cyrilzakka/clinical-trials huggingface dataset:
Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy

The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.

The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".

The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study

Exclusion Criteria:

* Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.
Assessment of Long-term Effects of Tachosil

This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application.


Eligibility Criteria:
Inclusion Criteria:

* type of surgery, indication for surgery, type of disease

Exclusion Criteria:

* dead patients, not available on call.
Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache

The study aims to evaluate which is the best approach for the non-pharmacological treatment of patients with different types of primary headaches (tension-type headache (TTC), trigeminal autonomic headache (TACs) and migraine) or cervicogenic headache by comparing three methods of intervention to control treatment (drug therapy): therapeutic exercise (TE), myofascial release + TE, and Mulligan's manual therapy + TE. The efficacy will be evaluated in terms of reduction of headache episodes, pain intensity and its duration.

Patients will be evaluated before the start of treatment (T0), at the end of treatment (T1), 3 months after T1 (T2), 6 months after T1 (T3). Results will be stratified by gender, age range, and type of headache diagnosed.

The 3 non-pharmacological treatment groups will carry out 12 treatment sessions, 3 times a week for 4 weeks, with a duration of 45 minutes each. The control group (CTRL) will carry out pharmacological treatment according to clinical practice, the patients of the CTRL group at the end of the last follow-up evaluation (T3 at 6 months) at their request will be randomized into one of the other three intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from primary headache or cervicogenic headache;
* Age \> 18 years;
* signature of the informed consent.

Exclusion Criteria:

* upper cervical spine instability;
* cervical arterial insufficiency
* cervical spine fractures
* pregnancies
* rheumatoid arthritis
* severe cognitive impairment
Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants

This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.

The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.

Eligibility Criteria:
Inclusion Criteria:

1. Women of nonchildbearing potential and men, ages 18 to 55 years, inclusive.
2. Healthy as determined by medical evaluation by the investigator.
3. Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lbs).
4. A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception.
5. Capable of giving signed informed consent and complying with study requirements.

Exclusion Criteria:

1. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
2. Serious risk of suicide in the opinion of the investigator.
3. History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
4. Any condition that could possibly affect drug absorption.
5. Receipt of SARS-CoV2 vaccine or booster as follows:

   * mRNA: within 14 days prior to dosing
   * Non-mRNA: within 28 days prior to dosing
6. Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
7. Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
8. History of HIV, hepatitis B, or hepatitis C infection, or positive result for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
9. Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
10. Abnormal clinical laboratory test results or vital measurements at Screening.
11. Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.
A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed

This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.


Eligibility Criteria:
Inclusion criteria:

* Patients 3 months to \<18 years of age at the time of informed consent
* Patients with AML after failure of the front-line intensive AML therapy
* Lansky score at screening \>=50 for patients from 3 months to \<12 years
* Karnofsky score at screening \>=50 for patients from 12 to \<18 years
* Use of highly effective methods of birth-control, if sexually active
* Parents/legal guardians and patients have given written informed consent and informed assent suitable for the respective age group

Exclusion criteria:

* Down syndrome
* Acute promyelocytic leukaemia and treatment-related AML
* QTc prolongation
* LVSF \<30%
* Cardiac disease and/or dysfunction
* Active uncontrolled infection
* HIV infection, acute or chronic hepatitis
* Inadequate lab parameters
* Impaired renal function
* Pregnancy or nursing
* Further exclusion criteria apply
Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells

The purpose of this study is to validate the ability to assess the genetic differences (DNA fingerprinting) on polar bodies (excess genetic material given off from the egg) and cells so that this technique may be used in the future to confirm markers of reproductive competence and improve the efficiency and safety of clinical human in vitro fertilization.

Our group has recently validated a technique involving whole genomic amplification followed by single nucleotide polymorphisms (SNP) analysis which allows DNA fingerprinting of single cells. Given that there are more than 3.3 billion base pairs that constitute the human genome, there are approximately 3 million sites where routine variation in the genetic code exists. These SNPs have been identified on average to occur approximately once every 1000 base pairs (bp) and are present on all chromosomes.

100 couples will undergo routine in vitro fertilization (IVF) stimulation, the protocol to be determined by the patient's primary doctor. Following oocyte retrieval and intracytoplasmic sperm injection (ICSI), the first polar body will be biopsied using standard laboratory procedures, and sent for genetic analysis. 24 hours later, the second polar body will be biopsied and sent for genetic analysis. Finally, the embryos will be biopsied prior to transfer and the cell will be sent for gentic analysis. Genetic results are not available prior to transfer and there are be no delays in the treatment schedule as a result of the study. Buccal swabs are collected from infants. SNP profiles are created from the polar body and embryo biopsies which are then compared to the SNP profiles created from the buccal swabs.

Eligibility Criteria:
Major Inclusion: The following are major inclusion criteria:

1. Maximum of one prior failed IVF treatment cycle
2. Female partner less than 43 years of age
3. Normal day 3 FSH level (\<12 mIU/mL)
4. Basal antral follicle count greater than or equal to 8
5. Ejaculated sperm specimen from the male partner with greater than 100,000 total motile
6. Donor sperm okay if patient is willing to purchase 3 extra vials for DNA testing

Exclusions: The following are exclusion criteria:

1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease
2. Diagnosis of endometrial insufficiency
3. Clinical indication for PGD
4. Testicular biopsy or aspiration procedures to obtain sperm
Evaluation and Development of Falls Prevention and Management in the Community for Older Adults

This study investigates how differently-framed messages can affect people's attitude towards falls risk and prevention in older adults. This study considers the potentiality of adult children acting as change agents in influencing parents in falls prevention.

A randomized controlled trial (RCT) will be conducted to test the effectiveness of two messaging types (positively vs negatively framed) via two target audiences (older vs younger adults).

The RCT evaluates the effectiveness of the differently-framed messages delivered to older and younger adults in affecting people's attitude toward falls risk and motivating them to learn about preventing falls. Also, the potential of adult children acting as change agents to positively influence parents in preventing falls is explored.

Older and younger adults who are eligible to participate in this study are randomly given one message. For older adults, the objective is to study which message is more effective in affecting their attitude towards falls risk and motivating them to learn about preventing falls. For younger adults, the aim is to understand which message is more effective in motivating them to learn about preventing falls for their parents.

Hypotheses:

H1: The negatively framed message is more effective than the positively framed counterpart in motivating older adults to find out about preventing falls. However, this effect decreases as the socioeconomic status decreases.

H2: The negatively framed message is more effective than the positively framed counterpart in motivating younger adults to find out about preventing falls.

Eligibility Criteria:
Inclusion Criteria:

* Singaporean or Permanent Residents (PRs)
* Read/speak English, Mandarin, or Malay
* Either age 60 years old and above, walk independently with or without assistive devices, have no self-reported/detected dementia or cognitive impairments or age between 30 and 59 years old and have either one of the parents age 60 years old and above who walk independently with or without assistive devices

Exclusion Criteria:

* Not Singaporean or PRs
* Do not read/speak English, Chinese, and Malay
* Age 29 years old and below
* Cannot walk independently with and without assistive devices
* Have self-reported/detected dementia or cognitive impairments
Does a Pre-operative Exercise Program Improve Post-operative Outcomes for Fusion Patients

A study found that in 1744 patients undergoing fusion surgery for adolescent Idiopathic scoliosis, 12% had back pain remaining after recovering from surgery. Rehabilitation prior to spine surgery or prehabilitation (prehab), has been shown to reduce costs and improve functional outcomes in patients who have had total hip or total knee arthroplasties. There is a lack of literature looking at prehab in the context of spine surgeries. The purpose of this study is to see if prehab can improve patient outcomes such as decreased pain, decreased length of stay in the hospital, and improved functional outcomes in patients undergoing fusion surgery for adolescent idiopathic scoliosis.

Adolescent idiopathic scoliosis (AIS) is the most common spinal deformity in adolescents and literature suggests that the link between back pain and AIS is underreported. Core stabilization exercises and scoliosis specific exercises have been shown to increase SRS scores related to pain (higher SRS scores indicate lower levels of pain). Additionally, higher SRS scores at pre-op were associated with a lower risk of residual postoperative pain following a fusion surgery. This suggests that preoperative exercise programs should lead to an increase in SRS pain scores post-operatively however, this direct relationship has not been researched. Rehabilitation exercises prior to surgery has been shown to improve functional outcomes in knee and hip arthroplasties however, the rehabilitation preoperatively has not been studies in the context of spine surgeries. The purpose of this study is to evaluate whether the prehabilitation exercise program can improve post-op outcomes including length of stay, decreased pain, decreased length of stay, and improved functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Included patients will have a diagnosis of AIS (ages 11-18). They will have a curve angle requiring surgery and be on the waitlist for surgery.

Exclusion Criteria:

* Patients will be excluded if they are currently enrolled in a physiotherapy designed exercise program prior to being enrolled in the study.
* They will be excluded if they have additional medical issues, limiting their ability to participate fully in the exercise program.
* Individuals with any cognitive disability that affects their ability to complete the questionnaires or follow instructions for the exercise program will also be excluded.
Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis

To evaluate the effect of peramanel for 48 weeks on progression of disease in subjects with ALS, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R)

Eligibility Criteria:
\[Eligibility Criteria for Interim Registration\]

* Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
* Patients who are male or female aged 40 years to 78 years at the time of obtaining informed consent
* Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
* The sum of the 3 respiratory items of the ALSFRS-R must total 12 points or more
* Patients within 2-year elapsed time period from disease onset at the time of obtaining informed consent
* Patients who can visit study site for out-patient treatment

\[Eligibility Criteria for Registration\]

Subjects who meet the following criteria in addition to the inclusion criteria for the interim registration

* The progression on score of ALSFRS-R during 12 weeks of observation period must be between -2 and -5
* Patients who has not initiated newly introduced riluzole therapy after starting the observation period. Or those who has not received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation
* Patients who has not initiated newly introduced edaravone therapy after starting the observation period
* Patients who are judged to be eligible for continuation of the study by the investigators

\[Exclusion Criteria\]

* Patients who underwent tracheostomy.
* Patients who experienced non-invasive positive pressure ventilation.
* Patients whose percent-predicted forced vital capacity (%FVC) is ≤80%.
* Patients with progressive bulbar palsy type.
* Patients with cognitive impairment, severe disease in the renal, cardiovascular, or hematological system.
* Patients with hepatic disease.
* Patients with malignant tumor.
* Pregnant women or women with a possibility of becoming pregnant.
* Patients who participated in another clinical study within 12 weeks before starting the observation period.
* Patients who has initiated perampanel therapy in the past or at present.
* Patients who are judged to be ineligible for study entry by the investigators.
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
* Willing and able to attend all study visits as required by the protocol.
* Willing to stop wearing habitual contact lenses for the duration of the study.
* Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* History of refractive surgery or planning to have refractive surgery during the study.
* Current or history of pathologically dry eye.
* Currently pregnant or lactating.
* Other protocol-specified exclusion criteria may apply.
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome

Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive assessment is frequently implemented during therapy and continued into survivorship to monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at 10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are comparable to or lower than patients without DS, however, these patients are at greater risk for treatment-related toxicities. Children with preexisting neurodevelopmental conditions, including DS, are systematically excluded from neurocognitive assessment on clinical trials, contributing to a gap in the investigators understanding of outcomes in these patients with preexisting neurocognitive vulnerability. The investigators propose a novel preliminary investigation of functional outcomes in children with DS and childhood leukemia. This study has implications for future treatment of leukemia patients with DS, and may generalize to leukemia patients with other predispositions or preexisting neurodevelopmental conditions (e.g., genetic disorders, acquired brain injury, autism, and epilepsy).

Primary Objective:

* To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down Syndrome using a novel assessment approach.

The investigators will recruit survivors of childhood leukemia with DS to participate in a one-time assessment of neurocognitive and psychosocial functioning. Potentially eligible families will be identified via medical record review at St. Jude Children's Research Hospital (SJCRH) and contacted to discuss study objectives, assess interest, and confirm eligibility. Eligible families will be scheduled for one study visit, estimated to last about 2.5 hours. Participants will provide informed consent prior to the start of any study procedures. Survivors who are ≥ 5 years old will complete performance-based neurocognitive measures. Caregivers (i.e., parents or legal guardians) of all participants, regardless of age, will complete ratings of executive function, behavior, and adaptive skills. Participants will be asked to identify and provide written permission to contact a secondary informant (e.g., teacher or work supervisor). Identified informants will be contacted by study team members and asked to complete behavior rating scales.

Eligibility Criteria:
Inclusion Criteria:

* Patient is an SJCRH patient with a diagnosis of leukemia.
* Diagnosis of Trisomy 21 DS as documented in the medical record
* Completed all cancer-directed therapy at SJCRH, since 1980, and at least 6 months prior to the study visit
* English as the primary language

Exclusion Criteria:

* Documented history of central nervous system (CNS) injury or disease that occurred after completing cancer-directed therapy
* History of or current substance use or abuse