cyrilzakka/clinical-trials huggingface dataset:
Stimulation for Bowel Emptying

The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Suprasacral spinal cord injury
* Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
* Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
* Neurologically stable
* At least 18 years old
* At least 12 months post neurological injury or disease diagnosis

Exclusion Criteria:

* Active sepsis
* Open pressure sores on or around pelvis
* Significant colon trauma or colostomy
* Crohn's disease
* Colonic obstruction or gastrointestinal surgery within last 3 months
* Significant history of autonomic dysreflexia
The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status

The findings of previous experiments suggested that alpha linolenic acid (ALA) has been linked to anti-hyperglycemic, and reducing the risk of diabetes.This is a randomized double-blind cross-over trial, aims to study the effect of ALA on glycemic status and human metabolism. Firstly, the investigators will investigate the efficacy of ALA on improving the indexes of glucose metabolism. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of ALA on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.


Eligibility Criteria:
Inclusion Criteria:

* Fasting blood glucose 6.1-8.4mmol /L;
* HBA1c 5.7-7.0%;
* OGTT 2h or postprandial blood glucose 7.8-11.1 mmol/L;
* Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.

Exclusion Criteria:

* Under 30 years old or over 75 years old;
* Suffering from severe obesity, thyroid disease, or other serious diseases, such as mental illness;
* Take nutritional supplements, such as fish oil capsules, Perilla seed oil and flaxseed oil capsules, for nearly one month;
* Intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month;
* Daily cooking oil is linseed oil or rapeseed oil and other α -linolenic acid rich vegetable oil;
* Have been diagnosed with type 2 diabetes and are currently receiving insulin injection;
* Allergic to the content of intervention;
* Failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.
A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood

Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.


Eligibility Criteria:
Inclusion Criteria:

* Physically and mentally healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders assessed as clinically relevant by the investigator
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome

The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Alagille Syndrome
2. Evidence of cholestasis
3. Moderate to severe pruritus
4. Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures

Exclusion Criteria:

1. Surgical disruption of the enterohepatic circulation
2. Liver transplant
3. History or presence of other concomitant liver disease
4. Females who are pregnant or lactating
5. Known HIV infection
Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18
* ASA I-II
* Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Palliative surgery
* Contraindications for epidural anesthesia
* Metastatic bladder cancer
* Patients with a history of any other malignancy
* Chronic opioids medication
* severe systemic disease (heart, lung, kidney, or immune system)
* Known hypersensitivity or suspected allergy to intervention drugs
* Intellectual Disability
Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People

Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.

Study hypothesizes that the intervention that involves utilization of a DDBHH CHN will result in (i) DDBHH patients demonstrating greater adherence to screening compared to DDBHH patients who were assigned to the standard of care group , and (ii) higher patient-physician communication rating by DDBHH patients compared to DDBHH patients who were assigned to the standard of care group. Bilingual ASL-English measures (e.g., sociodemographics, cancer knowledge, patient-physician communication) will be administered to the participant at baseline data collection and again after the final data collection or by 11 months for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3, Lifestyle Considerations) and availability for the duration of the study

Male or female at birth age 45-80yo or female at birth age 45-80yo; age-eligible according to screening criteria

Self-reported diagnosis of bilateral hearing loss at birth or prior to 13 years old (defined as "early deafness") and use ASL

Willingness to adhere to the CHN clinical trial regimen

Willingness to provide cancer screening verification documentation; this will be reviewed during the informed consent procedure

Access to necessary resources to support video-based communication

Non-adherent to one or more cancer screening guidelines for breast, lung, prostate, colon, cervical cancers will be those who reported not having had the appropriate recommended screenings within the past year to cancer screening questions in the HINTS-ASL survey

Exclusion Criteria:

* Presence of full ability to hear in one or both ears beyond 13 years of age

Younger or older than the age cutoff for the recommended cancer screening

Not capable of independently conducting the activities of daily living

In compliance with age- or risk-specific screening at the time of evaluation for study eligibility

Are currently undergoing cancer treatment or being evaluated for the presence of cancer at the time of evaluation for study eligibility

Will be engaged in more than 21 consecutive days of travel during the eleven-month study window

Knows other participants at baseline
Effects of COVID-19 in Chronic Pain

The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. In this cross-sectional study, 100 volunteer patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain were included. Age, gender, body-mass index (BMI) and systemic diseases of the participants were recorded as demographic data. Data were collected regarding the area of the body where pain is most dominant in the musculoskeletal system and how long the pain has been in these area, whether there is routine use of analgesics before and after the pandemic and the amount if any, whether the person or the person's relatives have a history of COVID-19, whether exercising regularly before and after the pandemic. Afterwards, the participants were asked to evaluate their general pain severity and global well-being assesment with the visual analog scale (VAS) in the pre-pandemic period and in the last month. For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad. The distance between the point marked by the patient and the starting point was measured. The higher the measured value meant the greater the severity of the patient's pain and the worse the patient's global assessment \[11\]. Subsequently, the patients were asked to answer questions on the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI) and Nottingham Health Profile (NHP) scales.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain

Exclusion Criteria:

* Having a history of trauma and surgical intervention in the last 3 months,
* Having a history of known inflammatory rheumatic disease,
* Having a history of chronic severe systemic or neurological disease,
* Having a moderate or severe impairment of cognitive status determined by the minimental test.
A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation

Pressure support (PS) is a commonly used mode of ventilation which is triggered based upon the patient's own inspiratory efforts. For the most part, pressure support is well tolerated by patients. However, because the trigger for pressure support is an inspiratory effort by the patient, and because the resulting support is constant, the ventilator response can be "out of sync" with the patient's needs. The problem of patient-ventilator asynchrony has been documented to be large in approximately one quarter of patients who require mechanical ventilation. Asynchrony is associated with increased or abnormal work of breathing (WOB) and prolonged duration of mechanical ventilation. Diagnosing asynchrony at the bedside can be challenging. Electrical activation of the diaphragm (Eadi) recording can provide clinicians with a more accurate picture of patient-ventilator synchrony and may thus result in decreased asynchrony and decreased or normalized work of breathing for the patient. The purpose of this physiologic study is to evaluate the role of protocolized pressure support ventilation (based upon Eadi) in comparison to standard pressure support ventilation.

Pressure support will be readjusted according to Eadi recording in different steps.

The optimized pressure support will be compared to the initial pressure support.

Eligibility Criteria:
Inclusion Criteria:

Patients who are ventilated using a partial ventilator support mode (i.e. pressure support) and meet one of the following criteria:

* Known chronic pulmonary obstructive disease
* Suspected Intrinsic PEEP on the expiratory airway pressure and flow tracings
* Resistive pressure (i.e. eak pressure-Plateau pressure) higher than 20 centimeters of water (cmH2O) at a flow of 60 L/min or higher than 15 at a flow of 45 L/min in volume controlled ventilation (preferably after a tracheal aspiration maneuver)
* Known chronic restrictive pulmonary disease with respiratory failure
* Restrictive pulmonary disease characterized by a measured compliance of less than 30 ml/cmH2O
* Obesity with BMI ≥ 30 kg/m2
* Existence of frequent asynchronies noticed on the ventilator waveforms
* Expected duration of ventilation of more than 24 hours

Exclusion Criteria:

* Contraindication to Naso/orogastric tube (NGT/OGT) placement (known esophageal problem such as hiatal hernia or esophageal varicosities, active upper gastro-intestinal bleeding, any other contraindication to the insertion of a NGT/OGT)
* Poor short term prognosis (defined by the clinician in charge as a high risk of death during the next 7 days) or ongoing palliative treatment.
* Patients with "Do not resuscitate" order already established and in palliative care
* Patients younger than 18 years old
Effects of Home-based Respiratory Muscle Training Progamme in Individuals with Ischemic Heart Disease

The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles), applied by telerehabilitation, is an effective intervention (versus placebo and versus inspiratory muscle training in isolation (IMT)) in improving quality of life, cardiopulmonary function and physical and psychological state in people with ischemic heart disease. In addition, the aim is to determine whether respiratory muscle training (IMT or IMT+EMT) is effective in enhancing the results obtained by a conventional cardiac rehabilitation programme on the aforementioned variables.


Eligibility Criteria:
Inclusion Criteria:

* Presence of ischemic heart disease
* Age 18 years or older
* Cardiovascular clinical stability

Exclusion Criteria:

* Any condition that contraindicate exercise training
* Inability to close the lips to hold the training device's mouthpiece (e.g., facial paralysis)
* Previous participation in a rehabilitation programme within the last 3 months
* Pregnancy
* Inability to adhere to remote monitoring
Ribociclib (LEE011) Rollover Study for Continued Access

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
2. Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.

Exclusion Criteria:

1. Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
2. Patients who do not meet parent protocol criteria to continue study treatment.
Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery

The purpose of this study is to compare the effects of remimazolam and propofol on postoperative recovery time, complications, and safety in patients undergoing ambulatory upper airway surgery under general anesthesia.

Patients scheduled for ambulatory upper airway (including nasal cavity, oral cavity, pharynx, larynx) surgery and who agree to participate in the study will be randomly assigned to the Remimazolam group and the Propofol group. In the Remimazolam group, general anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil. Once the surgery is completed, general anesthesia is recovered with flumazenil. In the Propofol group, general anesthesia is induced and maintained by continuous infusion of propofol and remifentanil using a target concentration controlled infusion method. In both groups, rocuronium is used for neuromuscular blokade, and sugammadex is used for reversal of neuromuscular blockade.

When the surgery is completed, recovery time, occurrence of adverse events, and anesthesia recovery indicators are examined in 3 stages: in the operating room, while staying in the post-anesthesia care unit(PACU), and while staying in the day surgery center.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 19 or older) undergoing ambulatory upper respiratory tract (nasal cavity, oral cavity, pharynx, larynx) surgery under general anesthesia
* American Society of Anesthesiologists physical class classification I, II, and III

Exclusion Criteria:

* Patients who refused to participate in the study
* Pregnant patients
* Patients with a history of hypersensitivity to drugs or additives used during surgery
* Patients with acute narrow-angle glaucoma
* Alcohol or drug dependent patients
* Patients with Child-Pugh class C liver dysfunction
The Effect of Gluten-free Diet on Parkinsonism

Recent data suggest that the brain-gut axis, chronic intestinal inflammation and microbiome may contribute to the pathogenesis of neurodegenerative diseases with alfa-synucleinopathy, which include Parkinson's disease (PD) and Multiple system atrophy (MSA). Environmental factors e.g. diets, microbiome, metabolites and immune mechanisms may play important role in pathogenesis of these diseases. In the human arm of this project, the investigators will address effects of an anti-inflammatory gluten-free diet (GFD) on motor and non-motor symptoms as well as its effects on immune and metabolomic characteristics in patients with PD and MSA. In the mouse arm, the investigations will focus on the effects of GFD in chronic MPTP-induced mouse model of PD in various settings (e.g. in young or aged animals, with respect to the lengths of exposure to GFD). The chronic MPTP model will be used to assess the effects of GFD on adaptive and immune characteristics, and metabolic signatures. Using germ-free animals, the microbiome-dependency of the GFD-mediated effects may be determined. The anti-inflammatory gluten-free diet and its related mechanisms represent novel, promising and relatively straightforward approach in a search to improve symptoms of PD as well as MSA or even in their prevention.

This project is based on two research lines, testing the effect of gluten-free diet in a patients with PD and MSA (a human prospective trial) and in the chronic MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)-induced mouse model of PD.

Research line 1. Assessments of effects of gluten-free diet (GFD) on clinical symptoms of Parkinson's disease (PD) and multiple system atrophy (MSA) in a prospective, controlled, randomized, rater-blinded human study. The goal of the research line 1 is to assess the effects of 12 months of administration of GFD on clinical symptoms of PD and MSA.

Research line 2. Effects of GFD on the development of PD in the chronic MPTP-induced mouse model of PD. The goal of the research line 2 is to study the effects of GFD in the chronic MPTP-induced mouse model of PD in order to evaluate its impact on clinical development of PD's features as well as immune and metabolomic characteristics that should shed more light on the possible mechanisms and potential novel treatment opportunities.

Eligibility Criteria:
Inclusion Criteria:

* subjects with establish diagnosis of PD in clinical stage 2-4 of Hoehn\&Yahr scale or with establish diagnosis of MSA
* stable treatment for \>4 weeks
* willing and able to give informed consent for participation in the study
* male and female subjects, aged 40 years or older
* able to understand and willing to comply with study procedures
* willing to avoid any other diet restrictions
* BMI 18-30

Exclusion Criteria:

* concomitant neurological, gastrointestinal or immunological disease
* diet restriction
* dementia affecting compliance
* acute psychiatric symptoms