cyrilzakka/clinical-trials huggingface dataset:
Effects of Intrapulmonary Percussive Ventilator on Respiratory Function

The goal of this clinical trial is to prove the benefit of intrapulmonary percussive ventilator in healthy volunteers. The main questions are:

* How can intrapulmonary percussive improve lung function？
* What is the subjective feeling through intrapulmonary percussive?

Participants will be undergoing treatment of intrapulmonary percussive. Then they will be assessed for lung function and EIT before and after intrapulmonary percussive.


Eligibility Criteria:
Inclusion Criteria:

* No respiratory system, heart disease
* Well cooperate with the MateNeb

Exclusion Criteria:

* No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month
* Couldn't finish three times pulmonary function test
A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System

The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Early onset spinal deformity with any etiology
* Cobb angle measurement of 30 degrees or greater at the time of primary surgery
* Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
* Age less than 11 years old at the time of MAGEC implant
* Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
* Patient has been implanted for a minimum of 6 months
* Patient signs informed consent for the use of their personal private data

Exclusion Criteria:

* Patient declines to sign informed consent for the use of their personal private data.
FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable disease by RECIST criteria
* Adequate organ system function, as defined by protocol

Exclusion Criteria:

* Prior systemic or radiation therapy for metastatic colorectal cancer
* Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
* Previously untreated brain metastases
* History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* History of hematemesis or hemoptysis \</= 1 months prior to study enrollment
* Significant cardiovascular disease or disorder
* History of abdominal fistula or gastrointestinal perforation \</= 6 months prior to Day 1
* Positive for hepatitis B, hepatitis C or HIV infection
* Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.

We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved \< 50% improvement in HARS at 3 month follow-up.
* Fluency in English
* Capacity to understand the nature of the study and willingness to sign informed consent form

Exclusion Criteria:

* History of epilepsy or head trauma (LOC \> 5 minutes) within the past 6 months
* Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery
* A review of patient medications by the study physician indicates an increased risk of seizure
* An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
* Substance use disorder or PTSD within the past 6 months
* Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder
* Any psychotic features, including dementia or delirium
* Concurrent psychotherapy and unwillingness to discontinue
* Medication change within the past 4 weeks
* Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months
* Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
* Any contraindication for participation in MRI scan
68Ga-NOTA Evans Blue PET/CT in Patients With Lymphatic System Related Diseases

To evaluate the potential usefulness of 68Ga-NOTA Evans Blue (68Ga-NEB) positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and efficacy assessment in lymphatic system related diseases.

Subjects with lymphatic system related diseases underwent 68Ga-NEB PET/CT either for a primary diagnosis or for efficacy assessment. Anomalies were detected by visual analysis and quantitative analysis of maximum standard uptake value (SUVmax). To compare the diagnostic sensitivity of 68Ga-NEB PET/CT lymphatic imaging with other lymphatic imaging such as 99mTc-dextran for lymphatic system related diseases.

Eligibility Criteria:
Inclusion Criteria:

* adult population (aged between18 years and 80 years)
* patients with suspected or new diagnosed or previously treated lymphatic system related diseases
* patients who had scheduled 68Ga-NEB PET/CT scan
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse.

Prospective multicentre open-label study

During visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. Tumor samples will be collected at surgery or through a biopsy.

Patients will then have a standard care follow-up for a period of 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.
2. Indication of preoperative and/or adjuvant chemotherapy.
3. Age ≥ 18 years old.
4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
5. Signed written informed consent prior to any screening procedures being performed

Non inclusion Criteria:

1. Contraindication to surgical assessment.
2. Pathological diagnosis of mucinous carcinoma.
3. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer).
4. Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.
5. Patient in urgency situation, adult under legal protection, or unable to give his consent.

Exclusion Criteria after histological exam:

Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.
Acupuncture Approaches for Chronic Pain

Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to participants from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach.

The primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for participants with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the participants' experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the participants' perspective.


Eligibility Criteria:
Inclusion Criteria:

* Referred by a primary care provider from one of our participating primary care health centers
* Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain
* Self-reported pain score of ≥4 for at least 3 months prior to program entry
* Able to provide consent for treatment and data collection in either English or Spanish

Exclusion Criteria:

* \< 21 years of age
* Chronic pain not documented OR self reported pain of ≥4 for less than 3 months.
* Currently taking oral or injectable anticoagulants.
* Lack of contact information OR unavailable for duration of entire treatment period (24 weeks)
* Inability to consent to treatment and data collection.
* Active psychosis
* Active substance abuse
Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Study to Assess Safety, Tolerability, PK and PD Response of PB1023 Injection Following Single and Multiple SQ Doses in Adults With Type 2 Diabetes Mellitus

Primary objective:

To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM.

Secondary objectives:

1. To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023.
2. To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).


Eligibility Criteria:
Inclusion Criteria:

* Males or post menopausal or surgically sterile females age 18-75 years of age inclusive.
* Diagnosed with T2DM for \> or = 6 months with HbA1c \> or = 6.0% but \< or = 9.0% while taking stable doses of one oral antihyperglycemic agent but \< or = 8.5% when taking two oral antihyperglycemic agents for up to a maximum of 3 months prior to screening.
* Fasting Plasma glucose between 115 mg/dL and 269 mg/dL.
* Fasting C-peptide of \> or = 0.8 ng/mL.
* BMI \< or = 40 kg/m2.
* Otherwise stable health except for T2DM.

Exclusion Criteria:

* Currently taking a non-oral antihyperglycemic agent.
* Have taken a PPARg agonist within 90 days of screening.
* Known allergy to an approved or investigational GLP-1 receptor analog/agonist.
* Unstable cardiovascular disease as defined in clinical protocol.
* History, symptoms or signs of pancreatitis or severe gastrointestinal disease.
* Personal or family history of medullary thyroid tumors history of Multiple Endocrine Neoplasia Syndrome Type 2.
* Poor glucose control as defined in clinical protocol.
* Clinically significant renal and/or hepatic dysfunction as defined in clinical protocol.
* Absolute requirement for corticosteroids or received systemic steroids within 90 days prior to PB1023 administration.
* Pregnant or lactating females.
* Known history or active alcohol or drug abuse within 12 months prior to screening.
* Positive for HIV, Hepatitis B surface antigen or Hepatitis C antibodies.
* Participating in any other study within 30 days prior to screening.
* Other medical or psychiatric condition which in the opinion of the investigator would place the subject at increased risk.
Incidence of the Out- and in Hospital Cardiac Arrest at a Tertiary Hospital in Germany

Incidence of the background information, incidence and special characteristics of out- and in-hospital cardiac arrest at a tertiary hospital in Germany.

To evaluate background information for planning a eCPR Program at a tertiary hospital, the investigators planned a prospective study of every out- and in-hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a cardiac arrest

Exclusion Criteria:

* not complete fill out evaluation forms
Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children

We performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. They were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). The primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications.

Femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. Conservative management is associated with good results, whether by single or double-limb cast fixations. We aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. Eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. Both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification.

Eligibility Criteria:
Inclusion Criteria:

* children aged 2 to 6 years
* Children with femur shaft fractures

Exclusion Criteria:

* Children younger than 2 years or older than 6 years
* Articular fractures or fractures that cant be managed with a cast
* Old fractures older than 3 weeks
Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder

The effects of a psychological treatment, Mentalization-Based Treatment, was studied using a research protocol with patients with mood swings and impulsive behavior (borderline personality disorder).

Background: Mentalization-based treatment (MBT) in borderline personality disorder (BPD) has a growing evidence base, but there is a lack of effectiveness and moderator studies. The present study examined the effectiveness of MBT in a naturalistic setting and explored psychiatric and psychological moderators of outcome. Method: Borderline and general psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a group of BPD patients (n=75) receiving MBT; assessments were made at baseline, and subsequently after 6, 12 and 18 months (when treatment ended). Borderline symptoms were the primary outcome variable.

Eligibility Criteria:
Inclusion Criteria:

* To be included, BPD diagnosis was confirmed by SCID-II interview and the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview, together with a consensus discussion between MBT therapists using DSM-IV and ICD-10 criteria. All patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion.

Exclusion Criteria:

* Exclusion criteria were: IQ\<85, psychotic disorder other than schizotypal personality disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder, bipolar disorder type I and severe eating or substance use disorder.
Confirmation of Ventilation and Intubation by Determination With Ultrasonography

Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.

Endotracheal intubation is an important aspect of managing critically ill patients. Chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. The objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care

Exclusion Criteria:

* Recent neck or chest surgery
* Cervical spine immobilization
* Lack of availability of operators or equipment for performing the ultrasound protocol
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3

The purpose of this study is to collect alcohol calibration data for the driving simulator.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion Criteria:

* History of drug and food allergy
* Alcohol dependence, drug dependence or abnormal drunken (including past history)
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   * Schizoaffective disorder
   * MDD
   * Bipolar disorder
   * Delirium, dementia, amnestic or other cognitive disorder
   * Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
4. Other protocol specific inclusion/exclusion criteria may apply
Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients

The purpose of this study is to determine the effectiveness of the herb sage in improving the mental function of individuals with Alzheimer's disease.

Study hypothesis: The administration of sage will improve cognitive function in patients with mild Alzheimer's disease.

The herb sage has been shown to enhance memory and mental function in healthy, young adults. However, studies assessing the herb's effectiveness in older adults with symptoms of Alzheimer's disease are limited. This study will determine the effect of sage extract on the cognitive function of patients with mild Alzheimer's disease.

This study will last 6 weeks and will comprise 4 study visits, approximately 10 days apart. Participants will be randomly assigned to receive either sage pills or no treatment during each 10-day period. The treatment assignments will be switched in 10-day intervals, so that during the course of the study, each participant will undergo two periods of sage treatment and two periods without treatment. At each study visit, participants will undergo cognitive testing, including tests to determine attention, memory, and visual cognition. Participants will also undergo an electroencephalogram (EEG) and an electrocardiogram (ECG) at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild Alzheimer's disease
* Partner, friend, child, spouse, or relative willing to accompany participants to all study visits, provide informed consent, monitor participants' pill-taking, and communicate changes in participants' health during the study

Exclusion Criteria:

* Significant medical illness other than Alzheimer's disease