cyrilzakka/clinical-trials huggingface dataset:
Hyaluronan in the Treatment of Painful Tendinopathy

The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 75 years of age and good general health condition.
* Signed written informed consent.
* Painful tendinopathy since ≥ 6 weeks.
* Pain according to Visual Analogue Scale (VAS; 100 millimetres (mm)) ≥ 40 mm.
* Ensured compliance of subjects for study period.

Exclusion Criteria:

* Treatment with any investigational product within 4 weeks prior to study entry.
* Patients with known hypersensitivity to the products (that is active compound and excipients) or any component or procedure used in the study.
* Severe intercurrent illness (for example: uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
* Concomitant disease at study relevant site influencing study evaluation.
* List of diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
* List of concomitant medications not allowed.
* Patients treated with: systemic and/or local steroids within the last 4 weeks, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.
* Recent history of drug and/or alcohol abuse (within the last 6 months).
* List of contra-indications to the treatment.
* Pregnant or lactating females.
* Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner during the treatment period and the first 4 weeks follow-up period.
* Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and or non completion of the study according to investigator's judgement.
Oxygen Consumption In Critically Ill Children

The investigators propose to examine the relationship between DO2 and VO2 in critically ill patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can provide complete support of heart and lung function. In so doing, the investigators will be able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow through the ECMO circuit.

Null Hypothesis:

Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not associated with an increase in oxygen consumption.

Alternate Hypothesis:

Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is associated with an increase in oxygen consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the Critical Care Unit on veno-arterial ECMO.
* Hemodynamic stability established, as adjudged by the treating CCU staff physician.
* Informed consent by parent or legal guardian.
* Approval by treating CCU staff physician to approach parents/guardians for consent process at any given time.

Exclusion Criteria:

* Patients in the Critical Care Unit on veno-venous (VV) ECMO.
* Inability to tolerate study period without red cell transfusion.
* Presence of a large leak around the endotracheal tube (\> 10% tidal volume).
* Patients requiring \> 70 % FiO2 at the time of potential enrollment.
* Parent or legal guardian refuse consent.
Study of Kids Itch Severity (SKIS)

This purpose of this study is to validate two measures of chronic itching in kids: itch severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).

There are many diseases that affect children where the primary symptom is pruritus. This study aims to validate an age appropriate pediatric version of the ItchyQoL, a pruritus-specific quality of life instrument, and the ItchyQuant, a self-reported itch severity scale, to better understand how pruritus affects the pediatric population. These instruments will comprehensively capture the severity and impact of pruritus in children. The physicians want to explore the opportunity to integrate patient-reported outcome measures (PROM) as a patient-reported tool in the ambulatory setting.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients between the ages of 4 and 17 (parents and clinicians will be older than 18 years, both male and female)
* Informed consent/assent signed and dated by the patient/parent
* Willingness and ability for the patient to commit to all follow-up visits/phone calls for the duration of the study

Exclusion Criteria:

* Inability to speak or read English
* Any other disabilities that would prevent them from completing a survey
* Unwillingness or inability for the patient to commit to all follow-up visits/phone calls for the duration of the study
Retained Lens Fragments After Phacoemulsification

The purpose of this study is to investigate postoperative events in patients noted to have retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in those who did not.

In this study, we investigate whether presence of retained nuclear fragments in the anterior vitreous noted during uncomplicated cataract surgery is associated with higher incidence of postoperative adverse events. We will be assessing events including cystoid macular edema, iritis, elevated intraocular pressure, and retinal detachment.

Eligibility Criteria:
Inclusion Criteria:

* Routine cataract surgery with phacoemulsification

Exclusion Criteria:

* Pre-existing macular edema
* Active uveitis
* Intraocular exclusion surgeries
* Significant ocular trauma
* Evidence of phacodonesis or zonular weakness .
Serum Procalcitonin and Post-cesarean Wound Infection

serum procalcitonin levels are important during infections and sepsis.The aim of this study is to evaluate the correlation between serum procalcitonin and severity of post cesarean wound infection

Bacterial infection is primarily a clinical concept that may require the use of supportive bedside or laboratory tests to confirm or exclude. There are two broad factors that are always necessary to confirm the diagnosis: inflammation or systemic dysfunction and direct or indirect evidence of a compatible bacterial pathogen. Inflammation may be localized or result in a systemic inflammatory response syndrome (SIRS).

Infection handling and prevention are now improving with an effective antibiotic discovery, complete immunization and modern sanitation. However, infection remains the most common cause of morbidity and mortality rate in many health care services in the world.

One of the most often serious complications in surgical procedure is surgical site infection. Surgical site infection (SSI) is defined as the presence of liquid pus or abscess which extends on a wound within 30day (RCOG Press, 2008; Bratzlr et al.,2006). Surgical site infection is diagnosed with clinical and laboratory examination. The diagnosis begins with an inspection to check any pus, abscess or inflammation reaction extends on the surgical site. An open wound is also being checked, as well as pus liquid or abscess that leaks from thewound. Pus or tissue specimen should be taken for culture examination and routine blood count for leucocyte count should be investigated and procalcitonin level Procalcitonin (PCT) and leucocyte count are indicators of systemic infection. Procalcitonin is one of the applicable markers to detect bacterial infection in adults. Plasma PCT level is comparable with specific response of bacterial infection, particularly for invasive or probably-invasive bacteria. High concentration of PCT indicates sepsis, severe sepsis or even septic shock condition. It may also represent another possibility and gives additional information towards conventional clinical data. Some studies state that procalcitonin is better, or at least has the same diagnosis potency with another infection marker such as CRP, leukocytosis and fever

Eligibility Criteria:
Inclusion Criteria:

* patients who will develop surgical site infection after their cesarean sections.
* 18-40 years old

Exclusion Criteria:

* History of chorioamnionitis, premature rupture of membranes or prolonged rupture of membrane.
* Urinary tract infections.
* Any infectious condition other than surgical site infection.
Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)

This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders. The investigators hope to show a positive effect on social functioning and language.

Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PDD
Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.

In this study, we found that sedation success rate was 100% in both ciprofol group and propofol group during the painless hysteroscopy. The incidence rate of injection pain and the intensity of pain in the ciprofol group were significantly lower than the propofol group. Also, the ciprofol group had lower incidence rate and severity level of adverse events and higher patient satisfaction. In addition, SBP, DBP, and MAP values in propofol group were found to be significantly lower than those in ciprofol group at the time of cervical dilation and of consciousness recovery.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old;
2. undergoing hysteroscopy examination and requiring intravenous anesthesia;
3. American Society of Anesthesiologists (ASA) physical status I to II;
4. without communication difficulties, and able to cooperate with intervention implementation;
5. participating in this trial voluntarily, and signing an informed consent form;

Exclusion Criteria:

1. with contraindications for hysteroscopy examination (such as cervical stenosis, difficulty in cervical dilation, reproductive tract infections such as vaginitis and cervicitis) or allergies to the intended anesthetic drugs;
2. with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases;
3. with a history of uterine surgery within the past three months;
4. body temperature above 37.5 ℃ before the anesthesia;
5. long-term use of sedative or analgesic drugs.
MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 85 years old
* Suspected BC based on cystoscopical evaluation.
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* History of serious cardiovascular, liver or kidney disease
* Uncontrolled serious infection
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* Patient refusing radical cystectomy or chemotherapy or BCG
* Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination
Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort

The purpose of this study is to assess the safety of lodenafil carbonate in patients with coronaropathy, evaluating the response of the body facing physical effort, including both heart and respiratory components, with and without use of lodenafil carbonate 80mg.

Phosphodiesterase 5 inhibitors (iPDE5) are effective drugs to treat erectile dysfunction (ED).

ED is linked to several factors, like advanced age and diabetes as predominant in its incidence. In addition, ED can be an early manifestation of cardiovascular diseases.

Among the iPDE5 existing in the Brazilian market there is a new molecule which called lodenafil carbonate. It was recently approve and release for use in Brazil, and has similar effectiveness and adverse reactions comparing with other drugs from the same family.

The molecule was evaluated with respect to possible changes in heart rate, blood pressure and QT interval, and the results point out excellent cardiovascular safety profile.

There is a corelated incidence between patients with coronary artery disease and erectile dysfunction. Although patients with stable angina and, under appropriate clinical treatment did not show increase in cardiovascular risks during sexual intercourse, the increased incidence of erectile dysfunction in this population determines a specific group of patients with high potential for use iPDE5.

Therefore it is essential that any new phosphodiesterase 5 inhibitors should be evaluated in patients with coronary artery disease, especially in heart rate, during physical effort.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease with obstruction \<70%, confirmed by prior catheterization, stable patient, and have already showed an acute event (unstable angina or myocardial infarction, according to the guidelines of the Brazilian Society of Cardiology) for at least 6 months;
* Age ≥ 18 and ≤ 60;
* Men;
* Stable for 6 months, regardless of previous myocardial infarction or revascularization;
* ejection fraction of doppler echocardiography ≥ 50%.

Exclusion Criteria:

* Use of nitrate;
* Use of bronchodilators;
* Smoking current period or in less than 6 months;
* Hemoglobin \<10 g / dL;
* Systolic pressure\> 160 mm Hg and \<100 mmHg;
* Diastolic pressure\> 110 mm Hg and \<60 mmHg;
* Body mass index (BMI)\> 30;
* Symptomatic peripheral artery disease;
* Event of angina or AMI, at any time, whether I've done some examination or not;
* Finger tip blood glucose \< 70 and \> 200mg/dL at the time of examination;
* Chest injury \> 50%;
* Triple arterial injury with surgery indication;
* Moderate or severe chronic obstructive pulmonary disease (COPD) confirmed by spirometry;
* Pulmonary hypertension with pressure \> 35mmHg confirmed by doppler echocardiography;
* Moderate or important aortic and/or mitral valvulopathy confirmed by doppler echocardiography;
* Changes in enzyme markers (Troponin I) after the first test;
A Safety and Efficacy Study of PVX108 in Children and Adolescents with Peanut Allergy

The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.


Eligibility Criteria:
Key Inclusion Criteria:

* Physician-diagnosed immunoglobulin E (IgE) mediated peanut allergy;
* Peanut specific serum IgE measured by ImmunoCAP® ≥ 0.7 kilounit allergy specific antibody per litre (kUA/L) at screening;
* Positive skin prick test to peanut with mean wheal diameter ≥5 mm greater than negative control at screening;
* Positive peanut double blind placebo-controlled food challenge (DBPCFC) with a reactive dose ≤300 mg peanut protein (≤443 mg cumulative reactive dose \[CRD\]);
* Able to perform spirometry or peak expiratory flow. Children who are 4 years of age at Screening Stage 1 visit and unable to perform peak expiratory may be enrolled providing they had no clinical features of moderate or severe persistent asthma within 1 year prior to the Screening visit;
* Forced expiratory volume in 1 second (FEV1) ≥80% predicted in adolescents and children with asthma capable of performing spirometry, or peak expiratory flow ≥80% predicted in participants with asthma unable to perform spirometry (at investigator's discretion).

Key Exclusion Criteria:

* History of or current clinically significant medical conditions or laboratory abnormalities which in the opinion of the investigator would jeopardise the safety of the participant or the validity of the study results;
* Severe or unstable asthma as assessed by the Global Initiative for Asthma (GINA) assessment of asthma control OR current treatment for asthma at GINA ≥Step 4 level;
* Participants with skin disorders that would hinder skin prick testing and/or its interpretation or study drug administration (eg, severe generalised poorly controllable atopic dermatitis);
* Any medical condition in which epinephrine (adrenaline) is contraindicated;
* Prior therapy aimed at desensitising peanut allergy, either in a formal study or in clinical practice;
* Severe or life-threatening reaction during the screening food challenge, at investigator discretion.
Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China

EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited. Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients, who are at \>=18 years
* Diagnosis of acute symptomatic or asymptomatic PE, objectively confirmed
* Indication for anticoagulation therapy for at least 3 months (as assessed by the attending investigator)
* Willing to participate in this study, having given informed consent and willing to participate in the routine follow-up during the period of rivaroxaban treatment.

Exclusion Criteria:

* Pre-treatment with any anticoagulant for the index PE more than the 2 weeks.
* Patients with another indication for anticoagulation other than VTE.
* Patients who participated in another study within 30 days
International Students Intervention

The proposed project aims to provide international students on F-1, J-1, or M-1 visas at Purdue additional culturally-relevant support by implementing and testing a psychosocial intervention. The intervention was designed based on the results of a recently published research study (Bhojwani et al., 2020) about international student concerns and needs in the time of COVID-19. This intervention is designed to test the effectiveness of a strengths-based intervention that targets the particular needs of international students during COVID. The intervention was designed based on evidence-based Cognitive-Behavioral and Systemic Therapy (Jafar et. al, 2016; Saravanan et. al., 2017) approaches to addressing stress and anxiety in a culturally-relevant manner and to decrease social isolation.


Eligibility Criteria:
Inclusion Criteria:

* International students who report being on J-1, F-1, or M-1 visas
* Currently enrolled in classes at Purdue at either the undergraduate or graduate level either remotely or in-person
* 18 years or older

Exclusion Criteria:

• active suicidality and/or homicidality
A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.


Eligibility Criteria:
Inclusion criteria:

* Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with osteoporosis
* BMD T-Score less than or equal to (\<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (\>=) -5.0 at all 3 sites

Exclusion criteria:

* Have been treated with other bisphosphonates or using chronic steroids within the past 6 months
* Have a history of major upper gastrointestinal (GI) diseases or have severe kidney dysfunction
* Have a spine fracture (identified on X-ray)
The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation

The aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly instilled through the supraglottic line of the endotracheal tube on post-extubation airway disturbances related to tracheal intubation. The primary endpoint will be the decrease of the incidence of sore-throat 15 minutes and 12 hours after extubation. Secondary endpoints will regard the effects on hoarseness and cough.

The study will be prospective, randomized, controlled. Patients will be premedicated with diazepam, 0.1 mg/Kg and scopolamine, 0.05 mg/Kg, i.m. one hour prior to their arrival in the operatory theatre. Anesthesia will be induced by fentanyl, 0.1 mg, and propofol, 1.5-2 mg/Kg. After obtaining muscle relaxation with cis-atracurium, 0.15 mg/Kg, a Taper Guard Evac Murphy Eye Oral Tracheal Tube (Mallinkrodt, Mirandola, Italy) with an internal diameter of 9 in men and 8 in women, will be positioned. These tubes have a line for suctioning above the cuff. The cuff pressure will be set to 20-30 cmH2O and checked every 6 hours with a proper inflating device. Patients will be connected to a mechanical ventilator and anesthesia will be maintained with sevoflurane 1-2.5% and remifentanil, 0.05-0.15 mcg/Kg/min. At the end of surgery, patients will be moved to the cardiac surgical intensive care, connected to a mechanical ventilator, and sedated with propofol and remifentanil until the conditions needed for weaning from the ventilator (control of bleeding, cardiovascular stability, thermal equilibrium) are achieved. Then, propofol infusion will be stopped and remifentanil dosage decreased to 0.02-0.05 mcg/Kg/min. After a successful t-tube trial of spontaneous breathing, tracheal tubes will be removed. Remifentanil infusion will be continued and dosage titrated on patient pain evaluated with a VAS scale; paracetamol 1 g will be given if need be.

Eligibility Criteria:
Inclusion Criteria:

* intensive care postoperative admission
* tracheal intubation for a total lapse of time between 10 and 18 hours

Exclusion Criteria:

* age \< 18,
* hypersensitivity to FANS and/or corticosteroids,
* a medical history positive for diseases affecting upper airways or trachea or causing cough, hoarseness, or voice disorders;
* intubation after more than two attempts or with aids (i.e. stylets, Airtraq, Glidescope, Fibroscopy).