18 years of age
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia

Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
* Male or Female aged 10 years or above.
* Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma.
* Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines.
* Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

* Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.
* Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
* Participants with circulating tumour cells in previous or current lab determinations.
* Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
* Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer

The purpose of this study is to analyze heterogeneity of prostate cancer（PCa）based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT)

PET/CT examinations were performed on different days using Siemens Biograph MCT PET/CT equipment. All patients were examined on the same scanner. Patients were fasted for more than 6 h before \[18F\]FDG PET/CT examination, blood glucose was controlled below 11.1 mmol/L, \[18F\]FDG injection dose was 3.7 MBq/kg, and \[18F\]FDG PET/CT examination was performed after 60 min rest. \[18F\]PSMA-1007 injection dose was 3.7 MBq/kg, and PET/CT scan was performed 60 min after injection. To avoid interference of prostate lesion detection by active urine in the bladder, patients were asked to urinate or undergo forced diuresis before the start of the examination. The scan was performed from the top of the head to the base of the thighs. Low-dose CT was taken with automatic milliampere-second 120 kV voltage scans with a matrix of 512 × 512 and a thickness of 5 mm, and PET/CT image acquisition was taken from 5-6 beds for 2-3 min each. CT data was used for attenuation correction at the end of the acquisition, reconstructed by the two-iteration method (21 subsets in total), and the True X +TOF algorithm was applied to reconstruct the images. Two nuclear medicine physicians with extensive experience in PET/CT interpretation evaluated the images using the LIFEx software v 7.1.0. Both readers were blinded to both clinical and pathological data

Eligibility Criteria:
Inclusion Criteria:

* Untreated patients with PCa confirmed by prostate systemic pathological biopsy
* Patients underwent \[18F\]PSMA-1007 and \[18F\]FDG PET/CT and the imaging interval was less than one month.

Exclusion Criteria:

* Patients received treatment at intervals of two imaging
* Imaging was less than 1 week after pathology biopsy
The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection & Cardiovascular Fitness

Elective percutaneous coronary intervention (PCI) is often associated with myocardial necrosis evidenced by peri-procedural troponin release. This is a surrogate for subsequent cardiovascular events. There is no study on the effect of peri-PCI oxygenation in in myocardial protection and cardiopulmonary fitness outcome. Patients with higher baseline cardiopulmonary fitness will have lower mortality.

This study is to assess the utility of oxygen to reduce ischaemia in patients with significant stable coronary artery disease scheduled for elective PCI. The secondary objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness and autonomic response.

OBJECTIVE: This study is to assess the utility of oxygen to reduce ischaemia in patients with significant stable coronary artery disease scheduled for elective PCI. The secondary objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness and autonomic response.

STUDY DESIGN: Randomized double blinded prospective pilot study SAMPLE SIZE: 30 patients scheduled for elective for PCI randomized to 2 groups, oxygen group ( 15L/min) and air group METHOD: Patient whom fulfil inclusion criteria were recruited and randomized to 2 groups via computer allocation system. The assigned inhaled gas will be delivered via high-flow mask at 15L/min for a minimum of 30 minutes immediately prior to and continued throughout the PCI procedure. Patients were blinded throughout the procedure but the practising cardiologist and staff nurses were not blinded. Routine care continued post PCI. Blood sampling for Troponin I was taken at 6 hours and 24 hours following stent implantation. Patients were discharged one day after the procedure as per current routine practice.

Patients were given routine follow up with the cardiac rehabilitation clinic in 4 weeks time post discharge. EST was arranged 6 weeks post procedure PRIMARY OUTCOME MEASURE: Troponin I at 6 and 24 hours SECONDARY OUTCOME MEASURE: METs, Heart Rate Recovery, Chronotropic Index

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years
* Haemodynamically important coronary artery disease (\>70% luminal stenosis angiographically in ≥1 major epicardial coronary artery

Exclusion Criteria:

* Significant chronic airways disease with type-2 respiratory failure precluding safe use of oxygen
* Coronary stenoses where evidence of plaque instability is evident e.g. rest pain, visual evidence of thrombus, elevation of Troponin T at baseline
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)

This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

The duration of treatment is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Elevated cholesterol

Exclusion Criteria:

* Unstable medical conditions or significant heart problems within 3 months prior to first study visit.
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies

The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.

Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of lymphoid malignancy with an expected complete response rate of less than 20 percent OR have failed at least one prior therapy.
* No chemotherapy within 3 weeks of entry into study and must have recovered from acute toxic effects of prior therapy.
* Life expectancy of at least 12 weeks.
* Performance status equal to or less than Zubrod 2.
* Signed informed consent.
* Patients with measurable disease.
* Age at least 16 years.
* Adequate bone marrow function (unless involvement of bone marrow by lymphoma) defined as AGC greater than 1500 and platelet count greater than 100,000.
* Adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than or equal to 4 times the upper limits of normal.
* Adequate renal function defined as serum creatine less than or equal to 1.5 mg %.

Exclusion Criteria:

* No serious intercurrent illness.
* Adequate contraception (if applicable).
* NO patients with significant cardiac disease, i.e. New York Heart Association (NYHA) class III or IV.
* NO experimental clinical trial within 3 weeks of study entry.
* NO patients with active CNS disease.
* Full recovery from any prior surgical treatment.
* NO active active infections.
Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes

Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.


Eligibility Criteria:
Inclusion Criteria:

* age 35-75 years
* type 2 diabetes (newly diagnosed)
* well glycemic control (HbA1c \</= 8.1)
* leucocyte count \> 6.2 or hs CrP \> 1

Exclusion Criteria:

* hs CrP \> 10
* type 1 diabetes
* previous treatment with antidiabetic drugs
EP-Catheter Guided CS-Lead Implantation

In patients undergoing CRT device implantation a lead positioning in the coronary sinus is required. Even this part of the surgical procedure is challenging. In this study we compared retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.


Eligibility Criteria:
Inclusion Criteria:

* CRT implantation due to heart failure
* full documented data

Exclusion Criteria:

* previous pacemaker/ICD/CRT implantation
Individual Choice of Delivery Mode

The primary aim of the study is to investigate personal attitudes regarding mode of delivery among both medical health care professionals and non-professionals. The investigators are also investigating whether providing detailed information that might influence one's decision regarding mode of delivery (such as education on pelvic floor disorders or advantages or disadvantages of epidural anaesthesia) will change participants´ opinion how to determine their preferred mode of delivery.

The choice of delivery mode is an individual decision that is affected by personal opinions and feelings about what might be best for one's own body and child. Increasing awareness about the risks of vaginal delivery has led to an increasing rate of cesearean delivery on maternal request.

The primary aim of the study is to investigate personal attitudes regarding mode of delivery among both medical health care professionals and non-professionals. The investigators are also investigating whether providing detailed information that might influence one's decision regarding mode of delivery (such as education on pelvic floor disorders or advantages or disadvantages of epidural anaesthesia) will change participants´ opinion how to determine their preferred mode of delivery.

A secondary aim of the survey is to gather information about personal attitudes regarding:

* epidural anaesthesia for pain relief during delivery
* systems of risk stratification
* postnatal recovery exercises The data will be acquired with an online questionnaire designed for this study. There will be two groups in this study. The first group ("medical professionals") consists of gynecologists with either subspecialization (urogynecology , fetal and maternal medicine, obstetrics, other) and other non-OB/GYN health care providers and medical staff, regardless whether they are nurses, medical assistants, physicians, physiotherapists, midwifes, administration staff. The group of "non-professionals" consists of women who are currently pregnant, and are not healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* able to fill out a questionnaire

Exclusion Criteria:

* minor people
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia

The research aims to investigate the relationship between self-control ability and blood glucose level in schizophrenic patients. The main purpose of the present study is to explore whether the close relationship of blood glucose and self-regulatory strength observed in healthy individuals, is applicable to schizophrenic patients. More specifically, the current study aims

* to investigate whether the exertion of self-control reduces blood glucose,
* to examine whether low level of blood glucose deteriorates subsequent self-control performances
* to examine whether restoring the glucose level eliminates these impairments, in schizophrenic patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 15 or above
* DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis NOS or delusional disorder
* Cantonese-speaking Chinese
* Ability to understand the nature of the study and sign informed consent

Exclusion Criteria:

* Organic Brain disorder
* Known history of intellectual disability
* Priority Follow Up (Subtarget or Target)
* All allergic to any sugar or artificial sweeteners
* Diabetics
* Physical Disability
Nasal High Flow in Bariatric Surgery

High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.

Morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. It provides 5-7 cm H2O positive end expiratory pressure to the airways and may prevent atelectasis. In the preoperative room, forced vital capacity, peripheral oxygen saturation (SpO2), respiratory frequency, heart rate (HR), blood pressure (BP), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. We will apply HFNC in the preoperative and postoperative period to Group I patients, while applying a constant O2 concentration to Group II patients. After appliying HFNC for two hours in Group I patients and O2 via face mask in Group II patients measurements will be repeated. During surgery, similar mechanical ventilation parameters will be applied to the patients. After the operation Group I patients will be applied HFNC, while Group II patients will be applied O2 via face mask in the recovery room for two hours. Measurements will be repeated. Primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after HFNC and O2 and postoperative times.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a body mass index of 40-55 kg/m2
* American Society of Anesthesiologists score II-III
* Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass

Exclusion Criteria:

* Obstructive sleep apnea syndrome
* Using a non invasive mechanical ventilation device preoperatively
* Patients whoo will predicted to postanesthesia care unit admission postoperatively
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.

In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.

In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.

The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status ≤ 1
* patient with metastatic anal cancer HPV+
* presence of a measurable target lesion according to radiological criteria (Recist V1.1)
* patient with more than 12 months of complete remission of metastatic anal cancer according to radiological criteria (Recist V1.1)after treatment by DCF regimen (Docetaxel, Cisplatin and 5-Fluorouracil)

Exclusion Criteria:

* pregnancy or lactation
* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization

Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.

Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.

Exclusion Criteria:

* abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.