cyrilzakka/clinical-trials huggingface dataset:
Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study

The goal of this clinical trial is to explore the effect on walking speed of a new robotic assisted balance and gait trainer (REACTION) and their subsystems in individuals with neurological disorders. The study will provide insight in the feasibility of REACTION.

Participants will:

* Participate in two sessions in which every session contains a walking task and balance tasks
* end the study with a semi-structured interview

The first day will be focusing on 4 conditions: tasks without aid, tasks with regular aid, task with the ABLE Regain and tasks with REACTION. The first and third condition consist of a walking task and balance tasks, The second and fourth condition is only focusing on the walking task with the aim of getting familiar to the device and the walking task.

The second day will also be focusing on four conditions: tasks without aid, tasks with aid, tasks with the GABLE Core and task with REACTION (Fig 3.2). The conditions 'tasks without aid', 'tasks with the GABLE Core' and 'tasks with REACTION' consist of a walking task and balance tasks (similar to day 1). The condition 'tasks with aid' only consists of a walking task.

A semi-structured interview with the corresponding physiotherapist and patient will be held to gather more information about usability and feasibility of REACTION from a therapist's and patient's perspective.

Eligibility Criteria:
In order to be eligible to participate in this study, a participant must meet all of the following criteria:

* Age \> 16 years
* Able to give informed consent

Stroke patients:

* first-ever ischemic or haemorrhagic stroke
* FAC score between 3 and 4
* (Sub)acute or chronic phase

SCI patients:

* Neurological injury levels ranging from C5 to T9
* Motor incomplete spinal cord injury (ASIA impairment score of C or D)
* Able to walk independently (without physical support)

Exclusion Criteria:

A potential participant who meets any of the following criteria will be excluded from participation in this study:

* Premorbid disability of lower extremity
* Progressive neurological diseases like dementia or Parkinson
* Skin lesions or severely impaired sensation at the hemiparetic leg
* Contraindication for mobilization, like lower limb fracture
* Insufficient knowledge of the Dutch language to understand the purpose or meth-ods of the study
* Pregnancy
Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria

The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce the risk of metabolic syndrome in patients with serious mental illness who receive treatment with antipsychotic medications.

The hypothesis of the study is that: the application of a physical health promotion program in people with serious mental illness, who receive treatment with antipsychotic medications, carried out by a mental health nurse, will decrease the presence of metabolic syndrome and contribute to improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of serious mental illness.
* Treatment with antipsychotics.
* Met at least 3 of the 5 criteria of metabolic syndrome According to the NCEP ATP III definition.

Exclusion Criteria:

* Medical contraindications to exercise
* Admitted to hospital.
* intellectual disability
Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients

Single-centre prospective randomized study will be included the patients who undergo elective cardiovascular surgery. Preoperative fluid deficit will be calculated by the formula as starvation period X 4 X weight. Patients will be divided into two groups: Group A (n=20); crystalloid as priming solution used in patients, Group B (n=20); colloids as priming solution used in patients. In addition to priming solutions, extracorporeal pump will be filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin. Standard anesthesia protocol will be administered to all patients. Ringer's Lactate will be given at first 30 minute after induction. Ringer's Lactate as fluid maintenance will be administered at a rate of 100 mL/h except in extracorporeal circulation. Goal-directed fluid management will be performed by PVI (Pleth Variability Index). Cut off level of PVI will be accepted %15.

For integrative investigation of the effects of priming solution and postoperative fluid management on the complex interrelation between microcirculation and reactive oxygen species; sublingual microcirculation using microcirculation imaging system (IDF, Cytocam, NL) will be displayed and measure ekstra vascular lung water (EVLW) using PiCCO and plasma levels of oxidative stress markers will be measured. Sublingual tissue microcirculation will be evaluated in all patients at different time points as before induction (T0), after induction (T1), before cross clamping-hypothermic period (T2), after cross clamping (T3), before end of pump (normothermic period, heating) (T4), acceptance to intensive care unit (T5), third hour after surgery (T6) and twenty forth hour after surgery (T7).

Eligibility Criteria:
Inclusion Criteria:

* cardiovascular surgery needed

Exclusion Criteria:

* no informed consent
The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study

It is a prospective cohort study.The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle. The pelvic floor muscle function is evaluated at 6 weeks,3 months and 12 months after delivery.

The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle.Evaluation of pelvic floor function is performed at 6 weeks, 3 months, 12 months after delivery. The modified Oxford Grading Scale and Levator ani testing are used to quantify PFM strength through vaginal palpation. Pelvic floor muscles strength, endurance, repetition,vaginal contraction pressure and the knack test are evaluated using a neuromuscular stimulation therapy system of PHENIX (Company: Vivaltis -Electronic Concept Lignon Innovation, Montpellier, France).

Eligibility Criteria:
Inclusion Criteria:

1. Women who give birth for the first time （Including vaginal delivery and cesarean section）
2. Term birth（37-42 weeks）
3. Single birth
4. Aged from 18 to 50
5. Plan to live locally for extended periods of time

Exclusion Criteria:

1. A history of incontinence before pregnancy
2. A history of fecal incontinence before pregnancy
3. Pelvic organ prolapse before pregnancy （prolapse out of the hymen ）
4. A history of abortion or induced labour over 16 weeks of pregnancy
5. Multiple pregnancy
6. The weight of the newborn is less than 2500g or more than 4000g
7. Precipitate labour
8. Operative vaginal delivery（obstetric forceps or vacuum extraction）
9. Laceration of perineum at least level III
10. Request for pelvic floor rehabilitation exercise（patients who have entered the group can not train the pelvic floor muscle）
11. Obesity （BMI before pregnancy over 25, BMI=weight (kg) / height square (m2) ）
12. Asthma
13. Long-term abdominal pressure（chronic cough for more than 1 months ，long-term constipation ect.）
14. Diabetes
15. Cotugno's disease
16. A history of pelvic floor surgery in the previous years
To Study the Effects of Host Genetic Factors on Liver Cirrhosis

The purpose of this study is to identify genetic determinants of susceptibility to liver cirrhosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis .


Eligibility Criteria:
Inclusion Criteria:

* hepatitis B

Exclusion Criteria:

* the casual aget of liver disease is not viral infection, such as alcohol abuse
Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung

Two-Year Disease Free Survival Rate of Stage IB\~IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.

Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of Lung
* Postoperative pathologic stage IB\~IIIA
* Complete surgical resection (R0 resection) N1-2: R0 resection with lobectomy and mediastinal lymph nodes dissection (MLND) N0: R0 resection with lobectomy with or without MLND
* Adjuvant treatment should start between 4 to 6 weeks after surgery
* ECOG performance status 0-1
* Weight loss during last 3 months should be less than 10%.
* Normal hematologic, hepatic and renal function Neutrophil count \> 1500 /microliter, Platelet \> 100,000/microliter, Hemoglobin \> 9 g/dL Bilirubin \<=1.5 x upper limit normal, transaminase \< 2.5 x upper limit normal Serum Creatinine \<=1.5 mg/dL
* Women in child bearing age should consent using contraceptive measures, and must have negative pregnancy test.

Exclusion Criteria:

* Other malignant neoplastic disease within 5 years.
* Neoadjuvant chemotherapy before surgery of lung cancer
* Patients who will be treated with postoperative radiation.
* Stage IIIB or IV lung cancer
* Severe infection, or cardiorespiratory, hematologic illness
* HIV positive cases
* Pregnancy or lactating women
* Autoimmune diseases or those who receiving immune suppressive treatment
* Symptomatic neuropathy \> CTCAE grade 1
* Those who consented other clinical trials within 3 months
* Other significant medical conditions contraindicated to clinical trial
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma

This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of multiple myeloma (MM).
* Measurable disease defined as at least 1 of the following:

  * Serum monoclonal protein \>= 1g/dL.
  * Urine M-protein \>= 200mg/24 hours.
  * Serum immunoglobulin free light chain (FLC) \>= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
* Relapsed after or are refractory or intolerant to all established MM therapies that are both known to provide clinical benefit and locally available.
* Received at least 3 prior lines of therapy including 1 or more immunomodulatory agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal antibodies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Adequate hematologic, renal and hepatic function as described in the protocol.
* Echocardiogram with ejection fraction \>= 50% and no other clinically significant findings that would increase the participant's susceptibility to cardiac toxicity.

Exclusion Criteria:

* Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor.
* Antineoplastic therapy (including any cytotoxic, targeted and/or investigational therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug and through the last dose of study drug.
* Autologous stem cell transplant within 90 days prior to start of study drug.
* Allogenic stem cell transplant within 180 days prior to start of study drug.
* History of acute or chronic pancreatitis.
* Significant unresolved liver disease.
* History of hepatitis B or human immunodeficiency virus (HIV) infection.
Exacerbations Among Patients Receiving Breztri (EROS Study)

EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.

EROS was a retrospective real-world evidence claims analysis study, assessing the relationship between the timing of Breztri Aerosphere following an exacerbation and the appearance of subsequent disease exacerbations of people with COPD.

The study used administrative claims data in the US sourced from the Inovalon MORE2 Registry® between July 2019 and March 2022. Inclusion required one of the following qualifying exacerbation events: ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment, be age ≥40 at the index date, and have ≥90 days of continuous enrollment following the index date.

Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model. Statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in COPD-related costs.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 1 prescription fill for BGF on or following July 24th, 2020 (Breztri approval date);
* Evidence of any of the following exacerbation patterns within the 12-month period preceding the initiation of BGF, all index exacerbation events must occur following BGF approval: (1) one moderate exacerbation (the exacerbation must occur following approval of Breztri) with presence of other inhaled therapy, (2) two moderate exacerbations (the second exacerbation must occur following approval of Breztri) without the presence of other inhaled therapy, or (3) Severe Exacerbation- Inpatient COPD hospitalization
* ≥ 12 months of continuous enrollment preceding the index exacerbation date
* ≥ 90 days of continuous enrollment following the index exacerbation date
* Age ≥ 40 years on the index exacerbation date

Exclusion Criteria:

* Presence of closed triple therapy during the baseline period
* Initiation of BGF 4/1/2022 or later
* Presence of an enrollment gap of more than 14-days from index exacerbation date to BGF initiation date
Upper Limb Reeducation Across Life Span

Program Ready2E.A.T. was developed to be tested in the upper limb reeducation on population at risk, such as:

* Children with dysfunction
* Cognitive impaired elderly
* Dementia people

Program Ready2E.A.T. consists on the training of specific upper limb tasks, including:

* reaching during attention tasks
* reaching during memory tasks
* reaching during sequential motor tasks
* reaching during fine hand movements

This program has been tested as a measure of functional status (cognitive and motor habilities) in population with different risks; It also has been tested as an effective program for reeducation in cognitive affected population.

Eligibility Criteria:
Inclusion Criteria:

* people with 60years old with cognitive decline
* children aging 6-10 years old with cognitive and motor dysfunction
* dysfunction in feeding participation

Exclusion Criteria:

* participants that do not understand 2 simnultaneous verbal commands
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Automated Telephone Follow-up in the Swedish Prison and Probation Services

The purpose of this study is to investigate whether automated telephony may be used for daily assessments of paroled offenders, and whether a brief intervention based on these daily assessments may result in a more positive development compared to daily assessments only.

To study whether automated telephony could be used in paroled offenders to perform daily assessment of variables associated with recidivism in crime and to study the effects of a brief intervention based on these assessments during 30 days following probation.

Eligibility Criteria:
Inclusion Criteria:

* Convicted criminals subject to parole
* Access to a mobile telephone
* Assigned parole officer at parole

Exclusion Criteria:

* No knowledge of spoken Swedish
* Additional intervention such as intensive supervision with electronic monitoring, or in-patient care at a health and rehabilitation clinic
Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques

The objective is to develop a novel system to predict and prevent nocturnal hypoglycemia in type 1 diabetic (T1D) patients, focused in patients with multiple daily injections (MDI) therapy. The general idea is to make use of previous-day information in the moment when patients go to sleep, and then predict if in the next following hours any hypoglycemic event will occur. If the system will have predicted any hypoglycemic event in that moment, it is expected that it will be able to warn the patient to take some action: such as reduce basal insulin dose or to consume a snack before sleep.

10 patients with T1D for more than five years will be included.

It is a longitudinal, prospective, interventional study in which every patient will use intermittently scanned Continuous Glucose Monitoring (isCGM) and a physical activity tracker during 12 weeks. Moreover, during this period, patients will store in a mobile application (Freestyle LibreLink) or in a reader information regarding their diabetes management activities, such as insulin delivery doses and meal consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years with Type 1 Diabetes:

  * \> 4 hypoglycemia / week (\< 70 mg/dl, including day and night), last 2 weeks and / or
  * One severe hypoglycemia during the last year and / or
  * Hypoglycemia unawareness (Clarke Test \>3)
* Disease duration \> 5 years
* On multiple doses of insulin (MDI) therapy using a rapid acting insulin analogue as prandial insulin (lispro, aspart or glulisine) and any basal analogue as basal insulin.
* A1c 6.5 - 9.5 %
* Able to use an intermittently scanned continuous glucose monitoring (isCGM) system.
* Performing \>4 self-monitoring blood glucose (SMBG) per day
* Using carb-counting
* Providing an informed consent
* No CGM user previously (during the last 3 months).

Exclusion Criteria:

* Patients with a previous Diabetic Ketoacidosis (DKA) episode in the previous 6 months.
* Patients with a severe hypoglycemia in the previous 6 months.
* Severe diabetic complications or comorbidities: eye, renal, cardiovascular...from the clinicians point of view.
* Pregnancy and breastfeeding.
* History of drug or alcohol abuse.
* Scheduled surgery during the study period.
* Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study.
* Subjects those are unlikely to meet the clinical study protocol, eg uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study.
* Using an experimental drug or device during the past 30 days.
Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery

This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.

SECONDARY OBJECTIVES:

I. Evaluate the tolerability of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.

II. Preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (RIF).

OUTLINE:

Patients undergo MLD breast massage over 30-60 minutes twice a week (BIW) for the duration of standard of care (SOC) radiation therapy and for 1 month thereafter.

After completion of SOC radiation therapy, patients are followed up at 2-4 weeks and 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation
* Age \>= 18 years
* Ability to understand and the willingness to sign a written informed consent in English or Spanish

Exclusion Criteria:

* Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
* Inability to provide written informed consent in English or Spanish
* Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded
* Individuals who are cis male, transgender female and cis female without intact native breasts will be excluded
A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Primary insomnia