cyrilzakka/clinical-trials huggingface dataset:
A Study of Effectiveness and Safety of the First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy for Advanced/Recurrent Non-Small Cell Lung Cancer in Japan

The purpose of this observational study is to assess the effectiveness and safety of Nivolumab plus Ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent NSCLC in the real world setting in Japan.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed advanced or recurrent NSCLC
* Participants who have received or scheduled to administrate nivolumab plus ipilimumab with or without chemotherapy as first-line treatment from the date of approval of nivolumab plus ipilimumab with or without chemotherapy to November 30, 2021.

  1. Pemetrexed plus cisplatin or carboplatin for participants with non- squamous histology and paclitaxel plus carboplatin for participants with squamous histology are only acceptable combinations of chemotherapy.

Exclusion Criteria:

* In participants with non-squamous histology, participants who are confirmed to be positive for EGFR gene mutation or ALK fusion gene for which EGFR tyrosine kinase inhibitor or ALK tyrosine kinase inhibitor is indicated.
* Participants who had antineoplastic treatment as first-line treatment of advanced or recurrent NSCLC prior to initiation of nivolumab plus ipilimumab with or without chemotherapy.

However, participants who correspond to a) or b) below will be included in this study.

1. Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
2. Participants who are received or have received bisphosphonates or denosumab for bone metastasis

   * Participants who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards.
   * Participants who received investigational anti-tumor drug in clinical trial after being diagnosed with NSCLC
   * Other participants who are judged by the investigators to be inappropriate for enrollment in this study

Other protocol-defined inclusion/exclusion criteria apply
Effectiveness Of Symbiotic Therapy In Jaundiced Patients

The aim of the present study was therefore to evaluate if the perioperative administration of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for hepato-biliary and pancreatic surgery.

Despite advances in preoperative patient's selection and anesthetic and surgical techniques, surgery in jaundiced patients is associated with significant morbidity and mortality as a consequence of septic complications. The evidence that nosocomial infections are frequently a consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of the "gut derived sepsis". Indeed, several studies have reported that jaundiced patients present an increased intestinal permeability and consequently a higher rate of bacterial migration from gastrointestinal tract across the lamina propria to local mesenteric lymph nodes and from there to extra-intestinal site. This phenomenon increases after surgical decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced patients is related to different mechanisms such as mucosal atrophy secondary to protracted absence of intraluminal bile that open para-cellular route for bacterial translocation and the decreased clearance capacity of Kuppfer secondary to cholestasis.

The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can improve the mucosal barrier function reducing the bacterial translocation of organism to mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating mucosal immune and non-immune mechanisms through antagonism/competition with potential pathogens.

Eligibility Criteria:
Inclusion Criteria:

* jaundiced patients scheduled for elective extrahepatic bile duct resections
* age between 18 and 80 year-old Exclusion Criteria:

Exclusion Criteria

* cirrhosis
* American Society of Anesthesiologists (ASA) score 4
* intestinal malabsorption
* emergency surgery
* intolerance to symbiotic
* diagnosis of primary or secondary immunodeficiency
* unresectability
Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression

Depressed subjects display a cognitive bias of information processing and emotional self-regulation, which reinforces negative experiences more than positive ones, known as the negativity bias. The link between depressive disorder and negativity bias has been much studied in terms of genetic, neurobiology, structural and functional neuroanatomy and cognitive sciences. It has been admitted that depressed subjects show impairment of facial expressions and prosody recognition, and of implicit memory.

Induction of depressive or elated mood with musical excerpts listening in healthy subjects influences facial emotions perception, respectively by reducing or enhancing recognition skills. However, no study to date already explored the interest of music-induced positive mood for alleviating negativity bias in depressed elderly population.

Main objective : to assess the impact of exposure to positive valence musical excerpts, on evaluation of facial emotions intensity, in a population of elderly patients hospitalized for depression, compared to neutral valence music listening.

Secondary objectives : to assess the impact of exposure to positive valence musical excerpts, on facial and vocal emotions recognition, and on implicit memory of faces, compared to neutral valence music listening.

The same methodology is also applied in a sample of control participants over 65 years to study the mood induction effect by music in elderlies.

The duration of the study, from first to last included subject, is estimated at 6 months, from January to June 2022. Each subject will participate for a period of 5 to 10 days.

Depressed group subjects will be pre-selected from all consecutive patients hospitalized or seen in consultation in geronto-psychiatric ward at Centre Hospitalier Le Vinatier, who agreed to participate in research. Patients will pass a basic cognitive task (MMSE) during the inclusion visit.

Healthy controls will be selected from relatives of patients admitted in Centre Hospitalier Le Vinatier, who agreed to participate in research.

Once included, subjects will be randomized, and will remain blind to study hypotheses until the study end.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women between the ages of 18 and 60 years old
* Major depressive episode of moderate to strong intensity, according to DSM-5 criteria, diagnosed by a Psychiatrist for subjects with depression ; GDS \< 5 for healthy subjects
* Being fluent in French

Exclusion Criteria:

* - Neurodegenerative disorder
* Cognitive impairments (MMSE\<26)
* Sensory loss not sufficiently corrected, compromising the perception of oral instructions or visual or auditory stimuli
* Impairment of awareness or attentional abilities restricting completion of cognitive tasks lasting 40 minutes.

And for Patients with depressive episode:

* Psychotic or catatonic features of current depressive episode
* Comorbid psychiatric disorder other than major unipolar depressive or anxiety disorders
* Current treatment by electroconvulsive therapy
Development Training in Babies Born Preterm

The specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. We hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior.

The long term goal of this research program is to develop detailed intervention options for physical therapy treatment of very young preterm infants at risk for disability. The ability of infants to start reaching marks the beginning of an infants' ability to independently explore objects, and impacts development across multiple domains, including cognitive, language, and social. The aim of this study is to determine if bi-daily movement training will advance the reaching abilities of infants born preterm as compared to non-movement trained controls.

Movement Training Group:

Parents/Caregivers will be instructed to improve their infants' awareness and ability to reach for toys with their arms and legs by performing two sets of 10 minutes of daily exercises with them. The first 10 minutes will focus on improving awareness of their arms and toys (such as bells on their wrists). The second 10 minutes of activity that focuses on introducing infants to a task-space they rarely experience at this age, the task-space required for midline reaching (such as moving the infant's arm to a midline toy). An experimenter will visit each family in their homes every other week (the week that is not a testing week) to assure correctness of training, encourage full participation and answer any questions.

Social Training Group:

To control for increased social interaction that accompanies the enhanced training, parents of infants in this group will serve as a control group. Parent/Caregivers will be asked to perform 2x a day of 10 minutes face-to-face social interaction with their infants. Parents and infants will receive a 10 minute audio tape of popular kids' songs. They will be instructed to place infants supine or in a bouncy seat and interact with the infant visually and verbally during this time period along with the music.

After the study is completed, each group will be offered the training booklet that the opposite group received.

Eligibility Criteria:
Inclusion Criteria:

* Infants born less than 33 weeks gestation (up to and including 32 6/7 weeks)
* Infants born weighing less than 2500 grams

Exclusion Criteria:

* Orthopedic, visual or hearing impairments
* Fetal drug exposure
Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.

The purpose of this study is to evaluate a methodology for detecting early forming cavities in children that is more accurate and reliable than the gold standard used by dentists around the world. The new method uses an electrical current device to detect early enamel mineral loss before it can develop into a cavity. The manual gold standard is for a dentist to probe the surfaces of the teeth with a fine pick, searching for areas of defect.


Eligibility Criteria:
Inclusion Criteria:

Children whose parents authorize participation by signing a consent form. Children who attend public school only. Children in good health. Children between 6 and 9 years of age. Children with all first permanent molars erupted. All permanent first molars must not have any signs of cavitation but only one molar can have some mineral loss(e.g. white spots).

Children must show some caries in the primary molars as a sign of caries susceptibility.

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Exclusion Criteria:

Children of parents or a guardian who do not agree to participate in the study. Children registered in private schools. Children not in good health. Children undergoing antimicrobial or antibiotic treatment. Children outside the range of age selected for the study. Children with one or more first permanent molars unerupted. Children with any cavitation in the occlusal surface of any first permanent molar.

Children who do not have a sign of dental caries in the primary molars as a sign of caries susceptibility.

Children who do not allow themselves to be examined.

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A Comparison of Two Behavioral Sleep Interventions Among College Students (ProjectTECH)

The study was a randomized controlled trial designed to examine whether augmenting traditional sleep hygiene and stimulus control procedures with technology use reduction stimulus control procedures would produce better sleep and technology usage outcomes.

Sixty college students were randomized to a 4-week sleep hygiene and stimulus control intervention (ACI) or an enhanced intervention including technology stimulus control instructions (TI).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old, enrolled at Oakland University, and reside in an on-campus dormitory to participate.

Exclusion Criteria:

* None
Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults

The aim of the current study is to investigate and compare the effectiveness of probiotic supplementation and tDCS stimulation on risky decision-making related to food choices in overweight people. Considering the relatively established communication and interaction between the gut-brain-microbiome axis, the investigators expect that transcranial direct current stimulation and probiotic supplementation can both improve decision-making (decrease risky and impulsive decisions) and increase self-control in overweight people.


Eligibility Criteria:
Inclusion Criteria:

* BMI over 25
* Higher than normal fat level

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Smoking more than 10 cigarettes a day
* Excessive consumption of alcohol
* Suffering from chronic cardiovascular and kidney diseases
* Chronic digestive diseases such as celiac disease,
* Chronic inflammatory bowel diseases such as colitis, intestinal surgery, cancer, etc.
* Suffering from acute and chronic diarrhea in the last one month
* Taking antibiotics in two months before the start of the study,
* Continuous use of prebiotic and probiotic products and drugs in one month before the start of the intervention
* Frequent use of antibiotics during the last month before the start of the intervention
* Taking weight loss medications and following a special slimming diet in the last 3 months before the intervention.
* History of epilepsy and seizures, stroke,
* Use of pacemaker
* Presence of metal implanted in the scalp or brain,
* Presence of skin lesions at the tDCS stimulation site, and history of head injury or brain surgery.
* Brain disorders and long-term and chronic use of neuropsychiatric drugs.
Piloting Visual Chat in Internet Obesity Treatment

CHAT is an internet-based weight loss research program designed for women with overweight or obesity who want to lose weight through dietary change and increased physical activity. Participants will be randomized into a group-based online program who meet via a text chat or a video chat.

The overall goal of this project is to determine whether weight losses can be improved if visual chat and electronic smart scales are added to an established 6-month online weight loss program. The primary aim is to assess weight change differences between subjects randomized to receive an Internet program alone (with text chat; INTERNET) vs. an Internet program with visual chat and electronic scales (VIDEO INTERNET). A secondary aim is to evaluate differences in social support experienced by subjects in both conditions. Overweight and obese adults (n=40) at two study sites (UVM and the University of South Carolina) will be randomly assigned to Internet (n=20) or Video Internet (n=20). All participants will receive the same 24 week web-based group weight control program which features synchronous facilitated chats and online behavioral tools. The only difference will be the delivery of the chat (text vs. visual) and the electronic smart scales given to the VIDEO INTERNET group. Assessments will be conducted at 0, 2 and 6 months and will include measures of body weight, treatment engagement (e.g., attendance, self-monitoring, website utilization), social support and treatment satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* BMI between 25 and 55
* Free of medical problems that would preclude participation in a behavioral weight reduction program containing an exercise component
* Not currently pregnant or pregnant in the previous 6 months or breastfeeding
* Must have a computer at home or work with access to the Internet
* Only one member of a household is eligible to participate
* Must successfully complete a self-monitoring diary of foods consumed for 3 days
* must be willing to share access to self monitoring information collected via My Fitness Pal by friending the CHAT research team
* Not currently on medication that might affect weight loss
* Not enrolled in another weight loss program

Exclusion Criteria:

* BMI less than 25 or more than 55
* Lost 10 pounds or more in the last 6 months
* Had a heart attack or stroke in the past 6 months
* Ever had weight loss surgery
* Currently taking medications for weight loss
* Persons required by their doctor to follow a special diet (other than low fat)
* Plans to move from the area in the upcoming 9 months
* Schedules that make it likely someone would have difficulty attending the scheduled chat groups
Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Patients of DM according to ADA guidelines
3. HbA1c \>8% and/or FBG \>130 on 3 consecutive occasions
4. DFU: Wagner grade 2 \& 3 or UTS 2-3B
5. Duration of ulcer \<12 weeks
6. Wound size: \>1cm2
7. Willingness to sign consent form \& participate in the study
8. Capacity to attend visits at hospital for review

Exclusion Criteria:

1. Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
2. Dialysis requiring CKD \& eGFR \<30 ml/min
3. Active Charcot foot
4. PEDIS 4: life threatening DFU
5. Pregnancy
6. ABI \<= 0.7
7. Refusal to give informed consent
MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

The study will evaluate the effectiveness of a culturally relevant, multi-component intervention for antenatal depression. The intervention includes an engagement session, and the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped care treatment for depression model.

The randomized control trial will evaluate the effects of a culturally relevant, multi-component intervention for antenatal depression. MOMCare has the potential to overcome patient, provider, and system-level barriers to care and engage depressed, low-income women in evidence-based treatments to reduce antenatal depressive symptoms, improve maternal psychosocial functioning, and ameliorate postpartum depression. Specific Aim 1: To evaluate the impact of MOMCare on treatment engagement and retention. Specific Aim 2: To evaluate the impact of MOMCare on maternal clinical symptoms and functional outcomes. Specific Aim 3: To conduct an incremental cost-effectiveness analysis for a health care and welfare agency perspective that includes a) tracking the medical costs of health service use in MOMCare and usual care patients; b) monitoring the use of infant preventative health services in both groups; and c) tracking the percentage of women on Medicaid and the percentage working in both groups.

The intervention will be assessed through a practical randomized controlled trial in which we have recruited 168 pregnant women with major depression and/or dysthymia who were on Medicaid and/or received Maternal Support Services (MSS) in selected public health centers in Seattle - King County (PHSKC). Patients who were eligible and consented to study enrollment were randomly assigned to either usual care (UC) or MOMCare. Baseline and four follow-up assessments (3 - 18 months post-baseline) are scheduled for study participants in both groups. The MOMCare intervention includes a choice of brief interpersonal psychotherapy or collaborative management of antidepressant medication. Treatment response will be monitored, and the treatment will be adjusted as necessary (adding treatments, increasing dosages).

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* pregnant: 12-32 weeks gestation
* able to speak English
* telephone access
* major depressive disorder or dysthymia
* on Medicaid
* receiving health care in King County, Washington

Exclusion Criteria:

* currently in psychotherapy
* currently receiving pharmacotherapy from a psychiatrist
* high suicide risk
* history of bipolar disorder
* history of schizophrenia
* substance use or dependence in previous 3 months
* currently in a relationship with severe interpersonal violence
* history of repetitive self-harm behavior
A Phase I Safety, PK and PD Study of KW-2478 in Patients With Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma

The aim of this study is to determine the safety, tolerability and dose-limiting toxicities of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for patients with relapsed/refractory MM, CLL or B-cell NHL.

This is a Phase I, open-label, dose-escalation study of KW-2478 in patients with relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or B-cell Non-Hodgkin's lymphoma who have no established therapeutic alternatives. Up to 42 patients will be enrolled at up to six investigational sites over a period of approximately 12 months until an MTD is reached. An additional 12 patients may be enrolled at the MTD in an expanded cohort of one or more of the eligible conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of Multiple Myeloma, Chronic Lymphocytic Leukaemia, or B-cell Non-Hodgkin's Lymphoma, who have had at least two prior standard treatment regimens and are without established therapeutic alternatives.
2. Signed IEC-approved informed consent
3. ECOG performance status of 0, 1 or 2;
4. Life expectancy of at least 3 months;
5. Adequate haematologic status, liver function and renal function
6. Patients of reproductive potential must agree to follow accepted birth control methods during the study

Exclusion Criteria:

1. No anti-cancer treatment for ≥ 3 weeks prior to receiving study drug
2. Any other severe, acute or chronic illness
3. No other prior or concurrent malignancy
4. Immunosuppressant therapy