cyrilzakka/clinical-trials huggingface dataset:
Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

This study aims to compare two groups of post-orthopedic patients who received a standard regimen, namely ketorolac 30mg, to the second group, which was given the standard regimen and adjuvant magnesium sulfate 30mg/kgBW 1 hour preoperatively. If it is proven useful, it is hoped that pain will be more controlled, reduce pain complications, reduce treatment costs, and reduce the duration of hospital stays.

The study design used was a randomized controlled trial (RCT) with double blinds. Double blind because neither the patient, the lead investigator, nor the investigator on record knew the drug or placebo that was administered. Research subjects were selected consecutively in patients who will undergo lower extremity surgery at the Cipto Mangunkusumo National Central General Hospital. Forty-eight research subjects will be divided into two groups, namely the group given Intravenous Magnesium Sulfate 30 mg/kgBW and the group given a placebo. Research subjects were randomized by type of surgery using randomization software by research assistants. The results of randomization were not known to the patient, the principal investigator, or the researcher taking notes.

This study aims to determine the effect of adding 30 mg/kg body weight of intravenous MgSO4 to 30 mg of ketorolac on the degree of pain and the need for opioids after lower extremity surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lower extremity orthopedic surgery under general anaesthesia.
* Patients aged 18-60 years.
* Physical status ASA 1-3
* Willing to participate in research.

Exclusion Criteria:

* Patients who are hemodynamically unstable.
* Patients with decreased renal function
* Patients with skeletal muscle disorders.
* Patients with Ketorolac allergy
* Patients with morphine allergy
Effectiveness of Nature Walks in Depressed Adults

Over the past few years, a growing number of campaigns from around the world, including Canada, are highlighting the positive impact of spending time in nature on well-¬being. Indeed, mounting evidence suggests that spending time with nature is associated with a myriad of affective and cognitive benefits. Surprisingly few studies to date have tested the assumption that walking in nature versus in urban settings could alleviate stress and depressive symptoms in clinically depressed adults.

The main purpose of this study is to investigate the effectiveness of walking in nature versus in urban settings to improve depression related symptoms and reduce stress. The trial initially included 2 primary outcomes: patients stress levels (salivary cortisol) and depression-related symptoms (eg, affect, rumination, executive functioning).

However, due to hygienic concerns in light of the COVID-19 pandemic in 2020, the collection of saliva samples (and in turn, the measurement of stress levels via salivary cortisol) was removed from the study's procedure. The main outcome was changed to effects on positive and negative affect.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 65 years, inclusively;
* Ability to speak French or English;
* Diagnosis major depressive disorder (DSM-IV);

Exclusion Criteria:

* Acute psychotic symptoms;
* Acute suicidal intent (within 48 hours);
* Unable to walk for 60 min or serious medical reasons (e.g. major surgery)
* Heart condition as per history or detected on electrocardiogram
Can MicroRNA's Predict Multicentricity in Breast Cancer?

The aim of this study is to determine if microRNA's have role in predicting multicentricity in breast cancer. If a specific microRNA will be found to be related with multicentricity, it will help us to make appropriate decisions on the treatment of patients with multicentric breast cancer.

In the study that will be held at Bezmialem Vakif University Medical Faculty, General Surgery Department, 20 unifocal and 20 multifocal breast cancer patients will be included. Tissues will be taken from both tumoral and normal breast tissues and they will be saved in microRNA later solution under -80°C. Then, 84 microRNA's will be studied in these tissues to see if they express any of these microRNA's.

Eligibility Criteria:
Inclusion Criteria:

1. Having breast cancer
2. Having no other malignancy
3. Female patient

Exclusion Criteria:

1. Having other malignancy
2. Under 18 years old
3. Male patient
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study

The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530).

The Objectives:

* To describe the incidence of virologically-confirmed hospitalized dengue cases.
* To characterize hospitalized dengue cases.
* To evaluate the occurrence of related and fatal serious adverse events (SAEs).

This study was a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530) where participants were initially randomized to receive 3 injections of either CYD dengue vaccine or control at 6 month intervals. Any SAE related to a study procedure or related to a previous injection from study CYD23, or any fatal SAEs (even if unrelated) were reported to the Sponsor.

An Independent Data Monitoring Committee (IDMC) was also involved in the regular review of virologically-confirmed hospitalized dengue cases. Any fatal outcome or related SAE were be promptly reviewed by the IDMC.

No study vaccinations were administered.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing participation in study CYD23 at the time of enrolment.
* Assent form was signed and dated by the participant (for participants \>= 7 years old), and informed consent form was signed and dated by the parent(s) or another legally accepted representative and by 2 independent witnesses.
* Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all study procedures.

Exclusion Criteria:

* Planned participation in another dengue clinical trial during the present study
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Registration of Skin-Temperatures and Sleep-Wake Behaviour

We study the skin-temperature (skin temperature measurement on different skin regions) and circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life.

This project will provide further information at which circadian phase vasospasms occur in daily routine life (one week recordings). Special interest lays on the time before sleep. The attained results could be used to establish a therapy with few side effects for people with difficulties initiating sleep because of vasospasm.

We study the skin-temperature and circadian rest-activity cycles of 40 women in their daily life.

20 women with vasospasm and difficulties of initiating sleep and 20 women without vasospasm and no difficulties of initiating sleep.

Women without contraceptives will be examined in the luteal phase (i.e. in the two weeks before menstruation). The ambulant registry will be done continuously during one week with so called i-Buttons (IButtonTM, Maxim, USA). These will be fixed to various parts of the body (i.e. wrist, ankle, ...) with Fixomull, a medical bond. Also the subjects have to wear a instrument for registration activity, the so called Actiwatch (Cambridge, UK). The data that will be gained from these instruments, shall help us to objectify sleep-latency and sleep-fragmentation ("sleeping-through").

Furthermore, the subjects obtain a sleep-and activity-dairy, that has to be filled before and after sleeping. At one day, that the proband can choose, saliva samples have to be taken by the subjects themselves. In the saliva, the concentration of melatonin will be qualified. The attained results could be used to establish a therapy with few side effects for people with difficulties of initiating sleep because of vasospasm.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have to show a vasospasm and difficulties of initiating sleep (screening with questionnaires and interview)
* Controls have to show no vasospasm and no difficulties of initiating sleep (screening with questionnaires and interview)

Exclusion Criteria:

* bad health or unhealthy conditions
* allergies (i.e. nickel)
* medication
* BMI\<18
* migraine
* delayed sleep phase syndrome
* advanced sleep phase syndrome
* alcohol- or drug problems
* smokers
* blood donation in last three months before study
* participation at an other clinical study in last three months before study
* shift work in last three months before study
* long-distance flight (\> 2 time zones) in last month before study
Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

The purpose of this study is to determine whether sedation with a combination of pethidin hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in relation to blood pressure drops during an transesophageal echocardiographic examination (TEE).

Randomisation is done immediately after information of the patient and obtaining of the informed consent. The average time for a TEE study is about 30 minutes. Data collection occurs during this time frame. ECG monitoring and data collection (blood pressure, heart rate, SO2) for the study protocol starts 6 minutes before the application of the sedation. At -6, -4, -2 minutes before the application of the sedation, baseline data are collected. The average systolic blood pressure of these three measures is taken as the reference blood pressure. This is the reference value to calculate the blood pressure drop during the examination. Blood pressure, pulse oxymetry, heart rate are taken every 2 minutes until the examination (TEE) is finished. The questionnaire (for second end points) is filled out by the patient within two hours after the examination. The patient will be followed for the duration of about one hour after the examination, if he is from the outpatient clinic. Patients from the hospital (inpatients) will be followed routinely in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* all patients scheduled for TEE in our department who have signed the informed consent except those younger than 18 years and patients with a second or third etc. TEE

Exclusion Criteria:

* \< 18 years
* intensive care patients
* emergency department patients
* breast feeding women
* pregnant women
* patients with an allergy to Propofol or its ingredient soy oil, Pethidin or Midazolam
Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.

Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.

The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) \<25mm


Eligibility Criteria:
Inclusion Criteria:

* 18-50 ages
* Singleton pregnancy
* 24(0) - 34(6) weeks of gestation
* Arrested preterm labor after primary tocolysis
* Transvaginal ultrasound cervical length less than 25mm at admission
* Agreement to regular follow-up and provision of written informed consent

Exclusion Criteria:

* pessary and no cerclage in situ
* vaginal bleeding
* placeta previa/accreta
* multiple gestations
* \<24(0) or \>24(6) weeks of gestation
* Cervical dilatation greater than 3 cm
* Chorioamnionitis
* Major fetal abnormalities
* Abruptio placentae
* PPROM
* Polyhydramnios or oligohydramnios
* IUGR/FGR with or without Doppler abnormalities
* Preeclampsia or pregnancy-related hypertension
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)

Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).

The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.

Eligibility Criteria:
Inclusion Criteria:

* All subjects

  -- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg/m\*2 (both inclusive).
* Patients with moderate hepatic impairment (Part 1)

  -- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).
* Patients with severe renal impairment (Part 1)

  -- Patients with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m\*2, who are not on dialysis and are not expected to start dialysis in the next 3 months (Stage 4).
* Healthy subjects

  -- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and with estimated glomerular filtration rate \>90 mL/min (according to Modified Diet of Renal Disease equation).
* Patients with moderate renal impairment (Part 2)

  -- Patients with moderate renal impairment with an estimated glomerular filtration rate 30-59 mL/min/1.73 m\*2 (Stage 3).
* Patients with mild renal impairment (Part 2)

  -- Patients with mild renal impairment with an estimated glomerular filtration rate (eGFR) 60-79 mL/min/1.73 m\*2 (Stage 2).
* Patients with mild hepatic impairment (Part 2)

  * Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan.
  * Patients with mild hepatic impairment (defined as Child Pugh class A).

Exclusion Criteria:

* Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV.
* Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration.
* Strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
* Known BCRP (breast cancer resistant protein) and OATP (organic anion-transporting polypeptide) substrates not specifically mentioned in the protocol within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
* Smoking more than 20 cigarettes daily.
Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain?

Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.

Study design: Three-arm, randomized controlled trial with a blinded assessor.

Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)

Patients: Sixty-three patients with chronic nonspecific low back pain.

Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as described by the manufacturer's manual. The patients assigned to the placebo group will receive a Micropore tape and the control group will not receive any intervention. All groups will be assessed before and 30 minutes after intervention

Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.

Limitations: Therapists will not be blinded.

Patients who are seeking care for low back pain at the physiotherapy clinic from Universidade São Paulo will be invited to participate in the study and informed about the objectives of the study and evaluation procedures.

Patients who agree to participate will sign a consent form.

Patients will be assessed at baseline and immediately after the interventions.

Investigators will collect data with regards to personal and anthropometric data, as well as pain intensity (measured by a 0-10 numerical rating scale in all follow up points) and disability (measured by the 0-24 point Roland Morris Disability Questionnaire at baseline only).

Finally, muscle activation will be evaluated by surface electromyography and the maximum voluntary contraction of the trunk at 30 degrees position for a lumbar dynamometer that will be adjusted to the anthropometric profile of patients. The average and maximum values of muscular strength will be obtained by maximum voluntary contraction. The electromyography will capture the muscle activity in an integrated manner to electrogoniometers and will transmit the data via Bluetooth to a desktop with a MWX8 software (Biometrics) that will analyze the data. Before instrumentation patients will be instructed to perform the trunk extension movement the therapist's commands to become familiar with the equipment. Soon after will be held instrumentation (placement of electromyography electrodes and electrogoniometers and lumbar dynamometer) maximal voluntary contraction will be collected in trunk extension without Kinesio taping

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain.

Exclusion Criteria:

* patients who have used the Kinesio Taping previously
* any contraindications to the use of Kinesio Tex Gold®, such as allergy or severe skin problems.
* patients with nerve root compromise
* patients with fracture, tumor, inflammatory and/or infectious diseases
* patients with severe cardiorespiratory and/or metabolic diseases
* previous spinal surgery
Intensive Referral to Reduce Smoking in Probationers

The purpose of this study is to determine if Intensive Referral Intervention increases motivation to quit cigarette smoking and quitting-related behaviors in probationers and also to determine if Intensive Referral Intervention improves short-term substance use outcomes in probationers with substance use disorder.

This is a longitudinal study of adults on probation who have a Substance Use Disorder (SUD) and smoke cigarettes. One-half of probation officers will be trained in the Intensive Referral Intervention (IRI) while one-half will deliver Standard Practice which is to encourage support group attendance. Research staff will assess fidelity to the IRI in trained probation officers. The investigators propose to enroll 150 probationers over a four month period and complete 3 and 6-month follow-up interviews to assess smoking and substance use measures.

Eligibility Criteria:
Inclusion Criteria:

* CBR-MH Probationers in Douglas County, NE
* SUD
* daily cigarette smoker

Exclusion Criteria:

* Under guardianship
* unwilling to provide personal contact information
* unable to pass Mini-Cog
Influence of Physical Exercise on Endothelial Function in Pregnant Women

The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.

Preeclampsia is a common maternal disease that complicates 5% to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality, especially in developing countries. Cost-effective interventions aimed to prevent the development of preeclampsia are urgently needed. Ethiopathogenesis of preeclampsia involves multiple mechanisms as oxidative stress, endothelial dysfunction, infections, maternal constitutional factors, and others. Regular aerobic exercise recovers endothelial function, decreases oxidative stress and improves maternal constitutional factors.

The purpose of this Controlled Clinical Trial is to determine the effect of regular aerobic exercise on endothelium-dependent brachial artery flow-mediated dilatation. Furthermore, the effect of exercise on biomarkers on vascular function and perinatal outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
* Live foetus at the routine ultrasound scan and a normal pregnancy.
* Gestational age 16 to 20 weeks
* Written informed consent will be obtained from each woman prior to the inclusion in the study.

Exclusion Criteria:

* History of high blood pressure
* Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
* Persistent bleeding after week 12 of gestation
* Poorly controlled thyroid disease
* Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
* History of miscarriage in the last twelve months
* Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).
Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics

The focus on this application is low-income, rural patients, since cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents. Health behavior counseling and follow-up care are required for patients with an elevated body mass index who have increased risk for CVD. Counseling is most effective when developed with, and tailored to, the patient and offered with resources that support healthy food intake and physical activity. Resource referral and follow-up is particularly important in rural low income residents who often have more severe social needs that impede healthy behaviors. The proposed research will leverage the candidate's digital health tool (PREVENT) for healthcare teams to use within the clinic visit. PREVENT visually displays patient-reported and electronic health record (EHR) data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. PREVENT may improve the quality of required care and promote cardiovascular health equity. This research will: 1) collaborate with rural and clinic partners to modify and integrate the PREVENT tool for low-income, rural patients with obesity (Aim 1); and 2) conduct a pilot pragmatic clinical trial of PREVENT to optimize feasibility, acceptability, appropriateness, and potential health equity impact.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-64 years at baseline
* low-income (household income \<200% poverty)
* a BMI ≥ 30
* Receiving care from the Missouri Highlands.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating

Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot flushes daily and a Hyperhidrosis Scale score ≥ 2


Eligibility Criteria:
Inclusion Criteria:

* Menopausal since ≥ 1 year
* ≥ 5 hot flushes /24 hours
* Hyperhidrosis Scale score ≥ 2

Exclusion Criteria:

* Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours