cyrilzakka/clinical-trials huggingface dataset:
Calcium, Protein and Gut Hormones

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.

Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).

Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women age between 18-65 yrs.
* Able to consume provided supplement.
* Weigh stable for the past 3 month (no change within 3%).

Exclusion Criteria:

* Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
* Not between the ages of 18-65 years
* A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
* Taking medications that may influence your metabolism
* Plans to change your lifestyle (diet and/or physical activity) during the study period
* Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
* Current smoker
Transcranial Electrical and Acoustic Stimulation for Tinnitus

Transcranial electrical stimulation (tES) is an umbrella term for non-invasive brain stimulation using weak currents. It comprises transcranial direct current stimulation (tDCS), which is the most established and used method applying constant direct current, transcranial alternating current stimulation (tACS) with sinusoidal current in a fixed frequency, and finally transcranial random noise stimulation (tRNS), which is a subform of tACS generating a random range of low and high frequency alternating currents.

A pilot study conducted by Shekhawat and colleagues in 2015 tested the effects of simultaneous electrical and acoustic stimulation. Using tDCS and bilateral broadband noise simultaneously, they found that more tinnitus patients report an improvement in tinnitus perception in comparison to conditions only using tDCS or sham. Further similar approaches very published in recent years, namely a pilot study conducted by Teissmann et al in 2014; study protocols of Rabau et al. in 2015 and Shekhawat et al. in 2015; and an experimental study by Lee et al. in 2017. Results were indicative of a superior efficacy of combined electrical and acoustic approaches, while large-scale controlled studies have not been performed. The need for extension and replication of these approaches is therefore timely.

The aim behind our proposed approach, similar to the bimodal approaches above, is to couple the effects of tRNS and acoustic stimulation (AS) for better temporary tinnitus suppression and possible reversal of maladaptive neuroplasticity related to tinnitus. We aim at targeting the (bilateral) auditory cortex with tRNS as in former studies and combine it with white noise (WN) stimulation. This specific combination is novel in its nature and is building on cortical excitability following tRNS.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years to 75 years of age (younger age limit according to corona virus protection concepts and measures of the FOPH: Schutzkonzepte und -massnahmen (admin.ch))
* Persistent chronic tinnitus with duration of more than 3 months
* Signed Informed Consent after being informed about the study
* Fluent in German or English
* Tinnitus with a THI Grade 2 to 4 (18-76 points)
* Willing and able to attend the study visits

Exclusion Criteria:

* Actual neurological or psychiatric disorders
* Hyperacusis
* Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics)
* Implanted pacemaker
* Surgical implants in the head region, such as cochlea implants
* Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss \> 40dB in any measured frequency up to 2kHz
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Known or suspected non-compliance, drug or alcohol abuse
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients

Adequate bowel preparation is critical for successful colonoscopy and a large volume of PEG was required for bowel preparation in patients undergoing colonoscopy. The investigators conducted a a prospective, randomized, controlled study to compare low dose of oral magnesium sulfate solution with high dose PEG. The investigators found that patients who took low dose of oral magnesium sulfate solution had similar bowel preparation quality to patients who took PEG,but accompanied with fewer adverse events and better tolerance.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent colonoscopy

Exclusion Criteria:

* known or suspected bowel stricture or obstruction;
* history of colorectal surgery;
* significant gastroparesis or gastric outlet obstruction;
* toxic colitis or megacolon;
* severe acute inflammatory bowel disease;
* active gastrointestinal bleeding;
* suspected or confirmed chronic renal insufficiency and heart illness;
* disturbance of electrolytes ;
* unable to provide informed consent
Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease

This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with idiopathic Parkinson's disease and hypophonia by a neurologist at least 6 months prior to participation.
* stabilized on antiparkinsonian medication.
* good general health.
* pass a 40 decibel hearing screening.
* proficient enough in English to participate in speech testing.

Exclusion Criteria:

* history of stroke or an additional neurological or motor control disorder.
* history of speech impairment that is unrelated to Parkinson's disease.
Kettlebell Swings and Paraspinal Muscle Function

The purpose of this randomized control trial is to determine the extent of muscle fatigue in the lumbar erector spinae musculature secondary to a high-intensity interval kettlebell swing protocol utilizing TMG previously published by Jay et. al in 2011.

Background: Kettlebell swings are commonly utilized to target the lumbar erector spinae and lower body musculature. This exercise exhibits distinct loading properties that requires cyclical contraction of the trunk extensors and posterior chain, potentially explaining its novel influence on muscle contractility. Tensiomyography (TMG) is a reliable, noninvasive, passive technique that may be used to examine muscular fatigue produced by kettlebell swings. Purpose: The purpose of this randomized control trial is to determine the extent of muscle fatigue in the lumbar erector spinae musculature secondary to a high-intensity interval kettlebell swing protocol utilizing TMG previously published by Jay et. al in 2011. Subjects: Forty-one adults between the ages of 18 and 45 were recruited. Inclusion criteria included subjects with no recent history of low back pain and clearance by the physical activity readiness questionnaire. Methods: Participants were randomly allocated to either a kettlebell swing group (KBS; n=21) or a control group (CON; n=20) who only performed the unloaded warm up. Participants were assessed at baseline, post-intervention, and 24-hours post-intervention for bilateral erector spinae fatigue, measured by five TMG parameters (Dm, Tc, Tr, Td, Ts).

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18 and 45 years of age.
* Clear PAR-Q

Exclusion Criteria:

* history of low back pain
* pre-existing injuries
* If "YES" was the response to any of the seven questions in the PAR-Q, the participant was deemed to be unable to exercise safely.
Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. Adequate organ function.

Exclusion Criteria:

1. Patients had distant metastasis.
2. oesophageal invasion of more than 3 cm.
3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
4. Previous chemotherapy or radiation therapy for any other malignancies.
Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.

The purpose of this study is to evaluate whether valproic acid in combination with fear memory reactivation is useful to enhance treatment stability of exposure therapy for specific phobia.

* There will be one screening visit (visit 1), one intervention visit (visit 2) and one follow-up visit (90 days after visit 2) (visit 3).
* On visit 2 all participants will undergo 30 min exposure therapy in virtual reality with pre-defined spider situations.
* Duration for an individual participant will be at most 15 weeks depending on the time passing between screening (visit 1) and intervention visit (visit 2).
* Change in phobic fear to baseline (visit 1) will be assessed on 90 day follow-up (visit 3).
* Documentation of all study relevant source data of every study participant will be done by completing the study specific electronic case report forms (eCRF, SoSci Survey) and study specific case report forms on paper (Adverse Events, Serious Adverse Events and concomitant medication). Data in the eCRF can be validated for completeness and discrepancies automatically. An audit trail system maintains a record of initial entries and changes (reasons for changes, time and date of changes, user identification of entry and changes).
* Quality insurance will be done by an external site monitoring (including study progress, accuracy and completeness of eCRF, fulfillment of protocol requirements, applicable local authority regulations and investigator's obligations).
* Monitoring includes 100% of safety parameters, primary endpoints, informed consent documents and the Trial Master File on the Initiation Visit and on Close Out.
* Standard Operating Procedures to address study activities such as patient recruitment, informed consent, study interventions, data collection, data management, data analysis, and reporting for adverse events exist.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of specific phobia (animal type: spider)
* BAT score (at screening) between 1 and 7 points
* Physically healthy
* Normotensive (90/60-140/90 mmHg)
* Male or female
* Aged between 18 and 40 years
* Native or fluent German-speaking
* Females have to be on effective birth control

Exclusion Criteria:

* Other axis I disorder except a further comorbid phobic disorder
* Concurrent psychotherapy or pharmacotherapy
* Previous exposure-based therapy for specific phobia
* Parallel participation in another study
* Body weight less than 50kg
* Long-term medication intake
* Substance abuse
* 5 or more cigarettes a day and/or inability of being abstinent for at least 5 hours
* Pregnancy or breast-feeding
* Kinetosis
* History of coagulation disease
* History of gastrointestinal disease
* Laboratory exclusion criteria: clinically relevant deviation of laboratory values (blood count, blood chemistry, coagulation status, liver and pancreas enzymes, electrolytes) from normal range
Results of Knee Arthroscopic Surgery for Treatment of Cruciate Ligament and Meniscus

This study is a retrospective review of chart. Clinical results including range of motion, muscle power and scores will be recorded. Arthrocopic surgery of cruciate ligament and meniscus will be re-evaluated for clinical application.


Eligibility Criteria:
Inclusion Criteria:

* ACL reconstructions
* PCL reconstructions
* Meniscectomy or Meniscus repair

Exclusion Criteria:

* Open surgery for knee lesion
* Combined fracture or other associated injury around knee
Burden of Influenza at Emergency Department (ED) Level in European Countries

This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.

Study objectives

Primary:

- Measure the proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season

Secondary:

* Describe the demographic and medical profile of influenza-related and non-influenza-related visits
* Identify socio-demographic or other risk factors associated with ED visit outcome
* Describe the influenza positivity rate among ED visits for different causes
* Measure the proportion of influenza positive patients without classical ILI symptoms

Eligibility Criteria:
Inclusion Criteria:

* All adult patients seeking care at participating ED during the influenza season
* Participants and/or guardian providing informed consent and/or assent, as appropriate, to participate.

Exclusion Criteria:

* Individuals reporting having suffered a traumatic injury without other conditions.
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy men and women
* women of childbearing potential who are using acceptable method of contraception
* Women who are not pregnant or nursing
* Body Mass Index (BMI) of 18 to 29.9 kg/m\^2, inclusive. BMI=weight(kg)/height(m)\^2.

Key Exclusion Criteria:

* Any significant acute or chronic medical illness.
* History of gastrointestinal (GI) disease
* Major surgery within 4 weeks of study drug administration
* Any GI surgery that could impact study drug absorption
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
* Blood transfusion within 3 months of study drug administration for women and within 2 months for men
* Inability to be venipunctured and/or tolerate venous access
* Current smoker or recent (within 1 month) history of regular tobacco use
* Recent (within 6 months of study drug administration) drug or alcohol abuse
* Participation in a bioequivalence study within the last 6 months of study drug administration
* Estimated creatinine clearance of \<80 mL/min using Cockcroft-Gault formula
* History of allergy to drug class or related compounds
* History of allergy to metformin or other similar acting agents
* History of any significant drug allergy
Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

This prospective study was performed to compare two ophthalmic viscosurgical devices, DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose 2% in terms of their overall clinical performance during phacoemulsification.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract
* Grade 1-3 lens opacities classification system (LOCS III)
* Pupil dilatation greater than 7.0 mm

Exclusion Criteria:

* Black, brunescent, traumatic or subluxated cataract
* Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3)
* Glaucoma, uveitis
* Previous ocular surgery
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis

The primary objective of this study is to evaluate the safety, tolerability of single-ascending doses of BIIB100 in adults with amyotrophic lateral sclerosis (ALS). The secondary objective of the study is to characterize the pharmacokinetic profile of BIIB100.


Eligibility Criteria:
Key Inclusion Criteria:

* Must meet the laboratory-supported probable, probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria.
* Participants taking concomitant riluzole at study entry must be on a stable dose for greater than or equals to (\>=) 30 days prior to the first dose of study treatment (Day 1). Participants taking concomitant riluzole must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that riluzole should be discontinued for medical reasons, in which case it may not be restarted during the study.
* Participants taking concomitant edaravone at study entry must be on a stable dose for \>= 60 days prior to the first dose of study treatment (Day 1).
* Adequate respiratory function as indicated by slow vital capacity (SVC) \>= 65% of predicted value as adjusted for sex, age, and height (from the sitting position).

Key Exclusion Criteria:

* Ongoing medical condition (e.g., wasting or cachexia, severe anemia) that would, in the opinion of the Investigator, interfere with the conduct or assessments of the study.
* Significant cognitive impairment or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression less than or equals to (\<=) 90 days of Screening, which in the opinion of the Investigator would interfere with the study procedures.
* Treatment with drugs that are transported by Breast Cancer Resistance Protein (BCRP) and P-glycoprotein (P-gp) including, but not limited to, rosuvastatin, sulfasalazine, dabigatran, digoxin and fexofenadine.
* Current enrollment or plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days or 5 half-lives of the agent, whichever is longer, prior to the Baseline Visit (pre-dose on Day 1). Participation in a noninterventional study focused on ALS natural history may be allowed at the discretion of the Investigator and after consultation with the Sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
9-Step Magnetic Bariatric Revisional Surgery

RYGB represents one of the best alternatives for weight loss in obese patients achieving a weight loss of up to 60% and a resolution of comorbidities of 70%. Revision surgery contemplates multiple techniques including the conversion from one surgical technique to another, structural changes to the primary technique, among others. GERD is now a long-term problem for patients who have undergone LGS. RYGB is one of the best techniques to resolve this problem.

Roux-en-y gastric bypass is performed with the patient in the French position by a bariatric surgeon with 8 years of experience. A single port was placed in the umbilicus, an additional trocar (5mm) was placed in the right side of the abdomen. The surgery is started by performing the liver retraction with the grasper plus magnet attached to the border for the correct visualization of the surgical field. Later, the division of the major curvature of the omentum is started, and as it is performed in a superior direction, the magnet is positioned to retract the fundus and finishing exposing the esophageal hiatus where a hiatal hernia is visualized, which is decided to be repaired transoperatively. For the hiatoplasty, after placing a reference around the stomach, the magnet is positioned in that reference to retract the stomach and esophagus and to be able to suture the hernia defect. Then we proceed to perform the RYGB with the simplified technique, starting with the reference attached to the magnet but this time at the opposite end to start the resection of the lesser omentum, a minor step prior to the confection of the pouch. The pouch confection is done with 3 blue cartridges. Continuing with the procedure, the retraction of the transverse colon is performed with the use of the magnet to visualize the treitz angle and start the 60 cm measurement of the biliopancreatic limb. Later, gastrojejunal anastomosis is performed traditionally. Once this step is finished, the 100 cm alimentary limb is measured and then, the magnet-assisted jejunal anastomosis is performed. The Petersen defect and the intermesenteric defect is closed assisted by magnets. A methylene blue leak test is routinely performed, with negative results, this time testing both anastomoses. Finally, the magnet-assisted omega section is made with the retraction of the limb to finish the Roux-en-Y.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Candidate to bariatric surgery
* Obesity
* BMI Greater than 30 kg/m2

Exclusion Criteria:

* Uncontrolled co-morbidities
* patients with pacemakers, defibrillators, or other electromedical implants
* Abnormal coagulation blood tests
* Patients with hepatic diseases