cyrilzakka/clinical-trials huggingface dataset:
Effects of Mirror Therapy on Lower Extremity in CP Children

A non-progressive condition that harms the developing brain both during and after birth is cerebral palsy (CP). It is a multifaceted syndrome marked by abnormalities in movement and posture, along with concomitant sensory-motor, cognitive, and behavioral impairments and seizures. CP can be divided into three types based on neurological classification: spastic, athetoid, and ataxic, impairments in motor skills and posture are hallmarks of cerebral palsy. Various strategies have been employed in motor skill improvement interventions. One of them, mirror-mediated treatment, works by stimulating mirror neurons in a specific region of the brain cortex. Mirror-mediated therapy involves the patient observing movement of his or her own limb reflected in a mirror, which activates mirror neurons. The application of mirror treatment improved gait capacity by elevating physical perception and balance ability. The purpose of the study will be to evaluate the effects of mirror therapy in lower limb hemiplegic cerebral palsy.

A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. Data will be collected at the National Institute of Rehabilitation Medicine in Islamabad following ethical clearance. 26 patients will be enrolled in the study based on inclusion criteria. Patients will be randomly assigned into 2 equal groups for the study. Children in the control group will receive conventional therapy for 60 minutes, while Children in the experimental group will receive 30 minutes of mirror therapy and 30 minutes of conventional therapy, for 12 weeks, 3 days every week. The primary outcome will be measured by Selective Control Assessment of Lower Extremity scale (SCALE), while the secondary outcome will be measured by the Pediatric Balance Scale (PBS). All gait parameters (stride length, step length, step width, cadence and foot angle) will be measured before and after the application of intervention. Data will be analyzed using SPSS 27.0.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years.
* Motor tone of effected lower extremity is 1 to 2 according to modified Ashworth scale.
* Patient with enough cognition to understand and follow instructions

Exclusion Criteria:

* Patients with any other neurological illness affecting their lower extremities (e.g., MS, Parkinson's, peripheral neuropathy).
* Patients with prior fractures of the lower limb (ankle or foot).
* Patients with other forms of musculoskeletal diseases such as severe arthritis, ankle surgery, leg length difference.
Randomized Controlled Trial of Home Telemonitoring for Elderly People

The DREAMING clinical trial is part of the DREAMING project, which has the objective to demonstrate that the DREAMING platform consisting of integrated health monitoring, alarm handling and videoconferencing services produces clinical benefits to its users and economic benefits to the health authorities. The study evaluates the long-term (30 months) effect of continuous use of the DREAMING subsystems and is testing the hypothesis that such use is superior to usual care alone in reducing the deterioration of health related quality of life that is associated to age and chronic disease. It also tests the hypothesis that the DREAMING environment is superior to usual care in delaying the transfer to nursing or elderly homes and in reducing the incidence and duration of hospitalisation episodes. The trial will also evaluate the cost-effectiveness of the DREAMING platform. Outcomes are assessed in six different health care systems (Denmark, Estonia, Germany, Italy, Spain and Sweden) and will represent a basis for the adoption of DREAMING services by the respective health authorities.

Homes of participants are equipped with environmental sensors, motion detection, and with wireless sensors for blood pressure, blood glucose, body weight, blood oxygen saturation, peak expiratory flow and electrocardiogram. Disease related parameters are monitored at least daily and the measured values are transmitted to a central monitoring unit. In case of abnormal values, health alarms are generated and transmitted to the local health authorities to trigger eventual intervention by the physicians and nurses who normally follow the participants. Participants and health professionals can stay in contact via an easy to use, home television based videoconferencing system. Participants are also equipped with a a personal alarm and GPS-enhanced localisation system.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Diagnosis of chronic heart failure
* Diagnosis of diabetes mellitus
* Diagnosis of chronic obstructive pulmonary disease

Only in the case that the number of recruited participants is not sufficient, inclusion criteria can be extended to one or more of the following conditions:

* History of myocardial infarction
* History of stroke (brain ischemia or hemorrhage)
* History of falls within the last two years
* Hospitalization during the last two years (for every reason)

Exclusion Criteria:

* Not willing to participate (e.g non signing informed consent)
* Inability to use the DREAMING equipment
* Significant impairment of language comprehension or expression (aphasia)
* Diagnosis of dementia
* Completely dependent on others for the activities of daily living
* Living without access to ISDN or DSL service
Efficacy of Epidural Steroid for Controlling Pain After Primary TKA

The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA

Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* 50-85 years old
* ASA class 1-3

Exclusion Criteria:

* unable to perform epidural anaesthesia
* history of drug allergies: lidocaine, steroid
* renal impairment (CrCl \<30 mL/min)
* liver impairment
* cognitive function disorders
* displacement of epidural catheter
Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.

After being informed about the study and potential risk all patients giving written informed consent then the study started. Patients who will undergo elective, gastrointestinal and other major abdominal surgery were included in the study. After patients were randomized by the investigator, patients were covered with disposable or reusable surgical drapes in accordance with hospital procedure. The body temperatures of the patients were followed for 2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes, sponges, compresses were measured with precision scales.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3
* Patients with abdominal surgery
* Patients receiving general anesthesia

Exclusion Criteria:

* Unwanted to participate in the study
* Patients over 70 years of age
* Presence of central (high) fever originating from the central nervous system resulting from conditions such as cerebrovascular disease, cerebral trauma, intracranial surgery, epilepsy or acute hydrocephalus
* Abnormalities of thermoregulation such as hypothyroidism, hyperthyroidism, history of malignant hyperthermia, or neuroleptic malignant syndrome
* Presence of infectious fever
* ASA 4 and above
* Emergency surgery
* Patients receiving pre-operative chemotherapy
* Having problems such as tearing and perforation of the covers during the work.
* Patients being hyperthermic in the intraoperative process
Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer

This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Epidermoid head and neck carcinoma locally advanced
* Indication of Cetuximab and radiotherapy
* Karnofsky \>= 60
* Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer

The radiotherapy will be delivered for curative aim (minimal dose 66 Gy)

Exclusion Criteria:

* other histology
* Metastatic disease
* Recurrent patients
A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
* 18 to 85 years of age (inclusive)
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative serum pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
* Subjects with ongoing severe, acute inflammatory bowel disease
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary.
* Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 100 mmHg).
* Subjects taking antibiotics within 7 days of colonoscopy.
* Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2).
* Subjects with known severe hepatic insufficiency (Child Pugh C)
* Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
* Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
* Subjects undergoing insulin therapy for any indication.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects allergic to any preparation component.
* Subjects using drugs of abuse, including abused prescription medications.
* Subjects who are withdrawing from alcohol or benzodiazepines.
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Developing Screening Clinical Breast Examination Implementation Strategies in South Africa

The goal of this observational study is to engage with multilevel stakeholders to collaboratively and to systematically develop a suite of strategies for implementing breast cancer screening using clinical breast examination (CBE) in the primary health centers within the catchment area of Chris Hani Baragwanath Academic Hospital (Bara Hospital), Johannesburg, South Africa.

The main questions it aims to answer are: What barriers and facilitators exist to conducting screening CBE in Soweto's primary care setting and what implementation strategies would support CBE in primary care clinics?

Participants will:

* Allow observation of study clinic workflows
* Participate in focus group discussions regarding screening CBE implementation


Eligibility Criteria:
In order to be eligible for inclusion in the focus group discussions held with screening CBE "adopters" and "implementers," an individual must meet all of the following criteria:

1. Be an employee or volunteer working at a participating PHC OR Be an employee or volunteer working at South Africa's National Department of Health OR Be an employee or volunteer working with a non-governmental organization that performs breast cancer related activities within the catchment area of a participating PHC
2. Be willing to commit to keeping the content of focus group discussions confidential

In order to be eligible for inclusion in the focus group discussions held with screening CBE "recipients," an individual must meet all of the following criteria:

1. Be female
2. Be between the ages of 40 and 65 years
3. Be living within the catchment area of a participating PHC
4. Be willing to commit to keeping the content of focus group discussions confidential
Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Giant cell arteritis (GCA), also known as temporal arteritis, is a disease that usually only occurs in older adults. GCA causes inflammation of blood vessels, or vasculitis. In order to properly treat this disease, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with GCA.

GCA is a rare autoimmune disorder and is the most common type of inflammation of medium- to large-sized blood vessels in the body. It usually only occurs in older adults. The most common symptoms of GCA include headache, pain in the shoulders and hips (polymyalgia rheumatica), pain in the jaw (jaw claudication), fever, and blurred vision. Organ-specific markers of injury or damage as well as direct markers of vascular damage and inflammation are currently used by clinicians to assess GCA disease progression; however, these markers are not very useful in guiding treatment. There are also blood tests that clinicians use to monitor GCA activity, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), but these tests lack specificity and sensitivity. Most treatments available now for GCA are toxic, therefore if other markers indicating disease activity can be found, it may lead to the development of less toxic treatments. This study will use new scientific methods to identify new biomarkers that can be used to monitor disease activity in GCA patients. These biomarkers may be used to help direct clinical care for GCA patients and assist in future drug development.

Study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will occur every 3 months; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:

  1. At least 50 years of age at disease onset
  2. New onset or new type of localized pain in the head
  3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
  4. ESR of greater than 40 mm in the first hour by the Westergren method
  5. Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells

Exclusion Criteria:

* Unable to give informed consent and sign the consent form
Cereals as a Source of Iron for Breastfed Infants

The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

* exclusively breastfed
* birth weight between 2500 and 4200g
* gestational age \>36 weeks

Exclusion Criteria:

* supplementing formula
* no iron drops
Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome

Abstract Background: With the progress of society and the deepening of people's understanding of Down syndrome (DS), research has shifted focus on how to improve the quality of life and education for young people with DS. This study shall pilot a shared book reading intervention to test for potential benefit and feasibility.

Methods: This study is an 8 weeks long pilot dyadic randomized controlled trial (RCT) comparing a shared book reading intervention to a minimal activity control, this study will then continue for 12 months as a single arm cohort study. Young people with DS and university undergraduate students will be recruited and formed into dyads then randomized to either intervention or control. The shared book reading activity will include partnering young people with DS and university students together for a weekly, 1-hour shared book reading session. The control group will be supplied with three books they can read in their free time during 8 weeks. The primary outcomes included young people with DS health-related quality of life measured using the Children's Quality of Life Scale (PedsQL4.0). Secondary outcomes include mental well-being in university students using the Engagement, Perseverance, Optimism, Connectedness, and Happiness scale (EPOCH). Measurements will be made at baseline (T0) and 8-week (T1). After 8 weeks all participants will be offered to continue in the study where all participants will join the shared book reading weekly intervention and outcomes measures will be made at 6-month (T2), and 12-month (T3) follow-up. Mixed linear regression models shall be conducted comparing intervention and control group at 8 weeks. At 6-months and 12-months follow-up change scores from baseline will be analyzed to test for potential long-term effect.

Anticipated results: If our pilot study can show that shared book reading activities for people with DS can be of benefit and feasible, this can lead to a fully powered randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria for Participants with Down Syndrome (DS):

* Clinical diagnosis of Down Syndrome (DS).
* Aged 2 years or older.
* Able to participate in the intervention and study evaluation independently or with the support of caregivers or family members.

Inclusion Criteria for University of Macau (UM) Students:

* Aged 18 years or older.
* Able to read and understand books in English or Chinese.
* Able to communicate in English, Mandarin, or Cantonese.
* Do not have severe visual or reading disabilities that may affect reading ability.

Exclusion Criteria:

-Have severe visual or reading disabilities.
Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above

To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Axillary temperature ≤37.0 ℃.
2. aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
3. Proven legal identity, could come each visit.
4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.

Exclusion Criteria:

1. Persons with a clear history of SARS-CoV-2 infection.
2. Using blood products after basic immunization or receiving immunosuppressive therapy.
3. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
5. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
8. Immunization with any vaccine within 14 days.
9. Any other situations judged by investigators as not suitable for participating in this study.
Brain Network Dynamics of Depression During Esketamine Treatment

This is a monocentric, observational clinical trial investigating the effect of Esketamine on brain network activity and a belief updating task in people with depression. We investigate the immediate and the long-term effect (approx. 8 weeks) of Esketamine on EEG signals, pupillometry and belief updating and the relation of those effects on depressive symptomatology.

The FDA approved the S-enantiomer of Ketamine in a nasal spray formulation (Esketamine, Spravato) in 2019 for treatment resistant depression in conjunction with an oral antidepressant. Albeit showing impressive short term clinical effects, the neurophysiological mechanism leading to clinical improvements are not understood. The investigators aim to add missing knowledge about the network dynamics of Esketamine in depression. Besides changes of neural signatures, Esketamine might impact cognitive processes like belief updating.

Previous studies have shown that people update their expectations of future life events after receiving novel information. The Belief Updating Task (BUT) measures this belief update in reaction to new information. Healthy individuals have been shown to update their beliefs "optimistically", making larger changes in their expectations in response to good news. Individuals with depression lack this optimistic belief update bias. Therefore, the investigators also aim to examine if Esketamine treatment reinstates the optimistic bias, how those changes are mediated by neurophysiological changes during the task and if a change in belief updated is related to a change of depressive symptoms.

The first session takes place at the start of the Esketamine treatment period, whereas the second experimental session is conducted closer to the end of the treatment period. In both experimental sessions, EEG/pupillometry and cognitive measurements are taken before and after Esketamine administration. Analyses will assess pre/post Esketamine effects within a session and between two sessions.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder
* Receiving Esketamine nasal spray treatment for depression
* Ability to understand study procedures and sign an informed consent.

Exclusion Criteria:

* None