cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard

A clinical study to determine whether an investigational medication (SEP363856) changes how long it takes for food to move through the stomach into the small intestine in patients with schizophrenia. This study is accepting both male and female subjects. It will be conducted in approximately 6 study sites in the United States. The duration of participation will be approximtely 10 weeks.

This is a randomized, open-label, single dose two-period crossover study with two treatment sequences. For each treatment sequence, subjects will receive a single-dose of SEP-363856 and prior antipsychotic (PA) standard of care (PA) in random order. Up to 3 separate cohorts of subjects will be randomized to determine the final dose of SEP-363856.

Eligibility Criteria:
Inclusion Criteria: (this list is not all inclusive)

* Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
* Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
* Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
* Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
* Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.

Exclusion Criteria: (this list is not all inclusive)

* Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).

  * Subject has attempted suicide within 12 months prior to Screening.
  * Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
  * Subject is at risk of harming him/herself or others according to the Investigator's judgment.
The Effect of Weight Loss and Dietary Protein Intake on Bone

The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. We will also examine how two levels of protein intake affects diet quality.

It is unclear whether protein intake during dieting influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will compare the effects of weight loss with a lower-carbohydrate, high-protein (HP) diet to a high-carbohydrate, moderate protein (HC) diet on bone mass and quality in postmenopausal women (ages 50-70 years) with the hypothesis that bone turnover and loss of bone will be reduced on the HP compared to the HC weight loss diet. In a secondary aim, we will examine bone markers, hormones and the impact of protein intake on diet quality.

Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, and B) weight loss with higher protein intake. All participants will attend regular counseling sessions (about 50 minutes per session) with a dietitian for approximately 1 year, and will be asked to take a daily vitamin/mineral supplement. Also, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density). Participants will be asked to attend 8 diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions during the year.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women who are more than 2 years since last menses
* Obese or overweight
* Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

* Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal EKG\], active malignancy or cancer therapy within the past year)
* History of kidney stones
* Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
* Participation in other investigational studies during the 12-month study period
* Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.

Thromboelastography can provide more in-depth and quicker analysis of the complex coagulation processes during surgery

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients undergoing elective surgery for malignant pleural mesothelioma

Exclusion Criteria:

* Unwilling or unable to provide consent
* History of bleeding disorder
* On medications that may affect hemostasis
Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine

In light of the increasing experience with magnetic resonance image-guided radiotherapy (MRgRT) and adaptive planning and advances in magnetic resonance (MR)-only planning, the investigators propose here to evaluate the feasibility and safety of same-session MR-only simulation and treatment with SMART for spinal metastases. Although spine SBRT is a standard-of-care treatment modality, this expedited same-session MR-only simulation and treatment with SMART workflow is novel. Previously, delivery of spine SBRT has typically required several days from time of consultation to simulation and then 1-2 weeks from simulation to the initiation of treatment. On this proposed study, patients will not undergo computed tomography (CT) simulation and will instead have same-session MR-only simulation and treatment planning, on-table, using SMART. In this manner, patients would initiate treatment within just several days from the consult. Feasibility of the workflow will be defined as successful delivery of the first fraction of same-session MRI-only simulation and treatment with SMART on the first on-table attempt for at least 70% of patients. Patients will be treated in five fractions over 1-2 weeks. Although the long-term goal will be to achieve a significantly shortened time from consult to treatment as compared to traditional stereotactic body radiation therapy (SBRT) using simulation, the present study will be driven by short-term goals of workflow feasibility and safety.


Eligibility Criteria:
Inclusion Criteria:

* At least one disease site deemed to be suitable for treatment with spine SBRT as per radiation oncology evaluation.
* Karnofsky Performance Status (KPS) ≥ 60.
* Deemed medically fit for SBRT by treating physician
* Diagnostic CT with images through the projected treatment area within six months prior to enrollment.
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed

Exclusion Criteria:

* Past history of radiotherapy within the projected treatment field to be treated by MRI-guided SBRT
* Medical contraindication to undergoing MR imaging.
* Spine metastasis resulting in symptomatic spinal cord compression.
* Any other condition that, in the opinion of the treating radiation oncologist, renders the patient unfit for SBRT.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Procalcitonin as a Marker for the Length of Antibiotic Treatment in Peritonitis and Intra-abdominal Infections

Procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by this method.

Prospective randomized trial

Eligibility Criteria:
Inclusion Criteria:

* More than 18 yo
* Patient requiring surgery for peritonitis or intra-abdominal infection following: perforation, necrosis, previous operation...
* Mannheim Peritonitis score \> 14
* SIRS present
* Probability of survival \> 72h
* Informed consent by patient/relatives

Exclusion Criteria:

* No SIRS
* Long date corticoid treatment
* Immunosuppression
* Thyroid medullary carcinoma
* Anaphylactic shock
* Acute hepatic deficiency
Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy

To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.

1. The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
2. Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
4. The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed with malignant tumor and malignant cavity effusion.
2. An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.
3. Normal cardiac, hepatic, renal and bone marrow functions.
4. Life expectancy \>3 months.
5. Not receive other anti-tumor treatment.
6. Not receive chemotherapy in pleural and abdominal cavity.

Exclusion Criteria:

1. Previous history of other malignancies.
2. Serious or uncontrolled concurrent medical illness.
A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers

A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male and Females \> 18 years of age
* High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria:

* Acute or chronic skin disorders
* Topical or systemic antibiotics within 4 weeks of study enrollment
* Use of medication that increases risk of methemoglobinemia or influences P. acnes counts
* Subjects with medical illnesses, anemia, elevated methemoglobin
* Women who are pregnant, nursing or planning a pregnancy
HORIZON-PFT: Pivotal Fracture Trial

HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Eligibility Criteria:
Inclusion Criteria:

* Female, 65-89 years old
* No history of severe liver, kidney or eye disease

Exclusion Criteria:

* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
* Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.
Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death

Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF \< 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF \< 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.


Eligibility Criteria:
Inclusion Criteria:

* documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), \> 40 days post the most recent MI;
* LVEF \< 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment
* Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy).
* Age ≥ 18 years; no upper age limitation.

Exclusion Criteria:

* Prior cardiac arrest, sustained VT or VF, or unexplained syncope.
* Attempted VT / VF induction at electrophysiological study.
* Need for a cardiac resynchronization therapy (CRT) device.
* Enrollment in another interventional trial.
Experiences Reported by Siblings of Children Hospitalized in the PICU

The care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. The needs and feelings of parents are relatively well supported in the literature. However, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience. The study consists of conducting two semi-structured interviews with siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital. The first interview will take place during the stay in intensive care, the second one 1 month after discharge from pediatric intensive care.

The care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. The needs and feelings of parents are relatively well supported in the literature. However, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience.

The study consists of conducting two semi-structured interviews, with an estimated duration of 15 to 30 minutes, with siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital. The first interview will take place during the stay in intensive care, the second 1 month after discharge from pediatric intensive care.

The study will concern children and adolescents aged 10 to 18 years old because this is a population at risk in this situation. Concepts of illness, death and its irreversible nature evolve during childhood. By definition, there are three major stages which are: 0-6 years; 7-11 years; 10-18 years. For older children (\> 10 years) these definitions are well established and they would be more at risk of presenting psychiatric disorders later (post-traumatic stress disorder, major depressive syndrome, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 10 to 18 years
* Whose sister or brother is hospitalized in pediatric intensive care at Necker-Enfants Malades hospital or Robert Debré hospital
* Holders of parental authority and children or adolescents informed and consenting to participate in the study

Exclusion Criteria:

* Death of patients
* Language barrier (French not mastered)
* Inability to participate in a semi-structured interview (intellectual disability)
Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma

Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.

A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma

Eligibility Criteria:
Inclusion Criteria:

* Written consent from female or male Japanese patients aged 20 years and over. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
* Previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic Medullary Thyroid Carcinoma(MTC).
* Patients who have a good overall health status(World Health Organization (WHO) Performance status 0-2).
* Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
* For patients with measurable disease(at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).

Exclusion Criteria:

* Patients with brain metastases or spinal cord compression.
* Patients with significant abnormal ECG (QTcB correction unmeasurable or more than 480 ms)findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease.
* Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
* Patients with significant abnormal laboratory findings (to include abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
* Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before registration.
RDEA3170 AME Study

This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of \[14 C\]RDEA3170 in healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 50 kg (110 lbs.) and body mass index ≥ 18 and ≤ 30 kg/m2.
* No clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
* Screening serum urate level ≤ 7.0 mg/dL.
* Subject has a minimum of 1 bowel movement a day.

Exclusion Criteria:

* History or suspicion of kidney stones.
* History of gastrointestinal ulcers, Helicobacter pylori infection, or other disorders of gastric pH.
* History of previous surgery on the stomach or small intestine (appendectomy is acceptable). Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 6 weeks prior to Day 1.
* Inadequate venous access or unsuitable veins for repeated venipuncture.
Obesity Intervention for Low-Income African American Preschoolers

The purpose of this study is to preliminarily validate a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (\> 85th BMI %tile). Half of the participants will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. The remaining participants will receive an attention comparison control condition (ACCC), which includes one home visit, 7 newsletters and 4 monthly support phone calls. It is hypothesized that children of parents receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables and fewer sugary beverages, and engage in more activity as compared to ACCC.

This study will do a preliminarily validation of a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (\> 85th BMI %tile). Participants will be randomly assigned to an intervention or attention control condition. Those in the intervention will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. Sessions include psycho-education and skills building exercises. The attention comparison control condition (ACCC) participants will receive one home visit, 7 newsletters and 4 monthly support phone calls. The content of this condition also focuses on nutrition and activity knowledge, motivation and parenting. Outcomes for the intervention and ACC conditions will be assessed at baseline, post-intervention and at a 6-month and 1-year followed up. Child BMI %tile, consumption of fruits/vegetables and sugary beverages, and activity level will be analyzed to examine intervention effectiveness across time.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children enrolled in Head Start preschool in Detroit, MI will be included. Parents must be 18 years of age or older and their child must be of preschool age, between 3 and 5 years of age. Based on recruitment from Detroit Head Start, families will be low-income and of African American descent. Children will have a current body mass index percentile at or above the 85th percentile.

Exclusion Criteria: Child BMI percentile below the 85th percentile.

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