cyrilzakka/clinical-trials huggingface dataset:
A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.


Eligibility Criteria:
Inclusion criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply
Stress Response to Virtual Risky Movement Exposure and Kinesiophobia After Anterior Cruciate Ligament (ACL) Surgery

In this study, patients who have completed their rehabilitation after Anterior Cruciate Ligament (ACL) reconstruction surgery will be examined with physiological stress response test while being exposed to risky athletic movements via virtual reality headsets. In the next, step patients' functional performance tests will be examined and their relation with stress responses will be examined.


Eligibility Criteria:
Inclusion Criteria for Study Group:

* 18 years or older
* Male gender
* Having history of isolated unilateral ACL reconstruction surgery
* Physician clearance for unrestricted physical activity after having at least 6-months of rehabilitation following surgery
* Willing to return to sports that require cutting and landing motions
* Not having any sports injuries past three months
* Not having any previous orthopaedic surgery other than ACL reconstruction surgery

Inclusion Criteria for Control Group:

* 18 years or older
* Male gender
* Playing sports that require cutting and landing motions
* Physician clearance for unrestricted physical activity
* Not having any sports injuries past three months
* Not having any previous orthopaedic surgery

Exclusion Criteria for Study Group:

* Having a reinjury during rehabilitation
* Having multiple ligament injuries before the surgery
* Diagnosed with knee osteoarthritis
* Diagnosed with knee cartilage injury
* Diagnosed with meniscus tear

Exclusion Criteria for Control Group:

* Diagnosed with ACL injury
* Diagnosed with knee osteoarthritis
* Diagnosed with knee cartilage injury
* Diagnosed with meniscus tear
Trigger Point Incidence After Lumbar Disc Herniation Surgery

Our purpose is to determine the incidence of trigger points in patients who remain in a fixed position for a long time during lumbar disc herniation surgery.

The 110 participants between 30-70 years are chosen from patients who had lumbar disc herniation surgery. The trigger points are determined by manually palpating quadratus lumborum, iliocostalis lumborum, gluteus Maximus, gluteus minimus, gluteus medius, ve piriformis muscles before and after surgery. Data will be recorded on the patient assessment file and transferred to the computer and analyzed. Data analysis will be performed with SPSS.20.

Eligibility Criteria:
Inclusion Criteria:

* To be between 30-70 years
* To have low back pain during minimum 6 weeks
* To be voluntary participation for this study
* To approve the informed consent form
* To have the trigger point causing low back pain on muscles including quadratus lumborum, iliocostalis lumborum, gluteus maximus, gluteus minimus, gluteus medius, ve piriformis muscles.

Exclusion Criteria:

* To be diagnosed with spinal stenosis or spondylolisthesis
* To have any skin problem affecting lower extremity evaluation
* To have tumor on spinal region
* To have rheumatological or any systemic problem that may interfere with trigger point diagnose
'Uptime' Participation Intervention in Girls and Women With Rett Syndrome

The aim of the study is to evaluate the feasibility and health-related effects of an individualized 12wk 'uptime' participation intervention in girls and women with Rett syndrome. Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation will be included. Each individual program focuses on participation in enjoyable activities to promote 'uptime' in home, school/day center and community settings. Primary outcomes are sedentary time and daily steps. Secondary outcomes are gross motor skills, walking capacity, quality of life and participation-level goals. Outcomes are evaluated on four occasions: at baseline and after a 6-week interval, immediately following the 12-week intervention program and 12 weeks after the intervention program.


Eligibility Criteria:
Inclusion Criteria:

* Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation
* Hoffer ambulation scale levels I-IV

Exclusion Criteria:

* Girls and women who have undergone orthopedic surgery in the lower extremities within the last 6 months
* Girls and women who have undergone spinal fusion within the last 12 months
The Prevention of Hypotension After Epidural Analgesia After Major Surgery

Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely and very successfully used routinely for perioperative pain control in patients undergoing major orthopedic and abdominal surgery since 1928. The choice currently depends on the preference of the APS physician in charge of the case. A frequent unwanted side effect of epidural block is hypotension due to the epidurally injected LA blocking the sympathetic nerves and thus the patient's response to hypotension, which is usually due to hypovolemia and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of this research study is to see if adding epinephrine, to the epidural anesthetic will decrease possible side effects, such as low blood pressure, and lead to a better effect of the epidural anesthetic.

Participants undergoing epidural analgesia to treat perioperative pain associated with major surgery will be approached for their willingness to participate in the study. Participants undergoing major thoracic, abdominal, or orthopaedic surgery for whom thoracic or lumbar epidural block would be indicated and planned for intraoperative and postoperative analgesia as per the University of Florida Acute Pain Service (APS) usual and routine practice will be included in this study.

All participants will receive a standardized continuous epidural block at the appropriate level for the planned surgery by the APS physicians in the block room that day. For the standardized continuous epidural block, placement will be confirmed with loss of resistance technique (LORA), wave form analysis or nerve stimulation.

Participants will be randomly allocated by computer-generated randomization to one of four groups. This will be a quintuple blinded prospective study. The anesthesiologist managing the intraoperative anesthesia, the anesthesiologists (APS) placing the blocks and following the participants on the floors, the research nurse taking the measurement, the surgeons, nor the participants will be aware of what combination of drugs are used for the epidural block infusion.

The three groups will consist of:

1. Group A (Ropivacaine 0.2% infusion; Control group)
2. Group B (Ropivacaine 0.2% + 2 mcg/mL epinephrine)
3. Group C (Ropivacaine 0.2% + 5 mcg/mL epinephrine)

Eligibility Criteria:
Inclusion Criteria:

* undergoing epidural analgesia to treat perioperative pain associated with major surgery
* undergoing major thoracic surgery
* undergoing major abdominal surgery
* undergoing major orthopaedic surgery

Exclusion Criteria:

* sepsis
* acute trauma
* coagulopathy
* preoperative hemodynamic instability
* symptomatic coronary artery disease
* patients from the ICU whose tracheas were intubated for any cause
* allergies to medications in the protocol
* primary or secondary block failure
A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects with Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy

The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:

• What the body does to the study drug, which is called "pharmacokinetic"

Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.

Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
* Have completely removed all of the cancer from the body surgically
* Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery

Exclusion Criteria:

* Have received anti-cancer therapy before surgery
* Have or had autoimmune disease in past 5 years
Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas

Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

Eligibility Criteria:
Inclusion Criteria:

* patients aged from 15 to 60 years
* previously untreated
* histologically proven aggressive NHL
* high aa-IPI (equal to 3)
* proper underlying organ function

Exclusion Criteria:

* transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation

Central blood pressure and pulse wave velocity were measured using a Complior Analyse device in Short and Long-term after kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* functioning graft longer than 3 months to 10 years
* no clinical cardiovascular disease during the 6 months preceding entry
* stable graft function- glomerular filtration rate \> 30 ml/min/1.73 m2, creatinine concentration \<2.5 mg/dl
* medical staff (medical doctors, nurses)

Exclusion Criteria:

* not meet the above criteria
* episode of illness (for example: infection)
* pregnancy
The VOICE-COVID-19

The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.

This study is an open-label, prospective, cross-over randomized study.

VOICE-COVID I: All individuals entering the Heart Failure (HF) Clinic of the McGill University Health Center will be asked to participate. A poster with instructions to ask the participants (employees or patients) to speak with the Amazon Alexa device. The participant will remain 6 feet away from the device. The Amazon Alexa will ask the survey questions. A study coordinator will then ask the same questions along with some additional questions about Amazon Alexa usability. VOICE-COVID II: A second cohort of 52 people will be then randomized to be screened for symptoms of COVID-19 with an Amazon Alexa or a coordinator. We will study the correlation between the Alexa response and the response to the study coordinator using K-squared statistic tests and screening question concordance.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>=18 yrs who is entering the HF clinic
* Speaks either English or French

Exclusion Criteria:

* None
Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports

This study evaluated the extent to which a shared health record facilitated better communication, increase individual responsibility for health care and reduce demand for health resources.

The study made individualised reports available to patients and General Practitioners and gave much more detail about participants chronic disease and treatments, and evaluated its effectiveness in a randomised controlled feasibility trial.

One third of patients received care as usual, two thirds of patients received the intervention.

Chronic illness is a major cause of health problems. Self-management programmes can improve care and reduce healthcare resource use, but rely on well educated patients who are able to take responsibility for their care, have effective communication with health care providers, and easy access to appropriately triaged services.

This study utilised Inflammatory Bowel Disease as an exemplar of chronic disease management.

To inform the intervention the investigators held a focus group with patients who told the investigators about their concerns relating to education, care planning and communication about their condition. The participants expressed a preference for individualised information about their care, and plans of what to do if symptoms increase.

The investigators departmental electronic patient record (GeneCIS), was extended to provide personalised, educationally enriched information to each participant about their Inflammatory Bowel Disease. The investigators customised GeneCIS to develop output reports i.e.: "My History", "My plan" and "My Update", that attach specific educational information to the detailed, structured clinical data held on the system, and shared this with participants and their General Practitioner.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Inflammatory Bowel Disease, specifically Ulcerative Colitis or Crohn's Disease.
2. Aged 18 to 90 years.
3. Under the care of Consultant Gastroenterologists.
4. Patient registered with collaborating General Practitioner practice.

Exclusion Criteria:

a. Participants who are unable to comprehend the study.
Impact of E-Cigarette Prevention Messages on Adolescents

The purpose of this trial is to determine whether a vaping prevention text message program reduces susceptibility to vaping among adolescents and young adults. This study addresses this issue by exposing participants to a vaping prevention text message program over a 28-day period in a randomized controlled trial with a matched attention control condition. A follow-up assessment is also made 4 weeks after the text messaging ends.

Tobacco prevention communication is a key tool for reducing tobacco use among adolescents and young adults. While the use of e-cigarettes and vaping has increased greatly among adolescents and young adults, there has been a dearth of research on effective communication strategies to reduce vaping. This study will test the impact of a text-messaging program on reducing susceptibility to vaping in a randomized controlled trial, illuminating whether such programs can be effective. The investigators focus on adolescents and young adults (ages 13-20) who currently vape or who are at risk of vaping.

Participants will be randomly assigned to receive either a vaping prevention text message program or a wellness text message program (control). Participants in the study will take 4 online surveys over an 8-week period - at Visit 1 (baseline), Visit 2 (2 weeks), Visit 3 (4 weeks), and Visit 4 (8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Ages 13-20 years old (inclusive)
* Have a phone that sends and receives text messages
* Ever vaped or are susceptible to using e-cigarettes or vaping

Exclusion Criteria:

* None
Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing carbetocin nasal spray 3.2 mg TID with placebo (matched placebo nasal spray TID) in subjects with PWS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and 5 through 30 years of age
* Prader-Willi syndrome with a documented disease-causing mutation
* Increased appetite with decreased satiety accompanied by food seeking (consistent with PWS Nutritional Phase 3)
* HQ-CT total score of ≥13 at Screening and Baseline
* CGI-S score for hyperphagia in PWS of ≥4 at Screening and Baseline
* Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits

Exclusion Criteria:

* Genetically diagnosed with Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal cognitive impairment besides PWS
* An active upper respiratory infection at the Screening visit or the Baseline visit
* Any clinically significant cardiovascular disorder, renal, hepatic, gastrointestinal, or respiratory disease, including severe asthma
* History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary
* Nasal surgery within 1 month of Screening visit or planning to have nasal surgery during the study.
* Unwilling to abstain from nasal saline, other nasal irrigation, and other intranasal medications during the Screening period and through the treatment period of the study
* Clinically significant irritability or agitation, requiring initiation of or increase in the dose of antipsychotic medication, within the 6 months prior to the Screening visit
* Used prostaglandins, prostaglandin analogues, or prostaglandin agonists in the 3 months prior to the Baseline visit. Inhibitors of prostaglandin synthesis, such as nonsteroidal anti-inflammatory drugs, are not exclusionary.
* Started a glucagon-like peptide 1 (GLP-1) agonist within the 6 months prior to the Screening visit. Treatment with GLP-1 agonist is allowed if the subject has been taking it for more than 6 months prior to Screening.
* Used oxytocin, desmopressin (DDAVP), or tesofensine within 6 months prior to the Baseline visit
* Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
* History of suicide attempt or inpatient psychiatric hospitalization
* New food-related interventions, including environment or dietary restrictions, within 1 month of the Screening visit

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
AFIX to Improve HPV Vaccination

The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.


Eligibility Criteria:
Inclusion Criteria: Pediatric or family medicine clinics or practices in WA, IL, or MI with

* at least 500 active records for patients, ages 11-17, in their states' immunization information systems.
Regional Anesthesia Database

This is a quality assurance database to prospectively examine regional anesthesia outcomes at Toronto Western Hospital.


Eligibility Criteria:
Inclusion Criteria:Patients having regional anesthesia -

Exclusion Criteria:Patients not having regional anesthesia

-
Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis

The objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a PCS (plus micronutritional supplements \[MNS\]) or control (MNS only) for the 6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months after completion of ATT).

The objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a PCS (plus micronutritional supplements \[MNS\]) or control (MNS only) for the 6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months after completion of ATT).

Eligibility Criteria:
Inclusion Criteria:

* female,
* HIV,
* age \> 18,
* CD4 \> 50,
* BMI\>16
* new TB diagnosis,
* not on anti-retroviral therapy,
* residence in Dar es Salaam

Exclusion Criteria:

* current anti-retroviral therapy,
* serious co-morbidities