cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss.

Facial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face.

Although common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and/or anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients.

The aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yo
* Systemic sclerosis according to the 2013 ACR/EULAR (American College of Rheumatology) classification criteria
* Systemic sclerosis with facial involvement defined by a MHISS score \> 6
* Immunosuppressive and/or anti-fibrosis treatment stable for at least 1 month
* Subject able to understand the objectives and risks of research and to give informed consent
* Subject enrolment in the health insurance scheme

Exclusion Criteria:

* Pregnancy
* Previous participation in a rehabilitation program of facial involvement
* Patient under legal protection
* Impossibility to give clear information of subject
Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes

Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.


Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 80 years of age.
2. Diagnosed with potentially resectable mediastinal mass.
3. With indication for uniportal-VATS.
4. For whom informed consent will be obtained before the study.

Exclusion Criteria:

1. Previous thoracic surgery at the same side.
2. Have to receive open surgery although uniportal-VATS is planned.
3. Pregnancy.
4. Refuse to sigh the consent
Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric cancer, yet the efficiency have not been fully investigated in Chinese people.

PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as locally advanced gastric cancer.

OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with pre-diagnosed as locally advanced gastric cancer. II. Assess the adverse effects associated with this technique.

OUTLINE: Surgery. Laparoscopy with cytologic examination.

PROJECTED ACCRUAL: Up to 450 patients will be accrued over approximately 2 years.

Eligibility Criteria:
Inclusion Criteria:

* sign written informed consent form
* age ≥ 18 years
* pathologically confirmed gastric or GEJ adenocarcinoma
* disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
* No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
* Adequate organ function as defined below:

Hematologic ANC ≥ 1.5\*109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100\*109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine \< 1.5 ULN

* KPS ≥ 70
* Adequate lung and heart function
* Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
* Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

* Refuse to provide blood/tissue sample；
* With distant metastasis diagnosed by CT/EUS；
* Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
* History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
* Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to \> 2 weeks of study enrollment)；
* Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
* Concurrent severe infection；
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)；
* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
* Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
* Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.
The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis

The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. However, the conventional pathogen mNGS has potential risks such as low detection rate, loss of intracellular bacteria and fungi. At present, the latest fully targeted pathogen capture mNGS technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. The aim of this study was to explore the value of fully targeted pathogen capture mNGS in improving etiological diagnosis in patients with sepsis compared with conventional methods.

This study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care Unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mNGS detection and follow-up etiological diagnosis based on blind method. The clinical diagnosis with clear etiology was taken as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Critical care patients aged ≥ 18 years old
* Patients with sepsis

Exclusion Criteria:

* Lack of traditional pathogen detection results
* Discharge diagnosis without clear etiology
Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy

The main objective:

To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.

Hypothesis:

The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.

Randomized clinical trial with blinding of the evaluator and the person analyzing the data.

A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
2. Ages between 5 and 12 years.
3. Levels I-III of the Manual Ability Classification System (MACS)
4. Levels I-III of the Gross Motor Function Classification System (GMFCS)
5. Able to understand and respond to verbal instructions.

Exclusion Criteria:

1. Cognitive impairment identified by the school report.
2. Hand orthopedic surgery in the last 6 months.
3. Neuropharmacological intervention in the last 6 months.
4. Allergy to upper limb orthosis material.
5. Affectation of the manual function not due to the neurological condition (trauma, burn ...).
6. Current treatments not compatible with the study.
7. Other significant neurological affections (crisis, severe visual impairment ...).
Efficacy of Cantharidin in Molluscum Contagiosum

The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.


Eligibility Criteria:
Inclusion Criteria:

* Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum.

Exclusion Criteria:

* Anyone with immunosuppression including HIV or previous organ transplantation.
* Anyone taking immunosuppressive medications.
* Anyone who has previously received treatment with cantharidin.
* Any female who has had her first menstrual period.
Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Non-diabetics
* Serum TG \>150 mg/dL and \< or = 600 mg/dL
* Serum LDL-C \>130 mg/dL

Exclusion Criteria:

* Type 1 or type 2 diabetics
* Fasting plasma glucose \>126 mg/dL
* Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):

  * Niacin or bile-acid binding agents and HMG CoA reductase inhibitors: 8 weeks
  * Fibrates: 8 weeks
  * Probucol: 1 year
* History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice
Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis

A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Female more than 40 years old in postmenopausal

Exclusion Criteria:

* Subject who has a history of malignant cancer
Group Intervention on Executive Function in Children With Autism Spectrum Disorder

Autism is a developmental disorder characterized by difficulties in social communication, repetitive behaviors, and social interaction. A key aspect of autism concerns executive functions, which are a set of cognitive processes that regulate attention, planning, inhibition, and impulse control. These functions are often impaired in children with autism, affecting their learning and daily functioning.

The present protocol aims to test the first absolute and then comparative effectiveness of two executive function development programs: the "APISMELA" training and the "UNSTUCK \& ON TARGET! SECOND EDITION". Two groups will be held at the same time and will conduct the two programs in reverse order. In fact, the protocol is divided into two phases.

Participants subjected to the APISMELA group, finished the intervention sessions will conduct an interim evaluation and then begin the intervention phases of the UNSTUCK \& ON TARGET! SECOND EDITION protocol.

Participants subjected to the UNSTUCK \& ON TARGET! SECOND EDITION group, finished the intervention sessions will conduct an interim evaluation and then begin the intervention phases of the APISMELA protocol.

Group intervention programs were chosen for two reasons: group intervention compared with individual intervention have lower costs for patients and their families and thus higher overall social acceptability. The second is that group intervention within the social-constructivist paradigm, to which the two chosen programs belong, becomes a fundamental resource for stimulating that augmentative learning that is a source of development on the cognitive and conceptual levels for human beings.


Eligibility Criteria:
Inclusion Criteria:

* Children with diagnosis of autism and autism spectrum disorder

Exclusion Criteria:

* Presence of other medical disorders
Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis

OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis.

II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis.

III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin.

IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.

PROTOCOL OUTLINE: This is a randomized study. Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies.

The first group is treated with capsaicin. A second group is given individually titrated doses of capsaicin: the dose is increased as tolerated or until symptomatic response is acceptable. A control group receives a placebo. Therapy for all groups is administered intravesically every week for 5 weeks.

Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies. One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks. The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule. The control group applies a placebo.

Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Women with interstitial cystitis by National Institute of Diabetes and Digestive and Kidney Diseases criteria Vulvar vestibulitis by International Society for the Study of Vulvar Disease, i.e.: Severe pain on touch or attempted entry of vagina Tenderness to pressure within the vulvar vestibule Vulvar erythema Duration of symptoms at least 6 months Absence of vulvovaginal infection, i.e.: No fungus No trichomonas No chlamydia No gonorrhea No "clue cells" in vaginal discharge
High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors

* Study No.: KSPNO-S-081 Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor
* Study No.: KSPNO-S-082 High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation
* Study No.: KSPNO-S-083 High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment

Although significant progress has been made in the treatment of brain tumors, the prognosis remains dismal in patients with relapsed tumor. The outlook for infants and young children is also poor, primarily because of the limited use of radiotherapy, although a recent report suggested that vigorous combination chemotherapy alone improved the survival of young children without macroscopic metastases at diagnosis. The prognosis is also not satisfactory when a large residual tumor remains after surgery or when leptomeningeal seeding is present at diagnosis. Given the above situation, we plan to explore the possible efficacy of high-dose chemotherapy and autologous stem cell rescue in patients with high-risk embryonal tumors, relapsed brain tumors and in infants and young children with brain tumors.High-dose chemotherapy and autologous stem cell rescue has improved the survival of children with high-risk solid tumors. this treatment strategy is based on the hypothesis that a dose escalation might improve the survival of children with high-risk solid tumors.Many investigators demonstrated that further dose escalation using sequential high-dose chemotherapy and autologous stem cell rescue might result in additional improvements in the survival of patients with high-risk tumors. As embryonal brain tumors are a chemosensitive tumors, a strategy using high-dose chemotherapy might be effective in the treatment of high-risk embryonal brain tumors and relapsed brain tumors. In addition, it might defer or eliminate irradiation in infants and young children with brain tumors

Eligibility Criteria:
Inclusion Criteria:

* KSPNO-S-081: newly diagnosed embryonal brain tumor, age \>= 3 years
* KSPNO-S-082: all high-grade or malignant brain tumor, age \<3 years
* KSPNO-S-083: recurrent embryonal brain tumors, recurrent CNS germ cell tumor

Exclusion Criteria:

* Patients with severe comorbid organ dysfunction (NCI grade \> 2 organ toxicity) prior to high-dose chemotherapy
* Patients with progressed tumor prior to high-dose chemotherapy
* Patients whose parents do not want to undergo high-dose chemotherapy and autologous stem cell rescue
The Effect of Sedation on Rebound Pain in Knee Arthroplasty

Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.

Randomization will take place before the patient enters the operating room. After spinal anesthesia is applied, 0.4 mcg/kg sedadomide loading will be done for 10 minutes in the sedation group, and then 0.4 mcg/kg/h sedadomide infusion will continue until the end of the surgery. Patients selected for the control group will be given the same amounts of saline. At the end of the surgical procedure, saline and sedadomide infusions will be stopped. All patients will undergo an adductor canal block under USG guidance in the recovery room. 50 mg of buvacin will be given to the block area. Patients will be fitted with a patient control analgesia device, which only provides bolus application and provides 20 mg of madol in each bolus. Postoperatively, sudden onset severe withdrawal pain outside the normal course of pain starting within 48 hours will be followed and Vas-bromage monitoring will be done at 0, 1, 2, 4, 8, 12, 24, 36, 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.

Exclusion Criteria:

* Situations in which spinal anesthesia is contraindicated
* Advanced organ failure states(cardiac,hepatic,respiratuar or renal)
* Pregnancy
* BMI \> 40 kg/m\^2
* Do not want to participate in the study
* Younger than 18 or older than 85
* Have bilateral total knee arthroplasty or resurgery
* Develop an unexpected intraoperative surgical complication
Assessing the Knowledge and Self-confidence of Healthcare Workers to Perform Transurethral Catheterization: A Multicenter Survey

Rationale: Healthcare professionals regularly perform transurethral catheterization. They may have not sufficient knowledge, experience, and self-confidence about urethral catheterization. This can cause an increased risk of urethral catheterization-related injury and morbidity. With an appropriate training program, we can raise the knowledge and self-confidence of healthcare professionals in performing transurethral catheterization.

Primary Objective: To compare knowledge and self-confidence amongst healthcare workers in performing urethral catheterization before and after the proposed urethral catheterization training program.

Secondary Objective: To compare the traumatic catheterization rates before and after the proposed urethral catheterization training program.

Study design: This study is a prospective multi-center trial using a questionnaire for assessing the healthcare professionals about urethral catheterization knowledge and self-confidence before and after a urethral catheterization training program, where their evaluation is scheduled 6 months after the training.

Study population: The study population comprises medical health workers (nurses, paramedics and doctors) from 5 different Medipol Hospitals working at surgical and non-surgical departments.

Intervention: An in-person urethral catheterization training program that utilizes training videos (demonstrating procedures, providing examples of ordinary and difficult cases, utilizing animation techniques as well) Main study parameters/endpoints: Primary endpoint is the change in self-reported self-confidence and knowledge in urethral catheterization following the training. The secondary endpoint is the change in complicated/traumatic urethral catheterization following the training. A complicated/traumatic catheterization is defined as a urethral catheterization requiring the intervention of a urologist.


Eligibility Criteria:
Inclusion Criteria: Healthcare workers (paramedics, nurses, and doctors) working in the emergency department, intensive care, operating rooms, departments of gynecology, general surgery, urology, orthopedics, neurology, internal medicine, cardiology, and anesthesiology -

Exclusion Criteria: Healthcare workers that not working non-clinic services,

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