cyrilzakka/clinical-trials huggingface dataset:
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors

The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile.

Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days.

Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet.

Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking.

Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking

Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking

All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.

Eligibility Criteria:
Inclusion Criteria:

* Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm.

Exclusion Criteria:

* Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz \& Reibold 1990), contraindications to increased levels of physical activity.
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.

A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.

Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
* American Society of Anesthesiologists (ASA) class I-III
* \> 18 years of age;
* Ability to give oral and written informed consent.

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Women who are or may be pregnant or are currently breast feeding;
* Renal insufficiency, as defined by glomerular filtration rate \< 30 ml/h creatinine.
* Previous retroperitoneal surgery at the site of the current surgery.
* Body mass index \> 35 kg/m2
FST-201 In The Treatment of Acute Otitis Externa

The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1).
* Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.
* Provide written informed consent or parental assent.
* Be willing and able to follow all instructions and attend all study visits

Exclusion Criteria:

All subjects must not:

* Have known sensitivity to any component of the study medications
* Have a current infection requiring systemic antimicrobial treatment
* Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.
* Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1
* Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.
* Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1
* Have taken any antibiotics within 3 days prior to Visit 1
* Have signs and symptoms of AOE for \> 4 weeks at Screening/Baseline Visit 1
* Have a non-intact or perforated tympanic membrane in the enrolled ear
* Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes
* Have a clinical diagnosis of malignant otitis externa
* Have overt fungal AOE
* Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)
* Have congenital abnormalities of the external auditory canal in the enrolled ear(s)
* Have obstructive bony exostoses in the enrolled ear(s)
* Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)
* Have malignant tumors of the external auditory canal
* Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed
* Have seborrheic dermatitis of the external auditory canal
* Have a current or prior history of immunosuppressive disorders
* Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus
* Be pregnant, nursing or planning a pregnancy.
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.

This trial has several objectives:

Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.

Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
3. Serum laboratory examination obtained at study entry:
4. Normal cognitive function.
5. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding.
2. Renal or hepatic dysfunction.
3. Significant cardiac disease (e.g. MI within 1 year).
4. Signs or symptoms of central neurological disorder, excluding SCI.
5. Severe psychological disorder requiring treatment.
6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo

The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months .All types of vitiligo will be included except universal vitiligo.

Study approval:

The study will be submitted for approval by the Scientific and Ethical Committees at Faculty of Medicine, South Valley University, Qena. An informed written consent will be obtained from all participants.

Study design:

A randomized controlled trial.

Study population:

The study will include patients who attend the outpatient Clinic of Dermatology, Venereology and Andrology, Faculty of Medicine, South Valley University, with clinical diagnosis of vitiligo. Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity will be excluded.

Methods:

* Wash out period: ( 4 weeks) During this period, initial medical evaluation will be performed, social demographic data will be collected and patients will be enrolled after obtaining a written consent.
* Test period: (6 months) \*Randomization: at the initial visit (visit 0), following the wash out period and before the start of treatment, patients will be randomly assigned to 2 treatment groups; Group (A) : patients will receive NB-UVB sessions twice weekly for 6 months. Initial dose will be 100 mJ/cm2, the dose will be increased by 10% per session.

Group (B) : patients will receive NB-UVB sessions twice weekly for 6 months with the same dose plus topical application of tacrolimus 0.03% ointment twice dialy for the first month of treatment and once dialy for the rest 5 months of treatment.

All Patients will be evaluated before the start of treatment (visit 0) and at monthly intervals for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* all patients with clinical diagnosis of vitiligo.

Exclusion Criteria:

* Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity.
Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.

Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives;

* subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.
* subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.

The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows:

* Treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives,
* Post-washout follow-up: 4 weeks after last treatment intake.

Eligibility Criteria:
Inclusion Criteria:

* Satisfactorily completion of HMR1726D/2001 study with respect to safety.
* If female subject, non-childbearing potential or child bearing potential with adequate contraception.
* Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
* Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
* Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
* Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.
* Willingness to participate in a long-term safety and efficacy trial.

Exclusion Criteria:

* Subject who did not complete HMR 1726D/2001 study for safety reasons.
* Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
* Pregnancy.
* Breast-feeding.
* Wish to parent.
* Likelihood of requiring treatment during the study period with drugs not permitted.
* Disallowed therapies such asw immunomodulators, immunosuppressants.
* Recent history of drug or alcohol abuse.
* Liver function impairment.
* Abnormal mental conditions.
Oral Health-related Patterns of Food Selectivity in Dental Populations

The present study was undertaken in order to describe the clinical profiles of food selective behavior in 35-65 years dental and non-dental populations.

The study population included 125 participants, recruited within the general population and in a dental clinic: -Non-dental group included 62 non-seeking dental treatment subjects, aged 30-65 years, previously recruited during the OralPom survey. -Dental group included 63 patients recruited from September 2019 to December 2020 among patients seeking/pending dental treatment within the university dental clinic of the Rothschild hospital (AP-HP Sorbonne University, Paris, France).

Both groups took part in an individual session with a dental practitioner during which food selectivity, medical history, and oral health status were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Non-dental group : non-seeking dental treatment subjects, aged 30-65 years.
* Dental group: patients seeking/pending dental treatment within the university dental clinic of the Rothschild hospital (AP-HP Sorbonne University, Paris, France), aged between 35 and 65 years, literate French speakers, willing and able to complete the survey in a single setting.

Exclusion Criteria:

* For non dental group :Declared painful conditions including temporo-mandibular disorder, cephalalgia, oral or dental pain, diagnosis of acute orofacial disease (i.e. rhinitis) or sensory trouble (i.e. anosmia, dysgeusia) neither at the time of the experiment nor in the recent past, pregnancy, head and neck irradiation, eating disorders, enteral or parenteral feeding, and cognitive impairment or impaired communication.
* Patients suffering from cognitive impairment or impaired communication are excluded.
A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer

A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose and recommended dose for phase II trial in patients with advanced solid cancer and explore efficacy of DHP107 in patients with gastric cancer

1. Primary objective To determine the maximum tolerated dose and the recommended dose for phase 2 clinical trial for the repeated administration of DHP107 (oral paclitaxel) on advanced solid cancer patients
2. Secondary objectives

   * To identify the dose limiting toxicity and the safety (toxicity) of DHP107
   * To evaluate the efficacy (tumor response rate) of DHP107
   * To assess pharmacokinetic (PK) characteristics of DHP107

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 70 years old
2. Patients prognosed with advanced or metastatic solid cancer by histopathology or cytology analysis who have no available standard therapy or who have failed at least once with the standard therapy
3. Adequate bone marrow function, liver function and adequate kidney function
4. Eastern Cooperative Oncology Group performance status ≤ 2
5. Life expectancy of 3 month or more
6. Written informed consent

Exclusion Criteria:

1. Major infectious or neurological disease and bowel obstruction
2. Brain metastasis or hematologic malignancy
3. Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
4. Patients with the history of failure to the taxane line of chemotherapy (with the exception of when it was used before 6 month as adjuvant therapy or when the treatment was discontinued due to docetaxel related side effect)
5. Patients who are required to continuously take P-gp (P-glycoprotein) suppressor, immune suppressor, proton-pump inhibitor or H2-receptor antagonist during clinical trial period
6. Patients deemed by the investigator to suffer from severe heart disease (myocardial infarction, congestive heart failure, arrythmia accompanying drastic changes on ECG, severe or unstable angina pectoris, or other severe heart disease) or accompanying other severe internal diseases (such as uncontrollable diabetes, chronic obstructive pulmonary disease)
7. Patients with prior history of participating in a clinical trial within 30 days from registration for current clinical trial
8. Patient with history of alcohol or drug abuse in the recent 3 months
9. Pregnant women, nursing mothers, or patients of childbearing age who did not agree to contraception (both men and women)
10. Patients with (or suspected to have) abnormality in bile acid secretion (e.g.,. patients with resected gallbladder)
11. Patients who had a history of serious gastrointestinal bleeding, or with diseases that could affect the absorption of oral medication (malabsorption syndrome, active peptic ulcer)
12. Patients with history of severe hypersensitive reaction to active ingredient and excipient of the investigational drug
13. Patient who are in a state that is deemed inappropriate to participate in the clinical trial by the investigator
Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)

A group of \~ 225 patients were switched from atorvastatin to an equivalent statin either by their physicians usual management or by an collaborative pharmacist coordinated process. We will compare the results of pharmacist process to the standard medical practice to find potentially which process is more effective, safer and efficient. We are surveying a total of 35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their satisfaction of the 2 processes.

This study is a retrospective analysis of patients converted from atorvastatin to another equivalent statin. It is observational because the patients were all on atorvastatin, had been informed by their prescription drug plan that it would not be covered, and that if agreed they would be changed to an equivalent that is covered by their plan. The patients were either converted with the help of pharmacist by collaborative practice agreement (CPA)or upon contacting their physician requesting a different medication. We are comparing the percentage first converted to the equivalent dose in each group and whether patients continued to be at hyperlipidemia treatment goal after the interchange.

Eligibility Criteria:
225 insured eligible subjects, 35 PCIM physicians
A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors

The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.

The study was prematurely discontinued on 14 September 2011 due to no significant pharmacological effects (safety/PD/efficacy) through 25 mg/kg cohort, the T1/2 based on VEGF binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. There were no safety concerns associated with the decision to terminate the program/study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy.
* Stage 2 only: Histologically or cytologically documented EOC or PPC with \< or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.
* Adequate coagulation, liver, and renal function.
* Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging \[DCE-MRI\] evaluation
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1

Exclusion Criteria:

* History of clinically significant toxicity to Vascular Endothelial Growth Factor \[VEGF\] inhibition.
* Evidence of bleeding problems.
* Uncontrolled hypertension.
* Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology
Stereotactic Radiation in Vestibular Schwannoma

The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).

Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial.

Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.

Eligibility Criteria:
Inclusion Criteria:

* vestibular schwannoma tumor size not more than 3 cm.

Exclusion Criteria:

* NF 2 patient
* underlying cerebrovascular disease
* tumor compress and efface brain stem ( Koos 4)
Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation

In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.

This study is a prospective multi-center registration study. The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform. The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform. The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3 months and 1 year was assessed.

Eligibility Criteria:
Inclusion Criteria:

Acute stroke patients

Exclusion Criteria:

No