cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery

The purpose of the study is to determine the minimum effective concentration of bupivacaine (EC50) in femoral block for analgesia by ultrasound after knee surgery.

45 patients classified as ASA P1 or P2 aged between 18 and 65 candidates for elective knee operation via arthroscopy were included in the study. All patients received femoral nerve block guided by ultrasound with bupivacaine, 22 ml. The first patient at a concentration of 0.25%. The other patients with higher or lower concentrations if the first patient has pain\> 3 or \<3 on visual analogic scale respectively after awakening of surgical anesthesia. For surgical anesthesia each patient will undergo general anesthesia. At the end of the surgical procedure and anesthetic awakening patients will be evaluated for analgesia by verbal numeric scale. The modified Dixon method was used to find the EC50 and EC95 of bupivacaine for analgesia of femoral nerve block guided by ultrasound. Concentration still correlated with motor block and side effects.

Eligibility Criteria:
Inclusion Criteria:

* patients to undergo knee surgery

Exclusion Criteria:

* patients with coagulopathy
* pregnant
* infection at the puncture site
* chronic pain
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)

The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index is less than (\<) 30.0 kilograms per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg
* Stable CF disease
* CFTR gene mutations on both alleles that are not responsive to CFTR modulator therapy

  o Example mutations include but are not limited to, mutations that do not produce CFTR protein (i.e., Class I): nonsense mutations (e.g., G542X, W1282X) and canonical splice mutations (e.g., 621+1G-\>T)
* Forced expiratory volume in 1 second (FEV1) value for SAD: greater than or equal to (≥)40 percent (%), MAD: ≥ 40% to less than or equal to (≤) 90%

Key Exclusion Criteria:

* History of uncontrolled asthma within a year prior to screening
* History of solid organ or hematological transplantation
* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
* Arterial oxygen saturation on room air less than (\<) 94% at screening

Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure

RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to severe pain associated with chronic anal fissure approved in June 2011 by the US Food and Drug Administration (FDA) for adults. The purpose of this study is to assess the safety, pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents

This is an open-label, multicenter study conducted in up to 10 sites in the United States. A total of 13 pediatric male or female patients age ≥12 to \<17 years will be enrolled. The patients will administer a dose of Rectiv® twice daily to characterize the safety, pharmacokinetics , and exploratory efficacy of Nitroglycerin Ointment 0.4% (RECTIV® )over 5 days

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female ≥12 and \<17 years of age
* At least 1 anal fissure for a minimum of 3 weeks in duration
* Anal fissure pain experienced over the last 24 hours at Screening and before enrollment
* Patient (and parent or caregiver as appropriate) has provided written informed consent

Key Exclusion Criteria:

* Current diagnosis of hemorrhoids
* Hypersensitivity, allergy, or contraindication to nitroglycerin
* History of hypertension and/or cardiovascular disease
* History or current diagnosis of inflammatory bowel disease
* History or current diagnosis of fistula(e)-in-ano or an anal abscess
* Fibrotic anal stenosis
* Previous anal surgery
* Diagnosis of cancer
* History of migraine or chronic headaches requiring treatment with analgesics
* Pregnant or lactating female patients
* Weight \<36 kg
Effect of OMT on Asthma Symptoms in Southwest Virginia

There is a high prevalence of asthma in southwest Virginia and there are multiple osteopathic manipulative techniques (OMT) which are thought to improve lung function. However, there are inadequate studies regarding the effectiveness of using osteopathic manipulative treatment (OMT) as an office treatment or a home treatment to address obstructive lung disease. In addition, there is little information on the level of acceptance, use, and cost effectiveness of using OMT in rural southwest Virginia. The purpose of this study is to determine the viability of OMT treatment with asthma, the level of acceptance in selected clinics in southwest Virginia, and the effectiveness of home OMT education in order to implement a program to improve asthma control. The study hypotheses are: 1. Osteopathic manipulation delivered to the asthmatic patient will significantly improve spirometry values, thoracic excursion, and subjective asthma symptoms. (.05 alpha) 2.Patients who are taught and use a home treatment regime for asthma will significantly improve spirometry values, thoracic excursion, and subjective asthma symptoms after two weeks, compare with those who do not have home treatment.

3.Physicians educated on the use of OMT for asthma will increase their perceived future use of OMT as an adjunct to treat this disorder.

In this study, participants will be recruited from several family practice, pulmonologist, and asthma specialist offices in southwest Virginia. These participants will undergo two visits. At the first visit, a lung assessment comprised of three components will be performed, then a 10 minute OMT session, then the lung assessment will be repeated. The lung assessment includes a patient symptom survey, a thoracic excursion measurement, and spirometry. The participants will then be divided into one of two groups. Group 1 will have no further instruction while group 2 will be taught some simple home OMT techniques and asked to do them at home. Both groups will return two weeks later for a follow up lung assessment. Results when then be studied to determine the effect of OMT on lung function in asthmatics as well as the effect of incorporating home OMT. In addition, physicians will be involved in learning about OMT and these techniques and they will be assessed for a change in attitude, awareness, and willingness to incorporate OMT when applicable.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-55
* mild intermittent, mild persistent, or moderate persistent asthma

Exclusion Criteria:

* severe persistent asthma
* congestive heart failure
* active pulmonary infection
* oral steroid burst in past month
* hospitalization for pulmonary causes in past three months
* OMT treatment directed towards thoracic and ribs in past three months
Is There a Relationship Between Serum Sodium Level and Mean Platelet Volume (MPV) Value

Is there a relationship between serum sodium level and mean platelet volume (MPV) value in patients undergoing transurethral prostate resection (TUR)?

Thirty one patients undergoing transurethral prostate resection (TUR)? will be evaluated.The relationship between serum sodium value and MPV value of patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status 1 and 3
* Patients between the ages of 18 and 80

Exclusion Criteria:

* Patients with bleeding disorder
* Patients with blood transfusion
* Patients are that sodium values are lower than normal range.
ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases

To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing the occurrence of bone metastases in prostate cancer patients at high risk of developing them. In addition, pain and analgesic scores and overall safety are to be evaluated throughout the study.

This is a prospective, randomized, stratified open-label (Zometa + hormonal ablation versus hormonal ablation alone) multicenter clinical study evaluating the efficacy of Zometa 4mg given every 3 month as an adjunct to hormonal or surgical castration for prevention of bone metastases in locally advanced, high risk prostate cancer patients, who are hormone-naiv at time of randomization. the primary efficacy variable is the time to occurrence of first bone metastases.

Zometa® (zoledronic acid) provided as 4mg lyophilised powder Supplementation 500mg Calcium +400-500IU Vitamin D p.o. qd

Arm A:

Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months

Arm B:

no reference therapy

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age \> 18 years
* Histologically confirmed diagnosis of carcinoma of the prostate
* ECOG performance status of 0, 1, or 2
* No radiological evident bone metastasis (negative bone scan or verification of suspected foci as benign lesions by additional radiological examination)
* T3-4 AND highest pre-study PSA \>20 ng/ml AND Gleason score = 8 (or Gleason grade = 4)
* Patients with prior prostatectomy or prior local radiotherapy are eligible for this study
* Patients are destined to receive medical (LHRH analogue) or surgical (orchiectomy) castration and Zometa® treatment will start not later than 6 weeks after surgery
* Patients should be fully recovered from prior interventions where applicable

Exclusion Criteria:

* Patients with a serum creatinine determination \>265 µmol/L (3.0 mg/dL)
* Patients that received prior medical (LHRH analogue) castration
* Current (or previous) evidence of metastatic disease to the bone
* History of any other neoplasm within the past five years except for nonmelanomatous skin cancer.
* Previous hormonal therapy with LHRH agonists or other forms of hormonal ablation
* WBC\<3.0x109, ANC \< 1500/mm3, Hgb\<8.0 g/dL, platelets \< 75 x 109/L
* Liver function tests \>2.5 ULN
* Prior treatment with Zometa® (zoledronic acid) or other bisphosphonates
* Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to the date of randomization (Visit 2)
* Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization (Visit 2)
* Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
* History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator.
Evaluation of Counseling for Partner Notification

* In the formative stage of the project, we have investigated through qualitative and quantitative studies to identify a potential intervention to promote partner referral for sexually transmitted patients in Bangladesh.
* We conducted a quasi-randomised trial to evaluate if single session counseling is effective in improving partner referral for patients with sexually transmitted infection.

The study was a quasi-randomized trial, alternating partner referral counselling and standard of care approach for each subsequent patient. First patients was randomly assigned by the project research physician in each clinic then alternative patients allocation was maintained by the study interviewers assigned in each clinic. For index cases assigned to the counselling arm, a same sex counselor conducted 10-15 minutes individualized sessions. Counselors were specifically trained to deliver partner referral counselling focusing on five issues related to STI prevention and transmission: (1) risk of re-infection if partners are not treated concurrently; (2) risk of developing complications; (3) risk of further spread of infection in the community; (4) the asymptomatic nature of infection; and (5) social obligations and personal coping with an STI. Patients in the standard care group received the existing services in the respective clinics, which included clinical consultation, prescription for medication but there was no partner referral counselling per se. In the public clinics, both the counselling and non-counselling group of clients received free medications, while in the NGO clinics they received subsidized fee medications. Both groups also received standard, pre-tested anonymous partner referral cards along with a short briefing by the interviewers that index clients need to hand over this card to their partner(s) to bring them to the respective clinics for assessment of STI status. Partner referral cards were used to follow-up partner referral by tracking the patient identification number and disease code of cards provided by referred patients. In addition, referral cards were useful for the partners to locate the study clinic, to be entitled to free or subsidized medication, and to distinguish the partners from index cases coming to the clinics.

Eligibility Criteria:
Inclusion Criteria:

* Each newly diagnosed STI patients
* Age \> 18 years
* Who had a sexual exposure in last three months
Epicardial Mitral Touch System for Mitral Insufficiency

To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or greater (2+) ischemic
* Functional Mitral regurgitation by 2D echocardiography using an integrative method
* Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)
* Patient is 22 years of age or older
* Patient is willing and able to sign Informed Consent Form
* Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States

Exclusion Criteria:

* Any evidence of structural (chordal or leaflet) mitral valve disease
* Inability to derive ERO, LVESVI or LVEDVI by TTE
* Prior surgical or percutaneous mitral valve intervention
* Contraindication to cardiopulmonary bypass (CPB)
* Clinical signs of cardiogenic shock
* Treatment with chronic intravenous inotropic therapy
* Severe, irreversible pulmonary hypertension in the judgement of the investigator
* ST segment elevation requiring intervention within 7 days prior to randomization
* Congenital heart disease (except PFO or ASD)
* Evidence of cirrhosis or hepatic synthetic failure
* Renal insufficiency (eGFR \< 30 ml/min)
* History of endocarditis or current endocarditis
* Ejection fraction \<25%
* NY heart class IV
* MV diameters \> 7cm
* Any coronary artery calcification at site of placement as determined by angiogram
* Myxomatous mitral regurgitation
* Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
* Abnormal cardiac anatomy discovered prior to surgery or during procedure
* Pericardial adhesions
* Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

Primary Objective:

To evaluate safety (4 weeks)

Secondary Objectives:

* To evaluate the long-term safety (12 weeks)
* To evaluate the efficacy
* To characterize the pharmacokinetic profile

The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Eligibility Criteria:
Inclusion criteria:

* Aged 6 months through 11 years
* Patients with atopic dermatitis

Exclusion criteria:

* Main itching scores are 4 or less than 2 on last three consecutive days before registration.
* Patients who have itching only on face, head, or diaper area.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery

This study was conducted as a randomized controlled experimental study. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The population of the study consisted of primiparous mothers who applied to the hospital. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The study was carried out in two stages. In the first stage, the data were collected in the delivery room, and in the second stage, the postpartum satisfaction levels of the mothers were measured in the postpartum service. The sample number of the investigators' study was determined as 96. Visual analog scale, birth satisfaction scale and birth follow-up form were used for the data of our study.


Eligibility Criteria:
Inclusion Criteria:

* Being primiparous to be in due time
* To have spontaneous vaginal delivery
* Ability to communicate verbally be between the ages of 18-35
* Not having a risky pregnancy
* Having a single fetus in the vertex position
* Having started contractions and continuing regularly
* Being in the latent phase of action (0-4 cm dilatation)
* Not having used any analgesia or using any pain medication to reduce pain during labor

Exclusion Criteria:

* Mothers who have a cesarean section decision
* Risky Pregnant
* Multiple Pregnancies
* Multiparous pregnant women
A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids

This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions. The study will also assess the effectiveness of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and symptoms, and improvement in patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

-Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment.

Exclusion Criteria:

-Significant pelvic pathology not associated with uterine fibroids.
Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.

Acute appendicitis is the most common surgical emergency in children. Diagnostic evaluation for possible appendicitis frequently leads to imaging studies. Magnetic resonance imaging (MRI) and computed tomography (CT) are currently the gold-standard techniques for the diagnosis or exclusion of acute appendicitis. However, these methods not always immediately available; may require administration of intravenous contrast material with the potential for allergic reactions and nephrotoxicity; and, in the case of CT, requires the administration of ionizing radiation that is linked to the long-term development of radiation-induced cancers. The current study will evaluate a potentially safer, radiation-free diagnostic method for acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of visualizing the appendix than conventional US imaging.

Eligibility Criteria:
Inclusion Criteria:

* Children who have had a conventional abdominal US study to rule out acute appendicitis and are scheduled for an MRI or CT examination.

Exclusion Criteria:

* Children with serious comorbid conditions, including but not restricted to severe cardiac, pulmonary, renal, or hepatic disease; prior bone marrow or solid organ transplant; cancer; or presence of a ventriculoperitoneal shunt.
* Children with an allergy to either the active or inactive components of Lumason.
* Pregnant or nursing patients.
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects

This is a Phase 1, multi-center, open-label, PK and safety study of a single dose of AAI101 in combination with cefepime in male and female subjects with mild renal impairment (Group 1, n = 6), moderate renal impairment (Group 2, n = 6), severe renal impairment (Group 3, n = 6), ESRD requiring dialysis (Group 4, n = 6), and normal renal function (Group 5, n = 6) as defined using the estimated value for creatinine clearance (CLcr) at Screening.

The study consists of a 28-day screening period, followed by a single dose administration of AAI101 in combination with cefepime antibiotic on Day 1, an in house period (assessment period) and follow-up visit. All subjects will be confined to the study site from Day -1 (the day before dosing) until the morning of Day 3. The follow-up visits will occur on Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on Day 14 (±2 days).

Group 4 (ESRD requiring dialysis) will have 2 in-house periods (separated by at least 7 days), and will receive the single doses of AAI101 in combination with cefepime antibiotic once after dialysis and once before dialysis. The follow-up visit for Group 4 will occur on Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on Day 14 (±2 days), counting from Day 1 of the second period.


Eligibility Criteria:
Main Inclusion Criteria

* Adult male or female subjects age 18 to 70 years, inclusive
* BMI 18.0 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2) Subjects with Renal Impairment (in addition)
* Stable renal impairment, defined as no clinically significant change in disease status, as judged by the Investigator Healthy Subjects (in addition)
* Subjects with normal renal function as evidenced by CLcr
* Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality OR Subject has a stable disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control.