cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

* Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
* Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening
* Patients who are HCV treatment-naive
* Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening
* Patients with HCV RNA ≥10,000 IU/mL at screening
* Patients with HIV-1 infection

Key Exclusion Criteria:

* Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry
* Patients infected with HIV-2
* Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed
* Evidence of decompensated liver disease, including radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
The Southampton Mealtime Assistance Roll-out Trial

The Southampton Mealtime Assistance Study aims to determine whether it is feasible and acceptable to introduce trained volunteers as mealtime assistants in five different departments of one large hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 70 years admitted to one of the wards under study

Exclusion Criteria:

* Patients with active bowel pathology
* Patients in the terminal phase of their life
* Patients who are artificially fed (parenterally or enterally)
Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty

Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty.

All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve.

The observed goals: pain intensity, the beginning and quality of rehabilitation.

Written consent will be obtained a day before the surgery. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

Before the beginning of operation, under ultrasound control, a catheter will be implemented to one of the chosen position: the adductor canal (the middle or lower third of thigh) or near the femoral nerve (below the inguinal ligament). The local anesthetic solution of 0.2 % ropivacaine will be started with an elastomeric pump (5 mL per hour, up to 72 hours) as soon as a catheter in the right position.

The pain will be measured with VAS (visual-analogue scale) 8, 24 and 48 hours after the end of operation, and at the discharge. At the same time, i.e.: 8, 24 and 48 hours from the end of surgery, the range of flexion and extension in the operated knee will be assessed. Moreover, the possibility of patient's sitting, standing up and walking will be noted.

All parameters will be reassessed before patients' discharge from the hospital. Each patient will receive paracetamol (1.0) and metamizol (1.0) intravenously (i.v.) q6h. 5 mg of morphine may be given as required, up to 2 dosages per day as a rescue medication.

Eligibility Criteria:
Inclusion Criteria:

* knee arthroplasty
* obtained consent
* subarachnoid anaesthesia

Exclusion Criteria:

* coagulopathy
* allergy to to local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
The Main Content of This Study is to Use Virtual Reality Technology Combined With Local Anesthesia With Lidocaine Injection at Different Times to Reduce the Pain of PICC in School-age Children

We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children. Using the convenience sampling method, the selection in May 2020, 2021 - may need to PICC placement of children as the research object, is divided into three groups A, B, c, group A in ultrasound guided by PICC placement; Group B and group C adopt VR intervention, and 5 min before the beginning of the next surgery using VR equipment. Group B was anesthetized after the needle was placed into the guide wire, and group C was anesthetized before the needle was placed into the guide wire.

This study investigated the effect of VR combined with lidocaine local infiltration anesthesia in peripherally inserted central catheter (PICC) insertion, aiming to improve one-needle puncture success rate, reduce pain, reduce fear, improve compliance and catheterization time.

From May 2020 to May 2021, children requiring PICC were recruited by convenience sampling and divided into three groups: A, B and C. Group A was implanted with PICC under ultrasound guidance. Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began. Group B was anesthetized after the puncture needle was sent into the guide wire, and group C was anesthetized before the puncture needle was sent into the guide wire.The success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three groups. A sample size and power analysis were conducted to determine the sample size required.The investigators assumed a medium effect size (f2 = 0.25) of the active VR. Using 2 tails and alpha = .05, a fixed-effect linear regression model would offer power greater than 0.80 with a total sample size of 159 children. To ensure adequate power, the investigators planned to recruit 56 participants for each group. Three groups were all operated by PICC specialist nurses, and the standard operation procedure of PICC catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 INS guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged between 6 and 12 years.
* Undergoing their inaugural ultrasound-guided PICC insertion in an up.
* Voluntarper limby participation and informed consent by parents or guardians.

Exclusion Criteria:

* Children with severe cardiocerebral conditionsor critical coagulopathies.
* Known lidocaine allergies.
* Severe mental illness or cognitive impairment in patients.
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men

This study aims to compare the effects of 8 months of diet modification, with or without exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and quality of life in obese men.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 30-65 years
* Body Mass Index (BMI) \>/= 27.5 kg/m2
* Waist circumference (WC) \>/= 90 cm

Exclusion Criteria:

* pituitary disease or cranial radiotherapy
* previous or current androgen replacement or deprivation therapy
* current treatment for sexual problems or LUTS
* glomerular filtration rate \< 60 ml/min
* liver disease
* alcohol intake exceeding 500 g/week in the previous 12 months
* use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel

The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.

Hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. But intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. The investigators hypothetically believe that application of HYALOBARRIER Gel at the end of the procedure, could be reduce the mean intrauterine rate to 50%. Thus, the investigators performed a multicenter (n = 20) prospective study non randomized in 220 patients with submucous myoma \< 3 cm of diameter, evaluated by preoperative ultrasound. The investigators prefer this study design, because the principal reason is the number of enrolled patient were more 200 patients in each group with a double blind randomized study. Now, in all patients, after hysteroscopic myomectomy which performed with a same technique in each center (bipolar coagulation and physiologic serum), a diagnostic hysteroscopy was performed at 2 month to determinate the existence of intrauterine adhesion. Secondary end points were in this study the tolerance and side effects of HYALOBARRIER Gel and the subsequent fertility at 2 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 aged-patients
* hysteroscopic diagnosis of one submucous myoma with less than 3cm diameter requiring operative hysteroscopy with saline type 0, 1 or 2
* negative plasmatic βHCG test
* non opposition
* patients with social security

Exclusion Criteria:

* multiple submucous myomas type 0, 1 or 2
* presurgical embolization
* presurgical impregnation with GnRH agonist
* coagulative disorders
* malignancies
* uncontrolled diabetes
* operative hysteroscopy with glycine
* known hypersensitivity to HyalobarrierR Gel Endo
* infection of the surgical area concerned
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, women aged 18 to 49 years.
* History of severe PMS symptoms over the last year, as determined by the investigator.
* Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.

Exclusion Criteria:

* Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
* Contraindication to combination oral contraceptives.
* Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Other exclusions apply.
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)

In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain, stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be investigated. It is expected, that a single dose of methylprednisolone 500 mg given intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can be seen already 2 weeks after drug administration.


Eligibility Criteria:
Inclusion Criteria:

* Age of ≥18 years.
* Definite diagnosis of AS according to the modified New York criteria.
* History of an inadequate response to ≥2 nonsteroidal antiinflammatory drugs (NSAIDs) taken for at least 2 weeks each or NSAIDs intolerance.
* Active disease as defined by the Bath Ankylosing Spondylitis DIsease Activity Index (BASDAI) value of ≥4 at screening despite concomitant treatment with an NSAID or without NSAIDs in case of intolerance.

Exclusion Criteria:

* The female subject is pregnant or lactating.
* Patients with other chronic inflammatory articular disease or systemic autoimmune disease.
* History of inadequate response to previous anti-tumour necrosis factor (TNF) α therapy.
* Treatment with any other investigational drug within 4 weeks of 5 half-life of the drug (whichever is longer) prior to baseline.
* Treatments with disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate within 4 weeks prior to screening (8 weeks for leflunomide or 4 weeks with a standard cholestyramine wash-out).
* Treatment with intravenous, intramuscular or intraarticular/periarticular steroids within 4 weeks prior to screening.
* History of oesophageal, gastric, duodenal or intestinal ulceration, clinically relevant gastrointestinal bleeding.
* History of or current signs of coronary heart disease, myocardial infarction, stroke or transient ischemic attack, peripheral arterial thrombotic events.
* Congestive heart failure (NYHA III-IV)
* Uncontrolled arterial hypertension.
* History of diabetes mellitus.
* History of glaucoma.
* Major surgery within 12 weeks prior to screening.
* Evidence of any other severe uncontrolled gastrointestinal, hepatic, renal, pulmonary, cardiovascular, nervous or endocrine disorders.
* Any active current viral, bacterial or fungal infection, a history of recurrent clinically significant infection, infections requiring treatment with antibiotics within 4 weeks prior to baseline.
* History of chronic infection with hepatitis B or C, history of HIV infection.
* Primary or secondary immunodeficiency.
* Any other conditions making the patient unsuitable in the opinion of the investigator for the participation in the current study.
A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction

The objective of this study was to assess the impact of a nursing intervention on therapeutic adherence in elderly patients after acute myocardial infarction compared to a control group

A comprehensive geriatric assessment was performed during the first admission in all patients. Patients were randomly allocated to a nursing intervention group or a usual care group. In patients from the intervention group, a nursing intervention programme was performed 3 months after admission, based on education, support and patient monitoring to improve therapeutic adherence and a 6 month phone call. The main outcome measured was therapeutic adherence at 12 months, as defined by a combination of adherence measurement tools (Morisky-Green and Hayness-Sacket scales, attendance at visits and withdrawal of medication from the pharmacy). Therapeutic adherence was assessed by nurses blinded to the assignment group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI)

Exclusion Criteria:

* Patients who refused to participate in the study
* Patients unable to perform geriatric assessment.
* Patients admitted to nursing homes or social health centres.
The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological and Cognitive Function

A randomized, double blind, counterbalanced, placebo controlled independent groups design to determine the effects of 3 month supplementation with tart cherry concentrate on indices of cardiometabolic health, exercise capacity and cognitive function. Following screening and recruitment, participants are familiarised with the testing equipment and procedures after which they will be randomly assigned to receive either Montmorency tart cherry concentrate (MC) or an isocaloric placebo (PLA), stratified by gender. The study is comprised of two experimental visits and outcome variables are assessed at baseline (before supplementation) and at 3 months (follow up; after supplementation).


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 40-60 years
* consume on average ≤5 servings of fruits and vegetables per day
* additionally have ≥1 risk factor for type 2 diabetes

Exclusion Criteria:

* not regularly taking medication (or stabilised ≥ 3 months, with no adverse symptoms) or antioxidant supplements
* history of cardiometabolic, gastointestinal disease or malabsorption syndromes
* stage 2 hypertension (SBP \>159 mm Hg or DBP \>99 mm Hg)
* individuals who report changes in dietary or physical activity patterns within 3 months
* vegetarians, vegans or known eating disorders
* alcohol intake of more than 21 units per week
* BMI ≥40 kg/m2
* are pregnant or planning to become pregnant during the study, lactating, or initiating or changing a hormone replacement therapy regimen within 3 months of the start of the study
Efficacy and Safety Evaluation of Anti-Caries Varnish

The purpose of the study is to determine the efficacy \& safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are:

1) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.

This is a single center randomized, double-blind, placebo-controlled, parallel-group trial. The treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. The control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. Half will be randomized to each arm. Subjects will be 6-24 mo of age and in good health. Children attending Maternal and Child Health (MCH) Immunization and Well Child programs in Pohnpei State will be enrolled. Primary Outcome Variables: 1) Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) Presence/Absence of dental caries lesions (d2-4mfs \>0) at 12 months post baseline. Secondary Outcome Variable: Adverse Events

Eligibility Criteria:
Inclusion Criteria:

1. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
2. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
3. The subject is a 6-24 months at the time of enrollment.
4. The subject must be in good general health as evidenced by parent report.
5. The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion.

Exclusion Criteria:

1. Previous treatment with fluoride varnish
2. Known allergy to iodine
3. Diagnosis of thyroid disease
4. Chronic, prophylactic use of antibiotics
5. Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit.
6. Visible cavities (d2-4)
7. Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared)
8. Parent anticipates the child will move from Pohnpei during the next 2 years.
Engineering Gut Microbiome to Target Breast Cancer

The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal females ≥ 18 years of age
* Histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage I-III
* Must have adequate organ function,
* Not receive systemic neoadjuvant therapy
* Be willing to provide tissue, blood, and stool samples for research study.
* Must not have taken any probiotics in the past 60 days prior to enrollment.

Exclusion Criteria:

* Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.
Functional Outcomes After Radial Head Fractures Treated Non-operatively

The purpose of this study is to investigate the effects of physical therapy as part of the non-operative treatment of radial head fractures.There is currently no data to support the use of physical therapy in the non-operative treatment of radial head fractures. Likewise, there is no data that shows that physical therapy is harmful to patients being treated non-operatively for radial head fractures. Investigators believe that prescribing physical therapy for patients with non-displaced radial head fractures treated non-operatively is unnecessary, and that that it would be equally efficacious to teach patients simple stretching exercises that they could perform by themselves. Subjects will be randomized into 2 groups: Group 1 - Patients will be prescribed physical therapy within the first month following fracture; Group 2 - Patients will be given simple stretching exercises to perform at home and will not be given a prescription for physical therapy. Patients who agree to participate in this study and sign the informed consent will be randomly assigned to one of the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Individuals to be approached for participation in this study will include all adult (age \> 18 years old) patients who are receiving or seeking medical care in the outpatient setting.

Exclusion Criteria:

* Patients who are initially determined to need surgical fixation of a radial head fracture will not be included in this study. There are no additional exclusion criteria.
Awake Craniotomy for Arteriovenous Malformation

The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.

Four patients' charts were retrospectively reviewed and neurological status before and after awake craniotomy was assessed to look for any deterioration.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of arteriovenous malformation in brain
* Awake craniotomy for surgical resection of arteriovenous malformation

Exclusion Criteria:

* Patients with incomplete records