cyrilzakka/clinical-trials huggingface dataset:
Comparative Study Between Alzheimer's and Multi-infarct Dementia

Dementia is a neurological disease that causes cognitive and behavioral impairments that could ultimately interfere with the ability to function at work or to do the usual daily activities. It is recognized as a healthcare and social burden and remains challenging in terms of proper diagnosis and treatment.

Biomarkers are needed to identify at-risk individuals, stage their disease, and track disease progression. Such biomarkers should be noninvasive, inexpensive, and simple to acquire. Neurodegeneration biomarkers in CSF include neurofilament light (NfL), Chitinase 3-like protein 1 (CHI3L1). NfL for example increases in several neurologic conditions, including AD. In addition, NfL can be detected in serum using standard immunoassay formats. Higher CSF levels of CHI3L1 are seen in patients with neurological disorders such as MS patients experiencing relapses of MS. In addition, C-X-C motif chemokine 13 (CXCL13) is a crucial homeostatic chemokine expressed in lymphoid organs, and it is essential for the recruitment and compartmentalization of lymphocytes. In MS, CXCL13 regulates homing of B cells and subsets of T cells to inflammatory foci in CNS by interacting with the CXCR5 receptor. The levels of CXCL13 are elevated in the CSF of patients with MS compared to healthy controls, as well as in other neuroinflammatory diseases. CXCL13 may be considered a CSF biomarker of intrathecal B cell response, as its levels correlate with the count of B cells, the IgG index, and the presence and OCBs in the CSF.

Transcranial magnetic stimulation (TMS) assesses several cortical properties such as excitability, plasticity, and connectivity in humans. TMS has been applied to patients with dementia, enabling the identification of potential markers of the pathophysiology and predictors of cognitive decline; moreover, applied repetitively, TMS holds promise as a potential therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women of at least 50-80 years of age.
2. Are reliable in individual data and willing to make themselves available for the duration of the study
3. Clear written informed consent obtained from 1st degree of relative from each patient participant and control himself in the trial.

Exclusion Criteria:

1. age below 50 years and above 80 years.
2. other neurological disorders or psychiatric disorders; previous history of stroke; metabolic disturbance; other major medical illnesses; epilepsy; inflammatory, autoimmune, or infectious disease; metallic objects in the body; craniotomy in the past.
3. Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
4. Participation in any other type of medical research that may interfere with the interpretation of the study.
5. Patients with severe motor disability (bed-ridden) that may interfere with the study procedure.
6. Patients with history of seizures or epilepsy including history in a first degree relative
Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.

The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT


Eligibility Criteria:
Inclusion Criteria:

* Male patients with comparable age (30- 65 years).
* All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.
* Opposing mandibular dentate arch including bilateral posterior teeth.
* All patients should have an adequate zone of keratinized mucosa.
* All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.
* All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants.

Exclusion Criteria:

* Patients with flabby maxillary ridges.
* Patients who are unwilling to accept implant overdentures as a treatment modality.
* Patients with temporomandibular and neuromuscular disorders.
Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers

It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe

Name of the study : SANIBA

Objective:

The gold standard to heal diabetic foot ulcers is complete off-loading. To wear continuously off loading shoe is very difficult The bad compliance of the patients can lead to infection of the ulcer and amputation of the foot.

The purpose of this study is to compare the efficacy of a new concept of off-loading shoe (a pair of SANIDIAB shoes) with a single BAROUK shoe to treat chronic plantar diabetic foot ulcer of the fore foot. The hypothesis is that the new concept is more efficient because of a good off-loading associated with a best compliance to wear the new concept of shoes.

The study will last 18 months with a duration of study of 6 months per patient It's a pilot prospective multicenter randomised study of 64 diabetic patients with a plantar neuropathic ulcer of the fore foot, treated after randomisation by an off loading shoe BAROUK or a pair of off loading shoes SANIDIAB.

Patients will be followed in a diabetic foot department every 14 days until healing and after healing until 6 months after inclusion in the study.

The main outcome measure is the healing duration of the diabetic foot ulcers in both group of treatment.

The secondary outcome measure is the rate of reulceration after healing , the rate of amputation and compliance of patients 64 patients will be included in 2 groups: 32 will wear SANIDIAB shoes and 32 BAROUK shoe.

Eligibility Criteria:
Inclusion criteria :

* More of 18 years old man or woman
* Type 1 or 2 Diabetes mellitus
* A new plantar ulcer of the fore foot or the toes
* GRADE 1A or 2 A of the University of Texas Classification
* Neuropathy assessed by absence of sensation in 10g monofilament test

Exclusion criteria

* Severe angiopathy (Grade 3 of the PEDIS classification)
* Osteomyelitis or cellulitis of the foot
* Transmetatarsal amputation
* Other study in course
* Immunosuppressive drugs, antibiotic therapy,
* Hepatic insufficiency
* No possibility to follow the patients every 14 days
* No state health insurance
* Pregnancy
Physiotherapy for Patients Awaiting Rotator Cuff Repair

POWER is a pragmatic multi-centre, external pilot randomised controlled trial with feasibility objectives using a parallel group design with 1:1 allocation ratio and integrated qualitative study. The study aims to answer the question: In adult patients diagnosed with tears of the rotator cuff and awaiting elective surgical repair, is it feasible to conduct a future, fully powered, multi-site RCT to test the hypothesis that physiotherapist-led exercise is superior to waiting-list control in terms of clinical and cost-effectiveness?

Tears of the shoulder rotator cuff tendons are a common cause of shoulder pain, disability, and absence from work. Once a decision to undergo rotator cuff repair surgery has been made, patients are placed on a waiting list, and it can take weeks or months to receive the surgery. While waiting for surgery, many patients continue to experience significant pain and disability, and some will be unable to work.

If treatment could be delivered to patients while on the waiting list with potential to reduce pain and disability, and also potentially reduce the need for surgery, there would be clear and significant patient benefit and also benefit to the NHS.

In this pilot study, the investigators will aim to find if it is possible to carry out a larger study to determine if a programme of physiotherapist-led exercise for patients awaiting surgery to repair torn shoulder rotator cuff tendons is clinically and cost-effective.

Working with 4 NHS hospitals, the investigators will recruit 76 patients waiting for rotator cuff repair surgery. One group of patients will receive a programme of specific exercise, supported by a physiotherapist. The second group will just continue waiting for surgery without additional treatment, which is current standard care. The programme of specific exercise can be supported over the telephone, via secure video platform, or face-to-face. the investigators will monitor patients through the study by asking participants to complete one questionnaire at the start and then three more electronic questionnaires after 6 weeks, 3 months and 6 months.

The investigators will invite approximately 25 patients to take part in an interview to discuss experience of the treatments and the study.

The study is being funded by the UK National Institute for Health Research.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.

Exclusion Criteria:

* Unable to provide informed consent.
Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.

Twenty normal weight adolescents between ages 12-18 that are age and gender would receive vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other demographic variables will be assessed.The primary endpoint in this study is the 25 OH Vitamin D level at 12 weeks.

Eligibility Criteria:
Inclusion criteria:

* Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.

Exclusion Criteria:

* Subjects with 25 (OH)- D levels \>80 ng/mL
* Serum calcium \>10.8 mg/dL
* Serum phosphorus \> 5.5 mg/dl
* Pregnancy or nursing
* Current cancer
* Patients on multivitamin supplementation
* Dietary calcium intake exceeding 1500 mg/day
* Hepatic or renal disorders
* Type 1 or Type 2 diabetes mellitus
* Those receiving insulin, metformin, or oral hypoglycemic medications
* Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)
Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)

The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.

This randomised controlled study will follow the clinical course of hemodynamically normal trauma patients with Organ Injury Scale (OIS) grade 4 or 5 blunt splenic injuries, undergoing SAE or observation only until day 7 post injury. Only hemodynamically normal patients will be considered for enrolment into the study, and written informed consent from the patient is required.

CONTROL The control arm in this randomized controlled trial will include only NOM patients diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will comprise clinical observation according to local routines and protocols. The patients will be observed with special focus on delayed bleeding and failure of NOM. A contrast enhanced US or CT scan with arterial phase will be performed on day 3-5 to exclude PSA. On day 7, the decision to perform SAE, splenectomy or continue NOM is left to the discretion of each participating institution, and registered in the case report form (CRF).

INTERVENTION The intervention arm will perform SAE as a central embolization of the splenic artery.

Additional peripheral embolization is left to the discretion of the interventional radiologist.

Each institution decides whether patients in the SAE group are to undergo immunization or not. The study does not interfere with local diagnostic work-up and treatment protocols.

We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM leading to fewer splenectomies in this group of patients without concomitant increased complication rates. Additionally, we want to explore the effects of pre-emptive SAE vs observation alone on all cause failure rate, operative procedures, repeat angiography rate, complications, critical care stay, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* blunt splenic injury OIS grade 4 or 5
* Adult trauma patients (according to local definitions)
* Present hemodynamically normal as judged by the responsible trauma consultant surgeon and eligible for NOM
* Randomised within 48 hours of injury
* Written informed consent is obtained

Exclusion Criteria:

* Hemodynamically compromised (not suitable for NOM)
* Needing transfusions
* CT shows evidence of significant contrast extravasation
* Other indications for laparotomy
* Prisoners
* Pregnant
* \>80 years old
* Penetrating injury
* Contraindication to iv contrast
OCT Guided Magmaris RMS in STEMI

Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<24 hours or with ongoing symptoms.
2. Signed patient informed consent.

Exclusion Criteria:

1. Age \< 18 or \> 70 years.
2. Pregnancy or breastfeeding.
3. Cardiogenic shock.
4. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
5. Infarct-artery reference diameter \< 2.7 or \> 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter \< 2.7 or \> 3.7 mm
6. Non-optimal vessel preparation after predilatation: residual stenosis \>30%.
7. Culprit lesion length \> 21 mm.
8. Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
9. Culprit lesion involving a saphenous vein graft.
10. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
11. Ostial right coronary artery
12. Severe calcification or tortuosity of the infarct-related artery.
13. Absolute contraindication to a 12 months dual antiplatelet therapy.
14. Life expectancy \< 3 years.
15. Patients taking oral anticoagulant therapy
At-Home Olfactory Training

The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.

This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.

Eligibility Criteria:
Inclusion Criteria:

* Have clinical olfactory dysfunction

Exclusion Criteria:

* Pregnant women
* Unable to perform routine follow-up
* Current participation in another clinical trial during this trial
* Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders
* Diagnosis of other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency
* Patients who are allergic to any of the smells or components of our olfactory testing
* Chronic rhinosinusitis, malignant tumors and/or oncologic therapies (radiation/chemotherapy)
* History of surgery on the nose or paranasal sinuses
* Patients using medications that may impact olfactory function (i.e. corticosteroids)
Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse

The purpose of this study is to determine whether Dialectical Cognitive Traumatherapy is effective in the treatment of severe and chronic Posttraumatic Stress Disorder (PTSD) following childhood sexual abuse.

Most studies on psychological treatments for PTSD exclude patients with severe, co-occurring psychopathology. We designed a new treatment (Dialectical Cognitive Trauma Therapy, or DCT) specifically to treat these patients. DCT includes elements of emotion regulation, mindfulness exercises, cognitive and exposure treatment, as well as new elements. This randomized controlled study evaluates the effect of inpatient DCT on these patients.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Minimum age of 17
* Childhood sexual abuse
* Posttraumatic Stress Disorder (criteria of SCID)
* At least one of the following diagnoses: Anorexia Nervosa, or Bulimia Nervosa, or substance abuse, or substance dependence, or major depression or at least 4 out of 9 criteria for Borderline Personality Disorder

Exclusion Criteria:

* Diagnosis of schizophrenia
* Mental retardation
* Body Mass Index lower than 16.5
* Acute delirium
* Perilous selfharming behaviour during the last 4 month
* Suicide attempt with the distinct intention to die during the last 4 month
* Unstability (e.g. homelessness, acute victimisation by offender)
* Pretreatment by DCT
Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.


Eligibility Criteria:
Inclusion Criteria:

* female
* DSM-5 eating disorder
* score 16 or higher on the Clinical Impairment Assessment
* experience nausea or stomachache after eating at least "sometimes"
* 18 to 40 years old
* body mass index between 18.5 and 26.5 kg/m2

Exclusion Criteria:

* medical conditions affect appetite or weight
* Recent pregnancy or current breastfeeding
* Dairy, strawberry or honey food allergy
* Specific phobia, blood-injection-injury type
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma

A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET.

The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Women must not be pregnant or breast feeding
* Histologic diagnosis of non-Hodgkin's lymphoma (any stage)
* Must undergo treatment with chemotherapy and/or radiotherapy

Exclusion Criteria:

* May not have received previous therapy with radiopharmaceuticals
* May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies
Iron Deficiency In Pulmonary Hypertension

Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were previously shown to have a decreased six-minute walking distance. Therefore the investigators hypothesized that intravenous iron administration would improve exercise capacity in iron deficient IPAH patients.

30 patients will be recruited for iron infusions. At baseline and after 12 weeks (endpoint)exercise test will be performed.

Background: Patients with pulmonary arterial hypertension (PAH) develop progressive right heart failure which eventually will lead to death. During progression of the disease the physical performance of the patients deteriorates. Maintaining their exercise capacity is a major goal in PAH treatment. Iron treatment is known to have a positive effect on physical performance in patients with left heart failure and iron deficiency. Whether this is also effective in patients with right heart failure (PAH) and iron deficiency is until now unknown.

Objective: To evaluate the effects of intravenous iron supplementation on exercise capacity in iron deficient IPAH patients.

Study design: Intervention study

Study population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency

Patients receive an iron bolus infusion of 1000 mg iron after baseline measurements.

Main study parameters/endpoints:

Primary endpoint: six minute walking distance (6WMD) Secondary endpoints: cardiopulmonary exercise test, myoglobin concentration in quadriceps muscle, quadriceps muscle fiber strength, serum iron parameters, serum inflammatory parameters, quality of life (QOL), and NYHA functional class.

The patients will be hospitalised two days at the beginning and two days at the end of the study to perform the exercise and strength tests, six minute walking distance and for biopsy of the quadriceps muscle. Also NYHA functional class will be determined and a QOL questionnaire has to be filled in. After the baseline measurements an iron infusion will be given (Ferinject 1000mg).

The investigators hypothesize that iron deficient IPAH patients will benefit from iron treatment with improved exercise capacity reflected in an increased 6MWD.

Eligibility Criteria:
Inclusion Criteria:

* Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months)
* iron deficiency (serum iron below 10 μmol/l, decreased transferrin saturation (\< 15% in females and \< 20% in males) and serum ferritin \< 100 μg/l) irrespective of the coexistence of anaemia

Exclusion Criteria:

* Current iron therapy (oral or iv)
* Current other study medication for PAH
* History of anaemia or current treatment for anaemia
* Liver function impairment
* Chronic disease other than PAH (rheumatism, asthma, chronic infection)
* Acute infection