cyrilzakka/clinical-trials huggingface dataset:
Long Duration Therapeutic Ultrasound for Tendon Healing

ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-65 years of age, inclusive
* Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon, or patellar tendon based on examination of medical history and confirmed by physical examination including either manual movements of the injured limb, e.g., a positive Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon;
* Body mass index (BMI) less than or equal to 30.0
* Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to document all pain medication use during the study period.

Exclusion Criteria:

* History or current diagnosis of tendon tear in treated tendon
* Known neuropathy
* Type I or Type II diabetes mellitus
* Had surgery in target treatment area within 6 months
* Refuse to agree to not increase current use or initiate new use of pain medication during the trial unless medically necessary to ensure patient safety
* Refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided
* Refuse to discontinue all other interventional treatment modalities (e.g., transcutaneous electrical nerve stimulation, other ultrasound therapy, etc.)
* Have had a local corticosteroid or platelet-rich plasma injection within the past 3 months
* Have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from patient before first documentation of treatment in the observational study.
* Type 2 diabetes mellitus
* Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
* No contraindication for use of Protaphane® or Levemir®

Exclusion Criteria:

* None
A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months
* Treated with multiple daily injection ≥ 12 months
* Treated with insulin glargine U100 or U300 or insulin detemir at screening
* Fasting C-peptide ≤ 0.30 nmol/L
* BMI: 18.5-28.0 kg/m² (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to IMPs, paracetamol or related products
* Type 2 Diabetes Mellitus
* Clinically significant abnormal haematology, biochemistry or urinalysis screening test, as judged by the investigator considering the underlying disease
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator
* Known slowing of gastric emptying, including gastroparesis and or gastrointestinal surgery that in the opinion of the investigator, might change gastrointestinal motility and food absorption
* Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening
Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-64
* Both genders
* Healthy

Exclusion Criteria:

* Under 18 or above 64
* Not healthy
Diagnostic Performances of Mandibular CBCT in Osteoporosis

In the last decade, there has been a shift towards Cone-Beam Computed Tomography (CBCT - regarding its low-dose radiation profile) in Dentistry/Implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3D acquisition higher resolution. Despite convergent and interesting preliminary results, most CBCT studies failed in highlighting a potential new osteoporosis diagnostic tool. TOMOSTEOp study aims to explore inter-relation between CBCT parameters and DXA Gold-Standard parameters in order to build resolutive explicative model of bone mineral density and test CBCT diagnostic performances.

In the last decade, there has been a shift towards Cone-Beam Computed Tomography (CBCT - regarding its low-dose radiation profile) in Dentistry/Implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3D acquisition higher resolution. Despite convergent and interesting preliminary results, most CBCT studies failed in highlighting a potential new osteoporosis diagnostic tool. TOMOSTEO aims to explore inter-relation between CBCT parameters and DXA Gold-Standard parameters in order to build resolutive explicative model of bone mineral density and test CBCT diagnostic performances.

TOMOSTEOp study will analyze CBCT and DXA acquisitions of \>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay) these 2 exams. Radiomorphometric (I/S/CTMI/CTI(S)/CTI(I)), Gray Values (cortical and trabecular) and Fractal Dimension Indexes will be measured on the whole mandibular arch, as well as cortical/trabecular thicknesses. Correlations and odds-ratio will be calculated regarding DXA parameters and T-scores (-2,5DS). Differences between osteopenic, osteoporotic and healthy women will be explored.

Eligibility Criteria:
Inclusion Criteria:

* \> 65 years old post-menauposal women
* Contemporanean (ie. 3months) CBCT and DXA exams performed in Nantes University Hospital.

Exclusion Criteria:

* \< 65 years old post-menauposal women
* CBCT and DXA exams interval superior to 3months.
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of advanced upper lobe predominant emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted and experiencing \< 30% or 300 mL improvement using bronchodilator; TLC \> 110% predicted; RV \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous disease
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or \> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype

1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).


Eligibility Criteria:
Inclusion Criteria:

* Infection with HCV genotype 1.
* HCV- infected subjects naive to treatment.
* HCV-infected non-responder subjects.

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* ALT \>/ or = 5X the upper limit of normal.
* AST \>/ or = 5X the upper limit of normal.
Preliminary Efficacy and Safety Study of ST101 in Alzheimer's Disease

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo.

Alzheimer's disease (AD) is a progressive and fatal neurological illness. It produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. Initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. As the disease progresses so does the severity of cognitive deficiency. Loss of speech and immobility occur in the terminal stages There is no cure for AD and no marketed treatment that modifies the underlying disease process. Available therapies improve some symptoms of AD by increasing brain concentrations of molecules involved in cognition. ST101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. It improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. These two properties suggest that ST101 may be a promising agent for the treatment of AD. This study is designed as a preliminary dose exploration/proof-of-concept investigation of the ability of ST101 to improve cognition during 12 weeks of administration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic evidence of mild to moderate Alzheimer's disease.
* CT or MRI results within the past 12 months that rule out dementia due to non-Alzheimer's etiology.
* A reliable and capable caregiver.

Exclusion Criteria:

* Subjects who reside in a skilled nursing facility.
* Subjects with B12 or folate deficiency.
* Subjects with chronic hepatic disease.
* Subjects with a recent history of hematologic/oncologic disorders.
* Subjects who have experienced a myocardial infarction with the past year.
* Dementia caused or complicated by other organic disease
Temperature Changes During Induction of General Anesthesia in Pediatric Patients

We aim that uncovering patients during induction of general anesthesia does not decrease core body temperature in pediatric patients.

Some anesthesiologists cover the pediatric patient with a blanket during the induction of general anesthesia, while others do not. Complaints have been raised by pediatric surgeons that if a pediatric patient is not covered during induction of general anesthesia, the child's core body temperature will be lower than normal following surgery and in the recovery room.

Children are at risk of significant heat loss in the operating room due to multiple factors, such as, exposure to cold temperatures, decrease in metabolism following induction of general anesthesia, increased surface-area-to-volume ratio, and through considerable respiratory heat loss.1

A decrease in temperature of 0.5ºC to 1.5ºC can occur during induction of general anesthesia in pediatric patients2. The use of heating blankets and warmers may increase temperature or result in a constant temperature on pediatric patients intra-operatively3. We want to investigate the differences in temperature between the two approaches, covering and not covering pediatric patients, during induction of general anesthesia of a urologic procedure with a caudal block and the difference in temperature post-operatively. We hypothesize that the core temperatures of:

1. the covered and warmed group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
2. both groups, covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group.

Eligibility Criteria:
Inclusion Criteria:

* The ages of the subjects ranging from 6 months to 3 years undergoing surgery for circumcision or hernia repair with caudal block.

Exclusion Criteria:

* ASA physical status classification greater than 2, unsigned or unattainable written informed consent form, induction of general anesthesia time of greater than 45 minutes, fever, or temperature regulation inability.
Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai

this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga Rasayanam in Padarthamarai ( Ring worm infection )


Eligibility Criteria:
Inclusion Criteria:

* patients clinically diagnosed with tinea infection.
* direct microscopy skin scraping test positive.

Exclusion Criteria:

* pregnant or nursing women.
* use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs either currently or during 2 weeks preceeding initiation of drug trial.
* allergy or hyperensitivity to any component of the drug.
* clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions, urticaria, intertrigo, tinea ungium.
* diabetic patients.
Impact of a Stress Management Training Course

Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.

Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.

The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.

The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.

Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.

Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.

Anxiety can affect students' performance, although not all studies have found a significant correlation between results and students' state of anxiety.

However, it is essential to take account of students' well-being, especially as it has been shown that medical students suffer from symptoms of anxiety and depression, some of which may be related to their studies.

It is therefore important to reduce these symptoms of anxiety in order to improve students' well-being, and eventually their performance during ECOS.

A number of studies have looked at ways of reducing student anxiety, including breathing relaxation techniques and anxiety management programs. Preparation, stress management and self-confidence can have a calming effect, and may even have a positive impact on exam performance.

The visual analog stress scale and the STAI questionnaire are two validated and commonly used methods for stress assessment. The investigators modified the visual scale to assess the functional impact of stress on ECOS performance.

The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.

The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.

Eligibility Criteria:
Inclusion Criteria:

* Medical students from Paris Saclay University, during hospital internships
* Agreeing to take part in the study

Exclusion Criteria:

* Refusal to participate in the study
Text Messages in Preventing Tobacco Use in Young Adults

This trial studies how well text messages work in preventing tobacco use in young adults. Text messaging may help to teach young adults about the risks of tobacco products.

PRIMARY OBJECTIVES:

I. To assess baseline knowledge and risk perceptions about the use of conventional and new and emerging tobacco products among a subset of community college students from the two participating Houston Community College (HCC) campuses (Central and Coleman campuses). (Phase 1.1) II. Test the text messages with university students enrolled in the health communications academic programs. (Phase 1.2) III. Assess the awareness, attitudes, receptivity, and comprehension of the harmful effects of conventional and new and emerging tobacco products among young adults. (Phase 2) IV. Identify the most effective combinations of text message framing for communicating information about the potential harmful effects of tobacco products to young adults. (Phase 2) V. To obtain an objective measure of the psychological (i.e., emotional and cognitive) effect of the messages on young adults. (Phase 3)

EXPLORATORY OBJECTIVES:

I. Define and analyze key moderators of young adult awareness, attitudes, receptivity, and understanding of the harmful risks and constituents of conventional, new and emerging tobacco products. (Phase 2)

OUTLINE:

PHASE I: Participants attend focus group over 2 hours.

PHASE II: Participants receive 2 text messages per day for 30 days at baseline and after 3 months.

PHASE III: Participants read 64 computer messages with or without images over 30 minutes and have their facial expressions assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25 (Phase 1, Phase 2, Phase 3)
* Attend classes at either Houston Community College (HCC) Central Campus or Coleman Campus (Phase 1 and Phase 2), Spring Branch Campus (Phase 2) or the University of Houston (Phase 3)
* Own a smartphone capable of receiving texts from the study's text messaging ) resource (Phase 1, Phase 2 and Phase 3)
* Use phone text-messaging features on a regular basis (Phase 1, Phase 2, Phase 3)
* Provide cell phone number (Phase 1, Phase 2, Phase 3)
* Speak and read English (Phase 1, Phase 2, Phase 3)
* Enrolled in a communication program (Phase 1, health communication student review)
* Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (Phase 3)

Exclusion Criteria:

-Currently a smoker (Phase 3)
Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study

Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.


Eligibility Criteria:
Inclusion Criteria:

* All patients who received a laparoscopic Roux-en-Y-gastric bypass

Exclusion Criteria:

* previous CCE
* open gastric bypass procedure
* previous bariatric procedure other than gastric banding
* patients lost to follow up