cyrilzakka/clinical-trials huggingface dataset:
Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study

Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple sugar intake. It would also reduce anthropological ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite associated to CVD.

This study has a randomized single blind crossover design that compares a plant-based diet towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each dietary intervention (plant-based and western) would last for 16 consecutive days separated by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in for the next 2 consecutive days (24h and 48h post treatment).


Eligibility Criteria:
Inclusion Criteria:

* Free-living, apparently healthy adults
* Bmi\>18
* Aged 18-70 years at recruitment
* Non-smokers

Exclusion criteria:

* Non-free-living adults
* Adults \<18 or \>70 years at recruitment
* BMI\<18
* Current smokers
The Monica Fetal Heart Monitor

The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.

If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours.

The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour.

Total time of patient's involvement will be 7 hours.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients between 24 and 28 weeks admitted to the antepartum service

Exclusion Criteria:

* Patients with a non viable pregnancy
* Patients with multiple gestation
* Clinically Unstable patients
* Non English speaking patients
TGRX-678 Phase I Oral Pharmacokinetic Study

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678

This study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on PK profile of TGRX-678 in healthy subjects. Safety and tolerability of the drug is also evaluated during study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants, male or female
* Age between 18 and 45 (both inclusive)
* Body Weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m\^2 (both inclusive)
* Signing informed concent at own will
* Able to communicate with researcher and able to complete study per protocol instruction

Exclusion Criteria:

* Clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ECG) test
* Positive results for Hepatitis B, Hepatitis C, HIV or Syphilis
* QT interval elongation as indicated by 12-lead ECG test during screening period
* Use of any medication that could impact CYP3A4 enzyme activities within 30 days prior to Screening period
* Use of any medication within 14 days of first dose of the investigational drug
* Vaccinated within 30 days of first dose of the investigational drug, or planning to be vaccinated during study
* History of instrumental cardiovascular diseases
* Received major surgery within 6 months prior to Screening, or with surgical wounds not completely healed
* History of any severe disease or conditions that could affect study results per investigator's discretion
* History of allergic conditions or is allergic to components of the investigational drug
* Having conditions that could affect drug absorption or difficulties to swallow
* History of smoking of \>5 cigarettes per day within 3 months prior to screening, or cannot stop tabacco using during study
* History of alcohol abuse, or alcohol consumption of \>14 unit alcohol within 3 months prior to screening
* History of substance use, or tested positive for drug test during screening
* History of specific food (i.e., grapefruit, mango) consumption, or/and large tea/coffee/caffeinated drink/grapefruit product intake of \> 8 cups per day, within 2 weeks prior to first dose
* Having special dietary requirement and cannot comply with food requirement of the study
* Pregnant or breastfeeding female, or tested positive in pregnancy test
* History of unprotected sexual activities within 1 month prior to screening
* Having plans for pregnancy during the study and within 6 months after study completion; or not agreeing to take strict contraceptive measures during study and within 6 months after study completion
* History of blood loss/ blood donation of ≥ 400 mL within 3 months prior to screening, or planning to donate blood within 1 month after study completion
* Any reasons that is deemed unsuitable for study participation as determined by investigator
Does Teaching Before or After Simulation Improve Learning?

The goal of the randomized educational intervention study is to test whether simulation preceding didactic teaching leads to improved knowledge and performance retention compared to a didactic lecture proceeding simulation for medical students

Participants will be randomized to one of two different groups with reverse orders for simulation and lectures.

Researchers will compare each group to see which way is better for learning.


Eligibility Criteria:
Inclusion Criteria:

- Second year medical student at the University of British Columbia

Exclusion Criteria:

- None
Foldable Capsular Vitreous Body Implantation Study

This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* Axial length between 16 and 28 mm (according the guidelines from the manufacturer)
* Loss of functional vision in study eye
* Visual acuity of 0.4 or better in fellow eye
* Requirement of (repeated) long-term silicone oil tamponade to maintain eye pressure and keep the retina attached

Exclusion Criteria:

* Visual acuity beyond 0.4 in non-study eye
* Severe general disease that is evaluated to impact live expectancy beyond the duration of the study follow-up (3 years)
* Retinal detachment under silicone oil fill
* Patients with a silica gel allergy or scar diathesis
* Patients with serious heart, lung, liver, or kidney dysfunction
* Patients with proliferative diabetic retinopathy, endophthalmia, uveitis and other uncontrollable eye diseases, or a contralateral eye that had intraocular retinal surgery
* Patients with history of drug abuse or alcoholism
* Patients are had participating in other drug or medical device clinical trials before screening for this trial
* Pregnancy, preparation for pregnancy during clinical trial, or breast-feeding
* Belief by any of the research doctors that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression
RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke

The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions.

Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age 18 years and above
* Post-stroke lower-limb spasticity
* Prior agreement with the patient to inject BoNT-A
* If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion).
* Therapeutic goals agreed jointly with the patient
* Functional Ambulation Classification (FAC) score 2-5
* Capacity to comply with the protocol
* Written informed consent

Exclusion Criteria:

* Documented positive antigenicity to botulinum toxin
* Neuromuscular disease
* Use of medications that interfere with neuromuscular transmission
* Severe muscle atrophy in any muscle to be injected
* Any other indication that might interfere with rehabilitation or the evaluation of results
* Any non-stroke spasticity diagnosis
* Pregnancy or nursing mothers
* Previous participation in any study using Goal Attainment Scale (GAS)
REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea

The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.
* AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
* BMI ≤ 32.
* Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).

Exclusion Criteria:

* Patient with prior tongue-base surgery
* Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
* History of mandibular and/or hyoid advancement to treat OSA.
* Any contraindications as listed in the approved Instructions for Use.
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants with metastatic triple negative breast cancer.

The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups:

* Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34)
* Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=33)
* Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=35)

The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.

The posted results represent the final results of Study G1T28-04, a Phase 2 study of the safety, efficacy and pharmacokinetics of trilaciclib (G1T28) in patients with locally recurrent/metastatic triple negative breast cancer receiving gemcitabine and carboplatin chemotherapy.

The final myelopreservation efficacy results are reported from database lock 1 (\[DBL1\], data cut-off \[DCO\] date of 30 July 2018). Final anti-tumor efficacy (ORR, PFS), and final summary exposure and safety data are reported from database lock 2 (\[DBL2\], DCO 28 June 2019) which occurred to support filing of the trilaciclib New Drug Application (NDA). Final overall survival (OS) data are reported from the final database lock which occurred on 17 July 2020 (with a last patient last visit date of 28 February 2020).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of hormone receptor (HR)-negative, human epidermal growth factor receptor 2 (HER2)-negative (locally recurrent or metastatic TNBC) breast cancer
* Available TNBC diagnostic tumor tissue (archived tissue allowed)
* Evaluable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Adequate organ function
* Predicted life expectancy of 3 or more months

Exclusion Criteria:

* More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If \> 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence the therapy will not be considered a line of therapy in the locally recurrent or metastatic TNBC setting.
* CNS metastases or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
* Investigational drug within 30 days of first trilaciclib (G1T28) dose
* Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose
* Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose
* Prior hematopoietic stem cell or bone marrow transplantation
Nutrition Knowledge for Spanish-speaking Parents

Providing child nutrition information is a major goal of every pediatric well-child visit. Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is challenging and insufficient. It is because of this that some have looked for innovative ways to enhance the delivery of this information. One such way is the use of touch screen computer programs containing nutritional information. Several studies have documented the value of patients receiving health information in such a manner.

Nonetheless, the use of this medium has not been well studied in Spanish-speaking care providers of young children. The investigators recently conducted a study that evaluated user's perception of the usability of such technology, finding that most users thought that the touchscreen was easy to use, despite their low computer confidence levels. The investigators also evaluated the impact of using nutrition modules on user's nutrition knowledge, finding that immediately after use; participant's nutrition knowledge was improved. I now propose to evaluate this technology further through a 4 armed randomized controlled trial. The goal here is to evaluate the longer term impact of the educational modules on nutrition knowledge and the impact, if any, of additional web access to the modules, on longer term knowledge. A secondary goal is to better understand nutritional habits in this population and perceptions of weight.


Eligibility Criteria:
Inclusion Criteria:

* Self identify as Latino/a
* Spanish-speaking
* Over 18 years old
* Primary caregiver to a child 2 years old and under

Exclusion Criteria:

* Child 2 years old and under has significant medical issue requiring special nutrition needs, e.g. g-tube or feeding tube dependent, severe food allergies.
* Person has used the nutrition modules before in prior studies
Validation of a Training Program for Patients With Alcohol Use Disorder

This study aims to detect how the Web-based program SALIENCE affects patients with alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.

In the web-based program SALIENCE ("Stop Alcohol In Everyday life - New Choices and Evaluations") the patient has to make decisions for non-alcoholic and against alcoholic drinks. Therefore there are several scenarios, which are supposed to let the patient integrate these choices into a realistic, everyday life, setting and help the patient to maintain abstinence in upcoming "high risk situations". It has been developed as an add-on therapy to increase the overall outcome.

Participating patients with alcohol-use disorder are to receive an initial screening including questionnaires and neuropsychological tests. Then the patients receive three training sessions with SALIENCE each week.

After three weeks there is another examination. After these three weeks, there is a 90 day period in which there are online follow-ups every two weeks to assess the craving and relapse of the participants. After the 90 day period there is a third examination analog to the first and the second one.

For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an interim evaluation will be performed after T2 as a pilot study, followed by optimization of the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2 in the pilot study.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* alcohol use disorder (DSM-5)
* inpatient or part inpatient treatment
* alcohol abstinence for at least 72 hours and maximum for three weeks
* normal or correctable eyesight
* Sufficient ability to communicate with the investigators, to answer questions in oral and written form
* "Fully Informed Consent"
* "Written Informed Consent"

Exclusion Criteria:

* Withdrawal of the declaration of consent
* severe internistic, neurological or psychiatric comorbidities
* severe withdrawal symptoms (CIWA-R \> 7)
* alcohol-intoxication (\> 0 ‰)
* Pharmacotherapy with psychoactive substances within the last 14 days (except Clomethiazole or Benzodiazepines within the alcohol withdrawal treatment; treatment with these medications has to be completed within last 3 days)
* Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)
Proprioception and Multi Sensory Training After DRF

Distal radius fracture is the most common upper extremity fracture with peak incidence among older women after the fifth decade of life. Proprioception is one constituent of a complex Sensory motor control process. Proprioception requires the reception and central integration of incoming afferent signals. Although various sensory and motor deficits have been correlated with significant functional impairment after wrist trauma, limited research exists on the effects of proprioception and multi sensory training after distal radius fracture.

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of distal radius fracture (aged 18 years and above). Both assessor and statistician will remained blinded.

Standard rehabilitation program for distal radius fracture treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group, in addition, will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).

The severity of pain with activity will be measured according to the visual analog scale (VAS). PRWE questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) and force sense (FS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 3 weeks and at 12 weeks following the end of the intervention.

Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.

All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosis of distal radius fracture.
* Wrist immobilization after lesion (unless 3 weeks)
* Capacity for sing inform concept and understand the exercises

Exclusion Criteria:

* Others associate fractures in hand or upper limb
* Wrist ligaments injuries
* Neurological disorder affecting the upper limb
* Have received previous proprioceptive training for upper limb injury.
ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment

This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of concurrent panic disorder
* At least 2 panic attacks within the 4 weeks before the screening visit
* Naïve to the CO2 challenge test
* Age 18-65 years (inclusive)
* Ability to comply with all procedures mandated by the study protocol
* Negative pregnancy test and adequate contraceptive measures

Exclusion Criteria:

* History of poly-pharmacotherapy for panic disorder or treatment resistance
* Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia
* History of abuse of benzodiazepines or tolerance to effects of benzodiazepine
* Any concomitant psychotropic medication
* Evidence of impaired hepatic, renal or cardiac functions
* Participation in any drug trial in the preceding 6 months
Media Impact on Preschool Behavior

This study tests the hypothesis that modifying the media diet of preschool children so that they watch more prosocial programming and less violent programming will result in decreased aggression and increased prosocial behavior.


Eligibility Criteria:
Inclusion Criteria:

* 2.5-4 years of age
* watches TV regularly
* English speaking

Exclusion Criteria:

* no TV
* non English