cyrilzakka/clinical-trials huggingface dataset:
The Influence of Mindfulness Meditation Retreat on Attention to Internal Experience

Although attention is thought to have a definitive functional role in mindfulness meditation training and its salutary mechanisms of action, extant empirical evidence is mixed and limited. In the proposed study, we propose to test whether 6 to 7-days mindfulness meditation retreats (N=90), relative to a wait-list control condition (N=45), will impact internal attentional processes or attention to internal experience (e.g., thoughts and bodily sensations); and whether these internal attentional change processes predict salutary outcomes of mindfulness meditation retreats. Participants will complete tasks designed to measure attention to internal experience before and then immediately following the retreat, as well as self-report measures of salutary outcomes before and 2-weeks post-retreat. Matched controls will complete the tasks at parallel time-points in the lab.

Broadly, the investigators first aim is to assess whether mindfulness meditation retreat will yield significant improvement at post-relative to pre-retreat, compared to matched control, in each of these internal attentional processes: (i) enhanced ability to disengage from negative self-referential thoughts; (ii) reduced selection bias to negative self-referential thoughts; (iii) enhanced interoceptive attention and sensibility to a broader range of locations, intensities and hedonic tones of bodily sensations in response to negative and neutral self-referential thoughts; as well as (iv) enhanced mindful awareness during mindfulness meditation as expressed in the objects and temporal dynamics of mindful awareness. Second, the investigators will assess whether each of the aforementioned internal attentional change processes from pre- to post-retreat, will predict change from pre- to 2-weeks post-retreat in mindful awareness in daily living, mindfulness-related processes (e.g., decentering), and mental health. Third, investigators will assess whether previous meditation experience moderates these effects.

Eligibility Criteria:
Inclusion Criteria:

* Retreat Group: Adults who register to participate in a 6 to 7-days mindfulness meditation retreats.
* Control Group: Adults participants will be recruited from social media and local community of meditation practitioners, and will be matched to the retreat group by gender, age and level of experience in meditation.

Exclusion Criteria:

* Younger than 18 years-old and older than 65-years.
* Have first language other than Hebrew.
* Self-report lack of fluency in speaking or understanding Hebrew-language.
* Not having access to a computer and headphones with a microphone (for completing behavioral tasks).
* Participation in a retreat 1 month before the first primary outcomes assessment or during the weeks between the second primary outcomes assessment and the 2-weeks follow-up.
Rivastigmine for Intensive Care Unit (ICU) Delirium

Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.

Objective: To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.

Study design: Multicentre, double-blind, randomized controlled trial. Study population: Consecutive adult ICU patients with delirium according to the CAM-ICU.

Intervention: Increasing dosage of rivastigmine or placebo as add-on medication.

Primary study parameters: Duration of delirium. Secondary study parameters: Delirium severity, length of ICU and hospital stay, functional status and mortality after 3 months.

Sample size: 440 patients will be included. Economic evaluation: includes a comparison of direct and indirect medical costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden: questionnaires (duration: 30 minutes). Risk: possible exposure to drug not indicated for the disorder. Benefit: possible treatment with according to experts possible beneficial drug. Consideration: The investigators of this study believe that the burden and risk do not exceed the expected benefit.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Positive CAM-ICU

Exclusion Criteria:

* Known allergy to rivastigmine
* Unable to receive enteric medication
* Pregnant or lactating
* Renal replacement therapy
* Hepatic encephalopathy
* Second or third degree atrioventricular block
* Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician
* Parkinson's disease.
* Lewy body dementia.
* ECG QT interval above 500 msec.
* No informed consent
Hormonal Contraception Access Through Pharmacist Prescribing Implementation

The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are:

1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy?
2. Does the HAPPI software make it easier for patients to access birth control?

Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access.

Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.


Eligibility Criteria:
PHARMACIST Participants

Inclusion Criteria:

* 18 years of age or older
* Provide birth control services in a participating pharmacy
* Use the HAPPI software to provide birth control services

Exclusion Criteria:

* None

PATIENT Participants

Inclusion Criteria:

* 18 years of age or older
* Seek birth control services at a participating pharmacy
* Use the HAPPI software to receive birth control services at a participating pharmacy

Exclusion Criteria:

* NONE
Associations of Plasma Fatty Acid Patterns With Gestational Diabetes Mellitus

Background: Limited studies have explored the difference of fatty acid profile between women with and without gestational diabetes mellitus (GDM), and the results were inconsistent. Individual fatty acids tend to be interrelated because of the shared food sources and metabolic pathways. Thus, whether fatty acid patters during pregnancy were related to GDM odds needs further exploration.

Objective: We aim to identify plasma fatty acid patters during pregnancy and their associations with odds of gestational diabetes mellitus (GDM).

Design: A hospital-based case-control study was carried out in urban Wuhan, China from August 2012 to April 2015. Pregnant women who screened for GDM at the outpatient clinics of the Department of Endocrinology, Tongji Hospital were invited to participant in the study. The inclusion criteria were as follows: 1) age ≥ 20 years; 2) gestational age at GDM screening ≥ 24 weeks; 3) singleton pregnancy. We excluded women who met any of the following items: history of diabetes (including but not limited to GDM), cardiovascular disease, cancer or other systemic diseases; pharmacologic treatment or dietary supplement use that might influence glucose or lipids metabolism; accompanied by other pregnancy complications; blood sample hemolysis or insufficiency; incomplete basic information. The diagnosis of GDM can be made if one or more glucose values are above the cut points of 5.1, 10.0 and 8.5 mmol/L at fasting, 1 and 2 h during a 75-gram oral glucose tolerance test (OGTT). Controls were randomly selected and individually matched to cases by age (± 2 years), gestational age (± 2 weeks) and parity. Finally, 217 GDM cases and 217 matched controls were selected in this study. All participants gave written informed consent before enrolling in the study. Fasting blood samples (≥ 8 h overnight fasting) were collected using anticoagulant tubes and centrifuged at 3000 rpm for 5 min. Plasma were separated from blood cells and stored at -80 ℃ for further assay. We measured plasma concentrations of fatty acids by gas chromatography - mass spectrometry, and derived potential fatty acid patterns trough principle components analysis. Conditional logistic regression and restricted cubic spline model were used to evaluate the associations between individual fatty acids or fatty acid patterns and odds of GDM.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years;
* Gestational age at GDM screening ≥ 24 weeks;
* Singleton pregnancy;
* With enough plasma collected for fatty acids detection.

Exclusion Criteria:

* History of diabetes (including but not limited to GDM), cardiovascular disease, cancer or other systemic diseases;
* History of receiving pharmacological treatment known to affect glucose metabolism;
* Incomplete basic information.
Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee

Background

Central sensitization has recently been documented in patients with knee osteoarthritis. So far, the presence of central sensitization has not been considered as a confounding factor in studies assessing the pain inhibitory effect of TENS on osteoarthritis of the knee.

Purpose

First, to explore the pain inhibitory effect of burst TENS in OAk patients. Second, to explore the prognostic value of central sensitization on the pain inhibitory effect of TENS in Oak patients.

Methods

Patients with knee pain due to OAk will be recruited through advertisements in local media. Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be measured. In addition, pain on a numeric rating score and WOMAC subscores for pain and function will be assessed. Patients will be randomly allocated to one of two treatment groups (TENS, sham TENS). Follow-up measurements will be scheduled after a period of 6 and 12 weeks.

Discussion/ conclusion

TENS influences pain through the electrical stimulation of low-threshold A-beta cutaneous fibers. The responsiveness of central pain-signaling neurons of OAk patients who are centrally sensitized may be augmented to the input of these electrical stimuli. This would encompass an adverse therapy effect of TENS. Therefore it might be interesting to identify a subgroup of symptomatic OAk patients, ie. non-sensitized patients, who are likely to benefit from burst TENS.


Eligibility Criteria:
Inclusion Criteria:

* To be included, patients need to be over 50 years old.
* All should have osteoarthritis in at least one knee fulfilling the American College of Rheumatology classification criteria and report peak knee pain over the last 24 h of more than 3 on a Numeric Rating Score (0-10 scale).

Exclusion Criteria:

* Patients are excluded if they have had a knee surgery or intra-articular corticosteroid injection within 6 months
* Current or past (within 4 weeks) oral corticosteroid use
* A history of knee joint replacement or tibial osteotomy
* Contraindications to burst TENS (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy) or if they are unable to apply TENS independently
Rates and Severity of PONV for Neuromuscular Block Reversal in Patients Receiving Gastric Bypass Bariatric Surgery

Patients who require bariatric surgery frequently bring a panoply of pre-existing comorbidities to the operating theatre. With body mass indices routinely in the 50s and 60s, patients who have bariatric surgery frequently have postoperative and post-discharge nausea and vomiting (PONV and PDNV)

There are many causes of post-operative nausea and vomiting in bariatric patients. These include (but are not limited to) the following: 1) mechanical manipulation of the stomach and bowel, 2) post-surgical inflammation of the tissue just operated on, 3) vagal stimulation of the viscera, 4) the administration of volatile anesthetics, 5) the administration of narcotics, 6) the underlying propensity of patient's for post-operative nausea and vomiting, based on prior history, gender, and other factors and 7) the administration of a cholinergic medication for muscle relaxant reversal. From previous work, it is known that alternate techniques are available to mitigate factors two through four, and patient screening has been available to help us determine the likelihood of patients becoming nauseous or vomiting postoperatively (factor #5). However, until the advent of sugammadex, there has been no alternative to factor 6. The use of sugammadex as a reversal agent could dramatically lower the incidence of PONV, while simultaneously providing an excellent level of reversal of neuromuscular blockade. There have been no published studies that have described laparoscopic gastric bypass, sleeve gastrectomy or duodenal switch procedures where complete prevention of PONV has been the result. A secondary objective will be the comparison of pulmonary function before and after surgery between the same two groups. In patients having gastric bypass surgery, not only does PONV aggressively aggravate the tissues which were just surgically manipulated, it also increases the likelihood of decreased ventilatory response, placing patients at risk for aspiration, atelectasis, pneumonia and respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* • \> 18 to \<= 70 years of age

  * Severe obesity requiring bariatric surgery
  * Willing and able to give informed consent, or if appropriate, have a legally authorized representative capable of giving consent on the participant's behalf
  * Willing to perform the FVC breathing test
  * Willing to be contacted at home via phone

Exclusion Criteria:

* • \<18 or \>=70 years of age

  * No pregnant patients will be enrolled
  * Patients with documented allergies to anesthesia agents or histories of malignant hyperthermia will not be enrolled.
  * Participants must be eligible to receive elective bariatric surgery
  * Participants who are discharged to skilled care facilities rather than home will not be considered for participation
  * Lacking capacity to provide informed consent
  * Prisoner
Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

In China, there is no recommendation for Hepatitis D virus (HDV) screening, but the fact is estimated that one-third of the world's population of individuals with chronic Hepatitis B virus (HBV) infection live in China while we do not know the prevalence of co-infection of HBV/HDV in China. So far, no nationwide study has been undertaken to evaluate the epidemiology of hepatitis D, on the other hand, reports of HDV infection rate in different regions of China are not consistent because of the different detection methods and detection objects. Here, we plan to test HDV-Ab/RNA for 5000 HBsAg reactive samples from 10 major tertiary hospital and to know the prevalence and disease burden of HDV in China.


Eligibility Criteria:
Inclusion Criteria:

1. Positive HBV surface antigen (HBsAg)
2. Age 18 yeas and above

Exclusion Criteria:

1. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia

The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).

This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1) between the treatment group and the control group.

The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation.

The control group will be observed for 12 weeks without any comparator.

Eligibility Criteria:
Inclusion Criteria:

* Fertile women between age of 20 and 49
* Patients with cervical intraepithelial neoplasia 1(CIN1)
* HPV(Human Papilloma Virus) positive(+)
* White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10\^6/L
* AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal
* Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray
* Be informed of the nature of the study and will give written informed consent

Exclusion Criteria:

* Malignant tumor in any organ other than cervical intraepithelial neoplasia
* Active liver disease, immune disorder and severe renal failure
* Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)
* Diagnosed diabetes
* Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)
* Pregnancy and breastfeeding
* Registered in other clinical trials
* Patients whom the investigator considers inappropriate to participate in the study
Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older

Primary objective:

* To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
* To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects

Secondary objectives:

* If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
* To describe the immune responses to REPEVAX in these subjects
* To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥40 years
* No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years

Exclusion Criteria:

* Medically diagnosed pertussis disease within the last 10 years
* Receipt of medication / vaccine that may interfere with study assessments
* Febrile illness or moderate or severe acute illness/infection
* Know pregnancy
* History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
* History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
* History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders
* Known or suspected immune dysfunction
* Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
* Chronic disease or intercurrent illness that might interfere with study assessments
Hybrid Assistive Limb Effect on Jump Height: a Clinical Study

The aim of this study is to investigate the effect of exercises performed with The Hybrid Assistive Limb device on the jump height of healthy non-athlete individuals.

Cyberdyne Waist Type device will be worn by attaching 3 electrodes to the waist area and then attaching the device to the waist and legs with the help of belts. Then, the appropriate modes will be selected for the participant with the adjustments made on the device. It has 3 modes; CVC, the mode that produces torque value, that is, movement, according to muscle activation with only the bioelectric signals received from the person's skin. CAC, the mode that produces movement by presenting automatic values to the participant with data designed according to the specific software and algorithm of the device. CIC, the mode that produces movement completely according to the participant's control. In our study, investigators will produce movement according to the muscle activation created by the participant using the CVC mode. In this way, investigators will provide the brain-muscle relationship and motor learning parameters. The exercises will be applied for 30 minutes, 5 days a week, for a total of 40 sessions.

Eligibility Criteria:
Inclusion Criteria

* Being between 20 and 40 years old.
* Tall individuals over 120 cm (for accurate visual feedback in the assessment of jump height)
* Weighting less than 100 kg
* People who can perceive and follow the given instructions without any problems
* People who have not had any surgery in the last 6 months
* People who are not allergic to electrodes
* They should not have any skin tissue related disorders.
* People who do not use pacemakers
* People who do not have a history of seizures or a risk of seizures (epilepsy).
* They should not have heart and respiratory problems.
* People who have not experienced back pain in the last 3 months.
* People whose waist circumference is not more than 120 cm and whose thigh circumference is not more than 80 cm.
* No orthopedic or neurological problems that will affect the balance mechanism (e.g. Vertigo, cerebellum damage, ataxia).
* Not having used a Waist Type Hybrid Assistive Limb device before
* Not having worked with visual feedback devices such as Tecnobody D-Wall before
* Not having worked with any of the Cyberdyne Hybrid Assistive Limb devices before

Exclusion Criteria

* People with back pain or who have had surgery on their back
* Having had surgery within the last 6 months.