cyrilzakka/clinical-trials huggingface dataset:
Efficacy of an Epidural Versus a Fascia Iliaca Compartment Catheter After Hip Surgery

The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. This is called a "fascia iliaca compartment" catheter.

The investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. Usually, patients would receive only one type of catheter for pain relief. To do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.


Eligibility Criteria:
Inclusion Criteria:

* Weight \>40 kg
* Radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy
* Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale \>4/20
* Age between 15 and 35 years
* Good or excellent preoperative joint congruency

Exclusion Criteria:

* Hematologic or neurologic contraindications to epidural catheter placement
* Significant renal, hepatic, or cardiac disease
* Peptic ulcer disease
* Bleeding disorders
* Severe asthma
* Hypersensitivity to non-steroidal antiinflammatory drugs
* Developmental delay
* History of substance abuse
* Chronic opioid use
* Chronic pain in non-hip locations
A Study of Guselkumab in Participants With Systemic Sclerosis

The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of systemic sclerosis (SSc) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
* Diffuse cutaneous SSc according to the LeRoy criteria that is, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
* Disease duration of ≤36 months (defined as time from first non-Raynaud phenomenon manifestation).
* Greater than or equal to (\>=) 10 and less than or equal to (\<=) 22 modified Rodnan skin score (mRSS) units at screening and Week 0
* Forced vital capacity (FVC) \>= 60 percent (%) of predicted at screening
* Diffusing capacity of the lung for carbon monoxide (DLCO) \>= 40% of predicted (hemoglobin-corrected) at screening.
* Participants who meet 1 of the following criteria at screening: increase of \>=3 mRSS units, compared with an assessment performed within the previous 2 to 6 months; Involvement of 1 new body area with an increase of \>=2 mRSS units compared with an assessment performed within the previous 2 to 6 months; and Involvement of 2 new body areas with increase of \>=1 mRSS units compared with the assessment within the previous 2 to 6 months

Exclusion Criteria:

* History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute \[mL/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has any known severe or uncontrolled SSc complications including hemoptysis, pulmonary hemorrhage, renal crisis
* Has an interstitial lung disease requiring oxygen therapy
* Has any rheumatic disease other than SSc such as rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), systemic lupus erythematosus, polymyositis/dermatomyositis that could interfere with assessment of SSc
* Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study)
TNFα Monoclonal Antibody for Acute Spinal Cord Injury

The purpose of this study is to evaluate the safety and effectiveness of subcutaneous injection of TNFα monoclonal antibody cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). The pathological process of spinal cord injury include primary injury (initial traumatic insult) and a progressive secondary injury cascade characterized by ischemia, proapoptotic signaling, peripheral inflammatory cell infiltration and the release of proinflammatory cytokines. Secondary injury plays a key role in the loss of spinal cord function after trauma. So early treatment to prevent the secondary injury is the key to improve prognosis. TNFα monoclonal antibody is a TNF-α inhibitor that could control inflammatory response, and now widely used in the treatment of Ankylosing spondylitis, Rheumatoid arthritis and other autoimmune diseases. In this study, the investigators will treat patients with acute spinal cord injury with TNFα monoclonal antibody and compare with the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 60 years
* Traumatic spinal cord injury
* ASIA Impairment Scale A-D
* The injury must be within two weeks
* Patients submitted written informed consent

Exclusion Criteria:

* Traumatic spinal cord injury with brain injury or peripheral nerve injury
* Patients with severe multiple injuries and unstable vital signs
* Non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc.
* Patients with central spinal cord injury
* Patients with a completely transected spinal cord
* Patients with fever or acute infection
* Ongoing infectious disease, such as tuberculosis, HIV, hepatitis, syphilis, etc.
* Patients with malignant tumour
* Patients with neurodegenerative diseases, or any neuropathies
* Patients with ankylosing spondylitis
* Patients with a previous history of spinal surgery
Histochemical Study of Vitiligo in Sohag University Hospital Patients

Vitiligo is a common acquired idiopathic disorder characterized by depigmentation of the skin, hair, and mucous membranes in the form of macules and patches due to selective melanocyte destruction . Incidence of Vitiligo is about 0.5% to 2% of the world's population, and its incidence continues to increase. Vitiligo can appear at any age group especially in the second and third decades of life. About one-third of vitiligo patients are children under ten years old Vitiligo can be classified into non-segmental, segmental, mixed and unclassifiable/undetermined types. Vitiligo has a negative impact on patient's quality of life by decreasing their self-confidence and causing significant psychological distress.

The pathogenesis of vitiligo is still unclear but some theories can explain it such as oxidative stress, autoimmunity, autocytotoxicity, genetic factors, neural and melanocytorrhagy . Loss of pigment which occur in vitiligo may be due to two main causes: absence of melanocytes and/or the inability of melanocytes to produce and store melanin in melanosomes in the process of melanogenesis.

High mobility group box protein B1 (HMGB1) normally presents in the nucleus to maintain genomic stabilization and regulate gene transcription. but, HMGB1 can be released outside the cell due to exposure to stressful factors such as oxidative stress and function as a damage-associated molecular pattern (DAMP) protein leading to strong proinflammatory effects. Recent data showed that HMGB1 is overexpressed in both blood and lesional specimens from vitiligo patients. Moreover, oxidative stress triggers the release of HMGB1 from keratinocytes and melanocytes, indicating that HMGB1 may participate and play a crucial role in the pathological process of vitiligo.

HMGB1 Directly induces Melanocyte apoptosis through stimulation with reactive oxidative stress (ROS) or ultraviolet B (UVB) in vitro which significantly increases the release of HMGB1 from keratinocytes, which inhibits the expression of melanogenesis-related molecules such as microphthalmia- associated transcription factor (MITF), tyrosinase-related proteins and the gp100 protein in a paracrine manner and finally activate caspase-3 to trigger melanocyte apoptosis

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients with vitiligo aged 18-50 years old.

Exclusion Criteria:

* Pregnancy
* Lactation
* Patient on immunosuppressive treatment for vitiligo over the last month
* Skin diseases, other than vitiligo.
* Systemic diseases particulary endocrine disorders and autoimmune connective tissue diseases.
Wean Early With HFNCO vs NPPV in Patients With AHRF

The main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

1. Orotracheal intubation；
2. PaO2 \<60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
3. Meeting criteria for weaning readiness；
4. Spontaneous breathing trial failure.

Exclusion Criteria:

1. Age\<18；
2. Duration of invasive ventilation \<48h；
3. Tracheotomy；
4. Percentage of cuff leak volume in tidal volume\<15.5%；
5. Unable to spontaneously clear secretions from their airway；
6. Recent oral，nasal，facial or cranial trauma or surgery；
7. Recent gastric or esophageal surgery；
8. Active upper gastro-intestinal bleeding；
9. Severe abdominal distension；
10. Lack of co-operation；
11. Chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.
pedCAPNETZ - Community Acquired Pneumonia (CAP) in Childhood and Adolescence

Establishment of a study network and patient cohort for pediatric CAP

The aim of the project is the development of a large pediatric CAP patient cohort based on the established pedCAPNETZ pilot cohort. The main objective is to improve knowledge on etiology, epidemiology, diagnosis and management of pediatric CAP in a developed country. pedCAPNETZ will enable the systematic and detailed characterization of pediatric CAP cases on an epidemiological, clinical and biological level.

Eligibility Criteria:
Inclusion Criteria:

* age \< 18
* symptoms of an acute lower respiratory tract infection with radiological confirmed pneumonia via ultrasound or chest x-ray

Exclusion Criteria:

* hospitalization for any reason within the last 28 days
* congenital or acquired immunodeficiency
* concomitant respiratory disease with impaired mucociliary clearance such as cystic fibrosis, primary ciliary dyskinesia, tracheostomy or other severe lung disease including pulmonary tuberculosis, malignancy, and cytostatic therapy during past 28 days or neutropenia (\< 1000/µl) or relevant immunosuppressive treatment
Determining the Effect on Patients of Internet-Based Diabetes Disease Management

This grant supports a 12-month randomized controlled trial comparing usual care versus collaborative disease management over the Internet among disadvantaged African-Americans with Type 2 diabetes. The project aims to: (1) determine the effect of case-managed, Web-based diabetes care on glycemic control, health care utilization, self-efficacy, and patient satisfaction; and (2) qualitatively identify enablers of the successful use of computers, the Internet, and e-Health applications by disadvantaged patients.

We propose to conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management over the Internet among disadvantaged African-Americans with type 2 diabetes. Subjects will be recruited from patients receiving primary care at Harborview Medical Center, the County facility administered by the University of Washington in Seattle. As part of a pretest-posttest experimental design, 30 intervention subjects will be trained to use an existing diabetes disease-management module comprising six Web sites that are accessed from home via links displayed within the University's "MyUW" Internet portal. These sites allow patients to:

1. View their entire electronic medical record, the same record used by providers,
2. Upload blood glucose readings stored in a digital meter,
3. Enter medication, nutrition, and exercise information into an online daily diary,
4. Communicate with providers regarding treatment recommendations or other questions using clinical e-mail,
5. Obtain additional information from a traditional patient education site with endorsed content, and
6. Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy.

All data can be viewed by patients and providers in online trended displays that a clinical pharmacist will use to review cases no less often than weekly. As an attention control, 30 subjects will also be trained to use a provided personal computer to access Internet knowledge resources, but will not have access to the case-management services and module being evaluated. By comparing the two groups, we aim to:

1. Determine the effect of case-managed, Web-based diabetes care on glycemic control, healthcare utilization, self-efficacy, and patient satisfaction, and
2. Use semi-structured interviews among a subsample of both trial arms to qualitatively identify enablers of the successful use of computers, the Internet, and e-health applications by disadvantaged patients.

Eligibility Criteria:
Inclusion Criteria:

* African American

Exclusion Criteria:

* non-English speaking
EURAD MRI Classification of US Indeterminate Adnexa Lesions

This research is targeting patients with sonographically indeterminate adnexal mass that are being referred for clinical MR imaging. Investigators from the UW will be contributing coded MR images and associated health information (US results, laboratory/pathology results) to the EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the research.

An adnexal mass is the most common indication for gynaecological surgery. Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patients management. Recently, the coordinating center developed the first MR scoring system named ANDEXMR SCORING system in a retrospective study which is accurate and reproducible. The objectives of this trial are to perform an external prospective validation of this scoring system to evaluate its potential impact on therapeutic strategy and to test its reproducibility.

This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be included from each participating center. One senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The reader will then classify the mass using ADNEXMR SCORING system.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* With indeterminate ultrasonographic adnexal mass

Exclusion Criteria:

* Patients under 18 years of age
Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual Syndrome

The purpose of this experiment is to evaluate the efficacy of supplemental health food Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules in improving physical and psychological symptoms, blood oxidative stress and inflammation indicators in women with premenstrual syndrome.

This study was a randomized, double-blinded and placebo-controlled research. This study was approved by the Institutional Review Board of the Chung Shan Medical University Hospital and all Participants signed the written informed consent to participate in the study.

Participants met the inclusion criteria, ie: age 20\~45 yr and a regular menstrual cycle (21\~35 days per cycle) were recruited through advertisements posted around the Chun Shan Medical university campus. In screening phase of this study, affective and one somatic symptom in before onset of menstruation in two consecutive cycles and was not affected by depression or anxiety disorder, she is examined by the Attending Physician of the Obstetrics and Gynecology Department to diagnosed a patient with premenstrual syndrome. In the intervention phase of this study, 105 eligible participant were randomly divided into intervention (Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules) and control groups (n=35/group). Both subjects and researchers were blind to the treatment assignment until the statistical analysis was completed. All participants received two oral capsules containing Hericium erinaceus Mycelium, probiotics or placebo every day for the 3 months. The capsules of intervention supplementations and placebo provided by Grape King Biotechnology Inc in identical appearance and package to guarantee the blindness.

Data collection A validated semi-quantitative Food Frequency Questionnaire was used to obtain daily nutritional values of participants. To assess the symptoms of PMS, all subjects need to fill out daily record of severity of problems on a daily basis in the 3 months of intervention period and 6 months after the intervention. In the 0, 1, 3 months of intervention, the anthropometric parameters and body composition were measured by using bioelectrical impedance analysis method ( MC-980 MA PLUS, TANITA BIA Technology). In the 0, 1, 3 months of intervention, venous blood samples were taken from all subjects for measuring the marks of oxidative stress and inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20-45
2. The menstrual cycle is 21\~35 days/time
3. PMS diagnosed by an obstetrician
4. Willing to sign the subject's consent form

Exclusion Criteria:

1. Those are with cancer, cardiovascular, kidney, liver, infectious and endocrine diseases, aw well as with depression and anxiety tendencies
2. Those have a surgery in the last 6 months
3. Those use of probiotics, estrogen and birth control pills
4. Body mass index \> 39 kg/m2, smoking, drinking
5. Death of a close relative and other stressful events within the last 6 months
Treatment of Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft

This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II gingival recession


Eligibility Criteria:
Inclusion Criteria:

1. Patients are systemically healthy based on questionnaire dental modification of Cornell index.
2. Patients are periodontally healthy with no contraindication for periodontal surgery.
3. All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
4. O'Leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation)
5. Buccal recession defects are classified as Miller Class I or II.
6. Presence of identifiable CEJ.
7. The papilla fill the interdental spaces as far as the contact area
8. Clinical indication and/or patient request for recession coverage.

Exclusion Criteria:

1. Miller Class III or IV recession defects
2. Pregnant female.
3. Smokers as smoking is contraindicated for any plastic periodontal surgery
4. Patients with special needs or with any mental problems.
5. Patients undergoing radiotherapy
6. Teeth with carious or non-carious lesion or cervical restorations
7. Rotated teeth and tooth extrusion with or without occlusal abrasion
8. Patient undergone any prior periodontal surgery in the relevant region.
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent to participate in the study
* In Korea, participants must be 19 years or older to be enrolled
* BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
* 500 μm ≥ CST ≥ 325 μm in the study eye at screening
* HbA1c ≤ 11% at screening

Exclusion Criteria:

* Any signs of proliferative diabetic retinopathy in the study eye
* History of rubeosis in the study eye
* Uncontrolled glaucoma in the study eye
* Aphakia or pseudophakia with AC-IOL in the study eye
* Active intraocular inflammation in the study eye
* Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
* History of rhegmatogenous retinal detachment in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* History of the following therapies in the study eye

  * History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME
  * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
  * Previous intraocular device implantation except PC-IOL
  * Laser (any type) to the macular area within 12 weeks prior to Day 1
  * Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
  * Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
  * Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with nAMD within 3 years prior to Day 1
  * Previous use of Ozurdex® or Iluvien® implant
* Any current or history of endophthalmitis in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
GnRH for Luteal Support in IVF/ICSI/FET Cycles

During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .

see above

Eligibility Criteria:
Inclusion Criteria:

* women undergoing IVF/ICSI or frozen embryo transfers (FET) that less than 40 years old.

Exclusion Criteria:

* day 3 transfers