cyrilzakka/clinical-trials huggingface dataset:
Antipsychotic Effects of Oxytocin

The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.

This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site.

The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women, 21 years of age or older.
* Meet DSM-IV criteria for Schizophrenia.
* Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
* Must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks.
* A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening.
* Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
* Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
* Must be able to use nasal spray.
* Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.

Exclusion Criteria:

* Are pregnant or are breastfeeding (negative pregnancy test at screening).
* A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
* Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
* Are unsuitable in any way to participate in this study, in the opinion of the investigator.
* Another current DSM-IV diagnosis other than Schizophrenia.

Permitted:

* Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.
Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer

RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer.

PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.

OBJECTIVES:

Primary

* To determine the additional effect of endoscopic ultrasound (EUS) staging compared with a standard staging algorithm on the selection of treatment in patients with gastric or esophageal cancer (GOC), including the numbers of patients treated surgically, with multimodality therapy, or with non-surgical means.
* To estimate the effect of EUS staging on the outcome of care of these patients.
* To assess the cost-effectiveness of EUS by comparing improvements in patient outcomes with the additional costs of the procedure.
* To estimate the proportion of patients with GOC who will benefit from EUS and therefore to determine the need for EUS facilities within a population.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor location (gastric vs esophageal vs gastroesophageal junction) and participating center.

All patients undergo standard staging methods. Patients with localized tumors are randomized to undergo either endoscopic ultrasound (EUS) or no further staging. Both groups receive treatment as follows, depending on the type of tumor:

* Mucosal tumors: Patients undergo endoscopic mucosal resection and argon-beam ablation of the surrounding mucosa.
* Resectable tumors: Patients undergo surgery and neoadjuvant chemotherapy comprising cisplatin and fluorouracil.
* Advanced localized disease without the possibility of complete resection: Patients receive chemoradiotherapy or chemotherapy alone depending upon the site. Patients with gastric cancer may undergo palliative surgery.

Quality of life is assessed at 1, 3, 6, 12, 18, and 24 months using questionnaires, including the EuroQol EQ-5D, the EORTC core module QLQ-C30, the EORTC esophageal module QLQ-OES24, and the EORTC gastric module QLQ-STO22.

After completion of study treatment, patients are followed every 3 months for a minimum of 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of gastric or esophageal cancer

  * Localized disease
  * No metastatic disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* American Society of Anesthesiologists grade 1 (no physiological disturbance) or 2 (minor well-compensated physiological impairment)
* Must be fit for surgery and chemotherapy

PRIOR CONCURRENT THERAPY:

* Not specified
Mobile Device to Help FRAX® Screening

Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests using the American high risk cut-points for considering treatment but also suggests deriving domestic cut-points from cost-effective approach. Establishing cost-effective domestic cut-points for policy suggestions coupled with mobile devices with wireless access would potentially increase the usage of FRAX® tool.

Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2) To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.

Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search Pubmed and international osteoporosis guidelines to better understand the clinical applications of FRAX® in other countries. Investigators will also search epidemiological data for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness, and translational approach FRAX® cut-points. 2) Three targeting populations from National Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric health exam clinics with American cut-points, group B: orthopedic clinics with translational approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A mobile device with app application coupled with the FRAX® tool is used by a trained research assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic) adults with informed consents. Participants are referred to geriatric clinics for systemic osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI medication reimbursement regulation and percentage of self-pay medications are calculated. Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the Department of Health.

Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis screening and management model. 2) Base on the study results and expert consensus, investigators will provide policy suggestions of FRAX® based reimbursement modifications.

This is an observational study. The study outcomes might base on clinical physician opnions to provide policy suggestion of FRAX® at which cut-point is considering for treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 40-90
* screen high risk from FRAX

Exclusion Criteria:

* treated with anti-osteoporosis medications within last 3-12 months (depends on medication types)
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Eligibility Criteria:
Inclusion Criteria:

* Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
* Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
* Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)

Exclusion Criteria:

* Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
* Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
* Active or unstable cardiac disease or heart attack within 3 months of starting study treatment
SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)

The objective of the Post Marketing Surveillance Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Neurologists in private practices in Germany should document the safety and course of the disease/change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonist treatment under routine conditions. Piribedil should be prescribed according to its marketing authorisation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years and older.
* Indication: Morbus Parkinson.
* Treatment with piribedil for the first time.
* Monotherapy with piribedil.
* Combination therapy with L-Dopa (from the beginning or secondary in combination with other antiparkinsonian drugs).

Exclusion Criteria:
Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs

Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.

The study will unfold in the followed day hospital's departments of the Paul Strauss Cancer Center (Strasbourg, France) : supportive care department, chemiotherapy department and radiotherapy department. The study is based on two questionnaires that include six sections : nutrition, social, psychologic, physiotherapy, pain and supportive care needs evaluation.

The first questionnaire gives information about the patient and allow to screen supportive care needs. It should be read by medical or paramedical staff who report the function of the reader and options that are proposed to the patient after reading the questionnaire.

The second questionnaire will be done after 4 to 6 weeks by a phone call from the clinical research nurse. The objective of this questionnaire is to determine what kind of care have been provided.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated for a cancer
* Age ≥ 18 years old
* Receiving treatment (chemotherapy and/or radiotherapy) in day hospital and/or supportive care department
* Able to speak, read and understand French
* Able to communicate by phone
* Written informed consent obtained from the patient
* Registration in a national health care system

Exclusion Criteria:

* Minor or protected adult
* Pregnant or breastfeeding woman
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

The primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement The secondary objectives are to determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes after hypofractionated radiotherapy followed by ipilimumab


Eligibility Criteria:
Inclusion Criteria

* Patient \> 18 years old
* Histologically confirmed diagnosis of melanoma
* Previously treated or previously untreated metastatic melanoma by AJCC staging criteria
* Presence of an index lesion \> 1 cm amenable to hypofractionated radiotherapy and at least one other additional lesion that can be followed for response using RECIST criteria
* ECOG Performance status 0 or 1
* Signed informed consent document
* Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)

Exclusion Criteria

* Prior systemic therapy within 14 days of study enrollment. Patients must be adequately recovered from prior systemic therapy side effects as deemed by the PI.
* Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
* Presence or history of central nervous system metastasis (including brain)
* Long-term use of systemic corticosteroids
* Prior RT that precludes the delivery of hypofractionated radiotherapy
Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma

This trial studies how well exercise prescription works in improving quality of life in elderly patients with multiple myeloma. Engaging and adhering to an exercise program may improve functional status and quality of life and decrease pain and skeletal-related events. This study is being done to see if elderly patients with multiple myeloma can participate in a physical activity program.

PRIMARY OBJECTIVE:

I. Assess the ability for elderly multiple myeloma patients to maintain a personalized exercise regimen and activity level for a period of 6 months.

SECONDARY OBJECTIVE:

I. Assess changes in biometric data.

EXPLORATORY OBJECTIVE I. Evaluate changes in bone metabolism markers as a result of exercise.

OUTLINE:

Patients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks.

After completion of study, patients are followed up every 6 months for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma
* If patients are undergoing an autologous stem cell transplant, then they will be enrolled after their transplant so that there is not an interruption in the study period
* Patients are eligible whether or not they have lytic bone lesions

  * If they do have lytic lesions, the lesions must be low risk for fracture (low risk by Mirel's score or less than 50% of vertebral body height)
  * If patients are high risk for bone fracture, they must undergo bone stabilization prior to being considered for enrollment
  * Patients will have to be at least 6 weeks from date of stabilization
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Subjects need to be within 24 months of their multiple myeloma diagnosis
* Subject must be able to stand and walk to perform baseline assessments
* Subjects must be able to text message (will need cell phone)
* Need to limit to able to read and understand English as video visit capability is only in English at this point in time and multiple questionnaires will not be translated into other languages

Exclusion Criteria:

* Presence of lytic lesions that cannot undergo appropriate stabilization
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
* Non English speaking
* Diagnosed greater than 24 months prior to screening
Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Viable, Singleton pregnancy
* Voluntarily seeking abortion between 19 and 24 wks gestation
* Able to give informed consent and comply with study protocol
* Fluent in English or Spanish

Exclusion Criteria:

* Allergy to misoprostol or mifepristone
Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
* Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
* HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
* Body mass index (BMI) below or equal to 45 kg/m\^2
* Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion Criteria:

* Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
* Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
* Known or suspected hypersensitivity to trial products or related products
* The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
Treatment of Forehead/Glabellar Rhytide Complex with Botulinum Toxin a Injection

This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.

In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.

Eligibility Criteria:
Inclusion Criteria:

* In good health
* Is 18-65 years of age
* Has static and dynamic forehead/glabellar wrinkles
* Has decided to receive Botox® treatment for their forehead/glabellar wrinkles
* Has the willingness and ability to understand and provide informed consent and communicate with the investigator
* Is willing to return for follow-up visits

Exclusion Criteria:

* Pregnant or lactating
* Has received the following treatments in the forehead or glabellar region:

  * botulinum toxin injections in the past 6 months
  * ablative laser procedure in the past 6 months
  * radiofrequency device treatment in the past 6 months
  * ultrasound device treatment in the past 6 months
  * medium to deep chemical peel in the past 6 months
  * temporary soft tissue augmentation material in the past year
  * semi-permanent soft tissue augmentation material in the past 2 years
  * permanent soft tissue augmentation material
* Is planning to receive within the next year, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
* Is planning to use tretinoin or retinoic acid in the next year
* Has an active infection in the forehead or glabellar region (excluding mild acne)
* Is allergic to cow's-milk protein
* Is allergic to albumin
* Taking aminoglycoside
* Is currently using anticoagulation therapy
* Has a history of bleeding disorders
* Is unable to understand the protocol or to give informed consent
* Is unable to return for follow-up visits
* Has a mental illness