cyrilzakka/clinical-trials huggingface dataset:
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis

The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 18 years old;
2. diagnosed with AS according to the 1984 New York Modified Criteria;
3. Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
4. BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
5. Subjects who need to take NSAIDs (including COX-1 or COX-2 inhibitors) as established treatment for AS, and the NSAIDs should be on a stable dose for at least 2 weeks (inclusive) before screening and the dose is expected to be stable during the study;
6. Voluntary treatment with adalimumab and secukinumab;
7. Appropriate contraceptive measures for women of childbearing age;
8. without other rheumatic diseases.
9. Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)

Exclusion Criteria:

1. With unstable vital signs, coma, mental and cognitive impairment;
2. Patients with severe systemic diseases and other serious chronic diseases;
3. Pregnant or lactating patients;
4. History of malignant tumor in the past 5 years;
5. Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
6. Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
7. Moderate to severe heart failure (New York Heart Association grade 3-4);
8. Allergic to any of the components of adalimumab (HS016) or secukinumab;
9. Subjects who are participating in clinical research of other drugs;
10. In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.
Effects of Dexmedetomidine on Breast Cancer Cell Function in Vitro

Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. Previous studies in cells and animals show that dexmedetomidine may promote cancer growth. Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or saline during surgery, we investigated the effects of dexmedetomidine on proliferation, migration and metastasis in MCF-7 breast cancer cells in vitro.

Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. Patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. Patients of control group will receive same amount of normal saline. Serum will be collected from patients of both groups at before induction and 1h post-surgery. The MCF-7 breast cancer cell line will be treated with patient serum from both groups. The effects of dexmedetomidine on cellular proliferation, migration and metastasis will be measured.

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I-III Age range of 18 to75 Patients diagnosed primary breast cancer(T2-3, N0-2, M0) Patients will have elective adenomammectomy

Exclusion Criteria:

* with history of breast operation Patients diagnosed carcinoma erysipelatodes Severe liver, renal, brain or lung disease with history of opioid addiction Patients diagnosed metastatic breast cancer
Potential Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

Background: Trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. The facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. Therefore it is important to do a new method in healing trophic ulcers. Stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing Method: This research is a clinical trial research "Open Trial". Phase 1 to see the side effects caused by the intervention. Minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. The main outcome is wound healing in terms of the length and extent of the wound. The secondary outcome is treatment toxicity 4 weeks after administration. Follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. If the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy


Eligibility Criteria:
Inclusion Criteria:

* Chronic ulcers in Morbus Hansen's patients aged 18-80 years
* Not recovering with routine therapy for at least 1 months
* Trophic ulcers degrees 2 and 3
* Willing to take part in the study
* As well as with the respondent's good health to follow this study.

Exclusion Criteria:

* Patients who took anticoagulants,
* Patients had hypertension
* Patients had any staging kidney failure
* Patients had a history of blood disorders and pregnancy.
Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis

The purpose of this study is:

1. To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic dermatitis.
2. To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis before and after treatment.
3. To determine how PDT alters sebum secretion rates in subjects with seborrheic dermatitis before and after treatment.

The researchers hypothesize that PDT will be efficacious in the treatment of seborrheic dermatitis.

This pilot project investigates the use of PDT may be useful in the treatment of seborrheic dermatitis based on the following: The Malassezia spp is capable of forming biofilms, 2) PDT has been shown to be effective against Malassezia spp PDT can break up bioflims of both bacterial and fungal origin and benzoyl peroxide, a prooxidant treatment similar to PDT, has been shown to be effective in the treatment of seborrheic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects 18 years or older with seborrheic dermatitis of the face will be included.

Exclusion Criteria:

* Subjects who are taking systemic corticosteroids (at doses of prednisone greater than or equal to 5 mg daily), antibiotics (PO, IM or IV) or using topical anti- fungals, steroids, antibiotics, permethrin, or calcineurin inhibitors within 2 weeks prior to the study will be excluded.
* The exclusion criteria will also include the presence of other untreated inflammatory conditions (such as lupus, atopic dermatitis, or psoriasis) or untreated malignancies on the face (including skin cancers such as basal cell carcinoma, squamous cell carcinoma and melanoma).
* Any subjects with known or suspected hypersensitivity to any constituent of the study medication or a history of photosensitivity due to conditions such as lupus erythematosus and porphyria will be excluded.
* Subjects who have had photodynamic therapy (PDT) to the face for any reason within the past year will be excluded as well.
* Adults unable to consent, individuals under the age of 18, pregnant or breastfeeding women and prisoners will be excluded from the study.
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.

The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy.

These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven diagnosis of HPV-related OPSCC
* Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)
* Patients must be eligible for definitive RT or CRT
* Must be ≥ 18 years of age
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in either English or French
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient registration
* Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
* The following radiological investigations must be done within 8 weeks of randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue primary tumors); PET-CT scan.
* Patient must consent to provision of, and investigator(s) must confirm location and commit to obtain a representation of formalin-fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays described in Section 12 (Correlative Studies) may be conducted. Please see the Correlative Manual for details
* Patient must consent to provision of samples of blood and plasma (for circulating cell free DNA) in order that the specific correlative marker assays described may be conducted.
* Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Exclusion Criteria:

* Previous chemotherapy or radiotherapy treatment for head and neck cancer
* Patients with an unknown primary.
Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty

The objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty.

Hip fractures in the elderly represent a significant public health challenge, marked by elevated rates of morbidity and mortality. The worldwide increase in life expectancy has led to a corresponding rise in the incidence of hip fractures. Notably, increased perioperative blood loss has been identified as a critical factor that heightens the risk of complications and mortality. Consequently, contemporary research efforts have focused on addressing this pivotal issue. Various strategies have been developed, including controlled hypotensive anesthesia and the utilization of pharmacological agents aimed at reducing the perioperative blood products. The necessity for the efficacy of tranexamic acid (TXA) in mitigating blood loss has been well-established across numerous surgical specialties. This study is motivated by the need for an effective and safe approach to perioperative blood salvage. To date, there appears to be a lack of research examining the effectiveness of the intraoperative periarticular injection technique (100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers) regarding blood loss reduction. Therefore, this study aims to investigate the following questions: 1) Is intraoperative periarticular injection an effective technique for minimizing blood loss in patients with hip fractures? and 2) What proportion of the salvaged blood loss can be attributed to hidden blood loss?

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of femoral neck fracture

Exclusion Criteria:

* Anti-aggregant, anti-coagulant or anti-thrombotic therapy
* Pathological fractures, periprosthetic fractures, or revision procedures
* Intolerance or allergy to the medications utilized in the study
* Refused to participation
Modality of Induction of Labor in Obese Women at Term (MODOBAT)

In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.

Obesity has for several decades become a global epidemic in developed countries. In case of pregnancy, obesity leads to an increased risk of obstetric complications, the indications of induction of labor are then more frequent. Unfortunately the rate of failed induction is also higher and therefore the risk of caesarean section is increased in obese women compared to normal-weight patients when induction of labor is indicated. However, in this context effectiveness of each mode of induction is not known. Some retrospective studies would suggest that the balloon would be more effective because it would not be affected by the increase in fat mass but this result are not , but the to confirm this hypothesis.

The aim of this study is to describe the caesarean section rate in induction of labor by vaginal dinoprostone and single balloon Foley catheter in obese women. Patients in the vaginal dinoprostone arm will be included retrospectively and patients in the single balloon Foley catheter arm will be included prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Medical indication of induction of labor
* BMI ≥ 30 kg / m2
* Bishop \< 6
* Singleton
* Gestational age \> 36 SA + 6j
* Cephalic presentation

Exclusion Criteria:

* Adults under guardianship or curatorship
* Scarred uterus
* Placenta praevia
Mixed and Match vs One-size-fits-all

Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation. While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness. This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.

A randomized controlled trial (RCT) will be conducted. One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong. Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline. Participants can choose to receive their own smoking cessation treatment options from our menu. Control group participants will only receive a self-help quitting leaflet

Eligibility Criteria:
Inclusion Criteria:

* have smoking in the previous 30 days.
* be above 25 years old
* able to speak Cantonese and read Chinese

Exclusion Criteria:

* who are receiving current smoking cessation services
* report psychological disorders
* at risk of suicide
Healing Lodge First Face Training Evaluation Study

The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training.

To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations.

With funding from the National Institutes for Health, the investigators created First Face for Mental Health. First Face is a culturally-appropriate community-based mental health training that prepares trainees to provide assistance to someone having a mental health crisis. The more community members within Tribal nations who are trained in a culturally sensitive program to provide support to youth in recovery and members struggling with mental health problems or crises, the better positioned that community is to create a supportive recovery environment for its youth. The investigators are in the process of launching First Face trainings and evaluations among several Tribal communities. Additionally, they will be training staff from the Healing Lodge of the Seven Nations (HL) in the First Face program. This particular application concerns the evaluation of First Face training among HL staff. The investigators will measure primary and secondary outcomes at pre-training, post-training, and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Employment at the Healing Lodge of the Seven Nations
* Selection to participate in First Face for Mental Health training

Exclusion Criteria:

° Previous completion of First Face for Mental Health training
The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children

The concentration of folic acid and homocysteine in the blood can be used as independent risk factors for a variety of diseases. A sustained decrease in blood folate concentration and an increase in homocysteine concentration can damage vascular endothelial cells, causing varying degrees of neurodevelopmental abnormalities. Many clinical studies have found that anesthetics can affect blood folate and homocysteine concentration, but the effects of sevoflurane and propofol on blood folate and homocysteine concentrations are not clear. Therefore, this study aims to investigate the effects of sevoflurane and propofol on blood folate and homocysteine levels in children.

Retrospective study: Study the medical history of infants and young children (less than 3 years old) who underwent sevoflurane or propofol general anesthesia for more than 3 hours from January 2018 to December 2018, and compare the preoperative and postoperative serum folate changes for retrospective analysis.

Prospective study：Ten infants and young children (less than 3 years old) who underwent general anesthesia from November 7, 2018 to December 31, 2018 in Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Inhalation of 1-8% concentration of sevoflurane for general anesthesia induced intubation, followed by sevoflurane 2.0 \~ 2.5 Vol% inhalation maintenance, according to the intraoperative situation to add opioids. Patients maintained a bispectral index (BIS) monitoring between 50 and 60. After induction of general anesthesia in all patients, Serum folate levels were measured before the start of surgery, every 1 hour during surgery, and at the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Children under 3 years old who underwent general anesthesia
2. Those who did not participate in other clinical trials within 3 months
3. No acute infectious diseases, systemic diseases
4. The family member of the child agrees to the test and signs the informed consent form.

Exclusion Criteria:

1. Refusal to join the group
2. severe liver and kidney damage
3. Hemodynamic instability (shock, blood pressure drop \> 30% of basal blood pressure)
4. Children with egg and milk allergy
5. Children with a family history of malignant hyperthermia
Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice

Retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (FUSE Full spectrum colonoscopy with 330° angle of view vs Pentax standard HD-colonoscopes and Pentax plus Endocuff): medical device of the category IIb (CE-marked device used within its intended purpose)

From March 2015 through February 2017 (phase A) patients referred for ambulant colonoscopy in a private Swiss gastroenterologist's practice were alternatingly allocated to one of the two endoscopy theatres. One equipped with a FUSE® endoscopy system from Endochoice (later: Boston Scientific, nA/FUSE®=1044 examinations), the other with an EPKi Processor and Pentax i10 colonoscopes (nA/Pentax=934 examinations). In March 2017 a second doctor joined the practice, but did not contribute to the study. These organizational changes required randomization to be switched from per-patient alternation to per-day alternation in phase B from March 2018 through September 2019. In phase B the FUSE® system was unchanged (nB/FUSE®=1386 examinations), while the Pentax i10 colonoscopes were additionally equipped with Endocuff® (nB/Endocuff®=750 examinations). Patients with contraindica-tion against Endocuff® (known or found diverticular stenosis) were excluded from the study (nB/removed=127). Patients were given their appointments to any free slot throughout the week without stratification. The study and data analysis was consented by the ethical committee EKNZ Ethikkom-mission Nordwest- und Zentralschweiz (Project-ID 2019-01643).

All procedures were performed by one experienced endoscopist (board certified 2004) under nurse assisted propofol sedation (NAPS).

Baseline characteristics, age, sex, BMI, smoking habits, diabetes as well as quality of bowel prepara-tion (measured by BBPS score) and indication for colonoscopy (screening, surveillance, diagnostic, such as diarrhea, bleeding, persistent abdominal pain) were assessed. Amount of sedatives, other medications given during endoscopy (e.g. Buscopan®) and time for the endoscopy e.g. time to ile-um, retraction time (pullback time minus intervention time) and time for intervention were measured by the assistant with a stopwatch. These parameters, polyp counts, size and their localisation (entered in a table and to an anatomical scheme), and satisfaction for all parts of the examination (bowel prep and overall satisfaction) were realtime entered to the database by a tablet computer. The data entry was done coded. Only the main investigator could subdue each single patient.

Statistics were done with a professional statistics, the co-author Dr. Leiner

Eligibility Criteria:
Inclusion Criteria:

* all patient fit for ambulatory colonoscopy

Exclusion Criteria:

* for Endocuff stricturing divertculosis