cyrilzakka/clinical-trials huggingface dataset:
Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Frailty is an age-related syndrome characterized with diminished physiological reserve that results in decreased homeostatic capacity and increased vulnerability to any stress from minor to major. Approximately 10% to 20% of adults aged 65 years and older present with frailty, and the incidence doubles among those of 85 years and older. Among elderly cancer patients especially those with digestive cancer, the prevalence of frailty and pre-frailty can be as high as 50%. Malnutrition often coexists with frailty, and indeed contribute to the development of frailty. As a matter of fact, the proportion of malnutrition also increases with age even in high-income countries.

Frailty is strongly associated with worsening outcomes in surgical patients, including higher delirium, high non-delirium complications, high perioperative mortality, as well as decreased activity of daily life, cognitive dysfunction and work disability in long-term survivors. Furthermore, malnutrition as a prominent factor in the development of frailty also has adverse impacts on the duration of hospitalization, complications, and survival after surgery. Therefore, it is urgently needed to understand how to enhance the recovery of these patients following surgery.

Exercises and rehabilitation, in combination with nutritional supplement, may reverse or mitigate frailty, promote postoperative recovery, and improve clinical outcomes. However, the reported effectiveness varies with interventions and are not sufficiently robust to guide good clinical practice. The purpose of this study is to investigate the effect of multimodal prehabilitation on early and long-term outcomes in elderly patients with frailty.

Eligibility Criteria:
Inclusion criteria:

1. Age ≥65 years but \<90 years;
2. Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract;
3. Clinical Frailty Scale ≥5;
4. Provide written informed consent.

Exclusion Criteria:

1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
2. Inability to communicate due to coma, profound dementia, or language barrier;
3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
5. Severe heart dysfunction (left ventricular ejection fraction \<30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher;
6. Other reasons that are considered unsuitable for study participation.
Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia

Fibromyalgia is a medical disorder characterized by chronic widespread pain, and a heightened and painful response to pressure. Fibromyalgia symptoms are not restricted to pain, leading to the use of the alternative term fibromyalgia syndrome for the condition. Other symptoms include functional gastrointestinal pain and discomfort.

The origin of these symptoms is not yet known, and a few hypotheses have been stated. One of the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic, low-grade, intestinal inflammation due to an increased intestinal permeability.

In this study, we hypothesise that the food supplement PERMEAPROTECT (that contains, amongst other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability and low-grade inflammation, thus improving gastrointestinal quality of life.

Patients diagnosed with fibromyalgia will enter the study and follow a run-in phase during which they will all be supplemented with prebiotics, probiotics and grape fruit seed extract for 5 weeks :

* Patients that do not present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will enter the randomised phase after 2 weeks +/- 1 week, at day D0.
* Patients that do present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will exit the study at that point, and follow their usual medical care.

Patients that enter the randomised phase will be supplemented with either PERMEAPROTECT or a PLACEBO, for 5 weeks +/- 1 week. Patients will then follow a 2 weeks +/- 1 week of wash-out, during which no supplementation will be made.

Measures of the outcomes will be made :

* at Day 0 (beginning of supplementation).
* at Day 35 (+/- 7) (end of supplementation).
* at Day 49 (+/- 7) (end of follow-up, end of study)

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 30 kg/m²
* Diagnosed fibromyalgia, according to the American College of Rheumatology criteria
* Functional bowel discomfort or pain
* Pre-menopausal woman with active contraception or post-menopausal woman

Exclusion Criteria:

* Allergy to one (or more) component(s) of verum or placebo.
* Disease or disease treatment that could interfere with the efficacy evaluation.
* Treatment with statin (or HMG-CoA reductase inhibitors) associated with adverse effect
* Treatment with Coumadin (or any other Vitamin K antagonists)
* Severe depression (Beck Depression Inventory score \> 16)
* Recent (during the previous month) change(s) in probiotic intake (including fermented milk, kefir, ...)
* History of major gastrointestinal surgery or inflammatory bowel disease
* Pregnant, breastfeeding or intention of pregnancy in the next three month
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes
* on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects

Exclusion Criteria:

* co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder
* history of seizure during the last 2 years, a tic disorder or Tourette's
* clinically significant ECG or laboratory abnormalities at screening or baseline
* taking clonidine or anticonvulsant drugs
* taking medications that affect blood pressure or heart rate
Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults

Valuation of the probability for a correct detection of paO2 \< 100 mmHg and paO2 \> 200 mmHg using the Oxygen Reserve Index

As mentioned above

Eligibility Criteria:
Inclusion Criteria:

* Indication of an elective surgery with invasive arterial blood pressure measurement in awake patients
* written informed consent

Exclusion Criteria:

* Emergency surgery
* Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation
* no written informed consent
The Use of Cannabis (Marijuana) and Cannabidiol (CBD) Among Cancer Patients: A Pilot Study

To collect information about how patients in the pain management clinic use cannabis/CBD, including how often it is used, why it is used (for example, to manage pain or other symptoms), and where patients get their information on cannabis/CBD for pain management

Objectives

Primary Objective:

The primary objective of this study is to investigate the prevalence of current and prior cannabis and/or CBD use in cancer patients who present to the pain management clinic at MDACC.

Secondary Objectives:

The secondary objective is to investigate the reason for cannabis/CBD use (e.g. pain, neuropsychiatric symptoms, recreational or other use), degree of symptom improvement with use, frequency of use, methods of use (e.g. inhaled vs. ingested), sources of information on cannabis/CBD, and patient interest in learning more from their physicians about cannabis/CBD for cancer pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Cancer patients who present to the MD Anderson Pain Medicine Clinic as a new patient or consult
3. Willing to give informed consent
4. Willing to complete the survey

Exclusion Criteria:

1. Refusal of informed consent
2. Refusal to complete the survey
3. Patients who previously completed the survey
4. Patients who opt-out or change their mind after agreeing to participate
5. Already an established patient at MDACC Pain Medicine Clinic
6. Patients scheduled to see Dr Abdi (PI).
Sleep Apnea in a Non-Clinical Population

To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).

BACKGROUND:

The study utilized an extremely rich source of data collected on the Wisconsin Sleep Cohort, one of the largest cohort studies of SDB and one with the longest periods of follow-up, to address a broad array of questions related to the pathogenesis and risk of SDB in the general community. The data-set was obtained between 1988 and 1998 in a population of 1400 workers age 30 to 60 years, including an overnight sleep polysomnographic in-lab study conducted on two occasions over an eight year period. The dataset contained a computerized analysis of over 300,000 apneas and hypopneas in this non-clinical population.

Although strong associations have been demonstrated between sleep disordered breathing and cardiovascular diseases, much is not known regarding the mechanisms by which SDB produces blood pressure changes and increases morbidity. Further analysis of the polysomnography and blood pressure data could yield important insights into the physiologic events responsible for cardiovascular morbidity. Such information could then be used to develop diagnostic tests that identify those people at highest risk and thus who might especially benefit from intervention. This would be of potentially great public health importance, given the prevalence of SDB and the availability of treatments for SDB.

DESIGN NARRATIVE:

The investigators used the computerized database of the Wisconsin Sleep Cohort to answer the following specific questions. What were the physiologic characteristics of SDB events in the non-clinical population in terms of severity, high airway resistance, obstructive and central components and associated after-effects on EEG arousal and ventilatory overshoots? Did these important elements of the SDB event change as SDB progressed over time? Did the ventilatory or cardiovascular consequences of apnea or hypopnea and its immediate aftermath determine the likelihood of subsequent sleep-disordered breathing events? 2. What were the immediate and long-term cardiovascular consequences of sleep-disordered breathing events; what characteristics of these SDB events (such as oxygen desaturation, arousal, ventilatory overshoot airway resistance, etc.) determined the cardiovascular responses and consequences? 3. What was the effect of aging on SDB and its sequelae as studied in the truly healthy elderly? 4. What role did anatomical characteristics of the upper airway play in determining the frequency and severity and type of sleep-disordered breathing? Did these anatomical determinants differ in the general non-clinical population versus the obstructive sleep apnea (OSA) population? ... in the obese versus the non-obese?

Organization responded that the study is non-FDAAA applicable and they do not accept transfer to their organization.

Eligibility Criteria:
No eligibility criteria
Evaluation of Levator Ani Muscle Injury in Primiparous

pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur . Transperineal ultrasonography study pelvic floor pathology with minimal discomfort to the patient and lower cost than magnetic resonance imaging.

355 eligible Egyptian women had been enrolled Maternal Medical, surgical and obstetrical history was obtained. Demographic data (maternal age, maternal body mass index, duration of second stage labor, episiotomy, maternal injuries, neonatal birth weight, and neonatal head circumference were obtained. A modified questionnaire on symptoms of pelvic floor dysfunction was filled by the patients in both visits. vaginal examination with the women to detect any pelvic organ prolapse (quantified according to POP-Q classification system.

All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GE Voluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3D/4D ultrasound transducer. After emptying the bladder, ultrasound was done while the patient in the supine position. The probe was covered with clean glove adjusted and wrapped with an adhesive tape to make it firmly contacted to the probe and then placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Two 3D volumes (one with the patient at rest and one during Valsalva maneuver) were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Primipara who had singleton fetus with cephalic presentation were recruited during their first post-partum visit ,1week post-delivery.

Exclusion Criteria:

Multi para, Multifetal pregnancy, congenital anomalies of the genital tract past history of pelvic floor surgery or trauma or inability to come for follow up after 6weeks
Fetal Clavicular Measurement to Predict Fetal Macrosomia

Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.

The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia.

Two terms are applied for fetal overgrowth, Large for gestational age (LGA) meaning fetal birth weight (BW) more than 90th percentile for specific gestational age while macrosomia is an absolute value regardless of gestational age which historically defined as 4000-4500 gm. Those two groups have increased risks for neonatal and maternal complications compared to general population and increase sharply when BW \>4500gm, the risks of macrosomia are continuum without threshold defining safe and risky outcome, some authors classify macrosomia into 3 grades, grade 1 (4000gm-4499gm), grade 2(4500-4999), grade 3 (≥5000gm).

Despite its implications, the accurate diagnosis is after birth and its prenatal prediction is poor although published formulas for estimating fetal weight shows correlation with BW, however the variability of the estimate is up to 20% with most of formulas, meta-analysis of 29 studies showed sensitivity of 56% and specificity of 92% in predicting BW ≥ 4000gm accuracy of ultrasound decreases with increasing BW, BW\>4500 accurate prediction is only 33-44 % of cases. Given the poor predictability of macrosomia, variety of other techniques and formulas are investigated, neither repeated US examination nor growth curves improves predictability, Youssef's formula measuring biacromial diameter (distance by between both acromial processes which joins clavicles at acromioclavicular joints) and macrosomic specific formula seems to be predictive. In study evaluating clavicle length for shoulder dystocia, it found that measuring clavicle was significant for macrosomia however the limitation is small sample size and its comparison with other fetal biometrics may be needed.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Gestational age between 37-42 weeks.
* Accepting to be included in the study.

Exclusion Criteria:

* Congenital fetal malformation affecting birth weight or affecting clavicle.
Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.

OBJECTIVES:

* Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo.
* Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral megestrol twice daily for 1 year.
* Arm II: Patients receive an oral placebo twice daily for 1 year. Quality of life is assessed at baseline and then monthly for 1 year.

PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of hepatocellular carcinoma (HCC)

  * Histologically confirmed OR
  * Meets 2 of the following criteria:

    * Radiological evidence of HCC on CT scan, MRI, or ultrasound
    * Serum alpha-fetoprotein level at least 400 µg/L
    * Positive lipiodol retention
* Not amenable to surgery

PATIENT CHARACTERISTICS:

Age:

* 20 to 100

Performance status:

* ECOG 0-3

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 5.8 mg/dL

Renal:

* Creatinine less than 1.7 mg/dL

Other:

* Not pregnant
* No clinical encephalopathy
* No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemoembolization for HCC
* No prior systemic chemotherapy for HCC

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
* No prior surgery for HCC

Other:

* No prior percutaneous injection for HCC
Impact of Cooking Process on Meat Protein Digestion and Metabolism

Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer.

This study aims to measure in vivo in humans the real digestibility of beef meat proteins depending 2 cooking processes, using ileal tubes and stable isotopes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI between 18 an 27
* Age between 18 and 45 years

Exclusion Criteria:

* Gastrointestinal or liver pathology
* Diabetes
* Pregnancy
* Vegetarian
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.

The study will be conducted in the following distinct parts:

Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing)

Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle).

Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles.

Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle).

Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)

Eligibility Criteria:
Inclusion Criteria:

* All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
* Eastern Cooperative Oncology Group status of 0 or 1
* Adequate baseline renal and hepatic function
* Central venous access
* Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance

Exclusion Criteria:

* Previous treatment for MDS or MPN for dose escalation cohorts
* Inadequate lung function
* Inadequate heart function
Corrective Calcaneal Kinesiology Tape in Adolescents With Pronated Foot

The aim of this study is to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of plantar fascia in adolescents with pronated feet.This study hypothesizes that there will be a statistically significant effect of a program of application of the corrective technique of kinesiotaping on plantar heel pain, foot function, and the sonographic picture of plantar fascia in a sample of Egyptian adolescents suffering from pronated feet.

This study will be conducted to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of the plantar fascia in adolescents with pronated feet. Thirty adolescents suffering from plantar heel pain associated with pronated feet will be included in this study. They will be distributed randomly into 2 groups: Group A will receive corrective kinesiotaping (50-75% stretch) for 6 weeks, 2 times per week with 1 day of rest; Group B will receive a home program of intrinsic foot strengthening and stretching exercises. Data will be collected pre- and post-intervention for all groups by using the visual analog scale (VAS), the first two subscales of the foot function index (FFI), and a sonographic picture of the foot for each adolescent. Participants will be recruited from outpatient clinics and schools.

Eligibility Criteria:
Inclusion Criteria:

* Children with unilateral or bilateral plantar fasciitis.
* pronated foot or foot on weightbearing in the navicular drops test.
* Pain and tenderness to palpation at the medial tubercle of the calcaneus for a minimum of 6 weeks and maximum of 6 months

Exclusion Criteria:

* Corticosteroid injection of the heel within the past 3 months.
* Posterior heel pain.
* Systemic inflammatory conditions.
* Diabetes.
* Surgery of the foot.
* Neuromuscular conditions e.g. CP.
* Individuals with BMI \> 25.
* Individuals engaged in regular athletic activities