cyrilzakka/clinical-trials huggingface dataset:
Effect of Colding of Endotracheal Tubes on Sore Throat

Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.

The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia.It is an undesirable events experienced by patients after general anaesthesia. Various pharmacological agents have been applied to reduce POST, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. However, these agents may have some systemic and local side effects. Therefore, various non-pharmacological applications have been investigated to reduce sore throat. Cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. Although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. Therefore, we hypothesized that colding of endotracheal tube may decrease POST associated with airway inflammation. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. This study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.

Eligibility Criteria:
Inclusion Criteria:

Patients who were entubated with an ETT. Those who accept the research Elective surgery Patients in American Society of Anaesthesiologists (ASA) I and II class 18 years and over Mallampati classification I and II Operation time more than 1 hour

Exclusion Criteria:

Patients with sore throat and lower respiratory tract infection Patients with a history of allergies
Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.

In this study glucose metabolism of pregnant women with a history of bariatric surgery, obese pregnant women and normal weight pregnant women was investigated. Three to six months after delivery the assessment of Glucose metabolism was repeated and the amount of ectopic lipids in the liver, heart and muscle was measured.

In this study pregnant women with a history of bariatric surgery, normal weight and obese pregnant women were invited to participate. Between the 24th and the 28th week of pregnancy an oral glucose tolerance test (OGTT), as well as an intravenous glucose tolerance test (IVGTT) was conducted. Three to six months after delivery the examinations were repeated. In addition the ectopic lipid content in the liver, heart and the muscle was measured with 1H-magnetic resonance spectroscopy and imaging three to six months post partum. The aim of this study was to compare the glucose metabolism during pregnancy between the three groups as well as to investigate the changes three to six months after delivery.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with a history of RYGB Operation
* normal weight pregnant women
* obese pregnant women

Exclusion Criteria:

* infectious diseases such as Hepatitis B or C, HIV, hematological diseases, acute infections, liver disease, renal disease, cancer
Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care

In order to facilitate the evidence-based goal setting and self-monitoring intervention into the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an electronic system provided available to the American Diabetes Association diabetes education programs, to set patient diet and physical activity goals, and connect patient self-monitoring information collected from smart phones and fitness trackers to Chronicle Diabetes system to facilitate educators' monitoring of patient adherence to their goals.

Specific Aim 1: To develop and test an interface with Chronicle Diabetes to transfer smartphone collected self-monitoring diet and physical activity information from patients to diabetes educators.

Specific Aim 2: To 2a) conduct usability testing and 2b) examine efficacy of this connected interface technology in a 3-month randomized clinical trial in 60 overweight or obese patients with type 2 diabetes in Houston, Texas and Pittsburgh, Pennsylvania.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes
2. Overweight or obese with an BMI \> 25
3. Able to read and write English
4. Own a smart phone that is Jawbone compatible

Exclusion Criteria:

1. Currently undergoing current treatment for a severe psychiatric disorder.
Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes

3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by general practitioner and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed three times during the study, at inclusion, 6 months and 12 months. Each assessment is composed of a standard geriatric assessment, a fall questionnaire, an autonomy scale (SMAF scale) and a quality of life questionnaire (EQ5D). Every falls will be considered as adverse events and will therefore be listed along the study and characterized in types and number.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged more than 75 years old
* Patient living in Limoges or Gueret nursing home
* Patient informed consent and/or proxy consent
* Patient able to understand the study, respect its imperatives and able to do evaluations
* Patient able to stand up from the bed
* Patient covered by the French health insurance

Exclusion Criteria:

* Patient with a short term prognosis pathology
* In multiple bed rooms, if at least one patient does not agree with the trial
Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot

The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome

This is a open clinical trial assessing the therapeutic efficacy of pl-vegf165 (Neovasculgen) in treating ulcers related to diabetic foot syndrome. Each patient will undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen) in calf of affected extrimity.

Study participants at the first study visit will complete study questionnaires, their foots will be assessed clinically for ulceration. After this initial assessment, the patients will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a calf altered with ulcers due to diabetic foot syndrome.

At three month post-injection, the patient will complete study questionnaires, their foots will be assessed clinically for ulceration, and their foots will undergo non-invasive transcutaneous oximetry measurement. At six months post-injection, the patient will again complete study questionnaires, their foots will be assessed clinically for ulceration and will undergo non-invasive transcutaneous oximetry measurement.

Eligibility Criteria:
Inclusion Criteria:

* obtained voluntary informed consent for participation in the clinical study
* presence of diabetic foot syndrome
* presence at least one active ulcer at baseline

Exclusion Criteria:

* Any disease that can, in the opinion of the treating physician, affect the outcome of the study
* Patients with addictive disorders or substance abuse
* Pregnancy or nursing
* All other exclusion criteria listed in the summary of product characteristics (SmPC)
A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

The main objective for this study is to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.


Eligibility Criteria:
Inclusion Criteria:

* Pre menopausal female adults with confirmed length and regular menstrual cycle
* Surgically diagnosed endometriosis
* Moderate to severe endometriosis related pain

Exclusion Criteria:

* Hormonal contraceptives or other drugs with effects on gynecological endocrinology
* Surgery for endometriosis within the 4 weeks prior to entry
* Uterine myoma
* Abnormal vaginal bleeding
* Hysterectomy or bilateral oophorectomy
* Pelvic infection
* Relevant abnormalities at gynecological exam at screening
* Disease with chronic abdominal pain of non-endometriosis origin
* Pituitary adenoma
Qigong for Pre-frail and Frail Older Cancer Survivors

To-date, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.

Frailty is an emerging concept in geriatric research and practice. It is defined as a state of increased vulnerability to adverse outcomes including death. A cohort study has found that respondents with cancer were significantly more frail compared to those without cancer. A plausible explanation is both cancer itself and the therapies used to treat it add additional stressors that challenge a patient's physiologic reserve. A systematic review has revealed a high prevalence of frailty and pre-frailty in older cancer patients, with the median estimates of 42% and 43%, respectively. Cancer treatment can hasten survivors' aging process and increase their risk of developing frailty, thus placing cancer survivors at heightened risk of such poor health outcomes as falls, fractures, and disability. This calls for effective interventions that would improve frailty in older cancer survivors.

Qigong, a type of mind-body intervention, is particularly suitable for older adults, as it is implemented without aerobic and musculoskeletal strain. This equipment-free form of exercise is ideal for settings with limited resources, as well as for the frail elderly, because it can be performed at home at any time, reducing such barriers as weather, transportation, and cost. Meta-analysis suggests that Baduanjin is beneficial in the general population in terms of improved quality of life, balance, handgrip strength, and trunk flexibility. To our knowledge, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is therefore to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥65
2. diagnosed with stage I-III non-metastatic cancer
3. completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
4. classified as pre-frail or frail based on Fried frailty criteria
5. can communicate in Cantonese or Putonghua
6. written informed consent

Exclusion Criteria:

1. regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
2. medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)
Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures

Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.


Eligibility Criteria:
Inclusion Criteria:

* Age range: children aged 4- to 12-years
* Health status: healthy children without significant medical conditions (ASA I or ASA II)
* Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
* Consent: written informed consent from the parent or legal guardian
* Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years

Exclusion Criteria:

* Allergies: children with known allergies to dogs or animal dander
* Children with a fear or phobia of dogs
* Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
* Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
* Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
* Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
* Advanced behavior guidance is indicated: children whose behavior for dntal examination is classified as "Definitely Negative" (Frankl 1)
Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients

The purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite® (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.Study hypothesis: The aqueous humor concentration 45 minutes following dosing of 0.1% Brimonidine Purite™ (pH 7.8) is comparable with 0.15% Brimonidine Purite® (pH 7.2)

The purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite® (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must:

  1. Be willing and able to provide written Informed Consent
  2. Be able and willing to follow instructions and likely to complete the entire course of the study.
  3. Be male or female of any race at least 18 years of age.
  4. Have visually significant cataract for which they have elected to undergo cataract surgery.

Exclusion Criteria:

* No subject may:

  1. Known allergy or sensitivity to the study medication or its components
  2. Contraindications to brimonidine therapy: concurrent use of monoamine oxidase (MAO) inhibitor therapy
  3. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.
  4. Any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months.
  5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears.
  6. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior chamber which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.
  7. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
  8. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception.
  9. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study such as, significant cardiovascular disease, hepatic or renal impairment, depression, Raynaud's, orthostatic hypotension; uncontrolled high blood pressure. or concomitant use of other potential CNS depressants and tricyclics, (Amendment 1, May 25, 2005)
The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of Combination of High-dose Dexamethasone and Tacrolimus versus High-dose Dexamethasone for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with ITP in China. Patients were randomized to tacrolimuis plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed newly-diagnosed, treatment-naive ITP;
2. Platelet counts \<30×109/L ;
3. Platelet counts \< 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
4. Active infection;
5. Maligancy;
6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
9. Patients who are deemed unsuitable for the study by the investigator.
Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study

The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
* Age 18-70 years
* ASA class 1-3
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.

Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects.
2. Fair skinned (Fitzpatrick Classification Level I - III).
3. Aged between 18 and 40 years inclusive.
4. Subjects who are able to comply with all study procedures, including follow-up assessment visits.
5. Subjects who are willing and able to give written informed consent to take part in the study.

Exclusion Criteria:

1. Subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (Fitzpatrick Classification Level IV - VI).
2. Subjects who are known hypertrophic or keloid scar formers.
3. Subjects who smoke.
4. Subjects with a body mass index of greater than 30 kg/m2.
5. Subjects with bleeding disorders or taking anti-coagulants.
6. Subjects with any other skin lesion sites or a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or which involve the areas to be examined in this study.
7. Subjects taking or who have taken prescribed drugs in the 30 days prior to Day 0, in particular, topical or systemic steroids, anti-inflammatories, anti-coagulants, anti-proliferative drugs, or antibiotics.
8. Subjects who regularly take aspirin, ginseng, gilboa, Alka Seltzer or any other over-the-counter medicine or complimentary health product that can affect the blood clotting process.
9. Subjects with a history of clinically relevant allergies.
10. Subjects with tattoos, scars or abrasions at the site to be studied.
11. Subjects with any clinically significant abnormality following review of pre-study laboratory data and physical examination.
12. Subjects showing evidence of drug abuse.
13. Subjects with any clinically significant mental illness in the opinion of the Investigator.
14. Females who are currently pregnant or breast-feeding. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined the protocol.
15. Subjects who have a past or present disease, which as judged by the Investigator may affect the safety of the subject or the outcome of the study.
16. Subjects who have participated in a clinical study within the 30 days prior to Day 0.