cyrilzakka/clinical-trials huggingface dataset:
Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment

The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat.

As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by CMIA. In vitro simulated digestion will be studied.

Expected results: The BA of VD in CM would not be lower than in fat


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Metabolic disorder
A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes

This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is \<50.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-75 years of age
* Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
* Treatment with diet and exercise
* BMI between 27 and 40 kg/m2

Exclusion Criteria:

* Type 1 diabetes
* History of ketoacidosis, hyperosmolar coma, or lactic acidosis
* Renal disease or renal dysfunction
* Evidence of significant diabetic complication
* Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
* History of anti-diabetic triple therapy
Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy

The GangTrainer GT I and the Lokomat have proven their effectiveness on stroke Patients, but a comparison on the same controlled study population has not been made so far. Aim of the study will not only be to establish which device will work better on acute, non ambulatory stroke Patients in terms of regain of gait ability and motor function, but also clinical matters, like the efficacy of the treatment period. As a result of the trial it should be highlighted which kind of therapy has to be suggested for Patients comparable to the study population. A significant better outcome of one device in regard to the other will suggest to use one device more than the other for future treatments.

A total of 120 Patients will be enroled in the study and divided into 2 treatment and 1 control group. Enroled Patients will all be first supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks.

Theywill undergo either robotic treatment with the Gangtrainer GT1 or the Lokomat in one of the 2 treatment groups for 30 minutes of gross therapy time every workday for a 8 weeks period if they are in the treatment group, or conventional physiokinetherapy for 30 minutes of gross therapy time every workday for a 8 weeks period if they are in the control group.

Primary outcome will be the Functional Ambulation Category (FAC) assessed at enrolment, after 4 weeks after 8 weeks and at 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* First supratentorial stroke (ischaemic, haemorrhagic or ICH) resulting in a hemiparesis
* Interval from stroke 3 - 12 weeks
* Non ambulatory (FAC \< 3)
* Free sitting on bedside for 1 minute, both feet on the floor, ev. holding on bedside by hands
* Barthel Index 25 - 65

Exclusion Criteria:

* Unstable cardiovascular system (in case of doubt, only after approval by a internist)
* Manifested heart diseases like labile compensated cardiac insufficiency (NYHA III), angina pectoris, myocardial infarction 120 days before study onset, cardiomyopathy, severe cardiac arrhythmia
* Severe joint misalignment (severe constriction of movement for hip, knee and/or ankle: more than 20° fixed hip and knee extension deficit, or more than 20° fixed plantar flexion of the ankle
* Severe cognitive dysfunction, which does not allow for comprehension of the aims of this study
* Severe neurological or orthopaedic diseases (like polio, Parkinson´s disease), which massively affect the mobility
* Deep vein thrombosis
* Severe osteoporosis
* Malignant tumour diseases
Phase II Study of ABI-007 for Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed gastric adenocarcinoma
* Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
* Age: 20 - 74
* At least one measurable lesion by RECIST criteria

Exclusion Criteria:

* History of Taxans use
* Patients with another active malignancy
* Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
* Chronic treatment with steroids
PULSED AF Post-Approval Study

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
* Failure or intolerance of at least one Class I or III antiarrhythmic drug
* Patient is ≥ 18 years of age
* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

* Long-standing persistent AF (continuous AF sustained \>12 months)
* Prior left atrial ablation or left atrial surgical procedure
* Patient with life expectancy \< 36 months
* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager
Influence of an App on Quality of Life of Women With Endometriosis

Comparison of quality of life before and after 14 days of use of Endo App® in endometriosis patients compared to non-users

Introduction: Endometriosis can significantly impair the quality of life of those affected. Multimodal self-help measures are recommended but often difficult to access. Smartphone apps have been shown to improve quality of life for other conditions with chronic pain. The aim of this study was to examine whether there is evidence of beneficial effects of the Endo-App and whether a multicenter randomized controlled trial should be planned to substantiate these effects.

Methods: In a sample of N=106 women affected by endometriosis the present study determined the influence of the use of a smartphone app (Endo-App ®) on their quality of life. Among others, the validated questionnaire Endometriosis Health Profile from Oxford University was used for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* suffering from endometriosis
* 18 years or older
* willing and capable of using a smartphone

Exclusion Criteria:

* minor under 18 years
* endometriosis excluded
* not capable of using a smartphone
Energy Expenditure During Seated, Seated Cycling, and Treadmill Walking Work Conditions (EE-Work)

The study is designed to measure the energy expenditure associated with a common office task (i.e., typing) while 1.) seated in an office chair, 2.) pedaling using a prototype pedal desk, and 3.) walking on a treadmill.

The anthropometrics will be measured first. The height and body weight will be collected by clinic staff in the clinic.

The metabolic testing of all conditions will take place in a real office setting. The participant will be fitted with a heart rate monitor fastened around their chest using an elastic strap. They will also be fitted with a portable metabolic system (COSMED). This unit fits around their waist and back, much like a backpack. The unit is attached to a face mask that fits over their mouth and nose and is secured by elastic straps which wrap around their head.

The participants will first rest motionless in a chair for 20 minutes. Following this, they will complete three different simulated working conditions by typing at a computer while 1) seated in an office chair, 2) seated pedaling while using a prototype pedal desk, and 3) walking on a treadmill. The order of testing for the seated pedaling and treadmill walking working conditions will be counterbalanced with participants randomly assigned to the two possible order permutations. They will complete the 3 working conditions for 15 minutes each at their own self-selected level of effort. A rest period of 5 minutes will be given between each condition. During the working conditions, they will be asked to retype a displayed standard set of text.

Eligibility Criteria:
Inclusion Criteria:

* You are a full-time employee at the Pennington Biomedical Research Center
* You are between 21 and 65 years of age
* You previously participated in the Pennington Biomedical Research Center's Worker's Acceptability of a Prototype Integrated and Interactive Pedal Desk study (WAPD study)
* You are familiar with using word processing software and comfortable using a standard computer keyboard
* You primarily sit while at work

Exclusion Criteria:

* You weigh more than 250 pounds
* You are pregnant or lactating
* You have high blood pressure (greater than 159 mmHg systolic or 99 mmHg diastolic).
* You use tobacco or other nicotine products
* You have a medical condition or take medications that influence heart rate or metabolic rate (for example - beta blockers, antihistamines, anti-depressants, diuretics, thyroid medications).
* You have physical limitations that prevent performance of pedal motions or normal walking. You have any previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks (TIAs), chest pain, unusual shortness of breath during physical activity, severe ankle edema (swelling), or intermittent claudication (pain caused by lack of blood flow during physical activity).
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction

Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.

The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI.

Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.

Eligibility Criteria:
Inclusion Criteria:

All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI.

Exclusion Criteria:

Patients are excluded if they were in cardiogenic shock.
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.

Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.


Eligibility Criteria:
Inclusion Criteria:

• Grade 2 and 3 acute ankle sprains

Exclusion Criteria:

* history of ankle sprains with persistent instability
* grade I lateral ankle sprains
* ankle fracture
* bilateral ankle sprains
* previous ankle ligament surgery
* neuromuscular disorders of the lower extremities
* rheumatoid arthritis,
* alcoholism,
* serious psychiatric or neurological illness
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.


Eligibility Criteria:
Inclusion Criteria:

* Adapted soft contact lens wearer;
* Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
* Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
* Correctable to 6/9 (20/30) in both eyes;
* Read, understood and signed the informed consent;
* Willing to comply with the wear schedule;
* Willing to comply with the study visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any active corneal infection, injury or inflammation;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Systemic or ocular disease which might interfere with contact lens wear;
* Strabismus or amblyopia;
* Corneal refractive surgery and any anterior segment surgery;
* Use of systemic/topical medication contraindicating contact lens wear;
* Use of gas permeable contact lenses within 1 month preceding the study;
* Participation in any concurrent clinical trial or in the last 30 days;
* Other protocol-defined exclusion criteria may apply.
Periodontal Impact of Eating Disorders (the PERIOED Study)

This study evaluated the periodontal status of patients suffering from eating disorders (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients have a higher risk for periodontal diseases than non-eating disorder subjects.

Eating disorders have been associated with poor oral health. However, the relationship between eating disorders and periodontal diseases is less-established. Participants will be periodontally assessed using a full-mouth clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* In and out eating disorder patients
* Subject with a diagnosis of anorexia nervosa or bulimia nervosa for at least 5 years
* Subject affiliated to the French social insurance

Exclusion Criteria:

* Subject who do not speak French
* Subject who is not able to read and/or understand the information form
* Subject who take anti-inflammatory medications or antibiotics at dental examination
* Subject who has received any dental treatment that could interfere with the periodontal status 3 month before the clinical examination (scaling and root planning, orthodontic treatment ongoing)
* Subject who has less than 10 teeth
Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy

This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.

Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.

Eligibility Criteria:
Inclusion Criteria:

* underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
* American Society of Anesthesiologist (ASA) physical status 1-3

Exclusion Criteria:

* psychological or neurological disorders (routine haloperidol consumption)
* history of allergic reaction to dexamethasone or haloperidol
* diabetes mellitus
* did not give the consent
Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

A transendoscopic enteral tubing (TET ) tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. This study aimed to evaluate the feasibility and safety of TET in mid-gut .

In recent years, fecal microbiota transplantation (FMT) has gained appeal as a therapeutic option worldwide. Traditionally, microbiota can be administered through the upper-gut, the mid-gut, and the lower-gut pathways. FMT via colonoscopy is a classic approach, but in our previous study on ulcerative colitis, those patients have difficulty to maintain the infused microbiota suspension for enough time through this way. Thus, the investigators designed the colonic transendoscopic enteral tubing (TET) technology, which made whole-colon administration of treatment and repeat FMTs possible. However, some patients are resistant to undergo bowel preparation for colonoscopy or some are not suitable for colonic delivering way. Therefore, mid-gut delivering way is an important option for those patients. In previous researches on FMT for Crohn's disease, patients and physician faced the similar problem that some patients need repeat FMT during hospitalization, and some may need enteral nutrition at the same time. In order to have a quicker and more convenient placement of mid-gut/nasal-jejunal TET tube than traditional methods, the investigators designed a novel mid-gut TET technique without further confirmation for the location of tube in gut by X-ray or other medical devices after the endoscopic procedure. This study aimed to evaluate the feasibility, safety, and value of the mid-gut TET technique.

Eligibility Criteria:
Inclusion Criteria:

Mild to moderate inflammatory bowel disease (Montreal classification) or suitability for endoscopy, and consented to undergo TET placement for their diseases and conditions

Exclusion Criteria:

No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.

With contraindication of endoscopy. Pregnant or lactating female
Postoperative Quality of Recovery After General Anesthesia With Remimazolam

126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.

This study was a randomized, single-blind, single-center, positive drug controlled, non-inferiority trial. According to the inclusion and exclusion criteria, 126 patients undergoing general anesthesia for elective non-cardiac surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. After the patient lost consciousness, routine analgesia and muscle relaxants were given, followed by tracheal intubation and mechanical ventilation. During the anesthesia maintenance phase, vital signs and depth of anesthesia were continuously monitored, sedatives and analgesics were continuously pumped, and muscle relaxants were added intermittently as needed. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.

Eligibility Criteria:
Inclusion Criteria:

1. ASA was classified as I-II
2. The operative time was less than 180 minutes
3. Age ranges from 18 to 65 years
4. Informed consent is signed by all study participants

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with Difficult Airways
3. History of severe neurological and muscular diseases and mental retardation
4. Patients with severe respiratory and circulatory diseases
5. Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
6. Urea or urea nitrogen ≥1.5×ULN, serum creatinine greater than the upper limit of normal
7. Take diazole drugs and/or opioids in one month or nearly three months
8. Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
9. Patients who could not monitor the depth of anesthesia for various reasons