cyrilzakka/clinical-trials huggingface dataset:
Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

This pilot study will examine the impact of pre-operative Medical Reiki© on the psychosocial well-being and recovery of underserved women undergoing breast cancer surgery.

Reiki is a form of energy therapy involving the facilitation of healing through the manipulation of biofields utilizing light touch. Practitioners lightly place their hands directly on or above the patient's body to transmit energy from the practitioner to the recipient. This process of targeting the energy fields around the patient's body is believed to stimulate the patient's natural ability to heal itself. Reiki is a safe treatment modality that emphasizes spirituality in healing and wellness whose origins are rooted in ancient Tibetan traditions. The prevalence of integrating complementary therapies such as Reiki into mainstream medical practices is demonstrated by the number of hospitals that make use of these therapies to help alleviate, for example, the fatigue, pain, anxiety, and diminished quality of life experienced by cancer patients and those with other illnesses. Reiki in particular, has become more widespread in cancer centers because of its potential to reduce cancer-related symptoms and enhanced wellness without posing harm to patients.

A pilot double-blind randomized-controlled design will be used to engage 32 women in a pre-operative Reiki intervention designed by Raven Keyes called Medical Reiki© with a follow-up of two months. Women diagnosed with stage I-III breast cancer undergoing mastectomy for their treatment will be recruited to study within two weeks of surgery. Patients will be recruited to receive Medical Reiki© vs Sham Reiki (attention control) before surgery, with medical and psychosocial outcomes assessment conducted at three time points: -T0 - Baseline/pre-surgery; T1 (1-month); T2 (2 months). These assessments will either be self-administered or administered via telephone by the research team. The study The study will aim to determine the feasibility of offering Medical Reiki to breast cancer patients immediately prior to breast surgery; the impact of pre-operative Medical Reiki© vs Sham Reiki on post-operative recovery at the identified timepoints based on the specified measures of Subjective QoL metrics and objective recovery metrics.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-99
* Breast Cancer Diagnosis Stage 0-III
* Undergoing unilateral or bilateral mastectomy (with or without reconstruction) within 2 weeks of recruitment
* English Speaking
* From within 50 miles of Bronx County, NY

Exclusion Criteria:

* Current, uncontrolled psychiatric co-morbidities
* Pregnant women
Quality of Life in Colorectal Cancer Survivors

BACKGROUND:

Colorectal cancer (CRC) and its treatment affect CRC survivors' quality of life (QoL), emotional distress and activities of daily living (ADL). It is assumed that occupational therapy interventions based on cancer education may be a feasible approach.

Aim To examine the effect of using cancer education based on healthy lifestyle by occupational therapist on QoL, emotional distress, ADL and healthy lifestyle behaviors in CRC survivors.

Methods Participants with CRC were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. These participants were randomly assigned to either an OT intervention or a non-intervention group (in a 1:1 ratio). Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation and on 1-month, 3-month follow-up clinic; the non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation. The primary outcome was the change in QoL measured using WHOOQOL-BREF. Secondary outcomes were changes in emotional distress, ADL and healthy lifestyle behaviors. Outcomes were examined in baseline (discharge preparation), 1-month and 3-months follow-up clinic.


Eligibility Criteria:
Inclusion Criteria:

* (1) had a new diagnosis of CRC and were suffering from cancer for the first time, (2) had undergone CRC hospitalization (surgical) treatments, (3) were able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

* Participants re-admitted within three months after discharge were excluded.
Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)

The purpose of the study is to compare the short- and long-term effectiveness of an individualized, resource-oriented joint protection intervention with the standard, problem-oriented joint protection intervention for patients with rheumatoid arthritis.

Joint Protection (JP)is an important intervention in the management of people with arthritis. Altering working methods (e.g. use of proximal joints, dynamic activities), energy conservation (balance between activity and rest) and using assistive devices should place less strain on joint structures weakened by the disease process. These strategies ought to decrease pain and stress on joints, improve function, and facilitate maintaining social roles.

The effectiveness of JP has been evaluated in a number of studies, all in a group setting. JP has beneficial short-term effects on pain and function in patients with established RA and moderate functional problems. Using assistive devices reduces pain during task performance in comparison to normal methods and altering working methods significantly reduces difficulties in activities of daily living (ADL). However this generally does not result in significant behavioral changes and a long-term impact on reducing pain and maintaining function may only be reached if JP is taught using behavioral education methods. Additionally, adherence of RA patients to different interventions is generally modest, which may well determine the effectiveness of any given intervention, especially in the long-term.

All previous studies were carried out in group settings, however, in Switzerland, standard JP education is provided on a one-to-one basis and an individualized education is assumed to be a promising approach.

This clinical trial aims to test the hypothesis that an individualized, resource-oriented JP education in RA patients leads to a better therapy success in the short and long-term, compared to problem-oriented standard JP education in terms of joint protection behavior. Secondary outcome parameters are self-perception, general and specific self-efficacy and general and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA according to ACR Guidelines (1988)
* Actual hand pain on activity or history of wrist and/or metacarpophalangeal(MCP) joint pain and inflammation
* Referred to OT for a Joint Protection intervention program
* Willingness to comply with the randomly assigned treatment and informed consent
* Functional Class: 2 to 4
* German speaking/understanding/reading
* Sufficient cognitive capacities to understand the aims and procedures of the proposed study and the requirements of participation

Exclusion Criteria:

* Functional class 1 (anticipated self-exclusion, as patients in class 1 will not be referred to JP).
* Severe finger, hand, elbow or shoulder deformities
* Insufficient ability to understand, speak and read the German language
* Insufficient cognitive capacities to understand the aims and procedures of the proposed study and the requirements of participation.
Smartphone Application for University Students With Binge Drinking Behavior

Alcohol use is a causal factor in more than 200 diseases and injury conditions (see ICD-10) and in France, alcohol is the first cause of hospitalization. Binge drinking (BD) has emerged as a major public health issue among student populations and is associated with negative consequences and social, cognitive and brain alterations. More than half of French university students have reported BD in the past month and are at increased risk of several alcohol-related consequences such as memory and sleep impairments, and reduced quality of life. BD is also a major risk factor in the development of alcohol addiction, with individual and environmental factors playing a role that is still poorly understood. Moreover, most students and young adults are reluctant to seek interventions when it is provided by health care professionals (only 4-5%) and have poor insight with regard to their alcohol use patterns / habits. Thus, there is an urgent need for developing effective prevention and intervention programs to reduce alcohol drinking in students. Recent studies have demonstrated that new types of technology-delivered interventions are promising tools for addressing unhealthy alcohol use. For example, an uncontrolled trial pilot study using a smartphone application-delivered intervention produced a reduction in both number of drinks per week and BD from baseline to 3-month follow-up. A recent review also showed significant outcomes of a mobile health intervention for self-control of unhealthy alcohol use. The investigators hypothesize that a timeline follow-back and personalized feedback based on the use of a mobile application can reduce excessive alcohol intake at 3-months. This study will provide scientific knowledge about BD in students, but also regarding a new type of intervention that could be effective for prevention in non-treatment seeking individuals and reducing the severity of health problems associated with excessive alcohol intake.


Eligibility Criteria:
Inclusion Criteria:

* Students between 18 and 25 years old
* AUQ score greater than or equal to 24, and AUDIT score greater than or equal to 3 for its first 3 items. Drinking details with the DDQ when necessary.
* BD behavior: at least one occasion with 6 or more drinks in the last 3 months.
* Consent to be included in the study
* Affiliated to social security

Exclusion Criteria:

* Not having a smartphone with an Apple or Android system.
* Previous use of the MyDéfi smartphone application
* Declaration of a psychiatric / neurologic condition
* Pregnant, parturient or breastfeeding woman
* Subject under guardianship, curators or restricted under public law
Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

Suicide cognitions are conceptualized as enduring, chronic vulnerability factors that predispose individuals to suicidal crises. Therefore, modification of these beliefs may reduce suicidal thoughts and behaviors. The goal of this research is to develop, refine, and pilot-test a mobile intervention to reduce cognitions that contribute to elevated suicide risk and to assess the impact of reductions in suicide cognitions and anger cognitions on suicide risk and functioning.

Suicide cognitions are conceptualized as enduring, chronic vulnerability factors that predispose individuals to suicidal crises. Therefore, modification of these beliefs may reduce suicidal thoughts and behaviors. In addition to suicide cognitions, another potentially modifiable risk factor for suicide is anger. The goal of this research is to develop, refine, and pilot-test a mobile interpretation bias modification intervention to reduce cognitions that contribute to elevated suicide risk and to assess the impact of reductions in suicide cognitions and hostile interpretation bias (a cognitive bias that is associated with anger) on suicide risk and functioning.

Eligibility Criteria:
Inclusion Criteria:

* Veterans 18 years or older
* Diagnosed with PTSD, established via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
* Report a score of 12 on the 5-item Dimensions of Anger Reactions Scale
* Can read at least 6th grade level material
* Report a score of 1-3 (indicating ideation without intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Have attended a mental health appointment within the past month, with another scheduled in the following month (i.e., be engaged in treatment with a mental health provider)

Exclusion Criteria:

* Diagnosed with bipolar or psychotic disorder.
* Current substance use disorder.
* Current imminent suicide risk or homicidal ideation requiring immediate intervention.
Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke

Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Functional ambulation category score 3
* 3 months ≤ Onset ≤ 12 months
* Korean Mini-Mental State Examination score \> 24

Exclusion Criteria:

* History of surgery of affected lower limb
* Fracture of affected lower limb
Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

Infantile Spasms (IS) are classically refractory to the usual antiepileptic drugs and often pose a therapeutic challenge. Since, there is associated significant morbidity, much effort has been directed over the past years to evaluate the role of various anticonvulsants in the management of IS. High dose oral prednisolone has been shown to cause early cessation of spasms and resolution of hypsarrythmia on Electroencephalogram. Recently, role of intravenous methylprednislone pulse therapy has been explored as one of the therapeutic modality in IS, in order to avoid the development of side-effects associated with prolonged oral steroid therapy and maintain long-term efficacy.However, there are no studies comparing iv methylprednisolone pulse therapy with high dose oral prednisolone..

Multiple studies have subsequently used higher dose of prednisolone in infantile spasms at the weight based dosing of 4-8 mg/kg/day with a maximum dose of 60mg/day. The results have shown high rates of clinical and elecroencephalographic remission with lower relapse rates.However, a major concern related to corticosteroids, especially in infants and children, is the possible development of side effects. The most frequent ones are excessive weight gain, hyperphagia, water retention with edema, cushingoid appearance, hypertension, behavioral disturbances, increased infection susceptibility, leukopenia, electrolyte disturbances, hyperglycemia, glycosuria, impaired glucose tolerance, frank diabetes and sleep disorders. Furthermore, long-term side effects such as hypothalamus-pituitary axis suppression, psychosis, osteoporosis, nephrocalcinosis, brain atrophy, cataracts and, in children, growth retardation, have also been reported.

Recently, role of intravenous methylprednislone pulse therapy has been explored as one of the therapeutic modality in IS, in order to avoid the development of side-effects associated with prolonged oral steroid therapy and maintain long-term efficacy. There have been few studies on use of iv pulse methylprednisolone in IS with small sample size, showing to a rapid improvement in EEG \& cessation of spasm in majority of the infants without significant adverse effects.

Emerging evidence suggests that intravenous pulse methylprednisolone might have superior efficacy and better safety profile when compared to high dose oral prednisolone in treatment of IS.

Hence, present study aims at comparing intravenous pulse methylprednisolone versus oral prednisolone in an open label, RCT for treatment of children with IS.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed patients aged 4 - 30 months with epileptic spasms in clusters with electroencephalographic evidence of hypsarrhythmia or its variants with or without developmental delay -

Exclusion Criteria:

1. Children with recognized progressive neurological illness will be excluded.
2. Children with chronic renal, pulmonary, cardiac or hepatic dysfunction
3. Severe malnutrition (weight for length and height for less than 3 SD for mean as per WHO growth charts)

   -
Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients

To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 30 to 80 years of age, inclusive.
* Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society Brain Bank criteria.
* Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.
* Dyskinesia of at least moderate severity as per MDS-UPDRS
* Amantadine and Monoamine Oxidase (MAO) inhibitors must be discontinued at least three weeks prior to randomization.
* Subjects currently receiving anti-parkinsonian medications, including all Levodopa preparations are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization.
* Concomitant use of antidepressants such as selective serotonin reuptake inhibitors are allowed, provided the dose has been stable for at least 1 month prior to randomization.

Exclusion Criteria:

* Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain Stimulation must not have been performed within one year of screening)
* Hoehn and Yahr score of 5 when "off".
* Subject with Cognitive impairment and/or history of psychiatric manifestations or active hallucinations.
* Subjects with any history of complete heart block, QTc prolongation, or torsades de pointes.
* Subjects with any family history of congenital QT interval prolongation syndrome.
* Subjects with history of postural syncope, or any history of unexplained syncope within the last 12 months.
* Subjects with a history of substance and/or alcohol abuse within the past 2 years.
Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Smoking at least 10 cigarettes/day for at least 1 year (confirmed by CO \> 8 ppm or NicAlert test of 6)
* Engaging in relighting for at least half of their CPD
* No smoking quit attempts in the past month nor intentions to quit in the next month
* Stable medical or psychiatric conditions with systolic blood pressure \< 160, diastolic blood pressure \< 100 and heart rate \< 105 bpm

Exclusion Criteria:

* Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month
* Currently trying or planning to quit smoking in the next month
* Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test.
Investigation of Urinary Biomarkers for the Detection of Prostate Cancer

The aim of this study is to investigate and possibly validate urinary biomarkers for prostate cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well.

This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with prostate cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.


Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Being able to understand and read Dutch
* For cancer patients: being diagnosed with prostate cancer
* For healthy volunteers: being male

Exclusion Criteria:

* For cancer patients: suffering from a blood cancer
* For healthy volunteers: diagnosed with cancer
Self-management Behaviors and Resilience Among Chronic Obstructive Pulmonary Disease Patients

This study conducted an assessment of the influencing factors and correlations that affect self-management behaviors and resilience in the COPD population.

A total of 100 participants with COPD from a medical center in Northern Taiwan were recruited from February 2020 to January 2021 in this cross-sectional study. Each subject completed self-reported questionnaires through face-to-face interviews, including 20-item COPD Self-Management Scale (CSMS-20) and a 25-item Connor-Davidson Resilience Scale (CD-RISC-25). A multiple linear regression model was used to examine the relationship between the levels of self-management behavior and resilience, controlling for sociodemographic and clinical factors.

Eligibility Criteria:
Inclusion Criteria:

The recruited participants have been diagnosed with COPD for at least a month by thoracic physicians based on the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Exclusion Criteria:

Participants who were diagnosed with serious mental disorders, cancer, terminal illness, or end-stage diseases were excluded from this study.