cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)

The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.

This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).

Eligibility Criteria:
Inclusion Criteria:

* patients who has history of FURESTEM-CD Inj. injection at least once.
* patients who understand and voluntarily sign an informed consent form.

Exclusion Criteria:

* any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
Evaluation of The Effects of Personal Protective Equipment During Airway Management

Covid-19 disease has caused a worldwide pandemic. However, it was necessary to reduce the transmission of the disease as much as possible. The highest risk of transmission is airway management. Medical personnel responsible for airway management are at the greatest risk. One of the most important ways to protect anesthetists from contamination is to use PPE. But, it should be considered that there is some disadvantage about using PPE. The investigators aimed to evaluate the effects of the use of personal protective equipment and standard uniform during airway management.

Objective: The investigators aimed to compare the effects of the use of personal protective equipment and standard uniform during airway management using direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope, I-gel laryngeal mask airway , ProSeal laryngeal mask airway and Frova intubation catheter on the manikin that created both difficult airway and normal airway conditions in the Department of Anesthesiology and Reanimation at the Derince Training and Research Hospital, University of Health Sciences.

Materials and Methods: The study will carry out with 24 participants in Health Sciences University Kocaeli Derince Health Education and Research Center. In the study, a simulation manikin will use to evaluate the effect of personal protective equipment use on airway management. Anesthesia technicians, anesthesia residents and specialists will include as participants. As demographic data, the clinical positions of the participants, their experiences with each airway method and the use of personal protective equipment, age, gender, height and weight information will be recorded. Each procedure will be explained to the participants by an anesthesiology specialist and a resident. Then the participants perform their procedure first with standard uniform and then by wearing personal protective equipment. Endotracheal intubation with direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter followed by I-gel and ProSeal laryngeal mask airway will be used, respectively. Each procedure will be carried out by creating normal and difficult airway conditions, respectively. Time, number of attempts and presence of optimization maneuver will be recorded for each procedure. Modified CLS (Cormack Lehane Score) and POGO (Percentage Of Glottic Opening) scores will be also recorded during intubation procedures. Each participant will be asked to give a score between 1 and 100 using the Visual Analogue Scale (VAS) in order to evaluate the difficulty of intervention after each procedure subjectively and it will be recorded. Finally, the other subjective effects of personal protective equipment using on participants (such as sweating, feeling of warmth) will be asked.

Eligibility Criteria:
Inclusion Criteria:

* Being an anesthesiology resident, specialist or nurse

Exclusion Criteria:

* Anxiety Disorder
* Severe heart or lung disease
* Claustrophobia
A Trial of Percutaneous Lumbar Discectomy Combined With Ozone for Treatment of LDH

Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, several minimal invasive surgeries have been uesd widely. Percutaneous lumbar discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and ozone therapy combined other minimally invasive treatment could improve other minimally invasive treatment's clinical effectiveness. The effectiveness of which has been proved to be comparable to conventional open discectomy.

In this study, a single-blind randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.

Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc herniation undergoing PLD.

The primary endpoints of the study will be changes in in pain and functional status by the Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include response evaluation by MacNab response evaluation criteria as measured at pre- and post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference in the mean change from baseline between the two groups.

For the first time,the results of this trial will provide scientific evidence as to the relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical treatment for symptomatic lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years.
* 4 or more weeks low back pain and/or lower-limb radiation pain.
* MRI and/or CT test confirm diagnosis lumbar disc herniation and level(s).
* Invalid after Non-steroidal anti-inflammatory medical therapy and physical therapy.
* Pain level（Visual Analog Scale）≥5.

Exclusion Criteria:

* Spinal tumors.
* Spine infections, fractures, slippage(more than I °) and other deformities.
* Combining with spinal stenosis, lateral recess stenosis, yellow ligament hypertrophy.
* Nucleus pulposus herniated too much, dural sac compressed more than 50%;
* Psychological, cognitive disorders which may affect the reliability of the outcome;
* Previous lumbar disc surgery;
* Bleeding tendency or severe cardiovascular disease can not tolerate surgery;
* Don't accept the trial's informed consent;
* Possible pregnancy.
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children

During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep. After the test, data from the device and from the PSG (HR, SpO2, BR) will be saved and analysed in the aim to assess the actual accuracy of the GBB with golden standard values (ECG, Oximeter, belly belt). In a second analysis, the aim is to improve the accuracy of the GBB algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Infants and children under 5 years of age
* PSG is required per standard of care
* Signature of consent form

Exclusion Criteria:

* Children having already done the PSG wearing GBB for this study
* Epileptic children (due to high motion/artifacts during sleep)
* Weight below 2.5 kg
Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms

The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is:

- Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD?

Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure.

Participants will:

* Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD.
* Fill in symptom forms before and one year after the surgical procedure.
* Attend control visits one week, one month, three months and one year after the surgical procedure.


Eligibility Criteria:
Inclusion criteria:

* Age older than 18.
* Hemorroids grade III.
* Surgical indication for hemorroid treatment.
* Signed informed consent.

Exclusion criteria:

* Acute hemorroidal disease.
* Previous hemorroidal surgery.
* Concomitant anal fissure.
* Concomitant perianal fistulae.
* Concomitant rectal prolapse.
* Inflamatory bowel disease.
* Anal or colorrectal cancer.
Efficacy of Decitabine in Clearance of MRD

In this open-label, prospective clinical trial, the investigators enrolled acute myeloid leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.

In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after consolidation therapy receive decitabine treatment if patients do not receive stem cell transplantation. The treatment regimen includes three course of decitabine regimen at a dose of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 14 to 55 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML after consolidation regimen.
3. Patients who had received induction and consolation therapy and reached CR.
4. ECOG score of ≤ 2;
5. Patients with eligible laboratory examination including liver,renal and heart function.
6. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria:

1. Secondary leukemia.
2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, undiagnosed MDS or MPD patients are included.
4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
5. With BCR-ABL fusion gene;
6. Pregnant or lactating women;
7. With ineligible renal or liver function;
8. With active cardiovascular disease;
9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
10. AIDS;
11. Patients had central nervous system involvement when they were diagnosed as AML.
12. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
13. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
14. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis

We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.

We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.

Eligibility Criteria:
Inclusion Criteria:

* Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.

Exclusion Criteria:

* Women with uterine cancer (stage I - IV) NOT treated in National Taiwan University Hospital, from January 2010 to September 2019.
Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Study of acute lower ischemia therapies based on data collected from the Swedish Vascular Surgery Registry between 1994 and 2014.

Primary endpoint is long term amputation-free survival and secondary end-points are 30 days and 1 year amputation-free survival as well as different revascularization techniques results and time trends.

The prospective Swedish Vascular Registry (Swedvasc) started in 1987 and since 1994 it has included more than 95 percent of the vascular surgical procedures performed nationwide. The registry has received extensive high internal and external validation. Roughly 16000 open surgical and endovascular revascularisation procedures for acute limb ischemia have been performed during this period of time.

The fact that every Swedish citizen has a unique personal identification number makes it possible to obtain 100 percent accurate survival and amputation data. Survival data were obtained through crosschecking the personal identification number with the national population registry in June 2016.

This offers a unique opportunity to study a large population-based cohort of unselected patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute limb ischemia
* Surgical procedure performed between 1 January 1994 and 31 December 2014 in Sweden and registered in the Swedvasc registry
* Infrainguinal occlusions

Exclusion Criteria:

* Acute limb ischemia secondary to trauma, bleedings, dissection or graft infections.
* Suprainguinal occlusions.
Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

The aim of this study was to compare the dual use of telmisartan and captopril vs the individual use of such drugs and placebo on the systemic inflammation of patients on hemodialysis (HD).

Once included, patients will be randomly allocated (by a computer-generated randomization list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan, group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets during a period of 3 months. All patients will have 3 HD sessions per week, with the same kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits. All laboratory measurements, including inflammation markers, will be performed in the Central Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same personnel blinded to patient's details.

Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* ≥2 months on hemodialysis
* Arteriovenous fistula as vascular access
* Endorsement of informed consent

Exclusion Criteria:

* Inflammatory cause of ESRD
* Liver disease, cancer, AIDS
* Any infectious disease 2 months before the study
* Failed kidney graft
* Hypersensitivity to angiotensin converting enzyme inhibitors or angiotensin receptor blockers
* Arterial hypotension
* Pregnancy
* Treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins, ACE inhibitors or ARB 3 months previous to the study
Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps

Continuous bupivacaine administration through an elastomeric pump (Pain Buster) has been found effective for post operative analgesia in a large range of surgery. Ropivacaine is a less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro anastomotic flaps (from the investigators knowledge). The aim of the study is to evaluate the usefulness of this drug and device for post operative analgesia, associated with patient controlled analgesia with morphine. For this purpose a controlled randomized double blind trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in order to measure total morphine consumption during the first 48 post operative hours and to evaluate analgesia and sides effects of morphine in each group.


Eligibility Criteria:
Inclusion Criteria:

* operated for latissimus dorsi and serratus micro anastomotic flaps.
* 18 to 75 years old
* ASA I-II
* hospitalized in Nantes CHU Burns ICU
* giving their written informed consent
* with healthcare protection

Exclusion Criteria:

* declining the study
* with known sides effects with morphine and local anesthetics
* with known allergy or other reaction with used drugs
* with disease incompatible with anaesthetic procedure
* under law protection
* taking antiepileptic or antidepressant drugs
* pregnant (not any gender criteria)
Effects of MET on PPDH, Neck Pain and Disability After Cesarean Section

The goal of this clinical trial is to determine the effect of Muscle Energy Techniques on post dural puncture headache, neck pain and disability after Cesarean Section.

.

Caesarean section (CS) is the worldwide process of pregnancy termination that delivers live or dead fetuses with an incision on the abdominal wall and uterine wall.

It is performed under neuraxial anesthesia (spinal and epidural anesthesia). Post- dural puncture headache (PDPH) is a major complication of neuraxial anesthesia which presents as a dull throbbing pain in a frontal-occipital distribution, aggravates on sitting or standing, and is reduced by lying down.

This study will be a randomized clinical trial. Subjects with PPDH meeting the predetermined inclusion and exclusion criteria will be divided into two groups: i.e. treatment and control group. Both groups will receive baseline treatments i.e. (heating pads \& TENS). In addition, treatment group will receive post-isometric relaxation of METs. Each subject will receive a total of 4 treatment sessions, with 2 treatment sessions per day

Pre-treatment will be done at day 1 and post-treatment will be done at day 2, using Headache Disability Index (HDI), Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI) as subjective measurements. Recorded values will be analysed for any change using SPSs

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 40 years
* Both Primiparous and multiparous
* Both elective and emergency Lower Section Cesarean Section
* Headache occurring within 24-72 hours post C-section
* Headache aggravates on getting in upright position

Exclusion Criteria:

* History of Trauma/fracture of head and neck region
* History of cervical spine surgery
* Had previous diagnostic Lumbar Puncture (LP)
* Any kind of infection, malignancy, inflammation and structural deformity present in head and neck region.
* Other serious forms of headaches including Migraine, Cluster, thunderclap, hypnic etc.
* Cervical Radiculopathies and spondylolisthesis
Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis

The investigators aimed to compare the home-based Pulmonary Rehabilitation with the hospital-based pulmonary rehabilitation in terms of pulmonary rehabilitation efficiency in patient with bronchiectasis.

While the benefits of pulmonary rehabilitation (PR) in cases of chronic obstructive pulmonary disease (COPD) have been well-documented, there have been only a limited number of studies investigating the efficacy of PR in patients with bronchiectasis. Some of these studies have reported positive effects of PR also in bronchiectasis patients, but have underlined the need for additional studies including larger patient groups to define PR indications, and to ensure that exercise protocols are specific for this patient group. There are many PR organizational types, such as hospital-based, telephone-mentoring with home-based or tele monitorization programs. Hospital-based supervised programs are time-consuming and costly practices. For this reason, there is a need for further studies on the effectiveness and benefits of unsupervised programs. In this study, we will compare unsupervised home-based PR and supervised hospital-based PR in terms of pulmonary rehabilitation effectiveness.

The pulmonary function tests, dyspnea perception, quality of life and exercise capacity assessments will performed before and after pulmonary rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-70
* Patients signing informed consent form
* Bronchiectasis patients in the stable phase who were diagnosed with High-resolution computed tomography (HRCT).

Exclusion Criteria:

* Decompensated heart failure, uncontrolled hypertension (Systolic Blood Pressure\> 200, Diastolic Blood Pressure\> 110),
* Additional diseases that may prevent exercise,
* To be regularly exercising regularly
Cannabinoid Medication for Adults With OCD

The purpose of this pilot research study is to test the effects of a medication called nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will receive either nabilone on its own, or nabilone in combination with a form of cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone is a synthetic cannabinoid and acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.

The two first-line treatments for OCD are a class of medications called serotonin reuptake inhibitors (SRIs) and a type of cognitive behavioral therapy called exposure and response prevention (EX/RP). But more than a third of patients with OCD do not respond to these treatments, and less then half become well. Thus, new treatment approaches are needed.

EX/RP is thought to involve fear extinction learning. Recent research suggests that modulators of the endocannabinoid system such as nabilone (a synthetic cannabinoid and agonist of the cannabinoid 1 receptor, CB1R) may enhance fear extinction learning and therefor could enhance EX/RP. However, nabilone could also work via modulating activity in cortico-striatal circuits, which contain high concentrations of CB1R, and thereby might reduce repetitive behaviors like compulsions seen in OCD.

To test both ideas, we will conduct a small pilot randomized trial to explore the effects of nabilone on its own for 4 weeks, vs. combined with EX/RP, in adult patients with OCD. This proof-of-concept study will investigate whether nabilone administration is feasible and well-tolerated in adult patients with OCD. The intent is to collect pilot data to support future grant applications.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Physically healthy, not pregnant
* Primary Obsessive-Compulsive Disorder (OCD)
* Patient off all psychotropic (except selective serotonin reuptake inhibitors \[SSRIs\]) and other types of drugs likely to interact with nabilone
* Ability to provide informed consent
* Ability to tolerate a treatment free-period

Exclusion Criteria:

* History of any significant medical condition that may increase the risk of participation
* Females who are pregnant or nursing
* Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
* Current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid
* Patients already receiving EX/RP