cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015

This is a single center, retrospective, observational cohort study to assess the safety and efficacy of drug coated balloon (DCB) angioplasty in all forms of coronary artery disease. The Investigators intend to report outcomes of all patients who received DCB angioplasty at their center during the above mentioned period for up to 10 years.

The Investigators expect to assess outcomes of all patients who received Drug Coated Balloon Angioplasty treatment, which is a novel therapy as opposed to standard Drug Eluting Stent insertion, for all types of coronary artery disease from 01/01/2009 till 31/12/2015 in their center. The Investigators believe the number exceeds 1000 patients.

The Investigators plan to collect demographic and procedural data from their existing data base. They will request up to date follow-up events from NICOR (National Institute for Cardiovascular Outcomes Research, UK) in 2017(data ending December 2016), by which time all patientswould have had minimum of 12 months follow up. The Investigators plan to incorporate these findings to their data set and report the comprehensive outcomes. Primary end point will be major adverse cardiac outcomes (MACE) defined as a composite of death, myocardial infarction and target vessel revascularisation. Secondary end points will be acute vessel closure and target lesion revascularisation. The Investigators also have a long term plan of requesting follow-up events from NICOR for up to 10 years, so they can report on long term outcomes of drug coated balloon treatment.

Eligibility Criteria:
Inclusion Criteria:

All patients who were treated with drug coated balloon angioplasty during 01/01/2009 - 31/12/2015 at Norfolk and Norwich University Hospital.

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Exclusion Criteria:

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Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Intractable Epilepsy

Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.


Eligibility Criteria:
Inclusion criteria:

* adult patients
* treated between 2010 and 2019 for refractory epilepsy by DBS of the anterior nucleus os the thalamus using microendoscopy
* minimum follow-up of 1-year
* refractory epilepsy defined as failure of at least 3 antiepileptic drugs

Exclusion criteria:

- age \< 18 years
Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 45-65 years
* Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17
* Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

* Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
* Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
* Known coronary heart diseases or cancer
* Body mass index \> 35
* Scheduled for surgery in any joint
* Known mental or psychologic diseases
* Known drug abuse
* Persons who already perform sports related moderate physical activity more than two times a week
* Contraindications for magnetic resonance imaging (specific point list at Diagnostic Imaging Division, Akershus University Hospital)
* Not speaking Norwegian
Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

a number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter.

Ninety infertile women included. Written informed consent was obtained before being included in the study. Three groups of patients according to type of intervention. Assessment of plasma hormone level was done for all. The quantification of serum TNF and IL-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (ELISA) methodology at a privately-owned laboratory.

Eligibility Criteria:
Inclusion Criteria:

1. The patient\&#39;s consent to participate in the research study is crucial for data collection and analysis.
2. Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process.
3. The age range of the female participants varied from 18 to 40 years.
4. Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined.
5. Male-related factors contributing to infertility were also taken into consideration.
6. The procedure involved the transfer of grade one embryos during a fresh cycle.

Exclusion Criteria:

Endometrioses, whether clinically suspected or discovered during laparoscopy, are of interest.

2. Instances of congenital abnormalities in the reproductive system are being examined.

3. Individuals above the age of forty are under consideration. 4. Individuals who do not possess G1 embryos are also included. 5. Patients with chronic systemic conditions (such as diabetes, hematologic disorders, hypertension, autoimmune disorders of the connective tissue, asthma, thyroid disorders) are a part of the study.

6. The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.

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Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis

To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participated in the study and signed an informed consent.
2. The age is 18-65 years old, regardless of gender.
3. Patients with chronic atrophic gastritis by gastroscopy and pathological examination.
4. Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.
5. Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.

Exclusion Criteria:

1. Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.
2. Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.
3. People who have had gastric surgery or required gastric surgery during the study.
4. Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).
5. Pregnant or nursing females.
6. Patients who are reluctant to accept endoscopy and treatment.
A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer

The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage.
* Have adequate organ function.
* Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have discontinued previous treatments for cancer.
* Are able to swallow capsules.

Exclusion Criteria:

* Currently enrolled in a clinical study.
* Have a serious concomitant systemic disorder.
* Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
* Have a significant cardiac condition.
* Have previously received an aurora kinase inhibitor.
The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg

Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.

1. Title:The median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.
2. Research center: Single center.
3. The population of the study: Age is between 18 and 85 years; ASA I andIII levels; Patients undergone elective ERCP surgery, non-intubation patients;
4. Sample size:The sample size was decided based on that of prior literature, which had demonstrated that at least six independent pairs with success/failure duodenoscopy insertion during ERCP are required for reliable estimates of the ED50 of remimazolam with the Dixon's up-and-down method, and data from seven independent pairs of patients were collected for this study. The ED50 (95% confidence interval, CI) of remimazolam for successful duodenoscopy insertion during ERCP was calculated according to the formula of Dixon and Massey.

6. Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent.If BIS\>75 and MOAA/S \> 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation..

Eligibility Criteria:
Inclusion Criteria:

* Age is between 18 and 85 years
* ASA I and III, levels;
* Patients undergone elective ERCP surgery, non-intubation patients;

Exclusion Criteria:

* Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
* BMI\<18,BMI\>30
* Abnormal renal function (BUN or Cr ) ;
* Previous abnormal surgical anesthesia recovery history;
* Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
* Suffering from esophageal reflux; • Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
* Expected difficult intubation ;
* Liver surgery history;
* Opioids allergy history;
* Take monoamine oxidase inhibitor or antidepressant within 15 days;
* COPD;
* Pregnant or parturient women;
* Involved in other drug trials within three months;
* Patients who can not communicate well with the researcher
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula

Study aim:

Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment

Participants/Inclusion and exclusion criteria:

inclusion Criteria : 1.Age between 18-70 years old 2.Occurrence of complex perianal fistula 3.Informed consent Exclusion Criteria: 1.Active inflammatory bowel disease 2.Synchronous perianal abscess 3.Alcohol,narcotic and stimulant consumption 4.Having active Hepatitis B,C,HIV or TB 5.Peregnancy and lactation 6.Uncontrolled diabetes mellitus 7.Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient

Intervention groups:

Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes and it's safety and efficacy was evaluated.

Design:

this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial.

Settings and conduct:

Patients with complex perianal fistula referred to Imam Khomeini hospital, will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for consecutive three weeks. Patients will reexamined and fill the questionnaire and MRI will done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examine for complications.

Main outcome variables:

Discharge amount; External orifice re-epithelialization ; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-70 years old
2. Occurrence of complex perianal fistula
3. Informed consent

Exclusion Criteria:

1. Active inflammatory bowel disease
2. Synchronous perianal abscess
3. Alcohol,narcotic and stimulant consumption
4. Having active Hepatitis B,C,HIV or TB
5. Peregnancy and lactation
6. Uncontrolled diabetes mellitus
7. Evidence of surgical contraindication
8. Psychological disorders and noncooperative patient
Early Versus Late Closure of Preventive Ileostomy

The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.


Eligibility Criteria:
Inclusion Criteria:

* Patients with temporary ileostomy after rectal resection for rectal cancer
* Patients willing to participate in the study

Exclusion Criteria:

* Anastomosis insufficiency detected clinically or radiologically.
* Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations

Antenatal consultations are experienced as traumatic for many couples. Moreover, when informations are given urgently ; comprehension and psychological impact aren't well evaluate.

This project aims to evaluate comprehension and psychological impact, for both members of the couple, when informations are provided urgently or during usual consultations.


Eligibility Criteria:
Inclusion Criteria:

* Parents whom pregnancies need antenatal pediatric consultation
* Non opposition

Exclusion Criteria:

* \< 18 years old
* Psychiatric illness
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.

Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation.

The percentage of patients with lost follow up is significantly high. Previously all other studies mainly focused on the radiographic outcome after acetabular fractures and rarely on patient reported functional outcomes and quality of life. The use of patient-reported outcome measures (PROMs) is increasing and may lead to modifications of treatment. Recent technologic advances, namely smartphones, capable of measuring outcomes after acetabular fractures are now very important in quantifying value-based care. This was previously accomplished through office assessments and surveys with variable follow-up but this strategy lacks continuous and complete data. Studies show that these remote modes of follow-up are safe and that patients are as equally satisfied with them as they are with in-person follow- up care

Eligibility Criteria:
Inclusion Criteria:

* all patients older than 18 years old who will have surgery for an acetabular fracture at assiut university hospitals from 1/10/2020 to 30/9/2022.

Exclusion Criteria:

* patients younger than 18 years.
Interest in the Use of Nasal High-Flow Oxygen Therapy (OptiFlow™) in Secondary Transport of COVID-19 Positive Patients

Since the beginning of COVID-19 pandemic situation, several modes of ventilation have been tried to correct the hypoxaemia induced by SARS-CoV-2 virus. A few recent studies have concluded that high-flow nasal oxygen therapy (OptiFlow™) is beneficial in COVID-19. All mainly conclude that the use of OptiFlow™ avoid intubations and decrease hospitalization duration in critical care services.

At the emergency medical service 83 (SAMU 83), it has been decided to extend this ventilation mode during patient secondary transfers (transfer from an intensive care unit/other hospital unit/emergency department to another hospital's intensive care unit).

The emergency medical service 83 has equipped its intensive-care ambulances with OptiFlow™ in order not to interrupt this ventilation mode during transport.

The hypothesis is that patients with a severe respiratory form of COVID-19 transported from one health facility to another by the emergency medical service 83 on high-flow nasal oxygen therapy has a reduced risk of intubation compared to the other modes of non-invasive ventilation (NIV) and High Concentration oxygen Masks (HCM).

Retrospective observational study in France including COVID-19 infected patients taken care of by the emergency medical service 83 (SAMU 83) for a secondary transport between1st March 2020 and 31th December 2021.

Eligibility Criteria:
Inclusion Criteria:

* COVID-positive patient diagnosed either by positive Polymerase Chain Reaction (PCR) or radiological interpretation of chest CT
* Patient in respiratory distress treated during transport by high flow nasal oxygen or HCM (with a minimum flow of 15 L/min) or other NIV modes
* Patient taken care of by the emergency medical service 83 (SAMU 83) for secondary transport (transfer from an intensive care unit/other hospital unit/emergency department to another hospital's intensive care unit) between1st March 2020 and 31th December 2021

Exclusion Criteria:

* Pre-transport intubation
* Patient opposition to participate in the study
Assessment of Kidney Function and Osteomuscular Status After Critical Care

This observational study aims to assess kidney function through direct glomerular filtration rate (GFR) using iohexol clearance, compared to estimated GFR based on creatinine and cystatin C equations. Kidney function will also be evaluated through renal fibrosis biomarkers. Kidney function will be correlated to body composition, muscle turnover biomarkers, and bone micro-architecture.

The investigators developed a post-ICU clinic where complications of the post-intensive care syndrome are detected. Muscle function is assessed by clinical testings, muscle strength measurement. Body composition is measured by electrical bioimpedance. Bone mass is assessed using dual-energy radiographic absorptiometry.

It is well known that ICU survivors experience a loss of muscle mass. This can lead to misinterpretation of estimated GFR based on creatinine equations.

The aim of the present study is to assess the evolution of kidney function after a prolonged stay in ICU, using GFR equations based on cystatin C, and to compare it to measured GFR using iohexol clearance.

The second aim is to explore the evolution of bone and muscle health in these patients.

Eligibility Criteria:
Inclusion Criteria:

* patients surviving an ICU stay of at least 7 days
* patients who experienced acute kidney injury (KDIGO criteria) during ICU stay

Exclusion Criteria:

* chronic kidney injury with dedicated follow-up before ICU admission
* chronic extrarenal epuration
* kidney transplant
* allergy to iohexol
* iodinated contrast allergy
* refusal
Geodon (Ziprasidone) for Posttraumatic Stress Disorder

Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone (Geodon), suggests possible anxiolytic and antidepressant properties. This research will assess the potential effectiveness of Geodon in civilian men and women who suffer from severe PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).

PTSD is a common disorder with 10% lifetime prevalence among Americans. The major causes of PTSD are sexual assault, accidents, disasters Despite this public health burden, only two drugs, sertraline (Zoloft) and paroxetine (Paxil), are approved by the FDA for the treatment of PTSD. New options for the treatment of PTSD are much needed. Approximately half of patients with PTSD respond to Zoloft and Paxil. Many patients experience psychotic symptoms with PTSD, which may not respond to treatment to Zoloft and Paxil.

Though classified as an anxiety disorder in the DSM-IV, PTSD is accompanied by psychotic symptoms in almost half of patients (Butler et al 1996; Hamner et al 1999, Lindley et al 2000). Also, PTSD has an extensive comorbidity with major depressive disorder (Davis et al 2000). While Geodon is approved by the FDA in the United States for the treatment of psychosis, it has not been evaluated for the treatment of PTSD . A clinical trial of Geodon in PTSD will help delineate the potential antidepressant spectrum of efficacy of Geodon as well as its anxiolytic profile.

Eligibility Criteria:
Inclusion Criteria:

* Men \& women with DSM-IV clinical diagnosis of PTSD who are able to attend weekly clinic appointments
* Age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control
* A willingness and ability to provide competent signed informed consent
* A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English)

Exclusion Criteria:

* Any diagnosis of schizophrenia or bipolar I disorder, or active substance dependence
* Unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders.
* Subjects with prior non-response to Geodon for the treatment of PTSD with an adequate trial
* Enrollment in any study drug within the last 30 days. Current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days.
* Pregnancy or nursing
* Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator