cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effectiveness of Different Home Exercise Programs

Aging is defined as a functional change in the organism which is not reversible with time progression. With this change in the organism, physical and cognitive functions are decreasing, and the potential of the individual to establish a balance between the systems decreased. For this reason, the aim of this is to investigate the effects of different home exercise programs on cognitive function, balance and daily living activities in healthy individuals.

40 healthy individuals between the ages of 60-80 who agreed to participate in the study will be included in the study. Participants will be divided into 2 groups randomly. Both groups will be given balance exercises with aerobic exercise. The second group will be given second additional cognitive task besides doing usual exercises that the first group is performing. Exercises will be given in the form of a home exercise program and the treatment will last for 6 weeks. The continuity of the exercises will be controlled by telerehabilitation method. The participants will be evaluated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 60 and 80
* Mini Mental Status Test score to be over 24

Exclusion Criteria:

* Cardiovascular disease
* Cardiovascular surgery operation, pacemaker etc.
Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study

The purpose of this 12-week, exploratory pilot clinical trial is to continuously and remotely assess a triad of bothersome multiple sclerosis (MS) symptoms (BAM: bladder, ambulation, mood) and test the benefit of proactively treating these symptoms according to an evidence-based, multi-disciplinary, personalized protocol.

MS is a chronic, debilitating disease of the central nervous system affecting approximately 2 million people worldwide and more than 400,000 individuals in the US. MS is the most common cause of non-traumatic neurological disability in young adults. Symptoms typically first afflict individuals during the prime of their professional and reproductive lives, between the ages of 20 and 40. Many affected individuals are unemployed, physically disabled, and at high risk for social isolation. While disease-modifying therapies (DMTs) can significantly reduce accumulation of disability in MS, patients still experience symptoms across a range of functional domains. Symptoms can include problems with bladder, walking, and mood (depression and anxiety). Often, these symptoms are only partially evaluated during routine MS clinic visits, and the long interval between clinic visits can result in them not being optimally managed.

The goal of the current study is to pilot a system of proactively monitoring a combination of symptoms (bladder, ambulation and mood) using an activity monitor and a smartphone.

Adult patients with MS who are experiencing symptoms in at least 2 of the 3 domains (bladder, ambulation, mood) will be enrolled. Visits will be at baseline (can be same day as routine visit to the MS clinic), and 3 months. Short surveys (\<3 minutes to complete) will occur weekly, and longer surveys will occur at baseline, 6 weeks and 3 months. FitBit activity monitors will be worn for the entire 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Any individual above the age of 18 with a confirmed diagnosis of MS
* Access to a smartphone
* Access to Wi-Fi at home
* Able to walk (including with a cane or walker)
* Willing to fill out surveys at multiple time points

Exclusion Criteria:

* Clinician's assessment of cognitive, dexterity, or visual impairment limiting ability to use a smartphone and subsequent technologies required by the study
* Inability to walk
Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. The investigators purpose was to further evaluate the efficacy and the feasibility of POEM for patients with achalasia in a prospective larger study.

1. Patients were eligible for enrollment in the study if they had an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of \> 7 cm).
2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Eligibility Criteria:
Inclusion Criteria:

* with an Eckardt symptom score ≥ 4
* The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
* Informed patient consent was obtained

Exclusion Criteria:

* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
* Pseudoachalasia
* megaesophagus (diameter of \> 7 cm)
Tight Glycemic Control With Intensive Insulin Therapy in PICU

In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.

Study type: Interventional study

Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study

Eligibility Criteria:
Inclusion Criteria:

* Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours

Exclusion Criteria:

* Expected stay \< 24 hours
* Therapy restriction upon admission
* No informed consent
* Other study enrollment
Topical Morphine for Analgesia in Patients With Skin Grafts

The management of pain endured by patients after skin grafting is complex. Pain is the single most distressing symptom but as it is difficult to manage, it is often under-treated. These patients may experience pain from two types of wound: the original injury and from "skin-donor" sites, areas of healthy skin from which skin is surgically removed and used to cover the original injury. As the section of skin which is removed is standardized, the wound created at the donor site is uniform and so provides a model of an acute wound.

Opioids (such as morphine) are the backbone of treating the moderate to severe pain experienced by any patient. But due to their potentially severe side effects and that some patients do not experience sufficient relief from the treatment, optimal treatment schedules are still being sought after.

Topically applied morphine has provided effective and safe analgesia in several clinical models. We, therefore, wish to apply this treatment modality onto skin-graft donor wounds. If found to be effective this could be an appealing non-invasive method to treat the pain of this type of wound.

Administration of morphine into the knee joint is the best-studied clinical procedure documenting the use of topically-applied opioids. When 1-5 mg morphine were injected into the knee joint, patients experienced pain relief for up to 24 hours, whereas similar doses given systemically (i.e. intravenously) were effective for 2-4 hours. Furthermore, the analgesic effect was reversed when the opioid antagonist naloxone was injected into the knee joint. Both these findings indicate that the effect is mediated by local opioid receptors in the knee joint.

Peripheral analgesic effects of opioids are not detectable in normal tissue but appear minutes to hours after initiation of inflammation. This suggests that opioid receptors are already present in the peripheral nerve terminals but under normal conditions they are not functional.

Research on application of opioids to skin wounds is very sparse and has primarily been performed in palliative care patients. These reports demonstrate that topical opioid gel (morphine or diamorphine) provided rapid and effective relief. In some patients pain subsided within 20 minutes after application with a long-lasting (7-8 hours) effect. Fundamental aspects regarding topical application of opioids onto skin wounds are still lacking. For example, issues such as optimal dose and dose-effect relationships have not been investigated. We hope to determine these in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing skin-grafting
* American Society of Anesthesiologists (ASA) classification I-II
* Written consent
* Either sex
* Able to self-asses and report their pain level

Exclusion Criteria:

* Alcohol abuse or addiction - current
* Opioids and benzodiazepines abuse - life time
* Known hypersensitivity to morphine
* Major renal or hepatic dysfunction
* Pregnancy or lactation
* Sleep-apnoea-syndrome
* Diabetes
* Participation in other clinical studies
Mat Pilates and Vascular Function in Obese Females

Obesity is associated with progressive decreases in arterial health and function. It is crucial to prevent or reduce the negative effects of aging on the vasculature by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a Mat Pilates training (MPT) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx) and endothelial function in obese premenopausal women with elevated BP.

Using a parallel experimental design, participants were randomly assigned to either MPT (n=14) or non-exercising control group (n=14) for 12 weeks. Participant in the MPT group trained 3 days/week . Participants' brachial to ankle PWV (baPWV), systolic and diastolic BP, AIx, plasma NO levels were measured at baseline and after 20 weeks of their assigned intervention.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 30-40 kg/m2
* \<1 h of regular exercise per week in the previous year
* systolic/diastolic BP: 120-129mm Hg systolic BP and ˂ 80 mm Hg for diastolic BP
* Nonsmokers

Exclusion Criteria:

* body mass index ˂30 and ≥40 kg/m2
* chronic diseases
* taking oral contraceptives
* pregnancy
Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children

Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.

Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for amygdalectomy
* American Society of Anesthesiologists Physical Status PI or PII
* Absence of congenital neuropathy
* Absence of cardiac pathology (any)
* Intolerance to one of the studied drugs.

Exclusion Criteria:

* Protocol violation
* Need to transfer for ICU intubated
Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).

Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse. Implants are positioned during surgery or postoperatively, within 12 weeks. Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. Before post-operative implantation, all patients undergo a breast computed tomography (CT) scan to visualize and expand the excision cavity and obtain the planning target volume (PTV), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. Through virtual simulation with a 3D treatment planning system (TPS), we define the implant catheter position. After implantation, in all patients a breast CT scan checked implant geometry. On CT images transferred to a TPS the surgical cavity is outlined and expanded, the PTV defined, and inactive and active source lengths measured.CT-based 3D software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the PTV. Dwell positions are activated for each catheter, and inactive and active lengths defined.Prescribed dose was 85% of the basal dose. Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. A dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (V100 and V150) was obtained for each patient. DHI, defined as V150 - V100/ V100 (7), is recognized as the most suitable quality index.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 40 years
* ECOG performance status 0-2
* T dimensions ≤ 2.5 cm
* Negative surgical margins
* Negative axillary lymph nodes
* Suitable breast anatomy for implantation

Exclusion Criteria:

* Age \< 40 years
* ECOG performance status \> 2
* T dimensions \> 2.5
* Positive surgical margins
* Positive axillary lymph node
* Infiltrating lobular histology
* Significant areas of lobular carcinoma in situ
* Paget's disease of the nipple
* Extensive intraductal component (EIC)
* Lymphovascular invasion
* Multifocality (n) skin infiltration
Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).

Adult IBS patients with symptoms refractory to standard medical treatment received nurse-administered, gut-directed hypnotherapy. The primary outcome measure was change in gastro-intestinal symptom severity.

IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, were consecutively included in the study. The patients received gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Between 2005 and 2015 patients received 8-12 sessions in an individual manner for 12 weeks. From 2016 the treatment was given in a group format. Effects of treatment were measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Eligibility Criteria:
Inclusion Criteria: IBS diagnosis. -

Exclusion Criteria: Organic GI disease.

-
Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer

This study is a pilot study to assess the feasibility and effectiveness of a 12-week intervention of personalized diet and lifestyle protocol based on the principles of Ayurveda's whole systems approach to achieving improvement in a) quality of life, b) digestive health, c) sleep among women breast cancer survivors.

Breast cancer is the most common cancer among women worldwide. Due to advancements in early diagnosis and treatment, the survival rate of breast cancer has significantly increased. According to the National Cancer Institute's office of cancer survivorship, as of January 2019, there are 3.8 million breast cancer survivors.

Evidence indicates that cancer survivors experience many adverse effects of treatment and suffer from significant quality of life (QOL) challenges such as depression, anxiety, emotional, social, psychological, physiological, and spiritual wellbeing.

Personalized diet, lifestyle and daily routine approaches to breast cancer survivorship are often undervalued. Generally, the dietary guidelines are based only on an individual's nutritional and caloric needs.

Due to the increasing number of breast cancer survivors, it has become essential to have evidence-based guidelines for breast cancer survivorship to improve digestive health, QOL, and general wellbeing. Understanding the science behind personalized lifestyle-related factors, including diet, exercise, and emotional and spiritual wellbeing in cancer survivorship, is urgently needed. Digestive health and the gut microbiome may play an important role in the QOL after surviving breast cancer; however, there are fewer studies on the relationship between diet and daily routine to gut health and breast cancer survivorship care.

This study will test whether personalized guidelines based on the principles of Maharishi Ayurveda - a whole systems approach to reducing strength, improving digestive health and living in harmony with the circadian rhythm to improve QOL for women diagnosed and treated for breast cancer. In addition to that, this pilot study may provide preliminary data to further develop a clinical practice guideline that is cost-effective and easy to follow for women breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* A breast cancer survivor in remission (Females ≥ 18 years)
* Diagnosis of stage I-IV breast cancer
* Three months or more after receiving conventional treatment (chemotherapy, radiation therapy, and/or surgery)
* Willing to comply with the study intervention recommendations for 12 weeks
* English speaking
* Have access to technology to participate in zoom visits

Exclusion Criteria:

* Male responders
* Inability to provide informed consent
* Physiological or psychological debility that would interfere with the ability to participate in the study fully
* Active metastatic or recurrent disease (to avoid early withdrawal from the study)
* Anticipates undergoing surgery during the duration of the intervention
* Substance abuse (to avoid early withdrawal from the study)
Acceptability and User Perceptions of Artificial Intelligence-based Mobile Applications Adoption for Weight Management: A Sequential Explanatory Study

To understand the user perceptions of AI and non-AI-based mobile apps for weight management in people with overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be recruited if they are above 21 years old, have a BMI ≥23kg/m2 and understand English language.

Exclusion Criteria:

* There will be no exclusion criteria to maximize representation of the general population of Singaporean who are overweight and obese.
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients affiliated to a social security reimbursement system
* Adults (men or women) aged between 18 and 65 years
* Negative test for pregnancy
* ECOG 0-1 or Karnofsky Index ≥ 70%
* Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted)
* Life expectancy \> 6 months
* Signed informed consent
* Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation

Exclusion Criteria:

* Pregnant woman or not willing to take effective contraception
* Classical contra-indications to the allogeneic stem cell transplantation procedure
* Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics
* Patients aged \< 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen
* An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection
* History of uncontrolled psychiatric condition
* Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.