cyrilzakka/clinical-trials huggingface dataset:
Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer(SCLC)

Patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance treatment. The objective of this study is to evaluate the progression free survival,overall survival,objective response rate,disease control rate and safety of etoposide as maintenance therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the hypothesis of this study is maintenance therapy using etoposide may improve progression free survival,overall survival for selected patients. The investigators will use the peripheral blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a subgroup of patients with better response to etoposide maintenance therapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of small cell lung cancer
* Extensive stage according to American Veteran Staging System
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST )1.1
* Eastern Cooperative Oncology Group (ECOG) scores for performance status of 0 to 2
* Age≥18 years
* Adequate organ function
* Consent form according with Guideline for Good Clinical Practice of the International Conference on Harmonisation (ICH-GCP)guidelines
* The expected survival≥2 months

Exclusion Criteria:

* Pathological diagnosis of mixed small cell lung cancer
* Limited stage according to American Veteran Staging System
* Other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator
* Known pre-existing interstitial lung disease
* Pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator
* Any other medical history or coexisting disease that may affect compliance of patients or the assessment of safety and effectiveness of the drug believed by the investigator
* Pregnant or lactating women
* Active phase of hepatitis B virus infection,Active phase of hepatitis C virus infection or known HIV carriers
Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg).

They will be monitored for the development of analgesia for a duration of 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

1. Signs a consent form to participate voluntarily into the trial
2. Induced labor
3. singleton pregnancy
4. primiparous
5. BMI 20-40 at the time of delivery
6. No history of allergy for lidocaine or fentanyl
7. sufficient command of Finnish language to understand the consent form and interview
8. Cervical dilatation at maximum 4 cm at the time of intervention

Exclusion Criteria:

1. Any contraindication for spinal or epidural analgesia
2. Allergy for lidocaine or fentanyl
3. The patient has received any opioid medication within 90 minutes prior to intervention
Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation

A seven-item simplified score (the MACOCHA score) has been validated to predict difficult tracheal intubation in intensive care unit patients. In the prehospital or in the emergency department settings, no such validated predictive score is available yet. The aim of the present study is to assess the feasibility the quick calculation of the MACOCHA score before emergent intubation, in the prehospital and emergency department contexts.

All patients who will have to undergo emergent tracheal intubation for any reason in the prehospital context or at the emergency department at a single 1100-bed regional and teaching hospital in France, will be included in this observational, prospective study, provided that neither the patient him/herself, if capable, or next-of-kin if present have declined participation.

Items of the MACOCHA score will be recorded before intubation by investigators, who are all certified emergency physicians skilled with urgent tracheal intubation.

For any intubation procedure, either in the out-of-hospital context or in the Emergency Department, one of these emergency physicians is always present.

The feasibility the quick MACOCHA score calculation before urgent intubation will be assessed by the number and percentages of patients for whom all the seven items of the score have been collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 yrs
* Patient who have to undergo rapid sequence tracheal intubation as judged by the Emergency Physician

Exclusion Criteria:

* Pregnancy
* Cardiac arrest of any cause as the indication for intubation
* Patient or next-of-kin declining participation
Don't Throw Your Heart Away: Patient Study 4

This empirical study tests whether transplant center performance data that reflect center donor acceptance rates influence patients and their family members to evaluate centers with high organ decline rates less favorably than centers with low organ decline rates. 400 transplant patients and family members will be recruited from transplant support group social media websites and randomized to one of four different information presentation conditions. Upon viewing a pair of outcome tables corresponding to their condition, the participants are asked to choose which hospital is higher performing (one hospital with a non-selective "accepting" strategy and one hospital with a more selective "cherrypicking" strategy.


Eligibility Criteria:
Inclusion Criteria:

Participants will be asked to participate if they confirm the following inclusion criteria in the consent form.

1. 18 years of age or older
2. must read and understand the information in the consent form
3. must want to participate in the research and continue with the survey
4. must be a pre- or post-transplant patient or family member of the transplant patient

Exclusion Criteria:

Participants who do not meet the primary criterion of being a pre- or post-transplant patient or family member of the transplant patient.
Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation

Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.

Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30). Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4. Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in descriptive statistics of the data, SPSS 22.0 program was used for the analyses.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II group
* 60 patients
* between the ages of 18 and 60
* planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,

Exclusion Criteria:

* severe heart, lung, liver disease
* kidney failure,
* bleeding diathesis
* fever,
* infection,
* electrolyte disorder such as hypokalemia, hypocalcaemia, acid-base disorder, hypothermia, allergy to drugs to be used, and study those who refused to be included were excluded
Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters for Causes Other Than Infertility

The purpose of this study is to evaluate whether clinical varicoceles are associated with abnormal semen parameters and whether varicocelectomy could improve the semen parameter in patients unrelated with infertility.

While most studies are continued to validate the observations of significant improvements in sperm density and motility after varicocele ligation in infertile patients, there have been few studies to investigate the effects of varicocelectomy on semen parameters in adult men unrelated with infertility. The purpose of this study was to determine whether varicocelectomy could improve the semen parameter of these patients as well as whether clinical varicoceles are associated with abnormal semen parameters in patients unrelated with infertility.

Eligibility Criteria:
Inclusion Criteria:

* men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass

Exclusion Criteria:

* adolescents
* men with proven fertility or azoospermia
* men with preoperative normal sperm analysis
* available data to compare between preoperative and postoperative semen analyses
Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy

The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.

This study is a prospective double blinded randomised controlled trial. 140 women will be recruited from the office hysteroscopy clinic in Cairo university hospitals.

All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide written consents. Only patients consenting to participate will be included in the trial.

Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a placebo acting as the control group.

Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg. The anterior wall, posterior wall and tubal ostea will be visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.

Base line characteristics will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for outpatient hysteroscopy
* Consent to the procedure

Exclusion Criteria:

* Premenstrual patients
* Known cardiac disease
* Known allergy to Tramadol
Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis

This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.


Eligibility Criteria:
Inclusion Criteria:

-Participants receiving rituximab no longer than 4 weeks before the start of monitoring

Exclusion Criteria:

-Not Applicable
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer

Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .


Eligibility Criteria:
Inclusion Criteria:

* All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest

Exclusion Criteria:

* Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.
Waitlist-Control Trial of Smartphone CBT for Obsessive-Compulsive Disorder (OCD)

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for obsessive compulsive disorder (OCD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in Y-BOCS scores than those in the waitlist condition at treatment endpoint (week 12).

The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with OCD recruited nationally. Eligible subjects (N=58) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for OCD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for OCD will be feasible and acceptable to individuals with OCD, and that it will lead to greater reductions in OCD symptom severity compared to the passage of time (waitlist control).

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* current diagnosis of primary DSM-5 OCD, based on MINI
* currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in ≥ 4 sessions of CBT for OCD
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
* Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
* Concurrent psychological treatment
* Does not own a supported mobile Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Robot-based Tele-echography II - A Comparative Study

The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. The second is bedside echography performed by emergency physicians according to the FAST (Focussed Assessment by Sonography of Trauma) examination.

1. Principal objective: to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods (robot-based tele-echography performed by radiologists in a remote location vs bedside echography performed by emergency physicians according to the FAST examination).
2. Objective 2: after the realization of a gold standard method, if there is a concordance between the two different echographic methods, sensitivity and specificity are estimated. If not, the evaluation of sensitivity and specificity of each method with analysis of their discordance is performed.
3. Objective 3: qualitative evaluation of each echographic method by the patient and the physicians.
4. Material and methods: This therapeutic, mono-centre, prospective, randomized, cross-over, open, controlled trial is being conducted in 70 patients. All the patients will have the two different echographic methods in a sequential but randomized way. The robot-based tele-echography is performed by a radiologist in the North University Hospital of Grenoble. The bedside echography is performed by the emergency physicians in the trauma center in the South University Hospital of Grenoble.

Eligibility Criteria:
Inclusion Criteria:

* Person registered with the French Social Security or benefiting from an equivalent health insurance system
* Person sent to hospital for thoracoabdominal high energy trauma

Exclusion Criteria:

* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person participating in another clinical study
Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes

The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event (primary outcome defined as CV death, nonfatal myocardial infarction \[MI\], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).

The purpose of this study is to evaluate the effect of two different treatment strategies on CV outcomes in patients with type 2 diabetes while aiming to achieve and maintain HbA1c \<7.0% in both groups. Only patients who have recently experienced an acute MI will be considered for participation in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 30 years old
* Have had type 2 diabetes for at least 3 months prior to Visit 1
* Were admitted to the Coronary Care Unit (CCU) within 18 days prior to Visit 1 for an acute MI
* Are capable and willing to do specified study procedures
* Have given informed consent to participate in the study in accordance with local regulations

Exclusion Criteria:

* Were on one of the following therapies prior to admission to the CCU for the recent MI: a)diet therapy only and have glycosylated hemoglobin (HbA1c) \<1.15 times the upper limit of normal or b) an intensive basal/bolus insulin regimen
* Are using any oral antihyperglycemic medication at the time of Visit 2 and are unwilling to stop the use of such medication for the duration of the study
* Have substantial myocardial damage, which would significantly outweigh the potential benefit of the treatment strategies for diabetes
* Have the most severe form of congestive heart failure
* Have liver disease so severe that it precludes the patient from following and completing the protocol
A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age equal to or above18 years at the time of signing informed consent
* Diagnosed with T2D at least 180 days prior to the day of screening
* HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)
* Stable daily dose(s) for 90 days prior to the day of screening of:
* Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of \<30 mL/min/1.73 m\^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination