cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.

Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

This is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. Patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. The prescription of the medicine is separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy.

There are no dose regimens or medical procedures defined within this study plan. Every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the Investigator in a routine clinical situation according to SmPC. The concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.

Eligibility Criteria:
Inclusion Criteria:

* Patients must comply with all of the following criteria in order to be enrolled into the study:

  * Histologically diagnosed advanced STS
  * Female or male aged 18 years or above
  * Signed written informed consent
  * Suitable to undergo treatment with trabectedin according to SmPC
  * Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents

Exclusion Criteria:

* Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.
Performance and Nutrition Program for Athletes in Adaptive Sports

Researchers are trying to evaluate and recommend sustainable and effective health and wellness programs for people with spinal cord injury (SCI) and other physical disabilities.


Eligibility Criteria:
Inclusion Criteria:

Group1 (Group with spinal cord injury):

* Participants with traumatic or non-traumatic spinal cord injury
* Able to perform progressive exercise program
* Willingness to participate in study

Group 2 (Able-bodied group):

* Functional upper extremity range of motion
* Able to perform progressive exercise program
* Willingness to participate in study

Group3 (Other physical disability group):

* Participants with a physical disability other than spinal cord injury
* Able to perform progressive exercise program
* Willingness to participate in study

Exclusion Criteria:

All groups:

• Any documented or reported health condition that would be contraindicated to a progressive exercise program
Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers

A biobank within the Swedish national heart failure quality registry SwedeHF.

The national heart failure quality registry SwedeHF started in 2003. It is the world's largest continuous HF registry enrolling clinician-judged HF (regardless of LVEF) at time of hospital or clinical visit. Eighty variables are entered into an electronic database managed by the Uppsala Clinical Research Center (UCR). There are \>140,000 registrations from \>110,000 unique patients from 70 hospitals in Sweden.

University hospitals in Sweden with access to central biobanking will collect a high-quality biobank linked to SwedeHF consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for HF patients. This will provide unique opportunities for future research within the national SwedeHF registry.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
3. Registered in SwedeHF

Exclusion Criteria:

1. Plasma donation within 1 month of enrolment or any blood donation/blood loss \>500 mL during the 3 months prior to enrolment
2. Previous allogeneic bone marrow transplant (genetics)
3. In the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
ARMS: The Arm Rest and Support Study

Primary Objectives

1. Determine the effect of an unsupported and poorly positioned arm on initial and average triplicate blood pressure done according to clinical practice guidelines with an automated device.

a. Hypothesis: Compared to blood pressure measurements obtained with the arm supported with mid-cuff positioned at heart level, blood pressures measured with an unsupported arm and/or with mid-cuff below heart level will be significantly higher.

Secondary Objective

1. To determine if the effects differ based on the following patient characteristics:

* Hypertensive blood pressure (SBP≥130 mmHg vs. \<130 mmHg).
* Age (≥ 60 years vs. \< 60 years) Greater vascular stiffness \> lesser vascular stiffness
* Regular health care (Last BP measured \>1 year ago vs. ≤1 year ago)
* Arm length:cuff width

The investigators propose a cross-sectional study of adult participants recruited from the community. Enrolled participants will have four sets of three automated blood pressure measurements, with each set taken with the arm positioned and supported as follows:

* Arm supported on a desk, with mid-cuff at mid-heart level (4th intercostal space)

  * Desk1
  * Reference measurement
* Arm supported on the participant's lap

  * Lap
* Arm hanging at the participant's side, unsupported

  * Side
* The last period of triplicate BP measurements will always have the arm supported and mid-cuff positioned at mid-heart level

  * Desk2

In the prior 3 periods, the arm position and support conditions are randomly ordered. Each participant will undergo a total of 12 systolic and 12 diastolic BP measurements

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, A-V shunts.
* Being mentally impaired
* Being pregnant
* Arm circumference exceeding 55 cm.
* \>80 years of age
Endovascular Function in Atrial Fibrillation (AF) Patients

1. recruit 50 patients with atrial fibrillation and 30 controls
2. endovascular function assessment with Peripheral Arterial Tonometry (PAT)
3. follow up the occurence of AF


Eligibility Criteria:
Inclusion Criteria:

* ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
* electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
* electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration \>1 year).

Exclusion Criteria:

* patients with cerebralvascular disease
* patients with coronary disease
* patients with peripheric artery disease
Treatment for the Mental Health Impact of Killing in War

The goal of this project is to test the feasibility, acceptability, and efficacy of a treatment module addressing the mental health and functional impact of killing in the war zone.

The investigators will enroll between 12-20 Veterans who have killed in war and have been diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the efficacy of the six-session treatment. Veterans will be randomized either to the treatment or to the waitlist control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD
* Veteran will need to endorse having taken another life in a war zone context
* Have received some prior evidence-based treatment for PTSD

Exclusion Criteria:

* Meet current or lifetime criteria for a psychotic disorder
* Participants in current PTSD treatment will not be excluded;however,if receiving medications they will need to be stabilized on current medications for at least one month.
* If receiving Prolonged Exposure Therapy or Cognitive Behavioral Therapy, individuals will need to wait two weeks after they have completed the treatment to enroll in the study.
Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults

To explore the effectiveness of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive home care and are at risk of sarcopenia.

The aim of this study is to investigate the effectiveness of consuming a whey-based protein ONS enriched with leucine and vitamin D, in conjunction with an online resistance-based exercise programme, versus the effectiveness of an online exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of sarcopenia and who require supportive home care.

The primary outcome will be functional and nutritional status measured using the Timed get Up and Go (TUG) test and the full form of the mini-nutritional assessment (MNA-FF). The secondary outcomes include feasibility of implementation, defined by recruitment, retention and adherence rates, measures of body composition, muscle strength and quality of life.

The groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an online exercise programme or (ii) an online exercise programme alone.

The exercise programme will be comprised of two sessions per week for 12-weeks and will be delivered using the UCD Zoom platform. The exercise programme will include strength movements that are intended to build muscle mass and improve physical function. The exercise programme will involve four phases split over the 12-week intervention: phase 1 (2 weeks), phase 2 (3 weeks), phase 3 (3 weeks) and phase 4 (4 weeks).

The ONS is a high protein, leucine and vitamin D enriched drink. Participants randomised to the ONS group will be asked to consume the drink twice a day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Older adults (70+ years)
* Requiring supportive homecare
* At risk of sarcopenia

Exclusion Criteria:

* Cognitive impairment
* Severe kidney disease (glomerular filtration rate \< 30 mL/min)
* Moderate to severe liver disease (Child-Pugh class B or C)
* Psychiatric disorder
* Receiving treatment or palliative care for cancer
* Receiving enteral or parenteral nutrition
* Hypersensitivity to any component of ONS
* Taking ONS
* Allergic to dairy products
* Regularly undertaking resistance (strength) training
* Advised by GP not to undertake physical activity
Exercise and Pelvic Floor Health Education Program Effectiveness

The aim of the study is investigation of the effectiveness of Pelvic Floor Health Education and exercise program in women with Urinary Incontinence. Women diagnosed with both stress and mixed type urinary incontinence were included the study. Pelvic Floor Health Education and exercise program were applied to women for 12 weeks.

3 group were created; the first group will applied Pelvic floor health education composed presentation about women health,urinary incontinence, teaching anatomy of the pelvic floor and bladder training ,second group will applied both pelvic floor health education and exercise of pelvic floor muscles for 12 weeks and third group will be control group.Women with urinary incontinence were included the study are continued 12 weeks . First evaluation is done before education and exercise program, and second evaluation in 6.week and last evaluation after 12 weeks exercise and education program.

Eligibility Criteria:
Inclusion Criteria:

1. The ages between 18-65 with urinary incontinence
2. Volunteer women who can regularly apply the Pelvic floor muscle exercise program

Exclusion Criteria:

1. Having pelvic organ prolapse (Stage≥2),
2. Women who are in the neonatal and postnatal period (up to 3 months after birth),
3. Situations that will prevent evaluation or communication (cognitive problems, etc.).
4. Having a neurological disorder,having urinary tract infection,
5. Those who received urinary incontinence treatment or had an operation, • Women who have received training on the pelvic floor before
A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity

Many metabolic complications of obesity are a consequence of abnormal responses of the liver, muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin, preventing metabolic complications.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30

Exclusion Criteria:

* Diabetes Requiring Medication
* Poorly Controlled Co-Morbidities
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

Adolescents and young adults with eating disorders undergoing refeeding on an inpatient unit often experience abdominal pain and anxiety either as a result of their medical condition or as an expected side effect of nutritional rehabilitation. The purpose of this study is to assess if VR (Virtual Reality) mindfulness therapy is more or as effective as the standard of care (supportive care such as aromatherapy, heat packs, distraction, and nausea bands) for treating and/or preventing anxiety and pain in patients with eating disorders during the re-nourishment process. The anticipated primary outcome will be reduction of abdominal pain and anxiety with utilization of this intervention.

In this study, investigators hope to 1) assess acceptance of VR mindfulness among inpatient adolescents and young adults with eating disorders 2) assess effects of VR mindfulness on perceived abdominal pain and 3) determine the impact of VR mindfulness on anxiety scores.

This study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical and nutritional therapies to treat their conditions.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the inpatient medical unit for refeeding for malnutrition

Exclusion Criteria:

* non-English speakers
A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Have no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration.
* Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs).
* Have current foot pain due to plantar fasciitis.

Key Exclusion Criteria:

* Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain.
* Has a clinically meaningful laboratory abnormality.
* Has a body mass index ≥35 kilograms per meter squared (kg/m\^2).
* Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium

The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.

Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.

Eligibility Criteria:
Inclusion Criteria:

* preschool children undergoing oral maxillofacial surgery

Exclusion Criteria:

* mental diseases
* history of neural system disease
* sedative medication history
* anticipated difficult airway
Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients

The goal of this clinical trial is to test the utility of patient navigation by comparing high intensity patient navigation to low intensity navigation approaches to improving cancer trial enrollment of patients treated in academic and community cancer centers. Patient navigation is a strategy for increasing patients access to cancer care by helping the participant overcome barriers in the participants communities and within the health care system by providing a bridge between the patient and the health care system. The primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in comparison to a low intensity patient navigation. Participants who agree to participate and are eligible will be randomly assigned to either the high intensity or low intensity approach.

This study is a pilot randomized two arm prospective study of a high versus low intensity patient navigation program with the primary endpoint of clinical trials enrollment rate between the 2 arms. The hypothesis of the study is that a high intensity patient navigation program will improve the enrollment rates on clinical trials. Candidates for this study will already have been identified by the patient navigator as being potentially eligible for a clinical trial. Randomization will be stratified by the type of site: community versus academic. There will be a single futility analysis after approximately 50% of the patients have been randomized and offered a clinical trial. Randomization and data capture will be via REDCap.

The primary endpoint of the study is the enrollment rate on clinical trials. With a sample size of 90 and conservatively assuming a clinical trial enrollment among clinical trial eligible patients of 50%, simulations show the investigators would be able to detect a 25% minimum difference (alternative 75% enrollment) in enrollment rates between the two groups with 84% power using a Z test of proportions with a one-sided alpha level of 0.10.

Eligibility Criteria:
1. Age ≥ 18 years
2. Patient with a current diagnosis of a primary solid tumor including: prostate cancer and kidney cancer
3. Being seen at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins University (JHU) or Wellspan Health Center
4. Available therapeutic trial for the patient as determined through pre-screening/medical record review
Early Postoperative Home Exercise Program After Cervical Spine Surgery

The overall objective of this two-group randomized controlled trial is to gather preliminary evidence on the efficacy and safety of early postoperative exercise for improving disability, pain, and general physical health in patients after anterior cervical discectomy and fusion (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed within the first six weeks after surgery will decrease disability and pain and improve general health, through increases in physical activity and self-efficacy and reductions in fear of movement. The results of our randomized trial will advance research on postoperative management for patients with cervical spine surgery and provide evidence in line with a value-based healthcare approach for optimizing outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Surgical treatment of a cervical degenerative condition (cervical stenosis, spondylosis, degenerative spondylolisthesis, disc herniation) using anterior cervical discectomy and fusion procedure;
2. English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
3. Age older than 21 years (younger individuals do not typically have a cervical degenerative condition)

Exclusion Criteria:

1. Patients having surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
2. Patients undergoing cervical corpectomy;
3. Diagnosis or presence of severe psychiatric disorder such as schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder;
4. Documented history of alcohol and/or drug abuse;
5. Patients having surgery under a workman's compensation claim; and
6. Unable to provide a stable telephone or physical address
Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.

A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.

Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.

Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.

Eligibility Criteria:
Inclusion Criteria:

- 1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).

2. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year.

Exclusion Criteria:

- Non-PCO patients as:

* Congenital adrenal hyperplasia
* Hyperprolactinemia.
* Recurrent implantation failure.
* Hydrosalpinx.
* Uterine pathology.
* Uncontrolled medical disorder eg DM, HTN
* Male factor infertility.
Can Mimic Emotional Expression Training Help Improve Emotion Processing

The main aim of the present study is to investigate whether mimicking emotional expressions training via FaceReader software can improve emotional processing and recognition in healthy subjects, especially individuals with hityer autistic traits.

Some mood and trait questionnaires such as Autism Spectrum Quotient, Social Responsiveness Scale,State-Trait Anxiety Inventory,Beck's Depression Inventory etc are asked to complete. 90 healthy male subjects will receive 16 times (4 times a week , 4 weeks) of mimicking emotional expressions training via Facereader. During training, 3 times of fNIRS (t2,t9 and t16) were recorded simultaneously. fMRI scanning, including emotion processing and emotion recognition tasks, 7 minutes resting data, ans DTI data will be collected before and after the training. After fMRI scaning, behavioral ratings (i.e. intensity and valence) and eye-tracking data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant, menstruating, taking oral contraceptives;
* medical or psychiatric illness.