cyrilzakka/clinical-trials huggingface dataset:
A Natural History Study of Preclinical Genetic Creutzfeldt-Jakob Disease (CJD)

Creutzfeldt-Jakob Disease (CJD) is the most common prion disease in humans causing a rapidly progressive neurological decline and dementia and is invariably fatal. The familial forms (genetic CJD, gCJD) are caused by mutations in the PRNP gene encoding for the prion protein (PrP). In Israel, there is a large cluster of gCJD cases, carriers of an E200K mutation in the PRNP gene, and therefore the largest population of at-risk individuals in the world. The mutation is not necessarily sufficient for the formation and accumulation of the pathological prion protein (PrPsc), suggesting that other, genetic and non-genetic factors affect the age at symptoms onset. Here we present the protocol of a cross-sectional and longitudinal natural history study of gCJD patients and first-degree relatives of gCJD patients, aiming to identify biological markers of preclinical CJD and risk factors for phenoconversion.

The study includes two groups: Patients diagnosed with gCJD, and first-degree healthy relatives (both carriers and non-carriers of the E200K mutation in the PRNP gene) of patients diagnosed with gCJD. At baseline, and at the end of every year (for 4 years), healthy participants are invited for an "in-depth" visit, which includes a clinical evaluation, blood and urine collection, gait assessment, brain MRI, lumbar puncture, and Polysomnography sleep lab (PSG). At 6 months from baseline, and then halfway through each year, participants are invited for a "brief" visit, which includes a clinical evaluation, short cognitive assessment, and blood and urine collection. gCJD patients will be invited for one "in-depth" visit, similar to the baseline visit of healthy relatives.


Eligibility Criteria:
Inclusion Criteria:

* First--degree relative of an E200K gCJD patient.
* Age 50 years or older at baseline.
* Willingness to undergo genetic testing.
* Ability to provide written informed consent under GCP, ICH, and local regulations.
* Willingness and ability to comply with scheduled visits, required study procedures, and laboratory tests.

Exclusion Criteria:

* a clinical diagnosis of CJD

  * Any other medical or psychiatric condition or laboratory abnormality, which in the opinion of the investigator might preclude participation.
  * Previously obtained MRI scan with evidence of clinically significant neurological disorder other than CJD.
  * Current anticoagulant treatment (e.g Non-vitamin K Antagonist Oral Anticoagulants (NOACs), Warfarin, Low Molecular weight Heparin) that might preclude safe completion of LP.
  * Conditions that preclude the safe performance of LP, such as severe lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  * Conditions that preclude the safe performance of MRI scannings such as subjects who have a pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, or any other known contra-indication for MRI.
  * Active malignant disease.
Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.

This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random.

In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF.

This study has no additional follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Respiratory insufficiency of infants in the neonatal unit who require respiratory support and supplemental oxygen in one of 4 the therapeutic categories (Intubated HFO, Intubated CMV, Non-Invasive nasal mask, nasal cannula).
* \<30 kg at study entry
* Informed Consent Form obtained as per EC requirement

Exclusion Criteria:

* Not expected to complete 48 hours of the current respiratory support therapeutic category
* Congenital anomalies
* Uncontrolled hemodynamics
* Severe airflow obstruction
* Intracranial hypertension
* Start of caffeine therapy within 12 hours
* Attending physician does not believe participation of the patient is in their best interest.
The Use of Virtual Reality Applications in Tension-Type Headaches

The primary aim of this research is to objectively assess the impact of virtual reality (VR) technology on pain symptoms in tension-type headache patients. This study is designed to understand the potential of VR in the treatment of tension-type headaches, exploring its ability to reduce pain severity and improve patients' quality of life.

Tension-type headache is a prevalent health issue that can cause significant discomfort to patients. The potential use of VR goggles as an effective alternative treatment option in these patients is crucial in clinical applications. The quality of life of tension-type headache patients is often affected. If VR goggle technology can enhance the quality of life for these patients, it would be a significant finding.

Additionally, our research may contribute more data to the scientific literature on the impact of VR goggle technology in headache treatment. This could assist future researchers in designing similar studies and better understanding the results. If VR goggle technology proves effective, it could contribute to diversifying treatment options for tension-type headache patients and improving access to treatment.

The primary objective of the study is to investigate the effect of virtual reality therapy on pain symptoms in tension-type headache patients. If the results are positive, VR technologies may alleviate pain and enhance the quality of life for these patients. It could also help them function better in their daily lives. If relaxation is found to be effective in the VR group, a new treatment option would be introduced for tension-type headache patients. This could contribute to the diversification of treatment options.

The study poses no risk to the patient. The patient will lie on the bed, and the VR goggles will be used accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 65
* Patients meeting the criteria for Tension-Type Headache (TTH) in the third edition of the International Classification of Headache Disorders
* Patients willing to participate in the study
* Patients indicating a VAS score of 50 and above
* Patients without other suspected diagnoses
* Patients with no known history of adverse reactions to the active ingredients of the drugs to be used
* Conscious patients
* Patients who are oriented and cooperative

Exclusion Criteria:

* Patients under the age of 18 and over the age of 65
* Patients who do not consent to participate in the study
* Patients with vital signs outside normal limits
* Patients with a history of adverse reactions to known NSAIDs
* Individuals unable to determine pain intensity on the VAS
* Patients with a VAS score of 50 mm and below
* Pregnant individuals
* Those with advanced systemic diseases
* Patients with malignancies
* Individuals with chronic liver and kidney diseases
* Those using sedative and analgesic neuro-psychiatric drugs
* Individuals with a history of psychological and neurological diseases
* Patients who used analgesics within 8 hours before the examination
Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites

The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives.

The expected outcomes are

Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months.

Secondary outcome:

1. Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups

* Need for repeated paracentesis : Number assessed
* AKI : Improvement or worsening of renal functions
* Hepatic encephalopathy: Grading as per West Haven Classification
* Hyponatremia
* Diuretic tolerability : Dose and duration tolerated
* Bacterial peritonitis : Ascitic fluid neutrophil count \> 250 cells/cumm
* Transplant free survival
* Risk of procedure related complications
* Changes in MELD or CTP between the groups ( Improvement vs worsening )
* Need for hospitalization between the groups


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine \< 2 mg/dl).

Exclusion Criteria:

* CTP \>12, MELD\>25
* Prior or current Spontaneous Bacterial Peritonitis (SBP)
* Recurrent or current overt hepatic encephalopathy
* Serum Creatinine \>2
* HVOTO (Hepatic Venous Outflow Tract Obstruction)
* Hepatic or extrahepatic malignancy
* Recent UGI bleed
* Sepsis
* Serum Sodium \< 120
A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method

This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients visiting our hospital for evaluation of mediastinal lymphadenopathy.

This study is investigator initiated, prospective, unblinded randomized study comparing conventional TBNA with EBUS-TBNA for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis when combined with transbronchial lung biopsy and endobronchial biopsy. It will be conducted on 80 consecutive patients with suspected sarcoidosis presenting to Department of Pulmonary Medicine and Sleep Disorders in AIIMS (All India Institute of Medical Sciences), New Delhi. This study will help to know whether EBUS (Endobronchial Ultrasound guided) or conventional TBNA is better for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis. It will also help to know the value of adding rapid onsite evaluation of the cytology smears to both the procedures. It will also help to determine the overall yield of different procedures when they are combined for obtaining tissue samples for a diagnosis of sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and suspected Stage 1 (mediastinal or hilar Lymphadenopathy (LAP)) or Stage 2 ( LAP and parenchymal abnormalities) sarcoidosis
* Significant mediastinal LAP (Short Axis Diameter more than 10mm)
* Lymph Node (LN) enlargement in station 4, 7, 10 or 11 and CT chest findings consistent with sarcoidosis.
* With or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ACE levels or restriction/obstruction on Pulmonary Function Tests (PFT).

Exclusion Criteria:

* Obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (Skin biopsy, superficial lymph nodes, Lofgren's Syndrome)
* Sarcoidosis Stage 3 and 4
* Mediastinal Nodes less than 10 mm in short axis diameter
* Absence of right paratracheal and subcarinal Lymph node enlargement more than 1 cm in short axis diameter
* Those who received empiric Steroid for \>2 weeks in preceding 3 months
* Contraindication to bronchoscopy and TBNA (Coagulopathy, Hypoxemia)
* Unwilling to give consent
Family MobilePhone Otoscopy in Diagnostics of Otitis Media

This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 - 35 mo
* Parents have iPhone 5, 5s or 6
* Child is in daycare
* Child has had at least one acute otitis media within 90 days preceding the enrollment
* Family agrees to give a mortgage of 40 euros from the CellScopeOTO

Exclusion Criteria:

* Tympastonomy tube present in tympanic membrane
* Chronic perforation of the tympanic membrane
* Condition of head/neck anomaly to affect middle ear or ear canal anatomy
* One child from the family already participating
The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement

Total knee replacement (TKR) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. The associated rehabilitation costs, however, impose a significant burden on the health system. In particular, inpatient rehabilitation - utilised by approximately 43% of private TKR recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000 (AU) per inpatient episode.

The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home.

The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.

Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility.

Superiority in these outcomes will be evident at six months after surgery.

As preferences for therapy can be a confounder in RCTs, patients will be asked their preference for rehabilitation post TKR, prior to randomisation.

Patients will be randomised once a hospital bed is available.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients presenting for elective, primary, unilateral TKR at the Whitlam Joint Replacement Centre (Fairfield Hospital) will be screened for eligibility at the pre-admission clinic by the study Project Manager (PM).
* primary diagnosis of OA

Exclusion Criteria:

* predisposition for requiring prolonged inpatient supervision (eg requiring assistance with at least one personal activity of daily living or lack of social support)
* inability to comprehend the study protocol.
* catastrophic complication arising post-surgery which precludes rehabilitation commencing within 2-3 weeks of surgery
Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy

The aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in addition to traditional treatment.

The main aim of the present study is to determine the effects of hippotherapy on the hip aductors spasticity in children with spastic cerebral palsy. Furthermore, as a secondary objective is to evaluate the changes in Modified Ashworth Scale (MAS) after intervention in children ages 3-14.

Eligibility Criteria:
Inclusion Criteria:

* Primor diagnosis of spastic cerebral palsy
* Children aged 3-14

Exclusion Criteria:

* Children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.
Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis

To date, the treatment for endometriosis is represented by the surgical removal of the lesions. Nonetheless, in the years following surgery, the lesions can recur, often due to excessive estrogen production. To balance estrogen, progestin- or estrogen-progestin-based medications are generally prescribed. On the other hand, progestins and estrogen-progestins act as contraceptives, preventing the onset of a pregnancy. At the same time, these can have side effects that can affect up to 30% of patients. For these and other reasons, some women refuse therapy with progestins or estrogen-progestins, preferring to resort to no treatment.

Considering the need to research effective molecules in the prevention of relapses that can maintain fertility and avoid unwanted effects, the research focuses on natural molecules, well tolerated by the body.

D-Chiro-Inositol (DCI) is a polyol normally present in human cell membranes, where, from a metabolic point of view, it acts as a second messenger of insulin, while from a hormonal point of view, it exerts an on the biosynthesis of androgens. This effect on steroidogenesis can be attributed to more than one mechanism. In the ovary, DCI stimulates direct testosterone production. Furthermore, it stimulates the accumulation of testosterone by reducing the activity of the aromatase enzyme, responsible for the conversion of androgens into estrogens. Considering the responsiveness of endometriosis to estrogens, and that these constitute a risk factor for recurrences following surgical removal, the use of DCI could be interesting from a clinical point of view.

The study plans to verify whether D-Chiro-Inositol dietary supplementation can be effective in reducing systemic estrogen levels in women with endometriosis, thus also reducing the risk of relapses and associated symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Women affected by endometriosis (regardless of the stage)

Exclusion Criteria:

* Treatment with hormones in the previous three months or during the study
* Treatment with Inositol and/or other insulin-sensitizers in the previous three months
* Obesity
* Diabetes
* Cancer (any site/stage)
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD

The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.

This is an intent-to-treat, two-arm, open-label, randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TOME or Control, balancing on site. Participants will receive the assigned intervention following randomization and will complete a three week follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

Potential participants must be:

1. 18 years of age or older;
2. Pregnant or be within 12 months postpartum;
3. Enrolled in MOUD (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed;
4. Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

Potential participants must not:

1. have suicidal or homicidal ideation requiring immediate attention.
Cataract Surgery In Patients With Advanced Age

This study evaluates and compares clinical outcomes of \< 85 and ≥ 85 year old patients who underwent cataract surgeries.

The medical records of patients who were underwent cataract surgery between January 2014 and October 2017 were investigated retrospectively and patients 65 years and older were recruited. Two groups were made according to age: group1 composed of patients age range between 65 and 85 years and group 2 composed of patients 85 years and older. Gender, presence of diabetes mellitus (DM), hypertension (HT), drug use were noted.

The results of best corrected visual acuity (BCVA) converted to LogMar, intraocular pressure (IOP) before and 3 months after operation, biomicroscopic and fundus examinations were investigated.

Additional ocular diseases such as glaucoma, age related macular degeneration (AMD), pseudoexfoliation syndrome, retinopathies and maculopathies related to systemic diseases were noted. Pupil dilation properties were also noted as poor, mid or full pupil dilation.

Cataract surgery techniques such as phacoemulsification, extra- and intracapsular lens extractions, peroperative complications, intracameral drug use were investigated.

these aforementioned outcomes evaluated and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 65 years and older patients who underwent cataract surgery

Exclusion Criteria:

* patients aged below 65 years who underwent cataract surgery