cyrilzakka/clinical-trials huggingface dataset:
Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021

Worldwide, prostate cancer is the most commonly diagnosed male cancer and the fourth leading cause of cancer death in men. Risk stratification is according to cancer stage, Gleason score, and PSA level .

Definitive treatment of localized disease ( low and favorable intermediate risk) includes watchful waiting , active surveillance , radiation therapy , radical prostatectomy and cryotherapy .Primary treatment of unfavorable intermediate risk , high risk localized disease and locally advanced prostate cancer , includes both radical prostatectomy (RP) and EBRT + long-term androgen deprivation therapy (ADT) .Treatment options of metastatic prostate cancer include pain medications, bisphosphonates, hormonal treatment, chemotherapy, radiotherapy, immunotherapy, focused radiation, and other targeted therapies .


Eligibility Criteria:
Inclusion Criteria:

* Patients at age of 18 years old and above.
* All stages and grades of prostate cancer.
* Epithelial types of prostate cancer.

Exclusion Criteria:

* Age below 18 years old.
* Presence of other malignancies.
Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)

The purpose of this expanded access protocol is to provide access to the investigational drug troriluzole in patients with spinocerebellar ataxia (SCA).

This is an Intermediate-Size Patient Population Expanded Access Protocol designed to provide treatment use of troriluzole to patients with spinocerebellar ataxia (SCA) who are considered to be eligible in the clinical judgement of the Investigator/treating physician. The population includes both troriluzole naive patients and patients participating in previous clinical trials with troriluzole (BHV4157-201 and BHV4157-206) who have a confirmed diagnosis of spinocerebellar ataxia.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient has a confirmed diagnosis of Spinocerebellar Ataxia (SCA), defined as either clinical evidence supporting diagnosis OR confirmed genotypic diagnosis.
* Adequate hepatic function.

Key Exclusion Criteria:

* Patient is known to have acute or chronic liver disease that is clinically significant in the judgement of the Physician.
* Patient has a history of a clinically significant medical condition that would interfere with the patients ability to comply with the expanded access protocol or would place the patient at increased risk.
A Study of Two Macitentan Formulations in Healthy Adult Participants

The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical and surgical history performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Body weight not less than 50 kilograms (kg) and body mass index (BMI) within the range 18.5 - 30.0 kilogram per meter square (kg/m\^2)(inclusive), at screening
* All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test at screening and must have a negative urine pregnancy test on Day -1 of each intervention period
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after the last study intervention intake
* Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to macitentan, fructose or drugs of the same class, or any excipients of the drug formulations
* History or clinical evidence of any disease or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention (appendectomy and herniotomy allowed, cholecystectomy not allowed)
* A history of repeated fainting due to cardiac cause, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* Veins unsuitable for intravenous puncture on either arm (example, veins that are difficult to locate, access, or puncture, and veins with a tendency to rupture during or after puncture)
* Woman who is breastfeeding/pregnant at screening or plans to breastfeed/become pregnant throughout the study until 30 days after last study intervention intake
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.

One group will be started on a bowel protocol of escalating doses of sennosides, plus a dummy polyethylene glycol (lactose), and the other will receive dummy sennosides capsules (lactose) plus polyethylene glycol, with the same dosing protocol. After three weeks of one active treatment the patients will switch to the alternate active product and dummy preparation. The total duration for the study will be 6 weeks for each patient.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient (18 years and above) with diagnosis of cancer.
2. Patient requires treatment or prevention of constipation.
3. Patient is able to communicate effectively with staff.
4. Expected prognosis more than 12 weeks.
5. On or starting opioid therapy

Exclusion Criteria:

1. Patient unable to take oral medication.
2. Allergy or previous intolerance to PEG or sennosides.
3. Lactose intolerant.
4. Contraindication to PEG or sennosides.
5. Known or suspected bowel obstruction or ileus.
6. Colostomy or ileostomy.
7. Inflammatory bowel disease.
8. Hospitalisation expected within the study period.
9. Patient unable to complete the study diary in English.
VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.


Eligibility Criteria:
Inclusion Criteria:

1. History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
2. Age \>30 years and \<80 years
3. Right or left sided weakness of upper extremity
4. UEFM score within designated range.
5. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits

Exclusion Criteria:

1. History of hemorrhagic stroke
2. Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
3. Significant sensory loss.
4. Presence of ongoing dysphagia or aspiration difficulties.
5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
6. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.
7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
8. Severe depression
9. Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
10. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
11. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
12. Pregnant or plan on becoming pregnant or breastfeeding during the study period
13. Currently require, or likely to require, diathermy during the study duration
14. Any health problem requiring surveillance with MRI imaging
15. Active rehabilitation within 4-weeks prior to therapy
16. Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
17. Severe spasticity of the upper limb
Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature

The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection.

This was a multicenter, randomized phase II study, half of participants will receive the high dose, while the other half will receive the low dose.

Eligibility Criteria:
Inclusion Criteria:

* The patients are diagnosed as being clinically full term small for gestational age infant.
* Girl are 3-6 years old, boys are 3-7 years old.
* Be in preadolescence (Tanner stage 1).
* The child did not achieve catch-up growth when he/she entered the group (the definition of catch-up growth is that the height is higher the third percentile with the same age and gender) (Appendix 2 and 3).
* The height of child is shorter than -2SDS of the median of normal children with the same age and gender when he/she entered the group (the mean height and height standard deviation of normal children with the same age and gender of normal children regard the height data in the physical development investigation data of children aged 0-18 in 9 cities of China (2005) as standard \[13\], Appendix 4 and 5).
* Within a year before entering the group, after any growth hormone stimulation test, the peak concentration of growth hormone in serum\>10 µg/L.
* Bone age≤ the actual age+1.
* The function of glucose regulation is normal: fasting blood glucose \< 5.6mmol/L.
* Birth gestational age ≥ 37 weeks.
* The subjects and their guardians sign the informed consent (if the subjects is lack of ability for signing the informed consent, his legal guardian can write the subjects name instead).

Exclusion Criteria:

* People with abnormal liver or kidney function (ALT\> 2 times the upper limit of normal value, Cr\> the upper limit of normal value).
* Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
* People with known highly allergic constitution or allergy to the drug or the excipient of the study.
* People with diabetes, severe cardiopulmonary, hematological system and malignant tumors diseases or general infection, immune deficiency and patients with mental disease.
* Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency.
* Potential tumor patients (family history).
* Patients who used growth hormone for treatment.
* Subjects took part in other clinical trial study within 3 months.
* Patients used other hormonal for treatment within 3 months (such as sex hormone, glucocorticoid and etc., treat for more than a month) and received the drug treatment which may interfere with the secretion of GH or GH function (oxandrolone, growth hormone releasing hormone and etc.);
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis

Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing.

In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Three different therapy option are created; first, nasal compression with tranexamic acid, second, simple nasal compression without any drugs. And third, packing with Merocel.


Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior epistaxis older than 18 year and accept to participate in the study

Exclusion Criteria:

* Patients younger than 18 years
* Patients who used anticoagulation therapy
* Patients who have hemodynamically instability
* Traumatic epistaxis
* Patients who have known bleeding disorder
A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A

This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.

During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).


Eligibility Criteria:
Inclusion Criteria:

- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).

Exclusion Criteria:

- None
The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering from Chronic Pathologies or Burn Injuries.

Single-center, randomized, controlled clinical trial (RCT) to evaluate the efficacy of VR on pain and anxiety in children with chronic diseases undergoing painful procedures in an outpatient or day hospital setting


Eligibility Criteria:
Eligibility Criteria: Inclusion

The study population includes children who meet the following criteria:

1. Diagnosis of a chronic condition, aged 3 to 18 years, without visual impairments or cognitive deficits, and with a confirmed diagnosis of the condition.
2. Children receiving care in the wound care nursing clinic or Medical Day Hospital (DH) who require minimally invasive painful procedures.
3. Assent and informed consent provided by both the children and their parents.
4. Children with chronic conditions that do not inherently cause chronic pain, which could alter pain perception (e.g., rheumatoid arthritis, diabetic foot, muscular dystrophy).
5. Children able to understand and communicate in Italian or English.
6. Parents able to understand and communicate in Italian or English. Eligibility Criteria: Exclusion

Children with the following characteristics will be excluded from the study:

1. Chronic condition not yet diagnosed.
2. Use of eyeglasses, presence of amblyopia or monocular vision.
3. Chronic pain, which could distort pain perception during the procedure.
4. Use of analgesic therapy within the last 8 hours, which could bias data collection results (the only prohibited therapy in the study and a reason for exclusion).
5. Cognitive impairment preventing the proper use of assessment scales.
An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence

This study evaluates the cell and biomarkers associated with the aggressive behavior of cancer.

PRIMARY OBJECTIVE:

I. High-resolution single-cell profiling of Cancer-associated fibroblasts (CAFs) in Human papillomavirus (HPV)+ Oropharyngeal Squamous Cell Carcinoma (OPSCC) and metastatic lymph nodes.

OUTLINE: This is an observational study.

Patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis/disease status: New diagnosis of head and neck cancer
* Allowable type and amount of prior therapy: No prior treatment
* Age ≥ 18 years.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients who have had treatment of head and neck cancer
Use of a Squatting Assist Device in Patients with Constipation

Constipation is a very common problem. Western style toilets that are nearly universal in the United States require the person to sit on the toilet. However, results from uncontrolled studies suggests that a squatting posture (as prevalent in many foreign countries) may be better at facilitating evacuation compared to a Western style commode. One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. Hence, the investigators propose to evaluate the benefits of a footstool on symptoms and anorectal functions in constipated patients. Hypothesis: the regular squatting assist device (7 inches) but not a sham device (2 inches tall) will improve symptoms of constipation.


Eligibility Criteria:
Inclusion criteria:

* Able to communicate adequately with the investigator and to comply with the requirements for the entire study
* Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis: a) \<3 SBMs/week b) hard or lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria.

Exclusion criteria:

* Current use of opioid analgesics. Patients on opioids will be allowed to participate if they have discontinued them for at least 3 days (72 hrs.) before date of screening and are willing to stay off them for the duration of the study.
* Current use of anticholinergics (e.g. nortriptyline, amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline upto 50 mg/day or amitriptyline upto 25 mg/day ) will be eligible provided they do not increase the dose during the study period. Patients on higher doses or on other anticholinergics are eligible to participate if they can discontinue their medication at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete.
* Current use of laxatives (MiraLax, Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete.
Ghrelin Levels in Children With Poor Growth

The investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. These patients may present with a variety of complaints and are often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The investigators hypothesize that ghrelin has a physiologically important role in linear growth and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a factor leading to poor growth, potentially by altering growth hormone secretion and/or by decreasing appetite. By measuring ghrelin levels in children with short stature and in children with gastrointestinal disease, the investigators will further elucidate the possible physiologic role of ghrelin in childhood growth and how it may be altered in conditions causing short stature and in certain gastrointestinal diseases.


Eligibility Criteria:
Inclusion Criteria:

* To be included in the short stature group, subjects must have had short stature, defined height less than -2 SD for gender and age or an abnormal growth velocity for gender and age).
* To be included in the failure-to-thrive group, subjects must have had poor weight gain, defined as weight less than -2 SD for gender and age or an abnormal weight velocity for gender and age.
* Patients in both groups will be evaluated for the presence of chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms. Patients who were affected in both weight and height will be stratified by which measurement was more severely affected, with poor weight gain being the primary problem in the "failure-to-thrive" grouping (Group 2) and "poor linear growth" being the primary problem in the short stature group (Group 1).
* Patients who have had chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms, but normal stature and growth, will be analyzed separately (Group 3).

Exclusion Criteria:

* Must not have a known diagnosis as an etiology for growth failure or GI symptoms prior to presentation.
Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo

This study was a retrospective, non-interventional, longitudinal, descriptive study. This study did not have a key underlying hypothesis, rather it was designed to explore the onboarding and adherence of SPMS patients in Australia to Mayzent (siponimod) treatment.

Initiating siponimod involves pre-screen tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing, and patients underwent a 6-day titration prior to maintenance. The MSGo platform was developed to support onboarding. It is an integrated digital platform that functions as a patient support service.


Eligibility Criteria:
Inclusion criteria

* Adult patients with SPMS as per the treating physician's clinical assessment (Therapeutic Goods Administration \[TGA\]-approved indication of Mayzent).
* Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 (inclusive).
* Patients accessing Mayzent via the Mayzent Experience Program (MEP) must have met the MEP criteria, and if available, the Pharmaceutical Benefits Scheme (PBS) restrictions recommended by the Pharmaceutical Benefits Advisory Committee (PBAC).
* Patients accessing Mayzent via the PBS must have met the PBS restrictions.

Exclusion criteria

* Patients who were contraindicated for Mayzent treatment according to the TGA-approved Product Information.
* Patients diagnosed with clinically isolated syndrome or primary progressive multiple sclerosis (MS).