cyrilzakka/clinical-trials huggingface dataset:
Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

The purpose of this study is to determine whether bacterial decolonization of the nares prior to treatment with radiotherapy (RT) for patients with nasopharyngeal carcinoma, can prevent high-grade radiation-induced oral mucositis (RIOM) and improve quality of life.

This study is being conducted because a randomized clinical trials form Yana Kost et al. have found bacterial decolonization in the nose prior to initiation of RT was effective for prevention of acute radiation dermatitis.

Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and mouth, and participants will also complete a quality of life questionnaire before and after RT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed nasopharyngeal carcinoma
2. No evidence of distant metastasis (M0)
3. ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. 18-70 years old

Exclusion Criteria:

1. Previous or existing mental or cognitive impairment;
2. Patients with other malignant tumors at the same time;
3. Have received bacterial decolonization therapy;
4. Oral mucositis or ulcers existed before radiotherapy.
5. Prior RT to the region of interest
Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial

The purpose of this study is to learn about bowel preparation (cleansing) before laparoscopic hysterectomy and/or sacrocolpopexy. We are most interested in the ability of the surgeon to view necessary anatomy for the surgery, which will be assessed by a questionnaire completed at the end of your operation by the surgeon. We hypothesize that bowel preparation before laparoscopic hysterectomy will result in improved ability of the surgeon to view necessary anatomy for the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing planned laparoscopic hysterectomy, with or without concomitant sacrocolpopexy, for benign indications with members of the Advanced Laparoscopy \& Pelvic Pain division and the Urogynecology division at UNC.

Exclusion Criteria:

* Patients with known or suspected malignancy and those with severe endometriosis of the posterior cul-de-sac where bowel resection
* Pregnant women.
* Women under 18 years old.
* Women who cannot provide informed consent.
Physiotherapy in Patients Hospitalized Due to Pneumonia.

Acute respiratory infections are the fourth cause of hospitalization in elderly. Various studies have examined the impact of hospitalization in patients with respiratory pathology, showing the need of interventions in order to reduce the impact of hospitalization. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients hospitalized due to pneumonia.

Acute respiratory infections are the fourth cause of hospitalization in elderly. Hospital admissions due to pneumonia range from the 1.1 and 4 per 1,000 patients, increasing with age. Hospitalization causes a decline in physical and functional status. Physical impairment involves a higher risk of disability and mortality in elderly people. Various studies have examined the impact of hospitalization in patients with respiratory pathology, and it has been shown that hospitalization implies a significant physical impairment in patients admitted for pneumonia showing that this deterioration increases with age. That highlights the need of interventions in order to reduce the impact of hospitalization. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients hospitalized due to pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pneumonia.
* No contraindication of physiotherapy.
* Signed written consent.
* Medical approval for inclusion.

Exclusion Criteria:

* Contraindications of physiotherapy.
* Neurological, orthopedic or heart disease.
* Prosthetic devices in lower limbs.
Establishment of Tongue Image Database and Machine Learning Model for Malignant Tumors Diagnosis

The tongue images of malignant tumors and corresponding healthy people will be collected to establish the tongue image database. Deep learning will be carried out by computer and artificial intelligence to construct the early screening, diagnosis, prognosis and prognosis model of various malignant tumors based on tongue image for the diagnosis and treatment of malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* 18≤age≤80
* Histologically or cytologically confirmed malignant tumor
* No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor
* Subject volunteers to join the study, Signs informed consent, has good compliance and can cooperate with follow-up

Exclusion Criteria:

* Two or more kinds of malignant tumors at the same time
* Malignant tumor that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy
* Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria:

* Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
First-in-Human Single and Multiple Dose of GLPG1837

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.

The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-child bearing potential between 18-50 years of age (included)
* Subjects must have a body mass index between 18-30 kg/m² (included)
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory findings

Exclusion Criteria:

* A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Current sexually active (and/or child wish) male; a contraception method should be used
* Pregnant or lactating women or women of childbearing potential
Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris

From the obtained results, topical Flutamide 1% gel can be a promising, effective, and safe alternative in treating patients with acne vulgaris with minimal side effects.

Flutamide is a non-steroidal anti-androgen, which is used to treat patients with prostate cancer. Due to its anti-androgenic properties can be used in cases of acne, hirsutism, and androgenic alopecia with successful outcomes. To minimize the unnecessary systemic side effects associated with the oral administration of Flutamide. It has been shown that the topical delivery of Flutamide can allow high drug levels at the site of action, decreasing the systemic side effects and improving patient compliance.

The Flutamide group received topical Flutamide 1% gel twice daily on the face for 8 weeks and the control group received the same gel components, without flutamide, twice daily on the face for 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Fifty adult patients with acne having inflammatory (papules and pustules) and non-inflammatory (comedones) of different sizes, distribution, and durations were included in this study.

Exclusion Criteria:

* Patients with a history of acne treatment with systemic or topical antibiotics, retinoids, or hormonal therapy within the last 3 months.
* Patients with a history of chronic renal failure, hepatic insufficiency
Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product

The primary hypothesis of the present study is that supplementation with the Tension Relief test product will reduce the severity of symptoms of a tension headache.

Patients will begin taking the capsules at the onset of headache symptoms. Onset is defined as the point in time the participant feels that it is necessary to take the test product for relief of symptoms. When the participant decides to take the test product, they will report symptoms in the headache diary prior to taking the product and rate their symptoms on a 10-point Mankoski scale. After consuming the product, the participant will complete a Mankoski scale at 15 minutes, 30 minutes and 1 hour after taking the product. If needed the participant will be allowed to take alternative medication (alternative treatment) after an hour after taking the product. If alternative medication is taken, the participant will record this in their headache diary.

Eligibility Criteria:
Inclusion Criteria:

Adult candidates who are in overall good health and who suffer from mild to moderate tension headaches.

Participants will be deemed to be in good health if they do not report any of the existing medical conditions asked about in the screening questionnaire.

Exclusion Criteria:

* Those who have been diagnosed with migraine headaches.
* Those who score between 36-49 or 60-78 on screening questionnaire.
* Is \< 18 years of age
* Those who have been diagnosed with fibromyalgia.
* Women that are pregnant or breastfeeding.
* Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion.
* Routine recreational drug use such as marijuana.
* Chronic renal disease
* Chronic liver disease
* Allergy to any of the following: Aspirin or any other product including Salicylates, Boswellia, Feverfew, Skullcap, White Willow Bark, Rice Hull, or Vegetable Cellulose.
* Unable to swallow pills.
* Unwilling to try test product for relief of pain and tension headache symptoms.
* Participants who are currently taking any anticoagulation medications daily. (Aspirin, Warfarin, Heparin etc.)
Visceral Somatization and Low Back Pain.

This study aims to verify the significance of the inclusion of procedures of a comprehensive therapeutic approach according to Eastern techniques to classical physiotherapy and to find out whether these Eastern techniques can contribute to the enrichment of standard physiotherapy. According to TCM and Ayurveda, another goal is to develop appropriate regimen measures to create a yoga regimen suitable for patients who have renal and bladder dysfunction according to TCM and whose main common symptom is chronic non-specific low back pain. The study is based upon comparing a four-week physiotherapy program according to the physician's indication and a physiotherapy program enriched with compiled regimen measures and yoga exercises in selected probands.

Two groups of probands were used - an experimental and control group. There were 6 probands in each group. The four-week therapy effect, which took place twice a week for 60 minutes, was compared. The control group received physiotherapy, as indicated by the physician. According to TCM and Ayurveda, the experimental group underwent physiotherapy as indicated by a doctor enriched with yoga exercises and regime measures. It was asked to perform yoga exercises daily at home. The therapy's effect was evaluated using the Short-form-36 Health-related Quality of Life Questionnaire (HRQoL), the VAS scale of pain intensity, the number of responses in the anamnestic questionnaire the author compiled the kinesiological analysis.

Eligibility Criteria:
Inclusion Criteria:

* More than half of the answers in the anamnestic questionnaire (n ≥ 14)
* More than half of the answers in the kinesiological analysis (n ≥ 7)
* Lower back pain lasting longer than 12 weeks
* Degree of pain ≥ 3 on a visual analog scale

Exclusion Criteria:

* Neurological or other structural cause of lower back or other pain key symptoms
* Serious systemic diseases (DM, heart or cancer)
* Contraindications to movements of the spine and other root joints of the body in full scope
* Pregnancy
* Simultaneous completion of another physiotherapeutic intervention, yoga exercise or treatment according to TCM
* Use of analgesics, antiphlogistics or muscle relaxants during therapy
Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.

Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.


Eligibility Criteria:
Inclusion Criteria:

* Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.

Exclusion Criteria:

* Refusal to grant in writing to participate in the study PADIS HTP
Effectiveness of Sealing Dental Caries

This study aims to evaluate, through a controlled clinical randomized study, the effectiveness of sealing carious lesions with composite resin in primary molars. For this, healthy children (n=100) with caries lesion reaching to the middle third of the dentin of primary molars, will be submitted to different treatments to remove the lesions. These patients will be randomly allocated in the following treatment groups: (1) cavity sealing (Non-invasive resin based dental sealing) without caries removal; and (2) Partial caries removal and Invasive resin based restoration. The clinical and radiographic success of the treatment groups will be verified by periodic examination of the restorations by USPHS criteria and radiographic subtraction, respectively, which will be checked progression or not of injury. The researcher responsible for these assessments will be blind to the study, whose evaluations will occur after 6, 12, 24 and 36 months of treatment.

The present study will be carried out as a randomized clinical study. Primary, occlusal caries lesions in children, aged 3-8 years old will be treated by non-invasive resin based sealing (n= 50) or resin based restoration (n=50). Randomization between sealing and restoration (1:1) was made by for a resercher at the Federal University of Rio de Janeiro and kept at the clinics in sealed envelopes. The treatments will be examined clinically and radiographically after 6, 12, 24 and 36 years. The treatments are performed and controlled by only one practitioner (the main reseacher of this study) from the Federal University of Rio de Janeiro, Brazil.

Sealing: The dentist will use a resin based sealing, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from the Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.

Restoration: The dentist will use preparation design and a resin based resin restoration, and follow their usual clinical procedures (partial caries removal) based on the instructions from the manufacturer and the guidelines from Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.

The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of children, or treatment related factors for assessing of statistically significant correlations.

The influence of each factor on the longevity and need for retreatment of occlusal sealants and restorations, will be assessed using apropriate analyses for statistical treatment of data.

Eligibility Criteria:
Inclusion Criteria:

* Children with good general health; children with caries lesion reaching to the middle third of the dentin of primary molars

Exclusion Criteria:

* Patients with systemic diseases; patient' guardians who did not consent with the study.
A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.

In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome and parameters related to glucose homeostasis, parameters related to metabolic syndrome and inflammation will be measured before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women.
* Negative pregnancy test.
* Adequate contraception during the study period and for 1 month following study completion.
* Overt or relative iron deficiency at screening defined as follows:

Serum ferritin \<50 ng/mL AND transferrin saturation \<20%, OR Serum ferritin \<30 ng/mL.

- Serum C-reactive protein: \<5 mg/L if not on oral contraception, OR \<20 mg/L if use of oral contraception

* Intolerance to oral iron formulations, or lack of efficacy of oral iron formulations.
* Minimum total score of 5 on the Visual analogic scale of fatigue.
* Normal levels of vitamin B12 and folic acid at screening.
* Availability and willingness to complete all study visits and procedures per protocol.
* Ability to sign an informed consent.

Exclusion Criteria:

* Age \<18 years.
* Menopause (defined as an amenorrhea of at least 12 months).
* Irregularly menstruating women (menstrual cycle outside a range of 24-38 days in duration) or experiencing overt metrorrhagia (simple spotting not being an exclusion criteria).
* Body mass index \<18.5 kg/m2 or \>30 kg/m2.
* Diabetes, defined as subjects with HbA1c ≥ 6.5 % and/or with fasting blood glucose levels ≥ 7 mmol/l and/or with a history of diabetes and/or by the use of anti-diabetic drugs.
* Hb level \<117 g/L or known haemoglobinopathy or haemochromatosis.
* Blood transfusion within the last 12 weeks.
* Intake of iron preparations 4 weeks prior to screening.
* Known hypersensitivity to FCM or to any other iron preparation.
* Suspicion of major depressive disorder based on Patient Health Questionnaire.
* Known chronic inflammatory disease, including human immunodeficiency virus, hepatitis B or hepatitis C virus infection.
* Active malignancy.
* Decreased renal function (estimated glomerular filtration rate using the CKD-EPI equation\<60 ml/min/1.73m2).
* Liver dysfunction (aspartate aminotransferase and alanine aminotransferase \> 3-fold upper limit).
* Angina (Class IV).
* Asthma.
* Documented sleep apnoea.
* Important recent weight loss (\>10% within the past month).
* Thyroid dysfunction (thyroid stimulating hormone \>4 µU/mL).
* Reported weekly alcohol consumption \> 14 standard drinks.
* Drug abuse (any drug consumption reported in the past 12 months).
Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?

This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.


Eligibility Criteria:
Inclusion Criteria:

1. patient characteristics suitable for subvastus approach as determined by single surgeon
2. patients willing to undergo ambulatory surgery
3. ability to read and verbally communicate via either English or French

Exclusion Criteria:

1. age \> 80
2. driving distance greater than 1 hour from hospital
3. no willing caregiver at home on night of surgery
4. renal failure requiring dialysis
5. Insulin-dependent diabetes mellitus
6. BMI \> 45
7. allergy to study medications
8. pre-existing neurologic deficit involving the ipsilateral limb
9. chronic high dose opioid use (defined as \>200mg/day of morphine equivalent for over 2 weeks).
10. inability to use or manage cACB catheter and pump independently at home
11. inability or refusal to cryocompressive therapy device.