cyrilzakka/clinical-trials huggingface dataset:
The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids

This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.

Magnetic resonance imaging (MRI) is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the body's organs and structures. This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI

In this research study, the investigators are:

* Investigating the use of MR imaging in gynecological tumors on imaging quality and comparison of tumor or fibroid structures and normal anatomy
* Investigating whether new MRI methods could help in characterizing the tumor and give information about the expected outcome

Eligibility Criteria:
Inclusion Criteria:

* Participants with suspected or histologically confirmed diagnosis of primary or recurrent gynecological cancer including uterine endometrial, cervical, vaginal, vulvar, ovarian, and smooth-muscle tumors undergoing routine clinical standard of care pelvic MRI
* Control subjects with benign fibroids undergoing routine clinical standard of care pelvic MRI
* Age ≥ 18 years
* ECOG performance status of ≤ 2, based on treating physician's discretion (Appendix A)
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other MR non-compatible device or implant
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Adults unable to consent
* Non-english speaking subjects
* Pregnant women
* Prisoners
Effects of NMES in Critically Ill Patients

Muscle wasting occurred early and rapidly in critically ill patients. Early therapeutic strategies to either maintain muscle structure and function should be encouraged. Neuromuscular electrical stimulation (NMES) is an attractive intervention to maintain muscle mass and strength in critically ill patients during the first week of ICU stay. This study will test the hypothesis that the number of contraction per day evoked by NMES in the first two weeks of illness may influence in muscle wasting, with beneficial effects on the physical and functional status in mechanically ventilated patients.

Patients with prolonged mechanical ventilation require deep sedation and mechanical ventilation, factors predisposing to the development of skeletal muscle wasting and acute muscle atrophy. Strategies to attenuate this process must be used. The neuromuscular electrostimulation (NMES) leads to the application of electrical currents in the skin aiming at muscle contraction, has beneficial effects for the population of critical patients. However, the number of contractions induced by NMES to attenuate the loss of muscle mass in this population is not yet established. This randomized controlled trial with 120 patients that will be randomized to one of the 3 study groups: 100 continuous daily contractions (100Cd), 50 continuous daily contractions (50Cd) and control group. Muscle thickness, NMES-induced strength, and clinical and functional parameters at the time of discharge from the ICU and hospital discharge will be assessed daily. The results of this project will provide an important contribution to the understanding of the mechanisms associated with NMES treatment as a tool to minimize the effects of muscle disuse, as well as providing scientific support for the clinical use of this resource in the treatment in the light of the policies' health system.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Intubated and expected to remain invasively mechanically ventilated the day after tomorrow
* laboratory confirmed COVID-19 (diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol or by nucleic acid based isothermal amplification)

Exclusion Criteria:

* Dependent for activities of daily living in the month prior to current ICU admission (gait aids are acceptable).
* Documented cognitive impairment.
* Proven or suspected spinal cord injury or other neuromuscular disease that will result in permanent or prolonged weakness (not including ICU acquired weakness)
* Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision maker are not committed to full active treatment
* pregnancy
* patients with unstable fractures in the vertebral column and lower limbs.
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

The purposes of this study are:

* To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);
* To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;
* To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.

The purposes of this study are:

* To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);
* To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;
* To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.

We will evaluate the assays in diverse populations:

1. STD clinic population
2. Men who have sex with men, with high prevalence of HIV infection
3. Pregnant women

The study will inform the development of testing strategies:

1. Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)
2. Increase cutoff values to increase PPV
3. Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 16-55 years of age

Exclusion Criteria:

* Those who refuse to get tested for HIV
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.

Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.


Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren
* Aged 9 to 11 years

Exclusion Criteria:

- no exclusion criteria
Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension

This is a Phase 1B, randomized, participant- and investigator-blinded, placebo-controlled, multi-center clinical trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).

The primary objective for this trial is to evaluate the safety and tolerability of GB002. The secondary objective for this trial is to evaluate the PK parameters of GB002. Exploratory objectives are to evaluate the PD readouts, change in WHO Group I functional class, and change in quality of life associated with GB002 treatment.

In this Phase 1B study, two dose levels of GB002 will be tested in adult participants with PAH. Four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo, with 3 subjects receiving GB002 and 1 subject receiving placebo. An additional 4 participants (3 active and 1 placebo) may be added to cohort 1 at the discretion of the Data Review Committee (DRC). The dose and dosing interval (i.e., once daily or twice daily) for the second cohort will be determined by review of the safety, tolerability, and drug levels in the blood from cohort 1. Cohort 2 participants will also be randomized such that 6 subjects receive GB002 and 2 subjects receive placebo.

Eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH) (Main study)
2. A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):

   1. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)
   2. PAH associated with one of the following connective tissue diseases (CTDs):

      systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus
   3. PAH associated with anorexigen or methamphetamine use
3. World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)

Exclusion Criteria:

1. Clinically significant systemic hypertension or hypotension (Main and OLE study)
2. History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)
3. History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication) (Main study)

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis

The purpose of this clinical study is to compare the efficacy and safety of three concentrations of topical methotrexate for the treatment of fingernail psoriasis.

The purpose of this clinical study is to compare, in a controlled fashion, the response to three concentrations of methotrexate in novel topical formulations in the treatment of subjects with psoriasis of the fingernails. Such a determination will be used as the basis for evidence of efficacy and safety of these formulations as a therapeutic treatment for fingernail psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed moderate fingernail psoriasis of at least two fingernails.
* Stable and unchanged psoriasis therapies for 2 months and must not have received methotrexate for 3 months prior to screening.
* Female patients who are not 5 years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests.

Exclusion Criteria:

* Target or control fingernails that are thicker than 2mm, abnormal or infected (bacterial or fungal).
* Patients with immunosuppression, HIV, or neuropathies of the hand.
* Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within 2 months of study visit 1.
* Use of more that one 2-week course of oral corticosteroid therapy or one injection during 3 months prior to the screening visit.
* Use of manicures or cosmetic nail products during and within 7 days of the start of treatment.
* Use of any drug known to have potential for toxicity to a major organ during and within 90 days prior to the start of treatment.
* Patients who are nursing, pregnant or plan to become pregnant or father a child within the study time frame including within three months of the last dose of study medication.
Acceptance and Commitment Therapy for Insomnia

Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. Treatment effects will assessed using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated pairwise contrasts to examine changes across time within groups will be used. Variables will analyzed using generalized mixed models (GMM).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic insomnia

Exclusion Criteria:

* Neurological degenerative disease
* Psychotic disorder
* sleep apnea, restless legs or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
* cognitive impairments
* unavailability in attending the sessions.
Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine

This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability.

The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.


Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers in good health aged over 18 years, both sexes;
* Full contractual capacity of the participants;
* Are in good health (as determined by vital signs and medical history);
* Negative urine or serum pregnancy test for females of childbearing potential;
* Are able to understand and comply with planned study procedures;
* Signed informed consent prior to initiation of study procedures;
* Absence of existence of any exclusion criteria.

Exclusion Criteria:

* Known allergy to eggs or other components of the vaccine;
* History of Guillain-Barré syndrome;
* Pregnancy or breast feeding or positive pregnancy test prior to vaccination;
* Immunosuppressive therapy in the preceding 36 months;
* Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
* Concomitant corticosteroid therapy, including inhaled corticosteroids;
* Psychiatric illness and/or concomitant psychiatric drug therapy;
* Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
* Vaccine therapy within 4 weeks prior to the study;
* Influenza vaccination within 6 months prior to the study;
* Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
* Documented HIV, HBV or HCV infection;
* Acute febrile respiratory illness within one week prior to vaccination;
* Experimental drug therapy within 1 month prior to vaccination;
* Alcohol or drug abuse.
Neuropsychological Functioning Among Children With Tourret's Disorder and ADHD

Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition with ADHD predicts an increased functional deficit among individuals with ADHD. The information about neuropsychological functioning among individuals with TD adn/or ADHD is little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and 60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV, CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI, APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this study will provide the primitive data to validate the TD and ADHD using neuropsychological and clinical measures.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 8-16 without the diagnosis of ADHD, and/or Tourette's disorder
* IQ \> 80
* both children/adolescents and their parents consent to participate and have the ability to complete self-administered measures in this study

Exclusion Criteria:

* diagnosis of psychotic disorders, bipolar affective disorders, pervasive developmental disorder, seizure, or major physical disorders.
* in addition, control subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD, ODD, or CD in addition to the above exclusion criteria.
Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-90 years at the time of initial recruitment
* Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1

Exclusion Criteria:

* Oesophageal squamous cell carcinoma
* Previous oesophageal and gastric resection
* History of another cancer within five years. If a new other cancer type is diagnosed within the sampling time frame, no further samples will be taken.
* Participants with co-morbidities preventing breath collection
* Unable or unwilling to provide informed written consent
* Pregnant women
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612

This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives \& outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase. No additional vaccines will be administered during this study and no new subjects will be enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
* A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.
* Written informed consent obtained from the subject/ from the parent or guardians of the subject.
* Written informed assent obtained from the subject, as applicable, at the time of study entry.

Exclusion Criteria:

• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.
Home Blood Pressure Monitoring Project

The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.

STUDY OBJECTIVES:

Primary:

• To determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines

Secondary:

The following parameters will be evaluated between groups:

* Change in BP measures between baseline and at 6 months
* Proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines
* Adherence to hypertensive medication regimen during the 6-month follow-up period
* Patient satisfaction with the care model.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85 years At least 1 diagnosis for hypertension,

  * Receive primary care from one of the participating clinics,
  * The two most recent BPs documented within that last 24 months are elevated (SBP\>140 and/or DBP\>90)
  * Receiving \< 3 antihypertensive medications, and
  * Have access to a computer with a USB port.

Exclusion Criteria:

* Pregnant, or breast-feeding,
* Patients on dialysis or being followed by nephrology,
* Patients with coronary artery disease, given these patients are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS),
* On KPCO "Do Not Call" or deceased list,
* PCP does not give permission to include patient in the study,
* BP is at or below target at the baseline study visit,
* Not English-speaking.