cyrilzakka/clinical-trials huggingface dataset:
Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective

Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However, a significant number of patients, especially those constipated patients, failed colonoscopies due to poor bowel cleaning. Inadequate preparation may also lead to missed colonic lesions. The study is based on the hypothesis: itopride hydrochloride, a prokinetic agent, its dual role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition make it an appropriate adjuvant for bowel preparation. It was reported to promote colonic peristalsis, shorten colonic transit time and accelerate propulsion of colonic luminal contents through inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo. So this study is to determine the efficacy, tolerance and safety of high dose of itopride, when given in different times before administration of PEG-E, for colonic preparation in patients with chronic constipation.

Colonoscopy is a reliable procedure for the investigation of colonic and distal terminal ileum disease. The diagnostic accuracy of colonoscopy is dependent on visualization of the colonic mucosa; hence an appropriate bowel preparation is essential for the examination. Despite multiple lavage were used throughout the years, the suboptimal cleaning level have been reported vary from 10% to more than 20% and up to one-third of incomplete or failed colonoscopies can be ascribed to poor bowel preparation. So it is important for us to search a new regimen for bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected colonic disease and suffered from chronic constipation were referred for colonoscopy and enrolled in the study. Chronic constipation was diagnosed on the basis of Rome III criteria.Suspected colonic disease was deﬁned as:

  * recent change of bowel habits;
  * obscure GI bleeding (hemafecia, melena or positive fecal occult blood test);
  * obscure abdominal pain;
  * weight loss;
  * positive ﬁndings in the colon on GI imaging;
  * serological test referred to colorectal cancer such as CEA elevated obviously;
  * family history of colorectal cancer or adenomatous polyps.

Exclusion Criteria:

* usage of prokinetic agents such as itopride, mosapride within 4 weeks and tricyclic antidepressants 8 weeks prior to entering the protocol;
* known allergies or other contraindication to PEG or itopride;
* a history of abdominal surgery or bowel obstruction;
* pregnant or lactating;
* conditions associated with severe cardiac, hepatic, or renal impairment.
The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

In order to elucidate if FSH can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (PSA), which normally is regulated by testosterone.

Normally, prostate specific antigen (PSA), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone. In order to elucidate if follicle stimulating hormone (FSH) can have testosterone like effects, samples from n=30 non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25) with pharmacologically induced gonadotropin deficiency will be studied. The men are currently recruited and during 5 weeks undergoing:

1. Pharmacologically induced gonadotropin deficiency w 1-3;
2. FSH-treatment of 50% (group A), w 1-5;
3. Testosterone (T) treatment of all (group A and B) w 4-5;
4. End and follow up after 5 weeks.

A subcutaneous injection with the GnRH antagonist degarelix (240 mg¸ Ferring GmbH Wittland, Kiel, Germany) results in drop of both FSH and LH-induced testosterone. Half of the men will get recombinant FSH (300 IU; Gonal-f, Merck Serrono S.A. Aubonne, Schweiz) back, whereas 50% will not. Three weeks thereafter, the full spectrum of FSH dependent changes occur and are reflected in blood. From this occasion testosterone (Nebido, Ferring GmbH Wittland, Kiel, Germany) will be given to all participants to diminish the side-effects of the castration. Blood samples are collected at start, after 3 wks and after 5 wks. At that point also a follow up is undertaken. This experimental design will provide samples from each individual during normal conditions, during castration, and after a standardised dose of FSH.

Eligibility Criteria:
Inclusion Criteria: Healthy, non-smoking, body mass index 20-25, Exclusion Criteria: Medication or drug abuse

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Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Modified Hoehn and Yahr Scale Stages II - IV
* Stable dose of L-dopa for at least 4 weeks prior to screening.
* Lack of control with L-dopa therapy.
* Women of child-bearing potential must use a clinically accepted form of birth control.

Exclusion Criteria:

* Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.
* Any abnormality, at screening, that is considered clinically relevant by the Investigator.
* Dementia
* Use of dopamine agonists within 4 weeks of screening visit.
* Participation in other investigational drug studies.
Perinatal Emotion and Relationships Longitudinal Study

This study, funded by the John Templeton Foundation, will examine birth and the early postpartum period (BEPP) as a transformative life experience that may shift women's experience of emotion in such ways as to a) support enhanced other-oriented emotions and b) underlie risk or resilience from psychopathology.

Specifically, the study will investigate the extent to which women can accurately have knowledge about and predict changes in self- and other-oriented emotion processes associated with BEPP. The investigators will also characterize the extent to which BEPP changes self- and other-oriented emotion processes and self- and other-oriented social behaviors. Further, the investigators will identify distinct trajectories of change in cognitive processes and self- and other-oriented emotion processes related to BEPP, and examine how those trajectories are associated with psychological adjustment (e.g., risk and relapse of psychopathology). Finally, the investigators will identify which particular features of BEPP are related to distinct patterns of change in self- and other-oriented emotion processes.

Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* Female
* Currently pregnant - approximately no more than 34 weeks gestational age
* Able to read and write in English fluently
* MDD Group: Meet DSM-IV/DSM-5 criteria for at least 1 past episode of Major Depressive Disorder
* MDD Group: DO NOT meet DSM-IV/DSM-5 criteria for any episodes of Major Depressive Disorder in past 2 months (currently in symptom remission)

Exclusion Criteria:

* Previous birth to a living child (i.e., this pregnancy is not their first child)
* Imminently suicidal or homicidal
* History of severe head trauma, stroke, neurological disease
* History of brain tumors or surgery
* Severe medical illness (e.g., autoimmune disorder, blindness, cardiovascular disease, HIV/AIDS)
* Endocrine disorders (e.g., Cushing's disease, thyroid disorder)
* Alcohol/substance abuse or dependence within the past six months
* Current psychotic episode (impairing ability to consent, participate, or keep patient and experimenter safe)
* Inability to follow study procedures
* CTL Group: Current or lifetime Axis I disorder (i.e., anxiety disorders, major depression, mania/hypomania, dysthymia, schizophrenia, schizoaffective disorder, substance abuse/dependence, eating disorders, hypochondriasis, pain disorder, or adjustment disorders)
Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

Mechanically ventilated intensive care patients will be sampled for a small amount of exhaled breath condensate from the ventilator circuit and for venous blood.

Proteomic analysis of the exhaled breath condensate will be performed using mass spectrometry and in the blood sample, corresponding changes in the DNA, RNA, proteins, and metabolites will be studied. Resulting profiles will be correlated with routinely monitored parameters in order to identify patterns corresponding to various pathologies in order to enable their early detection.

Exhaled breath condensate (EBC) is a product of gas exchange in the lungs. It contains plethora of substances of possible diagnostic value and its composition is likely to change rapidly in response to the development of pathological conditions, especially in the lungs.

Mechanically ventilated intensive care patients with various pathological conditions will be sampled for a small amount of EBC from the ventilator circuit and for venous blood. A sampling method not affecting relevant parameters of mechanical ventilation will be developed and standardised.

EBC samples will be frozen and after processing, proteomic analyses will be performed using mass spectrometry. In the blood sample, corresponding changes in the DNA, RNA, proteins, and metabolites will be studied using molecular biological methods. Resulting profiles will be correlated with routinely monitored parameters (such as inflammation markers, microbiological findings and mechanical ventilation parameters) with the aim of finding patterns corresponding to the early stages of various pathological conditions focusing on lung tissue. Identification of patterns specific to initial stages of lung and other organ pathologies would enable their early treatment possibly shortening mechanical ventilation/ICU stay and reducing morbidity/mortality.

Eligibility Criteria:
Inclusion Criteria:

Intensive care setting Mechanical ventilation Ventilator/ventilator circuit technically suitable for sampling of exhaled breath condensate

Exclusion Criteria:

Mechanical ventilation challenging to the extent that the insertion of the sampling kit into the ventilator circuit would substantially increase the risk for respiratory deterioration
Assays for and Reversal of New Anticoagulants

New anticoagulants are being introduced to replace warfarin. These drugs do not require monitoring and are safer. There is currently no recommended way to reverse these drugs rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to look at ways to reverse the drugs rapidly

We are developing in vitro assays of measurement of the effect of these drugs on the relevant coagulation pathways in plasma; such assays are not widely established. This will then allow us to test potential reversing agents such as activated Factor VII (Novo-Seven®), or Factor VIII inhibitor bypassing agent (FEIBA) for their ability to reverse these anti-coagulants invitro. The aims of this reversal research strategy is to provide a means whereby patients who present with serious bleeding or who need rapid reversal for surgery, for example, can be offered such treatment to allow rapid normalisation of their coagulation system.

As part of this developmental programme, we wish to obtain samples from patients receiving Rivaroxaban or Dabigatran for therapeutic reasons, to test the effect of the respective drug on the relevant coagulation factors and to test in vitro reversibility.

The only requirement for the patient is to have an extra 20ml of blood taken at a time when the patient is having other blood tests. There are no risks or experimental procedures planned to be carried out on patients.

Eligibility Criteria:
Inclusion Criteria:

* Receiving dabigatran for atrial fibrillation
* Or,for osteoarthritis of the hip or knee receiving rivaroxaban to prevent thromboembolic disease after total hip or knee replacement respectively

Exclusion Criteria:

* Failure to sign informed consent
Association of Synchronous Four-limb blOod pRessure and Pulse Wave velocIty With Cardiovascular Events

A multicenter prospective registry planned to recruit more than 100 000 patients 50 years old and older was carried out in China. This primary purpose of this study was to evaluate the association of synchronous four-limb blood pressure and pulse wave velocity with cardiovascular events. The secondary purpose was to evaluate the incidence rate,prevalence rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the effects of revascularization on cardiovascular events.

Although many studies with the correlation between synchronous four-limb blood pressure and pulse velocity measurement and cardiovascular outcomes have existed currently, the sample sizes are relatively small and the data on Chinese populations are lacking.Therefore, a multicenter prospective registry planned to recruit more than 100 000 patients aged 50 years old and older was carried out in China. This primary purpose of this study was to evaluate the association of synchronous four-limb blood pressure and pulse wave velocity with cardiovascular events in chinese populations. The secondary purpose was to evaluate the incidence rate,prevalence rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the effects of revascularization on cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years old at the time of informed consent
2. Chinese populations in hospital, community and physical examination center

Exclusion Criteria:

1. Patients with lack of limb,malformation of limbs, severe limb trauma or infection.
2. Serious organic disease affecting the quality of life, such as tumors, massive cerebral infarction, uremia, and etc.
Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive f(x)

This pilot clinical trial studies early brief behavioral intervention in treating sleep disturbance and improving quality of life in patients undergoing bone marrow transplant (BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and improve quality of life and cognitive function in patients undergoing BMT

PRIMARY OBJECTIVES:

I. To provide preliminary data on the feasibility and efficacy of brief behavioral treatment for insomnia (BBT-I) on insomnia in hematopoietic cell transplant (HCT) recipients.

SECONDARY OBJECTIVES:

I. To provide preliminary data on the influence of BBT-I on cancer-related fatigue (CRF) and cognitive status in BMT recipients.

II. To provide preliminary data on the influence of BBT-I on quality-of-life (QOL) in BMT recipients.

OUTLINE:

Patients complete the BBT-I, comprising the following modules: 1) "What to expect" in terms of fatigue and insomnia as it occurs with cancer and cancer treatment; 2) A review of the Spielman Model of insomnia; 3) A discussion (based on the Spielman Model) regarding how insomnia and fatigue may co-occur and interact in the context of cancer and cancer treatment; 4) An introduction to the concept and practice of Stimulus Control Therapy; 5) An introduction to Sleep Scheduling Specifically modified for cancer patients; 6) Sleep Compression; and 7) Concomitant Medications and Substance Use.

After completion of study treatment, patients are followed up at 1 month.

Eligibility Criteria:
Patients proceeding to BMT within the Stanford Adult BMT program will be screened for eligibility

Inclusion Criteria:

* Patient is scheduled to receive bone marrow transplantation.
* Patient has a diagnosis of Non-Hodgkin's Lymphoma
* Patient is at least 21 years old
* Patient is able to understand written and spoken English
* has preferred sleep phase between 9:00 pm and 3:00 am and a habitual rise time between 4:00 am and 11:00 am
* Patient receives a score of 8 or more on the Insomnia Severity Index or takes sleep medications 3 times a week

Exclusion criteria:

* Has an unstable medical or psychiatric illness (Axis I - current or within the last 5 years)
* Existing cognitive disability
* Is currently pregnant or nursing
* Has a history of substance abuse or meets criteria for current alcohol abuse or dependence
* Has a self-reported history of chronic pre-existing insomnia, sleep apnea or RSL syndrome
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study

This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation.

The compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age.

They will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.

Eligibility Criteria:
Inclusion Criteria:

* All patients with an Retinal Vein Occlusion for one group (patients)
* All patients with no Retinal Vein Occlusion for the other group (control)

Non-inclusion Criteria:

* minor
* Severe Insomnia
* Neuromuscular Disease with respiratory muscle impairment
* Chronic opioid medication
* Pregnancy women.
* Patient under guardianship
Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery

The enteroendocrine system is composed from different cells along the different parts of the gastrointestinal tract, secreting diverse hormones and bariatric surgery alters intestinal hormone secretion, affecting glycemic control and weight. The aim of the study is to characterize the composition and secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post bariatric surgery.

Obesity and Diabetes Mellitus (DM) impose a significant burden of morbidity on many individuals around the world. In recent years, the enteroendocrine cells system with its diverse hormones (Glucagon, GLP-1, GIP and others) was increasingly recognized as a key player in obesity and DM homeostasis.

Bariatric surgery induces weight loss as well as an improvement in glycemic control often leading to diabetes reversal and occasionally to postprandial hypoglycemic events. The aim of the study is to characterize the composition and secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* BMI\>= 35 or BMI\<=25 or 6-12 months after RYGB surgery

Exclusion Criteria:

* Known HIV infection
* Any NSAID'S usage in the last 3 months
* Known Celiac disease
* Concomitant disease with potential small bowel or colonic involvement (Tb, sarcoidosis, IBD, microscopic colitis etc')
* Pregnancy
* Participation in another clinical trial
* Any use of medications known to modulate glucagon levels such as GLP1 analogs, DPP4 inhibitors and/or SGLT2 inhibitors.
* Insulin-treated patients.
* Declined to sign an informed consent
Time Restricted Feeding, Muscle, and Metabolism

Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Resides in Northwest Arkansas
* Age 25-50 years
* BMI \> 25
* All ethnicities
* Female and male

Exclusion Criteria:

* Food allergies
* Pregnant or breastfeeding
* Dietary restrictions (e.g. vegetarian, vegan, etc.)
* Trying to lose weight in last 3 months
* Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)
* Prescription medications related to heart disease or type 2 diabetes
* Fear of needles
* Smoker or vaping
* Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes
* Consumes \>4 alcoholic beverages per week
Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.

A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.

The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.

Eligibility Criteria:
Inclusion Criteria:

For the subacute groups:

* Two weeks after the onset of stroke, however less than 0.5 year
* Mini-Mental State Examination (MMSE)\>21
* Able to sit up for at least 1 hour
* Fugl-Meyer Assessment (FMA) upper limb \<30
* Modified Ashworth Score (MAS) at the elbow, wrist and fingers \<3
* Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)

For the chronic device assisted group:

* At least 0.5 year after the onset of stroke
* Mini-Mental State Examination (MMSE)\>21
* Able to sit up for at least 1 hour
* Fugl-Meyer Assessment (FMA) upper limb \<30
* Modified Ashworth Score (MAS) at the elbow, wrist and fingers \<3
* Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)

Exclusion Criteria:

Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:

* Currently pregnant
* Dysphasia (language deficiency)
* Post-stroke neglect
* Pacemaker implantation,
* Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb
* The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).