cyrilzakka/clinical-trials huggingface dataset:
A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.

Background: Complications impact physical and psychological recovery and are associated with financial cost. General physical function has not been studied in relation to the development of surgical complications in this cohort.

Objective: Evaluate the physical function performance differences between those who develop complications and those who do not and determine their impact on recovery.

Design: Observational Setting: The pre-operative assessment unit in the University Hospital Limerick. Patients: Forty-nine participants who were planned to undergo abdominal surgery were recruited \& 43 completed the study.

Main outcome measure: Demographics, physical function, lung function, surgical parameters, complications and recovery data was collected.


Eligibility Criteria:
Inclusion Criteria:

* Written consent to participate in the study
* Eighteen years or above
* Planned for elective abdominal surgery
* American Society of Anaesthesia physical status score \<4.

Exclusion Criteria:

* Abdominal surgery within one year prior to study entry
* Unable or unwilling to give informed consent
* Inability (cognitive) to perform the pre-operative tests, as characterised by inability to understand the information in the patient information leaflet
* Current systemic acute illness
* Scheduled for non-abdominal surgery
* Unstable angina or myocardial infarction in the previous month
* Physical limitation precluding inability to participate in pre-operative tests.
A Wearable Morning Light Treatment for Postpartum Depression

This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock).

Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results.

The hypotheses regarding the bright light versus the placebo dim light of the study are:

* morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression
* morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms.
* morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.

Please note this project added a sub-study (HUM00235787, IRB approved on 7/31/2024) to the main study. However, the sub-study only applies to some of the participants and there are only exploratory outcomes, therefore, this will not affect the main study registration.

Eligibility Criteria:
Inclusion Criteria:

* less or equal (≤) to 26 weeks postpartum
* meet criteria for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V)
* not currently receiving treatment for depression (for example, prescription medications or psychotherapy).

Exclusion Criteria:

* Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder if the onset is outside of the perinatal period, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID.
* current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy.
* retinal pathology or history of eye surgery
* current use of photosensitizing medications,
* current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers)
* medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures).
* nightshift work
* currently pregnant
Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for Attention Deficit Hyperactivity Disorder (ADHD)

The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of nutritional formula supplementation on growth of prepubertal children treated with stimulants medications of ADHD.

70 Participants treated with stimulants medications of ADHD will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. Randomization will be stratified according to gender.

Participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (Powder added to water). The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.

In addition, 30 prepubertal healthy siblings will be recruited to the study in order to compare baseline eating and physical activity patterns of ADHD children treated with stimulants to their healthy untreated siblings at the same age range. Participants' siblings will only complete once the nutritional and physical activity questionnaire and report height and weight measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Boys aged ≤ 10 years and girls aged ≤ 9 years.
2. Children treated with stimulants medications for ADHD for at list 3 months.
3. Prepubertal -Tanner stage 1 (gonadarche) (boys: testicular volume \< 4, girls: breast at Tanner stage 1)
4. Normal weight status: BMI-SDS ≤ 85th percentile for age and gender according to the CDC 2000 growth charts
5. Signing inform consent forms

Exclusion Criteria:

1. Diagnosis of GH Deficiency or treatment with GH
2. Any known chronic disease or dysmorphic syndrome including bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
3. Any known gastrointestinal disease including malabsorption
4. Any known organic reason for growth retardation
5. Milk allergy.
6. Any chronic treatment with additional medication beside stimulants that might affect appetite, weight, or growth (for example SSRI's).
Khalifa Acute Effects

The primary hypothesis is that Khalifa's therapy has different acute effects in various organ systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects might indicate the pathway of the therapy.

According to our previous study that evaluated the efficacy of Khalifa's therapy the investigators have seen that the therapy has acute effects which resulted in better knee function and later even in better healing of the ACL injury. This study should clear exactly which effects and pathways are involved in the therapy from multiple (interdisciplinary) point of views. Therefore the investigators will measure parameters that might be associated with this special technique directly before and after the therapy.

Eligibility Criteria:
Inclusion Criteria:

* totally ruptured ACL - MRI verified, 2 weeks old as a maximum
* knee function: Any functional inhibition (stretching, bending or load)
* BMI: 18-25
* athletically active

Exclusion Criteria:

* any surgical procedures at the injured knee at any previous time
* any acute surgical indication
* diabetes mellitus and/or high blood pressure
* any permanent drug treatment
Tranexamic Acid in Functional Endoscopic Sinus Surgery

The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.

The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.

Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists grade I or II.
* Sex: Both sexes.
* Age between 18 and 40 years.
* Patients scheduled for FESS under general anesthesia.

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* History of venous or arterial thrombosis.
* history of cardiovascular diseases including AF, IHD, or hypertension.
* History of chest problems including pulmonary embolism, bronchial asthma and COPD.
* History of cerebrovascular stroke.
* History of drug or alcohol abuse.
* Taking opioids or sedative medications.
* Hepatic or renal failure.
* Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
No Code Artificial Intelligence to Detect Radiographic Features Associated With Unsatisfactory Endodontic Treatment

Developing neural network-based models for image analysis can be time-consuming, requiring dataset design and model training. No-code AI platforms allow users to annotate object features without coding. Corrective annotation, a "human-in-the-loop" approach, refines AI segmentations iteratively. Dentistry has seen success with no-code AI for segmenting dental restorations. This study aims to assess radiographic features related to root canal treatment quality using a "human-in-the-loop" approach.

The emergence of artificial intelligence (AI) and specifically deep learning (DL) have shown great potential in finding radiographic features and treatment planning in the field of cariology and endodontics. A growing body of literature suggests that DL models might assist dental practitioners in detecting radiographic features such as carious lesions, and periapical lesions, as well as predicting the risk of pulp exposure when doing caries excavation therapy. Although, the current literature lacks sufficient research on the interaction of participants and AI in an AI-based platform for detecting features associated with technical quality of endodontic treatment. This prospective randomized controlled trial aims to assess the performance of students when using an AI-based platform for detecting features associated with technical quality of endodontic treatment and predicting the long term prognosis of the treatment. The hypothesis is that participants' performance in the group with access to AI responses is similar to the control group without access to AI responses.

Eligibility Criteria:
Inclusion Criteria:

1.Being a last year dental student at the university of Copenhagen

Exclusion Criteria:

1. Having any previous AI-related experiences
2. Not accepting to sign the informed consent
Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer

The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy..

A new lipid emulsion enriched ω-3 fatty acid was manufactured, and was reported avoid hyperinflammatory situations in patients followed major surgery. However, the role of ω-3 fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver cancer is unclear. This study aims to evaluate the safety and efficacy of ω-3 fatty acid-based parenteral nutrition for cirrhotic patients with liver cancer followed hepatectomy.

A prospective randomized controlled clinical trial was conducted for cirrhotic patients with liver cancer underwent hepatectomy between March 2010 and September 2013 in the investigators institution. For postoperative parenteral nutrition, 20% Structolipid and 10% Omegaven were applied to the trial group, while only Structolipid to the control group for 5 consecutive days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* The cirrhotic malnourished patients who were diagnosed as liver cancer preoperatively and underwent hepatectomy were consecutively enrolled.

Exclusion Criteria:

* Contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C, indocyanine green retention rate at 15min (ICGR15)\>30%(12), serum hepatitis B virus (HBV)-DNA\>126 copies/ml and serum alanine aminotransferase (ALT) \> 2×ULN, serum triglycerides\>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause
* Pregnancy
* Age of\<18y or\>75y
* Performed intraoperative ablation
* Unresectable tumor during operation
* Allergic reactions against fish or egg proteins
Natesto Testosterone Nasal Gel for Hypogonadal Men

To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

The purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and provide written informed consent for the study.
* Ability to read and complete electronic questionnaires in English.
* Adult males between the ages of 18-64 years
* Mild-moderate ED based on SHIM score between 8-21 at study entry
* Ability to take daily Tadalafil
* Ability to undergo venipuncture
* Ability to provide ejaculated semen sample
* Stable female sexual partner with sexual activity at least 1-3 times/month
* Hypogonadism defined as two (one done as SOC within the last 6 months and one done at the time of screening) early morning total testosterone lab values \<300

Exclusion Criteria:

* Morbid Obesity - BMI \>35
* History of Diabetes (HBA1c \>6.0)
* Hematocrit \< 35% or \> 54% at study entry
* Concurrent or Prior use of other exogenous testosterone or hormone therapy (SERM, aromatase inhibitor, gonadotropins) within the last 3 months.
* Concurrent use of other prescription medications for ED including PDE5 inhibitors, intracavernosal injection therapy, urethral suppositories
* Concurrent use of nitrates in any form
* History of pelvic radiation
* Spinal cord injury
* Any progressive neurologic disease (Alzheimer's, Parkinson's, multiple sclerosis, etc).
* History of penile prosthesis
* History of prostatectomy
* History of transurethral resection of prostate
* History of stroke or myocardial infarction within the past 6 months
* History of congestive heart failure
* History of untreated obstructive sleep apnea
* History of liver disease (Serum transaminases \> 2.5 times upper limit of normal)
* History of chronic kidney disease (GFR\<60 or Serum Cr \>2)
* History of, current or suspected, prostate (abnormal DRE or elevated PSA \>4.0) or breast cancer.
* History of azoospermia or oligospermia (\<15 million/ml)
* History of vasectomy
* History of Priapism
* History of Polycythemia Vera
* Receipt of any investigational product within 4 weeks of study enrollment
* Recurrent upper respiratory or sinus infection (\>3 times/month for \>6 months)
* Recurrent epistaxis (\>3 times/month for \>6 months)
Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.

The aim of this study was to investigate the role of an oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in the treatment of CP/CPPS patients. The main questions the present study aims to answer are:

* Does PROSTYM® enhance quality of life of CPP/CPPS patients?
* Does it help reducing pain symptoms of CPP/CPPS patients?

Researchers will investigate whether PROSTYM® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.

Participants will:

* Take PROSTYM® every day for 6 months;
* Visit the clinic for follow-up visits at 3 and 6 months;
* Answer validated questionnaires and declare potential adverse events at follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* adult male patients (aged \>18 years)
* clinical affection by CP/CPPS with symptoms that persisted for ≥6 months;
* CPSI pain domain score ≥5 points;
* negative Meares and Stamey test score.

Exclusion Criteria:

* patients with prevalent BPH symptoms (CPSI pain domain \<5), acute prostatitis, chronic bacterial prostatitis (positive Meares and Stamey test), prostate or bladder cancer, urethral stenosis or neurological bladder;
* no other drug or supplement specific to chronic prostatitis in the previous 30 days.
Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.

This is a compassionate use protocol allowing sarcoma patients that have relapsed after prior therapies and are not eligible for other protocols involving the evaluation of aldoxorubicin to receive aldoxorubicin.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or unrectable sarcoma that has either relapsed or was refractory to at leat 1 prior chemotherapy or immunotherapy regimen and for which no standard approved therapy exists
* Must not be eligible for another CytRx-sponsored clinical trial
* Able to provide complete medical records for review by the CytRx Medical Monitor
* Able to receive treatment at a site that is participating or has participated in another CytRx-sponsored aldoxorubicin trial
* Capable of providing informed consent and complying with trial procedures
* ECOG performance status 0-2
* Measurable or evaluable tumor lesions according to RECIST 1.1 criteria
* Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study
* Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating

Exclusion Criteria:

* Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to screening for non-target lesion
* Exposure to any investigational agent within 30 days of screening
* Central nervous system metastases that are symptomatic
* Laboratory values: Screening serum creatinine \>1.5×ULN, ALT \>3×ULN, or \>5×ULN if liver metastases are present, total bilirubin \>3×ULN, ANC \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<25% for females or \<27% for males, coagulation tests (PT, PTT, INR) \>1.5×ULN
* Anion gap \> 16 meq/L or arterial or venous blood pH \< 7.30.
* Clinically evident congestive heart failure \> class II of the New York Heart Association (NYHA) guidelines
* Current serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V
* Baseline QTc \>470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed
* History or signs of active coronary artery disease with or without angina pectoris.
* Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF \<45% of predicted
* History of HIV infection
* Active, clinically signifiant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals
* Major surgery within 3 weeks prior to enrollment
* Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Subject-reported history of dry eye disease in both eyes for at least 6 months;
* History of use of artificial tear eye drops for dry eye symptoms;
* Total score of ≥40 on SANDE;
* TFBUT;
* Corneal fluorescein staining;
* Lissamine green conjunctival staining;
* Schirmer's test score.

Exclusion Criteria:

* Have participated in a previous tavilermide (MIM-D3) study;
* Have clinically significant slit lamp findings at Visit 1;
* Have a history of lacrimal duct obstruction within 12 months of Visit 1;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to Visit 1.
Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate

This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a kidney function measurement test as part of standard care.
* Written informed consent.

Exclusion Criteria:

* History of hypersensitivity to iodinated contrast media or one of the excipients in the formulation of iohexol (trometamol, sodium calcium edetate, hydrochloric acid).
* Subjects with (suspected or known) thyrotoxicosis.
* Pregnant women and women of child-bearing potential who are not using reliable contraception.
* Patients who are unlikely to comply to the trial's procedure (non-compliance).