cyrilzakka/clinical-trials huggingface dataset:
Effects of Substituting Sitting With Standing and Light Intensity Activity in Free-living Conditions on Glycaemia in Overweight and Obese South Asian Adults

The purpose of this study is to examine whether substituting sitting with standing and light-intensity activity in free-living conditions can reduce glycaemia in overweight/obese South Asian adults.

Anthropometric measurement tools including a stadiometer, a measurement tape and digital weighing scale, activity monitor and Flash Glucose Monitor and sensor will be posted to the participants' home or workplace or research team drop all these items to participants' doorstep to allow participants to take their measures including height, weight, and waist circumference.

Every participant will have to perform a try-out day of the SitLess regimen for 24 hours before starting the study and it will be performed after preliminary testing and before the first experimental condition. Those participants will be included for this study who will be able to adhere to the protocol based on a review of the activPAL activity monitor data that will be worn during the day. Additionally, a second attempt will be offered to them to adhere to the protocol if needed.

Participants will undertake two separate activity regimens in free-living conditions which will be lasting 4-day each condition in a random order:

# Sit regimen: Participants will be instructed to restrict walking and standing to ≤1 h/day each (total ≤2 h/day ) and the remainder of the waking day will be seated apart from visiting the toilet. They will be allowed to perform their daily activities including cooking and other household activities within the 2 h of permitted walking and standing.

#SitLess regimen: Participants will be instructed to substitute a minimum of 5h/day of sitting with ≥2 h of light-intensity physical activity and ≥3 h of standing. Participants will be advised to rise from the seated position for 2-5 min every 30 min to engage in standing /light-intensity physical activities to interrupt their sitting.

During each activity regimen, participants will be asked to record all of the activities in an activity logbook. In addition, they will be asked to weigh (using kitchen scales) and record food and beverage consumption in a diary for the first four days (days 1-4) and then replicate the dietary intakes and timings exactly for the second four days (days 8-11). They will need to make sure that each meal contains at least 50% carbohydrate. Kitchen scales and a food diary will be provided by the research team.

Throughout the 11 days, participants will be required to avoid alcohol consumption and performing exercise (e.g. brisk walking, sports, going to the gym, cycling, running etc).

Eligibility Criteria:
Inclusion Criteria:

* Self-identified South Asian ethnicity.
* Self-report sitting at least 7 hours per day.
* Overweight or obese

Exclusion Criteria:

* Unable to speak and read English.
* Not able to performing light-intensity activities.
* Diagnosed cardiovascular disease or diabetes.
Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

Controlled randomized trial looking at Standard nasal continuous airway pressure (CPAP) respiratory support versus High Frequency CPAP in neonates who require respiratory support or who are being extubated and require support post extubation. Patients will be evaluated for need to be reintubated and oxygen requirement and PaCO2 levels

This study is a randomized controlled trial comparing High Frequency nasal CPAP versus standard nasal CPAP. The patient population includes preterm newborns who require respiratory support but do not need to be initially intubated and preterm or term infants who are being extubated and will require support for the continued lung disease. After obtaining parental consent the patient will be randomized to one of the two treatments. Patients will be followed for requirement of level of oxygen and blood gases looking at acidity (pH) and PaCO2 and Bicarbonate(HCO3). A respiratory index score will be measured. Attending physician will determine the need for the patient to be intubated or reintubated depending on the patient selected. Additionally, frequency, duration and severity of Apnea, Bradycardia and Desaturation events will be recorded. Also safety issues to include pulmonary airleak, nasal injury, facial edema and scalp edema due to straps holding the device in place will be recorded. Also gaseous distension of the stomach and intestines will be assessed and compared between treatment arms. This study is not powered to look at long term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Newborn (0-28 days of age) admitted to Neonatal Intensive care unit (NICU)
* Ordered Respiratory treatment of Nasal Continuous Airway Pressure (NCPAP) respiratory support

Exclusion Criteria:

* Major congenital defect
* Known or suspected chromosomal disorder
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine \[CM\] study in adolescents) or 19357A (episodic migraine \[EM\] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Exclusion Criteria:

* The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
* During lead-in Study19356A or Study19357A:
* participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
* the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later.
* the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.
Sonographic Assessment for Prediction of Labor Induction Success

The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.

Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent.

After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured.

Relevant demographic and obstetric information will be collected from a computerized database.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Term pregnancy.

Exclusion Criteria:

* Multiple gestation.
* Fetal anomalies and malformations.
* Preterm pregnancy.
Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications

The purpose of this open, multi center trial is to evaluate a new biological replacement for synthetic slings in the treatment of female stress urinary incontinence.

It was estimated that more than 9 million French people are affected by urinary incontinence, of which 1% are treated surgically. Indeed, if medical treatment or rehabilitation fails, surgical treatment must be considered. Sling implantation is a commonly used surgical technique to treat stress urinary incontinence as it allows for a reduction in surgery time and morbidity and can be placed under local anesthesia. However, the risk of complications associated with the use of synthetic products is high and contributes to the recent decline of popularity of synthetic slings. As the demand for incontinence treatment remains high, fascia autograft surgeries are being proposed, even though they require an additional surgical procedure and expose the patient to complications at the donor site of the graft.

The study product aims to address the growing need for a safer but equally effective implant to avoid autografting while keeping the standard surgical technique.

The aim of this exploratory study is to evaluate a biological sling replacement to failed synthetic slings in the treatment of female stress urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Women over 40 years of age and under 75 years of age.
* Failure of primary surgical technique with synthetic sling requiring its removal due to complications such as vaginal exposure or urinal tract erosion.
* Inclusion more than 3 months after primary surgery.
* Any fistula or abnormality of the urinary tract, any erosion or complication due to the synthetic sling placement must be repaired during surgery. In case of persistence of complication or limited possibility to insert the UVT due to major vesical or urethral lesion, the patient will not be included.
* Patients with controlled urinal tract infections.
* Patients who received the study information and provided consent.
* Patients who are members or the beneficiary of a national health insurance plan.

Exclusion Criteria:

* Breast feeding women or women without effective contraception. In absence of effective contraception, a pregnancy test followed by an effective contraception are mandatories for non-menopausal women.
* Patients with mild cases treated by physiotherapy and pelvic floor exercises for urinary incontinence or without surgical complications.
* Patients with current urinary infection, severe anemia or other pathologies that counter-indicate surgery.
* Cystocele and rectocele not treated during the surgery.
* Persons under guardianship or confined by a judicial or administrative decision.
* Patients unable to have discernment for rehabilitation, unable to perform follow-up or unable to provide their consent.
Addiction Risk: Psychoeducational Intervention to Change Risk Perception Among Alcohol Patients in Residential Treatment

Based on previous research (Odenwald \& Semrau, 2012) the investigators know that psychoeducation on comorbid mental disorders during residential alcohol detoxification can improve subsequent treatment utilization. In this study they will study a hypothesized psychological mechanism that contributes to this behavior change.

The investigators will recruit alcohol dependent patients in residential detox treatment who all receive Treatment as Usual. Participants will be randomly assigned to an additional psychoeducational group therapy (intervention group) or to an additional neuropsychological group training (control group). Measurements will take place on the day before study inclusion, one week later and one month after release from index residential treatment. Measurements will include alcohol-related risk perception, alcohol use, treatment motivation, comorbid psychiatric symptoms and whether the patient has regularly completed treatment and whether he/she has been transferred to subsequent treatment. Furthermore, six months after release from index treatment information on re-admission to the clinic is assessed from patient files.

The investigators hypothesize that the behavioral effects of psychoeducational group intervention will be mediated by adaptive changes of the individual's alcohol-related risk perception.


Eligibility Criteria:
Inclusion Criteria:

* Alcohol Dependence (according to ICD-10)

Exclusion Criteria:

* treatment episode is acute crisis intervention
* acute psychosis
* acute suicidality
* no command of German language (reading writing)
Study of Midazolam in Healthy Adults

This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.


Eligibility Criteria:
Inclusion Criteria:

1. Can understand and provide signed informed consent
2. Is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ECG are within normal range
3. Has a willingness to comply and be available for all protocol procedures
4. Is between age 18 and 55 years, inclusive on the day of injection
5. If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to injection Note: A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful Essure placement with documented confirmation test at least 3 months after the procedure
6. If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception up to 1 month after the end of study visit Note: Acceptable contraception methods are restricted to effective devices (approved oral contraceptives, Intrauterine Contraceptive Devices, NuvaRing®)
7. If the subject is male, he agrees to practice abstinence from sexual intercourse with women or use acceptable contraception up to 1 month after the end of study visit
8. Has a body mass index (BMI) ≥18.0 and ≤26.0 kg/m2 at screening
9. Has a negative urine drug screen
10. Has a negative breathalyzer test
11. Subject is not taking any medications or St. John's wort and agrees to avoid grapefruit juice and alcohol until study completion on Day 28
12. Subject agrees to not take any vitamins or supplements 48 hours prior to dosing
13. Is available for follow-up for the duration of the study

Exclusion Criteria:

1. Received treatment with another investigational drug within 28 days of initial dosing
2. Has a current or history of drug and /or alcohol abuse
3. Is pregnant or breastfeeding woman
4. Has hypersensitivity or allergy to midazolam
5. Has hypersensitivity or allergy to benzodiazepines
6. Has a history of cardiovascular, pulmonary, neurological, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or psychiatric disease or any other reason, in the opinion of the investigator, that the patient should not participate
7. Tests positive for HIV-1, HIV-2, HbsAg, hepatitis C antibody, or syphilis
8. Has had a blood donation in the 8 weeks prior to the study period start date
Screening for Early Gastric Cancer in Shaanxi Province

This study collect the relevant data of local residents over 20 years old in 11 regions of Shaanxi Province, The basic information of the subjects was collected by filling in the questionnaire, and serum helicobacter pylori antibody detection was completed at the same time. The expert group determined the high-risk population of gastric cancer after comprehensive evaluation. All the high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in the designated hospital after signing the informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate.

From October 2020 to October 2026, after obtaining the informed consent of local residents over 20 years old in 11 regions of Shaanxi Province, the subjects' social demographic characteristics, living and eating habits, and previous diseases were collected by filling in questionnaires, and serum helicobacter pylori antibody was detected at the same time. After comprehensive assessment by the expert group, the high-risk population of gastric cancer was determined. All high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in designated hospitals after signing informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate. In this project, the research group was responsible for formulating the plan, designing the questionnaire, and conducting quality control and grass-roots guidance tour. Guanghua Science and Technology Foundation provided public welfare assistance, and distributed and collected questionnaires with the assistance of grass-roots clinics. Finally, the research group sorted out and analyzed the data.

Eligibility Criteria:
Inclusion Criteria:

* Local resident over 20 years old.
* Obtain verbal informed consent of the subject.

Exclusion Criteria:

* Refused to participate in this research project.
* Questionnaires or serological tests for helicobacter pylori antibodies were not completed.
* This study was not completed due to other reasons.
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty

The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.

1. Study design will be a Pretest-Posttest Control Group Design . Enrollment would be random assignment of 20 patients to a control group vs 20 patients to a treatment group for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary total knee arthroplasty. For specifics of patient assignment, please see below under Recruitment Procedures.
2. Unpaired t-Tests will be used to determine differences between mean scores for the dependent variables (pain, range of motion, functional mobility). Analysis of Covariance will be run to quantify the effect of the co-variates of age, gender, body mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at 95%.

Eligibility Criteria:
Inclusion Criteria:

* Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.

Exclusion criteria:

* bilateral total knee arthroplasties
* revision total knee arthroplasties
* unexpected decline in medical or mental status
* Subjects will range from 30 years of age to 80 years of age
* primary diagnosis of rheumatoid arthritis
Predictive and Associated Factors of Musculoskeletal Injuries

The aim of this research is to find out the factors associated with musculoskeletal injuries among office workers and also determine whether Functional Movement Screen (FMS) can predict musculoskeletal injuries or not? Prospective Cohort study will be done at the offices of Rawalpindi. The sample size is 208. Study duration will be of 6 months. Non probability Purposive Sampling will be used. Tools used in the study are FMS, Fat Caliper, Weighing machine \& Inches tape. Data will be analyzed through SPSS 23.

Musculoskeletal injuries and conditions represent a major public health problem, with significant social, economic, and health consequences. Office workers are forming a major group for musculoskeletal injuries as they have to work for a longer period of time on computer and sitting on a chair. Musculoskeletal discomfort in office workers is commonly caused by poor ergonomic workstation design, psychosocial, physical and organizational risk factor. There are several MSK disorders associated with computer use in people spending more than 9 hours or more every day using computer.

To combat workplace caused mental and physical exhaustion physical activity has been proven to be an efficient. Physical activity is known not to only treat but prevent the occurrence of a fore coming disease. Being physically active will lead to reduced stress levels and increased productivity. The Functional Movement Screen (FMS) is a physical examination used to measure essential movement patterns in a practical and dynamic way. Functional Movement screen was designed with a purpose of identify body asymmetries, assess mobility and stability within the kinetic chain of whole-body movements and to detect poor quality movement patterns. Other tools like modified Y-balance test have also been used to predict injuries.

Literature review: Previously in a study carried out on firefighters Contreras et al reported that 47% of the participants had an FMS score lower than 14 and they accounted for 72% of the total musculoskeletal injuries.

In another study carried out on Collegiate athletic association Division II athletes the overall prognostic accuracy of the FMS offered a slightly better than 50/50 chance of correctly classifying those most at risk for injury.

A study carried out to find the association between functional fitness scores calculated by FMS and musculoskeletal injury in police officers by Liana Lentz et al suggested that of all the participants, females accounted for 17.9% of the injured subjects.

Previously a study carried out by Michal Pan Tanowitz et al to find factors associated with musculoskeletal injuries in an infantry commanders' course suggested that army operators who sustained a spinal injury have a significantly greater BMI than those who did not, and also increased body fat combined with reduced physical fitness may increase the soldier's risk for injury.

Eligibility Criteria:
Inclusion Criteria:

* • Both Genders.

  * 25-45 years.
  * Office workers

Exclusion Criteria:

* any neuromusculoskeletal injuries