cyrilzakka/clinical-trials huggingface dataset:
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance

The purpose of this study is to support development of PillCam Endoscopy System applications.


Eligibility Criteria:
Inclusion Criteria:

* Subject's from 18 years of age.
* Subject is indicated for Capsule Endoscopy procedure.
* Subject agrees to sign the Informed Consent Form.

Exclusion Criteria:

* Female subject is pregnant.
* Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
* Subject has a pacemaker or other implanted electro-medical device.
* Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
* Subject suffers from life threatening conditions.
* Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study
Exercise Intensity for Down Syndrome Children

The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.

Two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. Also, functional mobility was assessed for both groups before and after the intervention. The within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* independent walking
* Intelligence quotient range from 40 to 70
* right dominant foot
* body mass index from 50 to 75

Exclusion Criteria:

* chronic diseases
* congenital anomalies
* involved in any competitive sport
* previous injury to the lower limb
Glaucoma Algorithm Validation Study in African Population - the MAGIC Study

Artificial Intelligence (AI) algorithms require validation in a variety of populations to ensure widespread clinical applicability. In Ophthalmology, AI algorithms are reaching maturity in diagnosis such as diabetic retinopathy and glaucoma. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.

A small scale validation study in consecutive patients in a large Eyesore unit in Mozambique will be performed to determine the diagnostic ability of these AI softwares in this population

Artificial Intelligence (AI) algorithm's are the next frontier in medical management, usually meant to improve diagnostic capabilities and to optimize the existing resources. They are particularly relevant in settings where there is a lack of specialised Human Resources such as physicians.

Ensuring these algorithms can be used in a wide population is therefore crucial to clinical implementation. Validation studies in specific segments of populations are needed to ensure all patients are represented and the results are therefore reliable. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.

A pilot study for validation of an AI algorithm for Glaucoma and Diabetic Retinopathy will be done for the MONA G-RISK® and diabetic retinopathy. Consecutive patients from a large Eye Unit in Mozambique's capital will be screened using these AI algorithms and validated using clinical standard as ground truth.

Eligibility Criteria:
Inclusion Criteria:

* subjects age above 18 years old presenting at the Eye Unit
* willingness to sign an informed consent for the screening process

Exclusion Criteria:

* none
* Poor quality in screening image will be included in the intention to treat analysis, but excluded from the diagnostic comparator outcome.
* Patients with a known glaucoma diagnosis will not be excluded from the screening
The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients aged ≥18 years old
* 2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \[International Workshop on Chronic Lymphocytic Leukemia\] criteria)；
* 3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on Zanubrutinib;
* 4.Prior or current use of Zanubrutinib for ≥3 months
* 5.At least one follow-up was recorded during Zanubrutinib treatment

Exclusion Criteria:

-
Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.


Eligibility Criteria:
Inclusion Criteria:- Males aged 18-60

* Back Pain
* Must be able to comply with study visit schedule and other study requirements
* Capable of performing the experimental tasks Exclusion Criteria:- Contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
* Known hypersensitivity to duloxetine or any of the inactive ingredients
* Uncontrolled narrow-angle glaucoma
Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.

* To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients.
* To evaluate the influence of Ocoxin®-Viusid® on tolerance to onco-specific therapy.
* Identify the changes that occur in the nutritional status of patients receiving the supplement.
* To evaluate the toxicity of Ocoxin®-Viusid® in combination with chemotherapy in patients with metastatic colorectal adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
* Patients that meet the diagnostic criteria.
* Patients with general health according to Karnofsky ≥70%.
* Life expectancy greater than or equal to 3 months.
* Patients eligible to receive FOLFOX-IV chemotherapy.
* Patients who have signed the informed consent.
* Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy:
* Hemoglobin ≥ 90 g / l
* Total Leukocyte Count ≥ 3.0 x 109 / L
* Absolute Neutrophil Count ≥1.5 x 109 / L
* Platelet Count ≥100 x 109 / L
* Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution.
* TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution.
* Creatinine values within the normal limits of the institution.

Exclusion Criteria:

* Pregnant or lactating patients.
* Patients with known hypersensitivity to (5 Fluoracil, Folinic Acid or Oxaliplatin).
* Patients who are receiving another product under investigation.
* Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
* Patients with brain metastases.
* Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.

It is planned to include a total of 40 patients in the study, taking into account 10% of losses.
Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents

This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).


Eligibility Criteria:
Inclusion Criteria:

* Alpha-feto protein \> 400 ng / mL or
* prior ultrasound with mass suspicious for hepatic malignancy or.
* clinical risk of hepatocellular carcinoma or
* prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma

Exclusion Criteria:

* Glomerulo-filtration rate \< 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study
* Previous diagnosis of hepatic malignancy
* Any conditions that would discount the ability to have an MRI scan
FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.

Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.

Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years of age, inclusive
* Body weight at least 50 kilograms
* PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
* Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved PAH therapy.
* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
* Reliable and cooperative with protocol requirements.

Exclusion Criteria:

* Nursing or pregnant.
* Received a prostacyclin within the past 30 days.
* PAH due to conditions other than noted in the above inclusion criteria.
* History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
* Use of an investigational drug within 30 days of Baseline
Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle

The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle.

Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.


Eligibility Criteria:
Inclusion Criteria:

acute brain injury patients with an invasive intra-cranial pressure monitoring

-

Exclusion Criteria:

patients affected by disease or trauma of eye ball patients or relatives that don't want to participate to the study

-
the Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Spastic Stroke Patient. The Patients Were Diagnosed With the Lateral Scapular Slide Test, Fugl-Meyer Upper Extremity (FMUE) Scale Scores & Scapular Balance Angle Test (SBA).

to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.

Background: Post stroke Scapular dyskinesia leads to scapulohumeral pain \& dysfunction were associated with decreased motor function, somatosensory function, limited range of motion, and spasticity.

Objective: to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.

Methods: sixty patients from both sexes were participated in this study. All the patients were diagnosed as spastic stroke patients. The patients were divided into two equal groups; group A (30 patients): with high scapular dyskinesia scores, group B (30 patients): with low or no scapular dyskinesia scores. The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores \& scapular balance angle test (SBA).

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed as stroke patient
* stroke onset at least 5 months prior to study enrollment and
* decreased sensorimotor function in the affected arm, but ability to use the arm to some extent in daily activities with functional to subfunctional manual muscle test
* age ranged from 35:50
* both sexes

Exclusion Criteria:

* difficulty to communicate or to understand test instructions
* other conditions that caused pain (for example fibromyalgia and arthritis)
* severe depression or other psychiatric symptoms
* patient with other upper limb musculoskeletal problems
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

The duration of treatment is 18 weeks.

Eligibility Criteria:
Inclusion Criteria:

* High cholesterol and high triglycerides

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study
Tissue Characterisation by Endoscopic GI-elastography

In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract.

The purpose of this study is to use endoscopic ultrasonography (EUS) with strain based elastography to identify strain traits separating malignant from benign lesions. We are registering feasibility of endoscopic strain imaging and compare diagnostic accuracy of EUS + elastography with previous data on EUS alone.

Inclusion criteria:

* Group 1: Focal subepithelial lesions in esophageal, ventricular or duodenal wall discovered by endoscopy or other imaging modality.
* Group 2: Pancreatic lesion discovered by other imaging modality.
* Group 3: Mediastinal or retroperitoneal lymph node or tumor discovered by other imaging modality.

Histology of lesions should not be known at the time of examination. EUS elastography findings are evaluated shortly after the examination and categorised by different methods; categorical score, VAS, Strain Ratio. The result is then compared to histology or cytology results. Patients who do not undergo tissue sampling are followed up to discover disease progress.

Eligibility Criteria:
Inclusion Criteria:

* Solid focal lesions in pancreas or pancreatitis
* Intramural lesions in esophagus, ventricle or duodenum
* Lymph nodes or tumour \> 1 cm in mediastinum or retroperitoneum accessible by EUS

Exclusion Criteria:

* Cystic pancreatic lesions
* Patients where the histology or cytology of the lesion in question is known at the time of examination
SLEEP-COPE: Sleep Intervention for Oppositional Children

Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.


Eligibility Criteria:
Inclusion criteria:

1. Child ages 8-12 with ODD (prior diagnosis) and insomnia
2. Child and parent English proficiency.

Insomnia:

1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia
3. baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights

Exclusion criteria:

1. Parent unable to provide informed consent or child unable to provide assent
2. Family unwilling to accept random assignment
3. Child/parent participation in another randomized research project
4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment
5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
9. Other conditions adversely affecting trial participation
School-based Health Programs on Children's Wellbeing in Lusaka, Zambia

This study evaluates the impact of a new and comprehensive school-based health program implemented in Lusaka, Zambia.

While school-aged children in low- and middle-income countries remain highly exposed to acute infections, programs targeting this age group remain limited in scale and scope. In this study, we evaluate the impact of a new and comprehensive primary school-based health intervention program on student health outcomes and academic performance in Lusaka, Zambia. The intervention involved the training of teachers to become school health workers and the provision of vitamin A supplementation and deworming medication on a bi-annual basis. Teachers in intervention schools were trained to deliver health lessons and to refer sick students to care. This study is designed as a prospective matched control study. Students from the seven intervention schools are matched with students from control schools.

Eligibility Criteria:
Inclusion Criteria:

* Children attending one of the 14 schools in the study.

Exclusion Criteria:

* Children not attending one of the 14 schools in the study.
The Natural History of Injury-Related Disuse Osteopenia

Determine the severity and time course (natural history) of disuse osteopenia that occurs in the lower extremity(ies) and lumbar spine of patients sustaining lower extremity injuries that require the patient to maintain restricted weight bearing status (12 weeks) following the surgical fixation of the patient's injuries.

The investigators hypothesize that there will be a significant decrease in the bone mineral density in the lower limbs of patients undergoing restricted weight bearing for peri-articular injuries of the lower extremity. This loss of bone mineral density is often prolonged in its duration and may lower subsequent fracture threshold and prolong the time to recovery and return to activities.

It is well documented that restricted weight bearing even for relatively short periods (12 weeks) associated with the surgical treatment of peri-articular injuries of the lower extremity (ie acetabulum, distal femur, tibial plateau, pilon, talus, calcaneus) can lead to a measurable decrease in bone density in the injured limb. Furthermore, this osteopenia can persist for extended periods of time - much longer than the original period of restricted weight bearing. This relative osteopenia can delay recovery from injury, lower fracture threshold for subsequent injury and potentially delay return to active duty in the case of a wounded warrior. There exists a significant body of research in the modulation of the osteopenia associated with restricted weight bearing as it pertains to long term space flight (microgravity).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 at time of injury
2. Previously normal community ambulator (without ambulatory aid) prior to injury

Exclusion Criteria:

1. Presence of a total or hemi hip prosthesis in the injured extremity
2. Presence of lumbar fusion L1-L4
3. Previous ipsilateral lower extremity trauma
4. History of medical treatment for known osteoporosis (Calcium and Vitamin D supplementation alone is NOT an exclusion criteria)
5. Ambulatory dysfunction prior to injury
6. Inability to cooperate with DXA scanning
7. Head injury on admission requiring invasive monitoring or treatment
8. Inability to adhere to weight bearing restrictions
9. Inability to provide consent
10. Non English speaking
11. Pregnancy