cyrilzakka/clinical-trials huggingface dataset:
Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.

The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.

Eligibility Criteria:
Inclusion Criteria:

* patient \> 17 years old
* ASA score 1-3
* undergoing major intra-abdominal surgery

Exclusion Criteria:

* ASA IV patients
* patients with known neurological or psychiatric disorders
* patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
* patients with long-term drug (opioid) or alcohol dependence
* patients with BMI\>30
* patients with intellectual disability
* patients who developed massive bleeding and coagulopathy
A Study of Ketamine as an Antidepressant

Recently, interest has emerged in the use of ketamine as an antidepressant. Recent placebo-controlled clinical trials administering a single dose and an open label trial giving repeated doses shown that ketamine is markedly superior to placebo at reducing depression, including in treatment-resistant patients, and that its antidepressant effects have a very rapid onset.

This clinical study consists of two phases. In Phase I, participants who satisfy inclusion criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or 0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II, they will receive repeated sessions of ketamine at variable doses over three weeks. During both phases, mood, psychiatric, and neuropsychological outcomes will be measured.

This clinical study consists of two phases. In Phase I, participants will receive variable doses of intravenous, intramuscular, or subcutaneous ketamine (0.1-0.5mg/kg) or placebo (saline, or 0.01mg/kg midazolam) weekly for up to 6 consecutive weeks. Prior to receiving ketamine/placebo, participants' mood and psychiatric symptoms will be assessed. Once they have received their treatment, mood, psychiatric side effects, ketamine blood levels, heart rate, blood pressure and biomarkers will be assessed. Mood and cognitive performance be assessed again after 4 hours. Finally, mood will also be assessed the next day.

Some participants may be eligible to continue to Phase II. In this phase, participants will receive doses of ketamine approximately weekly for up to 6 months. During this phase, participants' mood, psychiatric, biomarkers and cognitive outcomes will be assessed.

The purpose of the trial is to investigate the antidepressant and safety effects of using ketamine as a treatment in depression.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV-TR criteria for Major Depressive Episode
* 18 years or over
* Able to give informed consent

Exclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
* Known sensitivity or contraindication to ketamine
* Recent drug abuse
* Pregnant
Multi-joint Coordination Underlies Upright Balance Control in Elderly With Osteoporosis

Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury and even mortality. Identifying the factors related to falls occur within this population is essential for the development of effective regimes for fall prevention. The long-term objectives of this work are to ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis and to provide a basis for developing fall prevention programs. The entire body's center of mass (CoM) is a critical indicator for balance control and the coordination among joints and muscles to control the CoM is still unclear. The aim1 of this study is to develop biomechanical models that control the entire body's center of mass (CoM) during upright quiet stance in seniors with osteoporosis. The aim2 of this study is to identify the mechanism to control the entire body's CoM after receiving a balance perturbation in seniors with osteoporosis. The findings of this research can provide needed information regarding the processes of balance control in this vulnerable osteoporosis population, and has the potential to be applied to individuals with other neuromuscular and orthopedic deficits.


Eligibility Criteria:
Inclusion Criteria:

* for healthy older adults (OA)

  1. can stand for 5 minutes and walk for 6 minutes independently
  2. normal or corrected to normal vision
  3. an age between 65-85 years
  4. no osteoporosis (T-score above -2.5)
* for osteoporosis participants (OP)

  1. can stand for 5 minutes and walk for 6 minutes independently
  2. normal or corrected to normal vision
  3. an age between 65-85 years
  4. no osteoporosis (T-score below -2.5)

Exclusion Criteria:

1. pregnant women
2. cancer diagnosis
3. sensory-motor deficits
4. the BMI is larger than 30 or smaller than 18
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

Assess tolerability of different dosing formulations (adult versus pediatric).


Eligibility Criteria:
Inclusion Criteria:

* Have clinical signs/symptoms of AOM in at least 1 ear

Exclusion Criteria:

* Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor
* Previously diagnosed disease(s) of immune function
* Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment
Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort

ATHLETE will set up a prospective Europe-wide exposome cohort covering the first 2 decades of the life course, which will integrate data on the external, chemical, physical,behavioral, and social domains of the exposome, as well as on health outcomes and biological omics responses, from preconception until adolescence. As part of ATHLETE, the investigators will follow up a unique existing exposome cohort into adolescence (the HELIX Subcohort).


Eligibility Criteria:
Inclusion Criteria:

For the adolescent :

* Subject of the EDEN cohort included in the Helix cohort in 2014-2015 in Poitiers (16-19 years old)
* Subject benefiting from a Social Security scheme or benefiting through a third party

For the person legally responsible :

* The legal guardian, if possible the mother, of the adolescent included in Athlete ;
* Subject benefiting from a Social Security scheme or benefiting through a third person;
* Free subject, without tutorship or guardianship or subordination.

Exclusion Criteria:

* Concomitant participation in another clinical research study.
* Persons not benefiting from a Social Security scheme or not benefiting through a third party.
* Adolescents who are incapable or who do not give their consent to follow the study procedures
Systemic Effects of A Continuous Blood Flow Restricted Aerobic Exercise Session in COPD Patients: A Randomised Controlled Trial.

Patients with COPD that a pulmonologist classifies between Stage 1-2 in accordance with the GOLD criteria and age and gender-matched healthy individuals will be included in the study.

In both groups (n = COPD: 17, Healthy: 17), aerobic exercise (AE) in the target heart rate range of 50% intensity, performed by cycling accompanied by blood flow restriction, will be applied.

Target heart rate will be calculated from the formula "(Maximal heart rate-resting heart rate) x% desired intensity ratio + resting heart rate".

The target occlusion amount in the lower extremity will be calculated by calculating 45% of the complete occlusion rates reported by Michael et al. The proximal border of the thigh cuffs will be tied in line with the gluteal lines on both sides.

Exercise tolerance and dyspnea condition; Measurement properties in COPD will be evaluated using a well-defined modified Borg scale (MBS). Individuals will use any bronchodilator that their doctor sees fit before trying.

The target aerobic exercise intensity will be reached in the last minute of the first five-minute warm-up period by maintaining a 4-6 feeling of dyspnea in the MBS, by increasing pedal resistance and speed. In case of extreme shortness of breath, exercise intensity will be reduced to resting heart rate.

In the event of oxygen desaturation (85%) during the intervention, the intervention will be terminated.

Aerobic exercise training protocol; It was planned as 50 rpm speed and warming up at the lowest pedal resistance during the first 4 minutes, reaching the target exercise intensity range in the next 1 minute, aerobic training at the target heart rate range and appropriate MBS value for the next 20 minutes, cooling down in the last 5 minutes. The duration will be reduced in case of excessive shortness of breath, fatigue and muscle pain due to increased exercise volume. The distance, calories, and maximum speed values measured during the study will be recorded.

Before and immediately after the study, all participants had muscle damage (creatine kinase), anti-inflammatory response (CRP, neutrophil), oxidative stress response (uric acid, LDH), oxygen saturation, heart rate, systolic and diastolic pressure will be examined.

Institution of the Study: Karabuk University Research Hospital Chest Diseases Clinic Center / Karabuk. The study would be conducted in the presence of a chest diseases specialist.

Eligibility Criteria:
Inclusion Criteria:

* No drug change for at least 30 days for the COPD group
* Not participating in a structured activity program for at least six months
* Have the ability to cooperate

Exclusion Criteria:

* Presence of any pathology that limits physical activity performance
* Presence of severe or unstable heart disease
* Presence of peripheral artery disease
* Being in an exacerbation period of the disease
* Presence of another active disease (rheumatic, oncological, traumatic etc.)
* Any neurological or orthopedic disease that prevents exercise
Parenting Support Intervention for Families Coping with Metastatic or Locally Recurrent Solid Tumor Diagnosis

This clinical trial examines the acceptability and effect of a parenting support intervention for families coping with solid tumor that has spread to other places in the body (metastatic) or has come back (recurrent). Parenting support program may help to reduce common parenting concerns, improve communication between parents and children about cancer, and improve the overall psychological wellbeing of parents.

PRIMARY OBJECTIVES:

I. Examine the acceptability a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers. (Trial 1) II. Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers. (Trial 2) III. Evaluate the initial evidence for intervention efficacy relative to waitlist control (WLC) group regarding patient and spousal caregiver psychological symptoms (primary outcome) and parenting concerns and parenting efficacy (secondary outcomes) and patient end of life (EOL) healthcare utilization (exploratory outcome). (Trial 2) IV. Understand the patients and caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research. (Trial 2)

OUTLINE:

TRIAL 1: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.

TRIAL 2: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.

GROUP II: Participants receive standard of care.

After completion of study, participants in Trial 1 are followed up at 6 and 12 weeks and participants in Trial 2 are followed up at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants must (1) be diagnosed with a metastatic or locally recurrent solid malignant tumor and on active treatment; (2) be at least 18 years old; (3) have at least one dependent child between the ages of 4 and 16 and currently living with the parent; (4) be able to provide informed consent and (5) have a spousal caregiver over the age of 18 who co-parents the child(ren) (i.e. share custody) and is willing and able to consent to participate.\*

Exclusion Criteria:

* Participants and caregivers who do not read and speak English and who do not have access to the internet.
Azithromycin Treatment for the Airway Microbiome in Asthma

The purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms.


Eligibility Criteria:
Inclusion criteria (All participants):

1. Age 18 - 55 years
2. Able to provide informed consent
3. Smoking history \< 10 pack-years

Inclusion Criteria for subjects with poorly controlled asthma

1. Methacholine PC20 \< 16 mg/ml or PD 20 \< 400 mcg/ml or albuterol response \> 12% on FEV1 after 4 puffs of albuterol
2. Currently prescribed ICS + LABA
3. Meet definition for Th2-low asthma: peripheral blood eosinophil count \< 300 and exhaled nitric oxide level \< 30 ppb.

Exclusion Criteria (All participants)

1. History of allergy or intolerance to any medications used in this study
2. Medication exclusions:

   1. Current use of medications that prolong QTc interval
   2. Current use of omalizumab or other ant-IgE therapies
   3. Current use of anti-IL 5 therapies
   4. Current use of anticoagulants
3. Prednsione or other oral steroids within past 3 months
4. Pregnancy or lactation, or plans to become pregnant
5. Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)
6. Pre-existing liver disease by history
7. Smoking within the last 6 months
8. Exacerbation of asthma in past 3 months
9. Affected by a hearing disorder
10. Clinically significant medical condition (e.g., heart failure, seizure disorder) which may in-crease risk as determined by study investigator
11. Corrected QT interval \> 450 msec. Patients with known cardiac history or prolonged QT interval on a screening EKG are excluded given the small but real potential for macrolide-related side effects
A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers

The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of RDC5 given as a single dose to healthy volunteers at a number of different dose levels

This is an open-label, randomised, single dose, 3-way crossover study to characterise and compare the PK, safety and tolerability of RDC5 in 15 healthy male volunteers. Eligible subjects will undergo 3 Treatment Periods, each separated by a washout period at least 14 days. Subjects will receive a single dose of RDC5 during each of the three Treatment Periods in line with their randomized treatment sequence. A total of 4 dose levels will be evaluated within the study, though each subject will only receive 3 doses. A Data Review Team (DRT) will review the pharmacokinetic (PK) data from Treatment Periods 1 and 2 and select the doses to be evaluated in Treatment Periods 2 and 3. Subjects will return for a follow visit 21 days after the last dose of RDC5.

Eligibility Criteria:
Inclusion Criteria:

* Willing to use effective method of contraception
* Non smoker or ex-smoker within the previous 6 months

Exclusion Criteria:

* History or presence of any clinically significant findings upon screening
* Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
* Positive result for human immunodeficiency virus (HIV) and/or hepatitis B or C test
* Positive result for urine alcohol and drug screen
* Blood donation ≥ 450 mL in the previous 12 weeks
* Receipt of prescription medicines and/or St John's Wort in the previous 2 weeks
Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana

In French Guiana, malaria is endemic and two species predominate: P. falciparum and P. vivax. The treatments against Plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14 days against parasites dormant in the liver. Primaquine can cause iatrogenic hemolytic anemias in patients with favism, i.e. G6PD deficiency. This anemia can be severe enough to cause the death of the deficient patient. Thus, the WHO and HCSP recommendations indicate that a quantitative assay of the activity of this enzyme should be carried out before its prescription. This deficiency is a recessive inherited disease linked to the X chromosome characterized by more or less low levels of enzymatic activity which depends on the genotype of the patients but not only because the phenotype depends on the level of activation of the X chromosome for each cell.

Currently, obtaining a G6PD assay in French Guiana is a long process since it is done in mainland France and the pre-analytical conditions are quite demanding. Thus, in areas of transmission of P. vivax, patients usually have a bout of revival before being prescribed primaquine. This period includes: dosing G6PD at a distance from access, obtaining the result and then the nominal ATU to finally obtain and deliver the primaquine.

This is a interventional,prospective, multicenter, cross-sectional and comparative study.

To achieve this study, the following will be done:

* Selection of subjects according to their G6PD activity from the list of participants previously included in the ELIMALAR Palustop study and from known LHUPM patients in Cayenne following a request for a G6PD dosage, whether or not related to malaria.
* Collection of clinical data from participants (sex, age, ethnicity of parents and grandparents).
* Collection of blood samples from subjects showing G6PD activity of the following three categories "severe deficiency", "intermediate", "normal".
* Determination of G6PD activity by the "STANDARD G6PD" technique from SD BIOSENSOR versus the reference enzymatic method

Eligibility Criteria:
Inclusion Criteria:

* People with a known level of G6PD activity.
* People or their legal representatives who have received information on the research and have signed a written consent to participate in the study
* People aged over 18 for the "intermediate" and "normal" categories,
* People aged two years and over for the "severe deficit" category.

Exclusion Criteria:

* People with an unknown level of G6PD activity,
* People or their legal representatives who refused to participate in the study,
* People aged under 18 for the intermediate and normal categories,
* Children under 2 years old for the "severe deficit" category,
* People with a hemoglobin level below 11g / dL for men and 10g / dL for women and children.
* People who received a transfusion less than 4 months before the proposal to participate in the G6PD study
Mechanistic Effects of Colchicine in Patients With Myocardial Infarction

The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing the expression of adhesion molecules responsible for their recruitment in MI.

This is a pilot study to explore the mechanistic effects of colchicine in patients with MI. The study will be conducted sequentially in 3 parts:

1. Blood will be collected from up to 10 healthy volunteers for protocol development. (Group 1).
2. Blood will be collected from 20 MI patients within 24 hours of presentation at New York University (NYU) Langone Medical Center and Bellevue Hospital Center (BHC). Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism, using a Seahorse Analyzer will be evaluated pre- and post-addition of in vitro colchicine. (Group 2)
3. The standard low-dose loading regimen of colchicine (1.2 mg followed by 0.6 mg one hour later) will be administered to 20 patients with MI at BHC. Blood will be collected prior to drug administration, 2 to 3 hours after completion of the colchicine load, and 23 to 24 hours after the completion of the colchicine load. Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism will be evaluated pre- and post-addition of in vitro colchicine (exact markers will be determined based on the results of in viro studies above). (Group 3)

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age for the healthy volunteer subset.
* 18 years of age and within 24 hours of an MI for the MI subset.

Exclusion Criteria:

Subjects in all 3 groups will be excluded if they meet one of the following criteria

* history of myelodysplasia;
* Use of anti-inflammatory medications, with the exception of aspirin, within 5 half-lives;
* medications known to interact with colchicine;
* known creatinine clearance \<30 cc/minute (severe kidney disease);
* pregnant; or
* Unable to consent.

MI subjects who will have oral colchicine administered will have the following additional exclusion criteria:

* history of intolerance to colchicine;
* acute or chronic symptoms of diarrhea within 72 hours prior to enrollment;
* hemoglobin \<10 g/dL or clinical evidence of active bleeding during the study period.
A Study of Continuous Heart Rate Monitoring in Healthy Participants

The main purpose of this study in healthy participants is to find out whether a heart rate monitor will accurately pick up changes in heart rate caused by 2 different medications (pseudoephedrine and metoprolol), on the background of daily activities. Participants will wear a patch heart rate and activity monitor on the chest for the entire study. The study will last about 36 days and may include up to seven visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females
* Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have history of sensitive skin or chronic skin conditions, like eczema
* Regularly use known drugs of abuse
* Are women who are pregnant or lactating
* Have known allergies to medications used in the study