cyrilzakka/clinical-trials huggingface dataset:
FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life

Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term.

In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis.

Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.


Eligibility Criteria:
Inclusion Criteria:

* Receiving HHD or ICHDF for more than 3 months and less than 36 months.
* Haemoglobin equal to or greater than100 g/L at enrolment.
* Willing and physically able to undertake the study assessments/tests
* Willing to provide blood for storage and future analysis
* Able to give informed consent

Exclusion Criteria:

* Living donor transplant or change to peritoneal dialysis planned
* Physical assessments contraindicated for the following clinical reasons

  * Acute Coronary Syndrome (ACS) within the last 3 months (chest pain, ECG changes or typical biomarker elevation).
  * Any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness)
  * Symptomatic aortic stenosis
  * New York Heart Association grade IV Heart failure
  * Severe chronic obstructive pulmonary disease
  * Acute pulmonary embolus or pulmonary infarction in the last 3 months
  * Current acute myocarditis or pericarditis
  * Suspected or known dissecting aneurysm
  * Acute systemic infection, accompanied by fever, body aches or swollen lymph glands
* Pregnancy
* Life expectancy of less than twelve months
Comparison Between Low Level Laser Therapy and Active Oxygen Releasing Gel on Wound Healing Cleft Lip Patients

the study was performed on secondary cleft lip scars

the study aimed at comparing and Evaluation the effect of low-level diode laser and the effect of Active Oxygen releasing gel O3 (Blue-m gel) topical application on healing outcome in secondary cleft lip correction.

Eligibility Criteria:
Inclusion Criteria:

1. Age: can be done in any time after six months from the previous surgery if it severely disfiguring or in the preschool stage for children the time of surgery should be based on the severity of deformities
2. primary cleft lip repair was done
3. secondary lip repair with or without nose correction is indicated
4. the patient didn't undergo any surgeries procedures in the last 6 months

Exclusion Criteria:

1. previously subjected to secondary lip repair surgery.
2. syndromic cleft lip patient.
3. patient reporting abnormal reaction or scar healing in the previous surgery
4. smoking patients
Functional Decline and QoL in People Aging with HIV in Asia

This is a multi-center prospective cross-sectional study to determine the burden of decline in intrinsic capacity and functional ability, and the prevalence of geriatric syndromes, such as frailty, and disability in adult people living with HIV (PLWH) in Asia.

This research project is expected to have the following clinical impact

1. To understand the impact of impaired functional status in PLWH in Asia would be important to determine the long-term health burden needs in this aging population in this part of the world.
2. The identification of risk factors associated with impaired functional status would be important to guide clinical decisions in patient management, such as the choice of anti-retroviral regimen, and screening of and early intervention for modifiable risk factors. These are of paramount importance in the promotion of healthy aging in this population.
3. This proposed cross-sectional study lays the foundation for the establishment of a longitudinal cohort for long-term follow up of people aging with HIV in Asia, with the objectives of evaluating the long-term impact of aging on clinical outcomes and functional status in PLWH in this region.

Eligibility Criteria:
Inclusion Criteria:

* HIV antibody positive
* Age 35 years or above
* Asian ethnicity, including but not limited to Chinese, Malay and Indian

Exclusion Criteria:

* Inability or refusal to consent
* Active infections requiring in-hospital treatment
The Laparotomy Study

The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.

The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Elective open upper abdominal surgery
* Can read and understand Danish
* Informed consent

Exclusion Criteria:

* Known allergy to rocuronium or sugammadex
* Severe renal disease, defined by S-creatinine\> 0.200 mmol/L, GFR \< 30ml/min or hemodialysis
* Neuromuscular disease that may interfere with neuromuscular data
* Abdominal mesh with size larger than 5\*5 cm
* Lactating or pregnant
A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.

This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21-65 years
* Male or female
* Good general health
* Experience daily feelings of stress and anxiety within the past two weeks
* Experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks
* Have used alcohol products to help relax or sleep within the past two weeks
* Experience tension in the body within the past two weeks
* Experience problems with relaxing in the evening within the past two weeks
* Willing to abstain from alcohol for the duration of the study
* Willing to maintain stable use of other herbal supplements, over-the-counter medications, or prescriptions during the study

Exclusion Criteria:

* Chronic health conditions, including oncological and psychiatric disorders
* Taking SSRIs, sedative, or blood pressure-lowering medications
* Pregnant, breastfeeding, or planning to conceive within the next three months
* Currently enrolled or planning to enroll in another research trial over the next eight weeks
* History of substance abuse
* Known serious allergic reactions requiring an Epi-Pen
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers

This study is to determine whether a mathematical model can be used to choose a radiation delivery method to improve the rate of a rapid response.

Investigators hypothesize that using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years
* Pathologically (histologically or cytologically) proven diagnosis of p16+ or HPV+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, and may consist of pathology, palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
* American Joint Committee on Cancer (AJCC) 8th edition staging T1-3 N0-1 MO
* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
* CT or MRI performed at least 1 week apart. This can consist of diagnostic imaging and radiation therapy planning imaging.
* No evidence of distant metastases
* Eastern Cooperative Oncology Group Performance Status 0 to 3

Exclusion Criteria:

* Age \< 18
* Positive urine pregnancy test
* Evidence of distant metastases
* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that remove all clinically and radiographically evident disease
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Patients with a medical condition or social situation that at the discretion of the PI would preclude them from completion of the trial
A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)

To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatient or outpatient: Inpatient
2. Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
3. Enrollment in this study within 5 days after onset of symptoms of SARS-CoV-2 infection (COVID-19) (for asymptomatic patients, enrollment in this study within 5 days after collection of the sample that tested positive)

Exclusion Criteria:

1. Receiving oxygen therapy
2. Difficulty in swallowing oral medication
3. History of COVID-19
4. History of vaccination against COVID-19
5. Taking camostat mesilate
A Retrospective Non-Interventional Study to Evaluate the Impact of Eculizumab in Korean PNH Patients

This study is a retrospective non-interventional study, and the main objective of this study is to identify the impact of eculizumab treatment and the improvement of complications before and after eculizumab treatment, and to evaluate the safety during the treatment and the clinical unmet needs during the treatment in PNH patients in real-world.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PNH aged 18 years or older who started eculizumab treatment in accordance with drug label between 2012 and January 31st, 2020. (However, patients who have received eculizumab as part of a clinical trial or an expanded access program/compassionate use program prior to 2012 are also eligible.)
* Patients who are vaccinated against Neisseria meningitidis at least 2 weeks prior to starting eculizumab treatment. Patients who have been treated with appropriate prophylactic antibiotic therapy for 2 weeks after vaccination if they received eculizumab within 2 weeks after the vaccination.

Exclusion Criteria:

* Pediatric patients with PNH aged under 18 years
* Patients with hypersensitivity to the active ingredients of eculizumab, murine protein, or other components
* Patients with untreated severe meningococcal (Neisseria meningitidis) infection
* Patients who received other complement inhibitors for PNH before or during eculizumab treatment
CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

Primary objective:

* Pathological complete response (ypT0N0) rate

Secondary objectives:

* Histopathological R0 resection rate
* Pathological downstaging (ypT0-T2N0) rate
* One month surgical complication rate
* Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
* Safety
* Local and distant recurrence rates
* Progression-free survival
* Overall survival


Eligibility Criteria:
* Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
* No evidence of distant spread
* No prior therapy for chemotherapy or radiation therapy for rectal cancer
* Patient considered locally advanced by MRI:

  * Tumour beyond mesorectal fascia, or
  * Tumour ≤ 2mm from mesorectal fascia, or
  * T3 tumour \< 5cm from anal verge
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No peripheral neuropathy \> grade1
* ECOG PS ≤ 2
* ANC \> 1,500 x 10\^9/L
* Platelets \> 100,000 x 10\^9/L
* Creatinine \< 1.5 x IULN
* Bilirubin \< 1.5 IULN
* SGPT (ALT) \< 2.5 IULN
* No pre-existing condition which would deter chemoradiotherapy
* No uncontrolled diarrhoea or fecal incontinence
* No significant small bowel (\> 200cc or 6X6X6cm) delineated within the radiation fields
* No other serious uncontrolled concomitant illness
* Informed consent signed

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Anterior Cruciate Ligament Study

This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction.

The primary outcome is the rate of rupture of the anterior cruciate ligament as measured by the Lachmann test in which a positive value for re-rupture is an anterior translation of the tibia greater than 10mm relative to the femur Secondary Objectives: Verify predisposing factors to anterior cruciate ligament injuries (so anatomical factors such as tibial slope, trochlear groove), demographic factors (age, sex, weight, sports played), and the rate of return to sports, quality of life via questionnaires, and arthrosis at the operated knee


Eligibility Criteria:
Inclusion Criteria:

* - Males and females- attained skeletal maturity
* 18-65 inclusive
* Patients operated on anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
* Signature informed consent for patients who will be operated on in the prospective phase (from CE approval date to 2030)

Exclusion Criteria:

* failure to reach skeletal maturity

  * Concomitant ligamentous injuries (pcl, mcl, lcl)
  * Neuropsychiatric illness, developmental disorders
  * Pregnant women through self-declaration or breastfeeding
  * Minors
Study of Brain-spinal Cord Neural Connectivity in Spasticity

Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3 to 17 years included
* scheduled for selective rhizotomy surgery
* Having received informed consent to participate in the study (written consent from both parents)
* Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Contraindications to selective rhizotomy
* History of epilepsy
* Known neurological and/or psychiatric disorders with past and/or current medical treatment, or drug addiction
* Patient under legal protection
* Pregnant or breast-feeding women
Safety and Efficacy of AM712 in Patients with NAMD

The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).

The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.

Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.

The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with 50 years of age or older
2. Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea
3. The area of CNV must occupy at least 50% of total lesion
4. Total lesion area ≤ 12 DA
5. ETDRS BCVA letter score measured at screening and baseline
6. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye

Exclusion Criteria:

1. Any previous systemic anti-VEGF treatment
2. Any systemic treatment or therapy to treat neovascular AMD
3. Continuous use of systemic corticosteroids
4. Diseases that affect intravenous injection and venous blood sampling
5. Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye
6. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of IP or require medical or surgical intervention.
7. The area of fibrosis occupies ≥ 50% of total lesion area in study eye
8. Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye
9. History or any concurrent macular abnormality other than AMD in study eye
10. Current vitreous hemorrhage or history of vitreous hemorrhage in study eye
11. History of recurrent inflammation in study eye
12. History of treatment for nAMD
13. Subject having out of range laboratory values defined as:

ALT or AST \> 2 x ULN, total bilirubin \> 1.5 x ULN Serum creatinine \> 1.5 x ULN, BUN \> 2 x ULN HbA1c \> 7.5% at screening
Breastfeeding Education and Humor-Based Practices on Breastfeeding

The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.

Breastfeeding is the ideal source of nutrition for babies. The World Health Organization (WHO) recommends continuing breastfeeding exclusively with breast milk for the first 6 months and with complementary foods for up to 3 years. Breastfeeding is extremely effective on the health of the baby and mother. The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Having a healthy pregnancy,
* Being literate,
* 32-36. Being in the gestational week,
* Being primiparous,
* Not having any psychiatric diagnosis.

Exclusion Criteria:

* Not having attended one of the trainings
* incompletely filling out the questionnaires
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions

The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Subjects who have attempted suicide in the past.
* Subjects who have an unexplained history of sudden death in their family