cyrilzakka/clinical-trials huggingface dataset:
Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation

We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.

Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.


Eligibility Criteria:
Inclusion Criteria: receiving bone marrow transplant -

Exclusion Criteria: not receiving other growth factors

-
Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy

The purpose of this study is to see if male children with Duchenne muscular dystrophy (DMD) have changes in strength when given the drug Pentoxifylline as a rescue treatment. A total of 64 subjects are expected to participate through all other centers of the Cooperative International Neuromuscular Research Group (CINRG) worldwide.

The primary purpose of this study is to see whether the addition of pentoxifylline to a steroid regimen is effective in treating deteriorating muscle strength by comparing the muscle strength of PTX treated subjects and placebo treated subjects.

DMD is the most common and devastating type of muscular dystrophy (incidence 1 in 3500 live born males worldwide). DMD is characterized by a complete loss of dystrophin, leading to progressive muscle weakness and wasting.

No cure is currently available despite our present understanding of the disorder and the discovery and characterization of the causative gene and its protein product dystrophin in 1987. Corticosteroids (prednisone, deflazacort) may delay disease progression and until now it is the only treatment that proved to be beneficial for patients with DMD. Other alternative supplements like creatine and glutamine also delay diseased progression.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 7 years to 100 years
* Ability to ambulate for 10 meters. Assistive devices are allowed.
* Diagnosis of DMD confirmed by at least one the following:
* On stable dose of prednisone, prednisolone or deflazacort for at least 12 months prior to screening.
* Participants who are on stable dose of any combination of the following compounds (creatine, glutamine, coenzyme Q10, vitamin E, C or D, JUVEN, arginine, calcium) must have taken these medications for at least 2 months prior to screening. Subjects are not required to take these medications to participate in the study.
* All other herbs, supplements or green tea (other than those noted above) have been discontinued 3 months prior to screening.
* Ability to provide reproducible QMT bicep score with no more than 15% variation between scores during screening.
* Normal blood clotting ability evidenced by a platelet function assessment (PFA).

Exclusion Criteria:

* Currently enrolled in another treatment clinical trial.
* History of significant concomitant illness or significant impairment of renal or hepatic function.
* History of impairment of blood clotting ability (as evidenced by increased PT/PTT or PFA over the upper limit of normal (ULN)).
* Recent cerebral or retinal hemorrhage.
* History of bleeding diathesis or gastric ulcer.
Effect Evaluation of Independent Medical Evaluation (IME) in Norway

A randomized controlled trial comparing independent medical evaluation (IME) to treatment as usual (TAU). Participants will be individuals reaching six months uninterrupted sickness absence. Treatment as usual (TAU) is normal follow-up by a general practitioner (GP).

A randomized controlled trial in a Norwegian context, involving an effect evaluation, a cost-benefit evaluation and a qualitative evaluation. Independent medical evaluation (IME) will be compared to treatment as usual (TAU). Independent medical evaluation (IME) will comprise a consultation with an independent general practitioner (IME GP) who will assess whether the sick listed worker has been given eligible and available opportunities in return to work follow-up in Norway. The independent medical evaluation general practitioner (IME GP) will write a short report that is sent to the treating general practitioner as input from a colleague. The report can be used in the follow-up of the sick listed participant. The participants in the treatment as usual (TAU) group will not receive any other follow-up than normal follow-up by the treating general practitioner. The qualitative evaluation will be conducted to gain insight into the experiences of the general practitioners and the participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants on sick leave with an International Classification of Primary Care-2 diagnosis will be recruited through the Norwegian Labour and Welfare Administration's (NAV) registries, when reaching 22 weeks of sick leave (full or graded).

Exclusion Criteria:

* People with International Classification of Disease-10 diagnoses, cancer or dementia.
* People who are pregnant.
Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine


Eligibility Criteria:
Inclusion Criteria:

* The subject has a normal resting EEG at screening visit
* The subject is able to perform tasks with an auditory stimulus
* The subject is not visually impaired - normal prescription glasses are accepted
* The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.

Exclusion Criteria:

* The subject has worked shifts, including night duty, or has travelled across \>3 time zones \<2 weeks prior to the first dose of IMP.

Other inclusion and exclusion criteria may apply.
Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery

This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 years or above
* Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
* In the investigator's opinion, is able and willing to comply with all study requirements

Exclusion Criteria

* Participant who is unable to unwilling to give informed consent
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study
* Participants with known egg allergies, ovalbumin allergy and soya allergies
Clinical Evaluation of CelluTite Treatment

This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.

The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:

* The CelluTite - based on a minimally invasive, temperature-controlled Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and external electrode.
* The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner via an array of 24-electrode pins.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 18-70 having mild/moderate grade cellulites.
* The patients should understand the information provided about the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
* The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods in the treatment area for the last 6 months and during the entire study period.

Exclusion Criteria:

* Body fat layer thinner than 5mm.
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
* Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* Pregnancy and nursing.
* History of bleeding coagulopathies or use of anticoagulants.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
* Allergies, in particular to anesthesia.
* Mental disorders such as Body Dysmorphic Disorder (BDD).
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.


Eligibility Criteria:
Key Inclusion Criteria:

* Capable of understanding and complying with the protocol
* Has a confirmed diagnosis of RRMS
* Neurologically stable with no evidence of relapse within 30 days prior to randomization
* Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal

Key Exclusion Criteria:

* Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
* History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
* History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
* Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
* History of a myocardial infarction, including a silent myocardial infarction or unstable angina
* History of clinically significant drug or alcohol abuse within the past year prior to screening
* Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
* Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
* Prior use of Dimethyl Fumarate (DMF)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings
* Patient has successfully completed protocol procedures (with no clinically significant findings)
* Patient meets protocol criteria for Chronic Constipation(CC): \< 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:

  1. Straining during more than 25% of BMs
  2. Lumpy or hard stools during more than 25% of BMs
  3. Sensation of incomplete evacuation during more than 25% of BMs
* Patient demonstrates continued chronic constipation and bloating through Pretreatment Period
* Patient is compliant with Interactive voice response System (IVRS)

Exclusion Criteria:

* Patient has a history of loose or watery stools
* Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
Study of CAR-T Therapy in Older Patients

This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.


Eligibility Criteria:
Inclusion Criteria:

* are ≥60 years old (all cohorts)
* have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
* able to speak and understand English (cohort 1 only)

Exclusion Criteria:

* Any prior commercial or investigational CAR T therapy (all cohorts)
* Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
* History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report (cohort 1 only)
* Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
Increasing Uptake of Bowel Screening

Bowel cancer is the second biggest cancer killer in the UK, accounting for over 16,000 deaths per year. Screening can reduce deaths from bowel cancer if the people invited participate. The challenge is that high uptake of bowel screening is hard to achieve, and remains persistently below 65%.

The faecal immunochemical test (FIT) is the most widely used bowel screening test worldwide.

In the UK, FIT kits are mailed to people's homes without guidance on when the kit should be returned and only brief instruction on how to use it. Some people have said that even though they intend to complete and return the kit, they often forget or put off doing it.

Two approaches are proposed to addressing this issue: i) providing a suggested deadline for FIT return, because it is known from breast and cervical cancer screening that giving people an appointment time increases uptake compared to an open invitation, and ii) planning sheets, that have been found to help people act on their intentions in other health contexts.

This trial aims to evaluate the impact of providing a suggested deadline and a planning sheet on the return of FIT bowel screening kits.

The trial is integrated within the Scottish Bowel Screening Programme. The investigators will randomly allocate 40,000 consecutive people that are due to be sent a FIT kit to one of eight groups:

(i) control group (no deadline, no planning sheet), (ii) intervention group (1-week deadline, no planning sheet), (iii) intervention group (2-week deadline, no planning sheet), (iv) intervention group (4-week deadline, no planning sheet), (v) intervention group (no deadline, with planning sheet), (vi) intervention group (1-week deadline, with planning sheet), (vii) intervention group (2-week deadline, with planning sheet), (viii) intervention group (4-week deadline, with planning sheet).

It will then be examined if having a suggested deadline and a planning sheet affects how many people send back their completed FIT kit. It will also be examined if the deadline length makes a difference and whether having both a deadline and a planning sheet affects the number of people returning their kit.

Finally, the cognitive and behavioural mechanisms underlying any intervention effects will be assessed and the acceptability of the interventions explored, using questionnaires and in-depth interviews.


Eligibility Criteria:
Inclusion Criteria:

* 50-74 years
* Registered with a Community Health Index number in Scotland
* More than 2 years since last bowel screening invitation

Exclusion Criteria:

* Has self-excluded from Scottish Bowel Screening Programme
* Not sent a screening kit by the Scottish Bowel Screening Programme
Evaluation of Metzenbaum Technique in Correction of Caudal End Nasal Septal Deviation

• To evaluate the results of Metzenbaum 's technique in correction of the Caudal end septal deviation on nasal airway obstruction

Deviation of Nasal septum in different parts may have various functional or aesthetic effects . The etiology of a deviated septum is generally congenital, but may also be as a result of trauma or iatrogenic causes. Most important is the Caudal septal deviation which narrows the airway and impairs major mechanisms supporting the tip, leading to tip-ptosis and airway collapse. .The correction of caudal septal deviations can be a challenging problem so many techniques have been described and tested to correct caudal septal deflections . Attempts to correct nasal septal deformities were described in the medical literature as early as the late 19th century , and till now there is not one specific technique that is agreed upon by surgeons worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to Assiut University Clinic of Otolaryngology department.
* Aging from 16 to 45 years old
* Patients complaining of nasal airway obstruction causes by caudal septal deviation.

Exclusion Criteria:

* Other causes of airway obstruction e.g. nasal polyps, hypertrophied inferior turbinates'
* External nasal deformities
* Contraindications for general anesthesia
National Registry of Cardiovascular Surgery in Argentine

The National Registry of Cardiovascular Surgery in Argentina is a registry of patients undergoing cardiovascular surgery that involves the entire country with the ultimate aim of determining the results of said surgery throughout the country.

It is an observational registry with selective inclusion of patients who undergo certain cardiovascular surgeries, where the pre-surgical status will be analyzed, the determinants during surgery and the postoperative evolution of said patients will be evaluated

Eligibility Criteria:
Iinclusion Criteria:

Over 18 years

Myocardial revascularization surgery

Valvular surgeries

Ascending Aortic Surgery

Type A Aortic Dissection Surgery

Combined surgery

Exclusion Criteria:

Cardiovascular surgery for congenital pathologies

Peripheral vascular surgery

Cardiovascular surgery secondary to trauma

Thoracic and abdominal aorta pathology

Other surgeries
Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior to the initiation of study procedures.
* Men ≥ 18 years of age.
* Histologically documented prostatic adenocarcinoma.
* History of Castration-Resistant Prostate Cancer.

Exclusion Criteria:

* Known M1 disease.
* Undergone imaging study for metastatic prostate cancer ≤ 3 months.
* ECOG performance status ≥ 3.
* Known malignant pleural effusions or ascites.
* Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).