cyrilzakka/clinical-trials huggingface dataset:
Wrist Splint and Occupational Therapy to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop

To determine effectiveness of wrist splint and occupational therapy to improve pain, mobility and functional status in patients with wrist drop.


Eligibility Criteria:
Inclusion Criteria:

* • People with wrist drop

  * People between 20 to 40 years will be included (male and female)
  * Post-operative patients (nerve grafting and plastic surgery)
  * Patients with findings of nerve compression will be included

Exclusion Criteria:

* • People with nerve injuries other than radial nerve such as ulnar or median nerve

  * People suffering with other neurological disorders.
  * People who are not able to follow instructions
  * Any traumatic history
  * Diabetic patients, thyroid issues, pregnant females
An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis

In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label, 12-month pilot study of computerized cognitive training as part of the cognitive wellness program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and (2) the efficacy of Lumosity for improving cognitive outcomes in individuals with MS.

Approximately 50 current members of the Mercy MS Achievement Center will be provided with 12-month premium access Lumosity accounts. Study participants must be ≥18 years of age, and currently members of the Achievement Center participating in the cognitive wellness program. Those who consent will be provided with an account activation code and instructed on how to sign up for Lumosity.

Upon creating an account, users would be asked to complete a short demographic survey (Information About You, which includes age, sex, race/ethnicity, education, occupation) and two additional short surveys: a Computer Experience Questionnaire and a Perceptions of Brain Training questionnaire. In addition, participants will be assessed with the Montreal Cognitive Assessment (MOCA), and be directed to take the Brain Performance Test (on a laptop or desktop computer) within the first 7 days of creating their account. If not conducted within the previous 3 months, participants would also be required to have the following assessments at baseline (i.e., within the first 7 days): Multiple Sclerosis Neuropsychological Questionnaire (MSNQ), Multiple Sclerosis Impact Scale-29 (MSIS-29), and Beck Depression Inventory (BDI). After one week of using Lumosity, and then every other month for 12 months, participants would be asked to complete a short questionnaire about their experience with Lumosity. Every 3 months, participants would repeat the BPT, MSNQ, and BDI; and every 6 months, they would repeat the MSIS. Finally, at the end of the study, the end of the study they would also repeat the MOCA.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet the following criteria:

1. Signed informed consent
2. 18 years of age or older,
3. English-speaking,
4. Current participants in the MS Achievement Center Cognitive Wellness Program
5. Sufficient physical capacity to use a computer keyboard and mouse
6. Willing and able to use Lumosity at least 3 times per week

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from participation:

1. Under 18 years of age
2. Are taking medication that may impede cognitive functioning
3. Have other conditions or problems that may preclude regular computer usage
Cardiac Output in Preeclamptic

There is high incidence of hypertensive disorders during pregnancy.The maternal cardiovascular system had significant changes during pregnancy. The colloid oncotic pressure is decreased during preeclampsia.

Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pre-eclampsia
* Age 18-45 years.
* Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
* American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).

Exclusion Criteria:

* Body mass index \< 18 or ≥40 kg/m²
* Women presenting in labor
* Current administration of vasoactive drugs including salbutamol and thyroxin.
* Diabetes mellitus.
* Hemoglobin \<10 g/dl.
* Cardiovascular, cerebrovascular, or renal disease
* Increased serum creatinine level ≥1.1 mg/dL.
* Contraindications to spinal anesthesia:(increased intracranial pressure, coagulopathy, or local skin infection)
Impact of Left Atrial Function on Postoperative Atrial Fibrillation

We aimed to demonstrate the impact of left atrial functions which were evaluated by three different echocardiographic modalities , on postoperative atrial fibrillation.

Postoperative atrial fibrillation after coronary artery bypass greft operation (CABG) is major complication with a prevalence of 10-50%. Although the men mechanism is not known, in recent studies, age and left atrial function have been demonstrated as the most responsible factors. Velocity vector imaging (VVI) is a new modality which may give accurate and detailed information on both left atrial segmental and global function. In this study, our aim was to assess preoperative left atrial function by using three different echocardiographic modalities, VVI, tissue Doppler imaging and conventional echocardiography and evaluate the relation between the left atrial functions and the development of post-operative atrial fibrillation after CABG.

Eligibility Criteria:
Inclusion Criteria:

* 1Coronary artery disease evidenced by coronary angiography
* 2Patients with a decision of undergoing elective coronary artery bypass greft operation
* 3Sinus rhythm in electrocardiography

Exclusion Criteria:

* 1Rheumatic valve disease
* 2Having prosthetic valve
* 3CABG accompanied by other cardiac interventions (such as valvular surgery, ASD closure...etc)
* 4Left ventricular l ejection fraction \<40%
* 5Mild to moderate mitral stenosis or regurgitation
* 6Having atrial fibrillation or a history of atrial fibrillation attach during the last two weeks.
* 7Congenital heart disease
* 8Chronic liver disease
* 9Chronic renal disease
* 10Malignancy
The First United Arab Emirates National Representative Birth Cohort Study

In this study, a multidisciplinary team of researchers was established including credible researchers from the UAE, Australia and the United Kingdom to launch the First United Arab Emirates 3-year birth cohort study. The study aims to recruit 250 pregnant Emirati women within their first trimester, which is defined by the study as from 8 to 12 weeks pregnant, recruited from obstetric and gynaecology clinics in the UAE. Participants will be recruited via face to face interviews and will receive a total of 11 visits with 1 visit in each trimester of pregnancy and 8 visits after delivery. Maternal data collection includes, socio-demographic and lifestyle factors, dietary intake, anthropometric measurements, physical activity, maternal psychological state, and blood samples for biochemical analysis. Post-partum, visits will take place when the child is 0.5, 4, 6, 9, 12, 18, and 24 months old, with data collection including infant anthropometric measurements, young child feeding practices, dietary intake, supplement use and the eating environment at home, as well as all maternal data collection described above, apart from blood samples. Additional data collection for the child includes developmental assessments taking place at three timepoints, 1) within 2 weeks of birth, 2) at 10-14 months and 3) at 22 - 26 months of age. Developmental assessments for the infant include vision, health, neurological examination, neurodevelopmental and sleep assessments.


Eligibility Criteria:
Inclusion Criteria:

* Emirati Nationality
* Within first trimester of pregnancy (between 8 -12 weeks of gestation)
* Singleton pregnancy
* Absence of major illness preconception (Diabetes mellitus, hypertension, kidney disease, cancer, epilepsy, severe psychiatric illness, and other chronic diseases of infections such as autoimmune disorders, human immunodeficiency virus, and hepatitis).

Exclusion Criteria:

* Non-Emirati
* Unconfirmed viable, intrauterine pregnancy at first obstetric ultrasound during first trimester
* Twin or multiple gestation pregnancy and a history of multiple gestations
* History of chronic illness (i.e., T2DM, hypertension, etc.)
* Previously given birth to babies with malformation, intellectual disability, or inborn errors of metabolism.
* Experience of a miscarriage before 28 weeks of gestation
* On significant regular medications, including insulin, anti-hypertensive agents, psychotropic medications, anti-epileptic drugs, steroids, immune-suppressive agents, and chemotherapeutic agents.
Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational

Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.


Eligibility Criteria:
Inclusion Criteria:

* Both ERD or NERD patient who confirmed by EGD findings within 12 months prior to V1 and have a symptom with moderate or more, at least once per week within 1 week prior to V1 and Patients between age 20 and 80with typical reflux symptoms
* Among the patient who have not taken PPI or H2 blocker within 4 weeks prior to V1, needs to be prescribed PPIs 4\~8 weeks as a part of the routine clinical practice due to typical symptom
* Patients who give the signed informed consent

Exclusion Criteria:

* Patients with past history of gastrointestinal surgery
* Patients with known malignancy or history of such diseases
* Patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, COPD, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer

Long-term maintenance of physical activity behaviour change post-intervention remains challenging. This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.

This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.

The supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.

Participants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* a histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C
* completed cancer treatment within the last 24 months,
* be able to understand spoken and written English
* score of 80 or more on the Karnofsky Performance Status Scale

Exclusion Criteria:

* already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,
* recent myocardial infarction
* uncontrolled hypertension
* a pacemaker
* or unstable angina.
Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects

The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.

An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls

Eligibility Criteria:
Inclusion Criteria:

* BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test
* Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test

Exclusion Criteria:

* Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG
* Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study
* Family history of autoimmune disease
Cognitive Stimulation

This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.


Eligibility Criteria:
Inclusion Criteria:

* age 18-55
* in methadone maintenance or healthy volunteers
* healthy

Exclusion Criteria:

* Axis I disorder (except substance abuse and dependence in methadone maintenance patients)
* severe cognitive impairment
* serious untreated medical condition
Pediatric Alliance for International Neurogastrointestinal Functional Research

To explore the predictive value of alarm signs ("red flags") for a diagnosis of functional gastrointestinal disorders (FGID) in children.

To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients.

To document the benefit of various treatment regimens currently employed in managing FGID.

To assess the short- and long-term impact of various FGID regimens.

To allow physicians to gain a better understanding of the epidemiology of FGID.

Hypothesis:

There are presenting symptoms or results from diagnostic tests that are more likely to associated with conditions different from FAP or IBS.

Symptoms of children with FAP/IBS change overtime regardless of the treatments used.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 4 through 16 years of age (up to the day of the 17th birthday)
* Presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months may participate in the Registry.

Exclusion Criteria:

* Subjects age 10 and above will be asked to complete the questionnaire themselves. Those unable to complete the questionnaire (with only some help) should not be enrolled.
* Patients unable to participate in the program for at least 3 years should not be enrolled (i.e., anticipated move, etc.)
SMS - Study of Somatic Mutations Using Genome Sequencing

Disease and tissue aging are thought to be influenced by genetic changes, or mutations, acquired throughout life. These mutations provide clues regarding the genetic damage that occurred through the lifetime of the patient, and include mutations caused by environmental factors such as ultraviolet light from sunlight or tobacco smoke affecting the skin or internal tissues, respectively. Other mutations may occur due to errors in copying the genome as cells divide. Improvements in technologies that read the genetic code have made it possible for all or selected parts of the genetic code of a human being to be "sequenced", allowing mutations (changes in the genetic code) to be detected.

In this research, samples of blood, skin biopsies, plucked hairs, urine, surplus tissue removed during future planned surgery, and archived samples removed in the past will be used. The order of DNA bases in the genetic code (sequencing) in the samples will help to understand how the number and type of cells with changes in their DNA is different in tissues depending on a person's age, their exposure to environmental agents, or other factors such as disease history or treatments such as radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Controls: Healthy adults with capacity to consent
* Patients: Adults with capacity to consent who have been highlighted by research nurse or clinician as potentially having genetic damage caused by environmental factors, such as UV light or tobacco smoke, or other factors, such as disease history or treatments, for example radiotherapy.

Exclusion Criteria:

* Adults who lack capacity to consent.
* Children.
Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema

The aim of this study is To compare the anatomical and functional results of intravitreal( IV) injection of ranibizumab with sub threshold micropulse laser ( SML) in treatment of Diabetic macular edema (DME) both anatomically by spectral domain optical coherence tomography (SD OCT) and functionally by best-corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG).

Diabetic macular edema (DME) causes significant visual loss in diabetic patients. About 20% and 40% of patients with Type 1 and Type 2 diabetes mellitus (DM), respectively, develop DME. One-third of diabetic patients who have had DM for more than twenty years will develop DME . Early impairment in the function of the middle and inner layers of the retina has been reported in diabetic patients before appearance of vascular complications . A good independent guide of macular function in patients with DME is multifocal electroretinogram (mfERG) readings from the macular area, which strongly associate with morphologic alterations in the macula. Some investigators suggested that temporal characteristic (implicit time) of mfERG waves are more important than amplitudes for evaluation of retinal function in diabetic patients. They concluded that patients with DM show temporal changes indicating delayed neural transmission due to local impairment of blood glucose metabolism. In contrast, others emphasize the importance of both parameters (implicit time and amplitude) in identifying retinal affection in DM.

Intravitreal (IV) injections of anti-vascular endothelial growth factor (VEGF) agents provided good visual outcomes in treatment of DME. However, IV anti-VEGF injections are expensive, need to be repeated many times and have the potential risk of causing endophthalmitis . Subthreshold micropulse laser (SML) treatment of DME has the same effect as conventional laser treatment, nonetheless, there is less damage to adjacent tissues of the burn area in the retinal pigment epithelium (RPE). SML allows laser emission to be divided into bursts of short cyclic pulses that remain for microseconds permitting substantial cooling amid these short pulses .

Eligibility Criteria:
Inclusion Criteria:

* DME with BCVA\<0.5 decimal Snellen acuity.
* Controlled blood glucose (HbA1c) \<6.5%.

Exclusion Criteria:

* History of previous intraocular surgery,
* History of previous laser treatment,
* History of previous IV injection,
* Macular disease or ischemia,
* Proliferative diabetic retinopathy,
* Vitreoretinal traction,
* Interruption of external limiting membrane (ELM) or ellipsoid zone (EZ).
* Dense media opacity,
* Optic disc pathology
* History of strokes or ischaemic heart diseases.
* patients with (CST) \> 400 µm on OCT .
Cardiac Surgery as a Means of Reversing Frailty

Frailty is a multifactorial condition associated with older age, which leads to increased vulnerability to external stressors, such as infections or surgical procedures. Key features of frailty are unintentional weight loss, reduced strength and physical activity as well as the feeling of exhaustion.

When selecting patients for surgery, frailty can play an important part in resource planning and prognostication. Multiple studies have shown frailty to have a negative impact on mortality, perioperative adverse events, hospital length of stay as well as postoperative quality of life and functional status. Despite it being an important patient-centered outcome, postoperative quality of life tends to be overlooked when selecting patients for surgery.

Cardiac surgery presents a massive stressor to the frail patient, but on the other hand might have the ability to reduce disease burden and improve functional status, thus reducing frailty.

This prospective observational cohort study aims to assess frailty, as well as functional status and quality of life in cardiosurgical patients pre- and postoperatively, and evaluate its impact on postoperative clinical and functional outcomes.

The primary endpoint of this study is the change in postoperative level of frailty.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years
* elective cardiac surgery

Exclusion Criteria:

* age \< 60 years
* emergency procedures
* pulmonary thromboendarterectomy
* declined informed consent
* pregnant women
PemVin vs Vin in Previously Treated Metastatic Breast Cancer

Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin B12) for pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.

This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed, recurrent or metastatic breast cancer
2. HER2-negative
3. ECOG PS 0-2
4. Age ≥ 20 years
5. Anthracycline- and Taxane-pretreated
6. Wash-out period of 3 weeks for cytotoxic chemotherapy
7. Wash-out period of 2 weeks for hormone therapy or radiotherapy
8. measurable or non-measurable lesions by RECIST v1.1
9. Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL
10. Adequate liver functions
11. Adequate renal functions : sCr≤1.5mg/dL
12. Subjects willing to follow study protocol
13. Informed consent before study entry

Exclusion Criteria:

1. More than 3 lines of chemotherapy for metastatic breast cancer
2. Pregnant or breastfeeding women
3. Previous exposure to Pemetrexed or Vinorelbine
4. Neuropathy (grade 2 or more)
5. Symptomatic CNS metastasis
6. History of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer)
7. Hypersensitivity to study medication or related drugs
8. Concomitant vaccination for yellow fever