cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.

OBJECTIVES:

* Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941.
* Determine the prognostic importance of p16/p15 abnormalities in these children.
* Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients.

OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15.

PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphocytic leukemia and treated on protocol CCG-1941
* Material cryopreserved in the CCG cell bank

PATIENT CHARACTERISTICS:

Age:

* Children

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* See Disease Characteristics
Effectiveness of VestAid App

This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.


Eligibility Criteria:
Inclusion:

* Snellen visual acuity (corrected) greater than 20/40
* No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz
* Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity
* At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale)
* Internet access at home
* No significant residual from past musculoskeletal or neuromuscular conditions
* Ability ambulates unassisted
* Diagnosed with a concussion or inner ear problem the last 30 days
* Between 18-60 years of age
* Can read and understand English
* Has complaints of dizziness

Exclusion criteria:

* Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem
* No access to internet at home
* Younger than 18 years of age or older than 60 years of age
* Cannot read or understand English
* No complaints of dizziness and/or balance deficits
* Have significant neuropathy
* Cannot see tablet clearly at 1 meter
* Neck pain \&gt;5 on a 10-point pain scale.
Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial

This is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. Shull using v-NOTES).

patients with pelvic organ prolapse with a stage greater than or equal to stage 2 for the apical compartment who are candidates for surgical correction will be randomized and assigned to one of two treatment groups. The aim is to compare the anatomical, surgical and anesthesiological outcomes between these two surgical techniques, both of which are commonly used in clinical practice for the correction of this type of prolapse.

Eligibility Criteria:
Inclusion Criteria:

* consecutive women referred to one of the participating centers with symptomatic stage 2 or greater (point C≥ -1 pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal) with or without anterior and posterior compartment prolapse will be eligible for inclusion (Criteria for which patients in clinical practice are candidates for one of the two interventions under study)

Exclusion Criteria:

* age \<18 years, BMI \> 30,
* previous hysterectomy,
* inability to comprehend questionnaires, to give informed consent and to return for review,
* unable to undergo general anesthesia,
* prior laparoscopic prolapse repair or vaginal mesh prolapse procedure,
* desire for future pregnancy or current pregnancy diagnosis
* severe respiratory comorbidity,
* ASA III patients,
* need for concomitant anti-incontinence procedure.
Morning Versus Bedtime Dosing of Antihypertensive Medication

Previous studies have shown that elevated nighttime blood pressure (BP) was more closely associated with cardiovascular mortality and morbidity than daytime and clinic BPs. With increasingly advanced technology, not only 24-hour ambulatory but also home BP monitors can be used to evaluate nighttime BP. The validation study of the Omron HEM 9601T showed that the wrist-type home BP monitor could be a suitable and reliable tool for the diagnosis and management of nocturnal hypertension. However, up to now, there is no data on home nighttime BP in Chinese patients and it is unclear if different dosing time would reduce ambulatory and home nighttime BPs differently.

The investigators therefore designed a multicenter randomized clinical trial to compare between morning dosing and bedtime dosing of antihypertensive medications in the difference in nighttime, daytime and the 24-h BP reductions evaluated by both ambulatory and home BP monitoring, and in target organ protections.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18-70 years old;
2. Never treated for hypertension or stopped using antihypertensive drugs for at least 2 weeks;
3. In the two screenings,the clinical systolic BP should be in the range of 140-159 mmHg, the diastolic BP \< 100 mmHg;
4. The average 24-hour systolic BP ≥130mmHg, daytime systolic BP ≥ 135 mmHg, and nighttime systolic BP ≥ 120 mmHg;
5. The average of bilateral brachial-ankle pulse wave velocity ≥14m/s;
6. Be willing to participate in the trial, sign the informed consent form, and be able to visit doctors by himself or herself.

Exclusion Criteria:

1. Secondary hypertension;
2. Concomitant obstructive sleep apnea (STOP-BANG score ≥ 5), insomnia, Parkinson's syndrome, or nocturnal polyuria and other diseases that affect nighttime BP;
3. Need to work at night;
4. Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings);
5. Concomitant diseases that need taking medications influencing BP;
6. Coronary heart disease, myocardial infarction or stroke within recent 6 months;
7. Atrial fibrillation or frequent arrhythmia;
8. Abnormal liver function exemplified as an increased alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) over the double of the upper limit of normal range; abnormal renal function exemplified as a serum creatinine ≥176 µmol/L; and plasma potassium ≥5.5 mmol/L or ≤3.5mmol/L;
9. Pregnant or lactating women;
10. Contraindications of angiotensin II receptor blocker or calcium channel blocker;
11. Other concomitant diseases which are considered not suitable to participate in the trial, such as thyroid diseases, acute infectious diseases, chronic mental diseases, tumor, etc.
Treatment of Huntington's Chorea With Amantadine

Huntington's disease is a chronic disorder passed on through genetic autosomal dominant inheritance. The condition usually begins between the ages of 30 and 50 years and it is characterized by involuntary movements in the face and extremities, (chorea), accompanied by changes in behavior and gradual loss of the mental function. The disease typically ends in a state of disorientation, impaired memory, judgement, and intellect (dementia).

The objective of this study is to test the effectiveness of the drug amantadine for the treatment of chorea associated with Huntington's disease. Amantadine is an antiviral drug that has been used to treat a variety of illnesses including Parkinson's disease. Amantadine works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking the normal activity of glutamate there. Glutamate is an amino acid released by brain cells and has been associated with the symptoms of Parkinson's disease.

The objective of this study is to evaluate the acute effects of the putative NMDA-receptor antagonist amantadine on chorea of patients with Huntington's disease (HD). Participants in this study will have mild to moderate HD associated with chorea.

Eligibility Criteria:
All patients will carry a diagnosis of Huntington's disease confirmed by DNA testing.

Patients will have mild to moderate disease with associated significant chorea.

Ability to comply with study requirements and to report on their condition by telephone.

Males and females between the ages of 18 and 82.

No patients with the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.

No patients with renal impairment (serum creatinine exceeding the upper limit of normal).

No patients with a history of intolerance to previous exposure to amantadine.

No patients with an MMSE of less than 18/30.

No patients receiving other anti-chorea therapies (such as Haldol). Those receiving other anti-chorea therapies must stop taking these medications for at least 4 weeks prior to the study to be eligible.

No pregnant women.

Patients must practice effective means of birth control.
Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients

This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.

This study compares two approaches in lightwand intubation techniques in cervical immobilized patients. One is a conventional approach that involves scooping movement with mandible protraction. The other is a face-to-face approach that inserts lightwand with a front-facing position. This study is conducted as a randomized, prospective, single-blinded design.

Eligibility Criteria:
Inclusion Criteria:

* adults with American Society of Anesthesiologists physical status 1-3
* patients who received scheduled spine surgery under general anesthesia

Exclusion Criteria:

* patients with body mass index \<18.5 kg/m2 or \>35.0 kg/m2,
* patients who previously had head and neck surgery,
* patients who are at high risk of aspiration,
* patients with pathologic conditions such as tumors, polyps, or inflammation in the airway,
* patients who cannot sit due to severe spine deformity,
* patients who have compromised cardiopulmonary function patients with clinically significant neurovascular disease
Impact of Active Choice on Advance Directive Completion Rates

The overall objective of this project is to assess if an active choice intervention can increase advance directive completion rates.

Nearly 70% of Americans express the desire to die at home, and most individuals want to avoid aggressive or futile care. Despite this, more than half of Americans die in a hospital. Advance directives provide the opportunity to provide, in advance, one's wishes for end of life care, however their completion rates are low. The overall objective of this project is to assess if an active choice intervention can increase AD completion rates. Eligible participants for this study will be all new employees of the University of Pennsylvania Health System (UPHS) who need to complete their online employment paperwork via the On Boarding portal. Participants will have an advanced health care planning task programmed as part of their On Boarding online employment paperwork. Upon selection of the task, each participant will be directed a designated Advance Healthcare Planning (AHCP) website. Participants will be randomized into either the active choice or control arm of the study and proceed through steps to complete or not complete an AD according to the decision making process of the given study arm. All participants in both groups will have access to additional online and telephone resources thought the entire study for any questions. Participants in the active choice group will be given directions stating they are required to complete either the advanced directive or the declination form in order to complete their On Boarding process. Participants in the control group will be given directions stating that completion of the AD is optional.

Eligibility Criteria:
Inclusion Criteria:

* New participants of the University of Pennsylvania Health System who have not yet completed their On Boarding process.
* 18 years of age or older
* Have proficiency in reading, writing, and speaking English

Exclusion Criteria:

* All new UPHS employees will be enrolled
PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups:

* PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet
* PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet
* Only 1200Kcal/day diet

The effect on appetite and weight loss will be investigated.

A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups:

* PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet
* PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet
* Only 1200Kcal/day diet

The effect on appetite and weight loss will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Moderately obese patients (BMI 30-39 kg/m2)

Exclusion Criteria:

* Endocrinological diseases causing obesity
* Heart pacemaker
* Previous bariatric procedure
Stepped-care Telehealth for Young Children With ASD

This proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic behavioral approach to teach object and gesture imitation to young children with ASD within a play-based context. The efficacy of RIT has been demonstrated through a small randomized control trial, several single-subject design studies, as well as in independent replications. Prior research also suggests that parents can be taught to effectively use RIT with their children in person, and two single-subject design studies detail the development and feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest Online RIT may serve as an ideal platform for examining the potential of individualized telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to compare a stepped-care format of Online RIT to a waitlist control condition to determine initial feasibility and effectiveness of this innovative intervention and service delivery model.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of ASD or significant concerns of ASD
* Parent reported imitation deficits

Exclusion Criteria:

* Children of parents who are non-English speaking
* Actively participating in other parent training programs
The Association Between Urinary Incontinence, Physical Performance, Physical Activity Levels in Women With Low Back Pain

The study is searching for the correlation between low back pain(LBP), physical performance, urinary incontinence and physical activity levels in women. Lower physical performance, more frequent urinary incontinence and less physical activity are expected in women who have LBP.


Eligibility Criteria:
Inclusion Criteria For Healthy Group:

* 30-65 years women
* Agreeing to involve in the study

Inclusion Criteria For Women With Low Back Pain Group:

* 30-65 years women
* Having low back pain for at least 3 months
* Scoring pain at least 1 in Visual Analog Scale(VAS)
* Agreeing to involve in the study

Exclusion Criteria:

* Any kind of surgery history in low back area
* Surgery history in lower limbs
* Acute low back pain
* Having a neurological disease
* Having sensory deficists
* The ones with rheumatological diseases which can cause low back pain
* Being pregnant
* Having a disc hernia pressuring to sacral nerves
Psychoneurological Symptom Cluster in Oncology

A psychoneurological symptom cluster is increasingly documented in oncology. It is composed of cancer-related fatigue, sleep difficulties, pain, emotional distress, and cognitive difficulties. These symptoms are linked by strong but complex relationships, and reinforce each other, negatively impacting patients' quality of life and survival. The configuration of this cluster (i.e., the relationships between the symptoms) seems different according to the cancer diagnosis or moment in the cancer journey. It has however been very little studied. Network analysis is an innovative method that allows a deeper understanding of the interactions between these symptoms. It also allows to compare patterns of clustering between distinct populations or measurement times. Finally, it allows to determine one core symptom in a cluster (i.e., the one with the strongest associations with the other symptoms), which could represent a target of choice for interventions aiming to improve the whole symptom cluster. This innovative project has then two main goals. First, the investigators will assess the evolution of the psychoneurological symptom cluster in two populations of patients with cancer: women with breast cancer, and patients with digestive cancer, over two years. Second, the investigators will test the feasibility and preliminary benefits of a new mind-body group intervention specifically designed to address the core symptom of the cluster, determined with network analysis in each population. As suggested by many authors, the proposed intervention will be based on the common-sense model of self-regulation developed by Leventhal and focus on cognitive-behavioral, self-care and mind-body (i.e., hypnosis) empowering strategies. The aim is to assess the satisfaction of the participants regarding the intervention, as well as its impact on the symptoms involved in the cluster.


Eligibility Criteria:
Inclusion critera for WP1:

* Diagnosis of non-metastatic breast cancer, or digestive cancer (i.e., anal, colorectal, gastric, esophageal, liver, pancreatic cancers).
* ≥ 18 years old.
* No history of cancer, and not currently in relapse.
* Having completed the active treatments (i.e., surgery, chemotherapy, radiotherapy) for 5 years maximum, based on the methodology and recommendations of studies on symptom clusters in oncology

Additional inclusion criteria for WP2:

* No history of severe psychiatric disorders (e.g., schizophrenia, dissociative episodes) or substance abuse (to avoid severe dissociation during hypnosis).
* Score ≥ 4 for the core symptom selected to design the intervention, as suggest by previous interventional studies, and measured on a visual analogue scale from 0 to 10.
Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach

In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques.


Eligibility Criteria:
Inclusion Criteria:

* Possibility to collaborate in the necessary evaluations.
* Follow-up in the specialized consultation of Movement Disorders at the Neurology Service of Hospital Sant Camil-Consorci Sanitari Alt Penedes i Garraf.
* Legal capacity to provide informed consent.
* Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.
* Participant with criteria from Group 1 or 2:

Group 1:

* Confirmed diagnosis of tremor due to Parkinson's disease, clinically established, based on the diagnostic criteria of the Movement Disorders Society, and additionally:
* Tremor associated with bradykinesia of any duration.
* Confirmatory clinical diagnosis of tremor due to Parkinson's disease (stages 1 to 2 of Hoehn and Yahr) by the neurologist responsible for the participant's follow-up.

Group 2:

* Confirmed diagnosis of essential tremor, based on the criteria of the Movement Disorders Society, and additionally:
* Positional tremor plus kinetic and/or resting tremor with follow-up in outpatient neurology consultations for at least 3 years without a change in diagnosis.
* Absence of bradykinesia.

Exclusion Criteria:

* Patients undergoing treatment with antipsychotics or antidepressants.
* Patients with Parkinson's disease and dyskinesias.
* Patients undergoing treatment with dopaminergic agonists or primidone.
* Tremor of such severity that it prevents continuous tracing, at the investigator's discretion.
* Cognitive or affective pathology that limits the ability to collaborate with the study procedures.
* Participation in another clinical study involving an intervention, procedure, or visit frequency that is incompatible with the present study.
* Participants diagnosed with any of the following conditions:

Alcoholism of sufficient intensity to influence handwriting or cause neuropathy, at the investigator's discretion. Peripheral neuropathy of any cause. Dystonias. Previous stroke.