cyrilzakka/clinical-trials huggingface dataset:
Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block

To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant


Eligibility Criteria:
Inclusion Criteria:

Adult, age 18 to 65 years End stage renal disease patients for AV fistula creation

Exclusion Criteria:

Not suitable candidate as determined by the primary team Refusal for brachial plexus block History of allergy to dexamethasone or local anesthesia Pregnancy History of previous brachial plexus injury Coagulopathy Local skin site infection Known neuropathy involving the arm undergoing surgery Patients with glucose reading more then 12mmol/
Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects

Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

1. Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6\*1/\*1, \*1/\*6 and \*6/\*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.

Eligibility Criteria:
Inclusion Criteria:

* must be healthy volunteer

Exclusion Criteria:

* must not be under 18 years old
An Integrated Smoking Cessation and Alcohol Intervention for Young People

The study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with a drinking habit who will be recruited from smoking hotspots in Mong Kok. Participants will be randomized into a standard treatment (ST), II, or control arm. Participants in the ST arm will receive a brief smoking cessation intervention based on the Asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit, Assisting in quitting, and Arranging for follow-up and Relevance, Risks, Rewards, Roadblocks and Repetition models. Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention. Booster interventions will be provided to both ST and II arms at 1-week, 1-month, 3-month, and 6-month follow-up. Participants in the control arm will receive leaflets on smoking cessation and alcohol abstinence. Data collection will be done at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.


Eligibility Criteria:
Inclusion Criteria:

* smoked at least one cigarette in the past 30 days
* have consumed at least one cup of alcohol (10 ounces of beer, 4 ounces of wine, or 1 ounce of liquor) in the past 30 days
* speak Cantonese.

Exclusion Criteria:

* have a compromised mental status and/or communication problems
* participating in other smoking cessation interventions
A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer

Researchers are doing this study to look at whether sexual health counselling and using non-hormonal moisturizer at the start of ovarian suppression may be able to prevent or reduce side effects such as vaginal dryness and sexual dysfunction. Researchers will compare how effective this prevention intervention works compared to the usual approach, which is to treat these side effects after they start. All participants will also complete surveys about their sexual health. This information will help researchers learn more about the sexual health of women with breast cancer receiving ovarian suppression.

50 premenopausal or perimenopausal women who are receiving ovarian suppression as part of their breast cancer treatment will be randomized to upfront intervention vs at the time of symptom development (standard of care). Patients will have subjective and objective monitoring of vaginal dryness and sexual dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Women, 18 years of age or older
* Breast cancer patients with hormone receptor positive breast cancer , stage 0-III
* Premenopausal or perimenopausal women who have either been pregnant or had at least one menstrual period in the last 24 months or have/had an IUD in place
* Patients currently on or are being initiated on ovarian suppression
* Patients are asymptomatic for vaginal symptoms of estrogen deprivation (i.e. vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) and score a 3 or less on the VAS and VuAS

Exclusion Criteria:

* Postmenopausal women who have been without a period for ≥ 2 years
* Patients who score a 4 or above on the VAS and VuAS
* Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under Section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by Sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening
* In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements
* Women of non-childbearing potential and men using contraceptive measures

Key Exclusion Criteria:

* History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders
* History of asthma, chronic obstructive pulmonary disease, or emphysema
* Clinically significant neurologic disorder
* History of stomach or intestinal surgery or resection
* History of malignancy
Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C

The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection

Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.

Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent;
2. Male or female, age≥18 years;
3. Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
4. Serological detection of anti-HCV antibodies was positive at screening;
5. HCV RNA≥1×104 IU/mL at Screening;
6. HCV genotype 1\~6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory.

Exclusion Criteria:

1. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
2. Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
3. Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
4. Psychiatric illness or psychological disease or relevant medical history;
5. Solid organ transplantation;
6. Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.


Eligibility Criteria:
Inclusion Criteria

* Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy

Exclusion Criteria

* Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
* Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
* Has life expectancy of less than five days
Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.

The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .

Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients


Eligibility Criteria:
Inclusion Criteria:

* The patient must be informed about the study, and sign the informed consent

Exclusion Criteria:

* Positive Pap smear test
* Pregnancy
* Uterine malignancy
* Abnormal uterine bleeding
Sun Protection Factor Assay (338/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer

The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy.

Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers.

This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational.

Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.

PRIMARY OBJECTIVES:

I. To assess the prognostic value of pretreatment volumetric tumor growth velocity (TGV), weekly tumor kinetics (TK), and blood biomarkers of mucosal head and neck cancers during radiation therapy (RT), using magnetic resonance imaging (MRI).

SECONDARY OBJECTIVES:

I. To assess functional imaging kinetics as a marker of tumor locoregional control.

II. To correlate blood biomarkers with tumor kinetics during treatment. III. To generate preliminary data for future trials.

OUTLINE:

Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.

After completion of study, patients are followed up weekly.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven diagnosis of squamous cell carcinoma (SCC) of head and neck mucosa. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging
* No distant metastases, based on routine staging workup
* Consent for blood collection for biomarker analysis
* No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
* Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
* Dispositioned to curative intent radiotherapy
* For females of child-bearing age, a negative pregnancy test

Exclusion Criteria:

* Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
* Pregnant or breast-feeding females
* Contraindications to magnetic resonance (MR) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators)
* History of claustrophobia
* Contraindications to gadolinium contrast (e.g. kidney dysfunction)
R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion

Purpose: This randomised trial will compare outcomes and acceptability of an alternative medical abortion follow-up protocol using standardised text messaging, on-line questionnaire, or a phone interview and a low sensitivity pregnancy test with the current standard of care which consists of either a clinic visit and ultrasound scan or a telephone call and high sensitivity pregnancy test.

Hypothesis: The use of "alternative" methods to assess outcomes after early medical abortion will achieve a higher rate of follow-up than women undergoing "standard" follow-up

Primary aim: To determine the follow-up rate after early medical abortion with an alternative protocol as compared to a standard follow-up protocol

Secondary aims:

* To assess complication rates and receipt of further treatment among women in the two study arms
* To ascertain women's preferences for mode of communication regarding their post-medical abortion status
* To determine provider opinions and preferences for different follow-up modalities


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older,
* eligible for an abortion under the terms of the Abortion Act (1967),
* requesting an early medical abortion,
* willing and able to comply with the study protocol and visit schedule,
* access to either a mobile phone, intranet or telephone and willing to have communication by one of these means to assess post-medical abortion status,
* willing to have call back messages left,
* willing and able to provide valid informed consent, and
* able to communicate in English.

Exclusion Criteria:

* prior participation in this research study, or
* current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.
Benign Prostatic Hyperplasia in Taiwan

Primary Objective:

* To assess the sexual function of Benign Prostatic Hyperplasia patients

Secondary Objective:

* To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
* To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
* To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
* To assess the onset of action of XATRAL 10mg OD
* To assess the peak urinary flow rate
* To assess the safety and the tolerability of XATRAL 10mg OD


Eligibility Criteria:
Inclusion criteria

* Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)
* Sexually active
* Sexual attempts at least once per month

Exclusion criteria

* Known history of hepatic or severe renal insufficiency
* unstable angina pectoris
* concomitant threatening-life condition
* Previous transurethral resection of the prostate (TURP)
* Had a minimally invasive procedure within 6 months prior to inclusion
* Planned prostate surgery or minimally invasive procedure during the whole study period
* Active urinary tract infection or acute prostatitis
* Neuropathic bladder
* Diagnosed prostate cancer
* Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion
* Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion
* History of postural hypotension or syncope
* Known hypersensitivity to alfuzosin
* Patients illiterate or unable to understand or to complete the questionnaires
* Patients having participated in any clinical study in the past month
* Prostate Specific Antigen (PSA)\> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery

Major adverse cardiovascular events are the leading cause of perioperative morbimortality in non-cardiac surgery. Perioperative myocardial infarction is usually asymptomatic, with a mortality around 10-12%.

Myocardial Injury in Noncardiac Surgery (MINS), is defined as a myocardial injury that provokes a troponin increase due to myocardial ischemia. MINS is a predictor of morbimortality at short term and at long term.

The aim of the study is to improve the diagnosis of myocardial injury after non cardiac surgery in high-risk patients, improve its treatment in case of MINS and establish prevention strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders over 45 years scheduled for non-urgent surgery with in-hospital stay of 24 hours minimum who require general and or regional anaesthesia (epidural or subarachnoidal) that have signed the inform consent who will be operated of:

  1. High-risk surgery:
* Open abdominal aortic aneurism repair
* Major vascular surgery
* Major amputations
* Carotid endarterectomy
* Duodeno-pancreatic surgery
* Hepatic resection or resection of biliary duct
* Esophagectomy
* Suprarenal resection
* Cystectomy
* Pneumonectomy

  2. Medium risk-surgery with cardiovascular risk factors (see below):
* Intraperitoneal surgery (rectum, colon, small bowel, gastric surgery)
* Peripherical angioplasty
* Endovascular aneurism repair
* Head and neck surgery
* Major orthopedic surgery (hip, knee, column)
* Major urological or gynecological surgery
* Thoracic surgery (lobectomy or atypical pulmonary resections)

  a) With 1 risk factor:
* History of coronary artery disease
* History of cerebrovascular disease (history of transient ischemic attack or stroke)
* History of congestive heart failure
* History of vascular disease

  b) With 2 risk factors:
* Diabetes mellitus with medical treatment
* Renal disease (FGE \< 45 ml•min-1•1.73m2 )
* Functional capacity \< 4METs
* Intraoperative blood loss \>600ml

Exclusion Criteria:

* Patients without consent information
* Patients non included in the inclusion criteria
Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture

It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

Fracture is often responsible of pain in the paediatric emergency department (ED). This pain is very severe and needs effective drugs.

During a study made at the ED of Necker Enfants Malades Hospital, it has been shown that the oral morphine had a limited action on this kind of pain. Therefore it is interesting to increase the analgesia by making a drug association, for example with the midazolam witch is a benzodiazepine with a sedative and anxiolytic action, and which has got the MMA for the intravenous and the intra rectal forms for children older than 6 months.

The intravenous form has some disadvantages like an extra work and an increase of risk of side effects.

That is why the sublingual form seems to be interesting in this context. Even if some studies have shown the benefit of midazolam as a preanesthetic medication given to children scheduled for a surgical procedure, none has shown the interest of sublingual midazolam associated with oral morphine to relieve the pain due to a displaced fracture.

The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam . The pain will be quantified thanks to the visual analogical scale (VAS)before and 30 minutes after the drugs administration, and we will try to show a difference of 15 points(on 100) of the VAS at 30 minutes between the two groups.

60 patients aged from 5 to 16 years old and having a displaced fracture will be enrolled in this study which will last 1 year.

Patients having a contra-indication for morphine and midazolam won't be enrolled as patients with femoral fracture which needs a local anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* children between 5 and 16 years old
* children with a disjoined bone fracture
* children needed oral morphine analgesia
* written informed consent from one or the two parents or legal pad

Exclusion Criteria:

* ASA score \> 2
* concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
* concomitant administration of benzodiazepine less than 24 hours