cyrilzakka/clinical-trials huggingface dataset:
Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer

In this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the score of anal incontinence in the radiation dose≤50Gy group and \>50Gy group. The study population includes 124 patients with anal canal cancer or rectal cancer who have received sphincter preservation treatments (including radiochemotherapy), aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University. The primary outcome is the average resting pressure of anal sphincter. The secondary outcomes are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5......). Follow-up for each patient will be at least 2 years.


Eligibility Criteria:
Inclusion criteria 18-75 years of age. Anal cancer and rectal cancer with pathological diagnosis. Patient will undergo sphincter-preserving therapies. Eastern Cooperative Oncology Group (ECOG) score for performance status is 0-2. Written informed consent. Exclusion criteria Patients who have undergone pelvic surgery, such as rectal cancer surgery and gynaecological procedures. Patients who have received pelvic radiotherapy. Patients with other active malignant tumors. Patients with a history of prior peri-anal abscess, anorectal trauma, and inflammatory bowel disease (IBD).

Recently (less than 4 weeks) received surgery or patients with recent severe trauma.

Significant cardiac disease: congestive heart failure of New York Heart Association class ≥2; patients with recent (less than 12 months) active coronary artery disease (unstable angina or myocardial infarction).

Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep vein thrombosis.

Patients with toxicity (Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2) caused by previous treatment that has not subsided.

Women who suffered anal sphincter tear after vaginal delivery. Pregnant or lactating women.
Complicated Grief Among Children After a Death From Cancer or Another Cause: A Longitudinal and Prospective Study (CAPS)

The purpose of this study is to identify risk factors of Complicated Grief (CG) among children and adolescents who lost a parent to cancer or from an other cause.

Although the intensity of the grief and life disruption usually subsides in the months following the loss of a loved one, approximately 7% of bereaved individuals will continue to experience persistent and intense grief-related symptoms associated with marked distress and functional impairment years after the death.

While several studies aimed to evaluate risk factors of CG among adults, little is known regarding CG among children and adolescents. Therefore, prospective research directly examining the impact of bereavement on post-loss psychiatric symptoms, including CG, post-traumatic-stress disorder (PTSD), depression, attentional and behavioral avoidance among children are needed. Improving our understanding of CG risk factors among children will help direct healthcare professionals' clinical attention toward screening and care of this underserved population.

Furthermore, identifying mechanisms explaining why cancer bereaved children may be at greater risk for persistent psychological distress and CG will inform the development of preventive, early intervention and treatment strategies.

Participants will be recruited to the Child and Adolescent grief counseling of the College Hospital of Toulouse as well as with the Team Regional Resource Pediatric Palliative Care "Enfant-Do". At 3, 6 and 12 months post-loss, children and their parent will be invited to complete questionnaires assessing peritraumatic dissociative experiences, peritraumatic distress, security attachment, symptoms of CG, symptoms of PTSD and attentional avoidance.

Eligibility Criteria:
Inclusion Criteria:

Children :

* Having lost a parent within the last 3 months
* Signed consent form from the parent
* To have health care coverage by the French social security

Parents :

* Signed consent form
* Having lost mother or father of the child within the last 3 months

Exclusion Criteria:

Children:

* Both parents are dead
* Medical disease
* Ongoing legal procedure regarding the death

Parents :

* Decline to take part to the study
* Mental retardation or schizophrenia
* Ongoing legal procedure regarding the death
Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC confirmed by histopathology or cytology;
* Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
* Has active mutation of EGFR in exon 19 or 21;
* Has measurable lesion \[according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension \>= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and \>=15mm\];
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* expectancy life \>= 12 weeks;

Exclusion Criteria:

* Had be treated by HER-targeting agents;
* Had systemic anit-NSCLC treatments;
* Had local radiotherapy for NSCLC;
* Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
* Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
* Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
* Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
* Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral cavernous malformations-common Hispanic mutation (CCM1-CHM)
* Must be willing to travel to the University of New Mexico in Albuquerque, NM for 5 visits over the course of three months.

Exclusion Criteria:

* Incarceration
* Unable to pass MRI safety screening (pregnant females, claustrophics, or those with certain metallic items implanted in their bodies)
* Low kidney function or transplants, an eGFR below 60 mL/min
* Currently taking statin medications or have taken statin medications in the past 6 months
* Known allergy or intolerance to statins
* Known allergy or intolerance to gadolinium
* Liver dysfunction at baseline, AST \> 47 and/or ALT \> 49
* Consumption of large quantities of alcohol, men who consume more than 2 daily drinks and women who consume more than one daily drink
* CK level of 232 or higher
* Triglycerides greater than or equal to 500.
* Medications: gemfibrozil, cyclosporine, danazol, itraconazole, ketoconazole, posaconazole, ethromycin, clarithomycin, telithromycin, HIV protease inhibitors, nefazoldone, amiodarone, verapamil, dilitiazem, amlodipine, or ranalazine
Low-dose UVA1 Radiation in Cutaneous Lupus Patients

The investigators are conducting an open-label clinical trial determining the effects of UVA1 phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE) subjects indicates that this treatment is likely to be effective in treating cutaneous lupus with few side effects. The fact that most CLE patients are seen at dermatology clinics also increases the usefulness of this study because there is a large probability that phototherapy treatment will be accessible for many of the patients that stand to benefit from it.

Study subjects will receive low dose (20 J/cm2) UVA1 phototherapy treatment three times per week for 10 weeks. Each treatment will take less than 30 minutes. This period will be followed by an eight-week observation phase to assess longer term effects of the treatment. Patients will be assessed for disease activity, and blood studies and photos will be completed prior to, during, and after phototherapy treatment. Optional skin biopsies of affected and unaffected skin will be performed at the beginning and end of the active treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* You must be 18 years or older with a diagnosis of cutaneous lupus.
* You must have at least two active areas of cutaneous lupus.
* You will need to come in three days a week for a 10-week period.
* You will need to participate in four physician visits and blood draws.

Exclusion Criteria:

* You do not have a diagnosis of cutaneous lupus.
* You have less than two active areas of cutaneous lupus.
* You are unable to come in three days a week for treatment for a 10-week period.
Localization of Mental Foramen in Relation to Primary Molars A Cone Beam Computed Tomography Study

. The aim of this study was to determine the location of mental foramen in relation to the lower primary molars using Cone Beam Computed Tomography. And develop simple guidelines for the injection of mental block anaesthesia for children.

Cone Beam Computed Tomographies in a private radiology centre will be screened, Cone Beam Computed Tomography images of less than 10 years old, boys or girls were included in the study. Included Cone Beam Computed Tomography images should have either or both sides of the lower arch in the field of view, with the lower first and second primary molars with no or minimal root resorption. Images with pathologies, fractures, malformations, or abnormal location of teeth that would affect the anatomy or location of mental foramen were excluded from the study.

The vertical diameter of mental foramen was measured on the cross-sectional Cone Beam Computed Tomography images, while the horizontal diameter was measured on the axial scans. The ratio between horizontal and vertical diameters (H:V) was calculated to determine the form of mental foramen

Outcomes

1: vertical and horizontal location of mental foramen in relation to 1ry molars 2. subgroup analysis for the 1st outcome according to age, (\< 6 years) vs (\> 6 yrs) 3. Mental foramen form according to the Horizontal/Vertical ratio 4. If there is any relation between (location, form, vertical or horizontal dimension of mental foramen) and (Side or Gender)

Eligibility Criteria:
Inclusion Criteria:

Included cone beam computed tomography images should have either or both sides of the lower arch in the field of view, with the lower first and second primary molars with no or minimal root resorption.

Exclusion Criteria:

Images with pathologies, fractures, malformations, or abnormal location of teeth that would affect the anatomy or location of mental foramen were excluded from the study.
Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).


Eligibility Criteria:
Inclusion Criteria:

* Adequate organ function (Special Populations: serum bilirubin \>2 mg/dL or creatinine clearance \<50 mL/min)
* ECOG performance status \<2 (Special Populations: \<4)
* Relapsed or refractory CD30-positive malignancy

Exclusion Criteria:

* Receiving prohibited medication within 4 weeks
* Poor liver function (Child-Pugh class C)
* Current diagnosis of primary cutaneous ALCL
* Acute or chronic graft-versus-host disease
the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control

To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.

Myopia has been an increasing problem among school children, especially in Asian countries. High myopia is not only a refractive problem, but also a disease that can result in a number of sight-threatening complications such as macular degeneration, retinal detachment, glaucoma, and cataract. Atropine is a long-acting non-selective muscarinic antagonist that blocks accommodation by paralyzing ciliary muscles; it may affect remodeling of the sclera and suppress the elongation of axial length. Acupuncture and acupressure have been widely used in traditional Chinese medicine for thousands of years. Auricular acupoint stimulation by acupuncture or acupressure has been reported to improve visual acuity in myopic patients. Therefore, we want to compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those who treated with atropine alone.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 6 to 12 years with myopia, defined as spherical equivalent (SE) of -0.5 diopter (D) or less, were recruited from the outpatient clinics from January 2011 to June 2012.

Exclusion Criteria:

* (1) abnormal IOP (\>21 mmHg) at presentation, (2) astigmatism or anisometropia of more than 1.5 D, (3) amblyopia or strabismus, (4) the presence of any related eyelid diseases, ocular diseases, or auricular diseases, (5) the presence of hemostatic disorders or other related major systemic diseases, (6) history of allergy to atropine, (7) previous or current use of contact lenses, bifocals, progressive lenses, or other forms of treatment for myopia.
Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain

Craniosacral Therapy (CST) is a non-manipulative, very gentle manual treatment method. Although the mechanisms of action have not yet been investigated sufficiently, initial clinical trials support CST efficacy/effectiveness in chronic pain disorders such as back pain, neck pain, and fibromyalgia. In clinical practice, therapists also report pain alleviating effects of CST self-help techniques, offered to patients within a group concept. Yet, the effectiveness of teaching CST self-help techniques to medical laypersons has not yet been scientifically investigated.

Therefore, this study aims at collecting quantifiable data on the effectiveness and safety of a CST self-help group concept, developed for patients with chronic non-specific low back pain. The intervention group will receive 24 lessons of education and practice in CST self-help techniques over 12 weeks, while the control group will receive the same amount of self-help (education and practice) in progressive muscle relaxation. Six and 12 months after randomization, longer-term effects will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific / functional lower back pain for at least 3 months
* Functional impairment: minimal 11 and maximal 41 points on the ODI
* Willingness to participate in the group program and practice at home

Exclusion Criteria:

* Specific back pain due to:
* Severe congenital or acute degenerative diseases
* Severe inflammatory musculoskeletal or rheumatic diseases
* Neurological diseases
* Status after actue trauma/whiplash
* Status after neoplasms in the area of the spinal column
* Acute severe comorbid mental illness or other acute severe comorbid somatic illness
* Pregnancy
* Current pension application
* Regular use of corticosteroids, opiates, muscle relaxants, or antidepressants
* Simultaneous participation in other clinical trials
Tonabersat in the Prophylaxis of Migraine With Aura

Overall trial objectives:

1. Can treatment with tonabersat reduce the number of days with aura and/or migraine headache in patients with migraine with aura
2. How well tolerated is treatment with tonabersat

The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of aura and migraine headache and so be effective as prophylactic treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients with an established history of migraine of at least one year meeting the diagnostic criteria of the International Classification of Headache Disorders - Edition 2 (Appendix 2) and who experience at least one aura a month.
* Male or female patients between 18-65 years of age
* Women of child bearing potential must be using a reliable form of contraception (defined in the protocol) for at least 3 months prior to enrolment and they must have a negative pregnancy test at screening with no intention of becoming pregnant during the study period

Exclusion Criteria:

* Patients experiencing headache other than migraine or tension headache
* Overuse of acute migraine treatments defined as more than 14 daily doses per month with analgesics or more than 9 daily doses per month of ergots or triptans within the last two months
* Migraine prophylactic treatment within two months prior to entry to the trial
* Patients taking any of the following medications for migraine: beta-blockers, tricyclic antidepressants (during the last 2 months), antiepileptic dugs (during the last 2 months), calcium channel blockers, monoamine oxidase inhibitors, daily NSAIDs, daily paracetamol, high dose magnesium supplements (600mg/day). Parenteral administration of botulinum toxin is also excluded. These drugs are permitted when given for diseases other than migraine provided that, in the opinion of the investigator the dose can be kept constant throughout the trial.
* Patients who, in the opinion of the investigator, have significant cerebrovascular disease e.g. transient ischaemic attacks, stroke
* Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease
* Patients suffering from a current clinical diagnosis of a major depressive disorder or schizophrenia
* Patients with renal dysfunction , defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group
* Patients with hepatic dysfunction defined as a liver function test (AST, ALT, alkaline phosphatase, bilirubin) of greater than twice the upper limit of normal for their age group
* Patients with known alcohol or other substance abuse
* Use of an investigational drug (for any indication) within 30 days or 5 half-lives, whichever is the longer, prior to screening
* Women who are pregnant or breast feeding
* Women of childbearing potential not using a reliable form of contraception
* Patients with any other clinically significant condition which, in the investigators opinion, would render them unsuitable for this study
PureWick™ Adolescent Study

The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Adolescent Male or Female aged 12 through 21 years old
2. Able to independently and voluntarily void urine
3. Ability to speak and understand English.
4. Willing to comply with all study procedures in the protocol.
5. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Has urinary retention
2. Incontinent to feces
3. Has any irritation, wound, open lesion at the device application site.
4. For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
5. For females: currently pregnant at time of consenting (self-reported)
6. Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses.
7. Has ever been employed as a home health aide or homecare provider.
8. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.