cyrilzakka/clinical-trials huggingface dataset:
Inpatient Group Acceptance and Commitment Therapy (ACT) for Psychosis Spectrum Disorder

The pilot study that will serve as the basis for the larger project - a multicenter randomized controlled single-blinded trial (RCT) will focus on testing the feasibility and efficacy of an inpatient group ACT treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. The ACT-specific treatment program for inpatients with psychosis spectrum disorder is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates.

Inpatient hospitalization is an important time to provide patients with psychosis spectrum disorder with skills to better manage symptoms and improve functioning after discharge. The long-term goal is to reduce the negative consequences of these disorders and to have a lasting positive impact on the course of the disease. Against this background, the aim of a larger-scale future study project is to evaluate a specific ACT-based four-week treatment program providing inpatient group therapy interventions for patients with psychosis spectrum disorder. The ACT-specific treatment program is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates. The pilot study will focus on testing the feasibility and efficacy of the inpatient group ACT treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. Here, treatment will include a high-frequency four-week inpatient ACT group therapy program with a focus on the core ACT process of mindfulness in addition to standard inpatient treatment. Within the scope of the survey, possible side effects of the intervention will also be recorded and mapped by conducting qualitative individual interviews and documenting serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psychosis spectrum disorder with the following diagnoses according to the Diagnostic and Statistical Manual Diploma in Social Medicine 5 ("Schizophrenia Spectrum and Other Psychotic Disorders"):
* Schizophrenia
* Schizophreniform disorder
* Schizoaffective disorder
* Delusional disorder
* Brief psychotic disorder
* Psychotic disorder due to another disorder
* Substance-induced/medication-induced psychotic disorder
* Depressive episode with psychotic symptoms
* Manic or bipolar episode with psychotic symptoms

Exclusion Criteria:

* Patients decline to participate in the treatment program
* Language or intellectual abilities insufficient for study participation
Profile of Depressive Symptoms in Parkinsons Disease

To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.


Eligibility Criteria:
Inclusion_Criteria:

Observation criteria:

* are able to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* have idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society Brain Bank Diagnostic Criteria for Parkinsons disease
* show no impairment of cognitive function (MMSE score ?24)
* are with or without symptoms of depression (full range)
* are stable on anti-Parkinson/anti-depressive treatment for at least 1 month before entering the study
* are or are not on concomitant antidepressant treatment
* are in the on state during the observation period
* did not previously undergo PD surgery
Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program

The purpose of this study is to evaluate the process and outcomes of an implementation program designed to implement fear of cancer screening, referral and management into routine cancer care clinics, using a stepped-wedge cluster randomized controlled trial.

This study aims to test if a systematic fear of cancer screening program that employs implementation strategies including training, reflecting, evaluating, facilitating and adapting, increases the proportion of eligible patients screened and referred compared to usual control with no implantation strategies used. This study hypothesize that the implementation program will increase (i) the proportion of eligible patients screened and (ii) the proportion of patients with high fear of cancer referred for psychosocial support. For process evaluation, this study aims to use qualitative methods to assess the patients' and service providers' experience of the implementation program, and identify contextual factors (e.g., potential barriers and facilitators) likely to influence its adoption, implementation, and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with non-metastatic breast, gynecological, or colorectal cancer, and who have completed primary and adjuvant treatment within the past two years will be eligible for the proposed screening program.

Exclusion Criteria:

* All cancer patients beyond two years post-treatment; and diagnosed with metastatic cancer or non-breast, non-gynecological, and non-colorectal cancer.
EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study.

This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.

Hydrogen Peroxide levels in Exhaled Breath Condensate (EBC) is a direct biomarker of oxidative stress from the airway epithelium. Levels have been shown to be raised in asthma and Chronic Obstructive Pulmonary Disease (COPD) both in stable and exacerbating states.

Previously it has been difficult to measure this volatile compound away from a laboratory based setting. However a new device has been developed to measure Hydrogen peroxide levels in exhaled breath by the patients side.

This Pilot study will test this new device in a clinical setting. It will assess whether the device can monitor levels consistently and reliably and whether it can distinguish disease from healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness
* Subject has a confirmed, clinician made diagnosis of COPD for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC \<0.7) recorded at any time
* Subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
* Subject is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Subject has existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
* Subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
* Subject has received treatment for an exacerbation of their respiratory disease within the last 2 weeks.
* In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
* Subject is unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.
Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture

The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.

The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.

Eligibility Criteria:
Inclusion Criteria:

* De-identified positive blood culture specimens (6 mL aliquot)
* Seeded blood culture specimens (stock) from archived bacterial and yeast isolates

Exclusion Criteria:

* Sample volume available \< 6 mL
* Positive Blood Culture sample \> 8 hours post-positivity
* Sample from patient previously enrolled
* Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles
* Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco
Accuracy of Pulse Oximeters With Profound Hypoxia at Rest

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study
Healthy Volunteer Study Comparing Tablet and Capsule Formulations

Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
* Normal BMI (18 to ≤ 35 kg/m2)
* Have a negative urine drug screen/alcohol breath test on admission to clinic
* Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following completion of dosing
* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1
* Be in general good health
* Clinical laboratory values within normal range

Exclusion Criteria:

* Recent wound, or presence of an ongoing non-healing skin wound
* Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol
* History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
* Blood donation or significant blood loss within 30 days prior to the first study drug administration
* Plasma donation within 7 days prior to the first study drug administration
* Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
* Females who are pregnant or lactating
* Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
* Failure to satisfy the PI of fitness to participate for any other reason
* Active infection or history of recurrent infections
* Active malignancy and history of malignancy in the past 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
* Antibiotic treatment within 3 months
* Chronic medical condition
* Any acute illness within 30 days prior

Other protocol defined inclusion/exclusion criteria could apply.
Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

To learn how altered metabolism in GBM causes tumor growth and resistance to drug therapy. In this pilot research study, we will dose GBM patients with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative MRI consistent with a primary intracranial malignant brain tumor.
2. Must be 18 years of age or older.
3. Patient eligible for debulking surgery/resection.

Exclusion Criteria:

1. Inability to obtain pre-operative IV access.
2. Use of Tru Niagen, Basis (or any other nicotinamide riboside (NR)-containing NAD+ booster) or niacin supplements within one month prior to Study Visit 1.
3. Participation in studies involving investigational drug(s) within 30 days prior to Study Visit 1
4. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Study Visit 1 (participants may not donate blood any time during the study, through the final study day)
5. Presence of any condition that, in the opinion of Dr. Field, compromises participant safety or data integrity or the participant's ability to complete study days.
6. Pregnancy, lactation or \< 9 months postpartum from the Study Visit 1 date.
A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD

To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.

This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
* Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

Exclusion Criteria:

* Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
* Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.
The SBAR Effect on Safety Attitudes in the Perinatal Department

The aim of this study is to analyze the impact of SBAR by the SAQ questionnaire in the perinatal department.


Eligibility Criteria:
Inclusion Criteria:

* All Physicians and Nurses in the Perinatal Department

Exclusion Criteria:

* nil
Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease

The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Eluting Balloon (DEB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.

The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DEB currently available on the market.

Eligibility Criteria:
Inclusion Criteria:

* Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4;
* Target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm;
* Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee);
* Life expectancy \>1 year in the Investigator's opinion;
* Written informed consent.

Exclusion criteria:

Given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply:

* Patient unwilling or unlikely to comply with FU schedule;
* Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure;
* Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
* Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure;

  * 15 cm long inflow lesion (≥50% DS) or occlusion (any length) in the ipsilateral Iliac artery;
* Failure to successfully treat \< 15 cm long inflow lesion in the ipsilateral Iliac artery
Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

Erythritol is a low calorie sugar substitute that is being increasingly used to sweeten beverages and other food items. Greater amounts of erythritol are required to reach the sweetness level of a common soft drink as compared to aspartame, resulting in higher osmolarity for the erythritol sweetened beverage. Since associations have been noted between osmolarity and satiety, investigators propose that an erythritol sweetened beverage may enhance satiety more than a beverage sweetened with aspartame.

The effects of an erythritol sweetened beverage on satiety has yet to be specifically explored. In this double-blind, 2-way crossover trial, healthy volunteers will consume one of two beverages on each visit: either an erythritol sweetened beverage or an aspartame sweetened beverage. Both beverages will be prepared to the same level of sweetness.

Timed blood samples will be collected over a period of two hours following consumption of the sweetened beverage. Serum total ghrelin and serum insulin will be measured from all blood samples. A validated hunger scale will be administered three times within the two hour period. Data analysis for all measures will be reported with respect to deviation from the initial baseline measured at time 0.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI below 25
* Maintained a stable body weight for at least three months prior to volunteering

Exclusion Criteria:

* Exclude if smoking, substance abuse, have a chronic medical or psychiatric illness, regularly intake medications (except for oral contraceptives), regularly use supplements besides vitamins/minerals, have a history of gastrointestinal or renal disorders, have food allergies, have medical dietary restrictions, or have any abnormalities detected on physical examination indicative of disease.
* Participants must have intact gastrointestinal and kidney function to adequately absorb and eliminate the erythritol. Eligibility will be determined by self-reported medical history, physical examination, and specific questioning to exclude prior renal or Gastrointestinal disease after the informed consent process.
* Exclude if abnormal GI anatomy due to surgery (besides appendix removal) or congenital defect as may impair ghrelin production.
* Exclude if the patient is pregnant, lactating, or planning to become pregnant as erythritol has not been specifically tested in this population.
* Exclude if have a Body Mass Index over 25, as ghrelin as a marker of satiety may not be accurate at high Body Mass Index.
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole

Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 12 weeks of ropinirole implant treatment, and evaluate the side effects of this new formulation.


Eligibility Criteria:
Key Inclusion Criteria:

* Voluntarily provided informed consent
* Meet diagnostic criteria for idiopathic Parkinson's Disease
* On L-Dopa and oral ropinirole
* If female of child-bearing potential, willing to practice contraception from time of informed consent to Follow-Up Visit

Key Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant
* Active epilepsy within the past year
* Severe dementia or cognitive impairment
* Donated or lost \> 400 mL of blood within 1 month prior to Screening
* History of alcohol or substance use disorder within the prior 12 months
* Recent episodes of moderate to severe dizziness or syncope
* Definite or suspected hypersensitivity to ropinirole or ethylene vinyl acetate
* Used any other investigational drug within 60 days or 5 half-lives prior to Screening, or plan to take any such drug any time during the study
The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.


Eligibility Criteria:
Inclusion Criteria:

* Include pediatric patients with a baseline Sa02 \< 90% and no contraindications to using an adhesive sensor.