cyrilzakka/clinical-trials huggingface dataset:
Study of ALE.C04 in Patients With Head and Neck Cancer

The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and to assess anti-tumor activity of ALE.C04 in combination with pembrolizumab in patients with Head and Neck Cancer.

The study comprises a phase I and a phase II. The phase I dose escalation part for both ALE.C04 monotherapy and in combination with pembrolizumab and a recommended dose for expansion (RDE) part for ALE.C04 in combination with pembrolizumab. The phase II comprises a 1:1 randomized 2 arms assessing ALE.C04 and pembrolizumab given in combination versus pembrolizumab monotherapy

Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide written informed consents
2. Be 18 years of age on day of signing informed consent.
3. Have histologically or cytologically confirmed Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies.
4. Have provided tissue for claudin-1 (CLDN1), programmed death ligand-1 (PD-L1) and biomarker analysis in a central Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
5. Have measurable disease based on RECIST 1.1 as determined by the site.
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
7. Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer

Exclusion Criteria:

1. Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC (Phase II randomized combination part only).
2. Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or patient has not fully recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered treatment. Palliative radiotherapy to a limited field is allowed.
3. Severe immune-related adverse events leading to discontinuation of prior immune-oncology agent only for Phase I dose escalation monotherapy and combination and Phase II monotherapy.
4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
5. Dermatological conditions requiring active pharmacological treatment including psoriasis, atopic dermatitis, excessively dry skin or recurrent conjunctivitis, scleroderma, vitiligo, or any other active autoimmune dermatological disorder.
6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
7. Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1 or anti-PD-L2 (Phase II randomized combination part only).
Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab

Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. Clinical trials and real life experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment overtime.

Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation.

Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment remission rates as well as clinical and biochemical response.

Type of research and methods of data collection: A randomized controlled trial in 84 adults with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. Data will managed by investigators.


Eligibility Criteria:
Inclusion Criteria:

1. Established inflammatory bowel disease
2. Age ≥18 years old
3. At inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging:
4. Commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks.
5. Active luminal disease:

   CD- HBI ≥325, 26 UC- partial Mayo ≥227
6. Evident active disease on endoscopy or imaging within 2-week from inclusion or elevated inflammatory markers at screening (CRP\> 0.5 mg/dl, or fecal calprotectin\>100 μgr/gr stool or ESR \>40).

Exclusion Criteria:

1. CD- isolated small bowel disease (L1) UC- proctitis (E1)
2. Perianal disease
3. Pregnancy
4. Biliary obstruction
5. Concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy).
6. Curcumin supplementations within the last 6 months.
Microbiologic Findings of Acute Facial Palsy in Children

Objective: Microbiologic etiologies of facial palsy in children were investigated.

Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia burgdorferi, influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory syncytial-, coxsackie B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma gondii. Besides the routine tests in clinical practice, serum and cerebrospinal fluid samples were tested with a highly sensitive microarray assay for DNA of herpes simplex virus-1 and -2, human herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and varicella-zoster viruses.


Eligibility Criteria:
Inclusion Criteria:

* Age 0-16
* Facial palsy
Effects of Anthocyans on Cardiovascular and Sympathetic Function

Anthocyans modify cardiovascular and sympathetic function


Eligibility Criteria:
Inclusion Criteria:

* Ages 35 to 50 years old
* Males
* Hypertension
Bioavailability of Fatty Acids From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.

The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male
* Age 18 - 65 years
* Body mass index 18.5 - 30
* Informed consent, signed

Exclusion Criteria:

* Medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs)
* Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
* Any untreated medical condition affecting absorption of fat
* Type 1 and 2 diabetes
* Cancer or other malignant disease within past five years
* Periodical hormone replacement therapy
* High intake of oily fish (once a week or more) (i.e. salmon, herring, sardines, mackerel, vendace)
* Smoking
* Alcohol consumption \> 15 doses per week
* Females who are pregnant, breast-feeding or intend to become pregnant
* Hypersensitivity to any of the components of the test product
* Regular use of n-3 supplements 4 weeks before randomization
* Lack of suitability for participation in the trial, for any medical reason, as judged by the principal investigator
Transfer of Strictly Anaerobe Microbes From Mother to Child

This study aims to investigate the changes in the microbiota at different body sites in late pregnancy, in comparison with non-pregnant women, with particular emphasis on archaea, and to identify possible maternal-to-child transfer routes for acquisition of strictly anaerobic microorganisms by analyzing the gut microbiota of new born infants (delivered vaginally or by C-section).

The investigators hypothesize that changes occur in the microbial community during pregnancy in different body sites (vagina, oral etc.) and that the main source of these microorganisms is the mother for vaginally born infants, while C-section born infants acquire most of the anaerobic microbial communities from other sources rather than mother's vaginal and gut microbiota, such as the environment.

Specific Research Objectives will be:

1. To investigate diversity of archaea in the vagina of healthy women in the context with community state types (CSTs), and compare vaginal microbiome in pregnant with non-pregnant healthy women.
2. To identify the presence of archaea in different body sites (oral, gut) or body fluids (amniotic fluid, urine, human milk) within the perinatal microbial communities.
3. To investigate the presence of archaea in the infant's first-days-of-life intestinal community, and to identify the sources of these microorganisms by using source tracking approach.
4. To investigate Human Milk Oligosaccharides (HMOs) in maternal (serum, saliva, urine, breast milk) or intrauterine sources (amniotic fluid) as potential modifiers of the microbial communities in these sites.
5. To analyze associations of maternal/ intrauterine HMOs with infant HMOs and microbiota (meconium and infant stool) in order to investigate vertical transmission of microbiota to the infant.

Eligibility Criteria:
Inclusion Criteria:

* healthy women
* pregnant women: delivery at term (gestational age 37-42); contractions or rupture of membrane no longer than 12h before admission to hospital

Exclusion Criteria:

* bacterial/ fungal infections
* use of antibiotics/ probiotics in past 3 months
* fetal anomalies
* multiple pregnancies
* diabetes type 1, 2, gestational diabetes
* hypertension, preeclampsia/HELLP
* HIV ( human immunodeficiency virus), HCV (Hepatitis C)
* drug abuse, smoking
Development of a Fall Prevention and Fall Detection System for Ambulatory Rehabilitation of Parkinson's Patients

The investigators plan to conduct a first-stage experiment by recruiting ten subjects, including five PD patients and five non-PD patients. In the beginning, the information collected by the portable motion detector is used to compare the difference in the activities performed by PD and non-PD patients. Besides, the algorithm will be developed to identify the gait patterns of PD patients. Once the system detects the abnormal gaits, such as shuffling and festinating steps or freezing of gait, auditory cues will be given to the PD patients and caregivers by their sides. It can help the patient to maintain normal gait and improve the effectiveness of rehabilitation, as well as preventing falls in daily activities. Moreover, in case of accident falls, the real-time fall detection mechanism alerts the nearest caregiver for instant support and delivers this information to the remote family members and medical personnel.

After that, a second-stage experiment will be carried out by recruiting another five PD patients. By comparing the gait patterns identified by the system against those identified manually by the staff, the performance of the proposed system on fall prevention will be examined. For the patients and their family members, the developed system enhances the patients' safety in their daily activities. As for the medical personnel, it serves as an affordable tool that benefits the rehabilitation of PD patients in an easy manner.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease

Exclusion Criteria:

* Cardiac disease
* Mobility disability
Anterior Corneal Striae in Hypotony

The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>= 18 years of age
* History of glaucoma
* History of glaucoma surgery
* Intraocular pressure of equal to or less than 10 mm Hg by goldmann applanation

Exclusion Criteria:

* Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis
Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture

Patients operated for hip fractures are older and have several conditions that have negative influences on the perioperative and postoperative prognosis.

Hip fractures can also be painful, which is stressful for the physiology of the patient. Many old patients have received to little fluid intake. They often have diuretic therapy, which even worsens dehydration/hypovolemia.

Some patients have to wait several days for surgery. Several studies have shown a high degree of complications and an increased mortality in this patient group.

Early preoperative optimization can improve the outcome. The available methods for optimization of the patient are complicated and time consuming.

The investigators wish with this study to try new approaches to find which patients still are dehydrated when they come to the operation ward.

The aim is to measure the color and density of the urine as well as to register the the variability in the plethysmographic curve before spinal anaesthesia.

These results will be compared to circulatory instability during and after surgery as well as to postoperative complications.

All patients with hip fractures planed fore surgery at the Hospital in Norrkoping will come into consideration to participate in study.

Many will however not be able to give consent. These will not be included in the study.

Directly preoperatively urine will be collected. Color and density will be measured/registered.

The pulseoximeter reading will be registered (Saturation, pulse, PI and PVI) before spinal anaesthesia and after spinal anaesthesia as well as during the surgery.

Two to three days postoperatively a follow up will be performed, to register complications (Circulatory instability, confusion, infection, affected kidney function/creatinine rise).

30 day postoperative mortality will also be controlled.

These results will be compared, to see if pulse oximeter readings or urine concentration can predict complications.

Eligibility Criteria:
Inclusion Criteria:

* patients with hip fracture
* operation for the hip fracture
* informed consent

Exclusion Criteria:

* patients not giving consent
* patients not being able to understand information
Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

Biliary atresia patients with cholestatic jaundice were noted to have increased incidence of infectious complications. Previous animal models of bile duct ligation with acute jaundice ever demonstrated impairment of both humoral and cellular immune function. We performed the immunity study in biliary atresia patients due to the lack of comprehensive systemic immunity study in pediatric cholestatic model. Systemic humoral immunity (total serum IgG, IgA, IgM, C3 and C4), specific cellular immunity (lymphocyte classification, mitogen response, cytokines level after PHA stimulation test), and non-specific cellular immunity (absolute neutrophil count, PMN CD11b/CD18 expression level, PMN superoxide release function, and PMN phagocytosis function) were tested. Association with serum bilirubin level, nutritional status and blood biochemical values were tested to see the relation between systemic immune function and cholestatic jaundice.

Eligibility Criteria:
Inclusion Criteria:

Biliary patients older than 1-year-old status post Kasai operation.

Exclusion Criteria:

Received liver transplantation, immunosuppresant, systemic immunoglobulin (within 6 months) and obvious infectious episode (within 2 weeks).
The Effect of Maternal Scent on Sleep Wake States

This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to either 24 hours of exposure to maternal scent or standard of care. Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured using several electroencephalogram (EEG) parameters. Heart rate variability will be collected as part of vital sign collection.

Sleep is important for the growth and development of infants. There are different states that make up sleep wake cycles including quiet sleep, active sleep, and transitional sleep. The amount of time that infants spend in quiet sleep increases as they mature. There are different tools that can be used to measure sleep state including EEG, behavior, and vital signs. Recent research has looked at ways to improve sleep in infants admitted to the NICU including music and maternal voice. The investigators are interested in studying maternal scent. Maternal scent has been shown to improve infant feeding and to reduce infant crying during painful procedures. Therefore, the investigators are interested in studying how maternal scent might affect sleep wake state in infants admitted to the NICU. The investigators will observe infant behavior and use EEG and vital signs to assess sleep state in infant after they are exposed to maternal scent.

Eligibility Criteria:
Inclusion criteria:

* Infants born at 30 weeks gestation to 36 weeks gestation.

Exclusion criteria:

* Infants with congenital anomalies, neonatal abstinence syndrome, or head ultrasound findings of grade II intraventricular hemorrhage or greater.
* Infants participating in studies with similar interventions.
The Chimerix CMX001 Registry

The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.


Eligibility Criteria:
Inclusion Criteria:

* Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001.
* Willing and able to understand and provide written informed consent to participate in this observational study
* Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 10 years following the completion of study CMX001-301 or other qualifying clinical study.

Exclusion Criteria:

* None
Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis

This study is designed to evaluate the effectiveness and safety of tacrolimus combined with low-dose prednisone in the management of myasthenia gravis patients, compared to tacrolimus as initial immune monotherapy.

This is a single center, observational real-world study recruiting myasthenia gravis patients from Neurology Departments of Xuanwu Hospital, aiming to compare effectiveness and safety of 2 different inmunotherapy for MG. The study plans to recruit 160 MG participants and divides into 2 treatment groups according to physician's judgment and preferences of patients, one is combined immunotherapy group in which tacrolimus added with low-dose prednisone (0.25mg/kg/d), and the other is tacrolimus monotherapy group. Both groups can be treated with pyridostigmine to relieve symptoms. Patients are followed up at 1, 3 and 6 month after treatment initiation to assess the efficacy of both regimen. The primary outcome is the change of MG-ADL scores. Also, liver and renal functions are tested to monitor any side effects. Patients' clinical records are uploaded to an online database.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Clinical Diagnosis of MG is confirmed based on typical clinical features of fluctuating muscle weakness, with at least 1 of the following supporting evidence:

  1. positive clinical response to acetylcholinesterase inhibitor
  2. positive AchR-Ab or MuSK-Ab testing
  3. decrement \>10% in repetitive nerve stimulations study (RNS) or increased jitter on single-fibre electromyography (SFEMG)
* MGFA clinical classification: I - IV
* Baseline MG-ADL ≥ 3
* Disease course from onset to enrollment ≤ 12 months
* Cooperation to followup
* Written informed consent

Exclusion Criteria:

* Initiation of immunosuppressant for MG prior to screening, including Prednisone, Methylprednisolone, Azathioprine, Methotrexate, Cyclosporine A, Mycophenolate Mofetil, Tacrolimus and Cyclophosphamide
* Treatment of immunosuppressant for other concomitant disease 6 months prior to recruitment
* Rapid immunosuppressive treatments like Intravenous immunoglobulin or plasma exchange 1 month prior to recruitment
* Thymectomy within 3 months prior to Screening
* Concomitant chronic degenerative, psychiatric, or neurologic disorder that can cause weakness or fatigue
* Consciousness, dementia or schizophrenia
* Pregnancy or lactation, unwillingness to avoid pregnancy
* Uncontrolled hypertension or diabetes, Liver or kidney dysfunction, Cataract, Severe osteoporosis, Femoral head necrosis; Hyperkalemia, HIV, Acute or chronic infection
* Other conditions that would preclude participation