cyrilzakka/clinical-trials huggingface dataset:
Long-Term Study of IGIV, 10% in Alzheimer´s Disease

The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.


Eligibility Criteria:
Main Inclusion Criteria:

* Completed 18 months of study treatment and assessments in Baxter precursor study 160701
* Diagnosis of probable Alzheimer´s Disease (AD)
* Able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability)
* Has a caregiver (study partner) who is willing and able to participate

Main Exclusion Criteria:

* Significant neurological disease other than AD
* Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack)
* Contraindication to undergoing MRI (e.g. pacemaker \[with the exception of an MRI-compatible pacemaker\], severe claustrophobia, ferromagnetic implants such as a metal plate)
* Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae)
* Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment
* Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)
* Poorly controlled diabetes
* Serious problems with liver or kidneys
* Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin)
* Current or recent treatment with immunomodulatory therapies (with the exception of immunoglobulin and non-systemic and low-dose systemic corticosteroids)
* Recent use of investigational drugs or biologics, including those aimed at altering AD progression (with the exception of immunoglobulin)
* Active immunization for the treatment of AD at any time

There are reasons why it might not be appropriate to participate in this trial. Please contact Medical Information at medinfo@baxter.com for details.
Gut and Oral Microbiome of GDM Patients During Pregnancy

The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM.

The aims of the study are to reveal the possibly natural change of the gut and oral microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational weeks）and following the pregnancies till delivery. The stool samples and saliva samples of the recruits will be collected in 9\~14,24\~28 and 32\~37 gestational weeks separately. The investigators will also perform oral examination between 24\~28 weeks and sample subgingival plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to analyze microbiome. And part of the samples of GDM patients will be analyzed using metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome between GDM patients and healthy women will be expected, as well as the natural change during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* gestational age: before 13+6 weeks
* regular prenatal care in PUMCH

Exclusion Criteria:

* have medical history or current conditions： Gastrointestinal disorders, for example: Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD;
* pregnant, combine with malignancy diseases;
* pregnant, can't ensure regular prenatal check.
Effect of Incretin-related Drugs on Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus

It is well known that incretin, particular GLP-１enhances satiety and reduces energy intake in controlling appetite and dietary in humans (Flint A, et al. Gutzwiller JP et al.). Recently, incretin-based therapy has been attracted a lot of interest (Hare KJ, Knop FK). However, it is not clear how the incretin-based therapy affects energy and content of dietary intake in patients with type 2 diabetes mellitus (T2DM). Previously, the investigators reported the amount of energy and content of dietary intake in type 2 diabetic Japanese patients with more than 10 years of long time duration after discovery using questionnaire (Inoue K et al.) and the patients were impaired a secretion of active GLP-1 (Kamoi et al).

The investigators examine whether the incretin-based therapy effects on the energy and content of dietary intake in the same patients before and one year after administration of incretin-related drugs using the same method previously (Inoue K et al.).


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with T2DM without incretin-based therapy, who participated to examine the energy and content of intake using questionnaire reported previously.

Exclusion Criteria:

* Patients with a serious complication in the heart, liver or kidney

  * Pregnant or possibly pregnant patients or lactating patients
  * Patients complicated with a malignant tumor at present.
  * Patients participating in other clinical study.
  * Other than the above, patients judged inappropriate as the subjects of this study by the investigator
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

This is a first-in-human study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasian subjects aged 18-45 years inclusive
* Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
* Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.
Relationship Between Cervical Proprioception and Endurance With Hand-eye Coordination and Postural Control

The aim of our study is to investigate the relationship between cervical proprioception and cervical muscle endurance with hand-eye coordination and postural control in individuals with forward head posture (FHP) and to compare them with a control group with normal head posture. After the demographic information and physical characteristics of the individuals are recorded, their craniovertebral angles (CVA) will be measured and they will be assigned to Group 1 (forward head posture) or Group 2 (normal head posture). Then, the individuals' cervical proprioception, hand-eye coordination, postural control and cervical muscle endurance values will be measured respectively. Cervical muscle endurance will be evaluated last, taking into account possible muscle fatigue, in order not to affect other measurement results. The recorded values will be compared between groups and the relationship of cervical proprioception and muscle endurance with hand-eye coordination and postural control will be examined. All evaluations will be made by the same researcher.

Forward head posture is a malalignment defined as anterior translation of the head. This malalignment causes changes in cervical proprioception, decrease in the strength and endurance of the cervical muscles. A decrease in muscle endurance may cause a decrease in cervical proprioception. The cervical region is very important in terms of proprioceptive sensory input and has reflex connections to the (Central Nervous System) CNS. Therefore, abnormal proprioceptive sensory inputs received from cervical mechanoreceptors affect the CNS, which regulates postural control. It has been stated that FHP is associated with a decrease in static and dynamic balance. Head posture has an important role in the sensory information organization of the upper extremity. Hand-eye coordination allows the eyes to coordinate with hand movements.

Identifying the factors that may affect an individual with FHP is very important in planning the rehabilitation program.

The purpose of this study, investigate the relationship between cervical proprioception and cervical muscle endurance with hand-eye coordination and postural control in individuals with FHP and to compare them with a control group with normal head posture.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-24 years
* Volunteering to participate in the study

Exclusion Criteria:

* History of trauma or surgery involving the cervical or upper extremity
* Congenital anomaly of the cervical, thoracic or lumbar vertebra
* Abnormalities such as scoliosis
* Systemic arthritis or central nervous system disorders
Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women. On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by midwifes on days 0, 7, 14 and 28.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mastitis
* Staphylococcal and/or streptococcal count higher than 3000 colony-forming units per ml of milk
* Milk leukocyte count higher 6 log10/mL
* Must be able to provide a milk sample without the aid of a milk pump

Exclusion Criteria:

* Mammary abscesses
* Any kind of parallel disease
Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation

The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).

All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 and ≤ 70
* Signed informed consent
* Adequate vital organ function
* No active infection, or asymptomatic infection well controlled by antibiotic HIV negative by ELISA or RT-PCR \[if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive\]
* Hepatitis B and C negative by serology or RT-PCR
* Performance status: Karnofsky Performance Status Score ≥ 60%.

Exclusion Criteria:

* Those with any Sorror's co-morbidity factors with score \> 3
* 2 or more Sorror's factors with composite score of ≥ 3
The Cricoid Force Necessary to Occlude the Esophageal Entrance: Is There a Gender Difference?

the investigators have observed that women may require less CF than men to occlude the esophageal entrance, and that the routine use of 30 N in women may actually increase the incidence of airway-related problems. The objective of the current investigation was to test this hypothesis. In this study, real-time visual and dynamic means were used to assess the effectiveness of different forces applied to the cricoid cartilage in occluding the esophageal entrance in men and women. The patency of the esophageal entrance was directly visualized using the Glidescope Video Laryngoscope in anesthetized and paralyzed patients with and without CP. Evidence of closure of the esophageal lumen was confirmed by the inability to introduce a gastric tube (GT) into the esophagus under direct vision. New method , using Cricometer , was used to measure the applied force .

60 (30 men; ages 18 - 50 yr; body mass index \< 28 kg/m2 physical status 1, 2 patients were recruited for the study. These patients were to undergo general anesthesia with tracheal intubation. starting force was 20 N in both sex. These forces were standardized by reproducing a new device : cricometer. The sequence of the applied forces was done by using the up and down method in both sex. After preoxygenation, anesthetic induction, muscular relaxation and mask ventilation, the study commenced. Direct laryngoscopy using the Glidescope video laryngoscope was performed and the view of the glottis and the esophageal entrance was video recorded with each CF. 2 attempts to insert a lubricated gastric tube (GT; size 20 F, 12 F) were carried out by a "blinded" operator in each patient. A successful insertion of the GT indicated a patent esophagus. When this occurred while CP was applied, it indicated ineffective CP. An unsuccessful insertion of the GT while CP was applied indicated a non-patent esophagus (effective CP). The position of the esophageal entrance relative to the glottis during CP was assessed from the video recordings.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 2
* Easy Identification cricoid cartilage
* No contre indication to CP

Exclusion Criteria:

* obese patients
* ASA2 \& ASA3
* contre indication to CP
The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects

The purpose of this study is to investigate the possibility of an association between changes in neurocognitive function, as measured by a computerised test battery, and the use of two different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1 infected subjects commencing antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected males or females
* Signed informed consent
* No previous antiretroviral treatment
* Males with CD4+ lymphocyte count \< 400 cells/ųL and females with CD4+ lymphocyte count \< 250 cells/ųL
* Susceptible to all currently licensed nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)

Exclusion Criteria:

* Existing neurological disease
* Hepatitis B or hepatitis C co-infection
* Current history of major depression or psychosis
* Recent head injury
* Current alcohol abuse or drug dependence
* Active opportunistic infection or significant co-morbidities
Feasibility of Telerehabilitation in HIV-patients

The aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART).

HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* under HAART treatment
* native French speaker

Exclusion Criteria:

* AIDS diagnosis
* physical and/or psychiatric impairments that seriously impaired physical activity
* pregnant
* Unstable (defined by any modification of health outcomes during the last 6 months).
Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects

The purpose of the study was to investigate how Brazilian fruits peel affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Signed informed consent
* BMI 20 - 28 kg/m2 with weight change \<3 kg latest 2 months
* Must be able to accept plant-based foods/drinks

Exclusion Criteria:

* Below 18 years
* Uncomfortable speaking English and/or difficulties in understanding spoken English
* Smoking or using snuff
* Vegetarian or vegan
* Stressed by venous blood sampling or previous experience of being difficult to cannulate
* Receiving any drug treatment that may influence the study outcomes
* Pregnancy or breastfeeding
Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000 hospitalizations every year. Functional consequences of an acquired brain injury have a considerable impact on quality of lives of patients and care-givers with direct effects on balance, mobility and on psycho-social functions. Attention deficits are one of the most frequent and disabling consequences of severe brain injury. Within the wide spectrum of attentive problems, patients with traumatic brain injury frequently have shown difficulties in divided attention. Patients, care-givers and professionals frequently refer difficulties also in selective attention and vigilance as consequence of the trauma. It has been shown how these difficulties are tightly related with the missed return to work after two years from the injury.

The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of falling, attentive functions (selective and divided attention) in subjects which have had a traumatic brain injury at least 12 months before.

Inclusion Criteria:

Chronic traumatic brain injury (\>12 months) Age\>18, \<70 years old Presence of a moderate balance deficit identified by CB\&M with a score \< 65 or presence of a selective attention and shifting attention deficit identified by the TEA computerized battery (Tau\<37).

Eligibility Criteria:
Inclusion Criteria:

* Chronic traumatic brain injury (\>12 months)
* Age\>18, \<70 years old
* Presence of a moderate balance deficit identified by UBS with a score\>15 and \< 60 or presence of a selective attention and shifting attention deficit identified by the TEA computerized battery (Tau\<37).

Exclusion Criteria:

* Neurologic diseases associated with possible involvement of motor functions
* Medical conditions that could interfere with the safe conclusion of the study protocol
* Severe cognitive-behavioural diseases (LCF\<6),
* severe psychiatric diseases
* Use of walking aids
Efficacy of Soluble Dexamethasone in Refractory Sciatica

This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica

Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm

Eligibility Criteria:
Inclusion Criteria:

* Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral
* Duration of evolution greater than 3 weeks despite analgesic / AINS treatment, and less than 3 months
* EVA sciatica pain \> 4/10
* Oswestry 30 at inclusion
* Patient aged 18 years and older
* Patient affiliated to a social security scheme
* Patient able to understand the protocol and having signed an informed consent
* Patient with an indication for corticosteroid infiltration in the context of their pathology

Criteria for non-inclusion

* Signs or risks of infection, in particular signs of virosis
* Poor local skin condition
* Anticoagulation with VKA or anti-Xa, or haemorrhagic disease
* Neurological deficit \< 3/5 or signs of cauda equina irritation
* Tarlov's cyst or low dural sac below week 4
* Hypersensitivity to Lidocaine, Dexamethasone, or any of its excipients
* Infiltration of the spine within the previous 3 months
* Patient with bilateral sciatica
* Patient with sciatica of osteoarthritic origin
* Patients with chronic respiratory insufficiency
* Pregnant or breastfeeding women or women refusing effective contraception until M3
* Patient deprived of liberty or under legal protection (guardianship or curatorship)
* Patient under court protection
* Patients participating in another clinical research protocol involving a drug or medical device
* Patients unable to follow the protocol, as judged by the investigator
* Patient refusing to participate in the study
* Patient with clinically narrowed lumbar canal
* Patient with polyneuropathy or myelopathy
* Patient with sequelae of neuropathic pain