cyrilzakka/clinical-trials huggingface dataset:
Stem Cells Treatment of Complex Crohn's Anal Fistula

A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.

Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. In the present study the patient's own adipose tissue derived regenerative cells (ADRCs) will be used. Traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. Alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. The aim of this project is to develop a method for treatment of patients with Crohns fistula. The results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.

Eligibility Criteria:
Inclusion Criteria:

* patients with Crohn's anal fistulas and\> 18 yrs old.

Exclusion Criteria:

* Signs of suppuration around the fistula
* Active intestinal Crohn disease not in remission
* Malignancy within 5 years
* Previous radiotherapy of the abdomen and pelvis
* BMI under 18.5
* Coagulopathy
* Fistula with side branches
* Low anal fistula
* Verified syphilis, HIV, or hepatitis on screening test.
SYNOSTE Nitinail System Trial

SYNOSTE Nitinail System Trial is an international multicenter open label single-arm equivalence study to verify whether the leg-lengthening procedure can be adequately controlled with the SNS system as measured with the lengthening control index (LCI) at the end of the distraction period.

The SYNOSTE Nitinail System (SNS) is an assembly of an active implantable distraction nail (SYNOSTE Nitinail), Locking screws, accessory instruments for surgery and the home care unit (also External control unit (ECU) or Halo). It includes also, a software tool, Syndex, that supports setting up the number of lengthening activations needed per day.

The SNS is intended for lengthening of the femur by distraction osteogenesis.

The study will consist of a recruitment period of 3 months and an observation period of roughly 24 months (6 months after explantation). The observation period is split in two parts: The first part contains the most critical treatment phases from implantation surgery of the device through the actual lengthening phase up to the end of the bone healing. The second part contains only two visits: the explantation surgery of the device and a control at 6 months of further follow-up.

After the fist part of the trial, a primary analysis of the data including the hypothesis testing will be carried out. After the second part of the trial a follow-up analysis will be done.

16 (max 20) patients will be recruited in Finland and Turkey.

Eligibility Criteria:
Inclusion Criteria:

* Indication for femoral lengthening from different etiologies of max. 70 mm at single lengthening
* 18 to 65 years regardless of gender
* Suitable anatomy for SNS
* Able and willing to comply with study procedures

Exclusion Criteria:

* Other electronic implants
* Other Metallic implants in the affected limb below the osteotomy level
* Need for Magnetic Resonance imaging during the study
* BMI\>30kg/m2 or weight\>100kg
* Smoker
* Known hypersensitivity to Co, Ni, Cr or Ti metals
* Known hypersensitivity to Poly-Ether-Ether-Ketone (PEEK) or Ultrahigh Molecular Weight Poly-Ethylene (UHMWPE)
* Open growth plates
* Malignancy or tumor in bone
* Osteitis or soft tissue infection
* Significant existing deficit in range of motion of the adjacent joints
* Pseudoarthrosis
* Pregnancy
* Low psychological compliance (e.g. drug abuse)
* Simultaneous bilateral lengthening
* Need for osteotomies at multiple levels
Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture

This is an observational study, meaning participants will not receive any investigational treatment as part of this study.

Researchers will collect real-world data (RWD), based on usual care, to gain a more in-depth knowledge of the natural history and the treatment outcomes of Dupuytren's Contracture (DC) to evaluate the management of DC.

Each participant of the study will have their data collected from the date of confirmed diagnosis of DC to the date of enrollment in the registry, post consent. Data will be collected from the participants clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform.

Eligibility Criteria:
Key Inclusion Criteria:

* Any adult with a confirmed clinical diagnosis of DC.
* Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.
* Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.
* Having received DC treatment, either non-surgical or surgical, within 2 weeks before enrollment, at enrollment or any time after the date of enrollment or not having received DC treatment after confirmed diagnosis of DC.
* Able to participate in English based registry.

Key Exclusion criteria:

* Not having a clinical diagnosis of DC.
* Age less than 18 years.
* Do not provide informed consent.
Serratus Anterior Plane Block for Improving Pain and Respiratory Function in Patients With Multiple Rib Fractures

This is an observational study which will evaluate the efficacy of the serratus anterior plane block for treating pain and respiratory capacity in patients with multiple rib fractures. When resources are available for a SAPB to be performed, patients will receive this block in addition to traditional pain medications, while at other times, patients will receive traditional pain medications only.

Pain management by systemic analgesics and by nerve blocks are both standard of care and used in Emergency Department (ED) depending on the resources available. Not all ED physicians are trained or comfortable with the serratus anterior nerve block and thus it is not always available to patients and is provider dependent.

This is an observational study where patients with multiple rib fractures will receive either a serratus anterior plane block (SAPB) in addition to traditional forms of pain control when providers trained to perform the block are available, or will receive traditional forms pain control if trained personnel are not available. In addition to the serratus anterior plane block, standard forms of pain control in the Stanford Emergency Department include: oral or parenteral acetaminophen, oral or parenteral NSAIDs, oral or parenteral opiates, parenteral lidocaine, and parenteral ketamine.

Retrospective evaluation of the allocation of patients to either nerve block or no nerve block will be dictated by physician ability, time and resources to do the block. The efficacy of the block will be evaluated by serial measurements of pain score and respiratory capacity.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater or equal to 18 years of age
2. Presentation to Stanford University Hospital Emergency Department within 12 hours of a traumatic incident
3. Three or more anterior and/or lateral unilateral rib fractures diagnosed by CT
4. GCS 15, with the ability to discern and describe pain from rib fractures and give consent
5. Presentation to the Emergency Department between 7am and 11pm (for identification by research assistants)

Exclusion Criteria:

1. Posterior rib fractures
2. Bilateral rib fractures
3. Sternal fracture
4. Known allergy to local anesthetics
5. Pregnancy
6. Significant coagulopathy
7. Hemodynamic instability
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)

Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.

Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.

Eligibility Criteria:
Inclusion Criteria:

1. Mother willing to sign informed consent form.
2. Infant aged 0 to 49 days old.
3. No obvious congenital abnormalities or birth defects.

Exclusion Criteria:

1. Parents are not willing to have child's blood drawn.
2. Parents are planning to enroll child into another clinical study during the time period of this trial.
3. Mother not willing to have blood drawn and breast milk extracted.
4. Parents not willing to have field research assistant in home.
5. History of seizures or other apparent neurologic disorders.
6. Infant does not have proof of BCG and OPV since birth by immunization card.
7. History of acute illness and/or immunocompromised state of the child.
8. Immunocompromised or chronically ill mother
Role of Beta-blockers in the Prevention on the Arisen of a Severe Sepsis (TESS)

The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. The objective of this study is to evaluate this role.

The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. The adrenergic system is heavily involved in this pathological/physiological context. If the effect of various therapeutic strategies allowing the care of the SS/TS was widely estimated, the impact, positive or negative, therapeutic prescribed in the long term or more punctually - but be that as it may before the arisen of the sepsis - on the evolution of a community acute infectious pathology towards the SS/TS, had only little studied.

The main objective of this study is to estimate the possible protective role of a long-term prescription of a beta-blocker on the arisen of the SS/TS in patients having an acute infectious pathology of community origin.

The secondary objective will be to estimate, at the patients having developed a SS/TS, the impact of this long-term prescription of beta-blockers on the mortality in intensive care unit (ICU).

Eligibility Criteria:
Inclusion Criteria:

* Common characteristics of cases and controls:
* Patients aged of more than 18 years old
* Hospitalized patients, during the period of study, via the ICU of the participating hospital center, for a community infectious pathology:

  * lower respiratory infections (pneumonia)
  * intra-abdominal infections (cholangitis, diverticulitis, peritonitis)
  * urinary parenchymal infection (pyelonephritis complicated or without abscess, prostatitis, orchitis, epididymitis)
  * infections of skin and soft tissue infections (cellulitis, fasciitis)
  * meningitis, endocarditis, osteo-articular infections, salpingitis

Definition of cases:

* Patient included in the study and admitted to the emergency service either directly from ICU or after a hospitalization in a specialty for severe sepsis or septic shock on their infectious disease community.

Definition of controls:

* Patient included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before being released from the hospital.

Non inclusion Criteria:

* Opposition of the patient to the IT processing of its data within the framework of this observational study.
* Exclusion criteria: Occurrence, during hospitalization, a severe sepsis or septic shock associated with a nosocomial superinfection.
Probiotics for Chalaziosis Treatment in Children

There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.

Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.

Eligibility Criteria:
Inclusion Criteria:

* paediatric patients
* presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months)

Exclusion Criteria:

* eyelid infection
* chalazion duration \< 1 month
* nonpalpable chalazion
* suspicion of malignancy
Prevalence of Genetic Polymporphism on RNF213 rs112735431 Gene in Non-cardioemboli Ischemic Cerebrovascular Disease

To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease in Thai patients.

This is an cross-sectional observational study in Chulalongkorn hospital, to determine the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were admitted in Chulalongkorn Hospital for acute ischemic stroke treatment.

Eligibility Criteria:
Inclusion Criteria:

* Nationality in Thailand
* Age equal or more than 18 years
* Clinical and imaging diagnosis of acute ischemic stroke
* Patient consent to participate in the research

Exclusion Criteria:

* High risk for cardioembolic stroke by TOAST classification
* Contraindication for venipuncture
* Pregnancy or breast feeding patient
* History of head and neck radiation
* Down's syndrome
* Marfan syndrome
* Autoimmune disease such as SLE
* Ongoing malignancy or remission of malignancy less than 1year
TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors

This is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of high-grade osteosarcoma(cohort I),dedifferentiated liposarcoma or polytypic liposarcoma(cohort II),unsuitable for local treatment;
* The requirements for front-line treatment received by subjects are as follows:

  1. Subjects with osteosarcoma have failed at least first-line chemotherapy and are not suitable for re-receiving first-line chemotherapy ,or progression within 6 months of the end of first-line therapy;
  2. Subjects with dedifferentiated liposarcoma or polytype liposarcoma who have received at least first-line chemotherapy failure for recurrent/metastatic sites or relapse during postoperative adjuvant chemotherapy or within 6 months after treatment(considered first-line treatment failure).

Exclusion Criteria:

* History of hemolytic anemia from any cause (including Evans syndrome) within 3 months prior to first dosing;
* Subjects with osteosarcoma or dedifferentiated liposarcoma/polytype liposarcoma who have previously used antiangiogenic tyrosine kinase inhibitors (TKI) or bevacizumab or its biosimilar, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib;
* Previous antibody or fusion protein or small molecule drug targeting CD47 or Signal-regulatory protein α (SIRRP-α).
Reducing Pain With Focused Music Listening

Pain-reducing effects of music listening are well-established, but the effects are small and their clinical relevance questionable. Recent theoretical advances, however, have proposed that synchronizing to music, such as clapping, tapping or dancing, has evolutionarily important social effects that are associated with activation of the endogenous opioid system (EOS; which supports both analgesia and social bonding). Thus, active sensorimotor synchronization to music could have stronger analgesic effects than simply listening to music. However, to the best of the investigators' knowledge, the hypothesis of an EOS activation by sensorimotor synchronization to music has never been investigated. Accordingly, the investigators set up a test with the premise that if sensorimotor synchronization to music indeed activates the EOS, then it should have larger pain-reducing effects than simply listening to music. Using pressure algometry to the fingernails, specific amounts of pain were delivered to healthy adults either during music listening or silence, while either performing an active tapping task or a passive control task. As the dependent variable, perceived pain was rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong). In addition, to pain ratings, participants provided ratings of their emotional state in terms of pleasantness as well as arousal, and then rated their familiarity with the music (also on scales ranging from 1 to 9). Emotion ratings were obtained to explore whether the mechanisms driving pain-reducing effects of sensorimotor synchronization to music include emotion. At the end of the experiment, participants also rated their preference for the music on a scale ranging from 1 to 9 (see Method). Familiarity and preference ratings were obtained to elucidate possible contributions of these factors on pain reduction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Healthy

Exclusion Criteria:

* History of a psychiatric or neurological disease
* History of substance dependence
* use of any prescription drugs
* Hearing impairment
* Musical anhedonia
Exploring ProQOL, Health Status, Job Involvement and Turnover in Medical Professionals

The study design is a cross-sectional study. Purposive sampling will be conducted in three hospitals in the central of Taiwan. The participants will include physicians, nurse practitioners and nurses. The number of 550 participants will be recruited. The measurements are questionnaires include demographic data, professional quality of life scale (ProQOL), Job Involvement Questionnaire (JIQ), SF-36 and intention to stay questionnaire.

Medical and Nursing care is a high-pressure work environment. The charterer of medical and nursing care includes urgency of patients' problems, an unpredictable number of patients, and lack of medical professionals. This high-level of pressure working environment not only affects the persons' physical and mental health, increase turnover rate, but also might indirectly reduce the quality of care, even threaten the life of patients.

The purpose of this study is to explore the correlation between professional quality of life, health status, job involvement and intention to stay in medical professionals, and the predictive factors of intention to stay and turnover behavior.

The study design is a cross-sectional study. Purposive sampling will be conducted in three hospitals in the central of Taiwan. The participants will include physicians, nurse practitioners, and nurses. The number of 550 participants will be recruited. The measurements are questionnaires include demographic data, professional quality of life scale (ProQOL), Job Involvement Questionnaire (JIQ), SF-36 and intention to stay questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Aged over 20 years old
2. Currently serving as a hospital care provider
3. Job title as attending physician, resident, nurse practitioners, nurse
4. Directly practicing in patients' care

Exclusion Criteria:

1. Medical Director
2. Clinical Researcher
Clinical Characteristics and Outcome of Patients With COPD With Pneumonia

To identify the clinical characteristics of patients with chronic obstructive pulmonary disease (COPD) combined with community-acquired pneumonia (CAP) and the factors influencing clinical transition.

To identify the clinical characteristics of patients with chronic obstructive pulmonary disease (COPD) combined with community-acquired pneumonia (CAP) and the factors influencing clinical transition.Compared to other chronic airway diseases, COPD patients can often have CAP in combination, but there is a lack of comparative studies between COPD patients with CAP and non-COPD patients with CAP.

Eligibility Criteria:
Inclusion Criteria:

1. CAP meets the diagnostic criteria published in 2016 Chinese CAP diagnosis and treatment guidelines; CPOPD and AECOPD meet the diagnostic criteria published in Chinese 2013 COPD diagnosis and treatment guidelines;
2. Age ≧ 40years.

Exclusion Criteria:

1. age \<40years;
2. pregnancy;
3. positive for human immunodeficiency virus (HIV) antibodies;
4. suspected or confirmed tuberculosis or fungal infection of the lung.
MRI Exploration of Meningeal Inflammatory Disease

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added.

The MRI of routine care includes at least the following sequences:

* 3D T1 TFE 1.0 isotropic (2 minutes)
* T2 TSE (2 minutes)
* 3D FLAIR pre-injection (opt) (3 minutes)
* 3D FLAIR post-injection (3 minutes)

As part of the research, the following sequences will be acquired:

* FABIR pre-injection (3 minutes)
* FABIR post-injection (3 minutes)

Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes:

* 3D T1 TFE 1.0 isotropic (2 minutes)
* 3D FLAIR (3 minutes)
* FABIR (3 minutes)


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* To benefit as part of his treatment of an MRI with injection of gadolinium
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

For the ancillary study to meet secondary endpoint number 5:

* Patient over 18 years old
* To benefit as part of his treatment of an MRI with injection of gadolinium
* Hospitalized for an expected period of at least 48 hours after the time of inclusion
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman