cyrilzakka/clinical-trials huggingface dataset:
Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle

Since the use of botulinum toxin in treating spasticity has already been proven effective, we are now using magnetic resonance imaging to examine the toxin diffusion within muscle (post injection) in order to determine the specific toxin dose required for an optimal treatment response.

Over the past decade, botulinum toxins (BT) have been extensively used to treat any number of diverse disorders, including functionally significant, focal spasticity in the arm and leg of persons with injury/disease of the central nervous system. Spasticity is an involuntary muscle stiffness that limits movement of an extremity and often leads to pain, hygiene problems, difficulty in bed or wheelchair positioning, and functional deficits in self-care and mobility.

There are three BT products on the market: MyoBloc®, Botox®, and Dysport®. FDA approval for use of Botox® in spasticity is anticipated sometime during 2010. In the Weill Cornell Division of Rehabilitation Medicine alone, nearly 50,000 units of Botox® were injected for the treatment of spasticity during the 2008-2009 academic year. (Note: The vast majority of the BT market share in the US rests with Botox®.)

There is excellent evidence supporting the effectiveness of BT in decreasing tone and modest clinical evidence supporting functional improvement. Despite the frequent use, however, there is astonishingly little evidence delineating the impact on diffusion of dosing, dilution, approach to muscle localization, or serotype of BT. To better study these relationships we will be using advanced imaging to develop a model to characterize the physical characteristics of BT diffusion in human skeletal muscle.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of UMN disease
* clinically significant spasticity in the gastrocnemius muscle to warrant Botox® injection (made at the discretion of Dr. O'Dell)
* naïve to all botulinum toxins in the lower extremity

Exclusion Criteria:

* MR incompatibility with implanted ferromagnetic devices.\[Specifically, they may not participate in this study if they have a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices. They will be screened by the MRI staff for past surgical procedures to determine the possibility of having an implanted medical or metallic device, shrapnel, or other metal, such as metal in the eye.\]
* Pregnancy or breast feeding
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer

RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.

OBJECTIVES:

Primary

* Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.

Secondary

* Determine the histological response in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine postoperative morbidity in patients treated with this regimen.
* Determine the rate of potentially curative surgery in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed gastric adenocarcinoma

  * Locally advanced disease

    * Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
* Planning to undergo curative surgery after neoadjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

* 20 to 75

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC 4,000-12,000/mm\^3
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL

Hepatic

* AST and ALT ≤ 100 U/L
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine normal OR
* Creatinine clearance ≥ 50 mL/min

Pulmonary

* PaO_2 \> 60 mm Hg on room air

Other

* Able to swallow oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy for gastric cancer

Chemotherapy

* No prior chemotherapy for gastric cancer

Endocrine therapy

* No prior endocrine therapy for gastric cancer

Radiotherapy

* No prior radiotherapy for gastric cancer

Surgery

* No prior surgery for gastric cancer

Other

* No other prior therapy for gastric cancer
Placebo Effect of Paracetamol in Healthy Volunteers

Paracetamol is one of the most commonly used drugs in the world, indicated for the symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug used to relieve pain and reduce fever. The objective of this study is to analyze whether a placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of paracetamol is partly due to the simple fact of taking a drug.

Moreover, during the study you propose to do a saliva sample, optional, for biological research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your body..

Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.

Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers,

* Aged over 18 years and more than 50 years
* Males,
* Values of vital signs before administration of the test products:
* Systolic between 100-140 mm Hg
* diastolic between 50-90 mm Hg
* cardiac pulse between 45-90 beats per minute
* Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory)

Exclusion Criteria:

* Contraindications to the administration of paracetamol : Hypersensitivity to paracetamol, History of hepatitis B or C, Severe renal impairment
* Hepatic insufficiency
* Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain,
* Pathology evolutionary time of the review of inclusion
* Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse,
Water Intervention for Thinking in Kids (WITiKids ) Study

The aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. We hypothesize that an increase in water intake will result in greater cognitive performance. In addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

1. Parental/guardian consent
2. Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).

Exclusion Criteria:

1. Participants younger than 9 years and older than 10 years at the time of testing age.
2. Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
3. Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
4. Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System
5. IQ below 85
6. Use of medications that alter urinary excretion and water metabolism
7. Use of internal electronic device, such as a pacemaker
Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)

The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Received kidney transplant at least 1 month prior to study enrollment;
* Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment;
* Eligible to convert to EC-MPS because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen;
* At least 18 years of age;
* Willing to provide written informed consent; and
* Able to meet all study requirements including completing paper questionnaires and completing two study visits.

Exclusion Criteria:

* GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea);
* Acute rejection \< 1 week prior to study enrollment;
* Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception;
* Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
* Undergoing acute medical intervention or hospitalization;
* Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment
* Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Other protocol-defined inclusion/exclusion criteria may apply.
Run, Recovery, Repeat, Always Healthy ("Corre, Recupera, Repite, Siempre Saludable")

This study has as main objective to know how the processes of recovery are realized after a race of marathon. For this, the participants of a marathon race are divided into three work groups during the 9 days post-marathon, one with rest in the recovery period, another with continuous race three sessions every 48h and another with three sessions of elliptical every 48h .

The marathon runners suffer a high fatigue, as has been studied by different investigations, the proposal of this study is to know how the recovery processes are produced in runners who have completed a 42km test.

To do this, baseline measurements of the runners have been made through stress tests and determinations of biomarkers in blood and urine. Subsequently blood and urine samples were taken the day before the marathon test and blood and urine samples were then taken again on arrival at 24h, 48h, 96h, 144h, and 196h.

At the same time, an intervention was carried out in the recovery phase, with the runners in three groups. The first one performed rests during the 9 days after the race, the second performed continuous race monitored every 48h from the end of the race, and the third group performed aerobic work on an elliptical machine under the same conditions as the group of Continuous race

Eligibility Criteria:
Inclusion Criteria:

* Adults healthy with 30-45 years
* BMI between 16-24,99
* Time in marathon between 3h-4h in men
* Time in marathon between 3h:30min-4h:40min in women

Exclusion Criteria:

* Having heart disease
* Having kidney disease
* Taking a medication on an ongoing basis
Refractory IHCA and OHCA Treated With ECMO

Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-75 years old
* In and out of hospital Witnessed Cardiac Arrest
* No-flow time \< 5 min. or VF,VT,TP as rhythm of presentation
* Low-flow time \< 45 min.
* End Tidal CO2 \> 10 after 20 min.of CPR

Exclusion Criteria:

* Comorbidities such:
* Terminal Malignancy
* Aortic Dissection
* Severe Cardiac Failure without transplant indication
* Severe Aortic Valve Failure
* Known Severe Peripheral arteriopathy
Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive Disorder in Chinese Population

Depression is a kind of mental illness with high incidence, high recurrence and high disability. But so far, treatment remission rates for depression remain low. Therefore, it is necessary to develop more new treatments. Light therapy has been shown to be effective in treating depression with seasonal patterns. Although most studies have reported that light therapy is also effective in patients with depression without seasonal patterns, high-quality clinical studies are still rare and the conclusions are still controversial. In particular, it remains unclear whether light therapy is effective in treating depression without seasonal patterns in the Chinese population. In addition, there is a lack of biomarkers that predict the efficacy of light therapy.

In conclusion, this study intends to conduct an ADD-ON randomized controlled study to clarify the efficacy and safety of light therapy as synergistic therapy in patients with depression without seasonal patterns, and to screen peripheral biomarkers related to efficacy using transcriptome sequencing technology. It is expected that this study can confirm the effectiveness and safety of light therapy as synergistic therapy, provide an evidence-based basis for the research and exploration of light therapy in Chinese depression population, and provide more options for the synergistic treatment of antidepressants in Chinese depression population.


Eligibility Criteria:
Inclusion Criteria:

1）Meets DSM-5 criteria for major depressive disorder 2) Age 18-65; 3) HAMD-17 score ≥17; 4) No antidepressants or mood stabilizers were used at least 2 weeks before enrollment; 5) Sign informed consent.

Exclusion Criteria:

1. With seasonal pattern;
2. No previous mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma, cerebrovascular diseases caused by organic diseases;
3. No previous history of alcohol or substance dependence;
4. Current serious risk of suicide (e.g., previous attempted suicide or recent suicidal behavior); 5）Present with serious, active physical diseases that may interfere with research, including vision problems and photosensitivity disorders; 6）Have received electroconvulsive therapy (ECT or MECT) or transcranial magnetic stimulation (rTMS) in the last 6 months.
TADs Anchored vs Conventional Anchored Carriere Motion Appliance

Carriere Motion appliance (CMA) was designed to correct a Class II molar relationship into a Class I relationship by distalizing the whole posterior maxillary segment by means of class II elastics and mandibular anchorage. To revoke the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with TADs anchorage using miniscrews. The aim of this study is to evaluate TADs anchored CMA vs. conventionally anchored CMA for distalization of the maxillary buccal segment.

Twenty class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:

Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch.

Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.

For each patient, two CBCT will be obtained: one preoperatively and another after completion of distalization.

Comparing skeletal and dental measurements obtained from CBCT radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).

Eligibility Criteria:
Inclusion Criteria:

* Adolescent patients aged 11-17 years.
* Unilateral or bilateral Class II molar relationship.
* Bilateral Class II canine relationship.
* No history of previous orthodontic treatment.
* No malformed teeth, impacted teeth and unerupted teeth.
* No systemic disease.
* Good oral hygiene.
* No abnormal pressure habit.
* No periodontal diseases.
* No missing teeth in maxillary arch.

Exclusion Criteria:

* The need for extraction in the lower arch.
* Posterior crossbite.
* Presence of any craniofacial anomalies.
* Patients with syndromes.
The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty

The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily related to decrease in blood pressure and secondary to fluid loading during hypotensive anesthesia.

The specific aim of this prospective study is to collect serial hemoglobin levels intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous fluid substitution will change hemoglobin levels during the time the tourniquet is inflated (no blood loss).

The combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time.

Tubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet inflation and in PACU as well as POD 1.

Eligibility Criteria:
Inclusion Criteria:

* Non- inflammatory degenerative joint disease of the knee
* Patients scheduled for unilateral primary total Knee arthroplasty
* Age between 40 and 80 years
* Hypotensive spinal-epidural anesthesia with systolic BP \< 95 and diastolic BP \< 65.
* Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.

Exclusion Criteria:

* Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
* Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
* Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
* Congestive Heart Failure (at least one medication to treat congestive heart failure)
* Coronary artery disease (s/p bypass, stent or AMI)
* Kidney insufficiency (creatinine \> 1.5)
* Aortic or mitral valve disease
* Pulmonary hypertension
* Revision Knee Surgery
* Inadequate intravenous fluid substitution during the procedure 1.5L during 60 minutes.
Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).

The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability.

The participants will be divided into 2 groups: with or without preemptive pregabalin administration.

Pregabalin is a GABA analogue that has analgesic, anxiolytic and effects. There are studies indicating that this drug can be used as an element of multimodal analgesia to decrease opioid requirements in postoperative period. Such an effect would be particularly beneficial for patients with obesity scheduled for laparoscopic sleeve gastrectomy, most commonly performed bariatric surgery.

The investigators hypothesized that preemptive pregabalin administration may improve quality of postoperative pain score with less incidence of opioid side effects as well as similar or better intraoperative hemodynamical stability.

Eligibility Criteria:
Inclusion Criteria:

* Sleeve gastrectomy in patients with BMI \> 40 or \>35 with comorbidities
* Written informed consent

Exclusion Criteria:

* Patient's refusal
* Known allergies to study medication
* Inability to comprehend or participate In pain scoring scale
* Inability to use intravenous patient controlled analgesia
* Changes of operation extent during procedure
* Revisional operations
* End stage organ failure
Standard Versus Flexible Tip Bougie for Videolaryngoscopy

This study aims to compare the flexible tip bougie with standard bougie for tracheal intubation using non channelled, acute angled video laryngoscope using modified intubation difficulty scale score as primary outcome.

Videolaryngoscopes are devices which aid successful intubation of the trachea. Unlike standard (direct) laryngoscopes, they include a camera at the tip of the blade and display unit to provide an indirect view of the vocal cords (glottis). They are now routinely used for both standard and anticipated difficult tracheal intubation, and are recommended for difficult intubation in UK national guidelines.

Some videolaryngsocopes have a channel as a guide to help with placement of a tracheal tube and some are without a channel. The non-channelled videolaryngoscopes with acute-angled blades require a bougie or stylet to facilitate the passage of a tracheal tube through the glottis into the trachea.

One problem commonly encountered when using a standard bougie, is the tip of the bougie abutting on the anterior part of glottis and entrance to the windpipe (trachea) and not advancing further into the trachea. This is known as anterior impingement. This can increase the likelihood of repeated intubation attempts, failed intubation and airway trauma. C-Mac is a commonly used non-channelled videolaryngoscope and has been shown to have high first attempt success rate as compared to other videolaryngoscopes, however, the acute angled D-blade requires a bougie to facilitate tracheal intubation.

The recently introduced flexible tip bougie is likely to overcome the problem of anterior impingement, due to the ability to flex the tip in the posterior direction once the tip enters the glottis. Comparing the efficacy of these devices could help inform anaesthetists' decisions in the future when faced with a potentially difficult airway.

Eligibility Criteria:
Inclusion Criteria:

- Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.

Exclusion Criteria:

* Patients who are do not want to take part or do not give consent
* Patients below 18 years of age
* Patient physical status of ASA 4 and 5,
* Patients deemed to require awake intubation