cyrilzakka/clinical-trials huggingface dataset:
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD)

This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).

There is a pressing need in psychiatry to offer more individualised treatments, and to improve outcomes from clinical trials. This 'individualised medicine' approach requires the development of biomarkers of treatment response.

60 adults with ADHD are recruited from the Adult ADHD Clinic at the Maudsley Hospital, London, United Kingdom.

The study is developed over three sessions, two at baseline (DAY 1 and DAY 2) and one after two months of treatment (follow-up).

The first two sessions are conceived as a single-blind non-randomised placebo-controlled cross-over experiment. The first 30 participants enrolled in the study receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 before the behavioural assessment and magnetic resonance imaging (MRI) scan. The behavioural assessment and the functional MRI measurements are repeated two days after (DAY 2), under a clinically effective dose (20 mgs) of short-acting methylphenidate (MPH).

The order of the tablets is reverted for the remaining 30 participants to balance any potential expectation and practice effect between the two conditions. Placebo and medication are over-encapsulated with the same red opaque capsules by the pharmacy team. Also, the protocol followed during the two sessions is absolutely identical in respect of timing and tests administered in order to keep the participants blind to the drug condition (medication or placebo).

After the scanning sessions, all the participants receive the same prescription of a long-acting formulation of MPH, according to the clinical guidelines adopted by the Maudsley Hospital. Treatment response is evaluated clinically and behaviourally after 2 months of treatment (follow-up). Pre-treatment brain characteristics are tested as potential predictors (biomarkers) of treatment response.

Eligibility Criteria:
Inclusion Criteria:

* males
* aged 18-45 years old
* intelligent quotient (IQ) \> 70 (as measured by WASI)
* diagnosis of ADHD confirmed through clinical assessment (Adult ADHD Clinic)
* non-medicated (stimulant medication-naive or not taking stimulant medication for at least 4 weeks)

Exclusion Criteria:

* no other brain disorders other than ADHD
* no condition precluding MRI scanning (e.g., metallic implants, claustrophobia)
Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis

The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).

Investigators used their clinical judgement to decide if it might be beneficial, in terms of overall improvement and response to therapy, for subjects to enter the extension study. The planned total combined duration for the core study and this extension study was five years.

At Week 104 of the core study CAIN457Q12301, eligible subjects who completed the assessments associated with the core study visit subsequently continued in the extension study on the dose of secukinumab 300 mg administered every four weeks.

A total of 31 subjects were enrolled and received secukinumab 300 mg every four weeks until study termination. Recruitment in this study was stopped on 26-May-2023.

This study along with the core study (CAIN457Q12301) were terminated early by Novartis due to futile results of interim analysis 1 of the core study. There were no safety related reasons for early termination of either of the studies.

Eligibility Criteria:
Key inclusion criteria:

* Subject must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301.
* Subject must be deemed by the investigator to benefit from secukinumab therapy.
* Signed informed consent must be obtained prior to participation in the study.

Key Exclusion criteria:

* Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 Weeks). Highly effective methods of contraception are recommended due to the known teratogenic effect of SoC (MPA).
A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 27.0 kg/m\^2 (both inclusive).

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Controlled Fluid Resuscitation in Sepsis

To evaluate two different strategy of fluid resuscitation in sepsis patients

Early goal-directed fluid therapy (EGDT) had been regarded as an important fluid therapy strategy in early sepsis or septic shock patients. In recent years, several randomized control studies showed the EGDT therapy cannot make a better outcome in sepsis patients compared to the standard therapy. A strategy of controlled fluid resuscitation had showed good outcome in critical illness such as severe acute pancreatitis, major trauma. But many aspects of the so-called controlled fluid resuscitation remained controversial. In a previous study on severe acute pancreatitis, we described a bundle of controlled fluid resuscitation which had showed an ideal result with higher survival rate. So, we are going to use the bundle on sepsis patients, and to see if it can bring a better out come in sepsis patients compared to the EGDT strategy. This study aims to determine a better strategy of fluid resuscitation in sepsis patients

Eligibility Criteria:
Inclusion Criteria:

* 1.sepsis patients in accordance with the Sepsis 3.0 definition(SOFA increase ≥2 compared to the baseline，due to infection )
* 2.the first blood lactate in our hospital is ≥ 4mmol/L or MAP\<90mmHg after 20ml/kg fluid bolus
* 3.the shock is diagnosed within 24hrs after onset

Exclusion Criteria:

* - 1.\<18 years old
* 2.Pregnancy
* 3 with co-morbidity such as AE-COPD, stroke, seizure, lung edema, acute coronary syndrome
* 4 with contra-indication of CVC(central venous catheter) placement
* 5 trauma or major burn
* 6 poisoning
* 7 any cancer receiving chemotherapy
* 8.immunosuppression (for organ transplantation or disease of immune system)
* 9.acute pancreatitis
* 10.relapse sepsis
DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

Analysis of differential gene expression in patients with chronic rhinosinusitis without polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical outcomes.


Eligibility Criteria:
Affected patients:

* Two or more of the following symptoms should be present for 12 weeks or more: anterior mucopurulent drainage, posterior mucopurulent drainage; nasal obstruction; and facial pain-pressure-fullness.

  * Signs of nasal inflammation such as discolored mucus, edema of the middle meatus or ethmoid area should be documented by endoscopy.
  * The symptoms of rhinosinusitis have failed to resolve or have recurred after a treatment course with antibiotics and nasal and/or oral steroids.
  * The diagnosis of rhinosinusitis should be confirmed with a CT scan.
  * Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium
  * Patients were not previously diagnosed with reactive airway disease or aspirin sensitivity.
  * Patients also must meet the standard criteria for endoscopic sinus surgery and scheduled to undergo their procedure at MMC.

Unaffected Patients:

Patients undergoing elective nasal surgery at MMC.

* Patients deny symptoms of allergic rhinitis such as nasal congestion, nasal discharge, itching, sneezing.
* Patients deny symptoms of chronic or acute rhinosinusitis such as nasal obstruction, facial pain-fullness-pressure, anosmia, anterior and/or posterior mucopurulent drainage.
* Nasal endoscopy showed no evidence of nasal inflammatory disease, such as erythema, edema, polyps, or discolored mucus.
* Patients do not have history of prior sinus surgeries and were not previously diagnosed with CRS.

  1. Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium.
  2. Patients were not diagnosed with reactive airway disease or aspirin sensitivity.
* The absence of evidence of inflammation, such as inflammatory infiltrate or epithelial dysplasia on histopathologic exam of nasal mucosa obtained during surgical procedure.
Vibration Anesthesia for Propofol- Rocuronium Injection Pain

Despite numerous strategies for preventing or alleviating pain associated with propofol and rocuronium injections, it remains common and distressing for patients. Vibration is an effective method of reducing pain during facial cosmetic injections and some venipuncture procedures. But it has not been previously studied in the context of propofol or rocuronium injection pain. This randomized study aims to evaluate the effect of vibration anesthesia on the incidence and severity of propofol and rocuronium injection pain.

Due to their rapid onset and short duration of action, ease of titration, recovery, and favorable profile for side effects, propofol and rocuronium are agents frequently used together in anesthesia practice and for rapid-sequence intubation. However, both cause severe discomfort due to pain in the injection arm. Some patients recall the induction of anesthesia as the most painful part of the perioperative period.

Vibration anesthesia has repeatedly been shown to alleviate pain sensation effectively and safely. Vibration anesthesia device is designed to reduce the pain from minor procedures, such as injection of medications, suture or staple removal, phlebotomy and even venipuncture pain in pediatric patients. The advantages of this device include its low cost, lack of adverse effects, and ease of use.

It has been shown to reduce pain with a mechanism based on the gate control theory, which states that vibrations stimulate the dorsal horn neurons, the sites at which pain signals are modulated and thus block full transmission of the pain.The investigators therefore proposed this randomized controlled study to compare the effectiveness of a vibration device for propofol and rocuronium injection pain during general anesthesia induction.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Patients who are planned to undergo gynecology operations

Exclusion Criteria:

* Participants who were pregnant,
* Patients who had a recent history of a severe allergic or hypersensitivity reaction to propofol or rocuronium
Vitamin-D Insufficiency and Implants

Vitamin D is important for bone health, immune function, and inflammation, along with dental implant success. The study aimed to assess bone markers and cytokine levels in patients with and without vitamin D insufficiency to better understand the effects of vitamin D levels on dental implant integration. The study included 42 patients in 2 groups; with insufficient (Group IN-S; n=21) and sufficient (Group S; n=21) levels of vitamin D. Bone remodelling, proinflammatory and antiinflammatory markers were analyzed in bone and peri-implant crevicular fluid (PICF) using enzyme-linked immunosorbent assay (ELISA) and results were reported as concentration and total amount.

Background: Vitamin D is crucial for bone mineralization and plays a significant role in immune and inflammatory responses. Its deficiency is highly prevalent and might alter osseointegration of dental implants. Since successful osseointegration is a critical aspect of implant survival and the effects of vitamin D on implant osseointegration have not been well documented, the aim of this study was to evaluate bone markers and cytokine levels of patients with or without vitamin D insufficiency. Methods: A total of 42 patients were included and divided into two groups: Vitamin D insufficient (Group IN-S; n=21) and Vitamin D sufficient (Group S; n=21). Besides clinical periodontal parameters and implant stability measurements, bone and peri-implant crevicular fluid (PICF) levels of Receptor Activator of Nuclear Factor Kappa B Ligand (RANKL), osteoprotegerin (OPG), osteocalcin (OC), calcium (Ca), tumour necrosis factor alpha (TNF-α), Interleukin 1β (IL-1β), caspase-1 and Interleukin 10 (IL-10) were determined by enzyme-linked immunosorbent assay (ELISA). Results were represented as concentration and total amount.

Eligibility Criteria:
Inclusion Criteria:

Being volunteer to participate in the study, For the Vitamin D sufficient group (Group S) having a vitamin D level \>20 ng/ml; and 12-20 ng/ml for Vitamin D insufficient group (Groups IN-S).

Having sufficient bone height and width at the edentulous areas, Not having a systemic disease that may adversely affect osseointegration, Not smoking Maintaining oral hygiene

Exclusion Criteria:

Vitamin D deficient patients (\<12 ng/ml), already using vitamin D supplements Presence of any systemic disease, such as uncontrolled diabetes, that may affect implant success, Smoking, Presence of untreated periodontitis, Previous exposure to radiotherapy in the head and neck area, Presence of osteoporosis or other metabolic bone diseases, Usage of oral/intravenous bisphosphonates, History of bone grafting and/or sinus lift, Long-term corticosteroid usage.
Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors (Trial gRANADa)

Statin interference has been suggested among the mechanisms of reduction of the antiplatelet effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center, prospective, randomized, crossover study conducted in the Department of Heart and Great Vessels "Attilio Reale", Sapienza University, Rome, Italy. All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled.

Patients will be offered to participate to the trial at time of 1-month post-angioplasty follow-up visit.patients receiving dual antiplatelet therapy (prasugrel 10 mg or brilique 90 mg x 2 plus aspirin 100 mg) after percutaneous coronary intervention. Patients were randomly assigned to rosuvastatin (20 mg day) or atorvastatin (40 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

Platelet function will be evaluated using a validated method: the VerifyNow System (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system that measures platelet-induced aggregation. Platelet function will be measured with the VerifyNow P2Y12 test at baseline and after 30 days from rosuvastatin or atorvastatin administration.

Platelet reactivity will be expressed in P2Y12 reaction units (PRU). PRU values \>208 are suggestive of high platelet reactivity.

Statin interference has been suggested among the mechanisms of reduction of the antiplatelet effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center, prospective, randomized, crossover study conducted in the Department of Heart and Great Vessels "Attilio Reale", Sapienza University, Rome, Italy.

Eligibility Criteria:
Inclusion Criteria:

1. Angiographically-proven coronary artery disease;
2. Able to understand and willing to sign the informed CF;
3. Stable clinical condition;
4. treatment with dual antiplatelet therapy (with P2Y12 inhibitors);

Exclusion Criteria:

1. Other drugs or medications that affect CYP mediated drug metabolism;
2. Allergy or adverse reactions to administered drugs;
FAPI-PET/CT in Psoriatic Arthritis

68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease. Therefore, this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that develops in up to 30% of patients with psoriasis and characterized by diverse clinical features including peripheral and axial arthritis, enthesitis, dactylitis and nail dystrophy, leading to impaired function and reduced quality of life. Positron emission tomography (PET) allows for highly sensitive depiction of targets at the molecular level and can be used to specifically visualize immune cells of interest through the use of specific tracers. In this study, we used two tracers: 68Ga-fibroblast activation protein inhibitor (FAPI) and 18F-sodium fluoride (18F-NaF) to evaluate both joint inflammation and bone metabolism in patients with PsA. And the study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR)
* 18F-NAF PET/CT within two weeks
* signed written consent.

Exclusion Criteria:

* pregnancy
* breast feeding
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients

Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 diagnosis
* Prescribed DTG/3TC alone to manage HIV-1 infection as initial antiretroviral treatment at the study centers

Exclusion Criteria:

* HIV-2 diagnosis
* Previous antiretroviral treatment
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study

Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

The prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test
* Patients must have at least one prior systemic therapy
* Decision for treatment with ivosidenib according to current SmPC.
* Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module)
* For patients participating in the PRO module (optional):

  * Dated signature of informed consent form before start of study treatment.
  * Willingness and capability to participate in PRO assessment in German language.
* Other criteria according to current SmPC.

Exclusion Criteria:

* Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period.
* Other contraindications according to current SmPC.
Fractional Laser Vs. Ultrasound for Periorbital Wrinkles

The primary objective of this study is to compare the efficacy of intense focused ultrasound and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.

This is a prospective randomized comparison study comparing the efficacy of micro-focused ultrasound versus fractionated carbon dioxide laser for treatment of periorbital wrinkles. Subjects who meet inclusion and exclusion criteria will be enrolled in the study. The treated sites are both lower eyelids and lateral orbits. Each side will be randomized to receive 1550nm-fractionated laser treatment on one side and the contralateral side will receive micro-focused ultrasound treatment every 6-8 weeks for a total of 2 treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Age 35-60 years old male and female subjects with moderate lower eyelid rhytids and crowsfeet
2. Subjects with Fitzpatrick skin type I-III.
3. Subjects who are willing, have the ability to understand and provide informed consent, and are able to communicate with the investigator.

Exclusion Criteria:

1. Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months.
2. Subjects who were received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months.
3. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with periorbital treatment with energy devices.
4. Subjects who are allergic to lidocaine or prilocaine.
5. Subjects who have a history of abnormal scarring in the treatment area.
6. Subject who have ectropion or or other eyelid disfigurement.
7. Subjects who have history of isotretinoin use in the preceding year
8. Pregnant or lactating individuals