cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ambulatory outpatients 18-79 years old at screening
* Minimum 2-year history of Stage I/II hypertension
* Qualifying blood pressure criteria for study entry and for randomization
* Willing to adhere to the dietary compliance and undergo protocol procedures
* Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion Criteria:

* Have any form of secondary hypertension
* Have clinically significant respiratory or cardiovascular disease
* Presence/history of coronary artery disease or peripheral vascular disease
* Have diabetes mellitus, Type I or II
* Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery Study

The purpose of this study is to determine whether a rapid bedside diagnosis of group B strep (GBS) growing in the vagina and rectum can be performed with similar success to the routine culture in women who are in labor.

Group B Strep neonatal infections is one of the leading infections in newborns, most of which are acquired by vertical transmission at the time of childbirth. Most cases can be prevented by identifying women who are colonized with GBS in the vaginal-rectal area and giving colonized women prophylactic antibiotics in labor. About 15-20% of women are colonized and nearly all of these women are asymptomatic. Because it takes up to 48 hours to obtain culture results, it is currently recommended to perform cultures in the clinic about 5 weeks prior to their due date and then treat those with GBS when they come in for labor. There are several downsides to this strategy. All women who present with preterm labor are treated until culture results become available (overtreatment); women who go into labor while waiting for culture results are all treated (overtreatment); prior studies have shown 33% of women are positive at 35 weeks, but negative at birth (overtreatment) and 10% are negative at 35 weeks and positive at birth (undertreatment); lost or missing culture results (over- or undertreatment). Using microfluidics and fluorescent PCR, a new test can identify GBS reliably in 30 to 45 minutes in vitro. This study proposes to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive value) of the microfluidic rapid GBS technique in un-selected sequential women presenting to labor and delivery, comparing them to cultures taken at the same time and the 35-37 week cultures in these same women. We will also evaluate the identification of GBS before and after rupture of membranes (amniotomy) using both standard GBS culture and rapid PCR (HandyLab technology).

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older
* Mentally capable of giving informed consent
* Symptoms and signs at presentation related to possible labor or ruptured membranes (leakage of fluid, uterine contractions, pelvic pressure)
* Presentation for induction of labor irrespective of cause

Exclusion Criteria:

* Inability to give informed consent
* Conditions where the time taken to obtain specimens are potentially harmful to one or one's baby (heavy bleeding, low fetal heart rate, preterm premature rupture of membranes)
* Use of any antibacterials within the previous 7 days
A Study of Lasmiditan in Healthy Volunteers

The main purpose of the study is to investigate the blood concentrations of dabigatran etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin in combination with lasmiditan will also be evaluated in healthy participants. The study has two parts. Each part will last up to 17 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy
* Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* have known allergies to lasmiditan, dabigatran, rosuvastatin-related compounds or any components of the formulation of lasmiditan, dabigatran, rosuvastatin, or a history of significant atopy
* have an abnormal blood pressure and/or pulse rate as determined by the investigator
* have clinically significant abnormalities on electrocardiogram (ECG) as determined by investigator
* have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
* have any medical conditions, medical history, or are taking any medications that are contraindicated in the dabigatran etexilate or rosuvastatin label
* are intending to use over-the-counter or prescription medication, including dietary supplements, traditional medicines, and herbal supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone replacement therapy)
* currently use or show evidence of substance abuse (including alcohol abuse) or dependence within the past 6 months based on history at screening
* Part 1 Only: have known bleeding disorder including prior personal or familial history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (prothrombin time/international normalized ratio \[INR\] or partial thromboplastin time/activated partial thromboplastin time greater than upper limit of normal \[ULN\]) result at screening
* Part 2 only: have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping
Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD

In recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (OD). The investigators have demonstrated the acute and sub-acute therapeutic effect of TRP agonists on mechanical and neural swallow responses in patients with OD. The present hypothesis is that 6-months treatment with TRPV1 (capsaicin) or TRPA1 (piperine) agonists will improve the biomechanics and neurophysiology of the swallow response without inducing desensitization. The aim of this study is to evaluate the effect on biomechanics assessed by videofluoroscopy (VFS), neurophysiology (pharyngeal evoked sensory potentials -pSEP- and motor evoked potentials -pMEP-), and clinical outcomes during a 6-month treatment with TRP agonists added to the alimentary bolus 3 times a day in older patients with OD. Design: 150 older patients (\>70y) with OD will be included in a randomized clinical trial with three treatment arms, in which the effect of oral administration of 1) capsaicin 10µM (TRPV1 agonist), 2) piperine 150µM (TRPA1), and 3) placebo (Control), will be evaluated. Measurements: 1) VFS signs of swallowing safety and efficacy and timing of swallow response ; 2) Spontaneous swallowing frequency; 3) Latency, amplitude and cortical representation of pSEP and pMEP; 4) Concentration of substance P and CGRP in saliva, 5) Clinical outcomes (respiratory and nutritional complications). The results of this study will increase evidence for a new generation of pharmacological treatments for older patients with OD, moving from compensation to rehabilitation of the swallowing function.


Eligibility Criteria:
Inclusion Criteria:

* ≥70 years
* With a positive Volume-Viscosity Swallow Test for oropharyngeal dysphagia
* Penetration-aspiration scale \>1 in videofluoroscopy
* Able to follow the protocol and to give written informed consent.

Exclusion Criteria:

* Life expectancy \< 3m or palliative care
* Allergy to iodinated contrast or to the components of the treatment solutions
* Cancer or active infection
* Implanted electronic device
* Epilepsy
* Metal in the head
* Participation in another clinical trial (previous month).
Interventional Treatment of Refractory Pneumothorax by Bronchoscope

The purpose of this study is to determine whether injecting autologous blood or putting bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.

This is a multi-site, controlled, randomized study. Refractory pneumothorax is a challenge for respiratory physicians. Many patients present recurrent pneumothorax. Thoracic closed drainage is a basic and effective treatment to pneumothorax. Chronic obstructive pulmonary disease(COPD)is one of the main causes of spontaneous pneumothorax. Many patients precluded the performance of surgery for poor pulmonary function. In China, economical load is another reason for patients who are unwilling to surgery. So we want to seek a cheap, effective and safe method for refractory pneumothorax. We will adopt three methods in this study. Conventional thoracic closed drainage was continuously used in the control group, autologous blood was perfused to the target pulmonary segment in the treatment A group and self-made silicone bronchial plug was placed to the target pulmonary segment in the treatment B group. The leak position was detected by biliary lithotomy balloon. Main outcome measures: duration of continuous leakage. Secondary end-points included the lung reexpanded, hospital costs and hospital stays etc.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous pneumothorax has been treating with thoracic closed drainage for 7 days, the patient has still persistent air leakage;
* Patients informed consent to participate in this study and can complete the requirements of the follow-up visit

Exclusion Criteria:

* Patients with severe abnormal gas exchange are defined as PaCO2\>50mmHg(6.6kPa) or PaO2\<45mmHg(6.0kPa) ;
* Patients have systemic disease or cancer which affect the survival time ;
* Patients have other serious diseases (the researchers think patient is not an appropriate candidate) which affect the evaluation or follow-up in research;
* Patients are not suitable for or unable to tolerate bronchoscopy procedures;
* Patients have active tuberculosis;
* Patients have any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints including interference test of nerves or skeletal muscle disease;
* Patients have demonstrated unwillingness or inability to complete screening or baseline data collection procedures;
* Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study;
* Female patient of childbearing potential has a positive result from a pregnancy test.
Assessment of Injectable Medication Platforms

Background:

While medical advances for in-hospital care rapidly evolve, a mainstay of effective pre-hospital care remains the ability to treat medical emergencies such as anaphylaxis, prolonged seizure, overdose, or uncontrolled bleeding, through rapid administration of appropriate medication. Autoinjectors are used globally to deliver medications in a timely manner, often in environments where immediate access to medical facilities is limited. Rapid administration of intramuscular medication delivery is essential where oral or intravenous delivery is either not possible or ineffective. The purpose of the proposed study seeks to determine the efficiency various types of medication injection administration.

Research Objective:

To understand the efficiency of injectable medication delivery in the Canadian Forces and civilian world for improved care delivery in military and pre-hospital environments.

Participants:

Approximately thirty (30) participants will be recruited for the study.

Methods:

Data will be obtained on the technical comparison of efficiency for pre-filled syringes to the current standards of administration. The timing and accuracy for administering saline to an inanimate object using the traditional methods versus a pre-filled medication syringes will be compared.

Risks and Risk Mitigation:

The participants in this study are all practicing military personnel who are able to give free and informed consent. To reduce undue influence, LCol Meredith and Dr Gupta will not be involved in recruitment. As a result, these participants are a low vulnerability group. The risk of any adverse events is low since data scenarios, and participants may choose to skip any questions or scenarios that participants do not wish to do. Investigators will remind all participants that their participation is voluntary, and that they may choose to withdraw or stop at any time.

Benefits and Military Significance:

The proposed study will be the first of its kind to assess the efficiency of various injectable medication delivery platforms. This data will provide a background for improving injectable drug delivery practices in various setting (eg military and pre-hospital settings), including the potential to inform novel medical device development.

Eligibility Criteria:
Inclusion Criteria:

* any participant over the age of 18 able to provide consent

Exclusion Criteria:

* only participants with pre specified conditions impacting cognitive and/or manual dexterity will be excluded
* recent substance use
* non health care workers injection with experience with medication injection in last 12 months
A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients.

Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.

Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.

Patients receive SMX/TMP orally on a daily or thrice-weekly basis. Patients are clinically evaluated every 4 months. Patients on daily SMX/TMP who develop a drug-related toxicity may be switched to thrice-weekly SMX/TMP. Duration of follow-up is 12 months.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \<= 200 cells/mm3 OR a history of prior PCP.
* No active pneumocystosis. Patients or their guardians must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known treatment-limiting reaction to sulfonamides or trimethoprim.

Concurrent Medication:

Excluded:

* Other PCP prophylaxis or medication with anti-PCP activity.
Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy

The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.

Because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.

The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side.

The following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* American Physical Status I or II
* Elective laparoscopic Cholecystectomy

Exclusion Criteria:

* Patient refusal.
* Hematological diseases
* Bleeding disorders.
* Coagulation abnormality.
* Psychiatric diseases.
* Local skin infection
* Sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Emergency laparoscopic cholecystectomy
* If laparoscopic procedure converted to open.
Transversus Abdominis Plane Block on Stress Response

This study evaluates the effect of transversus abdominis plane(TAP) block combined with general anesthesia on perioperative stress response in patients undergoing radical gastrectomy. One third of participants will receive TAP block combined with general anesthesia, another one third of participants will receive epidural anesthesia combined with general anesthesia, while the rest will receive only general anesthesia.

Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Transversus abdominis plane (TAP) block, is another new regional anesthesia technique, has been introduced as an abdominal wall block capable of providing effective analgesia, reducing opioid consumption, and lessening opioid-related side effects. In addition,TAP block, somewhat as a pre-emptive analgesia approach, is a way of pain intervention before noxious stimulation which has been reported to be potent to attenuate the stress response. Although the analgesia efficiency of TAP block has been widely studied, its effectiveness to suppress stress response has little comparison with classic epidural block and general anesthesia. Unlike epidural anaesthesia, TAP block is easy to administer and lower incidence for side-effects.The investigators hypothesize that the TAP block reduces the stress response of surgery to the similar extent to epidural anaesthesia when combined with a standard general anaesthesia for abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Consent
* ASA 1-3
* No contraindication to epidural or ropivacaine
* First time surgery for current conditions
* Not on chronic pain medications or sedative

Exclusion Criteria:

* The subject has a known or suspected allergy to opioid analgesics or ropivacaine
* Emergency patients
* The subject has know central nervous system disease or neurological impairment
* The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, ages 12 to below 18 years at the time of signing informed consent
* BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes
* History of at least one self-reported unsuccessful dietary effort to lose weight

For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:

- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening

Exclusion Criteria:

* Prepubertal subjects (Tanner stage 1)
* History of type 1 diabetes
* A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)
* For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Human Epididymis Protein 4 in Normal Menstruating Women

The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

* women age 18-45 years old
* regular menstrual cycles (every 25-35 days)
* normal BMI (19-25)
* no hormonal contraception in the two menstrual cycles prior to enrollment

Exclusion Criteria:

* pregnancy
* pelvic mass