cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma
* Primary or metastatic tumor site accessible for biopsy
* Ability to swallow capsules
* Subjects with histologically confirmed, advanced stage IIIB or stage IV non-small cell lung cancer (NSCLC) with a primary histology of squamous carcinoma who have received prior systemic therapy for advanced NSCLC will be enrolled in Part 3

Exclusion Criteria:

* Uncontrolled brain metastasis
* Significant cardiovascular disease
* Inadequate blood counts
* Inadequate liver, kidney or lung function
* Gastrointestinal disease within last 3 months
* Infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or exposure to attenuated active immunizations
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ


Eligibility Criteria:
Inclusion Criteria:

* A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
* Lack of adequate relief with symptomatic medication during the previous grass pollen season
* Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter \>= 3mm) currently performed or not older than 60 days before screening

Exclusion Criteria:

* FEV1 \< 70% of predicted value at screening
* Bronchial asthma corresponding to GINA step 3 or more, even if controlled
* History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
* Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
* Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol

The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

The recrutement of the patient is done during the inclusion of the patient by the nurses of the ophtalmological service of clermont-ferrand and confirm by an ophtalmologist of the service.

A mesure of the OSDI is done before the injection, then at 1 day, on week by a phone call. Each of this mesures are done for the 2 other injections.

Before each of this injection, a clinical mesure is done by a lacrydiag: the atrophy of the meibomian glands, the non-invasive break-up time, interferometry, the heigh of the tear meniscum.

Eligibility Criteria:
Inclusion Criteria:

* Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
* Patient with 3 ocular intravitreal injections of anti-VEGF in one eye

Exclusion Criteria:

* pregnant or breastfeeding woman
* intravitreal injection before the study
* intravitreal injection in both eyes
* allergy of betadine
* guardianship patient
Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy:

* at meals, with CHO roughly assessed by the patient.
* during and after physical activity sessions qualified as moderate by the patient.

Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.

The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.

Eligibility Criteria:
Inclusion Criteria:

* Patient type 1 diabetic for at least one year
* Patient treated by external insulin pump for at least 6 months
* Patients with HbA1c \<9%
* Patient affiliated with Social Security.
* Patient able to perform two tests of physical activity of 30 minutes (one event in each treatment period);
* aged at least 18 years Patient;
* Patient who signed consent

Exclusion Criteria:

* All serious disease that could interfere with the study
* BMI \> 30 kg/m2
* insulin requirement \> 2 U/kg/day
* Patient benefiting from a measure of legal protection;
* Pregnant or likely to be women.
mHealth Intervention for Work-Related Stress

The objective of the trial is to pilot test the study protocol of a preventive, low-intensive mobile health (mHealth) intervention for work-related stress among nursing students. Work stress is a wide-spread problem affecting individual health as well as incurring substantial societal costs. mHealth solutions are among the most promising options for providing effective, scalable, and standardized interventions to employees.

Researchers generally agree that recovery is a key buffer against the negative consequences of stress. Recovery behaviors, such as mindfulness and physical activity, are well-known to have a positive effect on stress-related health problems. For this reason, a behavior change intervention that successfully improves recovery may be effective in combating the long-term effects of stress. In this pilot study, three groups of participants received different versions of an intervention, each version containing a distinct set of recovery strategies.

The motivation of the present study is to pilot test the intervention and a study protocol in preparation for a future randomized controlled trial (RCT). Pilot testing the intervention and study procedures at an early stage is critical to identify potential pitfalls that need to be addressed before conducting a full-scale trial. Through investigating the study and intervention in preparatory phases we can refine the study protocol and intervention design in order to maximize the chances of a successful RCT.

The research questions for this pilot study are:

1. Data collection procedure - What is the recruitment and retention rate of invited participants? Does the randomization algorithm function properly?
2. Engagement - How often do participants use the intervention? Do they find the application easy and engaging to use?
3. Acceptability - Do participants find the intervention overall satisfactory and perceive it as beneficial? Is the digital tool technically stable?
4. Measurement quality - What is the completion rate for questionnaire items? What is the within-person variability in the daily measures?

Eligibility Criteria:
Inclusion Criteria:

* Active employee or student.

Exclusion Criteria:

* No psychiatric disorder.
A Brief Family-centered Care Program for Bipolar Disorder

Family interventions have been emphasized in the treatment of BPD and have benefits for patients' symptoms and health; however, the effects of family interventions on family function and caregivers' health-related outcomes have not been well investigated. This randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at a medical center in northern Taiwan compared the effects of a brief family-centered care (BFCC) program with treatment-as-usual (TAU). The findings support both the feasibility of using the BFCC program for inpatients and its specific benefits for family function. An intensive family intervention during hospitalization has been suggested in psychiatric practice to support patients with BPD and family caregivers.

All of the family caregivers in two groups were invited to attend a routine 60-minute family discussion group about violence and suicide prevention. The TAU group without specific family interview for patient and family caregiver dyad. In the BFCC group, four 90-minute BFCC program sessions were additionally provided twice a week for each hospitalized family dyad. It was hypothesized that family caregivers in the BFCC group could primary increase their family function, and secondary improve perceived health status and reduce caregiver's burdens compared to the TAU. The results showed family caregivers in the BFCC group significant time group interaction effects in overall family function (p=0.03) and subscale-conflict (p=0.04), communication (p=0.01), and problem solving (p=0.04), but there were no significant interaction effects on the caregivers' perceived health status and caregiver's burdens.

Eligibility Criteria:
Inclusion Criteria:

* Patients were enrolled if they met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (American Psychiatric Association 1994) criteria for BP-I or BP-II disorder, were able to be interviewed, and had a Hamilton Depression Rating Scale (HDRS) score \< 17 and a Young Mania Rating Scale (YMRS) score \< 38 (Keck 2004) to prevent adverse effects caused by patients' mood instability.
* Family caregivers who were identified as: (i) significant in the patient's life, (ii) at least 18 years old, (iii) having lived with the patient for at least 6 months, (iv) able to speak and understand Chinese or Taiwanese, and (v) able to answer questionnaires written in Chinese were included.

Exclusion Criteria:

* Patients who had lived alone or lived with their family for less than 6 months, had been concurrently diagnosed with intellectual disability (DSM-5) (American Psychiatric Association 2013), had been newly diagnosed with BPD at this admission, or could not speak Chinese were excluded.
* Caregivers diagnosed with a serious mental illness or intellectual disabilities were excluded.
Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the day of consenting to the study.
* Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.
* ECOG PS ≤ 1.
* Adequate bone marrow and liver function at baseline as defined below:

  * Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl),
  * Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN.
* Recovered from prior anti-neoplasic treatment-related toxicity (grade \<2 persistent treatment-related toxicity as per CTCAE v4 are accepted).
* Willingness for follow-up visits.
* Covered by a medical insurance.
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

Exclusion Criteria:

* Patients having previously undergone

  * a major hepatic surgery (i.e. more than 3 liver segments) or
  * biliary major surgery.
* Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.
* Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.
Mechanisms of Obesity and Its Metabolic Complications in Youth

The overarching goal of this project is to determine whether the effect of gut microbiota on human metabolism might be mediated by short chain fatty acids (SCFA) and whether the SCFA might modulate lipid metabolism.

This would be the first study determining the effect of SCFA synthesis on hepatic de novo lipogenesis and to assess whether and how isocaloric dietary changes (namely low carbohydrates) might modify the composition of the gut microbiota and reduce the synthesis of SCFA during adolescence, a sensitive period for the development of obesity.

Eligibility Criteria:
Inclusion Criteria:

* Good general health,
* Taking no medication on a chronic basis
* Age 15 to 21 years,
* In puberty (girls and boys: Tanner stage III - V)
* BMI \>25th and \<85th for lean cohort; BMI \>95th for obese cohort
* Girls who begin menstruating must have a negative pregnancy test during the study.

Exclusion criteria:

* Baseline creatinine \>1.0 mg
* Food allergies
* Pregnancy
* Presence of endocrinopathies (e.g. Cushing syndrome)
* Significant chronic illness.
A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Weight \<200 lbs
* Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
* Others as dictated by protocol

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Breast feeding
* Smoking \> 10 cigarettes per day
* Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin \[Accutane\])
* Others as dictated by protocol
Response Predictors of Theta-burst Stimulation for Depression

The study consists of an open label trial designed to treat adult depression with TBS. Our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks.

Depressive disorders are among the leading causes of incapacity and disability worldwide. The burden of depression is expected to increase and is associated with negative impact on clinical conditions and physical and cognitive abilities. Given the limited efficacy of antidepressant drugs, novel treatments such as theta-burst brain stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), are being developed. However, to further advance the field towards treatment personalisation, increasing understanding of TBS antidepressant mechanisms and identifying treatment responders are important issues. Moreover, no studies have used neuroimaging in TBS trials in depression yet. Our group in Brazil is a leading brain stimulation centre, although neuroimaging expertise is lacking. We will conduct an open label trial designed to treat adult depression with TBS. Our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks. Scientifically, this proposal and its outcomes will help advance towards next-generation precision brain stimulation, by incorporating cognitive/neuroimaging readouts that inform about mechanism and individual response.

Eligibility Criteria:
Inclusion Criteria: participants aged from 18 to 65 years, with HDRS score ≥ 14, with MDD confirmed by MINI structured interview.

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Exclusion Criteria: other mental disorders (alcohol or other substance dependence, bipolar disorder, psychotic disorders or dementia), severe clinical or neurological disorders, suicidal ideation, presence of psychotic symptoms, severe depression characterized by HDRS score \> 28, manic symptoms characterized by score \> 8 in the Young Mania Rating Scale. In addition, patients with specific contraindications to magnetic stimulation or magnetic resonance imaging will be excluded, such as having any metallic implants, epilepsy or any electronic component in the head.
Real-world Study Comparing the Adherence and Effectiveness of Linagliptin vs. Acarbose

Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients


Eligibility Criteria:
Inclusion Criteria:

* Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form
* Chinese outpatients with confirmed T2DM
* Patients of ≥ 18, \< 80 years old
* Patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled
* HbA1c ≥ 7% and \< 12%
* New user\* linagliptin or acarbose as combination therapy with metformin ≥ 1500 mg/day or maximum tolerable dose \*New user defined as a T2DM patient initiating linagliptin or acarbose as an add-on therapy.

These are patients who are on metformin and whose glucose levels are not adequately controlled.

Exclusion Criteria:

* Type 2 diabetes mellitus patients who previously used any DPP-4 inhibitor/ GLP-1 receptor agonist at index date or any AGI at index date, are not eligible to participate. Also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin.
* Patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up.
* Patients who participated in a clinical trial within 2 months prior to study enrolment date.
* Patients diagnosed with Type 1 diabetes mellitus, secondary diabetes or gestational diabetes.
* Current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent.
* Patients with known significant GI disease as judged by the study physician.
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after \~4 months on treatment.

This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after \~4 months on treatment. After consent, all patients will get a tissue biopsy, and than half the patients will get fulvestrant alone (standard dosing) and the other half of the patients will get fulvestrant plus enzalutamide. At \~4 weeks, a biopsy will be done and therapy will be continued. Hormone therapy will continue for \~4 months at which point the patients will undergo surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* ER+ Her2- breast cancer
* Stage at least T2 or greater
* Planned to get local surgery
* Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression.
* At least 18 years of age
* Not on anticoagulants
* PS 0-2
* Able to swallow study drug and comply with study requirements
* ANC \>1000/uL, platelets \>75,000/uL at screening visit
* Total bilirubin \< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 times ULN or \< 5 times ULN if patient has documented liver metastases
* Creatinine \< 1.5 times ULN
* INR \< 1.5 times ULN, or if on warfarin, can safely transition off for biopsy
* Willing to donate blood for research at 4 time points
* Willing to undergo core biopsies for research at study entry and at \~4 weeks.
* Willing to donate tissue to research from the surgical specimen
* Written informed consent obtained prior to biopsies and blood samples

Exclusion Criteria:

* Current or previously treated brain or leptomeningeal metastases
* History of seizures
* Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464).
* Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.