cyrilzakka/clinical-trials huggingface dataset:
Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer

Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 39 to 69 years
* Patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy
* Patient with education level 3 "end of primary education"
* Patient with a good command of the French language
* Patient with access to the Internet from a computer at home
* Patient having signed the consent to participate in the study
* Patient with no pre-existing cognitive impairment at the time of cancer diagnosis
* Patient with a sleep complaint (ISI \> 7)

Exclusion Criteria:

* Patient with metastatic cancer
* Patient with a primary cancer other than breast cancer
* Patient with a history of neurological damage
* Patient with treated sleep apnea
* Patient with drug use or alcohol abuse (≥3 drinks/day on average and/or \>10 drinks/week)
* Patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics)
* Patient with a personality disorder and/or an evolving psychiatric pathology
* Patient with a contraindication to MRI (claustrophobia, metallic objects in the body)
* Patient with an uncorrected vision problem
Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly

Background: Accidental falls result in major physical and psychological morbidity in the elderly, especially stroke patients. To get optimal prevention of stroke falls, it is crucial to identify independent risk factors from multivariate analysis of related balance and gait parameters.

Aim: To evaluate the effects of balance and gait characteristics in determining whether or not accidental falls may happen. To investigate if the balance and gait parameters affect the time from lesion to when (and if) patients suffer from falls. To compare differences of balance and gait parameters in accidental fall patients between those with severe accidental injuries and those without severe injuries.

Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who have not had a previous stroke. They will be retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged. All subjects will be evaluated at 1 month and 6 months after stroke. These evaluations will include: mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer as well as range of motion of joints assessed by a biaxial electro-goniometry; functional independence measure; balance and gait pattern will be assessed by both clinical observation and objective laboratory examination (a dynamic posturography and computerized gait analysis system); falls and fall-related injuries during the proceeding year. Differences in baseline characteristics are tested by one-way ANOVA, Mann Whitney U or t tests, if appropriate. The investigators will identify the independent risk factors of accidental falls with logistic regression and use the log rank statistic of Kaplan-Meier survival curve to differentiate the risk of accidental falls or fall-related injuries in different groups.


Eligibility Criteria:
Inclusion Criteria:

* age\>65
* confirmed stroke by CT or MRI
* first-ever stroke
* with walking ability after stroke onset 1 month

Exclusion Criteria:

* fall history before stroke
* living in nursing home
* unstable physical sign
* seizure attack during study
* impaired cognition
High-Dose Cyclophosphamide for Steroid Refractory GVHD

RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy.

PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy.

OBJECTIVES:

* Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease (GVHD).
* Determine the efficacy of this regimen at 28 days post-treatment in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and filgrastim (G-CSF) subcutaneously once daily beginning on day 10 and continuing until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed weekly for 4 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II, that is steroid refractory

  * Steroid refractory GVHD is defined as GVHD that has progressed (increasing in grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR GVHD that has failed to improve (no change in grading stage) despite 4 days of treatment with methylprednisolone of ≥ 2.0 mg/kg
* Prior allogeneic hematopoietic stem cell transplantation using either bone marrow, peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required
* Evidence of myeloid engraftment
* No chronic GVHD

PATIENT CHARACTERISTICS:

* ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2 OR Karnofsky PS 60-100%
* ANC (absolute neutrophil count) \> 500/mm³
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Must be geographically accessible
* No allergy or intolerance to cyclophosphamide or mesna
* No HIV positivity
* No mechanical ventilation
* No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic cystitis
* No other uncontrolled illness including, but not limited to, the following:

  * Ongoing or active infection
  * Medical condition precluding patient from stopping azoles (e.g., fluconazole, itraconazole, or voriconazole) or other adequate antifungal therapy during cyclophosphamide administration
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Psychiatric illness/social situations that would preclude compliance

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Clinical Prediction Rule for Clinical Lumbar Instability

The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

Question: What clinical characteristics are associated with patients that respond positively to a program of core stabilization exercises?

Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be associated with a positive response to stabilization exercises.

Clinical identification of individuals with mechanical low back pain who would benefit from a program of stabilization exercises has been a struggle for the physical therapy profession. While changes in trunk muscle recruitment and motor control have been linked to patients with chronic low back pain and hypothesized to be adaptations for spinal instability, this has not been systematically established. However, a connection between spinal instability, poor trunk motor control, and low back pain is plausible. The real problem lies with the clinical identification of the subgroup of patients in either the acute or chronic phases of low back dysfunction who would most benefit from this approach to intervention.

In creating their preliminary clinical prediction rule, Hicks et al (2005), looked at many variables including patient demographics and characteristics, hip and trunk motion, special tests for instability, and functional measures of muscle performance. However, measures of the performance of core stabilizing muscles and assessment of trunk dynamic control/ coordination were not included as potential variables. The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

Eligibility Criteria:
Inclusion Criteria:

1. duration of the current episode of low back pain less than 3 months,
2. average pain intensity over past 3 days at least 4 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
3. no medical intervention for low back pain in last 6 months,
4. Oswestry score greater than 25%

Exclusion Criteria:

1. permanent structural spinal deformity (e.g., scoliosis)
2. history of spinal fracture or diagnosis of osteoporosis
3. diagnosis of inflammatory joint disease
4. signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
5. previous spinal surgery
6. frank neurological loss, i.e., weakness and sensory loss
7. history of neurologic disease that required hospitalization,
8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
9. leg length discrepancy of greater than 2.5 cm.
10. pregnancy
11. vestibular dysfunction
The Effect of Stress Ball on Recovery Quality and Hospital Discharge

This study aims to investigate the effect of stress ball application after transurethral resection of the prostate on patients' recovery quality and hospital discharge time.

The stress ball, one of the distraction methods, is an effective technique for ensuring cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. Squeezing a stress ball during a surgical procedure allows patients to have direct control over the object, enhancing their feelings of empowerment. In this way, it positively impacts anxiety and patient satisfaction without interfering with the surgical process. In the study by Yanes et al., the effects of the stress ball and hand-holding on pain, anxiety, and satisfaction were evaluated during skin cancer surgery performed under local anesthesia. Although anxiety was observed to decrease in all groups, no significant difference was found between the groups regarding pain and anxiety. It was noted that nearly all participants were very satisfied. The use of the stress ball appears to help reduce anxiety in anxious patients prior to the procedure. In a study conducted by Kasar et al. on hemodialysis patients, the effects of stress ball usage on stress, vital signs, and comfort levels were investigated. While the use of the stress ball did not affect vital signs and comfort, it demonstrated a positive impact on stress. In a study investigating the effects of distraction methods used during cystoscopy on pain, anxiety, and satisfaction, it was found that anxiety levels post-procedure were lower in the intervention groups (music, video, and stress ball) compared to the control group, while satisfaction levels were higher . Another randomized controlled study evaluated the effectiveness of three different non-pharmacological methods (coughing technique, spirometer blowing, and squeezing a stress ball) in reducing pain during intravenous catheterization. It was reported that the average pain levels in the coughing, spirometer, and stress ball groups were lower compared to the control group . In a study examining the effectiveness of distraction methods for pain and anxiety management during invasive venous surgical procedures, it was indicated that pain and anxiety levels were significantly lower in the interaction with nurses and stress ball group . In a study on managing dental anxiety with the application of a stress ball, no significant difference was found between the anxiety scores of patients who used the stress ball and those who did not. Similarly, in another study investigating the effects of distraction methods during lithotripsy, no significant difference was observed in pain and anxiety scores between the control and intervention groups (music and stress ball) .

Eligibility Criteria:
Inclusion Criteria:

Will be applied to patients who are over 18 years old. Have no hearing or vision problems. Can read and write, and can communicate effectively.

Exclusion Criteria:

Patients under 18 years of age. Patients with communication problems.
Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Histologically confirmed gastric mucosa-associated lymphoid tissue (MALT) lymphoma;
* Current infection with Helicobacter pylori (Hp): Diagnosis can be made if any of the following criteria are met: a) Positive result in at least one of the following: RUT (rapid urease test), histological staining, or bacterial culture of gastric mucosal tissue; b) Positive result in 13C or 14C-UBT (urea breath test); c) Positive result in HpSA detection. A positive result in serum Hp antibody test indicates past infection, and patients who have never been treated can be considered as having current infection.
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
* Lugano staging I-II1.
* Signed informed consent form.
* Evaluable lesions present.

Exclusion Criteria:

* Negative for Helicobacter pylori (HP);
* History of other tumors, except for cured cervical cancer or basal cell carcinoma of the skin;
* Patients with active HIV and syphilis infections;
* Pregnant or lactating women;
* Patients with severe active infections;
* Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
* Other comorbidities or conditions that may prevent patients from completing the clinical trial.
Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic radiation force impulse elastography in patients with chronic liver disease and healthy liver/kidney donors.

A recent new method for liver fibrosis assessment based on similar technology to transient elastography is acoustic radiation force impulse (ARFI) imaging. ARFI has the advantages which can be conducted in parallel ways of measuring points in the patients with chronic liver disease when they underwent routine ultrasound examination. Thus, the aim of this study was to identify the normal range of ARFI velocity and assess the best cut-off value by recruiting healthy living liver and kidney donors.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years
* chronic liver disease (hepatitis B, hepatitis C, liver cirrhosis) patients who are planned to liver biopsy
* Healthy liver and kidney donors
* The patients who is willing and able to provide written informed consent to participate in this study

Exclusion Criteria:

* Decompensated liver cirrhosis
* Patients with liver congestion due to heart dysfunction
* Patients who previously take antiviral agent and antifibrotic agent
* Healthy liver and kidney donors with any laboratory abnormalities regarding liver condition (Platelet count \< 150 x 103/ul, Fasting glucose \> 110 mg/dl, AST \> 40 IU/L, ALT\> 40 IU/L, Albumin \< 3.3 g/dl, Total bilirubin \> 1.2 mg/dl, GGT\> 54 IU/L, ALP \> 115 IU/L , Ferritin \> 322 ng/ml)
* A history of any other medical disease or condition that would make the patients unsuitable for this study
Contingency Management Treatment Duration

310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at community-based clinics will be randomly assigned to one of four conditions: (a) standard treatment as usual (ST) at the clinic without contingency management (CM); (b) standard treatment with contingency management for 12 weeks with a 0.5 probability of winning prizes for each negative sample submitted; (c) standard treatment with contingency management for 24 weeks with a 0.34 probability of winning prizes for each negative sample submitted; or (d) standard treatment with contingency management for 24 weeks with a 0.5 probability of winning prizes for each negative sample submitted. We expect that contingency management will decrease alcohol use to a greater extent than non-contingency management treatment, and that availability of contingency management for 24 weeks may result in longer term benefits than 12 week exposure to contingency management. This study will be the first to evaluate the effects of probability of winning prizes on response to contingency management.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* current DSM-IV diagnosis of alcohol abuse or dependence
* willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
* current DSM-IV diagnosis of opioid dependence
* in recovery from pathological gambling
Normothermia Versus Hypothermia for Valvular Surgery Patients

Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Isolated heart valve surgery
* Heart valve surgery plus CABG
* Age 20-80

Exclusion Criteria:

* urgent operation
* Left ventricle ejection fraction \< 35%
* Decompensated congestive heart failure
* Chronic renal failure (glomerular filtration rate \< 60 ml/min)
* Severe hepatic and pulmonary disease
* Bleeding diathesis or history of coagulopathy
* Planed deep hypothermic circulatory arrest
* History of acute myocardial infarction in the last 3 month
* Preoperative core temperature \>37oC
Acupuncture for Sleep Disruption in Cancer Survivors

The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. PSG data will be collected on the subsample of the population. Data will be gathered via pencil-and-paper measures before, during, immediately following, one month following the completion of treatment and six months after the conclusion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to and following treatment


Eligibility Criteria:
Inclusion Criteria:

* Females diagnosed with breast cancer who are not currently undergoing cancer treatment (hormonal treatment is permitted).
* The last cancer treatment ≥ 2 weeks prior to screening.
* ≥ 21 years of age.
* Able to understand written and spoken English.
* Have a habitual bedtime between 9:00 pm and 3:00 am and a habitual rise time between 4:00 am and 11 am.
* Meet DSM-IV criteria for insomnia (determined by the of the Duke Structured Interview of Sleep Disorders) with duration ≥ 1 month by Screening.
* Willingness to discontinue the use of any current sleep aides (prescription, OTC, or naturopathic agents).
* Properly executed Informed Consent.
* Karnofsky Performance Scale Index score ≥ to 70, (patients who score between 61-69 might be included per PI's evaluation).
* Insomnia Severity Index (ISI) \> 8 at Screening.
* Able to travel to Stanford University and vicinity for assessments and acupuncture treatments.

Exclusion Criteria:

* Unstable medical or psychiatric illness (eMINI, current or within the last 5 years).
* Exposure to acupuncture within 6 months prior to screening.
* Currently pregnant or nursing.
* History of substance abuse or meet criteria for current alcohol abuse or dependence.
* Center for Epidemiological Studies Depression Scale (CES-D) \>27 at Screening. Meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD) or STOP-BANG is ≥ to 3.
* Major surgery within 4 weeks prior to first acupuncture treatment.
A Study on the Intraject Instructions for Use

This study is designed to create an instruction set simple enough to be understood by migraine subjects as they were experiencing miagraine attacks.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Written Informed Consent